SURGICAL MESH DEFINED BY SCIENCE AND MEDICAL DATA – A COMPLEX REVIEW

By Mark A. York (July 11, 2019)

Past, Present and Future of Surgical Mesh With References

Abstract

Surgical mesh, in particular those used to repair hernias, have been in use since 1891. Since then, research in the area has expanded, given the vast number of post-surgery complications such as infection, fibrosis, adhesions, mesh rejection, and hernia recurrence. Researchers have focused on the analysis and implementation of a wide range of materials: meshes with different fiber size and porosity, a variety of manufacturing methods, and certainly a variety of surgical and implantation procedures. Currently, surface modification methods and development of nanofiber based systems are actively being explored as areas of opportunity to retain material strength and increase biocompatibility of available meshes. This review summarizes the history of surgical meshes and presents an overview of commercial surgical meshes, their properties, manufacturing methods, and observed biological response, as well as the requirements for an ideal surgical mesh and potential manufacturing methods.

Keywords: surgical mesh, hernia repair, abdominal wall reconstruction, biocompatibility

  1. Introduction

A hernia is defined as a protrusion or projection (prolapse) of an organ through the wall of the cavity where it is normally contained [1]. There are many types of hernia, mostly classified according to the physical location, with the abdominal wall being the most susceptible site. Specifically, reports show that the most frequently seen hernia is the inguinal hernia (70–75% of cases), followed by femoral (6–17%) and umbilical (3–8.5%) hernias [2]. Hernias are also found in other sites such as the ventral or epigastric hernia, located between the chest cavity and the umbilicus.

Hernias can be uncomfortable and are sometimes accompanied by severe pain, which worsens during bowel movements, urination, heavy lifting, or straining [3]. Occasionally, a hernia can become strangulated, which occurs when the protruding tissue swells and becomes incarcerated. Strangulation will interrupt blood supply and can lead to infection, necrosis, and potentially life-threatening conditions [4].

Hernia repair is one of the most common surgical procedures performed globally. It is estimated that there are over 20 million hernia repair procedures per year worldwide [5]. The number of procedures has been increasing and is predicted to further increase due to several risk factors such as obesity and prior abdominal surgeries [6]. Hernia repairs provide an important revenue stream for hospitals, estimated at $48 billion/year in the United States [7].

The use of hernia mesh products to surgically repair or reconstruct anatomical defects has been widely adopted: in fact, more than 80% of hernia repairs performed in United Sates use mesh products [8]. The surgical mesh firmly reinforces the weakened area and provides tension-free repair that facilitates the incorporation of fibrocollagenous tissue [9]. However, there are many types of meshes and there is a strong controversy regarding optimum performance and success of surgical procedures. Researchers have investigated metals, composites, polymers and biodegradable biomaterials in their quest to attain the ideal surgical mesh and implantation procedure [10]. The sought-after characteristics are inertness, resistance to infection, the ability to maintain adequate long-term tensile strength to prevent early recurrence, rapid incorporation into the host tissue, adequate flexibility to avoid fragmentation, non-carcinogenic response and the capability to maintain or restore the natural respiratory movements of the abdominal wall [9].

Currently, utilized surgical meshes exhibit many but not all of the desired characteristics [8]. Therefore, current research efforts focus on providing potential solutions that range from the utilization of novel materials to new designs that could ameliorate existent shortcomings [11]. The aim of this review is to illustrate the current research in surgical meshes used for hernia repair. This review provides a perspective of existent commercial surgical meshes, their properties, manufacturing procedures, and observed biological responses. Furthermore, the article seeks to establish the requirements for an ideal surgical mesh and potential manufacturing procedures.

  1. History

In 1890, Theodor Billroth suggested that the ideal way to repair hernias was to use a prosthetic material to close the hernia defect [12]. Many materials were used, but all failed due to infections, rejections, and recurrences [13]. Surgeons concluded that the main problem was built upon the multifilament suture material, which has been proven unsuitable in many other surgical procedures [14]. Surgeons became disenchanted with the popular cotton and silk sutures because of the frequently observed rejection syndrome and resultant endless recurring infections. The use of such sutures to secure mesh in place undoubtedly contributed to aggravate the existing bias against the surgical meshes [15].

In 1955, Dr. Francis Usher focused his attention on the materials that could solve existing problems. Nylon, Orlon, Dacron and Teflon were studied and were observed to have a variety of shortcomings such as: foreign body reaction, sepsis, rigidity, fragmentation, loss of tensile strength and encapsulation [16]. All of these precluded the acceptance of polymeric materials. After reading an article about a new polyolefin material (Marlex), which demonstrated remarkable properties, Usher started to develop a woven mesh [17]. Two years later, the marlex prostheses were implemented. These were made of large pores, which facilitated incorporation despite infections. The growth of tissue through its interstices was the main difference when compared to previous materials. After a few days of surgical incorporation, fibroblast activity was noticed to increase, more collagen was induced without giant cells, and the whole system gained strength [18]. Despite the numerous advantages of the woven and knitted polyethylene mesh, Usher continued the search for better systems. He soon found that knitted polypropylene had many more advantages: it could be autoclaved, had firm borders coupled with two-way stretching, and could be rapidly incorporated. Finally, in 1958, Usher published his surgical technique using a polypropylene mesh, and 30 years later the Lichtenstein repair (known today as “tension-free” mesh technique) was popularized for hernia repair [18]. Even when the benefits of meshes were accepted, the recollection of evidence-based cases was required to statistically quantify their advantages. In 2002, the European Union Hernia Trialists Collaboration, a group of surgical trialists who have participated in randomized trials of open mesh or laparoscopic groin hernia repair, analyzed 58 randomized controlled trials and concluded that the use of surgical meshes was superior to other techniques [19]. In particular, they noted fewer recurrences and less postoperative pain with mesh repair. These results were supported by other studies that demonstrated that hernia repair using surgical meshes reduced the risk of hernia recurrence compared to hernia reconstruction through other methods, in 2.7% vs. 8.2% in ventral hernia repair cases and by 50–75% of improvement through surgical meshes in inguinal repair [8].

Today, many surgeons agree that use of a prosthetic mesh is the preferred way to repair hernias. It should be emphasized that in the past, the success of repair was evaluated based on the strength and permanency of the mesh itself, not on the degree of scar tissue or other factors, which subsequently develop in and around the mesh [20]. The biocompatibility of the material has proven to be a strong contributor in the rejection of the prosthesis due to scar tissue developed by the immunological system. When a surgical mesh is implanted and lacks appropriate biocompatibility (either due to the material that it is made of or its structural design) the body responds by encapsulating the foreign system leading to the formation of a stiff scar which consequently results in poor tissue incorporation, causing hernia recurrence or infection of the mesh. A large percentage of meshes then have to be removed: approximately 69% of the explanted meshes are due to prosthesis infection [21].

Although the only treatment is surgery, there are new surgical procedures that ameliorate postoperative side effects such as the laparoscopic approach. Open surgery repair is performed by making an incision in the abdomen to identify and dissect the hernia sac through the subcutaneous tissues and fascia. Once the hernia sac is dissected away from any adjacent structures and examined for contents (intestine or any other tissues), these are inserted back into the peritoneal space, and hernia repair is carried out. Repair can be executed in two ways: (1) primary repair and (2) patch or mesh. The first involves sewing the tissue of the abdominal wall using sutures, while the second technique relies in the placement of a mesh to cover the hernia defect and reinforce surrounding tissue, fixing it with fibrin glue, staples or sutures.

In the case of a laparoscopic procedure, the surgeon starts by making several small incisions in the abdominal wall surrounding the hernia sac, in order to introduce surgical instruments and a laparoscope. In one of the incisions, carbon dioxide gas is introduced into the abdomen. The mesh or patch is then introduced, unrolled and fixed with staples or tacks. The procedure then continues with the release of the gas from the abdomen and closure of cutaneous incisions with sutures [22].

  1. Current Research on Surgical Meshes

Most surgical meshes used currently are chemically and physically inert, nontoxic, stable and non-immunogenic. However, none of them are biologically inert, a property related to the mesh physiology and its role into the hernia repair process [23]. Implantation of any prosthetic material is quickly followed by an extraordinarily complex series of events that mark the initiation of the healing process [14]. As for the physiology of abdominal mesh implantation, perhaps the greatest concern, and hence the area that most research focuses on, is inflammation and wound healing [24]. The passive substrate of the biomaterials in conjunction with devitalized tissues can actively contribute to bacterial growth, resulting in infection, which delays the wound healing process [25].

The introduction of a foreign material into the body triggers a healing response characterized by one of three stereotypical reactions: (1) destruction or lysis, (2) inclusion or tolerance, and (3) rejection or removal. When an implant is introduced into the body, the immune system recognizes it as a foreign material and therefore attempts to destroy it [26]; immunosuppressive drugs must be administered to prevent the body from attacking it [27]. The rejection of an implant is primarily driven by the immune response of the T lymphocytes (T cells). The T cells are stimulated by the presence of an antigenic determinant on the foreign material. T cells are reproduced faster than the time required for immunosuppressants to interfere with its proliferation, therefore resulting in rejection of the implant given the large number of T cells attacking the foreign material [28].

Inflammation is the reaction of vascularized living tissue to injury and is the primary biological reaction to implanted medical devices. In the case of implanted meshes, the inflammatory response is presented in four stages that are related both temporally and hierarchically [29]. Immediately after implantation, prosthetics adsorb proteins, which create a coagulum around it [30]. Coagulums are composed of albumin, fibrinogen, plasminogen, complement factors and immunoglobulins [31]. Platelets adhere to the proteins releasing a host of chemoattractants that invite other cells such as polymorphonucleocytes (PMNs), fibroblasts, smooth muscle cells and macrophages to the area in a different sequence [32]. The chemotaxis process is defined as the movement of cells towards a preferred migration site triggered by a chemical stimulus [33]. The attraction of PMNs, also known as neutrophils, to the wound site is attributed to chemotaxis, and is observed as the first stage of biological response to the injured site. During the first stage or acute phase of inflammation, neutrophils phagocytize microorganisms. The neutrophil may also degenerate and die during this process, releasing its cytoplasmic and granular components near or over the surface of the prosthesis, which may also mediate the subsequent inflammatory response [34].

When the acute inflammatory response is unable to eliminate the injurious agent or restore injured tissue to its normal physiological state, the condition could progress into a state of chronic inflammation, known as second stage of inflammation. In this stage, monocytes that have migrated to the wound site during the acute inflammatory response rapidly differentiate into macrophages. In addition to macrophages, other primary cellular components such as plasma cells and lymphocytes actively contribute to the inflammatory process. Macrophages increasingly populate the area to consume foreign bodies as well as dead organisms and tissue [14].

In most of the cases where chronic inflammation is related to a medical device or biomaterial, the inflammation process will lead to an immune response or foreign body reaction, corresponding to the third stage of inflammation, where chronic inflammation macrophages fuse into a foreign body giant cell as a response to the presence of large foreign bodies [35]. Foreign body reaction is a complex defense reaction involving: foreign body giant cells, macrophages, fibroblast, and capillaries in varying amounts depending upon the form and topography of the implanted material [36].

The fourth stage of inflammation occurs in the wound healing phase and is characterized by the replacement of damaged tissue with various cells that specialize in secreting extracellular matrix materials to form a scar [14]. Wound healing and scar formation follow the initiation of inflammation, but their progression and the magnitude of scarring can be affected by the degree of persistent inflammatory activity as well as the severity of the primary injury [37].

Fibroblasts are cells that mediate the wound healing phase. These cells enter the wound site two to five days after the injury occurs, typically once the inflammatory phase has ended. Fibroblasts proliferate at the wound site, reaching peak levels after one to two weeks. The main function of fibroblasts is to synthesize extracellular matrix and collagen to maintain the structural integrity of connective tissues; at the end of the first week, these are the only cells in charge of collagen deposition. Cells involved in the regulation of inflammation, angiogenesis (formation of new blood vessels from preexisting vasculature) and further connective tissue reconstruction attach to, proliferate, and differentiate on the collagen matrix laid down by fibroblasts [26].

From a histological standpoint, the interaction between prosthesis and organism is characterized by three main aspects: size of tissue reaction; cell density; and fibroblastic activity. As mentioned, fibroblastic activity peaks one to two weeks post-wounding, usually on the 8th day for the intraperitoneal plane and on the 10th day for the extraperitoneal plane. The optimum quantity of fibroblasts needed for a successful integration of the mesh is achieved approximately two weeks after wounding. Further accumulation of fibroblasts will cause an inflammatory phase with increased fibrosis and faster prosthesis integration associated with paresthesia and pain. Furthermore, the inflammatory process could cause contraction and shrinkage of the mesh, resulting in adhesions and fistulas, leading to prosthesis rejection and eventually explantation [25].

The wound repair process described above creates a mesh integration due to the conformational changes of the proteins. This integration is progressive, starting from the prosthesis implantation that is accompanied by the foreign body reaction followed by the inclusion of the prosthesis, which occurs within the first two weeks. The process is finalized as the overall strength increases gradually, which last about 12 weeks and results in a relatively less elastic tissue that has only 70–80% of the strength of the native connective tissue [32].

Although integration and collagen deposition that result from the inflammatory response provide long-term strength, as pointed out, an aggressive integration could also be harmful to the tissue that surrounds the wound site causing a severe body reaction, inflammation, fibrosis, infection, and mesh rejection [23]. The fibrotic reaction generated by the body when a prosthetic material is introduced, such as in the case of surgical meshes for a hernia repair, is governed by the chemical nature of the material implanted and its physical characteristics. The integration and overall healing process of implantable surgical meshes is highly dependent upon the intrinsic mesh characteristics such as, the primary material, filament structure, tailored coatings, and pore size.

Research in abdominal wall repair has provided valuable information on the parameters, properties, and design of the meshes that influence the immune reaction of the body to the prosthesis as well as the optimal parameters to reduce fibrosis [38,39]. These factors are discussed below.

3.1. Elasticity and Tensile Strength

A deterioration of the tensile strength of the mesh or a strained mesh could potentially lead to hernia recurrence or a poor functional result. Hence, materials employed in surgical meshes must possess the minimum mechanical properties necessary to withstand the stresses placed on the abdominal wall. The maximum intra-abdominal pressure generated in a healthy adult occurs when coughing or jumping and is estimated to be approximately 170 mmHg. Given this information, the mesh used to repair abdominal hernias must withstand at least 180 mmHg (20 kPa) before failing [38].

The tension placed on the abdominal wall can be calculated using Laplace’s law relating the tension, pressure, thickness, and diameter of the abdominal wall. According to the thin-walled cylinder model, the total tensile strength is independent of the thickness of the layer. Hence, a physiological tensile strength of 16 N/cm is defined, using a pressure of 20 kPa (2 N/cm2 as the maximum pressure to be experienced in the intra-abdominal wall), and 32 cm as the longitudinal diameter of the abdominal wall [39].

Studies over human abdominal walls have demonstrated that at the maximum tensile strength of 16 N/cm, the abdominal wall in males presents a natural mean distension of 23% ± 7% and 15% ± 5% when tissue is stretched in vertical and horizontal direction, respectively. In females, a distension of 32% ± 17% and 17% ± 5% in vertical and horizontal stretching has been observed [40].

3.2. Pore Size

Porosity plays a key role in the reaction of the tissue to the prostheses. Bacterial growth and cell proliferation are highly dependent upon porosity and pore size. Bacterial colonies are established principally in the spaces between pores and fibers. Macroporous meshes that have large pores have shown to facilitate entry of macrophages, fibroblasts and collagen fibers that will constitute the new connective tissue, integrate the prosthesis to the organism and prevent colonization of bacteria. Large pores have shown easy infiltration of immunocompetent cells, providing protection from infection [25]. Microporous meshes, with pores of <10 µm, have shown a higher rejection rate given that scar tissue rapidly bridges small pores resulting in minimum integration, these meshes are associated with chronic inflammation.

Although it would be helpful to classify pore size in a standard form, currently, there is not a formal classification. Earl and Mark proposed the following: very large pore: >2000 µm; large pore: 1000–2000 µm; medium pore: 600–1000 µm; small pore: 100–600 µm and microporous (solid) <100 µm [32,41].

3.3. Weight (Density)

Prostheses can be classified as: heavy-weight (HW), when they are above 80 g/m2; mediumweight (MW), between 50 and 80 g/m2; light-weight (LW), between 35 and 50 g/m2; and ultra-lightweight, below 35 g/m2 [25]. While a heavy-weight mesh is produced with heavy materials, small pore size and high tensile strength, a light-weight is composed of thin filaments with large pores, generally larger than 1 mm. Given that light-weight meshes contain less material, results have shown that less pronounced foreign body reaction is to be expected. A decreased inflammatory response results in better tissue incorporation [42].

3.4. Constitution

Surgical meshes could be fabricated using monofilament or multifilament (twisted) systems. A surgical mesh formed of monofilament yarns provides satisfactory reinforcement ability, but with stiffness and limited pliability. In contrast, a surgical mesh formed of multifilament yarns is soft and pliable. However, multifilament yarns meshes tend to harbor infectious matter such as bacteria, increasing erosion rates by 20–30% [43]. Particularly, the small void areas or interstitial spaces between the multifilament yarns may promote the replication and breeding of such bacteria, which measures approximately 10 µm.

3.5. Material Absorption

Surgical meshes could be made from an absorbable or non-absorbable material. Non-absorbable meshes can withstand the mechanical requirements, are easy to shape intraoperative and have long-term stability. However, complications such as mesh stiffness over time, hernia recurrence, mesh erosion, and adhesions have been documented. On the other hand, absorbable meshes were developed to reduce these long-term complications. These meshes favor postoperative fibroblast activity. Nevertheless, after prosthesis absorption, the resulting scar tissue is not as strong as it was, and alone is insufficient to provide the needed strength and could result in hernia recurrence.

3.6. Commercially Available Surgical Meshes

The ideal mesh should be able to be held in situ by peripheral sutures, resist the possibility of loading under biaxial tension (coughing or lifting actions) without failure especially during the early postoperative period, and should promote a fast and organized response from fibrous tissue with minimal inflammation [3].

Given the difficulty to find a single surgical mesh that fulfills all of the “ideal” characteristics, there are more than 70 meshes for hernia repair available in the market. These are classified according to the composition or type of material as: (1) first generation (synthetic non-absorbable prosthesis), (2) second generation (mixed or composite prosthesis), and (3) third generation (biological prosthesis).

3.6.1. First Generation Meshes

First generation surgical meshes are predominantly based on polypropylene (PP) systems. In 1958, the first polypropylene mesh was used to repair an abdominal wall; it was a heavyweight mesh with small pores. Due to intense fibrotic reactions, the search for an “ideal” mesh continued. In 1998, a lightweight first generation mesh was introduced: this system had larger pores and smaller surface area [38,43]. First generation meshes are mostly classified into three categories: (1) macroporous meshes, (2) microporous meshes, and (3) macroporous meshes with multifilament or microporous components.

Macroporous prostheses are characterized by a pore size larger than 75 µm. Polypropylene has been the material of choice with several brand names such as: Marlex, Prolene®, Prolite®, Atrium® and Trelex®.

Microporous meshes have smaller pores, commonly less than 10 µm and commonly made from expanded polytetrafluoroethylene (e-PTFE) under the brand name Gore-Tex® (AZ, USA).

Macroporous meshes with multifilament or microporous components contain plaited multifilamentary threads in their composition, the space between the threads is less than 10 µm and their pores are larger than 75 µm. Several systems are in the market such as: plaited polyester (PL) meshes (Mersilene® and Parietex®); plaited polypropylene (SurgiPro®, Minneapolis, MN, USA), and perforated polytetrafluoroethylene (PTFE) (Mycromesh® and MotifMesh®) [25]. Table 1 shows the classification of commercially available first generation surgical meshes.

Table 1

Classification of commercially available first generation surgical meshes [38].

Product (Manufacturer) Material Pore Size (mm) Absorbable Weight (g/m2) Filament Mechanical Properties Advantages and Disadvantages
Vicryl (Ethicon) Polyglactin 0.4 Yes, fully
(60–90 days)
56 Multifilament Tensile strength of 78.2 ± 10.5 N/cm in longitudinal direction and 45.5 ± 13.5 N/cm in transverse direction. Eliminates the risk of infectious disease transmission. Usually results in hernia recurrence after complete absorption
Dexon (Syneture) Polyglycolic acid 0.75 Yes, fully
(60–90 days)
56 Multifilament N.A. Adhesions fade as the mesh is absorbed. It is controversial whether the fibrous ingrowth into the prosthesis is sufficient to accomplish a permanent repair.
Sefil (B-Baun) Polyglycolic acid 0.75 Yes, fully
(60–90 days)
56 Multifilament N.A. High anatomic adaptability and low risk of late secondary infection. Retain 50% of its strength for 20 days.
Marlex (BARD) PP 0.8 No 80–100 Monofilament Tensile strength of 58.8 N/cm High tensile strength. Evokes a chronic inflammatory reaction.
3D Max (BARD) PP 0.8 No 80–100 Monofilament Tensile strength of 124.7 N/cm Anatomically designed. Reduced patient pain. Adhesions risk.
Polysoft (BARD) PP 0.8 No 80–100 Multifilament Burst strength of 558 N and a stiffness of 52.9 N/cm Low infection risk. Not used in extraperitoneal spaces as produce dense adhesions *.
Prolene (Ethicon) PP 0.8 No 80–100 Monofilament Tensile strength of 156.5 N/cm Facilitates fibrovascular ingrowth, infection resistance and improve compliance. Adhesions risk.
Surgipro (Autosuture) PP 0.8 No 80–100 Multifilament Tensile strength of 41.8 N/cm in longitudinal direction and 52.9 N/cm in transverse direction High tensile strength, ease of handling and position and retains properties in vivo. Difficult complete wound healing caused by mesh structure.
Prolite (Atrium) PP 0.8 No 80–100 Monofilament Tensile strength of 138 N/cm Monofilaments aligned in parallel spaced angles to maximizing material flexibility in two dimensions and a smooth and very uniform open architecture. Adhesions risk.
Trelex (Meadox) PP 0.8 No 80–100 Multifilament N.A. *
Atrium (Atrium) PP 0.8 No 80–100 Monofilament Tensile strength of 56.2 N/cm High tolerance to infection. Adhesions risk.
Premilene (B-Braun) PP 0.8 No 80–100 Monofilament Tensile strength of 41.4 N/cm in longitudinal direction and 36.5 N/cm in transverse direction Mesh adaptation to the longitudinal and latitudinal axes of the connective tissue where is used for the reinforcement, rapid healing and tissue penetration. Adhesions risk.
Serapren (smooth) PP 0.8 No 80–100 Multifilament N.A. *
Parietene (Covidien) PP 0.8 No 80–100 Multifilament Tensile strength of 38.9 ± 5.2 N/cm in longitudinal direction and 26.6 ± 4.2 N/cm in transverse direction *
Prolene Light (Covidien) PP 1.0–3.6 No 36–48 Monofilament Tensile strength of 20 N/cm Greater flexibility. Not used in intraperitoneal spaces as produce dense adhesions.
Optilene (B-Baun) PP 1.0–3.6 No 36–48 Monofilament Tensile strength of 58 N/cm Soft, thin and pliable. Ideal for inguinal hernia repair to reduce chronic pain. Not used in extraperitoneal spaces as produce dense adhesions.
Mersilene (Ethicon) POL 1.0–2.0 No 40 Multifilament Tensile strength of 19 N/cm Low infection risk. Evokes an aggressive macrophage and giant cell rich inflammatory reaction, followed by a dense fibrous ingrowth.
Goretex (Gore) e-PTFE 0.003 No Heavyweight Multifilament Minimum tensile strength of 16 N/cm Smooth and strong. Evokes a chronic inflammatory reaction.

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PP: Polypropylene. POL: Polyester. e-PTFE: Expanded polytetrafluoroethylene. N.A, Information not available in literature. * Duplicated properties.

3.6.2. Second Generation Meshes

Despite the improvements made within the first generation meshes (Table 1), which include high tensile strength in order to support intra-abdominal pressure, several complications such as hernia recurrence, infection, and adhesions still prevailed. Therefore, second generation meshes were developed combining more than one synthetic material into their composition. Nearly all of these kinds of meshes continued to use PP, PL or e-PTFE but now in combination with each other and/or with other materials such as titanium (Ti), omega 3, poliglecaprone 25 (PGC-25) and polyvinylidene fluoride (PVDF) as composite systems.

The main advantage of these composite meshes relied in the fact that these could be employed in intraperitoneal spaces causing minimal adhesion formation to neighboring surfaces given that each side of the mesh is tailored to specific needs. These meshes therefore require a specific orientation during implantation; the visceral side has a microporous surface to prevent visceral adhesion, whereas the non-visceral side is often macroporous to allow parietal tissue ingrowth. There are two categories of composite meshes: absorbable and permanent (non-absorbable). Absorbable composite meshes require hydration prior to usage, are not amenable to modification, mitigate viscera-mesh related complications, and can aid in tissue ingrowth. Parietex® is the first composite mesh to offer a resorbable collagen barrier on one side to limit visceral attachments combined with a three-dimensional polyester knit structure on the other side, to promote tissue ingrowth. Permanent composite meshes can be modified to fit specific applications and present less visceral adhesions and complications, taking advantage of the properties of both macro and micro porous meshes. Dual Mesh® (W.L. Gore & Associates, Inc., AZ, USA), Dulex® and Composix®(both manufactured by Bard Davol Inc., Providence, RI, USA)are some of the brand name meshes included in this category [42]. Table 2 lists some of the commercially available second generation surgical meshes.

Table 2

Classification of commercially available second generation surgical meshes [38].

Product (Manufacturer) Material Pore Size (mm) Absorbable Weight (g/m2) Filament Mechanical Properties Advantages and Disadvantages
Vypro, Vypro II (Ethicon) PP/polyglactin 910 >3 Partially
(42 days)
25 & 30 Multifilament Tensile strength of 16 N/cm Significantly decreased rates of chronic pain. Higher rate of hernia recurrence.
Gore-Tex Dual Mesh Dual Mesh Plus (Gore) e-PTFE 0.003–0.022 No Heavyweight Multifilament Minimum tensile strength of 16 N/cm (Gore-Tex Dual Mesh) and 157.7 N/cm (Dual Mesh Plus) Promotes host tissue growth and reduces tissue attachment. Infection risk.
Parietex (Covidien) POL/collagen >3 Partially
(20 days)
75 Multifilament Elasticity of 3.5 at 16 N Short-term benefit for anti-adhesion property. Greater infection rate (57%).
Composix EX Dulex (BARD) PP/e-PTFE 0.8 No Lightweight Monofilament N.A. Minimizes adhesions and provides optimal tissue ingrowth. Infection risk.
Proceed (Ethicon) PP/cellulose Large Partially
(<30 days)
45 Monofilament Tensile strength of 56.6 N/cm Low rates of hernia recurrence (3.7%). Risk of formation of visceral adhesions.
DynaMesh IPOM (FEG Textiltechnik) PP/PVDF 1–2 Partially 60 Monofilament Tensile strength of 11.1 ± 6.4 N/cm in longitudinal direction and 46.9 ± 9.7 N/cm in transverse direction Minimal foreign body reaction. Adhesions risk.
Sepramesh (Genzyme) PP/sodium 1–2 Partially
(<30 days)
102 Monofilament N.A. Reduces adhesions and the optimal tissue ingrowth is promoted. Sticky consistency difficult the surgeon manipulation.
Ultrapro (Ethicon) PP/PGC-25 >3 Partially
(<140 days)
28 Monofilament Tensile strength of 55 N/cm Reduced inflammatory response. Adhesions risk.
Ti-Mesh (GfE) PP/titanium >1 No 16 & 35 Monofilament Tensile strength of 12 N/cm (mesh of 16 g/m2) and 47 N/cm (mesh of 35 g/m2) Reduced inflammatory response. Low tensile strength.
C-Qur (Atrium) PP/omega 3 >1 Partially
(120 days)
50 Monofilament Ball burst strength of 170 ± 20.1 N Short-term benefit for anti-adhesion property. No significant difference for adhesion grade or amount relative to other meshes.

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PP: Polypropylene. e-PTFE: Expanded polytetrafluoroethylene. POL: Polyester. PVDF: Polyvinylidene fluoride. PGC-25: poliglecaprone 25. N.A, Information not available in literature.

3.6.3. Third Generation Meshes

Even with the improvements made on the second generation meshes (Table 2) where composite systems were designed to maintain the mechanical stability of first generation meshes (Table 1) and reduce inflammation and infection risk by mesh surface modification, the problems encountered with second generation meshes, such as the prevalence of adhesions, led to the development of biologic prostheses. Biologic mesh materials are based on collagen scaffolds derived from donor sources and they represent the so-called third generation meshes. Dermis from human, porcine, and fetal bovine sources are decellularized to leave only the highly organized collagen sources in addition to the dermal products included in porcine small intestine submucosa and bovine pericardium. The concept of these surgical meshes is that they provide a matrix for native cells to populate and generate connective tissue that could replace the tissue in the hernia defect [25]. Table 3 lists some of the commercially available third generation surgical meshes.

Table 3

Classification of commercially available third generation surgical meshes [38].

Product (Manufacturer) Material Tensile Strength (MPa) Advantages Disadvantages
Surgisis (Cook) Porcine (small intestine submucosa) 4 No refrigeration is required. Long history of safety data. Requires hydration. Susceptible to collagenases.
FlexHD (J&J) Human (acellular dermis) 10 No refrigeration or rehydration is required. N.A.
AlloMax (Davol) Human (acellular dermis) 23 No refrigeration or rehydration is required. Available in large sizes. Hydration required.
CollaMend (Davol) Porcine/Bovine (xenogenic acellular dermis) 11 No refrigeration or rehydration is required. Available in large sizes. N.A.
Strattice (LifeCell) Porcine/Bovine (xenogenic acellular dermis) 18 Available in large sheets. Limited long-term follow up.
Permacol (Covidien) Porcine/Bovine (xenogenic acellular dermis) 39 No refrigeration or rehydration is required. Available in large sizes. N.A.
XenMatrix (Davol) Porcine/Bovine (xenogenic acellular dermis) 14 Available in large sheets. Limited long-term follow up.

N.A. Information not available in literature.

Third generation surgical meshes (Table 3) serve as biological scaffolds for repopulation and revascularization of host cells, showing a superior biocompatibility than first and second generations. These meshes do not trigger an inflammatory response from the body, though their high cost has hampered their wide acceptance.

3.7. Manufacturing Processes for Surgical Meshes

Surgical meshes are produced from different synthetic materials and in different mesh structures, the knitted structure being the most common [44]. Surgical filaments are mainly manufactured by extrusion processes and then knitted accordingly. As mentioned, meshes are typically manufactured from PL, PP, PTFE, e-PTFE, PVDF and composite materials (e-PTFE/PP) [45]. The knitting pattern can be significantly altered resulting in a broad range of properties. Thickness, pore size, tensile strength, flexural rigidity, and surface texture are highly dependent upon the knitting pattern; the resultant interplay among these characteristics imparts different performance [44]. These characteristics, besides altering the biocompatibility of the mesh given its affinity to cells, also dictate the mechanical properties of the mesh such as rigidity and deformation. Knitted meshes are a subset of the non-woven mesh configuration. However, there is much more order and consistency with pore size using a knitted design [46]. Knitting, by definition, is the construction of a fabric or cloth from the interlocking of threads through the formation of loops. Recent studies have been focused on treating the surgical mesh as a high-tech textile rather than as a prosthesis [44].

3.7.1. The Extrusion Process

Melt extrusion is the least expensive and simplest form of fiber extrusion [47]. This process consists of melting the polymer pellets through a combination of applied heat and friction. The molten polymer is then forced under high pressure through a small orifice or a “shower head” spinneret. The molten polymer flows out of the spinneret and freezes into a solid fiber, which is then typically reheated and drawn numerous times to further align the molecules and hence strengthen the fiber [48].

Most of the surgical meshes are made from filaments initially developed to be used for surgical sutures. Surgical sutures are made from polymers like PP [49], PL [50], e-PTFE [51] or PVDF [52] monofilaments and have been successfully used by the medical profession for decades. Filaments used for surgical sutures have to possess several characteristics such as [53]:

  1. Ability to attach to needles by the usual procedure.
  2. Capability to be sterilized using ethylene oxide or ultraviolet radiation.
  3. Ability to pass easily through tissue.
  4. Ability to resist breakdown without developing an infection.
  5. Possess minimal reaction with tissue.
  6. Maintain its in vivo tensile strength over extended periods.

Commonly, the monofilaments used for surgical meshes have diameters in the range of 100–300 microns [54]. Multifilaments have also gained attention and have been used to fabricate surgical meshes. Lubricants are commonly applied to these filaments before the yarns are knitted. Suitable lubricants can be either hydrophobic lubricants [55] or hydrophilic lubricants such as polyalky glycol [56].

3.7.2. The Knitting Process

During the knitting process, fibers or yarns are curved to follow a meandering path and not oriented unilaterally as in weaving; therefore, the resulting fabric tends to be much more flexible and elastic than woven fabrics. The basic structure of a knitted fabric consists of courses and wales. Courses are rows running across the width of the fabric, while wales are columns running across the length of the fabric. When the wales are perpendicular to the course of the fiber/yarn, this is called weft knitting. When the courses and wales are approximately parallel to the direction of the fiber/yarn, the process is known as warp knitting [57]. Figure 1 shows a warp structure.

Figure 1

Schematic of: (a) woven; and (b) warp knitted structures.

Warp knits and weft knits have been generated for use as implantable meshes to repair specific tissue sites and organs, such as those needed in hernia repair. Because of the looped stitches, the knitted structure is soft, flexible, and stretchable. It easily adapts to the movement of the human body [58], and has high elasticity, tensile strength, bursting strength and excellent porosity, which are key requirements for any implantable device that needs to mimic the biomechanical characteristics of the abdominal wall: tension of 16 N/cm with a 38% elasticity [38]. Given the interweaving, warp-knitted materials have a fixed structure that neither loosens nor peels off during cutting, regardless of the direction [55]. These material systems have been successfully commercialized and currently used worldwide. Table 4 lists some commercially available meshes classified according to the knitted technique, material, and type of filament.

Table 4

Classification of commercially available surgical meshes [59].

Mesh Structural Textile Technique Polymer Fiber
Marlex Woven PP Mono
Prolene® Warp PP Mono
Atrium® Warp PP Mono
Vypro® Warp PP/PG-910 Multi
UltraPro® Warp PP/PGC-25 Mono
TiMesh® Warp PP/Ti Mono
DualMesh® Warp e-PTFE Foil *
Mersilene® Warp Polyethylene Terephthalate (PET) Multi
Dynamesh® Warp PVDF Mono
Vycril® Woven Resorbable undyed Polyglactin Multi
Gore-Tex® Woven e-PTFE Multi

* Membrane/patch.

The most commonly used systems in the knitting manufacturing process are the Tricot [60] and Raschel knitting machines [61], which are used to create warp or weft knitting structures [62]. Warp knitted meshes are the most popular system used to repair hernia defects, and are manufactured using the Raschel machine with a basic configuration consisting of two bars where latch-type needles are collectively mounted (running the full knitting width of the machine) and guide bars to hold yarn beams individually. The needle bars follow up and down movements, while the guide bars move back and forth across the needles of each bar to form continuous loops. The warp knit fabric design and lapping sequence is controlled by the shagging or traverse motion of the guide bars [63].

In principle, the Tricot knitting machine is very similar to the Raschel knitting; the only difference is the use of spring beard or compound needles instead of the latch needles used in the Raschel knitting machine. In addition, Tricot sinkers not only performed the function of holding down the loops whilst the needles rise as Raschel sinkers, but also support the fabric loops. The small angle of fabric take-away and the type of knitting action in Tricots creates a gentle and lower tension on the knitted fabric, ideal for high-speed production of fine gauge [64].

A double Raschel warp knitting machine (DR 16 EEC/EAC) has 16 guide bars and enables the production of textiles with different yarn materials and counts. The machine is equipped with two different gauges, E18 and E30. This system allows the design of a mesh configuration that could be adjusted to match given design parameters such as size, shape, Young modulus, and porosity [65]. The ultimate mechanical properties of the meshes are determined by the intrinsic properties of the filaments and the final configuration of the knitted fabrics.

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  1. Future Perspectives

Despite the clinical success and vast body of knowledge that has been gained regarding manufacturing of surgical meshes, material properties, and surgical procedures, it is obvious that the ideal mesh has not been developed. It is well known that meshes still suffer from contraction and/or infection after implantation [66]. Furthermore, adhesions between the visceral side of the mesh and adjacent organs still occur. These complications may have serious consequences, such as chronic pain, intestinal obstruction, bowel erosion, or hernia recurrence. All of these problems have opened a great number of opportunities to create a new generation of surgical meshes [67]. This new generation will have to show a better integration with the tissue of the abdominal wall, but no adhesions on the visceral side. Based on the ideas of van’t Riet [68], Ebersole [69] and Xu [70], new alternatives rely broadly on surface mesh modification by novel coatings to existent meshes and/or integration of nanofiber based systems.

4.1. Coatings

A variety of biocompatible and biodegradable natural and synthetic polymers are being investigated. Extensive research focuses in the development of a bi-layer composite hernia mesh in order to minimize the risk of infections and reduce adhesions on the visceral side [71,72]. Materials that had been studied are: Polylactic acid (PLLA) [20], oxygenated regenerated cellulose (ORC) [67], n-vinyl pyrrolydone (NVP) and n-butylmethacrylate (BMA) [67], polyglycolic acid (PGA) [73], carboxymethylcellulose (SCMC) [74], omega-3 fatty acid [75], messenchymal stem cells (RMSC) [76], human dermal (HDF) and rat kidney fibroblasts (RKF) [76], collagen [77,78,79], chitosan [80], nanocrystalline silver particles (NCSP) [81] and titanium [82,83]. Table 5 shows some of the properties that have made these materials attractive as active ingredients in surgical meshes [71,80,84,85,86].

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PLLA: Polylactic acid. PGA: Polyglycolic acid. ORC: Oxygenated regenerated cellulose. SCMC: Carboxymethylcellulose. NVP: N-vinyl pyrrolydone. BMA: N-butylmethacrylate. RMSC: Messenchymal stem cells. HDF: Human dermal. RKF: Rat kidney fibroblasts. NCSP: Nanocrystalline silver particles.

Most of the recently published literature still presents PP surgical meshes as the “gold standard” though with surface modifications made with materials mentioned in Table 5. Studies have primarily concentrated on: thickness and concentration of the materials used in the coating to be in contact with the visceral and/or abdominal side (Ex: 95% of oxidized collagen and 5% of chitosan) [26] and surface density (measured in g/m2). The following Table 6 presents a summary of the obtained results based on the inflammatory response and percentage of adhesion.

Table 6

Examples of surgical mesh coating parameters.

Reference Analyzed Parameter
Material Surface Density
Pascual et al. [86] Oxidized collagen Chitosan Oxidized collagen 95%/ Chitosan 5%
Ciechańska et al. [71] MBC 6.7 g/m2 (one side)
5.31 g/m2 (two sides)
Cohen et al. [81] NCSP 310 g/m2
640 g/m2
1130 g/m2
Niekraszewics et al. [85] Chitosan 20 g/m2 (one side)
20 g/m2 (two sides)

MBC: Modified bacterial cellulose. NCSP: Nanocrystalline silver particles.

In general, the new composite meshes show highly improved performance regarding peritoneal regeneration and visceral adhesion [84]. These studies have developed composite surgical meshes with high potential for adoption. Further studies with a focus on long-term adhesion and structural performance will complement obtained results.

4.2. Nanofibers

Nanofiber systems made from a large variety of materials have been explored extensively in the last decade. Scaffolds for tissue regeneration are strongly deemed as a potential application of these systems [87]. Mimicking the extracellular matrix (ECM) is vital to control cell behavior, such as adhesion, proliferation, migration, and differentiation. Tissue Engineering (TE) has been extensively explored to provide answers associated with current problems encountered in the interaction of the surgical meshes with the human body. One of the challenges of TE is to mimic the natural extracellular matrix (ECM) of the abdominal wall to promote an efficient integration. Researchers are actively exploring the implementation of nanofiber systems to effectively mimic the ECM [88,89,90].

Nanofibrous structures present several advantages, such as high specific surface area for cell attachment, higher microporous structure and a 3D micro environment for cell–cell and cell–biomaterial contact, these being associated with unique physical and mechanical properties. These structures when compared with commercial surgical meshes possess higher porosity and smaller pore size. These properties make nanofiber systems suitable for biomaterials used in wound care, drug delivery, and scaffolds for tissue regeneration [20,44,91].

Scaffolds for tissue engineering must possess a porous structure able to facilitate cell migration, a balance between surface hydrophilicity and hydrophobicity for cell attachment, mechanical properties comparable to natural tissue, and biocompatibility. Studies have shown that the abovementioned characteristics are also highly influenced by average diameter of the fibers and pore size. Effective cell attachment and proliferation has been observed in fiber systems with average diameters smaller than 1 µm and average pore size of 14 µm [92]. In commercially available meshes, even when it has been shown that cells are able to proliferate in micrometer/macrometer regimes, the cells in fact have difficulty attaching and proliferating. Cells are seen around the fibers whereas, on nanofiber based meshes, the cells attach to the fibers and quickly proliferate while making strong contact with underlying nanofibers, therefore promoting interlayer growth.

The application of nanofiber systems has been hampered due to its poor mechanical properties and nanofiber availability. Most of the available studies have focused on nanofibers prepared through solution processes. The properties of the developed fibers can be controlled by different parameters such as utilized solvent, concentration of polymer, processing methods, and ambient conditions. For example, in the case of nanofibers made of polypropylene (one of the highly used polymers for commercially available surgical meshes), decahydronaphthalene (decalin) and cyclohexane have been used as preferred solvents. Polypropylene nanofibers prepared with cyclohexane exhibited a rougher surface when compared to the fibers prepared with decalin, suggesting that the surface morphology of the nanofibers depend on the boiling point of each solvent [93]. When stress–strain behaviors of the nanofibers are investigated, a tensile strength of 61.4 ± 1.5 MPa with 35.2% ± 1.7% of strain, and a Young modulus of 174.6 ± 1.7 MPa was obtained for the decalin based nanofibers, whilst the cyclohexane nanofibers exhibit a tensile strength of 18.2 ± 1.1 MPa with 46.7% ± 1.2% of elongation and a Young modulus of 39.1 ± 1.4 MPa [94]. The abovementioned results were obtained from bundles of nanofibers rather than individual fibers, these properties are strongly dependent on fiber orientation within the tested sample, bonding between fibers, and slip of one fiber over another [94].

Regarding nanofiber availability, there are several methods to prepare nanofiber systems. These methods include wet chemistry, Electrospinning (ES) [95] and Forcespinning® (FS) [96] techniques. Most of the available literature has used ES processes; these studies have proven the potential of these nanofiber systems towards solving many of the challenges encountered in TE. ES processes have been limited to laboratory-based research given the challenges associated with increasing yield and opportunity to work with melt based systems. FS, a technique that has been recently introduced is based on developing nanofibers through the application of centrifugal forces. The method has been proven effective to produce yields that could satisfy industry requirements (i.e., several hundred meters per minute) as well as to produce nanofibers from melt based systems therefore removing the requirement of a solvent and subsequently the potential contamination of the materials with toxic organic solvents, and cost associated with the solvent itself and solvent recovery procedures. Other scaffolds had been produced by 3D printing procedures. Such biomimetic scaffolds are promising techniques as they could allow precise control over the geometry and microstructure [46,97].

Table 7 presents a summary of recently published work regarding the manufacture of nanofiber based surgical meshes.

Table 7

Nanofiber based surgical meshes.

Nanofiber Material Manufacturing Process Diameter (nm) Tensile Strength (MPa) Advantages and Disadvantages Reference
Poly-ε-caprolactone (PCL) Electrospinning 1280 ± 330 3.11 ± 1.09 Better adhesion, growth, metabolic activity, proliferation and viability of 3T3 Fibroblasts. Lack of in vivo testing. [87,98]
Polydioxanone (PDO) Electrospinning 860 ± 420 3.76 ± 0.49 Bioresorbable polymer. Reduction of long-term foreign body response (LTFBR). No fulfill the mechanical requirements. [99]
Polylactide-Co-Glycolide (PLGA 8218) Electrospinning 3280 ± 570 6.47 ± 0.41 Exceed the minimum mechanical requirements for hernia repair applications. Bioresorbable polymer. Reduction of LTFBR. Lack of in vivo testing.
PLLA Electrospinning 1480 ± 670 3.59 ± 0.25 In vivo advantages. Exceed the minimum mechanical requirements for hernia repair applications. Lack of in vivo testing.
Polyurethane (PU) Electrospinning 890 ± 330 18.9 ± 5.9 Elastic deformation.
PET Electrospinning 710 ± 280 3.17 ± 0.23 Adequate mechanical attributes. No evidence of intestinal adhesions. Trigger of a large foreign body reaction. [100]
PET/Chitosan Electrospinning 3010 ± 720 2.89 ± 0.27 Adequate mechanical attributes. No evidence of intestinal adhesions. Trigger of a large foreign body reaction.
PCL/Collagen Electrospinning 1000 2.13 ± 0.36 Biological and biomechanical stable, support skeletal muscle cell ingrowth and neo-tissue formation [101]

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PCL: Poly-ε-caprolactone. PDO: Polydioxanone. PLGA 8218: Polylactide-Co-Glycolide. PU: Polyurethane. PET: Polyethylene terephthalate.

Nanofiber systems are certainly showing a strong potential to be used in the next generation of surgical meshes, the increased availability (FS process) will certainly promote the development of practical applications. Nanofiber developed through the FS system have shown promising results regarding adhesion, growth, metabolic activity, proliferation, and viability of 3T3 cells [70,102]. It is expected that these systems will be used in combination with existent commercial meshes to satisfy other requirements such as mechanical strength needed to bear the intra-abdominal pressure exerted by human body and implantation requirements to mention some. Future studies in this area will include the effect of nanofiber morphology, mesh design (i.e., uniaxial aligned, radially aligned, orthogonally patterned) needed to improve structural properties, and in vivo testing.

In summary, this review synergistically complements recent reviews made in this important area. Table 8presents a comparative table with recent published reviews [38,103,104,105,106]. Besides having in common the history and present scenario, this review also presents information regarding manufacturing methods (manufacturing of these meshes has a strong influence in the medical results, therefore the ultimate functionality will be strongly dependent upon the manufacturing method) and future perspectives.

Table 8

Aspects related to hernia meshes compared in recently published reviews.

Baylon et al. (This Review) Brown et al. [38] Sanbhal et al. [103] Guillaume et al. [104] Todros et al. [105] Todros et al. [106]
Introductio
History
Present Scenario
Properties Discussed Elasticity/tensile strength
Pore Size
Weight (density)
Constitution
Material absorption
Tensile strength
Pore Size Weight
Reactivity/Biocompatibility
Elasticity
Constitution
Shrinkage
Complications
Weight
Pore Shape, size/porosity
Mesh elasticity/strength
Properties discussed for particular meshes, varies from the type of mesh being discussed. Pore size
Density
thickness
Biomechanical properties
Uniaxial tensile testing
Biaxial tensile testing
Ball burst testing
Surgical Mesh
Manufacting Processes > 2 processes considered
Future Perspectives 2 perspectives considered
Comments Comparison of meshes divided by generations: First generation (18 meshes), second generation, (10 meshes), third generation (7 meshes) Comparison of meshes divided by constitution, Multi (3 meshes), multifilament and monofilament (13 meshes), and foil (1 mesh). Biomaterial meshes (10 meshes) Comparison between synthetic meshes (15 meshes) Comparison between composite meshes (12 meshes) Meshes divided by Biologically Derived Matrices, Biodegradable synthetic structures, Anti-inflammatory mesh, Meshes with enhanced cytocompatibility, Anti-adhesive Mesh, Antibacterial meshes. Review also discusses mesh fixation, self-expanding systems, post-implantation visible mesh, cell coated meshes, and growth factor loaded meshes. Comparison between synthetic surgical meshes: HWPP (5 meshes), LWPP (6 meshes), PET (1mesh), ePTFE (1 mesh), PVDF (1 mesh)
Comparison between Multilayered meshes (10 meshes)
Comparison between synthetic surgical meshes: HWPP (5 meshes), LWPP (3 meshes), PET (1 mesh), ePTFE (1 mesh), PVDF (1 mesh).
Comparison between Multilayered Meshes (10 meshes)
Total meshes compared 35 27 27 24 21

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  1. Conclusions

Surgical meshes have become the system of choice for hernia repair. Even though it is not the optimum method, so far it is the one that has shown a lower rate of recurrence. Currently, there are more than 70 types of meshes commercially available. These are constructed from synthetic materials (absorbable, non-absorbable, or a combination of both) and animal tissue. Despite reducing rates of recurrence, hernia repair with surgical meshes still faces adverse effects such as infection, adhesion, and bowel obstruction. Most of these drawbacks are related to the chemical and structural nature of the mesh itself.

An optimum integration with the abdominal wall and negligible adhesion on the visceral side are the most important after sought features for the “ideal” mesh. A surgical mesh will trigger one of three different responses from the body: it may be integrated, encapsulated or degraded. In order to have a minimal inflammatory response to better integrate it to the body, it is highly important to improve biocompatibility.

To overcome this obstacle, researchers are actively exploring methods to improve biocompatibility, with the goal of developing a mesh that can be effectively incorporated with minimal inflammation and/or infection. Nanofibers have been recently considered as a strong potential intermediary structure to be used as a coating, given their ultralightweight quality, which could contribute to minimize the inflammatory response from the body and given its functional porosity, which could promote cell adhesion and proliferation.

Acknowledgments

The authors gratefully acknowledge support received by the National Science Foundation Partnership for Research and Education in Materials (PREM) award under Grant No. DMR-1523577: The University of Texas Rio Grande Valley–University of Minnesota Partnership for Fostering Innovation by Bridging Excellence in Research and Student Success. This work was also funded by Tecnológico de Monterrey—Campus Monterrey, through the Research group of Nanotechnology and Devices Design. Additional support was provided by Consejo Nacional de Ciencia y Tecnología (CONACYT), Project Number 242269, Mexico.

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FDA BANS THE USE OF PELVIC MESH PRODUCTS – How Will This Affect The TVM Litigation?

Will this move by the FDA re-ignite the mass tort engine in TVM litigation or possibly force settlement in Ethicon TVM MDL 2327?

By Mark A. York (April 17, 2019)

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Manufacturers of pelvic synthetic surgical mesh products must stop selling and distributing their products in the United States immediately, the US Food and Drug Administration ordered Tuesday. The surgical mesh is typically used to repair pelvic organ prolapse (POP) and incontinence, but reported side effects have included permanent incontinence, severe discomfort and an inability to have sex.  The key issue with the product for many years is the fact that its made from polypropylene, basically the same material as fishing line.

The FDA said it “has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”

The FDA said its April 16, 2019 action to remove surgical mesh products from the market is part of its commitment to ensuring the safety of medical devices. In a November statement, the agency said that it “regulates more than 190,000 different devices, which are manufactured by more than 18,000 firms in more than 21,000 medical device facilities worldwide.”

FDA Release January 4, 2019

FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

Summary: The U.S. Food and Drug Administration issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

FDA Finally Takes Action

Each year, thousands of women undergo transvaginal surgery to repair pelvic organ prolapse, a condition where weakened muscles and ligaments cause the pelvic organs to drop lower in the pelvis, creating a bulge or prolapse in the vagina. In the 1990s, gynecologists began implanting surgical mesh for the transvaginal repair of the condition and in 2002, the first mesh device specifically for this purpose was cleared for use by the FDA, according to the agency’s statement.

“We couldn’t assure women that these devices were safe and effective long term,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

For years, medical device companies have stated that the products they are developing and placing into the marketplace are safe and helping patients in the USA and worldwide. That is often not the case and people around the world are suffering.

Medical device makers and compensated doctors have touted FDA approved implants and other devices as the surgical cure for millions of patients suffering from a wide range of pain disorders, making them one of the fastest-growing products in the $400 billion medical device industry. Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S. and as a treatment for an aging population in need of chronic pain relief and many other afflictions.

2017 Pelvic Mesh Study in England Showed High Number of Adverse Events:

Scientific Reports Volume 7, Article number: 12015 (2017) |

Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women

Conclusions

Summary: This is the largest study to date of surgical mesh insertions for SUI. It includes all NHS patients in England over an 8-year period. We estimate that 9.8% of patients undergoing surgical mesh insertion for SUI experienced a complication peri-procedurally, within 30-days or within 5 years of the initial mesh insertion procedure. This is likely a lower estimate of the true incidence. Given concerns about the safety of these procedures, this study provides robust data to inform both individual decision-making and national guidance.

Why Device Makers Tout FDA Approvals

  1. “Medtronic receives FDA clearance for two heart devices”
  2. “FDA approves device to help curb cluster headaches”
  3. MRI approved for young infants in intensive care

Manufacturer headlines like these instill consumer confidence that medical devices are safe and effective. After all, they have the FDA’s stamp of approval, right? NO!

The reality is, the FDA seldom requires rigorous evidence that a device works well–and safely–before allowing it onto the market. Medical devices are the diverse array of non-drug products used to diagnosis and treat medical conditions, from bandages to MRI scanners to smartphone apps to artificial hips.

This low standard of evidence applies to even the highest risk devices such as those that are implanted in a person’s body. Surgical mesh, pacemakers and gastric weight loss balloons are just a few examples of devices that have had serious safety problems.

Devices are subject to weaker standards than drugs because they’re regulated under a different law. The Medical Device Amendments of 1976 was intended to encourage innovation while allowing for a range of review standards based on risk, according to legal expert Richard A. Merrill. An array of corporate lobbying has since prompted Congress to ease regulations and make it easier for devices to get the FDA’s approval.

In 2011, an Institute of Medicine panel recommended that the “flawed” system be replaced, because it does not actually establish safety and effectiveness. At the time the FDA said it disagreed with the group’s recommendations.

Defective devices cleared through this system have included hip replacements that failed prematurely, surgical mesh linked to pain and bleeding and a surgical instrument that inadvertently spread uterine cancer.

Bard took the Avaulta implants off the market in 2012 and did the same with the Align inserts in 2016. The company chose to remove the products the day after the U.S. Food and Drug Administration in 2010 ordered Bard and other mesh-manufacturers, including Johnson & Johnson (Ethicon), Boston Scientific and Endo (American Medical S), to review their mesh products, which also resulted in J&J removing four lines of synthetic surgical mesh products from the market. .J&J’s Ethicon subsidiary is facing more than 50 thousand lawsuits regarding its synthetic mesh device in Ethicon (J&J) Pelvic Mesh TVM Litigation MDL-2327.

The Ethicon MDL is in the same West Virginia federal court as the Bard and other mesh manufacturer multidistrict litigation, which are all being heard by Judge Goodwin.  Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements. He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

The FDA forcing mesh manufacturers to stop the use of synthetic mesh is long overdue, and how this action results in renewed interest by mass tort firms across the country, remains to be seen. Regardless, it would seem that Ethicon and the other defendants in the pending TVM litigation that have been unwilling to discuss settlement, may now be forced to deal with the catastrophic consequences of manufacturing and marketing medical devices that have injured untold thousands of patients around the world.

To access the most current TVM case status and other real time information on Mass Torts  sign up for:

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  1. For the most up-to-date information on all MDL dockets and related mass torts visit www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
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The FDA 510(k) System Overhaul -Process For Medical Device Approval: Is this a win for Big Pharma?

 

IS BIG PHARMA LOBBYING DICTATING FEDERAL REGULATORY POLICY IN WASHINGTON D.C. NOW?

By Mark A. York (December 5, 2018)

 

 

 

 

 

 

 

Official FDA announcement: FDA changes 510(k) program for approval and review of medical devices Nov. 26, 2018

(MASS TORT NEXUS MEDIA) On November 26, 2018 the FDA announced an overhaul of the 510(k) system that is meant to prompt manufacturers to base new products on technologies that are 10 years old or less. Almost 20% of the products currently cleared by the system were based on devices older than 10 years. For consumer safety, the FDA is considering whether to publicize the manufacturers and their devices that are based on older products.

The FDA is supposed to protect the interests of the general public and ensure that new devices, as well as existing ones are functioning as designed. More often that is not the case, as the FDA either fails to review medical device failures or simply ignores them.

The FDA has a reporting and tracking database that permits the public to review and see what devices are unsafe or causing adverse events, see FDA Medical Device Adverse Event Report Database.

Now there seems to be an effort by the FDA to pull back on the reporting functions in their official oversight duties. This includes the reporting requirements for problematic medical devices.

But earlier this year, the FDA made a rule change that could curtail that database, which was already considered to be of limited scope by medical researchers and the FDA itself.

For the FDA Medical Device Reporting Program (MDR): FDA.gov/MedicalDevices/Safety/ReportaProblem

BIG PHARMA LOBBYING INFLUENCE

Pharmaceutical companies and medical device makers, collectively Big Pharma, spend far more than any other industry to influence politicians. Big Pharma has poured close to $2.5 billion into lobbying and funding members of Congress over the past decade.

Hundreds of millions of dollars flow to lobbyists and politicians on Capitol Hill each year to shape laws and policies that keep drug company profits growing. The pharmaceutical industry, which has about two lobbyists for every member of Congress, spent $152 million on influencing legislation in 2016, according to the Center for Responsive Politics. Drug companies also contributed more than $20m directly to political campaigns last year. About 60% went to Republicans. Paul Ryan, the former speaker of the House of Representatives was the single largest beneficiary, with donations from the industry totaling $228,670.

Over the past decade, manufacturers have also paid out at least $1.6 billion to settle charges of regulatory violations, including corruption and fraud, around the world, according to the consortium, which published its report findings on November 26, 2018.

The new FDA rule, which had been sought by medical device manufacturers, opens the door for a decrease in reported information for nearly 9 out of 10 device categories, a recent review found. It could allow manufacturers to submit quarterly summarized reports for similar incidents, rather than individual reports every time malfunctions occur, meaning there will be much less detail about individual cases.

As part of the worldwide scrutiny of medical devices and at times, the  affiliated dangers, a massive investigation known as “The Implant Files” was undertaken by a group of journalists around the world.  Led by editors and reporters from the International Consortium of Investigative Journalists, it took a year to plan and another year to complete

ICIJ partnered with more than 250 journalists in 36 countries to examine how devices are tested, approved, marketed and monitored. This included an analysis of more than 8 million device-related health records, including death and injury reports and recalls.

The Implant Files review encompassed more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices over 10 years, and reported to the U.S. alone.

Like the rest of Big Pharma, the medical device manufacturers have created an intricate web of corporate and political influence including at the Federal Drug Administration, where the FDA is charged with oversight of medical devices.

The new rule is one of several regulatory changes favoring the medical device industry that have been proposed and enacted since the beginning of the Trump administration. They are part of a decades-long campaign to decrease U.S. regulation of the pharmaceutical and medical device industry, which is a massive global business that has existed for years with minimal international scrutiny.

A recent analysis of the 10 largest publicly traded medical device companies in the U.S. found that since the start of the Trump administration, the companies have spent more than $36.5 million on efforts to influence rules and legislation. Some of these companies manufacture a variety of medical products, including pharmaceuticals and lab equipment, but four of the 10 exclusively manufacture devices and lobbying disclosures for all 10 emphasize efforts to influence policy around devices.

BUYING A PRESENCE IN WASHINGTON

The medical device industry was worth $405 billion worldwide in 2017, according to an Accenture market analysis. Despite its size, the medical device industry has only a patchwork of international oversight, even though when things go wrong with a device, the consequences can be serious.

But the single largest medical device market in the world is the U.S., worth an estimated $156 billion in 2017, according to the U.S. Department of Commerce. As the medical device market has boomed over the past several decades, the industry has built a sizable presence in Washington, D.C.

Many medical device companies have built sophisticated lobbying arms, often employing their own team of lobbyists in addition to hiring outside firms for specific issues. Several of the largest companies used between 15 and 50 lobbyists in 2017 alone, an analysis by the Center for Responsive Politics (CRP) found.

There are also two main trade groups for the industry to which device makers contribute membership fees to, both of which pack a hefty lobbying punch on their own. Since the start of 2017, the Advanced Medical Technology Association (AdvaMed), the older and larger group, has spent more than $6 million and the Medical Device Manufacturers Association (MDMA) has spent nearly $2.6 million. The groups’ policy goals echo those that individual companies list on their lobbying disclosures, among them: decreasing taxes on devices, increasing insurance coverage and reimbursement and the FDA’s approval process for bringing a device to market.

The medical device lobbying effort is vast, with lobbyists seeking to be heard on Medicare and Medicaid reimbursement codes, device purchasing policies at the Veterans Administration, even cybersecurity and trade issues. Companies regularly lobby Congress and target agencies and offices across the executive branches in D.C., from the FDA to the Center for Medicare and Medicaid and the National Security Council.

Altogether, the industry has spent more than $20 million per year for the past five years lobbying the federal government, according to an analysis of campaign finance and lobbying data from CRP.

With the change in administration in 2017, that spending increased to more than $26 million, $2.2 million more than its highest level in any of the previous four years. Based on disclosures from the first three quarters of the year, medical device lobbying in 2018 is on pace to exceed 2017 levels.

An industry spokesperson noted that the U.S. pharmaceutical industry spends more heavily on lobbying than the device industry. Big Pharma-pharmaceuticals, which was worth more than $453 billion in the U.S. in 2017, spent more than $171 million the same year, more than six times as much as the device industry, according to a Statista market analysis.

The lobbying resources of the device industry far outweigh those of consumer and patient advocates, which are often on the other side of regulatory debates on Capitol Hill.

Very few advocacy groups spend time lobbying on devices, said Dr. Diana Zuckerman, a former HHS official under Obama and president of the National Center for Health Research, a nonprofit advocacy organization based in Washington.

“When we’ve talked to congressional staff about this,” she said, “they say things like, ‘Well, we’re getting calls every day, all day long from various device companies or their lawyers,’ and the nonprofits are basically going to the Hill for visits a few hours a year.”

Zuckerman’s group is one of about a half dozen to lobby on devices over the past few years. Each of the largest spends no more than a few-hundred-thousand dollars annually to lobby on devices and all other consumer issues, according to their federal lobbying disclosures.

Trial lawyer groups, which the device industry spokesperson noted often sue device makers, also spent less than one third of what the device industry did in 2017, a CRP analysis found.

Three companies that spent the most on lobbying in the past five years were  ask about their lobbying efforts. Baxter International and Abbott Laboratories did not comment. Medtronic said, “Despite the company nearly doubling in size, our lobbying-related efforts over the last 10 years have remained relatively stable.”

Previously, Abbott, Medtronic and a half-dozen other international device makers told the International Consortium of Investigative Journalists that they conduct business with the highest ethical standards, adhere to all laws and have rigorous programs to prevent employee misconduct.

In a statement, Mark Leahey, president of MDMA, said, “As millions of Americans benefit daily from the more than 190,000 different medical devices available and in use in the United States, our members continue to work with patient groups and policy makers to advance policies that promote improved access for patients and providers. This dynamic innovation ecosystem remains committed to developing the cures and therapies of tomorrow, while reducing adverse events and learning from ongoing research and each patient’s experience.”

OBAMA – TRUMP COMPARISON

During its eight-year tenure, the Obama administration permitted some deregulation but also instituted the first FDA product ban since the 1980s.

Beginning in 2014, warning letters to industry began to drop steeply and approval of new devices to rise. By 2017, the number of FDA warning letters to device manufacturers about product safety had dropped to nearly 80 percent less than those issued in 2010, while approval numbers for new devices were more than three times as high as at the beginning of the decade. The FDA says the decrease in warning letters is due to a more interactive approach to working with violative companies, and the uptick in approvals is due to an increase in staffing and efficiency.

Under Obama, some FDA regulators responsible for overseeing the device industry pushed for deregulation. Administrators largely kept it in check, said Peter Lurie, an FDA associate commissioner during the Obama administration.

“It was accompanied by very heavy lobbying on Capitol Hill as well,” said Lurie. Priorities included faster device approval times and decreasing taxes.

During Obama’s final year in office, the FDA banned its first device in more than 30 years, a type of surgical glove and proposed a ban on a home shock collar for behavior modification. That ban is still pending.

The industry successfully pushed for changes in a proposed regulation on unique device identifiers, the identification codes for individual devices, similar to automotive vehicle identification numbers, and won the suspension of a tax on medical devices created to help fund the Affordable Care Act.

“Now with the advent of the Trump administration,” said Lurie, “the deregulatory gloves are off and we’re seeing a number of the device industry’s most desired objectives come to fruition.”

President Trump vowed to cut regulations across the government by 75 percent when he came into office.

In 2002, Congress instituted a program in which the device industry pays “user fees” to fund the FDA office that oversees it, amounts which are agreed upon in negotiations between industry and the regulator every five years. In its first year, the fees provided 10 percent of funding for the device center, but by 2018, the fees brought in more than $153 million, providing more than 35 percent of the center’s budget.

“It’s carefully negotiated for weeks and months at a time,” said Jack Mitchell, former director of Special Investigations for the FDA. “And there’s a laundry list of things that the industry gets FDA to agree to and that they’re paying for.”

If the most recent agreement, negotiated in 2017, had not gone through by the deadline, the agency would have legally been required to temporarily layoff at least one third of its device center staff. The final agreement included a decrease in approval time for certain devices.

“We do not believe user fee funding has influenced our decision making,” the FDA said in a statement, noting that other parts of the FDA are also funded by user fees.

The agency also noted that it held meetings with patient stakeholders in addition to industry when negotiating the user fee agreement, saying, “Patients are a critical part of the user fee process.”

The FDA emphasized that it does not always agree with the industry, citing as examples its support of legislation that makers of reusable devices provide instruction on how to prevent bacterial contamination, and including device identifier codes in insurance claims forms.

MAKING FDA APPROVAL EASIER FOR BIG PHARMA

The changes to how adverse events are reported was seen as an overwhelming industry success.

The FDA database in which surgical complications are entered is known as the Manufacturer and User Facility Device Experience Database (MAUDE), which includes more than 750,000 incidents per year. The adverse events range from minor malfunctions to patient deaths linked to products being used around the world.

Despite its size, it’s widely accepted that the database is only a rather limited record of the full scale of medical device complications and adverse events.

The rule went into effect in August. The FDA said in a statement in November that though the reports are valuable, they were never meant to be sole source for determining if a device is causing harm.

“This type of reporting system has notable limitations,” said the FDA, “including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data.”

Patients are able to report adverse events to the database themselves, but few know to do so. Companies are required to report the events, once they are notified., which they don’t always do. The FDA said thirty-three percent (33%)  of all FDA warning letters to device makers were to companies that failed to meet rules for reporting complications with devices.

The more companies that fail to file properly, the less the database accurately reflects what is happening to patients with devices.

Under the rule change, companies could be allowed to submit quarterly summarized reports for similar incidents, rather than individual reports each time malfunctions occur. Previously, qualified manufacturers could submit summarized reports if they filed a request with the agency. Now they can do so without making a request.

“[The database] is the way we’ve learned about some very serious health issues,” said Rita Redberg, a cardiologist at the University of San Francisco who studies adverse events like Hershey’s. “It’s the most widespread and publicly available database for adverse events, which is extremely important for patient safety.”

In a public comment in support of the rule change, AdvaMed called the change a “commonsense approach” that will reduce the volume of reports manufacturers need to submit to the FDA and streamline the information the FDA receives about malfunctions.

“This process will actually make it easier for third parties to assess the malfunction data in [the database],” said Greg Crist, a spokesperson for AdvaMed. “Comparing the old alternative summary reporting program to this new initiative is comparing apples to oranges.”

In response to public comments that critical report information would be lost with the change in reporting, the FDA wrote in the published rule that, “We do not believe there will be an adverse impact on the content of information provided to FDA.”

In a statement, the agency said the new program “streamlines the process for reporting of device malfunctions and allows us to more efficiently detect potential safety issues and identify trends. It also frees up resources to better focus on addressing the highest risks.”

But Redberg, is worried that the new rule change will make searching an already unwieldy database more difficult, decreasing the ability of researchers and the public to search for misfiled reports or see accurate numbers of adverse events.

“It makes things easier for industry, it makes things worse for patients,” she said. “I really think it’s a public health crisis. We have more and more devices in use, and for many of them we really have no idea how safe they are because we don’t have accurate reporting.”

How these changes are affecting medical care in the US, and more importantly the publics right to be informed of adverse events and problems with medical devices, their approval process and who’s lobbying who and for what in the FDA should be open and transparent.  

(Certain images and text excerpts in this article were reprinted from third party media sources)

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$35 Million In Punitives Added To Bard TVM Trial Verdict in NJ Court

“TOTAL VERDICT OF $68 MILLION IN SYNTHETIC SURGICAL MESH TRIAL”

Mark A. York (April 18, 2018)

SYNTHETIC MESH COMPANIES FACING THOUSAND OF LAWSUITS

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) C.R. Bard, Inc. was ordered to pay an additional $35 million in punitive damages, added to the $33 million the jury initially award for a total of verdict of $68 million in the first Transvaginal Mesh trial for Bard in New Jersey state court. Plaintiff Mary McGinnis was successful in her claims that Bard’s synthetic vaginal mesh implants are defective, asserting that Bard defectively designed the product, ignored warnings and related FDA notices about the numerous adverse events related to their synthetic surgical mesh products.

Bard, a subsidiary of global medical supplier Becton-Dickinson of Franklin Lakes, says it will appeal the verdict. In a statement, the company said McGinnis knew of the inherent risks in having the vaginal implants. This case docket can be found under Mary McGinnis and Thomas Walsh McGinnis v. C.R. Bard Inc., et al., case number BER-L-17543-14, Bergen County Superior Court, Judge James DeLuca.

The punitive damage award was added after the initial $33 million verdict was returned and the judge set a hearing to address the punitive damages award. The jury decided that there were grounds to award plaintiff Mary McGinnis and her husband the large verdict based on trial testimony and evidence that Bard was aware of the mesh product dangers and chose to ignore the thousands of adverse events reported related to post-surgery complications claimed by women across the country.

The Bard synthetic mesh products are designed to provide pelvic support for any number of medical issues primarily affecting women, with synthetic mesh recognized as often causing major medical complications and leaving patients in permanent pain. The jury held the company liable for two products that McGinnis had implanted in March of 2009: an Avaulta Solo mesh, and an Align Transobturator and Bard was forced to concede that both products have been taken off the market.

The verdict comes as Murray Hill, New Jersey-based Bard is pushing to a flood of litigation its surgical mesh implants , which have been criticized by women for damaging internal and often affecting or stopping normal sex lives. Bard has settled more than 13,000 cases since 2014, and as of September 2017, the company still faced more than 3,000 suits over allegedly defective synthetic mesh devices still in litigation. Those cases are part of the Bard-TVM-Litigation-MDL-2187 Briefcase, in front of Judge Goodwin, US District Court of West Virginia.  While Bard still faces another 150 lawsuits in New Jersey state court, which previously had been perceived as a favorable home court legal venue by the company.

McGinnis alleged Bard’s Avaulta and Align implants shrank after being implanted, causing nerve damage and leaving her unable to engage in sexual activity and that she was forced to undergo four surgeries in attempts to remove all the mesh from her body.

Bard took the Avaulta implants off the market in 2012 and did the same with the Align inserts in 2016. The company chose to remove the products the day after the U.S. Food and Drug Administration in 2010 ordered Bard and other mesh-manufacturers, including Johnson & Johnson (Ethicon), Boston Scientific and Endo (American Medical S), to review their mesh products, which also resulted in J&J removing four lines of synthetic surgical mesh products from the market.J&J’s Ethicon subsidiary is facing more than 50 thousand lawsuits regarding its synthetic mesh device in Ethicon (J&J) Pelvic Mesh TVM Litigation MDL-2327.

The Ethicon MDL is in the same West Virginia federal court as the Bard and other mesh manufacturer multidistrict litigation, which are all being heard by Judge Goodwin.  Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements. He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

Bard has been accused in many lawsuits of using a form of polypropylene mesh in the devices, that their mesh supplier and manufacturer had warned wasn’t suitable for human implantation. Bard officials countered that the mesh was a safe substance from which to make the inserts, ignoring the safety sheet warning issued by the polypropylene mesh product maker.

Last year, C.R. Bard was acquired by medical-device company Becton, Dickinson & Co. $24 billion, combining two of the world’s biggest health-care suppliers.  How the thousands of remaining mesh lawsuits affect the company business model and potentially moves them towards serious settlement discussions remains to be seen.

This case can be found at: Mary McGinnis v. C.R. Bard, Inc., Docket No.: BERL1754314, Bergen County, New Jersey Superior Court (Hackensack).

 

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ETHICON, INC. AND J&J FACING THOUSANDS OF TVM AND HERNIA MESH LAWSUITS: WILL THEY SETTLE SOONER OR LATER?

“New Jersey State Court Opens Ethicon Hernia Mesh Consolidation”

Mark A. York (April 17, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Ethicon’s Pelvic Repair System litigation also known as Transvaginal Mesh (TVM) litigation, (see Mass Tort Nexus Ethicon TVM MDL 2327 Briefcase) and the more recent hernia mesh legal filings, are the latest in a series of ongoing legal battles facing Johnson & Johnson and its Ethicon subsidiary. Ethicon is facing over 50,000 mesh lawsuits in state and federal courts across the country where plaintiffs have filed suits over their synthetic mesh surgical implants. The numbers are increasing daily as the TVM plaintiffs are being joined by plaintiffs filing “hernia mesh” lawsuits, where the allegations are very similar to claims asserting that J&J’s failed to warn and choosing to ignore the thousands of FDA filed adverse events related to its hernia mesh products.

EMERGING NEW JERSEY STATE COURT ETHICON MESH CONSOLIDATION

Ethicon now faces a home state hernia mesh legal battle as the New Jersey Supreme Court posted the Application for Multicounty Litigation (MCL) status on April 11, 2018 regarding the emerging Ethicon/J&J multi-layered hernia mesh products litigation pending in New Jersey state courts. The filing requests the Ethicon hernia mesh cases be consolidated in Bergen County in front of Judge Rachell Harz, over litigation related to Ethicon’s Proceed, Physiomesh and Prolene synthetic hernia mesh products. For information regarding the New Jersey Ethicon Hernia Mesh Litigation see Mass Tort Nexus Briefcase Re: Ethicon Hernia Mesh New Jersey State Court Consolidation, adding another docket of mesh cases to the ever growing J&J/Ethicon defense of its synthetic surgical mesh products.

Ethicon TVM litigation has been underway for close to six years in MDL 2327, (MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation court link) currently pending in the U.S. District Court in West Virginia, where U.S. District Judge Joseph Goodwin is also overseeing seven other  multidistrict litigations (MDLs) established for cases against different manufacturers. When you add in other synthetic mesh manufacturer lawsuits besides J&J, there are more than 100,000 mesh lawsuits pending against Ethicon and other manufacturers, including Boston Scientific, C.R. Bard, American Medical Systems (AMS) acquired by Endo, Coloplast, Cook Medical, Neomedic and others.

Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

Only American Medical Systems, Inc has resolved substantially all of their claims over their mesh products, agreeing to pay about $1.6 billion to resolve more than 20,000 claims.

PRIOR MESH SETTLEMENTS

While manufacturers have had some success in defending the safety of the products in a handful of cases, most of the claims that have gone before a jury so far have resulted in substantial damage awards, suggesting that TVM settlements will likely cost the companies several billion dollars.  There have been settlements by some mesh makers including End International, Inc. on behalf of American Medical Systems, Inc, where Endo agreed to pay $775 million in August 2017 to resolve the remaining cases, where there had been over 22,000 lawsuits filed over its vaginal mesh implants. They had previously agreed to a $400 million settlement of more than 10,000 mesh lawsuits (~$48,000 per case) in October 2014. This has been part of Endo’s decision to exit “substantially all” the remaining lawsuits against its AMS unit, with the $400 million being in addition to $1.2 billion previously pledged by Endo to cover mesh litigation. Including its $830 million settlement to resolve thousands of mesh lawsuits (~40,000 per case) in May 2014. That settlement came a day after the FDA said transvaginal mesh should be reclassified as a high-risk medical device and subject to stronger regulatory scrutiny.

ETHICON TRIAL VERDICTS

Although Ethicon attempts to defer blame and causation for the often life altering medical conditions that occur post mesh implant surgery, they are often found liable at trial with verdicts being anywhere from $1.5 million to more than $100 million and often include major punitive damages. The punitive damages, which are designed to punish Ethicon for conducting its business with malice towards women who were implanted with the products, finding that the company knew that the synthetic mesh products caused severe complications, but failed to warn the medical community.

With Ethicon (Johnson & Johnson) facing more vaginal mesh lawsuits than any other manufacturer. Here are trial verdicts from lawsuits that have resulted in major losses for Ethicon/J&J again and again:

  • In March 2018, a jury in Indiana awarded $35 millionto Barbara and Anton Kaiser. They’d sued Ethicon (a subsidiary of Johnson & Johnson) after Barbara Kaiser’s Prolift mesh allegedly caused her pelvic pain. They awarded her $10 million in damages and hit Ethicon with $25 million in punitive damages.
  • In December 2017, a Bergen County, NJ jury awarded$15 million to Elizabeth Hrymoc. Ms. Hrymoc said she received a defective Prolift mesh implant in 2008, which left her in such pain that she had to have it removed and replaced. She cried as the jury announced their verdict.
  • In September 2017, a Philadelphia jury awarded $57.1 millionto Ella Ebaugh, who says she suffered chronic pain and incontinence because of two Ethicon pelvic mesh implants that eroded into her urethra. Ms. Ebaugh says she required three surgeries to remove the mesh. Ethicon vowed to appeal.
  • In April 2017, a Philadelphia jury awarded $20 millionto a woman who claimed she was in constant pain because of her TVT-Secur transvaginal mesh, a product of Johnson & Johnson subsidiary Ethicon. A spokesperson for Ethicon said the company would appeal the decision, but it was the fifth major loss over the mesh products since 2014.
  • $13.5 million verdict awarded to Sharon Carlino of New Jersey in February 2016. According to the lawsuit, Carlino received Ethicon’s transvaginal tape (TVT) for stress urinary incontinence and it left her with constant pain and discomfort. Two surgical attempts to fix the device did not rid her of pain. $10 million of the verdict came in the form of punitive damages. The jury said that Carlino’s doctor would not have used the Ethicon mesh had the device risks been known.
  • $4.4 million jury award to Florida resident Tessa Taylor in February 2016. The jury found that ObTape sling (made by J&J subsidiary Mentor) caused Taylor’s back pain, bladder pain, and difficulty urinating over a 7 year period. Taylor received the mesh to treat urinary incontinence, but she was re-diagnosed with the condition in spite of the device. $4 million of the verdict was for punitive damages to “discourage others from behaving in a similar way.”
  • J&J agreed to pay $120 million to settle 2,000-3,000 mesh lawsuitsin January 2016. The settlement marked the first serious attempt by J&J to settle a significant number of mesh lawsuits. A regulatory filing at the time showed that J&J still faced more than 42,000 mesh cases.
  • $12.5 millionverdict awarded to Indiana resident Patricia Hammons, including $7 million in punitive damages. Hammons was implanted with Ethicon’s Prolift device, which she says caused severe pain, sexual difficulties, and incontinence–even after corrective surgery.
  • $5 millionsettlement reached in September with plaintiff Pamela Wicker, implanted with Ethicon’s Prolift mesh device. Wicker claims that Prolift eroded inside of her and necessitated numerous surgeries to remove the device. A law professor said that the large settlement showed the costs of dealing with mesh litigation would be a lot higher than expected.
  • $5.7 millionverdict awarded to Coleen Perry in March 2015 by a California jury. Perry was implanted with the J&J/Ethicon TVT Abbrevo and says she expects to have pain the rest of her life. The jury found that the TVT Abbrevo has design problems and that Ethicon failed to warn about potential health risks. The verdict included $5 million in punitive damages for conduct that amounted to “malice.”
  • Two confidential settlementsinvolving 115 mesh victims were reached in January 2015. One of the settlements resolved 4 cases in Missouri over Ethicon’s Prolift mesh device and the other resolved 111 cases in Georgia over the ObTape Transobturator Sling (made by J&J subsidiary Mentor). The Missouri women claimed that the mesh in Ethicon’s Prolift insert shrinks and damages organs, causing constant pain and making sexual intercourse difficult, while the Georgia women alleged that ObTape causes permanent injuries.
  • $3.25 millionverdict awarded to plaintiff Jo Husky over the J&J/Ethicon Gynecare TVT-O mesh device. The verdict was reached by a West Virginia jury in September 2014 following a two-week trial. Jurors found that the TVT-O was faulty and that Ethicon failed to warn of side effects.
  • $1.2 millionverdict awarded to Linda Batiste, implanted with the Gynecare TVT Obturator (TVT-O) mesh sling (made by J&J unit Ethicon) in April 2013. The jury concluded that the device’s design was flawed.
  • $11.1 millionverdict (including $3.35 million in compensation and $7.76 million in punitive damages) awarded to Linda Gross of South Dakota, who was implanted with J&J’s Gynecare Prolift vaginal mesh device. A New Jersey jury reached the verdict in February 2013, saying that J&J fraudulently misled Gross about device risks.

ETHICON MESH LITIGATION

Judge Goodwin is overseeing coordinated pretrial proceedings for all federal vaginal mesh lawsuits, as the cases involve nearly identical allegations that the products used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women are defectively designed and can cause severe and deforming complications, including infections, puncturing organs and eroding through the vagina.

The MDLs were established for cases against each manufacturer to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and serve the convenience of the parties, witnesses and the courts. However, as hundreds of cases become “trial ready”, and manufacturers continue to make little progress in settling claims, Judge Goodwin faces the prospect of remanding large numbers of lawsuits back to U.S. District courts nationwide for individual trials, which could take decades to complete.

Plaintiff complaints against Ethicon all consistently assert that Ethicon was and is aware of the dangers posed by their synthetic mesh products, and choose to ignore the thousands of adverse event reports filed with the FDA as well as the fact that more than 50,000 plaintiffs have filed lawsuits over Ethicon synthetic mesh implants. The legal claims assert injuries due to the defective design of the most every synthetic mesh product made by Ethicon regarding its vaginal mesh, including mesh erosion, mesh contraction, inflammation, pain during sexual intercourse, urinary incontinence, chronic pain, and recurring prolapse of organs.

As a result of the post surgical complications, plaintiffs have been known to undergo as many as four operations to have the mesh removed, often resulting in massive levels of pain as well as financial impact of repeated surgeries and rehabilitation.  There are many instances where the the surgeons were unable to remove all the mesh due to the mesh adhesion to internal organs and surfaces within the body that were never intended as a post surgical complication.

While the outcome of the MDL cases and other trials are not binding on other cases in the vaginal mesh litigation, Ethicon and its parent Johnson & Johnson should gauge how juries have responded to certain evidence and testimony via recent major trial verdicts in most every mesh trial they’ve faced in both federal and state courts. How Ethicon counsel views the recent trial verdicts and the impact on the thousands of other cases they face, and the potential for the trial results to be repeated throughout these cases, would seem to have an impact on J&J’s views of starting substantive settlement negotiations. To date, this has not been a significant part of the Johnson & Johnson legal business strategy, potentially resulting in an ongoing windfall for the thousands of plaintiffs for years to come.

 

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Bard Loses $33 Million In Pelvic Repair Mesh Trial In New Jersey State Court: Punitive Damage Hearings Today

“New Jersey State Courts Not Legal Safe Haven Lately For Companies HQ’d There”

By Mark A. York (April 13, 2018)

C.R. Bard Avaulta Synthetic Surgical Mesh

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) In another win for plaintiffs, a jury in Bergen County, New Jersey awarded plaintiff Mary McGinnis $23 million and her husband Thomas, an additional $10 million in actual damages, with a hearing taking place today on how much in punitive damages will be be added. This $33 million verdict in New Jersey state court, where defendant C.R. Bard is headquartered, closely follows the $117 million verdict of last week against another New Jersey company, Johnson & Johnson in a baby powder trial.  This was the first C. R. Bard case to go to trial in the Bard consolidated New Jersey state court docket, where Bard is facing hundreds of additional lawsuits over its defective pelvic mesh implants, also known as Transvaginal Mesh or TVM.

The jury directed the company to pay the $33 million in compensatory damages over claims the business knew its pelvic mesh products were unsafe and failed to warn doctors about potential risks related to devices that caused a woman debilitating pain and related inability to enjoy life as she did prior to the surgical implant of the synthetic mesh device.  Bard and others makers of both TVM and hernia mesh products are under highly increased scrutiny and being hot with major trial verdicts over claims they ignored the dangers of implanting synthetic mesh products, primarily made from polypropylene, the same product most fishing line is made from, into the human body. This case docket can be found under- Mary McGinnis and Thomas Walsh McGinnis v. C.R. Bard Inc., et al., case number BER-L-17543-14, Bergen County Superior Court, Judge James DeLuca.

The jury took less than a day to decide on the verdict following the four-week trial, after finding that Bard was responsible for a defective design of the Avaulta mesh product and failure to warn doctors or consumers of the defective design. . Of note is that Bard had removed the Avaulta mesh line from the market by 2016.

The jury found that Bard’s Avaulta and Align synthetic mesh products, which were  implanted to treat McGinnis’s bladder prolapse and stress urinary incontinence were defectively designed and caused incapacitating injuries as well as impacting her relationship with her husband. Bard claimed repeatedly that they tested Avaulta extensively as well as their other mesh products, and Mrs. McGinnis’ unrelated medical conditions caused her injuries

Hearings over punitive damages and how much they should be are scheduled to start this morning. Bard is probably keeping in mind the $80 million in punitive damages awarded last week in a similar state court punitive damages hearing in the J&J talcum powder cancer trial in New Brunswick, which is less than 50 miles from the Bergen County court.

Bard has historically been hit with ongoing verdicts over its synthetic mesh line of products in trial across the country, as far back as 2012 where a previous Avaulta mesh trial in California state court ended in a $5.5 million verdict and in a 2013 West Virginia federal court trial, a verdict was returned for  $2 million verdict against Bard and its Avaulta mesh.

TVM MESH IS SUBJECT TO MAJOR LITIGATION

Surgical Mesh Makers Facing Litigation

 

 

 

 

 

 

 

Major litigation against CR. Bard/Davol, Ethicon (J&J), Boston Scientific and other surgical mesh manufacturers has been ongoing for few years in both federal and state courts and will continue into the foreseeable future, based on the hundreds of thousands of synthetic mesh implants used in surgical procedures in the United States over the last 15 years.

Bard has been known to settle mesh cases, in the Wise v. Bard, bellwether case selection, that was set for trial back on February 18, 2015, settled a week before the trail start date for a confidential amount. The Wise lawsuit was part of the Bard MDL 2187, see Bard-TVM-Litigation-MDL-2187 Briefcase, where thousands of lawsuits are still pending against C.R. Bard, additionally there are other MDL’s where every other synthetic surgical mesh manufacturer in the US marketplace is facing more than 50 thousand lawsuits over their synthetic mesh surgical products.” See Ethicon (J&J) Pelvic Mesh Litigation MDL-2327-TVM Briefcase.

OTHER TVM MESH VERDICTS

 There were $26.7 million and $18.5 million mesh verdicts against Boston Scientific see  Boston-Scientific-TVM-Litigation-MDL-2362 Briefcase, in two transvaginal mesh MDL trials. On November 13, 2014, a Miami, Florida jury awarded $26.7 million to four women implanted with Boston Scientific’s Pinnacle mesh devices. On November 20, 2014,  a Charleston, West Virginia jury awarded $18.5 million to four women implanted with Boston Scientific’s Obtryx mid-urethral slings. The Obtryx verdict included $4 million in punitive damages, with $1 million awarded to each plaintiff.

The women in the Florida Pinnacle trial were each awarded between $6.5 million and $6.7 million. Boston Scientific’s Pinnacle mesh devices were implanted during pelvic organ prolapse surgeries and are no longer on the market. The individual awards for the women in the Pinnacle mesh trial include:

Transvaginal Mesh Adverse Events

Transvaginal mesh and vaginal sling products have been linked to thousands of reported serious, life-threatening side effects or adverse events from seven surgical mesh manufacturers. The complications are associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The mesh devices are typically placed transvaginally for minimally invasive placement.

Complications and Adverse Events Include:

  • erosion through the vaginal tissue
  • mesh contraction
  • mesh extrusion
  • inflammation
  • fistula
  • infection and abscess
  • pain
  • blood loss
  • chronic and acute nerve damage
  • pudendal nerve damage
  • pelvic floor damage
  • scar tissue
  • chronic pelvic pain
  • urinary problems and/or incontinence
  • recurrence of prolapse
  • bowel, bladder, and blood vessel perforation
  • dyspareunia or pain during sexual intercourse

Treatment of the complications includes additional surgical procedures to revise or remove the mesh, blood transfusions, drainage of hematomas, drainage of abscesses from infection, IV medication, pain injections, botox injections, physical therapy, among other treatments to alleviate the complications.

In July 1, 2012, Bard stopped selling the Avaulta Meshin the United States because the FDA required additional clinical trials and testing.

On June 4, 2012: Johnson and Johnson/Ethicon withdrewfour mesh products from the US Market, including its controversialGynecare Prolift, Prolift+ M, TVT Secur and Prosima systems.

History of Warnings

Surgical mesh is a metallic or polymeric screen surgically implanted to reinforce and support weakened soft tissue or bone. On the market since the 1950s for use in abdominal hernias, gynecologists in the 1970s began using surgical mesh to reinforce vaginal tissue to treat pelvic organ prolapse. In the 1990s, surgeons began using surgical mesh to treat stress urinary incontinence in women.

Transvaginal mesh was approved for sale through the 510(k) process simply by comparing it to the kind of mesh used to treat abdominal hernias. Most transvaginal mesh products on the market today are based on Boston Scientific Corp.’s ProteGen mesh, which the FDA approved in 1996 as the first surgical mesh to treat stress urinary incontinence. Two years later, the FDA approved Johnson & Johnson’s Gynecare TVT mesh through the 510(k) process after the company claimed the mesh was substantially equivalent to ProteGen.

However, in October, 1999, the FDA recalled Boston Scientific’s ProteGen sling due to the large number of complications experienced by women, including erosion of the vaginal tissues. The complete irony is that a majority of the transvaginal mesh are based upon this recalled defective device.

On October 20, 2008, the U.S. Food & Drug Administration (FDA) issued an urgent public health notification to physicians and patients regarding serious complications associated with transvaginal placement of surgical mesh in repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).

On May 16, 2011, the New England Journal of Medicine (NEJM) Study on Transvaginal Mesh Complications confirmed that the use of surgical mesh to treat pelvic organ prolapse carries the risk of serious side effects including bladder perforation and pelvic hemorrhaging.

On July 13, 2011, FDA issued an updated safety communication warning that surgical placement of transvaginal mesh to repair POP may expose patients to a greater risk of side effects than other treatment options. In addition to the increased risk of side effects, the FDA stated that vaginal mesh offers no greater clinical value or improved quality of lifeover other surgical methods.

On August 25, 2011, Public Citizen called on FDA to recall the vaginal mesh in response to a high number of reports linking vaginal mesh products to erosion, pain, bleeding and urinary incontinence.

Transvaginal Mesh Products & Manufacturers

Ethicon

  • Secure
  • Prolift
  • Prolift +M
  • Gynemesh/Gynemesh PS
  • Prosima
  • TVT
  • TVT-Obturator (TVT-O)
  • TVT-SECUR (TVT-S)
  • TVT-Exact
  • TVT-Abbrevo
  1. R. Bard
  • Align
  • Avaulta Plus™ BioSynthetic Support System
  • Avaulta Solo™ Synthetic Support System
  • Faslata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex™ Polypropylene Mesh
  • PelviLace
  • InnerLace
  • Uretex

American Medical Systems 

  • SPARC®
  • Mini-Arc
  • Apogee
  • Elevate
  • Monarc
  • In-Fast
  • BioArc

Boston Scientific

  • Obtryx® Curved Single
  • Obtryx® Mesh Sling
  • Obtryx Transobturator Mid-Urethral Sling System
  • Prefyx Mid U™ Mesh Sling System
  • Prefyx PPS™ System
  • Uphold Vaginal Support System
  • Pinnacle Pelvic Floor Repair Kit
  • Advantage Transvaginal Mid-Urethral Sling System
  • Advantage Fit System
  • Solyx SIS System

Coloplast

  • T-Sling-Universal Polypropylene Sling

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Johnson & Johnson Hit With $35 Million Surgical Mesh Implant Verdict

$35 Million Verdict For Plaintiff In Ethicon Prolift Mesh Implant Trial Including $25 Million In Punitive Damages

ETHICON PROLIFT SURGICAL MESH

 

 

 

 

 

 

 

 

 

A jury trial in the US District Court of Northern Indiana returned a verdict against Johnson & Johnson and its Ethicon division, that included $25 million in punitive and $10 million in compensatory damages. The jury found that that Ethicon was negligent in the design of the Prolift surgical mesh implant device, as an unreasonably dangerous product, resulting in post-implant injuries to plaintiff  Barbara Kaiser of Valparaiso, Indiana.

This verdict is the latest plaintiff trial win in the ongoing Ethicon Pelvic Mesh MDL 2327 litigation (See Ethicon MDL 2327 Litigation Briefcase), which includes the overall master docket data which guided the Barbara Kaiser case, prior to being remanded back to the Indiana court for trial by Judge Joseph Goodwin, from the US District Court of West Virginia, where the Ethicon Pelvic Mesh MDL cases are docketed. The Ethicon pelvic mesh litigation still has thousands of remaining cases, where plaintiffs have asserted claims against Ethicon and J&J over their surgical mesh line of products.

The trial took place in the United States District Court for the Northern District of Indiana, where a nine-person jury returned a verdict against Johnson & Johnson et al., the industry leader in  pharmaceuticals and medical devices, after finding that Johnson & Johnson marketed, sold, and recruited physicians worldwide to implant the controversial “Ethicon Prolift” mesh device for Pelvic Floor Repair in women that suffered from pelvic prolapse.

The verdict was handed down after nearly a two-week jury trial that began on Monday, February 26th, concluding on March 8th, 2018.

The verdict confirmed claims that Johnson & Johnson and Ethicon are  liable for its defective product line, designed for use in surgical procedures where the Pelvic organ prolapse repair is used, confirming primary plaintiff claims that the Defendants were negligent in the design of Prolift as an unreasonably dangerous product, resulting in long term injuries to Mrs. Barbara Kaiser of Valparaiso, Indiana as a result of the surgical implant of the Prolift device. The jury found Ethicon deliberately failed to warn of the risks to Prolapse patients prior to consenting to the Prolift mesh implant surgery and sold a Prolift product in a defective and unreasonably dangerous condition.

“The $35 million verdict is one of the largest verdicts in the country,” said lead trial counsel Thomas Plouff, further stating “Ethicon defended an indefensible product and the jury stood up for Barb Kaiser. They were asked to send a message to Ethicon to deter future wrong doing and they certainly did, a company that sold a medical device without doing any clinical testing and caused thousands of women to suffer painful complications from mesh in their pelvic area.”

The trial in front of the Honorable Judge Philip P. Simon, in Northwest Indiana, in what is known as a fairly conservative court venue for plaintiffs seeking damages against manufacturers of products, with Northwest Indiana being a major manufacturing center and not being known for massive verdicts such as the Kaiser mesh award. The verdict requires the Johnson & Johnson corporate conglomerate to pay $35 million, which is $10 million for compensatory damages (for Mrs. Barb Kaiser’s dyspareunia, pelvic pain, levator myalgia, painful bladder spasms, and groin pain), and $25 million in punitive damages. The high punitive damage figure would seem to send a clear message to J&J that their conduct related to the design and marketing of the Prolift product was wrong and intentional, resulting in the very large punitive award.

The Kaiser mesh lawsuit is part of an ongoing legal battle between plaintiffs and surgical mesh makers across the country regarding the many thousands of injuries resulting from various mesh products being surgically implanted. The Ethicon Pelvic Repair MDL 2327 has been in existence since 2012 and the judge is moving toward resolution of those 40 thousand plus claims against many of the largest medical device manufacturers in the world. However, the currently evolving “hernia mesh” legal and medical issue are outline below.

 Hernia Mesh Injuries and Complications

Unlike sutures, which have relatively few and minor possible complications, hernia mesh frequently causes life-threatening complications. Hernia mesh can erode into the bowel, requiring multiple additional surgeries, weeks of hospitalization, partial bowel removal, colostomies, and more. The mesh failure frequently causes patients to experience a systemic infection. We recently observed high rates of dental infections associated with mesh failure. Many victims report all of their teeth suddenly rotting out. Even if there is a slightly lower rate of hernia recurrence when mesh is used, it doesn’t justify the risk of life-threatening complications.

Hernia mesh is used to repair both ventral hernias and inguinal hernias. Various injuries and complications can occur depending on what part of the body the mesh is placed. A coated hernia mesh is also more likely to cause injuries such as infection than a non-coated hernia mesh. The follow is a list of the array of complications we observed:

  • Infection, including sepsis. An infected hernia mesh almost always requires removal.
  • Adhesions form to connect the bowel to the hernia mesh. Adhesions frequently form when ventral hernias are repaired with a coated mesh.
  • Bowel Obstruction caused by adhesion formation. Evidenced by a change in bowel habits or the inability to defecate.
  • Abdominal Pain is a sign of possible adhesion formation, a bowel obstruction, infection, or nerve damage.
  • Rashes are commonly observed in association with hernia meshes such as the C-Qur V-Patch and Ventralex ST.
  • Leg, Groin, and Testicular Pain are all common to inguinal hernias repaired with mesh. This pain can be debilitating.
  • Pain with Sex (Dyspareunia) caused from the mesh used to repair an inguinal hernia attaching to the spermatic cord.
  • Testicle Removal may be necessary if the mesh erodes far enough into the spermatic cord.
  • Diarrhea can be an early symptom of the mesh attaching to the bowel.
  • Constipation can be a sign of a bowel obstruction. You should consult a doctor if your constipation persist for several days.
  • Nausea can be an additional sign of adhesions to the bowel and stomach.
  • Seroma is a fluid capsule surrounding the mesh. Seromas can be present with and without infection.
  • Fistula. An abnormal tunnel between two structures. Our attorneys observe many fistulas connecting to the bowel, which are associated with infections.
  • Dental Problems. Medical reviewers have observed a large number of patients who have lost their teeth after a hernia mesh infection.
  • Autoimmune Disorders. An alarming number of our patients have developed autoimmune disorders after being implanted with a pelvic or hernia mesh.
  • Neurological Changes. Several different patients that have been implanted with the same type of mesh have been diagnosed with unexplained neurological changes on a CT scan.
  • Severe Headache. Typically a sign of a larger problem, such as an infection.
  • Fever. Associated with both an autoimmune response to the mesh and infection.
  • Renal Failure has been observed in those implanted with large coated meshes. The coatings are absorbable and put a great deal of strain on the kidneys.
  • Liver Abnormalities have also been documented in those implanted with coated hernia meshes. The liver is also responsible for cleansing the body.
  • Joint Aches and Pain can be caused by increased systemic inflammation due to infection and an autoimmune reaction to the mesh.
  • Abnormal Sweating can be related to an autoimmune response or to an infection.
  • Meshoma is the migration, contracture, or bunching-up of an artificial mesh. Meshomas become hard, tumor-like bodies.

         SURGICAL MESH ISSUES

  • Composite Mesh: The Most Dangerous Type of Hernia Mesh
  • Any mesh with a coating is known as a composite mesh. Most of the manufacturers promote the meshes coating as a “barrier” and instruct surgeons to use the coating as a barrier. The FDA requires any “barrier” type of medical device to undergo Pre-Market Approval and pre-clinical studies to ensure the device’s safety. Instead of conducting safety studies, companies just told the FDA that they wouldn’t promote their hernia mesh as a “barrier.” A majority of the meshes currently being used in hernia repair are untested composite meshes that have only been on the market for a few years. There is currently no reliable data on these hernia mesh products. Medical reviewers are currently noticing a very high rate of complications associated with hernia meshes that are coated.
  • Big Profits Making Composite Mesh
  • Due to the complications that polypropylene was causing when it came in direct contact with the bowel, the demand for composite hernia mesh skyrocketed. Any company with a composite mesh could rapidly increase its nationwide market share. Mesh products were already one of the most profitable medical devices a company could manufacture, many making over $100,000,000 a year! A composite mesh also sells for approximately 15 – 20 times more than an uncoated polypropylene mesh. Suddenly, every device manufacturer rushed to get a composite mesh on the market. Many companies created and sold several different types of composite hernia mesh at the same time. If one type of composite mesh caused too many side effects, the company would simply quit manufacturing that particular composite mesh. There are currently over 350,000 hernia repairs in the United States each year.
  • There are many different hernia mesh products available, many of which are manufactured by different medical device companies. The strengths and weaknesses of a hernia mesh lawsuit are in part determined by which company manufactured the hernia mesh and the exact mesh that was utilized. Below is a list of products that have received a large number of complaints. Bookmark this page and check back soon, this list is growing and we continue to add more unique content every week!
  • Ethicon – Johnson & Johnson
  • Proceed Hernia Mesh
  • The Proceed hernia mesh came to market in 2003. The Proceed is a light-weight hernia mesh with an Oxidized Regenerated Cellulose (ORC) fabric covering the polypropylene. The cellulose is adhered to the polypropylene with polydioxanone (PDS). Ethicon touts the Proceed’s barrier as supporting “safe and comfortable healing.” Ethicon has previously issued limited recalls on the Proceed hernia mesh, because of the cellulose layer separating from the polypropylene and increasing the risk of bowel complications. The Proceed hernia mesh continues to delaminate and should be permanently recalled. Physicians have submitted 100’s of adverse event reports to the FDA and Johnson & Johnson regarding the Proceed hernia mesh being defective and injuring patients.
  • Physiomesh:
  • The Physiomesh was withdrawn from the market in May of 2016. Ethicon maintains that they did not recall the Physiomesh. The Physiomesh was a composite hernia mesh. Multiple studies revealed that Ethicon’s Physiomesh had high rates of complications, including subsequent hernias and additional surgeries. Ethicon admitted that they’re unable to determine why the Physiomesh is defective, or how to decrease complications for those who had a Physiomesh implanted. Part of the problem was likely that the Physiomesh had a coating on each side of the mesh. The coating prevented the Physiomesh from properly incorporating with the host tissue. Prior to removing (not recalling) the Physiomesh from the market, Ethicon created a new hernia mesh called Physiomesh Open.
  • Prolene Hernia System:
  • The Prolene Hernia System(PHS) was introduced to the market in 1997. The Prolene Hernia System is similar to polypropylene mesh plugs with a polypropylene onlay. In fact, the Prolene Hernia System cites Bard’s Perfix plug as a predicate device. Our hernia mesh lawyers have observed similar complications associated with the Prolene Hernia System and the Perfix plug. The Prolene Hernia System utilizes heavy-weight polypropylene. In 2007, Ethicon came out with the Ultrapro Hernia System, a light-weight version of the Prolene Hernia System. Light-weight polypropylene was believed to cause less complications than heavy-weight polypropylene. Injuries associated with the PHS include debilitating pain, nerve damage, and sexual dysfunction necessitating testicle removal.
  • Covidien – Medtronic
  • Parietex:
  • The Parietex hernia mesh was Covidien’s first polyester hernia mesh. The Parietex originally came to the market in 1999 as a heavy-weight polyester mesh. The original Parietex caused many problems similar to polypropylene based hernia meshes, such as adhesions, infections, and bowel complications. Like polypropylene, polyester also shrinks and contracts to a significant degree after it is implanted in the body. As the Parietex contracts, tension increases and the mesh has a tendency to tear where the tacks or sutures were used to secure it. Severe pain and a recurrence of the hernia typically result when the Parietex mesh rips apart. After the Parietex detaches it can migrate to other parts of the body.
  • Parietex Composite Mesh:
  • Parietex ProGrip/Plug and Patch System
  • The Parietex Composite(PCO) mesh is composed of a polyester base with a resorbable collagen barrier. The resorbable collagen barrier is intended to prevent the polyester base from adhering to the patient’s bowel. Covidien touts the Parietex as a unique material that “works with the body’s natural systems.” However, many of our clients would disagree. The collagen layer of the Parietex Composite hernia mesh is very thin and delicate. The collagen layer disappears quickly after implantation and does little to nothing to protect the bowel and underlying organs from the polyester base. Recently, Covidien came out with the Parietex Optimized Composite Mesh in an attempt to fix the problems associated with the collagen layer. The hernia mesh lawyers at the Hollis Law Firm frequently see severe adhesions, bowel obstructions, and infections associated with the Parietex Composite hernia mesh. Additionally, like the original Parietex, the Parietex Composite tears easily on sutures or tacks as it begins to contract post implantation.
  • The Parietex ProGripand the Parietex Plug and Patch System are made from polyester weaved together with a partially semi-resorbable polylactic acid (PLA) layer. The Parietex ProGrip is a “self-fixating” mesh because it has thousands of hooks that are intended to keep the mesh in place. However, the thousands of hooks also cause patients to experience severe pain and make the hernia mesh nearly impossible to remove. When the Parietex ProGrip fails and complications result, multiple surgeries are usually required to remove the underlying problem: the defective Parietex ProGrip hernia mesh. Covidien was recently acquired by Medtronic for nearly $50 billion. Covidien is also one of many defendant mesh manufacturers in the pelvic mesh litigation
  • Atrium – Maquet – Getinge Group
  • C-Qur Hernia Mesh:
  • The C-Qur is a composite hernia mesh that came to market in 2006, and was initially marketed by Atrium Medical Corporation. Maquet, a subsidiary of the Getinge Group, acquired Atrium in 2011 and now manufactures the C-Qur hernia mesh. The FDA has issued several warnings letters and even sued Atrium Medical Corporation for violations. Recently, the FDA shut down one of Atrium’s facilities that manufactured the C-Qur hernia mesh. Atrium has only issued recalls on the C-Qur’s packaging, not on the actual C-Qur hernia mesh itself.
  • The C-Qur hernia mesh has an Omega-3 Fatty Acid coating that causes severe allergic reactions. The C-Qur hernia mesh is also associated with life-threatening systemic infections. Removing the C-Qur mesh is extremely difficult and can result in further injury. The C-Qur hernia mesh remains on the market, even as lawsuits continue to mount. Our hernia mesh recall lawyers continue to receive frequent complaints related to the C-Qur hernia mesh.
  • Davol – C.R. Bard
  • Kugel Hernia Mesh:
  • The Kugel hernia mesh was one of first and most well known hernia meshes to be recalled. C.R. Bard recalled several lots of the Kugel hernia patch in 2005, 2006 and 2007. The Kugel hernia mesh patch has a ring in the middle of the mesh to help it keep it’s shape. Multiple lots of the Kugel hernia mesh were recalled due to a large number of reported ring breaks. Many patients have suffered bowel perforations as a result of the inner ring of the Kugel hernia patch breaking. Davol only recalled limited lots of the Kugel, claiming that certain lots had defective rings. Davol continues selling the Kugel hernia mesh to this day. The real problem with the Kugel hernia mesh is that it’s made of polypropylene, which shrinks over time. As the polypropylene mesh shrinks, more and more force is applied to the ring. Eventually, the ring breaks due to the shrinkage of the polypropylene.
  • 3d Max
  • The 3DMax is a bare heavy-weight polypropylene mesh used to treat inguinal hernias. In 2008, Bard released a light-weight version of the 3DMax called the 3DMax light. Patients nationwide have experienced severe, debilitating pain after being implanted with the Bard 3DMax mesh. The 3DMax mesh can erode through soft tissue and then attach to the spermatic cord in men, causing severe sexual dysfunction and testicle pain. Once the mesh is attached to the spermatic cord, there is a risk of losing the testicle when removing the mesh. The 3DMax is curved, and is intended to be implanted without any sutures or tacks. Our hernia mesh attorneys have identified many cases where the Bard 3DMax has folded over upon itself and migrated inside the patient. As can be seen in the picture, the outer sealed edge of the 3DMax also has a tendency to easily break and tear. The sealed edge is intended to help the 3DMax maintain its shape. Bard’s 3DMax simply is not fit for permanent, life-long human implantation.
  • PerFix Plug
  • The PerFix Plugis a bare polypropylene mesh used to treat inguinal hernias. The PerFix Plug looks like a double layer dart with an overlay patch. The polypropylene of the PerFix Plug has been observed to come unwoven over time. Many experience severe pain and difficultly exercising and even walking after being implanted with the Bard PerFix Plug. The PerFix Plug is another hernia mesh that has caused many men to loose a testicle. The PerFix Plug is not necessary to repair an inguinal hernia.
  • Ventralex (Supramesh)
  • In 2007, Bard bought the license to Sepramesh from Sanofi Genzyme. The Sepramesh was intended to “Separate the polypropylene from the bowel.” Bard then created the Ventralex ST hernia mesh by combining the Sepramesh and the Kugel mesh. Bard recalled several lots of the Kugel hernia mesh approximately a decade ago. Bard has yet to issue a recall on any lot of the Ventralex ST hernia mesh.Bard also claims that the Ventralex SThernia mesh’s coating is similar to the coating used on the C-Qur hernia mesh. Like with the C-Qur, researchers are seeing severe inflammatory reactions, infections, and adhesions related to the Ventralex ST. Please note that Sepramesh, Ventrio ST and Ventralight ST are also included in the Ventralex ST lawsuit.
  • Scientific Articles on Hernia Mesh
  • The below articles are on hernia mesh in general. Each hernia mesh subpage also contains additional case specific scientific articles.
  • August 2016: Evaluation of Long-Term Surgical Site Occurrences in Ventral Hernia Repair: Implications of Preoperative Site Independent MRSA Infection.
  • 632 patients were studied for two years after being implanted with hernia mesh. 31% experienced complications within just two years. Complications included cellulitis, necrosis, nonhealing wound, seroma, hematoma, dehiscence, and fistula. Patients with a preoperative MRSA+ infection from any site (urine, blood, surgical site), might be at an elevated risk for hernia mesh complications.
  • August 2016: Oral, Intestinal, and Skin Bacteria in Ventral Hernia Mesh Implants.
  • 36 patients with failed hernia mesh were studied. All participants were found to have gingivitis and 33% had infected gums and teeth. Oral bacteria was discovered on 43% of explanted hernia mesh. The study discusses the difficulty in knowing the real rate of hernia mesh infections, due to lack of standardized criteria to define infection, lack of follow-up exams, and lack of intervention when complications arise. It notes that hernia mesh infection is the most common reason for mesh removal.
  • June 2016: Sepramesh and Postoperative Peritoneal Adhesions in a Rat Model.
  • The study notes that “postoperative peritoneal adhesions occurred at the extremities of the mesh, where there was close contact between the polypropylene and viscera, or where the fixation suture was placed.”
  • August 2015:Previous Methicillin-Resistant Staphylococcus Aureus Infection Independent of Body Site Increases Odds of Surgical Site Infection after Ventral Hernia Repair.
  • 768 patients underwent hernia repair. 10% experienced a hernia mesh infection. 33% of patients with a preoperative MRSA+ infection experienced a hernia mesh infection.
  • May 2014: Comparison of Outcomes of Synthetic Mesh vs Suture Repair of Elective Primary Ventral Herniorrhaphy: A Systematic Review and Meta-Analysis.
  • 637 hernia mesh repairs and 1145 suture repairs were compared. Hernia mesh repair was associated with a slightly lower rate of recurrence, but a higher rate of severe complications. The authors admit that “further high-quality studies are necessary to determine whether suture or mesh repair leads to improved outcomes for primary ventral hernias.”
  • November 2013: Coated Meshes for Hernia Repair Provide Comparable Intraperitoneal Adhesion Prevention.
  • Uncoated polypropylene was compared to various types of coated polypropylene placed intraperitonally via laparoscopic procedure. The uncoated polypropylene hernia mesh resulted in significantly more adhesions.
  • October 2013: Biologic Meshes are Not Superior to Synthetic Meshes in Ventral Hernia Repair: An Experimental Study with Long-Term Follow-Up Evaluation.
  • The study notes that “In laparoscopic incisional hernia repair, direct contact between the prosthesis and the abdominal viscera is inevitable, which may lead to an inflammatory reaction resulting in abdominal adhesion formation.” The authors advise additional research is necessary, and to be wary of short-term experimental results on laparoscopically placed hernia mesh.
  • October 2013:Intra Peritoneal Polypropylene Mesh and Newer Meshes in Ventral Hernia Repair: What EBM Says?
  • The authors are concerned about using polypropylene mesh (PPM) for laparoscopic hernia repair. They question if paying 15-20 times more for a composite mesh is worth it. The study notes “Complications of intraperitoneal PPM (adhesions, infection, intestinal fistulization, sinus formation, seroma and recurrence) can occur with the newer mesh also. There is no statistically significant difference in the incidence of these complications between these meshes.”
  • August 2012: Ventral Hernia Repair with Synthetic, Composite, and Biologic Mesh: Characteristics, Indications, and Infection Profile.
  • The study notes that polypropylene “is unsuitable for intra-abdominal placement because of its tendency to induce bowel adhesions.”
  • August 2011: Complications of Mesh Devices for Intraperitoneal Umbilical Hernia Repair: A Word of Caution.
  • The surgeons note experiencing serious complications in several patients implanted with a composite mesh. Injuries included small bowel resections and mesh removal. The study notes “We think that, if preperitoneal deployment of such mesh devices is possible, this should be the preferred position, notwithstanding the fact that these meshes have a dual layer. There is a complete lack of convincing data on these mesh devices in the medical literature.No long-term data have been published, and, for three of the four mesh devices available, no publications on their use in humans were found.”
  • July 2011: Mesh Infection in Ventral Incisional Hernia Repair: Incidence, Contributing Factors, and Treatment.
  • The study discusses the need for a better identification, classification and reporting systems for hernia mesh infections. It notes part of the difficulty is that hernia mesh implants have a tendency to remain dormant for long periods of time. It can take years before a hernia mesh infection is identified.
  • January 2010: Oral Biofilms: Emerging Concepts in Microbial Ecology.
  • The overall health and biology of an individual is closely linked to which oral biofilms develop.
  • June 2009: The Problem of Mesh Shrinkage in Laparoscopic Incisional Hernia Repair. 
  • Laparoscopic hernia repair requires expanding the abdomen with approximately 3 liters of gas. The surface area of the abdominal wall is stretched by about 80% during laparoscopic repair. Surgeons must anticipate significant mesh shrinkage in laparoscopic hernia repair. Mesh shrinkage remains one of the unsolved problems of laparoscopic incisional hernia repair.
  • How Does the FDA Learn About Hernia Mesh Complications?
  • If a hernia mesh fails within a few years and the same surgeon that implanted the mesh removes the mesh, the surgeon will sometimes report the complication to the manufacturer. It is then the manufacturers duty to determine if the complication warrants notifying the FDA. Through our investigations, we uncovered that many manufacturers fail to report adverse events related to hernia mesh to the FDA. Surgeons will also occasionally file adverse event reports directly to the FDA, but the process is very time consuming. As a result, the FDA is only aware of a very small percentage of total hernia mesh complications. The manufacturers of hernia mesh then cite to low rates of hernia mesh complications reported to the FDA as evidence that hernia mesh is safe!
  • Are There Other Ways to Report Hernia Mesh Complications to the FDA?
  • If you have suffered hernia mesh complications, you can alert the FDA through a MedWatch Report. You can also alert the FDA by filing a hernia mesh lawsuit against the manufacturer of the mesh. When a manufacturer is notified of a pending hernia mesh lawsuit, the manufacturer must report the basis of the hernia mesh lawsuit to the FDA. Medical device companies are allowed too much discretion on if they have to notify the FDA when a surgeon reports a hernia mesh adverse event. The medical device companies do not have discretion on reporting a hernia mesh lawsuit to the FDA. The companies must report every single hernia mesh lawsuit to the FDA.

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“PELVIC MESH” – WHAT’S CHANGED SINCE JANUARY 2016? HAS THE FDA LOOKED CLOSER AT THE THOUSANDS OF FILED ADVERSE EVENTS? MESH IS NOW A CLASS III HIGH RISK MEDICAL DEVICE

Who’s Telling Who About The High Risk Of Synthetic Surgical Mesh?

By Mark A. York (February 21, 2018)

Do you want polypropylene “fishing line” in your body? That’s what surgical mesh is made of.

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) FDA labels pelvic mesh as a “High Risk Medical Device” yet minimal review, investigation or action has been undertaken regarding the thousands of annual adverse events that are recognized in the medical industry as caused by “plastic or synthetic mesh” which is comparative to high quality polypropylene fishing line, which in both mesh and fishing line is available in various strengths. Is this something that’s either disclosed by your doctor and would it have an affect on your surgical decision?

WHO DISCLOSES RISK?

In January 2016, the FDA said vaginal mesh will now be classified as a “high-risk” medical device with a class III warning. Previously the implants were considered “moderate-risk” devices and carried a class II warning. Are healthcare professionals and surgical mesh manufacturers making sure this is a known factor in pre-surgical decisions? If notice to the public of the high risk designation of surgical mesh devices follows historical medical device manufacturers standards, that answer is an emphatic “NO”- medical device makers and their sales and marketing staff do not advertise or declare FDA and other regulatory defined risks to the public unless forced to, which includes patients undergoing surgeries. You physician may disclose whatever minimal product warning or risk statements that they’ve been provided by the medical product manufacturer.

DOES THIS HELP PATIENTS?

Mesh surgical implants used to repair pelvic organ prolapse in women, a condition that frequently develops after childbirth, will face tougher federal scrutiny following thousands of injuries reported with these devices.

The Food and Drug Administration said Monday that pelvic mesh will now be considered a class III, or high-risk, medical device, and manufacturers will be required to submit premarket approval applications demonstrating the safety and effectiveness of their products.

The change follows years of reports of pain, bleeding and infection among women who had the devices implanted to correct pelvic organ prolapse (POP). The condition occurs when the bladder or other reproductive organs slip out of place, causing pain, constipation and urinary issues. The new FDA requirements do not apply to mesh products used to treat other conditions such as hernias or urinary incontinence.

Plastic mesh is often used to strengthen the pelvic wall and support internal organs in cases of prolapse. The mesh is often inserted through the vagina, using a small surgical incision. The Washington Post recently reported that as many as half of women may experience pelvic floor symptoms in their lifetime, and 200,000 undergo such operations each year.

Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. The majority of surgical mesh devices currently available for use are made from man-made (synthetic) materials or animal tissue.

Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic materials used can be either absorbable, non-absorbable, or a combination of absorbable and non-absorbable materials.

WHAT IS MESH?

Animal-derived mesh are made of animal tissue, such as intestine or skin, that have been processed and disinfected to be suitable for use as an implanted device. These animal-derived mesh are absorbable. The majority of tissue used to produce these mesh implants are from a pig (porcine) or cow (bovine).

Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement in strength to the urogynecologic repair. Absorbable mesh will degrade and lose strength over time. It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended to provide strength to the repair.

Surgical mesh can be used for urogynecologic procedures, including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI. There are three main surgical procedures performed to treat pelvic floor disorders with surgical mesh:

  • Transvaginal mesh to treat POP
  • Transabdominal mesh to treat POP
  • Mesh sling to treat SUI

MESH REPAIR VERSUS SUTURES

The FDA action comes more than four years after the agency concluded that women getting vaginal mesh have more complications than women who undergo traditional surgery with stitches. Mesh products were introduced for pelvic repair in the 1990s and promoted as a way to speed patients’ recovery time. But the FDA said in 2011 that about ten percent of women experienced complications from mesh, sometimes requiring multiple surgeries to reposition or remove it.

50,000+ MESH LAWSUITS FILED

Patients have filed tens of thousands of lawsuits against mesh manufacturers, including Johnson & Johnson, Boston Scientific and Endo International. In 2014, Ireland-based Endo said it would pay $830 million to settle more than 20,000 personal injury lawsuits.  For more information see Mesh Litigation Briefcase -50,000 Cases Pending and More Each Day along with TVM mesh cases there are now two more “hernia mesh” multidistrict litigation cases , designated as “Ethicon Physiomesh MDL 2782 (Ethicon Physiomesh MDL 2782 Briefcase Re: Hernia-Mesh-Litigation) and the Atrium Medical C-Qur Hernia Mesh MDL 2753 (ATRIUM MDL 2753 Re: C-QUR-HERNIA-PATCH Briefcase) these case apply to synthetic hernia mesh complication with adverse systems and long term medical complications, being the same as those alleged in the massive TVM litigation, which are pending in federal court across the country.

In a second rule, the FDA said vaginal mesh will now be classified as a “high-risk” medical device with a class III warning. Previously the implants were considered “moderate-risk” devices and carried a class II warning.

FDA recommends that women be aware of the risks associated with surgical mesh. On an advice page on the FDA website, the agency writes: “Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options.”

Non-surgical options include pelvic floor exercises known as Kegels. There are also non-invasive devices such as the PeriCoach, a smartphone-connected pelvic floor muscle training device for incontinence.

WHY WAS THERE AN FDA DELAY?

The FDA first proposed the 2016 changes in 2014 draft orders, why would a regulatory safety agency wait two years to announce the high risk designation of a product being used over 200 thousand times a year in the USA? This reflects the back office control and influence of the medical manufacturing industry as a whole and how they use influence to defer and often stop disclosure of adverse risk s related to the medical products they sell to consumers. Profits before patient in the general rule in most device manufacturer boardrooms..

Like 90 percent of medical devices sold in the U.S., pelvic mesh was originally cleared under a streamlined FDA review process for devices deemed similar to older products. This has resulted in billions of dollars in profits for major medical manufacturers and the medical field as a whole, while thousands and thousands of patients have been afflicted with life changing post-surgical complications and until the FDA or other parties make the high risks known, many thousands more patients will have plastic products surgically implanted into their bodies, without knowing the true risks.

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The Week In Mass Torts By Mass Tort Nexus for December 18, 2017

 

 

 

 

 

 

 

 

By Mark York, Mass Tort Nexus Media

(December 21, 2017)

New Jersey Supreme Court Review Reinstatement Of Accutane Experts

The New Jersey Supreme Court recently granted petitions and cross-petitions to appeal a state appellate court’s reversal of expert exclusions in the state’s Accutane multicounty litigation and the reinstatement of 2,076 dismissed cases (In Re:  Accutane Litigation, C-388 September Term 2017, C-329 September Term 2017 and C-390 September Term 2017, N.J. Sup.) See Mass Tort Nexus Accutane Briefcase Accutane New Jersey State Court Litigation.

New Trial Denied in 3rd Xarelto MDL Bellwether Case After Defense Verdict

Judge Eldon Fallon, overseeing the Xarelto multidistrict litigation, recently denied a motion for a new trial by the plaintiff in the third bellwether trial, where Bayer was found not liable in the Dora Mingo trial that took place in a Mississippi federal court in front of Judge Fallon. He ruled that plaintiff was unsuccessful in presenting new findings, among other things, that the plaintiff’s “newly discovered evidence” is actually cumulative of previously known and admitted evidence (In Re:  Xarelto [Rivaroxaban] Products Liability Litigation, MDL Docket No. 2592, E.D. La., 2017 U.S. Dist. LEXIS 205422). See Mass Tort Xarelto Briefcase for the entire Mingo trial transcripts as well as full transcripts of the Orr and Boudreaux trials, XARELTO MDL 2592 US District Court ED Louisiana Including Trial Transcripts.

 With Last 2 Cases Gone, Pradaxa MDL Judge Again Recommends Termination

With the final two pending cases now closed, the Illinois federal judge overseeing the Pradaxa multidistrict litigation on Dec. 11 again recommended that the Judicial Panel on Multidistrict Litigation (JPMDL) terminate the MDL (In Re:  Pradaxa [Dabigatran Etexilate]Products Liability Litigation, MDL No. 2385, No. 12-md-2385, S.D. Ill.).  After a global settlement was reached in 2014 with defendant Boehringer Ingelheim Pharmaceuticals Inc., the JPMDL suspended the transfer of tag-along actions into the MDL, and now the judge has moved for termination of the Pradaxa MDL. However, there remains over 700 Pradaxa cases pending in the State Court of Connecticut, Complex Litigation Docket, known as “Connecticut Pradaxa Actions”, see Mass Tort Nexus Pradaxa Case Briefcase,  Connecticut Consolidated Pradaxa Litigation.

Boehringer To Pay $13.5M To End Off-Label Marketing Claims

Drugmaker Boehringer Ingelheim Pharmaceuticals Inc. has agreed to distribute $13.5 million among all 50 states and the District of Columbia to end allegations that it marketed four of its prescription drugs for off-label uses, attorneys general announced Wednesday.
The settlement would resolve allegations that Boehringer marketed its prescription drugs Micardis, Aggrenox, Atrovent and Combivent for uses that weren’t approved by their labels or backed by scientific evidence. (Getty) The settlement, of which New York will receive about $490,000, would resolve allegations that the drugmaker marketed it products for off-label use, which often leads to unknown or studied adverse events and medical complications for patients taking these drugs for unapproved purposes.

 J&J Fined $30 Million Over French Opioid Drug Smear Campaign In Efforts To Sell Fentanyl Patch

France’s antitrust enforcer fined Johnson & Johnson and its Janssen-Cilag unit €25 million ($29.7 million) on Wednesday for hindering the marketing and sale of a generic version of the company’s Durogesic pain patch.The French Competition Authority found that Janssen and J&J had not only successfully delayed a generic competitor for the powerful opioid for several months, but had also done lasting damage by discrediting rival versions of the drug with doctors and pharmacists in a country where medical professionals still remain reluctant to opt for prescribing opioids.  The J&J conduct reflects the same claims being asserted against opioid drug makers in the US, where lawsuits have been consolidate into Opiate Prescription Litigation MDL No. 2804, in the US District Court of Ohio, see Mass Tort Nexus Opioid Crisis Briefcase, OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION.

11th Circuit Affirms Pelvic Mesh Group Trial, Exclusion Of 510(k) Status

(October 24, 2017, 1:25 PM EDT) -The 11th Circuit U.S. Court of Appeals on Oct. 19 said multidistrict litigation court judge did not err in consolidating four pelvic mesh cases for a bellwether trial and in excluding the so-called 510(k) defense raised by defendant Boston Scientific Corp. (BSC) (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818, 11th Cir., 2017)   See Mass Tort Nexus Mesh Case Briefcase, All Pelvic Mesh Litigation Case Files.

Preemption Summary Judgment Reversed By 9th Circuit In Incretin Mimetic MDL Appeal

The Ninth Circuit U.S. Court of Appeals on Dec. 6 unsealed its Nov. 28 opinion reversing summary judgment in the incretin mimetic multidistrict litigation, saying the MDL judge misapplied a U.S. Supreme Court precedent, improperly blocked discovery, misinterpreted what constituted new evidence and improperly disqualified a plaintiff expert (In Re:  Incretin-Based Therapies Products Liability Litigation, Jean Adams, et al. v. Merck Sharp & Dohme Corp., et al., No. 15-56997, 9th Cir., 2017 )

Pennsylvania Appeals Court Affirms $29.6M Remitted Zimmer Knee Judgment

A Pennsylvania appeals court panel on Dec. 15 said a trial judge did not err when remitting a Zimmer Inc. knee verdict to $29.6 million and said it declined to substitute its judgment in place of the jury’s (Margo Polett, et al. v. Public Communications, Inc., et al., No. 80 EDA 2017, Pa. Super., 2017 Pa. Superior Court)

Risperdal Gynecomastia Cases Barred By Michigan Shield Law, Pennsylvania Panel Says

A Pennsylvania state appeals panel on Nov. 28 affirmed the dismissal of 13 Risperdal gynecomastia cases, agreeing with a trial judge that the plaintiffs’ claims are preempted by Michigan’s drug shield law and that the plaintiffs could not prove that the fraud exception

applied to their claims (In Re:  Risperdal Litigation versus Janssen Pharmaceuticals Inc., et al., No. 55 EDA 2015, et al., Pennsylvania Court of Appeals, 2017.

U.S. Supreme Court Asks Solicitor General To Weigh In On Fosamax Preemption

The U.S. Supreme Court on has invited the U.S. solicitor general to express the views of the United States on whether there is “clear and convincing evidence” that the Food and Drug Administration would have rejected a stronger warning about femur fractures from the osteoporosis drug Fosamax (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Supreme Court)  This is a unique turn when the Supreme Court is seeking input from an outside agency in what is now a common legal issue placed in front of the court, where dug makers are using the FDA regulatory process as a shield in defending thousands of claims where warnings of drug dangers are not clear or not provided. See Mass Tort Nexus Fosamax Case Briefcase, FOSAMAX MDL 2243 (FEMUR FRACTURE CLAIMS).

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WEEKLY MDL and MASS TORT UPDATE by MASS TORT NEXUS for Week of November 27, 2017

By Mark A. York (November 30, 2017)

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This week in mass torts around the country:

Opioid Crisis: See Mass Tort Nexus Briefcase Re: OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION

> Superseding indictments of Insys Therapeutics Executives Unsealed in USDC of Massachusetts

BOSTON — A federal indictment against seven high-ranking officers of opioid maker Insys Therapeutics Inc. was unsealed Oct. 26 in a Massachusetts federal court charging the men with racketeering, mail fraud and conspiracy for a scheme to pay kickbacks to doctors for, and to fraudulently induce health insurers into approving, off-label prescriptions for the company’s addictive Subsys fentanyl spray (United States of America v. Michael L. Babich, et al., No. 16-cr-10343, D. Mass.).

>Doctor Pleads Guilty To Opioid Health Care Fraud, Taking Kickbacks From Insys

PROVIDENCE, R.I. — A Rhode Island doctor on Oct. 25 pleaded guilty to health care fraud and taking kickbacks for prescribing the opioid Subsys to unqualified patients (United States of America v. Jerrold N. Rosenberg, No. 17-9, D. R.I.).

 > Opioid Distributors Support MDL While Municipalities Oppose

WASHINGTON, D.C. — The “Big Three” national drug distributors on Oct. 20 told a federal judicial panel that they support centralization of more than 60 opioid lawsuits filed against them by various cities and counties (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, JPML).

Related Mass Tort Nexus Opiod Articles:

>California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense: Will other insurers say no to opioid coverage? Nov 15, 2017

>Targeting Big Pharma and Their Opiate Marketing Campaigns: Across The USA Nov 3, 2017

For more Mass Tort Nexus Opiod Crisis Information See: Mass Tort Nexus Newsletters and MDL Updates

IVC FILTERS:

Cook Medical IVC: See Mass Tort Nexus Briefcase Re: Cook Medical IVC Filter MDL 2570

>First Cook IVC Bellwether Trial Starts in USDC SD of Indiana

INDIANAPOLIS — The first bellwether trial in the Cook Medical Inc. inferior vena cava (IVC) filter multidistrict litigation got under way on Oct. 23 in Indianapolis federal court (In re:  Cook Medical, Inc., IVC Filters Litigation, MDL Docket No. 2570, No. 14-ml-2570, Elizabeth Jane Hill v. Cook Medical, Inc., No. 14-6016, S.D. Ind., Indianapolis Div.).

Cordis IVC Filters: See Cordis IVC Filter Litigation Alameda County, California Superior Court

>Cordis IVC Filter Plaintiffs Tell Supreme Court Trial Proposal Is No ‘Mass Action’

WASHINGTON, D.C. — Plaintiffs in an inferior vena cava (IVC) filter case on Oct. 18 told the U.S. Supreme Court that their suggestion of individual bellwether trials does not convert their actions into a mass action under the Class Action Fairness Act (CAFA), 119 Stat. 4 (Cordis Corporation v. Jerry Dunson, et al., No. 17-257, U.S. Sup., 2017 U.S. S. Ct. Briefs LEXIS 4013).

Taxotere: See Taxotere MDL 2740 (US District Court Eastern District of Louisiana)

>Taxotere MDL Judge Denies Statute of Limitations Motion by Sanofi

NEW ORLEANS — The Louisiana federal judge overseeing the Taxotere multidistrict litigation on Oct. 27 denied without prejudice a motion by defendant Sanofi-Aventis U.S. LLC to dismiss claims barred by applicable statutes of limitations (In Re:  Taxotere [Docetaxel] Products Liability Litigation, MDL Docket No. 2740, No. 16-md-2740, E.D. La.).

Pelvic Mesh: Boston Scientific TVM Litigation MDL 2362

>Exclusion of 510(k) Defense in Boston Scientific Pelvic Mesh Case:

ATLANTA — The 11th Circuit U.S. Court of Appeals on Oct. 19 said multidistrict litigation court judge did not err in consolidating four pelvic mesh cases for a bellwether trial and in excluding the so-called 510(k) defense raised by defendant Boston Scientific Corp. (BSC) (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818, 11th Cir., 2017 U.S. App. LEXIS 20432).

PLAVIX: See Mass Tort Nexus Briefcase Re: PLAVIX MDL 2418 USDC NEW JERSEY

>Plaintiff Loses Plavix Case on Summary Judgment Over Late “Learned Intermediary” Declaration

TRENTON, N.J. — The judge overseeing the Plavix multidistrict litigation on Oct. 26 granted summary judgment in a case after ruling that the plaintiff’s “eleventh hour” declaration by one treating physician did not overcome California’s learned intermediary defense for defendants Bristol-Myers Squibb Co. (BMS) and Sanofi-Aventis U.S. Inc. (In Re:  Plavix Products Liability Litigation, MDL Docket No. 2418, No. 13-4518, D. N.J., 2017 U.S. Dist. LEXIS 177588).

Abilify MDL 2734: Mass Tort Nexus Briefcase Re: Abilify MDL 2734

 >Abilify MDL Judge Orders Defendants To Name Settlement Counsel

PENSACOLA, Fla. — The Florida federal judge overseeing the Abilify multidistrict litigation on Oct. 25 ordered the defendants to engage settlement counsel for monthly settlement conferences (In Re:  Abilify [Aripiprazole] Products Liability Litigation, MDL Docket No. 2734, No. 16-md-2734, N.D. Fla., Pensacola Div.).

Mirena IUD: Related-Federal Court Reopens Mirena IUD Product Liability MDL Nov 3, 2016

>2nd Circuit Affirms Exclusion Of Mirena MDL Experts, Termination Of Litigation

NEW YORK — The Second Circuit U.S. Court of Appeals on Oct. 24 affirmed the exclusion of general causation experts in the Mirena multidistrict litigation and a court order terminating the MDL before any trials were held (In Re:  Mirena IUD Products Liability Litigation, Mirena MDL Plaintiffs v. Bayer HealthCare Pharmaceuticals, Inc., Nos. 16-2890 and 16-3012, 2nd Cir., 2017 U.S. App. LEXIS 20875).

Hip ImplantsSee Mass Tort Nexus Briefcase Re: Wright Medical, Inc. MDL 2329 Conserve Hip Implant Litigation

>Wright Medical Settles Remaining Wright Hip Cases; Judge Closes MDL 2329

ATLANTA — Wright Medical Technology Inc. and plaintiffs in a multidistrict litigation have entered two additional agreements settling the remainder of the litigation, a Georgia federal judge said Oct. 18 (In Re:  Wright Medical Technology, Inc., Conserve Hip Implant Products Liability, MDL Docket No. 2329, No. 12-md-2329, N.D. Ga., Atlanta Div

Testosterone Replacement Therapy: See Mass Tort Nexus Briefcase Re: TESTOSTERONE MDL 2545 (AndroGel)

>Testosterone Bellwether Out and Pre-emption Denied

CHICAGO — An Illinois multidistrict litigation judge on Oct. 23 granted summary judgment in one of two testosterone replacement therapy bellwether cases but denied preemption in the second case (In Re:  Testosterone Replacement Therapy Litigation, MDL Docket No. 2545, No. 14-1748, N.D. Ill., Eastern Div., 2017 U.S. Dist. LEXIS 176522).

 

>AbbVie, AndroGel Plaintiff Spar Over Mixed Verdict In 1st Bellwether Trial Verdict

CHICAGO — AbbVie on Oct. 25 urged the judge overseeing the testosterone replacement therapy multidistrict litigation to not disturb a bellwether trial verdict where a jury awarded $0 compensatory damages (In Re:  Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, Jesse Mitchell v. AbbVie, No. 14-9178, N.D. Ill.).

Fosamax MDL 1789: See Mass Tort Nexus Briefcase Re: MDL 1789 Fosamax Products Liability Litigation USDC New Jersey

>Fosamax Femur Plaintiffs Urge Supreme Court To Deny Preemption Review

WASHINGTON, D.C. — Counsel for more than 500 Fosamax femur fracture plaintiffs on Oct. 25 urged the U.S. Supreme Court to deny certiorari to Merck Sharp & Dohme Corp., arguing that their claims are not preempted by “clear evidence” that the Food and Drug Administration would have rejected stronger warnings for the osteoporosis drug (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Sup., 2017 U.S. S. Ct. Briefs LEXIS 4064

 

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