BARD HERNIA MESH MDL 2846: WHAT YOU NEED TO KNOW TO GET INVOLVED

IS YOUR FIRM LOOKING AT THE BARD HERNIA MESH LITIGATION?

By Mark A. York (October 9, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) One of the fastest growing emerging mass torts is the C.R. Bard/ Davol, Polypropylene Hernia Mesh Products Liability Litigation, MDL No. 2846, (Judge Edmund A. Sargus, US District Court, Southern District of Ohio). Bard/Davol controls close to 70 percent of the hernia mesh implant market in the United States and have for close to 10 years, and by simply doing the math you can calculate the number of cases that will be filed into the MDL.

With more than 300,000 surgical mesh implant procedures per year, and a conservative failure rate of 20% and Bard’s 70% market share, the numbers for just the last 5 years would exceed 200,000 potential cases. Using the same figures reflects over 42,000 potentially new failures per year, and accordingly the number of potential cases.

For real time case docket information see the Mass Tort Nexus briefcase: BARD-DAVOL-Hernia-Mesh-MDL-2846-(Polypropylene-Mesh)-USDC-Southern-District-of-Ohio

The U.S. National Library of Medicine reports that incisional hernia repair involving mesh has a recurrence rate of 20-45%. Overall, patients with complex ventral hernias (a bulge in the abdominal wall which can include incisional hernias) have a recurrence rate of approximately 30-40% nationally.

Additional synthetic mesh failure data: “Hernia Reoperation Rate Underestimates Real Recurrence Numbers”. American College of Surgeons, Oct. 24, 2017

http://www.mdedge.com/acssurgerynews/article/55911/general-surgery/hernia-reoperation-rate-underestimates-real-recurrence

Discussions on the Bard Hernia Mesh MDL 2846 took place with Kelsey L. Stokes of Fleming, Nolen & Jez, L.L.P., Houston, Texas, co-lead counsel, who commented “We represent hundreds of clients that have been seriously injured by hernia mesh products manufactured by Davol/C.R. Bard.  We have observed that these devastating injuries are occurring all across the United States.

For additional case related information or potential case referrals, please contact Kelsey Stokes at Kelsey_Stokes@fleming-law.com.

MESH WARNINGS OFFERED LONG AGO

The history of synthetic mesh failures and formal warnings being raised can be traced back more than 20 years, after news broke that mesh firms were warned 21 years ago about the risks of the device’s material. Court filings and other sources reveal that manufacturers were warned decades ago that plastic should not be used to make implants.

CR Bard and its subsidiary Davol were allegedly warned that they should discontinue their use of polypropylene resin back in 1997.

Marlex, the Bard supplier of the synthetics resins,  said repeatedly that they were afraid of being sued if the product was used in implants. In 2004, formal warning notices were sent stating that Marlex was “not for human implantation” and told medical mesh companies that they did not want their custom mesh products used “at any price.”

In an email, CR Bard vice president Roger Darois said “We purchase our polypropylene monofilament from an extrusion supplier who purchases the resin directly from the resin manufacturers,” he said. “Thus, it is likely that they do not know of our implant application. Please do NOT mention Davol’s name in any discussions with these manufacturers. In fact, I would advise purchasing the resign through a third party, not the resin supplier, to avoid a supply issue once the medical application is discovered”

 Different Types Of Mesh Placement

  • Overlay– The hernia mesh is placed between the skin/subcutaneous tissue and the rectus abdominis. Mesh is easiest to remove when it is placed in the overlay position.
  • Inlay– The hernia mesh is placed between layers of the rectus abdominis.
  • Underlay– The hernia mesh is placed between the rectus abdominis and the peritoneum. The hernia mesh has a higher chance of attaching to the patients underlying organs when placed in the underlay position.

THE BARD MDL 2846 POLYPROPYLENE HERNIA MESH PRODUCTS

  • Composix
  • Composix E/X
  • Composix L/P
  • Ventralight
  • Spermatex
  • Sepramesh
  • Ventralex
  • Ventralex ST
  • Kugel Patch
  • Composix Kugel
  • Ventrio
  • Visilex
  • Ventrio ST
  • Marlex (AKA Flat Mesh; Bard Mesh)
  • Perfix Plug
  • Perfix Light Plug
  • 3D Max-Lite
  • 3D Max

 

FDA Hernia Surgical Mesh Implants Information and Links

FDA describes hernias, the different treatment options to repair hernias and recommendations for patients that are considering surgery for their hernias. The FDA wants to help patients make informed decisions about their health care and to facilitate a discussion between patients and their surgeons

Official FDA Links: Hernia Surgical Mesh

htts://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/ucm317438.htmsurgeons.

 https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/ucm317440.htm

 https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/ucm317438.htm

 Hernia Surgical Mesh Implants- Reporting of Adverse Events to the FDA

(Review these sources and checklists for case evaluation and product identification)

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with surgical mesh, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

FDA Related Hernia Mesh Information:

Hernia mesh specifics:

  • Manufacturer’s name
  • Product name (brand name)
  • Catalog number
  • Lot number
  • Size
  • Date of implant
  • Date of explant (if mesh was removed)

Hernia repair involving surgical mesh operation specifics:

  • Preoperative diagnosis, postoperative diagnosis and operative procedure
  • Hernia description including size, location, and status (e.g. reducible, sliding, nonreducible, strangulated)
  • Mesh placement (e.g. onlay, underlay, bridging, extent of fascial overlap, fixation method)

Adverse event specifics:

  • Description of the problem including time of onset, inciting factors and severity,
  • Time to resolution
  • Detailed description of the medical and/or surgical interventions (if required) undertaken in response to the adverse event

What is a Hernia?

A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue. Hernias often occur at the abdominal wall.  Sometimes a hernia can be visible as an external bulge particularly when straining or bearing down.

Types of Hernias

The most common types of hernias are:

  • Inguinal:occurs in the inner groin
  • Femoral:occurs in the upper thigh/outer groin
  • Incisional:occurs through an incision or scar in the abdomen
  • Ventral:occurs in the general abdominal/ventral wall
  • Umbilical:occurs at the belly button
  • Hiatal:occurs inside the abdomen, along the upper stomach/diaphragm

Causes of Hernias

Most hernias are caused by a combination of pressure and an opening or weakness of muscle or connective tissue. The pressure pushes an organ or tissue through the opening or weak spot. Sometimes the muscle weakness is present at birth but more often it occurs later in life. Anything that causes an increase in abdominal pressure can cause a hernia, including obesity, lifting heavy objects, diarrhea or constipation, or persistent coughing or sneezing. Poor nutrition, smoking, and overexertion can weaken muscles and contribute to the likelihood of a hernia.

Treatment Options for Hernias

Hernia repairs are common—more than one million hernia repairs are performed each year in the U.S. Approximately 800,000 are to repair inguinal hernias and the rest are for other types of hernias.1

  • Non-Surgical
    • Watchful Waiting– Your surgeon will watch the hernia and make sure that it is not getting larger or causing problems. Although surgery is the only treatment that can repair hernias, many surgical procedures are elective for adult inguinal hernias. Watchful waiting is an option for people who do not have complications or symptoms with their hernias, and if recommended by their surgeon.
  • Surgical
    • Laparoscopic– The surgeon makes several small incisions in the abdomen that allow surgical tools into the openings to repair the hernia. Laparoscopic surgery can be performed with or without surgical mesh.
    • Open Repair– The surgeon makes an incision near the hernia and the weak muscle area is repaired. Open repair can be done with or without surgical mesh. Open repair that uses sutures without mesh is referred to as primary closure. Primary closure is used to repair inguinal hernias in infants, small hernias, strangulated or infected hernias.

Hernias have a high rate of recurrence, and surgeons often use surgical mesh to strengthen the hernia repair and reduce the rate of recurrence. Since the 1980s, there has been an increase in mesh-based hernia repairs—by 2000, non-mesh repairs represented less than 10% of groin hernia repair techniques.

The use of surgical mesh may also improve patient outcomes through decreased operative time and minimized recovery time. However, recovery time depends on the type of hernia, the surgical approach, and the patient’s condition both before and after surgery.

Information found in medical literature has consistently demonstrated a reduced hernia recurrence rate when surgical mesh is used to repair the hernia compared to hernia repair without surgical mesh. For example, inguinal hernia recurrence is higher with open repair using sutures (primary closure) than with mesh repair2.

Despite reduced rates of recurrence, there are situations where the use of surgical mesh for hernia repair may not be recommended. Patients should talk to their surgeons about their specific circumstances and their best options and alternatives for hernia repair.

 What is Surgical Mesh

Surgical mesh is a medical device that is used to provide additional support to weakened or damaged tissue. The majority of surgical mesh devices currently available for use are constructed from 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 absorbable, non-absorbable or a combination of absorbable and non-absorbable materials.

Animal-derived mesh are made of animal tissue, such as intestine or skin, that has 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) source.

Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement to the repaired hernia. 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.

Hernia Repair Surgery Complications

Based on FDA’s analysis of medical device adverse event reports and of peer-reviewed, scientific literature, the most common adverse events for all surgical repair of hernias—with or without mesh—are pain, infection, hernia recurrence, scar-like tissue that sticks tissues together (adhesion), blockage of the large or small intestine (obstruction), bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the surgical site (seroma), and a hole in neighboring tissues or organs (perforation).

The most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).

Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.

Please refer to the recall notices here for more information if you have recalled mesh. For more information on the recalled products, please visit the FDA Medical Device Recall website. Please visit the Medical & Radiation Emitting Device Database to search a specific type of surgical mesh.

If you are unsure about the specific mesh manufacturer and brand used in your surgery and have questions about your hernia repair, contact your surgeon or the facility where your surgery was performed to obtain the information from your medical record.

The FDA approved most Bard hernia mesh devices for use in hernia repair surgical procedures through the FDA 510(k) process.  The 510k process does not require a manufacturer to prove that a product is safe for its intended use, but merely requires a showing that a device is a “substantive equivalent” to a product or products already approved by the FDA.  In fact, post-approval, the FDA has advised consumers that adverse events as a result of hernia mesh devices are possible.  The FDA did so as a result of receiving a number of complaints about hernia mesh devices in general.(2)

According to the FDA, “[t]he most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).” (3)

Hernia Mesh Injuries And 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 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.

In addition to the Bard MDL 2846, there is other hernia mesh litigation in courts across the country, including the Ethicon Physiomesh MDL 2782, Judge Richard W. Story, US District Court-Northern District of Georgia. For current information on MDL 2782, see the Mass Tort Nexus briefcase Ethicon-MDL-2782-Physiomesh-Hernia-Mesh-Litigation for all up to date docket and case filing information.

There is also the Ethicon Physiomesh New Jersey State Court Multi-county litigation, see Ethicon Physiomesh MCL Designation to Superior Court Atlantic County Notice (New Jersey Supreme Court Aug 15, 2018), for information and to discuss potential referrals in the New Jersey Ethicon Physiomesh litigation contact, Joshua S. Kincannon, at JKincannon@lomurrofirm.com, where Josh is the head of the LoMurro Firm mass tort practice group in Freehold, NJ.

Meet The Hernia Mesh Lead Counsel in November
Kelsey Stokes, lead counsel in the Bard MDL 2846 from the Fleming, Nolen & Jez firm and Joshua Kincannon, lead counsel on the New Jersey Ethicon Physiomesh litigation from the LoMurro Firm will both be speaking at the upcoming Mass Tort Nexus “CLE Immersion Course” November 9 -12, 2018 at The Riverside Hotel in Fort Lauderdale , FL.  
For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.
For the most up to date information on all MDL dockets and related mass torts visit www.masstortnexus.comand review our mass tort briefcases and professional site MDL briefcases.
To obtain our free newsletters that contain real time mass tort updates, visit www.masstortnexus.com/news and sign up for free access.  

 

 

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