FDA – Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma: Who Knew and When?

A Litigation Review by Mass Tort Nexus

July 30, 2019

https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan

By Mark A. York 

(Mass Tort Nexus Media) The  Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Since the FDA’s decision, the breast implant business has boomed, now exceeding $1 billion in revenue a year and projected to reach $2 billion by 2025. More than 1.6 million women worldwide received cosmetic breast implants in 2017, including an estimated 345,236 in the U.S., 235,950 in Brazil, 67,478 in Mexico and 54,045 in Italy. As of 2017, breast enlargement was the most common cosmetic surgery in the world.

Link to: FDA criminal-investigations/warning-letters/mentor-worldwide to Alex Gorsky CEO Mentor (J&J) March 18, 2019 -llc-acclarent-573520-03182019

To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. Allergan agreed and is removing these products from the global market. The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.

What is the connection between textured breast implants and cancer?

Studies have shown that patients with textured implants face a higher risk of a rare form of cancer called breast implant associated anaplastic large cell lymphoma (BIA ALCL). BIA ALCL is not a breast cancer but a cancer of the immune system. Plastic surgeons have identified at least 688 cases of BIA ALCL worldwide, as of February 2019. The FDA estimates the risk of BIA ALCL among patients with textured implants as between 1 in 3,817 and 1 in 30,000, but newer data from Australia has placed the risk as high as 1 in 1,000.

While the vast majority of BIA ALCL cases occur in patients with textured implants, the FDA has identified at least 24 in patients with smooth-surfaced implants.

Breast Implants Can Cause Cancer

There is now a link between cancer and breast implants emerging in scientific and medical circles. Just recently in France, their National Cancer Institute released a study that found a “clearly established link” between Anaplastic large cell lymphoma (ALCL) and breast implants. French officials have now recommended that breast implants in their country must carry a “cancer warning.”

There is also more evidence to back this connection now that a study conducted by Cambridge University in the UK found that nearly all cases of ALCL were discovered in women who had breast implants.

When you think about how breast implants are inserted — indeed it is quite gory and gruesome surgery — and about the horrific chemicals they are comprised of, it makes sense that they would, of course, pose a cancer risk. And now we have the data to support this.

The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC (Johnson & Johnson)

Sientra, Inc.

 

Melissa Shirley vs. Mentor Worldwide (J&J) Complaint USDC ND Georgia (May 15, 2017)

 Silicone Breast Implant Lawsuit Not Preempted, Case to Proceed USDC ND Illinois Ruling

As of July 6, 2019, the Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This total includes all MDRs the FDA received with any mention of “ALCL” or other spelling variations (for example, “anaplastic lymphoma,” or “anaplastic”) in the event narrative. BIA-ALCL MDRs are counted for those reporting a diagnosis or treatment of ALCL, or confirmed pathology/cytology test, or Anaplastic Lymphoma Kinase (ALK) and CD30 biomarkers.

The tables below summarize unique BIA-ALCL MDR data from the U.S. and worldwide that the FDA has received as of July 6, 2019.

Table 1: Summary of US and Global Deaths Reported in MDRs Received as of July 6th, 2019 (N = 33)

https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma

These data are a tabulation of global deaths reported in MDRs and literature reported as MDRs submitted to the FDA.  We excluded apparent duplicates. The data is stratified by factors that we considered in our analysis.

ALCL Deaths from MDRs and Literature reported as MDRs* Deaths through 7/6/29 (n=33)
n %a
Age at time of diagnosis (years) Median 52
Range 37-83
Not specified (# of reports) 13 39
Time from the last implant to diagnosis (years) Median 9
Range 1-20
Not specified (# of reports) 23 70
Implant Surface Textured 15 48
Smooth* history of textured 1 3
Not specified 17 48
Implant Fill Silicone 14 42
Saline 8 24
Not specified 11 33
Reason for Implant Reconstruction 5 15
Augmentation 17 52
Not specified 11 33
Clinical presentation (breast)b Seroma 6 18
Breast swelling/pain 3 9
Capsular contracture 1 3
Peri-implant mass/lump 13 39
Others 7 21
Not specified 7 21
Anaplastic lymphoma kinase (ALK) Positive 0  0
Negative 12 36
Not specified 21 64
CD30 Statusc Positive 12 36
Negative 0 0
Not specified 21 64
Implant manufacturer Allergan 12 36
Mentor 1 3
Unknown 20 61
Reporter country: US or OUSd US 12 36
OUS 21 64
Not specified 0 0

a Percentage in terms of the total 33 deaths. There are no reports of deaths associated with tissue expanders.
b MDRs sometimes list more than one clinical presentation, e.g. seroma and peri-implant mass/lump, in which two presentations were counted.
c CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and BIA-ALCL.
d US/OUS is counted as the country reported in the narrative or the recorded reporter’s country in the MedWatch form.
* Includes 1 case of B-Cell Lymphoma

Table 2: Summary of US and Global Data as of July 6, 2019 (N=573)

These data are a tabulation of US and global BI-ALCL cases reported to the FDA in MDRs.  We excluded apparent duplicates.  The data is stratified by factors we considered in our analysis.

Unique ALCL cases1 Cases through 9/30/18
(n=457)
Cases through 7/6/19
(n=573)
n %a n %b
Age at time of diagnosis (years) Median 53 53
Range 27-90 27-90
Not specified (# of reports) 111 24 161 28
Time from the last implant to diagnosis (years) Median 9 8
Range 0-34 0-34
Not specified (# of reports) 110 24 169 29
Implant surface Textured 310 68 385 67
Smooth 24 5 26c 5
Not specified 123 27 162 28
Implant fill Silicone 274 60 343 60
Saline 183 40 197 34
Not specified 0 0 33 6
Reason for implant Reconstruction 108 24 115 20
Augmentation 104 23 111 19
Not specified 245 54 347 61
Clinical presentation (breast)d Seroma 266 58 302 53
Breast swelling/pain 135 30 150 26
Capsular contracture 69 15 73 13
Peri-implant mass/lump 82 18 94 16
Others 43 9 56 10
Not specified 105 23 147 26
Anaplastic lymphoma kinase (ALK) Positive 0  0 0 0
Negative 229 50 255 45
Not specified 228 50 318 55
CD30 statuse Positive 215 47 246 43
Negative 0  0 0 0
Not specified 242 53 327 57
Implant manufacturer Allergan* includes McGhan, Inamed 386 84 481 84
Mentor 36 8 38 7
Sientra 2 0.4 6 1
Other Manufacturerf 5 1 6 1
Unknown Manufacturer 28 6 42 7
Reporter country: US or OUSg US 276 48 320 56
OUS 181 32 253 44
Not specified 0 0 0 0

1Patients with bilateral BIA-ALCL are counted as 2 cases of BIA-ALCL.
a Percentage in terms of the total 457 MDRs.
b Percentage in terms of the total 573 MDRs.
c In the 26 cases of smooth implants, 12 have unknown prior history of implants, 7 have a history of textured implants, and 7 have a history of prior implants with an unknown texture. There are no reports of cases associated with tissue expanders.
d MDRs sometimes list more than one clinical presentation, e.g., seroma and peri-implant mass/lump, in which two presentations were counted.
e CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and BIA-ALCL.
f Other Manufacturers include: Bristol Myers Squib, Nagor, Polytech Silimed, Silimed and Sientra/Silimed
g US/OUS is counted as the recorded reporter’s country in the MedWatch form, or if the event was noted to be from a foreign source in box G3 of the MedWatch form. Please note that the reporter country may not reflect the country where the event occurred or the country where the device is marketed.

History of Adverse Events Has Been Known 

The FDA has  coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updates to the public regarding BIA-ALCL.

According to a complex analysis of FDA adverse event data, the number of suspected breast implant injuries jumped from an average of fewer than 200 a year through 2016, before the FDA’s more rigorous reporting rules, to 4,567 events in 2017 and at least 8,242 in the first half of 2018. More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.

The agency was aware of the true number of reported injuries but did not disclose them until recently. In Europe, some manufacturers have avoided reporting ruptures altogether, Dutch regulators were told. This was discovered during the  International Consortium of Investigative Journalists long term investigation titled, Implant Files investigation , which revealed the ongoing health problems plaguing many thousands of women with breast implants as part of its global research project that was released in November 2018.

Experts worldwide agree that more long-term studies are desperately needed, but neither Allergan nor Johnson & Johnson’s Mentor completed the studies of 40,000 women ordered by the FDA.  After two years, about 40 percent of the participants in the breast augmentation section of the Allergan study had dropped out; after three years, Mentor had lost about 80 percent of its breast augmentation study subjects.

The FDA now says that although it does not have evidence to support a link between breast implants and systemic illness, safety studies “would need to be much larger and longer than those conducted so far” to clearly rule out an association. Allergan and Mentor faced no consequences for failing to complete the mandatory studies.

In September 2018, researchers at the MD Anderson Cancer Center in Houston reported the results of the largest-ever long-term safety study of breast implants. The study found associations between silicone implants and three autoimmune diseases. In the same month, an Israeli study of tens of thousands of women also discovered a link between breast implants and autoimmune diseases. Several smaller studies conducted in recent years in the Netherlands and the U.S., reached similar conclusions.

In March 2017, the FDA issued a breast implant cancer warning, indicating that it was aware of at least 359 medical device reports involving women diagnosed with a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The illness has been linked to at least nine deaths.

The agency indicated at the time that the lymphoma cases appeared to be more common among breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not able to be made.

Australia’s Therapeutic Goods Administration (TGA) launched an effort monitor the association between breast implants and anaplastic large cell lymphoma, more than doubling the recognized number of cases identified among Australian patients between September 2016 and April 2017.

Researchers from the TGA published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.

The TGA has estimated that the breast implant lymphoma risk may be between 1-in-1,000 and 1-in-10,000, with most cases occurring between 3 and 14 years after implant, but the median being 8 years and some cases diagnosed as much as 37 years after breast surgery,

Due to the potential lymphoma risk with breast implants, regulators have made efforts to increase awareness among health care providers about cases of the rare cancer linked to textured breast implants, indicating that they should discuss the benefits and side effects of the implants with their patients.

The FDA has also recommended that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.

Each year in the United States more than 300,000 women and undergo breast augmentation, with the total number of breast implants procedures each year being  anywhere between 5 to 10 million around the world.

Before the operations women are often told by their surgeons that it is a safe procedure with “very little” risk, with the . FDA generally supporting that incorrect statement, by offering that “breast implants are relatively safe” which is now being shown to be very inaccurate.

There is a growing body of evidence, now supported by  thousands of examples of adverse events from women all over the world who have had implants. Facts are emerging that breast implants have been and continue to cause  debilitating autoimmune disorders  as well as emerging evidence of links to certain types of cancer.

No implant on the market today can last a lifetime. Every type is prone to leaking and rupturing, and instance, the saline valve implants, can even become black with mold, causing a systemic fungal problem in a person’s body.

Breast implant lawsuits are underway as of October 2016. In March 2017, the FDA issued a warning confirming that breast implants cause ALCL cancer. Lawsuits for ladies with BIA-ALCL are currently being organized. In April 2017, a bipartisan bill called the Medical Device Safety Act H.R. 2164 was introduced and needs your help in being passed to hold the manufacturers accountable for the harm they have caused. In January 2018, a Mentor MemoryGel Silicone Breast Implant case was able to in part pass preemption.

Background:

In the early 2000s, Allergan and Mentor were approved for premarket Investigational Device Exempt (IDE) studies where a limited number of plastic surgeons were allowed to use silicone breast implants, accordingly they were supposed to inform women of the study and follow up on them. In November 2006, Mentor and Allergan silicone breast implants were conditionally approved and six postmarket studies were to be conducted, see Mentor Approval Order and Allergan (formerly Inamed) Approval Order. The manufacturer premarket and postmarket studies have overall failed to follow up on women and provide real statistics on health problems that arise.

Presently, in 2018, there are over 50,000 women in breast implant illness Facebook support groups. Similar to the Dow times, the manufacturers have again pushed a campaign marketing the safety and inertness of implants rather than disclosing the truth of lack of real statistics and follow ups, the adjuvant immunologic effects of silicone, and the numerous heavy metals and chemicals used in manufacturing. With the lack of awareness on the matter, there is currently a public health crisis as the medical community at large has failed to help women identify breast implants as playing a role in their symptoms and has led to many misdiagnoses, unnecessary medications and treatments, and body parts being removed (thyroid, gall bladder, uterus, etc.). History is repeating itself and the manufacturers need to be held accountable for the alleged lack of informed consent and toxicity caused by saline and silicone breast implants.

Current Breast Implant Lawsuits:

Silicone

  • Weber v. Allergan (2012)
  • Ebrahimi v. Mentor (2016)
  • Mize v. Mentor Nguyen v. Mentor (Spouse Plaintiff) (2017)
  • Gravitt v. Mentor Gravitt v. Mentor (Spouse Plaintiff) (2017)
  • Skelton v. Allergan – BIA-ALCL (2018)
  • Cashen v. Mentor | Cashen v. Mentor (Spouse Plaintiff) – BIA-ALCL (2018)
  • Rea v. Allergan – BIA-ALCL (2018)
  • Vieira et al v. Mentor Worldwide, LLC et al (2018)
  • Sewell et al v. Mentor (2018)

Saline

  • Laux v. Mentor (2015)
  • Allergan Saline Lawsuits (2016)

Mentor Silicone Breast Implant Lawsuits:

Lawsuit Filed Against Mentor Worldwide Over Mentor MemoryGel Silicone Breast Implants 

(September 28, 2016)

A Seattle woman, Sara Ebrahimi, has filed suit against Mentor Worldwide LLC and its parent company, Johnson & Johnson Services, Inc., alleging the defective manufacturing of Mentor MemoryGel™ Silicone Breast Implants. The lawsuit alleges that Mentor and its parent company, Johnson & Johnson, repeatedly failed to follow the requirements imposed by the Food and Drug Administration (“FDA”) in connection with the approval of Mentor’s premarket approval application. It is further alleged that the companies failed to warn the FDA and women receiving the implants of the devices’ known dangerous propensities. The lawsuit — Ebrahimi v. Mentor Worldwide LLC, et al. (case no. 2:16-cv-07316-DMG) — was filed in the Central District of California in Los Angeles, where Mentor is headquartered.

Mentor develops, manufactures, and markets products for surgical and non-surgical procedures, including Mentor MemoryGel™ Silicone Breast ImplantsThe lawsuit alleges that chemicals Mentor used in the manufacturing process bled through the implants, and into Ms. Ebrahimi’s body, causing her to suffer serious medical problems. It is alleged that Mentor and Johnson & Johnson knew that their devices were defective, yet allowed them to be surgically implanted in Ms. Ebrahimi and other unsuspecting women. It is further alleged that Mentor and Johnson & Johnson failed to warn the FDA of these risks by not providing adequate follow-through studies.

Mentor MemoryGel™ Silicone Breast Implants are regulated medical devices under the Food, Drug and Cosmetic Act that require FDA approval. As a condition of approval, the FDA required that Mentor conduct six post-approval studies to demonstrate, over time, that its silicone implants were safe and effective. The lawsuit alleges that Mentor failed to design effective studies and, as a result, failed to provide the FDA with the longitudinal studies that were required as a condition to the devices’ approval. It is alleged that:

It was Mentor’s obligation to design and execute a study where women were able to access internet forms that are easily understood and provide a working forum to report their experience with implants. Mentor intentionally and systematically failed to make this happen which is a violation of the FDA’s conditions for approval. Data collection was sparse and potential serious side effects and harmful complications were downplayed and under-reported due to inadequate sample size.

This lawsuit influenced a new wave of breast implant litigation. Its research and structure are being used as a model being replicated by the following lawsuits below.

Rexina Mize, et al. v. Mentor Worldwide LLC

(February 2nd, 2017)

The case is Mize v. Mentor Worldwide LLC, No. BC-649083, California Superior Court (Los Angeles). In March 2017, the case was transferred and reassigned to the federal judge handling Ebrahimi v. Mentor and the case number was changed to CV 17-1747 DMG (KSx). In August 2017, the case was remanded back to state court.

Her husband, Spouse Plaintiff Minh Nguyen, is also suing Mentor on loss of consortium.

From the article, Johnson & Johnson Unit Sued Over Leaking Breast Implants:

Catherine Gravitt, et al. v. Mentor Worldwide LLC

(July 25th, 2017)

The case is Gravitt et al v. Mentor Worldwide LLC, No. 1:2017cv05428, Illinois Northern District Court (Chicago). Catherine Gravitt and her husband Travis Gravitt are the plaintiffs who filed against Mentor, see Complaint. She was implanted with textured Mentor MemoryGel Silicone Breast Implants in 2010 and in 2016 she discovered a rupture. Health complications included abnormal thyroid levels, swollen lymph nodes, severe and random skin rashes, blackouts and periods of disorientation, extreme fatigue and weakness, muscle soreness, frequent flu like symptoms, anxiety, depression, and more. Additionally it is alleged she gave birth to a son and daughter who both developed defects related to the toxic materials leaking from her breast implants. See the docket and the news article, “Couple’s lawsuit faults California breast implant maker.

In January 2018, U.S. District Judge Gary Feinerman allowed the case to in part pass federal preemption, see Memorandum Opinion and Order. This is a significant court ruling for all breast implant cases. See the news article, “Mentor Silicone Breast Implant Lawsuit Not Preempted, Cleared To Proceed: Judge.”

Renee Cashen, et. al v. Mentor Worldwide LLC, Ethicon, and Johnson & Johnson 

(April 27th, 2018)

The case is Cashen et al v. Mentor Worldwide LLC, filed in the Superior Court of New Jersey. Renee Cashen and her husband Richard Cashen are plaintiffs. In February 2008, she was implanted with textured Mentor MemoryGel Siltex Round Moderate Gel Breast Implants. After implantation, she was discharged from the post-market study she had been enrolled in. In 2016, she noticed a lump under her right armpit. A month later a biopsy was done and ALCL was discovered but it took several weeks later until her doctors associated it with her Mentor breast implants. In May 2016, Mrs. Cashen had explant surgery and six lymph nodes removed. In July 2017, she began chemotherapy treatments. The Defendants allegedly failed to comply with their post-approval surveillance obligation.

They are represented by Ross Feller Casey, LLP and McEldrew Young, both in Philadelphia, Pennsylvania.

Vieira et al v. Mentor Worldwide, LLC et al

(June 27th, 2018)

Nicole Vieira and Emilia Barozzi filed complaints in Los Angeles County Superior Court, Case No. BC711663. Plaintiffs were implanted with Mentor MemoryGel Silicone Breast Implants and afterwards they “experienced various medical complications, including fatigue, weakness, memory loss, and nausea.” After explantation it was discovered that the implants’ silicone gel had bled. The complaint alleges mistakes in Mentor’s manufacturing of the implants and defects in the silicone used. These resulted in silicone gel to bleed and therefore triggered the medical complications.

In July the case was moved to Federal Court, Case No. 2:18-cv-06502, and in September it was remanded back to Los Angeles Superior Court.

Allergan Silicone Breast Implant Lawsuits:

Nicole Weber v. Allergan No. 13-17017 (9th Circuit 2015)

The case was filed in 2012 and is moving to trial in early 2018.

“Weber appealed the district court’s dismissal of Weber’s diversity action brought against Allergan Inc, asserting strict product liability and negligence, and alleging that Allergan’s Natrelle Style 20 [silicone] breast implants are dangerous.” (Sept 21, 2015). See youtube video on her 9th Circuit court hearing. (The opposing attorney talks at 37:00)

Her amended claim was found to adequately state parallel state law claims (Oct. 23, 2015).

“Weber has identified to the extent possible without discovery, the standards she believes the manufacture of her implants violated, adequately stating parallel state-law claims.” the court said.

Vivian Skelton v. Allergan – BIA-ALCL

The case was filed as Skelton v. Allergan, No. BC696400 in Los Angeles County Superior Court. It was transferred to California Central District Court and the case number was changed to 2:18-cv-02617. She was diagnosed with breast implant-associated anaplastic large cell lymphoma, this is an Allergan BIA-ALCL Lawsuit.

Rhea v. Allergan – BIA-ALCL

(May 8th, 2018)

Michele Rea and Carl Rea from Fairfax, Virginia filed in the Superior Court of New Jersey in May 2018, see case here.

From Ross Feller Casey in ‘Another Lawsuit Alleges Breast Implants Cause A Rare Cancer‘:

Rea underwent reconstructive surgery for a partial mastectomy in 2011. About five years later, she was diagnosed with anaplastic large cell lymphoma, which was caused by a Natrelle Style 410 [highly cohesive silicone gel] implant made by Allergan, Inc., the suit alleges.

Allergan Saline Lawsuits:

In Jacksonville, Florida, the law firm of Terrell Hogan is filing hundreds of lawsuits against two local plastic surgeons – Dr. Loren Clayman and Dr. Mark Clayman. There are also allegations of fraud, as well as a lawsuit against Allergan.

“I represent about 150 women,” said Attorney Chris Shakib.

Shakib, the lead attorney in the case, called his findings unbelievable.

For further information, see articles on this here (June 1st, 2016) and here (November 29th, 2016).

Mentor Saline Lawsuits:

Anita Laux v. Mentor Worldwide LLC

(December 29, 2015)

The case is Laux v. Mentor Worldwide LLC, No. 2:16-cv-01026-ODW(AGR), filed in Ventura County Superior Court and moved to federal court. She is represented by Robert A. Zeman (Law Offices of Robert A. Zeman) and Alan C. Milstein (Sherman Silverstein Kohl Rose and Podolsky).

Breast implants are categorized as Class III medical devices (along with hip implants, pacemakers, cardiac stents, etc) and are very difficult to sue due to the 2008 Supreme Court case, Riegel v Medtronic which gave broad federal protection to manufacturers. To sue a manufacturer, one would need a product liability case and these are generally governed by state laws under theories of negligence, strict liability, and breach of warranty. The Supreme Court ruling with Riegel created a precedent for preemption of state laws, essentially citing that Class III medical devices are solely accountable to the regulations and surveillance of the FDA. After Riegel, the only way to sue is to assert parallel state law claims where one must prove the manufacturer deviated from a guideline they were approved by (a violation of a federal requirement, such as a FDA guideline), the violation of an identical state law, and how that violation of that federal requirement caused injury.

BIA-ALCL

Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is a cancer of the immune system caused by breast implants. It is generally found in fluid collection in between the implant and capsule, in a seroma, or in a nodule in the capsule. Physical signs are effusion, swelling, pain, inflammation, mass, ulceration, and others. The overwhelming symptoms in a majority of patients is a delayed seroma, persistent swelling, and pain. While even more rare some patients may present skin changes, lymphadenopathy, capsular contracture, or a potentially palpable mass.1 CD30 is the diagnostic test being used to distinguish ALCL. It is found to occur at a much higher rate in textured breast implants, however there have been some smooth surfaced breast implant cases as well.

Risks:

“[S]tudies reported in medical literature estimate that the lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from 1 in 3,817 to 1 in 30,000.” – FDA Update 3/21/18

Medical Device Reports (FDA)

Update: As of July 2017, Dr. Mark Clemens states that worldwide there have been 464 adverse event reports in relation to BIA-ALCL and 12 deaths. See PSEN Breast Implant Associated Anapestic Large Cell Lymphoma.

As of February 2017, the FDA has received a total of 359 medical device reports (MDRs) of breast-implant-associated ALCL, including nine deaths. Out of those 359 total reports, only 64% (231 reports) listed data on the surface at the time of reporting:

  • 87% (203 out of the 231 report) were with textured surfaces
  • 12% (28 out of the 231 reports) were with smooth surfaces

Although it is rare, breast-implant-associated ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants.

Sample of the FDA Adverse Event Reports on BIA-ALCL:

Note: Parentheses represent redacted information to protect privacy.

  1. Company rep reported right side anaplastic large-cell lymphoma and “subcutaneous nodules and lymph nodes. ” the pt had a bilateral reconstruction seven years ago with style 410 breast implant placed on the left side and a style 115 placed on the right side. The pt had done well until she presented last week with a pathology report from her oncologist stating that she had alcl. The pt stated that she had nodules on the right axilla. A pet scan was carried out that showed metastasis in the lung and bone marrow involvement. No seroma was noted. The oncologist has decided on her treatment plan to exclude radiation. Explant surgery will take place (b)(6) 2013. (Reported in 2013, Allergan silicone) Link.
  2. Anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an (b)(6) report written in aesthetic plastic surgery 2013 reports alcl, seroma, pain. Additional information noted in article anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an italian report written in aesthetic plastic surgery 2013 article notes in regards to the right side, “necrosis and chronic inflammation signs are present” and “skin above the implant became red and painful and the patient had febrile episodes. ” treatment noted for the event of seroma as “a broad-spectrum antibiotic. ” (Reported in 2013, Allergan silicone) Link.
  3. Healthcare professional reports a case of lymphoma and other b-symptoms via mw (b)(4) the mw notes that: “the reporter called on behalf of a pt who was diagnosed with alcl. The pt presented with anaplastic large cell lymphoma, diagnosed in 2013. History of hodgkin’s lymphoma diagnosed in 2011. These two events came about after the pt underwent breast augmentation in 1994. In 2010, pt presented with an abnormal mammogram performed in 2010. Breast pain, skin color change, skin texture change, and inflowing diffusion form the right breast up to right neck and shoulder. The pt was running a fever throughout the entire process. After an mri and subsequent test, the pt was diagnosed with hodgkin’s lymphoma and underwent mantle radiation. In 2012, the pt underwent surgery essentially for a breast mass, but the pt also desired a mastectomy for removal of right and left implants and capsules. The pathology of the operation soon reported that the pt also has alcl; the mass had come from the lymphoma. ” (Reported in 2013, Allergan saline) Link.
  4. Pt is a female who underwent left mastectomy in 1996, for ductal carcinoma in situ with tissue expanders and saline implant reconstruction. She presented in 2010, with a peri-implant hematoma, though possibly post-traumatic. She underwent evacuation of the hematoma and change to a silicone gel implant. All pathology specimens were negative for tumor. She again presented in 2012, with a spontaneous hematoma and at surgery multiple biopsies revealed anaplastic large cell lymphoma (alcl) limited to the periprosthetic capsule and hematoma fluid. After an extensive hematologic and metastatic workup which was negative, she underwent removal of the implant and total periprosthetic capsulectomy. Capsular pathology showed alcl. (Reported in 2012, Mentor silicone) Link.
  5. On (b)(6) 2010, diagnosed with anaplastic large cell lymphoma (alcl) alk-negative. Possibly related or caused by breast implants received in (b)(6) 2002 for augmentation. Experienced complications with left implant diagnosed as capsular contraction. Implant replaced on (b)(6) 2008. Still experiencing capsular contraction after replacement. (b)(6) 2010 – (b)(6) 2011: received 12 doses of chemotherapy, received 20 doses of radiation therapy. Preparing for stem cell transplant scheduled for (b)(6) 2011. (b)(6) 2010: needle biopsy – diagnosis lymphoma. (b)(6) 2010: surgical biopsy – diagnosis alcl. (b)(6) 2010: surgical biopsy – diagnosis alcl. (Reported in 2011, Allergan saline) Link.
  6. The original purchase date of this device was (b)(6)2004. In (b)(6) 2006, the pt was implanted with mentor siltex saline devices during a revision augmentation procedure. In (b)(6) 2008, the devices were replaced with mentor smooth saline devices due to a left device deflation. In (b)(6) 2010, the pt had both implants removed due to recurring fluid accumulation in the right breast. On (b)(6)2010, the pt was diagnosed with alcl (t-cell lymphoma). No further info is available at this time. (Reported in 2010, Mentor saline) Link.
  7. It was reported by a physician that a (b)(6) year old female patient was diagnosed with alcl on (b)(6) 2017. This patient’s medical history includes diagnosis of left breast invasive ductal carcinoma in (b)(6) 2015. She underwent bilateral mastectomy and bilateral tissue expander placement in (b)(6) 2015. The patient had mentor tissue expanders that were implanted from (b)(6) 2015. The patient then had mentor memory shape low high moderate plus profile breast implants (catalog #334-1507, r. Side serial # (b)(4)) implanted in (b)(6) 2015. On (b)(6) 2017, the patient experienced a large right breast effusion that developed over 24-48 hours. The effusion was aspirated and tested using flow cytometry and cd30 ihc and came back positive for bia-alcl on (b)(6) 2017. The time between patient signs/symptoms of peri-implant alcl to definitive diagnosis was 1 week. The patient did not have any complications such as infection, hematoma, or implant rotation during implant course prior to alcl diagnosis. The patient did not experience skin lesions, fevers, night sweats or weight loss. There was no pain, redness, palpable breast mass, or capsular contracture. The lymphoma cells were found in the seroma fluid surrounding the implant. Immunohistochemical and flow cytometry testing showed alk negative and cd30 positive results. This is a pathologically confirmed stage ie primary diagnosis of alcl. Based on histology, there is no capsular involvement. The lymphoma cells were found in the effusion fluid surrounding the implant. The patient underwent bilateral implant removal and capsulectomies with no implant replacement on (b)(6) 2017. The implants were intact and not ruptured upon removal. (Reported in 2017, Mentor Memory Shape Silicone) Link.

Above is only a sample of six reports to the FDA. As of July 2017, Dr. Mark Clemens states the FDA has received 464 adverse event reports in relation to BIA-ALCL and 12 deaths. Join the Facebook group ALCL in Women with Breast Implants BIA-ALCL to view reports by country.

BIA-ALCL Causation Theories:

The cause is still unknown but is actively being studied. Some researchers have theorized that biofilm contributes to lymphoma and others have thought the chemicals in the implants irritate the immune system. Both theories rely on the presence of persistent inflammation, which means chronic activation of immune cells and particularly the T lymphocytes, which are white blood cells involved with ALCL.

Throughout the body, there are many diverse populations of bacteria that are both beneficial and harmful. In recent years, there has been an increased focus in characterizing bacteria and analyzing patterns of bacteria to understand the possible correlation between normal versus infectious/cancerous scenarios – especially in relation to breast cancer. What has been discovered is that similar to how the gut has its own microbiome of good and bad bacteria, the normal breast tissue and human milk also have their own microbiology that over time is influenced by factors such as dietary and sugar changes. The article “Microbiota of the Human Breast Tissue” delves into the various specific bacteria that were found in human breasts. Since breasts are not sterile, if a foreign object is placed inside the body, it will be colonized and infected.

Biofilm is bacteria that adheres to the surfaces of medical devices. It can result in a low grade chronic bacterial infection, chronic inflammation, and capsular contracture. Some bacteria produce acid as they grow and this reduces the pH of the surrounding environment. In the closed off space between the surface of the implant and the inner capsule surface, the bacteria coating the implant could form an acidic environment that contributes potentially to the breakdown of silicone. Australian researchers found that biofilm from capsular contracture cases was different from the biofilm identified on 26 implants from lymphoma patients. This brings biolfim to light as “a possible infectious contributing cause” for the lymphoma.

The chemicals used in the manufacturing process, which are neurotoxic and carcinogenic, are also believed to be playing a role in the development of lymphoma. The majority of ALCL cases have been found with textured implants, the roughness of the surface is triggering chronic inflammation. Textured implants were designed to keep the implants in place, thus, the capsules embed themselves on and around the textured surface. This creates an intimate, hand in hand connection between the scar tissue and chemically abrasive textured surface. Over time, this can lead to a direct abrasive irritation of the immune system, significantly affecting T cells.

It is interesting to note the connection between polyurethane coated implants and textured implants. Polyurethane coated implants were the first type of breast implant linked to cancer, and textured implants have now become the second type of breast implant linked to cancer – what they both have in common is a chemically abrasive fuzzy surface. Polyurethane implants were in production from about 1980 to when the manufacturer voluntarily withdrew them in 1991 due to significant safety concerns. These implants were the precursors to the textured breast implants since the textured surface was thought to be important in reducing capsular contracture and firmness, but the implant manufacturers could not use polyurethane so instead they created the textured surface currently manufactured today (since the mid-1990’s). This textured surface is also linked to an increased occurrence of forming double capsules (scar tissue surrounding the implants) and seromas, thereby going against its intended purpose.1,2

Protocol: 

In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer case worldwide were probably not reported, and noted that doctors and patients may not be aware the ACCL risks. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.

BIA-ALCL and Mammograms:

There have been cases reported in the BIA-ALCL FB Support Group where mammograms have triggered breast swelling and led to BIA-ALCL diagnoses.

Resources:

Government Health Agencies and Other Sources

Science and Medical: 

Please see the Scientific Articles page for over 200+ references to breast implant related scientific articles. They are organized into eight categories: 1. General, 2. Researchers, 3. Saline Implants & Mold, 4. Ruptured Silicone Implants, 5. Biofilm & Infections, 6. Breast Feeding with Implants and Effects on Children, 7. Biomaterials, and 8. ALCL (cancer).

Current Experts:

Dr. Pierre Blais (chemist and biocompatibility expert – Canada), Dr. Arthur Brawer (rheumatologist and silicone toxicity expert – Long Branch, NJ), Dr. Yehuda Shoenfeld (physician and autoimmunity researcher – Israel), Dr. Cohen Tervaert (rheumatologist – Edmonton, Canada), Dr. Henry Dijkman (pathologist – Netherlands), Dr. Diana Zuckerman (President of National Center of Health Research), Dr. Sarah Myhill (UK), Dr. Lu-Jean Feng (plastic surgeon – Cleveland, OH), Dr. Victor Urzola (plastic surgeon – Costa Rica), Dr. H. Jae Chun (plastic surgeon – Newport Beach, CA), Dr. Matthew G. Stanwix (plastic surgeon – Henrico, VA), Dr. Susan Kolb (plastic surgeon – Atlanta, GA), Dr. Edward Melmed (plastic surgeon – Dallas, TX), Dr. Rita Kappel (plastic surgeon – Netherlands), Dr. Michael Harbut (environmental medicine specialist – Detroit, MI), Dr. S V Maharaj (silicone breast implants and platinum expert). See here for some of their publications.

Educational Links:

What You Need to Know About Breast Implants (National Center For Health Research)

Breast Implant Illnesses: What’s the Evidence? (National Center For Health Research)

Safety – Junk Science, ‘New’ Cohesive Gel, and Toxicity for Silicone and Saline Implants

Breast Implants and Cancer (BIA-ALCL) and BIAALCL.com

Dr. Myhill –

Silicone Breast Implants and Injections

Chemical Poisoning – Diagnosis

Detoxification

Dr. Urzola –

Breast Implant Illness

“Over the past year and 8 months I have learned and researched a lot about this condition. After explanting over 100 patients and seeing the extraordinary post operative reports with over 85% of patients reporting complete remission of their symptoms or at least an important improvement, we are committed to starting a scientific investigation with the purpose of validating BII as a syndrome and getting the medical community to recognize it as a problem affecting thousands of women around the world.” (2017)

Dr. Feng –

Breast Implant Removal: Basics I

Topic: Linda L. Haas, Feng Clinic CEO, answers basic scheduling questions from patients who have just started researching breast implant removal. Videos: Part I and Part II.

Breast Implant Removal: Basics II

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Note: (Excerpts within this article include other online media sources)

____________________________________________________________________________

Additional Resources On Breast Implant Complications and Adverse Events

Topics: pathology, mold/microorganisms, detoxification, coinfections/diseases, selecting a surgeon, silicone vs. saline, capsule removal, lymph node removal, hormones and symptoms of BII. Videoand Transcript.

Breast Implant Removal: Basics III

Topics: the aesthetics of the breast, muscle repair, mastopexies or breast lifts, fat transfer and who is a candidate. Video and Transcript.

Breast Implant Removal IV: Detoxification

Topic: An in-depth discussion of detoxification before and after breast implant removal. Video.

Will I recover from breast implant illness without lymph node removal? (Video)

Is There A Connection Between Lyme Disease and Breast Implant Illness? (Video)

MTHFR and breast implants (Video)

Dr. Feng Webinars I-IV and YouTube Channel

Research articles and studies

Dr. Chun –

“Many patients suffer from BII(Breast Implant Illness) from their saline or silicone breast implants.” – Dr. Chun’s Breast Implant Removal Page

YouTube Channel – with videos on explantation, ruptured implants, difficulty associated with detecting ruptured silicone, and an en bloc capsulectomy explant (graphic).

Instagram where you can see Dr. Chun’s meticulous skill and expertise in doing perfect en bloc explants.

FDA Testimony

Dr. Kolb –

If something is of use to women affected by breast implant illness, it will be provided on this website regardless of politics.

Doctors, are you listening?

Immune Protocol

Silicone Immune Treatment Protocol

Inositol for Silicone Detoxification Provided by Dr. Douglas Shanklin

Videos: Dr. Susan Kolb discusses silicone breast implants and saline breast implants

Book: The Naked Truth About Breast Implants: From Harm to Healing

Note: There are currently four pending medical malpractice lawsuits filed against this plastic surgeon.

Dr. Blais –

Breast Feeding

Truth on ‘Cohesive’ Gel Implant

Technology and composition of silicone breast implants

How do implants rupture and cause injury

Testimony to the FDA (2000) 

All articles on breast implants by Dr. Pierre Blais, click here. Topics include: rupture, cancer, breast feeding, polyurethane, saline implants, cohesive gel, explant problems etc.

Dr. Blais is a chemist and expert in the biocompatibility of implant materials. He has been analyzing breast implants and conducting breast implant failure analyses for over 40+ years. There is currently a backlog due to the high demand and he is not accepting any new breast implants. Dr. Blais is a significant resource, he is a wealth of information on most breast implant matters.

Dr. Brawer –

Case Report: Silicone is not fun in the sun (2018)

ASIA vs. the mechanisms of silicone toxicity (2017)

Vague Syndromes (2017)

Mechanisms of Breast Implant Toxicity (2017)

Autoinflammatory Syndrome Induced by Adjuvants (ASIA) Syndrome is Misguided (2017)

Destiny rides again: the reappearance of silicone gel-filled breast implant toxicity (2017)

Breast Implant Toxicity (2016)

Bones, Groans, and Silicone (2012)

Amelioration of Systemic Disease after Removal of Silicone Gel-filled Breast Implants (2000)

Silicon and matrix macromolecules: new research opportunities for old diseases from analysis of potential mechanisms of breast implant toxicity (1998)

Chronology of systemic disease development in 300 symptomatic recipients of silicone gel-filled breast implants (1996)

Clinical features of local breast phenomena in 300 symptomatic recipients of silicone gel-filled breast implants (1996)

Dr. Schoenfeld

Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis (2018)

The ASIA syndrome: basic concepts (2017)

Autoimmune/Inflammatory syndrome induced by adjuvants (ASIA) and thyroid autoimmunity (2017)

Sjörgen’s Syndrome and Environmental Factors (2016)

Silicone and Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA). (2015)

Silicone implant incompatibility syndrome (SIIS). A frequent cause of ASIA (Schoenfeld’s syndrome). (2013)

Autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld’s syndrome): clinical and immunological spectrum (2013)

The spectrum of ASIA: ‘Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants’ (2012)

’ASIA’ – Autoimmune/inflammatory syndrome induced by adjuvants (2010)

Fibrosarcoma after silicone breast augmentation: is there a connection? (1998)

Light and electron microscopic study of an invasive cribriform carcinoma with extensive microcalcification developing in a breast with silicone augmentation (1994)

Breast carcinoma occurring in association with silicone augmentation (1993)

Doctors Speak Out –

Dr. Bernard PattenDr. Al LevinDr. Robert Goldwyn,

Dr. Frank Vasey (the “Dark” side of silicone breast implants)

Dr. Stephen Edelson (goes into symptom mechanisms)

Dr. Britta Ostermeyer (on dangers of silicone implants)

Other Educational Videos –

Breast Implant Illness – Dr. Faria

Integrative en-block treatment – Dr. Hovsepian

Capsular contracture – ruptured breast implants – Dr. Cassileth

Silicone Toxicity and Detoxification – Dr. Jennings

Immune Response to Silicone (skip to 5:38 for the effects on children)

Dr. Urzola’s Live Feed on Breast Implant Illness (2017)

Other links:

National Birth Defect Registry

  • Did you have breast implants while pregnant?
  • Did you breastfeed with breast implants?
  • Was your child born with a birth defect? Was your child born with a birth defect?

The National Birth Defect Registry might be able to help us research any possible link between breast implants and birth defects. If you’d like to help, please go to their website and register. Click here for more info.

***Search here if a doctor is receiving payments from a manufacturer and here (such as fees in research, consulting, speaker, sponsor, etc).

Petitions –

Breast Implant Petition

Request FDA Hearing

Medical Device Safety Act H.R. 2164

Surveys –

Dr. Victor Urzola’s Breast Implant Illness Data Collection Database

Dr. Yehuda Shoenfeld’s ASIA survey

PIP Implants Survey – if you have or had PIP, please fill out this survey

Concerns for estrogenicy of silicone breast implants

Allergan manufacturing patent

Method of making textured surface implants patent (Mentor)

UK MHRA PIP Implant Ingredient Analyses

Dr. Harbut response to FDA on platinum toxicity

Dr. Maharaj and Dr. Lykissa responses to FDA on platinum toxicity

Facebook Support Groups:

US: Breast Implant Illness – The Ticking Time Bomb

Breast Implant Illness and Breast Cancer Survivors Home

Canada: Breast Implant Failure and Illness – Canada

Australia: Breast Implant Illness – (Australia & New Zealand) Healing and Support

UK: UK Breast Implant Illness and Healing Support Group

ALCL: ALCL in Women with Breast Implants (BIA-ALCL)

For all medical devices: Medical Device Problems

Mothers: Breast Implants and Children

There are over 160+ breast implant illness support groups and awareness pages on Facebook where women share their experiences.

Personal Stories and Videos:

The Naked Truth // My Life with Breast Implants

Personal stories

Alex Chafen – Breast Implants, a Husband’s Perspective

Andrea Conti Cowder (Video and BII Story)

Pursuing Explantation – My path to health after breast implant illness

Beth Maturevich – Breast Implant Illness (Saline) Video

Raylene Hollrah – Diagnosed with ALCL, story

Implant Illness Awareness – Breast implants are not safe. We are the proof.

Mybreastimplantillness WordPress 

nothappywithmentor.blogspot.com

The faces of breast implant illness – Video

Jamee Cook –

Pursuing Explantation – My path to health after breast implant illness

YouTube channel on breast implant illness

Advocacy Groups:

US:

Canada:

Australia:

Netherlands:

UK:

Scotland:

Ireland FB Group: PIP Ireland

France:

Italy FB Page: Protesi PIP and Blog

Sweden:

Switzerland: Informationen zu Brustimplantaten

Venezuela FB Group: Protesis Mamarias PIP

Brasil: Breast Implants Illness (Doença Prótese Mamária) Brasil

Singapore FB Page: Implant Illness and Detox Singapore

South Africa: Breast Implant Illness – South Africa

Breast Implant Illness Websites:

Breast Implant Victim Advocacy (BIVA)

Breast Implant Failure

BIA-ALCL

BIA-ALCL Awareness –  Just Call Me Ray Foundation  (Non-Profit)

Breast Implant Info (Non-Profit)

No Grit No Pearls.org (Non-Profit)

Toxic Discovery (Non-Profit)

Life Since Explant Club

Reversing Breast Implant Illness

Healing Breast Implant Illness

Discover Breast Implant Illness

Miss Diagnosed

BII Aware

Prothese Mammaire Danger

Fake Breasts Real Women

Breast implant illness websites and forums have been around since the late 90s and early 2000s:

Silicone Poison Report

Silicone Holocaust

Implant Information Network (founded in 2004)

Breast Implant Awareness – Humantics Foundation (founded in 2001)

Silicone Implants Survivors (forum since around 1999) and PS List

Silicone Hypersensitivity (owner passed away)

In addition, there were Yahoo support groups and breastimplantsupport.org was another popular forum but now is no longer running.

Breast Implant Manufacturer FDA Information:

Recalls

Allergan Natrelle Silicone & Allergan Silicone Timeline 

Allergan Natrelle 410 Cohesive Anatomical Silicone & Allergan Silicone Timeline

Mentor MemoryGel Silicone & Mentor Silicone Timeline

Mentor MemoryShape Silicone & Mentor Silicone Timeline

Sientra Silicone & FDA Timeline

Allergan Natrelle Saline & Saline Timeline

Mentor Saline & Saline Timeline

Ideal Saline & Saline Timeline

For more information on breast implant FDA links and how to do more FDA research, click here.

Books:

The Naked Truth About Breast Implants: From Harm to Healing by Dr. Susan Kolb

The D.I.R.T. Committee by Gail Hamilton

  • Must read, especially if you had Dow
  • D.I.R.T = Document Investigation & Review Team

The Boobie Trap: Silicone, Scandals, and Survival by Barbara Stanistreet

Informed Consent by John A. Byrne

Dr. Andrew Hall Cutler:

Dr. Cutler has a PhD in chemistry from Princeton University and has extensive study in biochemistry and medicine. He himself got mercury poisoning from amalgam fillings and created these books to provide guidance for detoxification.

Movies: Two Small VoicesBreast Men, Absolutely Safe

Press Articles & News:

Crystal Hefner Removes Breast Implants, Says They ‘Slowly Poisoned’ Her

Mother feels she is dying after her 32E breast implants ‘poisoned’ her

Dr. Britta Ostermeyer testifies to FDA in 2000 on the dangers of silicone breast implants.

Safety of breast implants under review in South Korea after silicone gel found in breast milk

FDA panels put silicone breast implants back under microscope (2011)

The silicone implant scandal (2012)

Breast Implants: America’s Silent Epidemic

Breast Implant Illness by Maya

Sara-Jane Fitness Cover Story

The Troubled History of PIP’s Implant Man in America **Implant manufacturers all operate in relatively similar ways and this article provides a glimpse of the dirty and corrupt business.

The “Dark” Side of Silicone Breast Implants

Toxic Moldy Breast Implants

Breast Implant Toxicity – on the radio with Danielle Delaney & Alex Charfen

The Ill Effects of Breast Implants

Why are celebrities removing their breast implants?

Explant Breast Surgery: Why women are getting their breast implants removed

Devoted mother-of-four dies from heart failure after implants trigger dormant TB

46 cases of ALCL diagnosed in Australia & New Zealand

Australia’s health regulator has confirmed that women with breast implants have a much higher risk of cancer (7 News Sydney – Video)

Patients accuse breast implant manufacturer of fraud (2016 – Allergan)

Breast implant illness conference – Texas (7/16/16)

News Segment on a lady with breast implant illness & saline implants

Monsters Inside of Me – Discovery Channel on saline implants with mold

Mold and Breast Implant Illness – The Doctors (TV show)

2017 – Important Year for Breast Implant News –

Breast implant illness gains nationwide coverage and becomes a movement:

French court says German firm must compensate for faulty breast implants

Woman who beat breast cancer once says breast implants caused cancer again

Johnson & Johnson Unit Sued Over Leaking Breast Implants

Johnson & Johnson, Mentor Worldwide LLC Senior staff target Support Groups

Former Playboy Models Get Their Breast Implants Removed Believing They Caused Illness

Mother-of-two is left with ROTTING breasts after silicone implants leaked into her blood stream – as cosmetic procedures fall to a ten-year low in the UK 

Can implants kill you?

Phoenix Valley women speak out on breast implant illness: ‘I just had to get them out’

Doctor’s Breast Implant Illness Denial Elicits Strong Response

Breast Implants Cause Rare Form of Cancer, FDA says

9 deaths linked to rare cancer form breast implants

In the News: Breast Implants Linked to Rare Cancer (Diana Zuckerman)

Former Women’s IFBB Pro Jackie Paisley dies after long battle with illness (silicone toxicity)

Breast Implant Survey Suggests Doctors Divided on Safety

Nicola Robinson’s Deepest Regret (silicone breast implants)

Breast Implant Illness + 6 Other Breast Implant Dangers (Dr. Axe)

Playboy Models Claim Implants Caused Health Problems (The Doctors, show)

Former Playmate of the Year on removing breast implants: ‘I literally thought I was dying’ (AZ Family News)

Women complain that their breast implants made them sick (West Palm Beach – WPTV News)

Her Hidden Dangers (Illinois – 23WIFR News)

Breast implant patient’s life ‘could have been saved’ – Hairdresser Kandi du Cros died after breast implant operation flared up rare existing disease (BBC News)

2 Massachusetts Women, Thousands Nationwide Say Breast Implants Made Them Sick (CBS Boston News)

Women concerned about implants after learning they may be linked to rare cancer (Fox 59 Indianapolis News)

Caldwell woman diagnosed with cancer from her breast implants, insurance won’t pay to remove them (KIVI 6 On Your Side – ABC Idaho)

A Shocking Diagnosis: Breast Implants ‘Gave Me Cancer’ (NY Times)

DeLauro Statement on Breast Implants Connected to Lymphoma (United States Representative Rosa DeLauro)

Swedish breast implant illness news story: Johanna, 31, varnar andra: “Implantaten gjorde mig jättesjuk”

Danish: Johanna fik opereret brysterne større – aldrig har hun fortrudt noget så meget

Woman reveals danger of implants, horror of lawsuits – silicone poisoning brings on 20 year suit with Dow Chemicals (UB Media Biz)

Conflict of Interest: The FDA & Big Pharma – Does the FDA Work for Big Pharma? (Drug Watch)

Breast prostheses: For a national registry of complications (Dr. José Budo)

Colorado women claim breast implants made them sick (Denver 7 News)

Did breast implants make Valley woman sick? (ABC15 Arizona)

9 Investigates health concerns with silicone breast implants (WFTV9 Orlando, FL)

Brit Boob Implant Cancer Bombshell – Two breast surgery patients die from a ‘bombshell’ cancer linked to implants

Rare cancer reignites debate over breast implants’ safety

Silicone Breast Implants are back – This Time the Issue is Cancer

Sydney mother’s dire warning after breast implants almost ruined her life. (Australia News)

Dr. Robert Whitfield MD, FACS describes breast implant-related illness (The Plastic Surgery Channel)

The Explant Phenomenon (Huffington News)

Former ‘Playboy’ playmates have ‘toxic’ breast implants removed after they make them sick (Inside Edition)

Women say breast implants caused unexplained illness for years (WSB-TV Atlanta, GA)

Why scores of women are having their implants removed (Tucson News, AZ)

More Canadian women having their breast implants removed, surgeons say (CTV News)

2018

Women battling illness after breast implants urge awareness, education (CBS Miami)

The breast implants that may be linked to blood cancer: Linzy was baffled by her symptoms but doctors solved the mystery in time for her to make a full recovery (Daily Mail UK)

South Florida Woman: Breast implants ruined my life (West Palm Beach – WPTV News)

CBS 5 Investigates: Chemist claims breast implants make some women sick (CBS Arizona)

Why Kiwi women are getting their breast implants removed (New Zealand)

I spent the last five years managing my health so my body could cope with these toxic bags’: Why more women are having their breast implants REMOVED following debilitating complications (Daily Mail Australia)

Facing unexplainable symptoms, metro women argue silicone breast implants made them sick (Fox 4 Kansas)

Arkansas women want doctors, FDA to recognize seriousness of ‘Breast Implant Illness’ (THV11 Arkansas)

My breast implants were killing me – how I took my life back (Elephant Journal)

Calls to ban textured breast implants after two die and 23 develop same type of cancer (My Vue News – UK)

Kiwi woman says seven-year illness caused by breast implants (Stuff – New Zealand)

Perth mum Ricci Jess reveals painful truth behind fake boobs (Perth Now – Australia) 

Explants: breast implants removal surgery grows among Perth women (Perth Now – Australia)

My breast implants nearly destroyed my life: how S Club 7’s Hannah Spearritt was left in agony following the boob job she craved (Daily Mail UK)

After 17 years with breast implants, Princeton woman leads calls for more education, safety (WFAA 8 ABC – North Texas)

Mount Pleasant woman says breast implants caused serious health problems (4News – Mount Pleasant, South Carolina)

Breast Implant Illness: What we don’t know can hurt us (Swaay)

Glamour model who got a boob job at 18 shares her plastic surgery nightmare that destroyed her kidneys and has left her on dialysis (Daily Mail Australia)

Facing health issues, Georgia woman has breast implants removed (Fox5 – Atlanta, Georgia)

Breast Implant Illness: Two metro women say implants caused years of complications (13 WHOtv – Iowa)

Breast Implant Illness: Woman claims implants made her sick (7 WJHG – Panama City Beach, Florida)

Former local 4 reporter says breast implants caused years of chronic fatigue, depression, hair loss (Click On Detroit – Michigan)

Auckland woman ‘s painful lesson about the dangers of breast implants (News Hub – NZ) 

What this yoga teacher learned from her mistake with breast implants (Charlotte Five)

Biocell textured breast implants under scrutiny as women complain of pain (CBC – Canada)

Breast implants reveal problems in tracking device safety (AP News) 

Breast Implant Injuries Kept Hidden As New Health Threats Surface (ICIJ)

Under the skin of ICIJ’s Implant Files (ICIJ)

Breast implants study reveals serious safety concerns (The Guardian)

The Implant Files reveal how breast implants linked to rare cancer set off alarm bells (ABC – Australia)

The Implant Files: Faulty breast implants leave women in limbo (Financial Review – Australia) 

Bare dager etter at hun opererte inn silikon i brystet, merket Karin Wenke Osthaug at noe var galt (Aftenpolten – Norway)

Cancer lié aux prothèses mammaires (LAGC) : l’inertie des autorités sanitaires (France Culture)

Temor, burocracia y dolor: hablan tres argentinas damnificadas por implantes mamarios (Perfil – Argentina)

British women are hit by new breast implant cancer scare seven years after PIP scandal as concerns grow over most commonly-used implant banned in France but still allowed in UK (Daily Mail – UK)

Rare form of Blood Cancer Linked to Certain Type of Breast Implants Used by Thousands of Women (People)

Breast Implants May Increase Your Risk of A Rare Type Of Cancer (Women’s Health)

Some medical devices deemed unsafe in other nations still sold in U.S. (NBC News)

Breast-implant-related complications, including cancer, kept secret thanks to broken reporting system (The Star)

My Breast Implants Made Me Sick – and Nobody Believed Me (Cosmopolitan)

Hidden dangers: patients, doctors not informed of defective implants (ICIJ)

Many Women Getting Breast Implants Removed In Light Of Health Concerns (CBS Philly)

Mother, 34, who was left ‘slowly dying’ by her ‘toxic’ C-cup breast implants has them removed after four years of agony (Daily Mail and The Sun)

Richmond woman warns of breast implant illness (K12 – Virginia)

As the Allergan breast implants disaster explodes, isn’t it time women say enough is enough? (Huffington Post – UK)

Allergan’s textured breast implants recalled by French authorities (NBC News)

 

 

 

Read More

ALLERGAN BREAST IMPLANTS RECALLED WORLDWIDE TODAY JULY 24, 2019

“Textured implants linked to rare form of cancer per FDA”

By Mark A. York (July 24, 2019)

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) A worldwide recall of breast implants by Allergan Inc. was issued Wednesday for textured models because of a link to a rare form of cancer. The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan’s Biocell breast implants with a textured surface account for a disproportionate share of rare lymphoma cases. The move follows similar action in France, Australia and Canada.

The FDA is not recommending women with the implants have them removed if they are not experiencing problems. The FDA had ruled earlier this year the implants could stay on the market.

The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC

Sientra, Inc.

According to a complex analysis of FDA adverse event data, the number of suspected breast implant injuries jumped from an average of fewer than 200 a year through 2016, before the FDA’s more rigorous reporting rules, to 4,567 events in 2017 and at least 8,242 in the first half of 2018. More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.

The agency was aware of the true number of reported injuries but did not disclose them until recently. In Europe, some manufacturers have avoided reporting ruptures altogether, Dutch regulators were told. This was discovered during the  International Consortium of Investigative Journalists long term investigation titled, Implant Files investigation , which revealed the ongoing health problems plaguing many thousands of women with breast implants as part of its global research project that was released in November 2018.

https://www.cbsnews.com/news/breast-implant-recall-allergan-recalls-textured-implant-linked-to-rare-cancer-today-2019-07-24/

Nine deaths from a rare form of cancer have been linked to breast implants, the Food and Drug Administration announced in 2017.

In March 2017, the FDA issued a breast implant cancer warning, indicating that it was aware of at least 359 medical device reports involving women diagnosed with a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The illness has been linked to at least nine deaths.

The agency indicated at the time that the lymphoma cases appeared to be more common among breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not able to be made.

Australia’s Therapeutic Goods Administration (TGA) launched an effort monitor the association between breast implants and anaplastic large cell lymphoma, more than doubling the recognized number of cases identified among Australian patients between September 2016 and April 2017.

Researchers from the TGA published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.

The TGA has estimated that the breast implant lymphoma risk may be between 1-in-1,000 and 1-in-10,000, with most cases occurring between 3 and 14 years after implant, but the median being 8 years and some cases diagnosed as much as 37 years after breast surgery,

Due to the potential lymphoma risk with breast implants, regulators have made efforts to increase awareness among health care providers about cases of the rare cancer linked to textured breast implants, indicating that they should discuss the benefits and side effects of the implants with their patients.

The FDA has also recommended that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.

Biocell implants feature a textured surface designed to prevent slippage and to minimize scar tissue. Such models account for just 5 percent of the U.S. market. The vast majority of breast implants used in the U.S. have a smooth surface.

Health authorities first linked textured implants to cancer in 2011. The disease is not breast cancer but lymphoma that grows in the scar tissue surrounding the breasts. It grows slowly and can usually be successfully treated by surgically removing the implants.

As recently as May, the FDA said that the danger did not warrant a national ban on the devices. But the FDA said Wednesday that new data show a direct link to cancer with Allergan’s implants not seen with other textured implants.

“Once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action,” said FDA deputy commissioner Amy Abernethy in a statement.

The FDA said the latest figures show more than 80 percent of the 570 confirmed cases of the lymphoma worldwide have been linked to Allergan implants. The updated figures reflect 116 new cases of the cancer since the FDA last released figures earlier this year.

The new numbers still reflect a rare disease considering an estimated 10 million women globally have breast implants.

There is no firm agreement on the exact frequency of the disease, known as breast implant-associated anaplastic large cell lymphoma. Published estimates ranging from 1 in 3,000 patients to 1 in 30,000 patients.

Diana Zuckerman, a researcher who has studied breast implant safety, called the removal of the devices inevitable.

“Either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so,” Zuckerman said in an email.

In May, the country’s three largest breast implant manufacturers — Allergan, Sientra and Mentor — told CBS News textured implants have been extensively tested for safety and comply with FDA monitoring and that patient safety is their top priority.

___________________________________________________________

March 20, 2019   FDA NOTICE ON TEXTURED IMPLANTS

 

 

FDA News Release March 20, 2019

FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

For Immediate Release

Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.

The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California.  Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer.

“Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations,” said FDA Commissioner Scott Gottlieb, M.D. “We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety.  Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.”

The FDA’s warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer’s post-approval study for its MemoryShape breast implant, first approved in 2013, including that the manufacturer had failed to enroll the required number of patients in the study. The action also notes Mentor had poor follow-up rates with patients in the study. Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. While the FDA had concluded after reviewing several interim study reports submitted by Mentor that progress on the post-approval study appeared adequate at that time, the agency advised Mentor of concerns about patient enrollment, follow-up rates and data inconsistencies.

Mentor’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA’s warning letter to Sientra, Inc. (Sientra) noted a serious deficiency in the manufacturer’s post-approval study for its Silicone Gel Breast Implants, first approved in 2013. The manufacturer had poor follow-up rates with patients. Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. In the response to the manufacturer’s most recent interim study report, the FDA notified the manufacturer that the study progress was inadequate because of low follow-up rates. Sientra’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA requested responses from both manufacturers within 15 working days of the issuance of the warning letters, with details about how the noted violations will be corrected. The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate.

The FDA’s actions today are part of the agency’s ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices. As part of the Medical Device Safety Action Plan, the FDA committed to streamlining and modernizing how the agency implements postmarket actions to address device safety issues to make responses to risks more timely and effective, including taking actions against manufacturers when their postmarket studies are non-compliant with any study requirements. The FDA has issued several warning letters in recent years to manufacturers who did not adequately fulfill certain postmarket study requirements, reflecting the agency’s commitment to take more aggressive actions against manufacturers who fail to comply.

In addition to the required post-approval studies, the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. For instance, FDA staff have coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updatesto the public regarding BIA-ALCL.

Additionally, the FDA has worked with multiple stakeholders to facilitate the development of the National Breast Implant Registry (NBIR) to provide a platform for collecting additional real world data on the safety and performance of breast implants. This newly launched registry will greatly add to the information we collect in our own post-approval studies about the long-term safety of breast implants, and potentially enhance our understanding of the long term safety and risks associated with breast implants.

The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness. The FDA welcomes public dialogue about breast implant safety and risk at the upcoming public meeting of the General and Plastic Surgery Devices Panel at the FDA’s headquarters in Silver Spring, Maryland on March 25-26, 2019, which will also be available via webcast.

Health care professionals and consumers should report any adverse events related to breast implants to the FDA’s MedWatch Adverse Event Reporting program.  The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

End

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WILL JOHNSON & JOHNSON FACE “OPIOID CRISIS LEGAL JUSTICE” IN OKLAHOMA VERDICT?

Florida, Texas, Nevada, North Carolina, North Dakota, Tennessee, Massachusetts and others have their own Opioid Litigation in state courts across the country

By Mark A. York (July 15, 2019)

Live-video-opening-statements-for-oklahoma-opioid-trial vs. Johnson & Johnson

J&J defense-rests-in-opioid-trial-closing-arguments-set-for-July 15th

(MASS TORT NEXUS MEDIA) The time has now arrived for Opioid Big Pharma, in all forms to face the facts that for close to 20 years they have flooded the mainstream commerce of America with massive amounts of opiates with little to no oversight, which whether caused by a catastrophic systemic failure on many levels, or simple greed, the time has now come for the opiate industry to face the music of complex litigation in state and federal court venues across the country.

What remains to be seen is where and how the directly affected “individuals” who were prescribed millions of addictive opiates and subsequently became addicted and where thousands more overdosed and died, fit in to the “opioid litigation solution” and if they will actually receive treatment services and assistance on a substantive level.

Johnson & Johnson used promotional gimmicks for its opioid painkillers that are similar to how criminal drug dealers try to boost sales, a pharmaceutical-industry critic told a judge hearing Oklahoma’s claim that the company helped fuel a crisis of addiction.

J&J’s use of coupons allowing patients to get free Duragesic pain patches was improper, said Andrew Kolodny, a Brandeis University professor and opioid researcher who testified at the trial Wednesday on behalf of the state, which says the company is liable under public-nuisance laws.

Closing arguments are underway today, July 15, 2019 in Oklahoma’s case against Johnson & Johnson alleging the consumer products giant and its subsidiaries helped fuel the state’s opioid crisis.

Each side had about two hours Monday to make their cases to Cleveland County District Judge Thad Balkman, who is expected to issue his ruling at a later date.

See Original Complaint – State of Oklahoma vs. Purdue Pharma et al, June 30, 2017 (Cleveland County, OK District Court)

https://kfor.com/2019/07/12/defense-rests-in-opioid-trial-closing-arguments-set-for-July 15th

Oklahoma Attorney General Mike Hunter has described consumer products giant Johnson & Johnson as the “kingpin” company that helped fuel the state’s opioid crisis during closing arguments in the state’s case against the drugmaker.

Oklahoma claims that J&J aggressively marketed opioids in the state in a way that overstated their effectiveness to treat chronic pain and understated the addiction risks.

For a look at the Federal Opiate Litigation MDL 2804 see “OPIOID-CRISIS-BRIEFCASE -MDL-2804-OPIATE-PRESCRIPTION-LITIGATION” where counties, cities, indian tribes as well as unions, hospitals and individuals have filed more than 2000 lawsuits against the opioid industry as a whole.

Bad Conduct of Opioid Big Pharma Outlined

In a June 2017 memo to Purdue officials, titled “Confidential Program Recommendation,” Matt Well, a founding partner of the Washington, D.C.-based public relations firm The Herald Group, details a campaign that included attacks on undisclosed attorneys general. The attacks were intended to deter other states from suing the company.

Link to Purdue Pharma Opioid Marketing Campaign Documents

“Our goal is to make state attorneys general think twice about joining the litigation,” Well wrote in the proposal.

Other recommendations included targeting outside law firms hired to help in the cases by calling into question the attorneys’ credibility and personal profit motive.

The final recommendation included working with journalists and placing stories in specific publications to tell what the firm labeled “the anti-story”. The anti-story refers to the public relations firm finding legal experts to talk to reporters or write op-eds for publications that slam lawsuits filed by states and shift the blame for the epidemic to victims in an attempt to sway public opinion to the company’s favor.

At one point, the opiate industry attempted to raise arguments stating that the Food and Drug Administration hasn’t yet determined whether narcotic painkillers are unnecessarily dangerous – a central question in any litigation, which was quickly denied and seems to show that Opiate Big Pharma is once again attempting to hide behind the FDA shield.

BILLIONS IN PROFITS

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

KEY POINTS AT OKLAHOMA TRIAL 

  • Lawyers for the state, including Attorney General Mike Hunter, told a judge in Norman, Oklahoma that J&J knew opioids were addictive yet played down their dangers when promoting them, leading to an oversupply of pills that caused overdose deaths.
  • The case is one of around 2,000 actions by state and local governments accusing drug manufacturers of contributing to the opioid epidemic.
  • J&J denies causing the epidemic. Its lawyers have argued that its products made up a small share of opioids prescribed in Oklahoma and carried U.S. Food and Drug Administration-approved labels that warned of the addictive risks.

Lawyers for the state of Oklahoma on Monday urged a judge to hold Johnson & Johnson responsible for fueling the U.S. opioid epidemic, as the first trial nationally in litigation over the drug crisis came to an end.

Attorney General Mike Hunter, told a judge in Norman, Oklahoma that J&J knew opioids were addictive yet played down their dangers when promoting them, leading to an oversupply of pills that caused overdose deaths.

“This company went out and sponsored lies,” Brad Beckworth, a lawyer for the state, said in his closing argument.” They went out and said the risk of addiction was less than 1%.”

He urged Judge Thad Balkmanm, who presided over the multibillion-dollar nonjury trial, to find Johnson & Johnson liable for creating a public nuisance.

The case is one of around 2,000 actions by state and local governments accusing drug manufacturers of contributing to the opioid epidemic. Opioids were linked to a record 47,600 overdose deaths in 2017, according to the U.S. Centers for Disease Control and Prevention.

The Oklahoma trial is being closely watched by plaintiffs in other opioid lawsuits, particularly in 1,900 cases pending before a federal judge in Ohio who has been pushing for a settlement ahead of an October trial.

At trial, lawyers for Oklahoma argued that J&J, which sold the painkillers Duragesic and Nucynta, had since the 1990s marketed opioids as “safe and effective for everyday pain” while downplaying their addictive qualities.

The state has accused J&J of acting as the “kingpin” behind the epidemic and says the company was motivated to boost prescriptions not only because it sold painkillers but because it also grew and imported raw materials that opioid manufacturers like OxyContin maker Purdue Pharma LP used.

J&J denies causing the epidemic. Its lawyers have argued that its products made up a small share of opioids prescribed in Oklahoma and carried U.S. Food and Drug Administration-approved labels that warned of the addictive risks.

J&J, whose lawyers were expected to deliver their own closing arguments later on Monday, argues the state is seeking to stretch the bounds of a public nuisance statute in order to force J&J to pay up to $17.5 billion to remedy the crisis.

Purdue and Teva Pharmaceutical Industries Ltd were originally also defendants in the case. Purdue reached a $270 million settlement with the state in March and Teva settled for $85 million in June. Both deny wrongdoin

One contributing factor behind the opioid epidemic is the increase in the use of prescription painkillers nationally. From 1991 to 2011, the number of opioid prescriptions dispensed by U.S. pharmacies tripled from 76 million to 219 million.[4] This increase in the use of opioids is unique to America. The United States represents less than 5 percent of the world’s population but consumes roughly 80 percent of the world’s supply of opioid drugs.[5] There is also wide variation from one state to another in opioid-prescribing rates. In 2012 twelve states had more opioid prescriptions than people: Alabama (142.9 per 100 people), Tennessee (142.8), West Virginia (137.6), Kentucky (128.4), Oklahoma (127.8), Mississippi (120.3), Louisiana (118), Arkansas (115.8), Indiana (109.1), Michigan (107), South Carolina (101.8), and Ohio (100.1).[6]

The impact of the opioid epidemic touches every aspect of our public safety and judicial system. Drug-related arrests involving opioids are skyrocketing. In many communities, court dockets and probation caseloads are filled with individuals with opioid-use disorders. Access to treatment, particularly medication-assisted treatment combined with cognitive behavioral interventions, is limited—particularly in rural communities. This epidemic also comes at a price. In 2015 the Ohio Department of Mental Health and Addiction Services began providing substance-abuse treatment in Ohio’s prisons, spending an estimated $30 million per year on drug treatment in prisons, $4 million on housing for individuals in recovery, and $1 million over two years for naloxone to reverse drug overdoses. The Ohio State Highway Patrol spent over $2 million to expand and improve their crime lab to keep up with substance testing.

UP TO $500 BILLION SETTLEMENT?

The current “Opiate Prescription Litigation MDL 2804” is being compared to the 1998 Tobacco Litigation settlement where Big Tobacco paid a settlement of $200 billion to cities, states and other governmental entities. The Opioid Litigation is expected to reach settlement figures of 3 to 4 times that amount, projected to be at the $500 billion plus figure, due to the rampant corporate boardroom directed policies that flooded the US marketplace for the last 15 years. Corporate sales and marketing policies and lack of oversight, enabled hundreds of millions of opioid prescription drugs to reach all areas of the country, thereby causing in excess of 100 thousand deaths and unknown catastrophic economic damages in every corner of the United States.

INSURERS ARE FIGHTING BACK

In 2018 ravelers Insurance and St Paul Fire and Marine Insurance scored a legal victory when they were granted a declaratory judgment win related to defending Watson and it’s parent company Activis, Inc in the Orange County-Santa Clara County litigation, after the California Appellate Court declared the Traveller’s/St Paul  opioid coverage policy void due to the “Watson’s Deliberate Conduct” in relation to sales and marketing of opioid prescription drugs, which was determined to be improper. The decision also voided the Watson-Activis coverage in the City of Chicago vs. Watson et al, in Chicago federal court, see  California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense. This may be a trend for insurance carriers as they’ve filed other legal action to void coverage on behalf of opioid drug makers including Insys Therapeutics, Inc and defense of its Subsys fentanyl fast acting drug.

To access the most relevant and real time information on Mass Torts  sign up for:

Mass Tort Nexus “CLE Immersion Course”

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For class attendance information please contact Anne Marie Kopek at 954.837.3423 or AnneMarie@masstortnexus.com

  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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Note: (Excerpts within this article include reference materials from CBS, ABC, NBC US Department of Ju

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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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Did Trump and Epstein Rape Two Underage Girls?

Did Trump and Epstein Rape Two Underage Girls?

Before we address the question, Did Trump and Epstein Rape Two Underage Girls” we will first discuss Attorney General Bob Barr’s highly unusual decision to un-recuse himself from the Epstein case and actually take direct control over the case, despite have previously announced he was conflicted from having anything to do with the matter.

 

Why did Barr Un-Recuse?

Mass Tort Nexus researcher, Mark York, discovered a civil lawsuit filed in 2016 by Katie Johnson (now an adult), she accuses Trump and Epstein of committing multiple acts of sexual violence against herself (13 at the time) as well as a 12-year-old. (see excerpts below or download the complaint at:

Donald Trump – Jeffrey Epstein Federal Complaint (USDC California 2016) Re: Minor Sex Abuse

Given Epstein’s history of secretly taping famous people taking sexual advantage of young women procured by Epstein, if the allegations in the Johnson complaint are true, Trump has every reason to be concerned that tapes might exist which would prove Johnson’s allegations.

Would Bob Barr Obstruct Justice to protect Trump?

Evidence to date would suggest that Bob Barr is more than willing to pervert our justice system and even defy elected officials to protect his boss.

Would Trump ask Barr to Un-Recuse Himself?

The Presidents history (in his own words) related to Jeff Session’s recusal from the Russia Probe and subsequent refusal to un-recuse himself provide strong evidence that the President would ask an attorney general to un-recuse himself despite any previously addressed conflicts.

Why would Trump want his loyal Protector in Chief (Barr) in charge of the Epstein matter?

The remainder of this article will provide information on which the reader can draw their own conclusions as to why Trump may need Barr to interfere in the Epstein Case.

White House Initial Reactions to Epstein Indictment

Kellyanne Conway took the airways shortly after the new Epstein indictment was announced claiming that the president had not talked to nor seen Epstein in 10 to 15 years. If this claim was intended give the impression that the President and his hold friend had not cross paths in over a decade, the Lawsuit filed by Katie Johnson against Trump and Epstein in 2016 (co-defendants) accusing the pair of committing multiple acts of sexual violence against Johnson (then 13) and another girl (12 at the time) makes the statements made by Kellyanne Conway highly questionable. (see excerpts from complaint below)

 

Also See:

https://www.politico.com/story/2019/07/09/trump-jeffrey-epstein-kellyanne-conway-1402997

NOT FAKE NEW’s

After reading the excepts provided below from the Johnson complaint, you decide is Trump may need someone (Barr) to run interference on his behalf before the Epstein matter spills over and creates yet another potential reason Trump may have to be concerned about his future, not just as President but also as total loss of his choice of clothing (being restricted to a single orange jumpsuit).

 

Excerpts from Complaint:

FACTUAL ALLEGATIONS

The Plaintiff, Katie Johnson, alleges that the Defendants, Donald J. Trump and Jeffrey E. Epstein, did willfully and with extreme malice violate her Civil Rights under 18 U.S.C. ; 2241 by sexually and physically abusing Plaintiff Johnson by forcing her to engage in various perverted and depraved sex acts by threatening physical harm to Plaintiff Johnson and also her family. The Plaintiff, Katie Johnson, alleges that the Defendants, Donald J. Trump and Jeffrey E. Epstein, also did willfully and with extreme malice violate her Civil Rights under 42 U.S.C.; 1985 by conspiring to deny Plaintiff Johnson her Civil Rights by making her their sex slave.

The Plaintiff, Katie Johnson, alleges she was subject to extreme sexual and physical abuse by the Defendants, Donald J. Trump and Jeffrey E. Epstein, including forcible rape during a four month time span covering the months of June-September 1994 when Plaintiff Johnson was still only a minor of age 13.

The Plaintiff, Katie Johnson, alleges she was enticed by promises of money and a modeling career to attend a series of underage sex parties held at the New York City residence of Defendant Jeffrey E. Epstein and attended by Defendant Donald J. Trump.

On the first occasion involving the Defendant, Donald J. Trump, the Plaintiff, Katie Johnson, was forced to manually stimulate Defendant Trump with the use of her hand upon Defendant Trump’s erect penis until he reached sexual orgasm.

On the second occasion involving the Defendant, Donald J. Trump, the Plaintiff, Katie Johnson, was forced to orally copulate Defendant Trump by placing her mouth upon Defendant Trump’s erect penis until he reached sexual orgasm.

On the third occasion involving the Defendant, Donald J. Trump, the Plaintiff, Katie Johnson was forced to engage in an unnatural lesbian sex act with her fellow minor and sex slave, Maria Doe age 12, for the sexual enjoyment of Defendant Trump. After this sex act, both minors were forced to orally copulate Defendant Trump by placing their mouths simultaneously on his erect penis until he achieved sexual orgasm. After zipping up his pants, Defendant Trump physically pushed both minors away while angrily berating them for the “poor” quality of their sexual performance.

On the fourth and final sexual encounter with the Defendant, Donald J. Trump, the Plaintiff, Katie Johnson, was tied to a bed by Defendant Trump who then proceeded to forcibly rape Plaintiff Johnson. During the course of this savage sexual attack, Plaintiff Johnson loudly pleaded with Defendant Trump to “please wear a condom”. Defendant Trump responded by violently striking Plaintiff Johnson in the face with his open hand and screaming that “he would do whatever he wanted” as he refused to wear protection. After achieving sexual orgasm, the Defendant, Donald J. Trump put his suit back on and when the Plaintiff, Katie Johnson, in tears asked Defendant Trump what would happen if he had impregnated her, Defendant Trump grabbed his wallet and threw some money at her and screamed that she should use the money “to get a fucking abortion”.

On the first occasion involving the Defendant, Jeffrey E. Epstein, the Plaintiff, Katie Johnson, was forced to disrobe into her bra and panties and to give a full body massage to Defendant Epstein while he was completely naked. During the massage, Defendant Epstein physically forced Plaintiff Johnson to touch his erect penis with her bare hands and to clean up his ejaculated semen after he achieved sexual orgasm.

On the second occasion involving the Defendant, Jeffrey Epstein, the Plaintiff, Katie Johnson, was again forced to disrobe into her bra and panties while giving Defendant Epstein a full body massage while he was completely naked. The Defendant, Donald J. Trump, was also present as he was getting his own massage from another minor, Jane Doe, age 13. Defendant Epstein forced Plaintiff Johnson to touch his erect penis by physically placing her bare hands upon his sex organ and again forced Plaintiff Johnson to clean up his ejaculated semen after he achieved sexual orgasm.

Shortly after this sexual assault by the Defendant, Jeffrey E. Epstein, on the Plaintiff, Katie Johnson, Plaintiff Johnson was still present while the two Defendants were arguing over who would be the one to take Plaintiff Johnson’s virginity. The Defendant, Donald J. Trump, was clearly heard referring to Defendant, Jeffrey E. Epstein, as a “Jew Bastard” as he yelled at Defendant Epstein, that clearly, he, Defendant Trump, should be the lucky one to “pop the cherry” of Plaintiff Johnson.

The third and final sexual assault by the Defendant, Jeffrey E. Epstein, on the Plaintiff, Katie Johnson, took place after Plaintiff Johnson had been brutally and savagely raped by Defendant Trump. While receiving another full body massage from Plaintiff Johnson, while in the nude, Defendant Epstein became so enraged after finding out that Defendant Trump had been the one to take Plaintiff Johnson’s virginity, that Defendant Epstein also violently raped Plaintiff Johnson.

After forcing Plaintiff Johnson to disrobe into her bra and panties, while receiving a massage from the Plaintiff, Defendant Epstein attempted to enter Plaintiff Johnson’s anal cavity with his erect penis while trying to restrain her. Plaintiff Johnson attempted to push Defendant Epstein away, at which time Defendant Epstein attempted to enter Plaintiff Johnson’s vagina with his erect penis. This attempt to brutally sodomize and rape Plaintiff Johnson by Defendant Epstein was finally repelled by Plaintiff Johnson but not before Defendant Epstein was able to achieve sexual orgasm. After perversely sodomizing and raping the Plaintiff, Katie Johnson, the Defendant, Jeffrey E. Epstein, attempted to strike her about the head with his closed fists while he angrily screamed at Plaintiff Johnson that he, Defendant Epstein, should have been the one who “took her cherry, not Mr. Trump”, before she finally managed to break away from Defendant Epstein.

The Plaintiff, Katie Johnson, was fully warned on more than one occasion by both Defendants, Donald J. Trump and Jeffrey E. Epstein, that were she ever to reveal any of the details of the sexual and physical abuse that she had suffered as a sex slave for Defendant Trump and Defendant Epstein, that Plaintiff Johnson and her family would be in mortal danger. Plaintiff Johnson was warned that this would mean certain death for herself and Plaintiff Johnson’s family unless she remained silent forever on the exact details of the depraved and perverted sexual and physical abuse she had been forced to endure from the Defendants.

 

MATERIAL WITNESSES

Tiffany Doe, a former trusted employee of the Defendant, Jeffrey E. Epstein, has agreed to provide sworn testimony in this civil case and any other future civil or criminal proceedings, fully verifying the authenticity of the claims of the Plaintiff, Katie Johnson. Witness Tiffany Doe was employed by the Defendant, Jeffrey E. Epstein, for more than 10 years as a party planner for his underage sex parties. Despite being subject to constant terroristic threats by Defendants Epstein and Trump to never reveal the details of these underage sex parties at which scores of teenagers, and pre-teen girls were used as sex slaves by Defendant Epstein and Defendant Trump, witness Tiffany Doe refuses to be silent any longer. She has agreed to fully reveal the extent of the sexual perversion and physical cruelty that she personally witnessed at these parties by Defendants Epstein and Trump.

Material witness Tiffany Doe fully confirms all of Plaintiff Katie Johnson’s allegations of physical and sexual abuse by Defendants Donald J. Trump and Jeffrey E. Epstein. Tiffany Doe was physically present at each of the four occasions of sexual abuse by Defendant Trump upon the person of Plaintiff Johnson, as it was her job to witness all of the sexual escapades of Defendant Epstein’s guests at these underage sex parties and later reveal all of the sordid details directly to Defendant Epstein. Defendant Epstein also demanded that Tiffany Doe tell him personally everything she had overheard at these parties explaining to her that “knowledge was king” in the financial world. As a result of these underage sex parties, Defendant Epstein was able to accumulate inside business knowledge that he otherwise would never have been privy to in order to amass his huge personal fortune.

Material witness Tiffany Doe will testify that she was also present or had direct knowledge of each of the three instances on which Defendant Jeffrey E. Epstein physically and sexually abused the Plaintiff, Katie Johnson. Tiffany Doe will testify to the fact that the Plaintiff, Katie Johnson, was extremely fortunate to have survived all of the physical and sexual horrors inflicted upon her by Defendants Epstein and Trump.

(end excerpts from Johnson Complaint)

Would Trump Do Such Things? 

 

“The fact that Donald Trump had a friendly relationship with Epstein — he told New York Magazine in 2002 that “(Epstein’s) a lot of fun to be with … It is even said that he likes beautiful women as much as I do, and many of them are on the younger side”

http://nymag.com/nymetro/news/people/n_7912/

Not Just Locker Room Talk

 

Is it Normal to Agree that your Daughter is a “Hot Piece of Ass? 

More Creepy Daddy Moments 

 

Do You Enjoy Kissing Your Daughter More than Kissing  your Wife?

 

 

 

 

Daddy Really Loves His Little Girl

 

 

 

Trump and Epstein Like Them Young

10 Creepy Things Donald Trump Has Said About Ivanka

Conclusion

Do you think Trump has a reason to want Bob Barr heading up the Epstein case?

Do you think Barr would be willing to run interference for Trump, even if it meant giving Epstein a break?

Do you think Trump might engage in the acts alleged in the Johnson Complaint?

Will Trump Supporters be OK with this?

More Background Information 

 

In case you have not been following the Epstien Case, the following should get you up to speed:

 

Other News and Links:

Donald Trump and Prince Andrew met up in London ahead of Jeffrey Epstein’s arrest on new sex trafficking charges

 

 

 

 

 

 

 

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