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Vaginal Mesh LawsuitInjuries from Mesh Implant Severe and Debilitating

Vaginal Mesh Lawsuit

Transvaginal mesh is a medical device that is generally used to repair weakened or damaged tissue (specifically, to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI)). Throughout the years, thousands of women reported side effects, including severe pain and debilitating injuries. As a result, lawsuits were filed against the manufacturers of vaginal mesh products.

TorHoerman Law is no longer accepting transvaginal mesh cases.

Litigation Updates

Most Cases Settled, Others Being Prepared for Pre-Trial Discovery

August 2018 - The overwhelming majority of cases either have been settled or are in settlement programs now. Unsettled cases, not otherwise involved in settlement programs, are being set for pre-trial discovery, and in some cases, remanded to appropriate district courts for trial.

Remaining TVM Cases Are Being Prepared for Trial

April 2018 - Following the settlement of thousands of cases on, January 30, 2018, MDL Judge Goodwin ordered that hundreds of remaining TVM cases be worked up for trial.

C.R. Bard Hit With $68 Million Pelvic Mesh Verdict in NJ

April 13, 2018 – A New Jersey state jury awarded a plaintiff $33 million in compensatory damages and $35 million in punitive damages to be paid by vaginal mesh manufacturer, C.R. Bard. After four weeks of trial and deliberations, the jury found Bard guilty of manufacturing unsafe pelvic mesh products as well as failing to warn doctors and consumers about the potential adverse health risks associated with the company's pelvic mesh products.

 

The plaintiff, Mary McGinnis, filed the lawsuit in 2011, claiming that her injuries were a result of the defective design of Bard's pelvic mesh products – Avaulta Solo Support System & Align Trans-Obturator Urethral Support System. The lawsuit further claimed that Bard failed to properly inform doctors and patients of the adverse health risks associated with the products.

The jury found Bard guilty on both counts, awarding McGinnis $23 million and her husband, the co-plaintiff in the lawsuit, $10 million in compensatory damages. In addition to the compensatory damages, C.R. Bard must pay $35 million in punitive damages, bringing the grand total to $68 million.

McGinnis underwent Avaulta Solo procedure in March 2009 to support her bladder. The Align system was meant to treat stress urinary incontinence.

McGinnis claims that her subsequent injuries were a direct result of her pelvic mesh device. The plaintiff went on to argue that Bard failed to make public the known risks associated with the device and, if she or her doctor were aware of these risks, neither herself nor her doctor would have chosen to undergo the 2009 procedure.

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$57 Million Verdict in Philadelphia J&J Ethicon Pelvic Mesh Case

September 7, 2017 - A Philadelphia jury awarded $57.1 million to a woman who claimed Johnson & Johnson's pelvic mesh product had caused her severe and life-altering injuries. The jury's unanimous decision included a $7.1 million award for compensatory damages and $50 million in punitive damages. The jury found that Ethicon was guilty of negligence and that the manufacturer's pelvic mesh product was defectively designed, which resulted in the mutilation of Ebaugh's urethra and her near-incontinence.

 

Ella Ebaugh (plaintiff) was implanted with J&J's TVT-Secur pelvic mesh product in May 2007. In 2010, Ebaugh was made aware by her doctor that the device had eroded into her urethra, causing severe pain in the pelvic region, as well as causing her to experience frequent urges to urinate. Ebaugh underwent a number of operations to remove the defective pelvic mesh device. Even after multiple operations, the scarring around her urethra was so severe that it left her almost completely incontinent.

Ebaugh's claim against J&J subsidiary, Ethicon, is the fifth case against the manufacturer's mesh products to be tried in the Philadelphia County Court of Common Pleas. The four other pelvic mesh product cases ended with similar awards to the plaintiffs — Ethicon had thus far paid out a total of almost $50 million in damages in those four cases.

In a statement made after the court adjourned, Ethicon spokeswomen Kristen Wallace said that the manufacturer stands behind their mesh product's safety and efficacy. Ethicon plans to appeal the decision.

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Another Big Win for Plaintiff in Ethicon Transvaginal Mesh Lawsuit

May 26, 2017 -  A Philadelphia state order required Johnson & Johnson subsidiary Ethicon to pay out on a $2.16 million verdict awarded to Sharon Beltz who claimed she had suffered adverse health effects from the pharmaceutical manufacturer's pelvic mesh device.  This is the fourth consecutive loss for Ethicon's Pennsylvania branch for transvaginal mesh lawsuits.

 

The transvaginal mesh lawsuit filed against Johnson & Johnson was tried in the Philadelphia Court of Common Pleas. The woman was implanted with Ethicon’s Prolift mesh as a corrective measure, an effort to treat stress urinary incontinence and pelvic organ prolapse.

The plaintiff's testimony attests that, subsequent to the implant, the transvaginal mesh device eroded into her vagina and bladder, causing irreversible, permanent medical complications. According to her testimony, these complications include chronic pelvic pain, incontinence, urinary tract infections, and intolerable pain during sexual intercourse.

In a matter of hours, the jury came to a conclusion, ruling in favor of the plaintiff.

 

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$20 Million Awarded to Plaintiff in Ethicon Vaginal Mesh Case

May 1, 2017 – A Pennsylvania jury awarded $20 million in damages to a woman who claims to have suffered similar adverse effects due to an Ethicon transvaginal mesh device. The plaintiff, in this case, endured severe pain and underwent several surgeries to have the mesh removed.

Jury Awards $13.5 Million in Second Ethicon Transvaginal Mesh Case in Philadelphia

February 11, 2016 - A Philadelphia jury has just awarded a woman $13.5 million dollars in a lawsuit against Johnson & Johnson subsidiary, Ethicon. The plaintiff, Sharon Carlino, proved that Ethicon's transvaginal mesh implant caused her permanent injuries, including painful intercourse, that will likely remain with her for the rest of her life. The device that was the subject of the lawsuit, the TVT mid-urethral sling, has long been touted by Ethicon and its' experts as the "gold-standard" device on the market for incontinence — even to this day. The jury disagreed and awarded the plaintiff $3.5 million in compensatory damages and $10 million in punitive damages to punish the company for its conduct.

As Ms. Carlino's lawyers argued, and as the jury apparently agreed, the TVT sling had four major problems. First, the pores in the mesh were too small, creating scar tissue that caused the area with the implant to pull on adjacent tissues and organs, including the vagina. Second, when the mesh is implanted, it changes shape, causing it to curl, twist, fray and erode. Third, the TVT tape was cut with a machine instead of a laser, which meant that the edges could fall off and become embedded in the body. Fourth, the very polymer that the mesh is made of degrades when implanted in the transvaginal area.

The loss is the second loss for Ethicon in the Philadelphia trials, with a prior jury awarding $12.5 million to a similarly injured woman just two months ago. Perhaps in response to that loss, Ethicon pulled out all the stops in its defense of this case, including arguing that Ms. Carlino filed her lawsuit too late and arguing that the implanting doctor was responsible for not warning Ms. Carlino of the mesh's problems. Ethicon's defense was so aggressive that the lawyers for Ethicon earned themselves a rare sanction from the trial court when Ethicon's lawyers improperly violated a court order while questioning a doctor.

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Jury Ruled in Favor of Manufacturers, Boston Scientific and C.R. Bard

February 4, 2016 – A Missouri jury ruled in favor of transvaginal manufacturers Boston Scientific and C.R. Bard. The lawsuit was brought by Eve Sherrer.

Federal Appellate Court Approves $2 Million Verdict For Vaginal Mesh Victim

January 14, 2016 - Thousands of women injured by transvaginal mesh implants won an important legal victory yesterday when the United States Court of Appeals for the Fourth Circuit affirmed a $2,000,000 jury verdict in favor of Donna Cisson. Donna, like many women, had a transvaginal mesh implant to address her pelvic organ prolapse and stress urinary incontinence and suffered severe and debilitating pain as a result.

The Court's opinion also addressed four issues of importance to all women who have brought claims.

First, Bard, the manufacturer of Donna's "Avaulta Plus" implant, claimed that the trial court was wrong when it prevented Bard from trying to distract the jury by claiming that Bard's compliance with federal law somehow meant the jury could not find that they were negligent and responsible for Donna's injuries. In short, the Bard "Avaulta Plus", like most transvaginal meshes, was allowed to be sold by the FDA because it met the requirements of the "Section 510(k)" loophole, in which a medical device manufacturer can sell a medical implant without any real testing so long as the manufacturer convinces the FDA that the implant is similar to some other implant on the market.

The federal appellate court disagreed and said: "the clear weight of persuasive and controlling" case law said, "the 510(k) procedure is of little or no evidentiary value" because it was merely "a qualification for an exemption" and that it imposed no specific requirements on the device's design. The appellate court agreed that allowing that evidence would amount to "subjecting the jury to many hours, and possibly days, of complex testimony about regulatory compliance could lead jurors to erroneously conclude that regulatory compliance proved product safety."

Second, Bard argued the jury should not have been allowed to hear that the polypropylene used in the Avaulta Plus included a specific "MEDICAL APPLICATION CAUTION" that warned against using the material "in medical applications involving permanent implantation in the human body." The appellate court disagreed, and held that the warning was rightly presented to the jury to show "that Bard received the warning and then responded either by ignoring it or withholding it from other parties."

Third, Bard argued that Donna had somehow not presented enough evidence to prove the mesh caused her injuries. The appellate court completely rejected this argument, saying:

Dr. Lennox Hoyte, a urogynecologist, and Dr. John Miklos, one of Cisson's treating physicians, respectively testified that the arms on the Avaulta Plus constituted a design defect and caused Cisson's pain; Dr. Bernd Klosterhalfen, a pathologist, and Dr. Jim Ross testified that inadequate pore size can cause the implanted mesh to shrink and can lead to inflammatory reactions and rigid scarification inside the body; and Dr. Anthony Brennan, a professor and expert in material sciences and biomedical engineering, Dr. Klosterhalfen, and Dr. Brian Raybon, another of Cisson’s treating physicians, testified that polypropylene can degrade in the human body, degradation can cause internal inflammation, and that Ms. Cisson's mesh was degraded. This and the other evidence presented at trial was more than enough for the jury to conclude that the alleged defects caused Cisson's injuries.

If Bard had put as much energy into ensuring the safety of these implants as Donna Cisson did into showing how they hurt her, none of this would have happened.

Fourth, Bard argued that the $1.75 million the jury awarded in punitive damages was so "excessive" as to violate their constitutional right because the jury awarded only $250,000 in compensatory damages. The appellate court made short work of this argument, noting that the United States Supreme Court had never recognized any particular amount of punitive damages as "excessive." (Notably, Bard never challenged the jury's findings of "the degree or reprehensibility of the defendant’s misconduct," perhaps because they realized that "ignoring or withholding" a blatant warning about the dangers of their device was undeniably reprehensible).

All in all, the federal appellate court's decision is a tremendous victory for women nationwide. The appellate court completely rejected all of the mesh manufacturer's complaints about the trial, thereby affirming the right of other injured women to present the same type of evidence in their trials.

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Vaginal Mesh Manufacturers Begin Settlement Discussions

October 2013 - After several plaintiffs were awarded million-dollar verdicts and others settled for undisclosed amounts, five of the largest transvaginal mesh manufacturers began discussing a settlement for the thousands of remaining plaintiffs. On September 30, Bloomberg News reported that legal counsel for American Medical Systems, Boston Scientific, Coloplast, Cook Medical and C.R. Bard began discussing settlement plans. Johnson & Johnson has decided not to partake in these talks.

This news is a positive step for the thousands of plaintiffs who have been injured by mesh devices manufactured by these companies. Attorneys for the plaintiffs have requested that Judge Joseph Goodwin in the Southern District of West Virginia appoint a settlement committee in order to expedite the resolution of these cases.

Generally, in mass torts such as this, settlement discussions include what injuries should be compensated, for how much and what proof of injury the manufacturer would require for settlement. Discussions may also include what medical conditions could affect the effectiveness of the mesh, which could result in a lower settlement amount.

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C.R. Bard Settled Vaginal Mesh Case

September 17, 2013 - C.R. Bard Inc. agreed to settle a vaginal mesh implant case that was set for trial later this month according to undisclosed sources who spoke to Bloomberg News. The settlement amount, as of now, is also undisclosed.

The case, which was filed in New Jersey, centered on Melanie Virginal's claims that Bard's Avaulta Plus insert caused her urinary and other internal problems. Melanie's case was set to begin on September 23 in state court in Atlantic City.

 

 

Second C.R. Bard Transvaginal Mesh Trial Ends in Settlement

August 21, 2013 - The second bellwether case to go to trial, Queen v. C.R. Bard, Inc., regarding C.R. Bard's Avaulta transvaginal mesh settled for an undisclosed amount on the day it was set to go to trial, August 21, 2013.

Wanda Queen, the North Carolina plaintiff, allegedly suffered permanent vaginal mesh injuries after she was implanted with the Avaulta Solo Anterior Synthetic Support System. She was forced to undergo six revisionary surgeries.

The case never made it to court as the settlement happened on the morning the trial was scheduled to begin.

Although attorneys for C.R. Bard maintain that they will consider each case based on the facts and merits, this settlement should be seen as a good sign for all plaintiffs – it appears that Bard is taking responsibility for the injuries caused by their Avaulta Support System.

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First C.R. Bard Transvaginal Mesh Trial Ended Favorably For Women Injured

August 2013 – The first of four bellwether trials against C.R. Bard resulted in a favorable outcome for Donna Cisson who was implanted with C.R. Bard's Avaulta Plus device in 2009.

Similar to many other women, Ms. Cisson's suffered from severe vaginal mesh complications after her procedure and had to undergo several unsuccessful revision procedures. Ms. Cisson was finally forced to have the mesh removed. Mr. and Mrs. Cisson sued C.R. Bard alleging that Bard executives knew about the potential dangers associated with the Avaulta devices, yet intentionally failed to warn about these complications.

Donna Cisson’s case was the first bellwether case to be tried by the Southern District of West Virginia, which was appointed by federal courts to oversee the vast majority of transvaginal mesh lawsuits.

In her trial, Judge Goodwin instructed the jury that C.R. Bard should be found responsible for the Plaintiff's injuries if her attorneys were to prove three things:  (1) a defect in the Avaulta Plus device; (2) the defect existed at the time it left Bard's control; and (3) the defect in the product was the proximate cause, or most significant factor, of the injury.

After listening to both sides, the jury found that C.R. Bard designed and marketed a defective product that was not suitable for human use. The jury of four men and four women took just 12 hours to determine that C.R. Bard, Inc. was liable for Cisson's severe injuries resulting from her Avaulta Plus mesh device. The jury awarded the plaintiff $2 million consisting of $250,000 for compensatory damages and $1.75 million in punitive damages.

This transvaginal mesh trial comes just weeks after information was made public that Bard executives had knowledge of potential complications with their transvaginal mesh device. In June, Bloomberg BusinessWeek disclosed emails and other evidence was demonstrating that Bard knew that the plastic they were using in their mesh products was "not suitable for human use." According to the Bloomberg article, Bard (specifically, Davol which is a Bard company) used a resin-based plastic that they knew was not suitable for implanting in people. The manufacturer of this plastic went as far as to warn Bard not to use the material in medical applications even in the case of brief or temporary implantation in the human body unless they have an explicit agreement with the company regarding this use. Despite these clear warnings, Bard continued to use and market this mesh as a safe and effective option for women.

The email evidence from 2004-2007 contained warnings from a Bard executive to colleagues not to tell the manufacturer of the plastic that they were, in fact, using the material in humans. Bard tried to hide this information when confronted by the manufacturer, stating, "It is likely they do not know of our implant application. Please do not mention Bard's name in any discussion with these manufacturers." Even though Bard had information that this product was not fit for humans, the company decided it was not cost-effective to conduct clinical trials to test this for themselves.

In a deposition of Jim Ross, a Bard Consultant, Ross stated that the company knew it was going to cost several million dollars and take a few years to conduct clinical trials, so they did not think it was worth it. Rather, Bard decided to immediately market and distribute this product to thousands of women under the theory that other companies were distributing similar products. Unsurprisingly, these companies such as American Medical Systems, Johnson & Johnson and Boston Scientific Corporation, to name a few, are also now facing thousands of transvaginal mesh lawsuits.

Although Bard has not commented on any of the emails or documents filed in federal court, they still maintain their position that the Avaulta propylene mesh is safe and effective for human use. It will now be up to the juries to determine whether Bard’s mesh was safe and provided proper warnings against injury or whether Bard placed profit over safety and hid the truth from their suppliers and consumers.

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Jury Awards Plaintiff Millions in Damages for Failed Ethicon Transvaginal Mesh

February 2013 - In a resounding victory for Plaintiff, Ms. Linda Gross, in the Superior Court of Atlantic County, N.J., the jury reached a verdict in her favor against Johnson & Johnson for their defective Ethicon's Prolift Pelvic Floor Repair System.

Gross, a former nurse, had the device implanted in mid-2006 for pelvic organ prolapse, but instead of strengthening and relieving pain, the device actually caused more agony.  Gross was so uncomfortable and in such excruciating pain, she was unable to sit down.

In this instance, Johnson & Johnson improperly decided to forego testing their transvaginal mesh product before placing it on the market for sale, choosing instead to compare it to Gynecare Prolift, a similar product already on sale. Further, Johnson & Johnson placed their product for sale prior to FDA approval.

The jury set a commanding precedent for future decisions. Unethical business practices with zero accountability and only profit margins as the goal are no longer tolerable. The safety and well-being of consumers must be the first priority.

The verdict was affirmed and Ethicon's petition for review was denied by the New Jersey Supreme Court in 2015.

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C.R. Bard $5.5 Million Dollar Verdict

July 23, 2012 – Medical manufacturer C.R. Bard Inc. has been handed a $5.5 million dollar verdict. The trial, which was held in California, revolved around a woman whose vaginal-mesh implant left her incontinent and in chronic pain.

Christine Scott and her husband were awarded the damage award because of injuries caused by Bard's Avaulta Plus product. The jury found that Bard was negligent in their handling of the vaginal implant devices; devices which were used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Even after Christine Scott's verdict, Bard still is proclaiming innocence. "While we empathize with the complications suffered by the plaintiff, those complications are not the fault of any conduct by the company," Scott Lowry, a Bard spokesman, said in a follow-up statement.

Nevertheless, what the jury saw seemed to paint a different picture. The past and ongoing actions of many of these manufacturers, not just Bard, display a sense of disregard for patient’s safety that cannot be ignored.

These factors are just a few of the concerns that have surfaced since allegations involving these devices began.

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Several Vaginal Mesh MDL’s Consolidated

February 7, 2012 -  The U.S. Judicial Panel on Multidistrict Litigation (JPML) issued an order consolidating several vaginal mesh multidistrict litigations into a single proceeding to be heard in the Southern District of West Virginia. The order consolidated MDL's against three manufacturers – Boston Scientific Corp. (MDL No. 2326), American Medical Systems (MDL No. 2325), and Johnson & Johnson's Ethicon (MDL No. 2327); all of whom manufacture a number of different kinds of vaginal mesh that tend to produce similar injuries and complications.

Multidistrict litigation is an option that provides efficiency in litigation when handling numerous lawsuits by different plaintiffs against a defendant or group of defendants in various districts. Unlike class actions, MDL's allow for plaintiffs to maintain their individual causes of action while consolidating pretrial disclosures and eliminating inconsistent pretrial rulings by multiple judges. In consolidating the above mentioned MDL's the JPML noted their decision "conserves the resources of the parties, their counsel, and the judiciary."

The JPML further reasoned the consolidation was proper because "actions in each MDL share factual issues arising from allegations of defects in pelvic surgical mesh products manufactured by AMS, Boston Scientific, and Ethicon, respectively.

"A number of these actions are brought by plaintiffs who were implanted with multiple products made by multiple manufacturers. Centralization of the three MDLs in one court will allow for coordination of any overlapping issues of fact in such multi-product, multi-defendant actions."

The consolidated MDL will take place before Judge Joseph R. Goodwin, who is familiar with vaginal mesh MDL's because he presided over a similar action against C.R. Bard that was established in 2010.

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What is Vaginal Mesh?

Transvaginal mesh, also known as pelvic mesh or bladder slings, is a surgically implanted mesh device used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. POP occurs when the muscles holding pelvic organs in place are weakened, resulting in the bladder dropping (or prolapsing) and pressing against the walls of the vagina. SUI, on the other hand, occurs when an activity such as coughing or sneezes causes urine to leak out of the urethra. Vaginal mesh is used to repair these issues by providing extra support to the weakened or damaged tissue. It is made from either porous synthetic material or biologic material.

Surgical mesh has been used since the 1950s, but during the 1990s, surgical mesh began to be used to treat abdominal repair of SUI. In 2002, the product was approved and used for transvaginal repair of POP to lower the POP relapse rate following traditional surgery. However, the product soon began to cause issues and women suffered debilitating side effects. According to a 2017 study, researchers suggest that up to 40% of women suffer injuries as a result of medical instruments used to implant transvaginal mesh.

The synthetic vaginal mesh has edges that, in some cases, pierce the surrounding tissue and are capable of puncturing the bladder, uterus, or bowel. The sling can also migrate and in the process, do irreparable damage as they move around. Women can also suffer horrible infections because of the mesh.

These types of mesh underwent virtually no safety review by the FDA or any other regulatory agency before being put on the market by manufacturers. Of those manufacturers, C.R. Bard, American Medical Systems, Boston Scientific, Ethicon (a subsidiary of Johnson & Johnson), Coloplast, and Cook Medical are the most prominent. A vaginal mesh lawsuit was filed against the manufacturers of vaginal mesh products.

 

What are the Injuries?

The injuries that women are alleged to have suffered from this mesh implant are severe and debilitating and could have been avoided had people had the proper information.

The edges of the mesh/sling can cut through the skin after implantation, causing infection and cutting into nearby structures sometimes puncturing the bladder, bowel, and uterus.

Complications from these infections can include incontinence, extreme pain during intercourse, UTI, back pain, inability to walk, etc. Some of these infections can spread through the whole body and lead to death.

Studies estimate that the actual rate of injury is likely to increase significantly, which should not be surprising considering that more than 100,000 of these types of procedures are performed annually. There could be tens of thousands of injuries and hundreds of deaths according to reports made to the FDA. Yet, sometimes these injuries can take years to develop after the initial surgery. Tens of thousands of women have filed lawsuits alleging they were injured by pelvic mesh products.

Unfortunately, about 30 percent of women who underwent mesh surgery for POP will need another related surgery.

Due to the high complication risk, the FDA has re-classified vaginal mesh used to treat POP as a high-risk device. The classification does not, however, apply to the vaginal mesh used to repair SUI. Regardless, many surgeons have stopped using vaginal mesh altogether because of the risks involved.

There are other safer alternatives to synthetic mesh, such as biological mesh, that should be considered before the decision is made to use synthetic materials.

 

What Can Be Done To Avoid Vaginal Mesh Injury?

Women with these products in their body should be aware of symptoms indicating movement of the mesh so that they can know when to seek medical care. If you suffer any complications or symptoms that you think could be related to the placement of a mesh implant, alert your physician immediately. Following the advice of a qualified physician is most important.

The failed mesh implants commonly require a removal surgery. Unfortunately, this is much easier said than done.

 

Can the Pelvic Mesh be Removed?

Once the mesh is implanted, it is very difficult to remove. Even after multiple surgeries, doctors are sometimes unable to remove all of the mesh, which by that point has become infused with the surrounding tissue, causing life-long problems and severe pain.

 

Who Manufactured Vaginal Mesh?

  • Johnson & Johnson
  • American Medical Systems (now a unit of Endo Pharmaceuticals)
  • Boston Scientific
  • C.R. Bard

The four listed manufacturers are all considered to be the top manufacturers of transvaginal mesh products in the United States. Together, they faced thousands of lawsuits.

 

Vaginal Mesh Lawsuit

More than 100,000 vaginal mesh lawsuit(s) have been filed over the years. Many have resulted in settlements, with some resulting in multimillion-dollar settlements, however, some vaginal mesh lawsuit(s) are still on-going. At this time, TorHoerman Law is no longer accepting vaginal mesh cases.

 

If you have any questions regarding the vaginal mesh lawsuit, please contact us.

 

Timeline

Cutting Their Losses: Endo to Stop Making AMS Transvaginal Mesh

March 31, 2016 - Endo International closed its Astora Women's Health device unit and will cease the production and marketing of American Medical Systems (AMS) transvaginal mesh implants. The closure is seen as an effort by Endo to reduce future fallout from soaring legal costs and large settlements paid to injured women through product liability lawsuits.

Endo’s decision comes in light of new U.S. Food and Drug Administration (FDA) rules that require transvaginal mesh manufacturers to submit new safety and effectiveness data on pelvic organ prolapse (POP) surgeries by the summer of 2018. Companies like Endo are electing to stop selling the devices in lieu of going through a lengthy regulatory process required by the FDA, according to a Minneapolis Star Tribune report. Endo and Johnson & Johnson subsidiary Ethicon are the two largest suppliers of mesh devices in the U.S.

Mesh Devices Reclassified

January 4, 2016 - The FDA reclassified mesh devices from a medium risk category (Class II) to a high-risk category (Class III). This change would require the devices to get premarket approval with the FDA as well as require the manufacturers to prove the safety and effectiveness of the products on an ongoing basis.

Ethicon Pelvic Floor Systems Pulled from the Market

June 2012 - Prompted by the prospect of more litigation, Johnson & Johnson's Ethicon unit told a federal judge in West Virginia it intends to stop marketing four vaginal mesh implant systems as a result of lawsuits filed by women who say the products caused internal injuries. Those four Gyencare products are:

  • TVT Secur
  • Prosima Pelvic Floor Repair System
  • Prolift Pelvic Floor Repair System
  • Prolift MTM Pelvic Floor Repair System

In a letter to the Judge, Ethicon notified the court that it will no longer "commercialize" these products but that it has requested 120 days from the FDA to allow stop the marketing. This time frame will be needed in order for Ethicon to warn doctors, change their website, and to gather all marketing materials.

Post-Market Safety Studies Required

January 4, 2012 - The FDA ordered 33 manufacturers of vaginal mesh devices to conduct post-market safety studies on their products. The FDA ordered the additional safety studies in response to growing concerns about the safety of transvaginal mesh.

Ethicon Pulled Four Mesh Devices from Market

2012 - Ethicon decided to pull four popular mesh devices from the market. Despite the multitude of FDA warnings and the mounting lawsuits filed against them, Ethicon is standing by their claim that their products are still safe and that they chose to pull certain devices due to commercial concerns alone.

The FDA has since required Ethicon, along with 20 other transvaginal mesh manufacturers, to conduct research to explore the possible risks associated with their devices.

FDA Issued Drug Safety Communication

July 13, 2011 - The FDA issued a safety communication informing the medical community and patients that serious complications from use of surgical mesh for transvaginal repair of pelvic organ prolapse (POP) are not rare. In fact, the FDA noted that they have received thousands of voluntary reports from patients, friends, or doctors indicating complications occurring as a result of the vaginal mesh/bladder sling, with at least 10 of the reports alleging death as a result of mesh complications.

In relation to the effects of using surgical mesh for treatment of urine leakage during moments of physical activity (stress urinary incontinence), the FDA will assess the safety and effectiveness of the surgical mesh devices through review of adverse event reports submitted to the agency.

FDA Issued Public Health Notification

October 2008 – The U.S. Food & Drug Administration (FDA) issued a public health notification to doctors and individuals to warn of the risks associated with transvaginal mesh and how to reduce the risks

 

 

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