Vaginal Mesh Lawsuits in 2024

This page is for women who are considering bringing a vaginal mesh lawsuit in 2024.

Vaginal mesh litigation has become one of the most significant mass torts in recent history, involving thousands of lawsuits against multiple transvaginal mesh (TVM) product manufacturers.

This article provides a history of the vaginal mesh litigation and gives you the lay of the land for bringing a vaginal mesh lawsuit in 2024. Our lawyers also discuss our average settlement amounts and jury payouts for victims with successful claims.

Vaginal Mesh Lawsuits News and Updates

December 23, 2024: New Study on Desing Flaws in Vaginal Mesh Materials

A newly published study found that the majority of vaginal and pelvic mesh implants may have been destined for failure due to major flaws in their design and manufacture. The study, which was done by a team from the University of Sheffield in England, found that the plastic material that is the primary component in most vaginal mesh implants was basically defective. The study reported that the material actually begins to degrade within just 60 days after being implanted inside the body.

December 1, 2024: Pre and Post-Market Failures

The vaginal mesh crisis didn’t happen overnight—it’s the result of failures at two critical points: before the product hit the market and after it was already being used by patients.

Manufacturers didn’t conduct the rigorous testing these products deserved. Many vaginal mesh devices were rushed through the FDA’s 510(k) process, which allowed them to skip extensive clinical trials. They were approved based on their similarity to products already on the market, not on solid evidence of safety. The assumption? That mesh materials used for hernia repairs would work just as well in the pelvic floor—a completely different environment. That assumption turned out to be dangerously wrong.

Even after the mesh was in use, problems kept piling up because manufacturers and regulators failed to keep track. Adverse events like erosion and organ perforation were reported late…or sometimes, not at all. Follow-up studies were limited and focused on short-term outcomes, ignoring long-term complications like chronic pain and inflammation that patients started experiencing years later.

These failures mean that patients—perhaps like you—were left to suffer from complications that could have been prevented if transvaginal mesh makers had taken a breath and put people over profits.  Manufacturers did not do enough to ensure the products were safe.  And when problems emerged, they slow-walked the problem.

If you’re pursuing a vaginal mesh lawsuit, these are the systemic flaws that fuel your case, showing just how badly manufacturers and regulators let patients down. This fight is about holding them accountable and ensuring no one else has to go through what you have experiencing.

October 30, 2024: New Study on How Awful Polypropylene

A new study examined how polypropylene (PP) mesh degrades over time after being implanted in the bodies of sheep, focusing on both surface and structural changes.  Doctors were told that polypropylene mesh is safe and stable in the body.  Is it safe?

This study says no. After 60 and 180 days of implantation, the PP mesh underwent significant changes that could cause problems for patients. Researchers found that the mesh surface started degrading, oxidizing, and shedding tiny particles into the surrounding tissue. The longer the mesh was in the body, the worse this got—by 180 days, cracks appeared, the mesh stiffened, and even more particles were released.

These particles, which you have to remember are embedded in the tissue, are highly oxidized, contributes to inflammation. This cycle of degradation and inflammation leads to the very complications our lawyers hear about when we talk to women.

The study leads to the conclusion that all the talk from the transvaginal mesh makes that polypropylene mesh would be equally effective in all parts of the body was, to put generously, flawed. The material is stable and more reactive than women and doctors were led to believe.

This study is one more piece of evidence that polypropylene mesh used in pelvic surgeries is not as stable or biocompatible as manufacturers have claimed. The research demonstrates that PP mesh degrades over time, leading to oxidation, cracking, and the release of harmful particles into surrounding tissues, which can trigger inflammation and chronic pain. These findings directly challenge the assertion that polypropylene mesh is safe for long-term use in the body, particularly in sensitive areas like the pelvic floor.

For plaintiffs’ transvaginal mesh lawyers, this study underscores the link we already knew existed between the material’s inherent instability and the painful, often debilitating complications many women have experienced. This supports vaginal mesh lawsuits  claims that the manufacturers failed to account for these risks in design and testing.

October 22, 2024: New Study on Suffering from Transvaginal Mesh Complications

October 20, 2024: Why Vaginal Mesh Lawsuits Have Higher Settlement Payouts Now

September 25, 2024: Minnesota and Massachusetts

Most of the new vaginal mesh lawsuits are being filed in state courts in Minnesota and Massachusetts because you can sue Coloplast and Boston Scientific in those states because there is diversity of citizenship.

September 2, 2024:  Vaginal Mesh Malpractice Lawsuit

Some transvaginal mesh complications can also be the result of medical malpractice.  In Oregon, a state court jury is hearing a medical malpractice case against a urologist and a hospital charged with implanting a pelvic mesh device in a woman despite FDA advisories against it.

The plaintiff, claims the “Uphold Lite” transvaginal mesh by Boston Scientific used in her 2019 surgery for pelvic organ prolapse caused severe injuries and necessitated further surgical attempts for removal. Boston Scientific is no longer a defendant. (I’m not sure if they settled or were voluntarily dismissed).

August 24, 2024: Another Transvaginal Mesh Lawsuit in Minnesota State Court

August 19, 2024: Another UK Update

Around 140 women in England who suffered severe side effects from vaginal mesh implants have won a significant settlement, expected to total “millions of pounds,” after taking legal action against manufacturers Johnson & Johnson, Bard, and Boston Scientific.

These women experienced complications such as chronic pain, infections, bleeding, bladder and bowel perforations, and difficulties with urination after receiving the implants, which were intended to treat stress urinary incontinence and prolapse. Many had to undergo surgery to remove the mesh, but some continue to suffer from long-term effects.

August 9, 2024: UK Proposed Compensation System for Pelvic Mesh Victims

Health regulators in Great Britain are working to implement a government-sponsored claims system to provide compensation to women who were harmed by defective transvaginal or pelvic mesh implants. The proposal would initially award award directly harmed women a fixed sum of £20,000 starting in 2025 and women with more serious injuries would be able to apply for more compensation. This proposal is an indication of the global damage caused by defective vaginal mesh implants.

July 26, 2024: New Vaginal Mesh Lawsuit in Massachusetts

In a new pelvic mesh lawsuit against Boston Scientific filed in federal court in Massachusetts, the plaintiff seeks damages for a defective sling.

the plaintiff underwent a medical procedure to address stress urinary incontinence and pelvic pain, which included the implantation of the Obtryx II Transobturator Mid-Urethral Sling System, a pelvic mesh product that is a common target in pelvic mesh lawsuits.

Initially, the plaintiff sought treatment for her symptoms from her doctor, who recommended the vaginal hysterectomy, bilateral salpingectomy, and mid-urethral sling implantation.

Following the surgery, the plaintiff began experiencing severe pain, which she initially attributed to menopause. However, the pain worsened over time, and both she and her doctors began to suspect that the pelvic mesh was the source of her discomfort. The plaintiff experienced a range of symptoms, including vaginal dryness, right-sided pelvic pain, and painful sexual intercourse, which was particularly distressing as it involved mesh erosion, where the mesh material physically eroded through the vaginal tissues.

The plaintiff’s condition necessitated further medical interventions, including a revision surgery to adjust the tension of the implanted sling. Despite these efforts, she continued to suffer significant physical and emotional distress, including chronic pain, bladder spasms, and stress incontinence. These awful symptoms severely impacted her daily life and quality of life, leading to difficulties in engaging in normal activities as women who have suffered from this know all too well – physical exercise, intimate relations, and just living a normal pain-free life.

July 22, 2024: Federal Appeals Court Reinstates Transvaginal Mesh Lawsuit

A federal appeals court reinstated transvaginal mesh lawsuit pelvic mesh after the West Virginia Supreme Court clarified the burden of proof for design defects.

The Fourth Circuit ruled that the federal trial court improperly restricted the couple’s expert testimony, which only needed to show that alternative feasible designs could substantially reduce the injury risk, not eliminate it entirely.

The West Virginia state court clarified that plaintiffs only need to prove that an alternative design would have substantially reduced the risk of the specific injury suffered, leading to the reinstatement of the vaginal mesh lawsuit.  The trial court had improperly barred the couple’s expert witness from testifying about alternative mesh designs due to a misinterpretation of West Virginia law.

June 21, 2024: Court Upholds $2.5 Million Verdict

Good news yesterday from the Eleventh Circuit. The court upheld a $2.5 million verdict against Coloplast Corp. in a lawsuit alleging that a woman was implanted with defective pelvic mesh.

The big issue was whether the plaintiff met the deadline to file a vaginal mesh lawsuit. The court rejected Coloplast’s argument that the claim was filed too late, noting that her symptoms in 2009 were not significantly different from expected post-surgery complications to alert her to the defect. It was only the more severe symptoms in 2014 that indicated the mesh might be defective, keeping her case within Florida’s four-year statute of limitations. The jury found Coloplast’s mesh defective and the complaint timely, leading to the substantial award.

June 4, 2024: New Study Examines Complications Associated With Mid-Urethral Sling Surgery 

A new study examined risk factors for complications within five years after mid-urethral sling surgery for stress urinary incontinence (SUI). The study reviewed records from 1,961 women who underwent their first mid-urethral sling surgery between 2003 and 2018. The study identified significant risk factors for surgical complications such as secondary surgery and urinary retention. Findings showed that 4.7% of patients experienced complications within five years, with those complications being more likely in older patients, those with a history of menopausal syndrome, hormone replacement therapy (HRT), slower average flow rate, and longer voiding time. HRT was significantly associated with an increased risk of complications, especially urinary retention.

The identification of HRT as a risk factor for complications post-mid-urethral sling surgery underscores the importance of patient-specific factors in assessing the safety and effectiveness of mesh implants. This study suggests doctors—and maybe manufacturer guidelines—should consider individual patient histories, such as HRT use, when recommending and implementing these devices. It also highlights the necessity for thorough preoperative evaluations and personalized treatment plans.

May 26, 2024: New Transvaginal Mesh Lawsuit Filed In Minnesota State Court

A new transvaginal mesh lawsuit has been filed in state court in Minnesota against Coloplast Corporation, alleging injuries from the defective Supris medical device used to treat stress urinary incontinence.

The Supris is a transvaginal mesh device designed to treat stress urinary incontinence.  The device is made from polypropylene mesh, which has been shown to cause chronic inflammation, tissue degradation, and severe adverse reactions in many patients.

The complaint asserts that Coloplast, a Delaware corporation with its principal place of business in Minnesota which is how it ended up in state court, manufactured, marketed, and sold the Supris device, which caused serious complications including pelvic pain, vaginal pain, incontinence, and mesh erosion/exposure.

Despite undergoing a partial removal of the mesh in September 2023, the plaintiff continues to suffer from these symptoms and requires ongoing medical treatment. The long-term prognosis remains uncertain, with the potential for additional complications and the need for further surgical interventions. The plaintiff alleges that these injuries were caused by the defective design and inadequate warnings provided by Coloplast regarding the risks associated with the Supris device.

March 14, 2024: Federal Court Judge Rules Transvaginal Mesh Lawsuit Against Boston Scientific Is Allowed To Proceed

A woman’s vaginal mesh lawsuit against Boston Scientific over injuries allegedly caused by the Obtryx pelvic mesh is allowed to proceed, a federal court judge in Massachusetts ruled yesterday.  Her lawsuit alleges that she started to suffer from pain and disfigurement following the partial removal of the Obtryx Transobturator Mid-Urethral Sling System mesh, which was initially implanted to address pelvic disorders.

February 26, 2024: West Virginia Married Couple Files Vaginal Mesh Lawsuit

In a new vaginal mesh lawsuit, a married couple from West Virginia, seeks damages against Boston Scientific Corporation. The complaint alleges that Boston Scientific, a corporation registered in Delaware with its principal business in Marlborough, MA, is responsible for injuries suffered due to the implantation of a pelvic mesh product. This product, designed for treating stress urinary incontinence and pelvic organ prolapse, is claimed to have been defectively designed and manufactured, leading to significant health complications for one of the plaintiffs.

According to the lawsuit, the female plaintiff underwent surgery where a pelvic mesh product, specifically the Solyx Single-Incision Sling System, was implanted to address stress urinary incontinence.  The Solyx Single-Incision Sling System, a product designed for the treatment of Stress Urinary Incontinence (SUI), has been the subject of controversy and litigation due to complications experienced by patients who have undergone procedures involving this medical device.

In this case, after surgery, the woman  experienced adverse symptoms including urinary retention, frequency, severe abdominal and pelvic pain, and painful sexual intercourse due to mesh erosion into her vagina. Despite undergoing a procedure to remove the mesh, she continued to face substantial pain due to remnants of the mesh that could not be fully extracted, impacting her daily life and work.

The couple accuses Boston Scientific of failing to adequately warn both patients and healthcare providers of the potential risks associated with their pelvic mesh products. They argue that the company misrepresented the safety and effectiveness of these products, which led to the plaintiff’s injuries. They are seeking compensatory and punitive damages for medical expenses, pain and suffering, emotional distress, and the impact on their marital relationship, including loss of consortium.

February 4, 2023: New Study Compares Robotic Sacrocolpopexy with Transvaginal Mesh Surgery

In a new study, researchers compared the effects of two types of surgery on bladder function in women with pelvic organ prolapse. They looked at robotic sacrocolpopexy (RSC) and transvaginal mesh surgery (TVM) from March 2020 to June 2022. They used questionnaires and medical tests to measure bladder function before and after the surgeries. The study found that women who had the RSC surgery were more likely to experience new cases of stress urinary incontinence compared to those who had TVM surgery.

Both groups saw a decrease in bladder closure pressure after surgery, but the RSC group had a significant increase in stress incontinence. However, both surgeries improved some symptoms, like difficulty in voiding and urine retention.

The conclusion was that both RSC and TVM surgeries help improve voiding function in women with pelvic organ prolapse, but RSC might lead to a higher risk of developing new stress urinary incontinence.

January 22, 2023: New Study Finds Most Women Experienced Improved Sexual Function Following POP Surgery

A new study finds that most women experienced improved sexual function after undergoing pelvic organ prolapse (POP) surgery using a transvaginal mesh. This surgery was performed on women who had previously had a hysterectomy. Out of 48 participants, about 80% reported better sexual function, while a small number saw no change or a decline.

This study is hopeful because it shows that using transvaginal mesh for POP surgery may be beneficial and does not necessarily worsen sexual function.

This is a small study done at a hospital in the Czech Republic of 48 women. So it is hardly conclusive.  But it does provide some encouraging news.

December 7, 2023: New Vaginal Mesh Lawsuit Filed Against Boston Scientific

A new vaginal mesh lawsuit was filed on Friday against Boston Scientific.  In this case, the plaintiff underwent transvaginal surgery in November 2022, during which the Boston Scientific Solyx BlueSling System was implanted by at TriStar Centennial Medical Center in Nashville, Tennessee. The implantation of this product led to significant pain, expense, embarrassment, disfigurement, and harm for the plaintiff.

A removal procedure was performed in July 2023 at the same medical center. However, parts of the system, specifically the clamps, remain attached to the plaintiff’s bladder, continuing to cause pain and suffering, according to her vaginal mesh lawsuit. The plaintiff faces the possibility of future surgeries and ongoing significant pain and medical expenses. The plaintiff has sustained, and will likely continue to experience, severe and debilitating injuries, serious bodily harm, mental and physical suffering, and economic loss that may persist into the future.

The lawsuit alleges that the removal of transvaginal mesh, specifically the Boston Scientific Solyx BlueSling System, implanted in patients can require multiple surgeries, leading to scarring and damage in pelvic tissues and muscles. The defendant is accused of continuing to promote these products as safe and effective without adequate clinical trial support for their long-term or short-term efficacy or safety. The suit claims that the defendant failed to disclose known risks and did not warn of potential dangers associated with the products. It is argued that the products were defectively marketed due to inadequate warnings, instructions, labeling, and testing, given the known safety concerns.

October 27, 2023: After Math Of 2015 Boston Scientific Settlement

In June 2015, Boston Scientific agreed to a transvaginal mesh settlement with 1,200 victims for approximately $53 million. This was not a great settlement – the average mesh settlement was only $44,000.

An independent Special Master, appointed by a Texas court, oversaw the fair distribution of these funds. Using a point allocation formula based on factors like the severity of complications and required surgeries, each claimant’s settlement amount was determined. Two women, for example, were awarded initial gross minimum payments of $130,560 and $104,448, respectively. Additionally, an Extraordinary Injury Fund provided further compensation for claimants with severe complications or further surgeries, from which both women received extra amounts.

Years later, these women filed a lawsuit against their attorneys, alleging mishandling of their cases and coercion into the settlement. However, the court ruled that their claims were time-barred as they were filed beyond the statute of limitations period. The court noted that the plaintiffs had been fully informed of the settlement terms and had agreed to them years earlier. Consequently, the court granted summary judgment in favor of the defendants, dismissing Benoit and Smith’s claims with prejudice.

October 24, 2023: 27 Vaginal Mesh Lawsuits Filed In Past Year

Over the last year, a total of 27 vaginal mesh product liability lawsuits have been filed against Boston Scientific Corp. in federal courts across the country. All but 10 of those cases remain open and pending. Most of the ten that are no longer pending were settled.

October  20, 2023: Maryland Woman Files Vaginal Mesh Lawsuit 

A Maryland woman became one of the most recent plaintiffs to file a vaginal mesh lawsuit. The lawsuit was filed in the U.S. District Court for Maryland against Boston Scientific Corp last week. The Complaint alleges that in 2020, the plaintiff had an Advantage Fit transvaginal mesh implanted for the treatment of vaginal prolapse. Following the implantation, the plaintiff experienced regular and continuing pain and discomfort, along with urinary problems. In 2023, the plaintiff underwent surgery to have the vaginal mesh removed. She is now suing Boston Scientific based primarily on theories of design defect and negligent failure to warn.

September 1, 2023: Boston Scientific Corp. Settles Lawsuit In Georgia Federal Court

Boston Scientific Corp. has settled a lawsuit in a Georgia federal court over allegations related to its pelvic mesh product, Obtryx. The lawsuit claimed that the mesh caused debilitating pain and complications.

The settlement terms were not disclosed, and the agreement is expected to be finalized within 90 days. The plaintiff filed the suit in 2022, contending that the mesh led to chronic pain and nerve damage. The lawsuit further alleged that Boston Scientific was aware of the risks associated with the product, as indicated by FDA warnings in 2011, but continued to market it as safe. This settlement follows previous legal actions involving Boston Scientific’s surgical mesh products.

Defendants do not want to let these cases go to trial if they are unsure they can win because it restarts the energy in the litigation.

July 25, 2023: New Jersey Supreme Court Addresses McGinnis v. C.R Bard, Inc.

Today, in McGinnis v. C.R. Bard, Inc., the New Jersey Supreme Court addressed whether Bard was denied a fair trial by not being allowed to present FDA 510(k) clearance evidence for its pelvic mesh devices.

What is FDA 510(k) clearance? FDA 510(k) clearance is a regulatory process in which a medical device manufacturer demonstrates that their new device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed without undergoing the rigorous premarket approval process.

The court in this case concluded that while 510(k) clearance typically only demonstrates substantial equivalence rather than safety and efficacy, it was crucial in this case because plaintiffs argued Bard’s failure to conduct clinical trials was unreasonable. Therefore, the exclusion of such evidence deprived Bard of a fair defense, warranting a new trial with proper limiting instructions for the jury.

Additionally, the court examined whether New Jersey’s Products Liability Act precluded punitive damages in cases involving 510(k) clearance. It determined that the Act does not bar punitive damages merely due to 510(k) clearance since this process does not equate to FDA approval of safety and effectiveness. The court affirmed the Appellate Division’s judgment, emphasizing that 510(k) evidence should be admissible during the punitive damages phase to assess the reasonableness of Bard’s conduct, provided plaintiffs had opened the door to such evidence during the trial

March 24, 2023: Court of Appeals Upholds $500,000 Verdict

The 11th Circuit U.S. Court of Appeals has upheld a $500,000 verdict in a pelvic mesh case against Coloplast Corp. The court determined that the evidence supported the jury’s finding that the mesh device could cause the claimed injury and specifically caused the plaintiff’s injury. The plaintiff, who suffered from stress urinary incontinence and pelvic organ prolapse, received two different mesh implants, one by Coloplast and one by Boston Scientific Corp., which led to complications including erosion, pain, and bleeding. The court rejected Coloplast’s argument that there was insufficient evidence for general causation and that the mesh’s benefits outweighed its risks. It also ruled that expert testimony supported the verdict, emphasizing that the jury considered substantial evidence regarding the potentially harmful effects of polypropylene mesh. The decision affirmed the jury’s conclusion that the mesh’s risks outweighed its benefits, and it clarified that the ruling did not establish automatic liability for prescription-only products but was based on the specific evidence presented during the trial.

April 12, 2022: Woman Warded $2.5 Million In Lawsuit Against Coloplast 

A woman was awarded $2.5 million in a lawsuit against Coloplast following injuries sustained from her pelvic mesh implant. The jury concluded that the mesh was defectively designed, and Coloplast failed to provide sufficient warnings to the surgeon about its risks. Additionally, the jury found that Coloplast made negligent misrepresentations about the mesh’s safety and fraudulently concealed its dangers, leading to her injuries.

Origins of Vaginal Mesh Use and Problems

Transvaginal mesh is a medical device used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. These conditions occur when the pelvic muscles and tissues weaken, causing organs like the bladder, uterus, or rectum to descend into the vagina. To address this issue, surgeons began using surgical mesh in the 1970s for the abdominal repair of POP. In the 1990s, the use of mesh was expanded to treat SUI through a transvaginal approach.

The U.S. Food and Drug Administration (FDA) cleared the first TVM product for marketing in 1996 through the 510(k) clearance process, which allows medical devices to be approved without clinical trials if they are considered substantially equivalent to an existing approved device. This paved the way for other manufacturers to enter the market, and by the 2000s, several companies were producing TVM products.

However, soon after the introduction of TVM products, patients and healthcare professionals began reporting complications associated with their use. Some of these complications included mesh erosion (where the mesh wears through the vaginal wall), organ perforation, infection, chronic pain, and urinary problems. These complications often required multiple revision surgeries, causing significant physical and emotional distress for the affected women.

Vaginal Mesh Complications

Women have been through a lot with the defects in how these vaginal mesh products.  Vaginal mesh complications can be severe and life-altering, affecting patients’ physical and emotional well-being. Some common complications associated with vaginal mesh implants include:

1. Mesh erosion: The mesh can erode through the vaginal tissue or other surrounding organs, causing pain and discomfort, often requiring additional surgeries to repair or remove the mesh
2. Pain: A critical element of damages in these lawsuits is the chronic pain, usually in the pelvic region, that women have during intercourse or even while sitting or walking
3. Infection: Mesh implants can lead to infections, which may require antibiotic treatment or even surgery to remove the infected mesh
4. Organ perforation: In some cases, the mesh may puncture nearby organs, such as the bladder, bowel, or blood vessels, requiring immediate medical attention and possibly additional surgeries
5. Urinary problems: Women may develop urinary incontinence, retention, or recurrent urinary tract infections due to the mesh implant
6. Vaginal scarring or shrinkage: The mesh can cause scarring or shrinkage of the vaginal tissue, leading to discomfort or pain, particularly during sexual intercourse
7. Recurrence of pelvic organ prolapse (POP) or stress urinary incontinence (SUI): In some instances, the original condition for which the mesh was implanted may recur, necessitating further treatment or surgery
8. Emotional and psychological distress: Dealing with the physical complications of a vaginal mesh implant can lead to pain and suffering, and juries have to compensate victims for that emotional and psychological distress

FDA Warnings and Public Awareness

In response to the growing number of reports about transvaginal mesh complications, the FDA issued a Public Health Notification in 2008, warning healthcare providers and patients about the potential risks associated with TVM devices. The notification highlighted complications such as erosion, pain, infection, and organ perforation, and urged manufacturers to provide more comprehensive information about these risks in product labeling.

In 2011, the FDA released an updated safety communication, significantly raising the alarm by stating that serious complications associated with TVM products for pelvic organ prolapse (POP) repair were not rare. The FDA emphasized that there was no clear evidence to prove that TVM was more effective than non-mesh methods for treating POP.

This announcement, coupled with the media coverage it received, brought widespread public attention to the potential dangers of TVM devices. The FDA also noted that mesh contraction (shrinkage), which could lead to severe pain and other complications, was a newly identified risk associated with TVM. These updates spurred further scrutiny and debate over the safety and efficacy of TVM products, leading to increased awareness and calls for stricter regulatory oversight.

Continuing the regulatory response, in 2012, the FDA ordered TVM manufacturers to conduct post-market surveillance studies to further investigate the safety and effectiveness of these products. This mandate required companies to gather more data on complications and outcomes, adding to the growing body of evidence regarding the risks associated with TVM.

By 2016, the FDA had reclassified TVM devices for POP repair from Class II (moderate risk) to Class III (high risk), reflecting the increased understanding of the serious health risks posed by these products. This reclassification required manufacturers to submit premarket approval (PMA) applications, providing detailed evidence of safety and effectiveness before these devices could be marketed.

In April 2019, the FDA took further action by ordering manufacturers to stop selling and distributing TVM products intended for POP repair. This decision came after the FDA concluded that the manufacturers had not demonstrated reasonable assurance of safety and effectiveness for these devices. The agency’s determination was based on extensive review and consideration of adverse event reports, scientific literature, and public input.

Beginning of Vaginal Mesh Litigation

The first transvaginal mesh lawsuit was filed in 2009, marking the beginning of the vaginal mesh litigation. In the following years, thousands of lawsuits were filed against various TVM manufacturers, including Johnson & Johnson (Ethicon), C.R. Bard, Boston Scientific, American Medical Systems (AMS), and Coloplast.

These lawsuits alleged that TVM manufacturers were negligent in their design, testing, and marketing of the devices and failed to warn healthcare providers and patients about the potential risks and complications associated with their use. The plaintiffs sought compensation for their physical and emotional suffering, medical expenses, and lost wages.

MDL Class Action and Bellwether Trials

Due to the growing number of vaginal mesh lawsuits, the Judicial Panel on Multidistrict Litigation (JPML) consolidated federal cases into several multidistrict litigations (MDLs) in 2012. Each MDL targeted a specific manufacturer, streamlining the pretrial process and allowing for more efficient handling of the cases.

Lawsuits involving vaginal mesh were consolidated into seven multidistrict litigations (MDLs) against C.R. Bard, Inc., American Medical Systems, Inc., Boston Scientific Corp., Ethicon, Inc., Coloplast Corp., Cook Medical, Inc., and Neomedic. This coordinated litigation expanded to encompass over 100,000 cases, making it one of the largest mass tort litigations in the history of the United States.

The United States Judicial Panel on Multidistrict Litigation assigned these MDLs to U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia’s Charleston courthouse. At this point, only a tiny fraction of the original cases are still ongoing.  But new vaginal mesh lawsuits are still being filed in 2024.

Bellwether trials, which are test cases intended to gauge the strengths and weaknesses of both sides’ arguments and potentially guide settlement negotiations, were held in several of these MDLs. Some of the notable bellwether trial verdicts included:

Vaginal Mesh Verdicts

Over the years, a handful of vaginal mesh lawsuits have gone to trial both in and out of the MDLs. The plaintiffs in these cases have consistently won significant verdicts from juries. Below is a list of the results of the major vaginal mesh trials.

If you average these cases, it is $27 million.  Is the average vaginal mesh settlement $27 million in 2024?  Of course not. But the point it that when these lawsuits hit, they can hit big and that has an impact on vaginal mesh settlement amounts.  At this point, these companies can hardly be surprised by big jury payouts.

Settlements and Continued Litigation

Many vaginal mesh manufacturers have negotiated global settlements to resolve large blocks of cases and avoid further litigation and the potential for large jury verdicts. Most of these global settlement deals occurred within the MDLs, resulting in small payouts for individual plaintiffs.

• In 2013, AMS agreed to settle around 20,000 lawsuits for a total of $1.6 billion
• In 2014, Coloplast settled approximately 400 lawsuits for $16 million
• In 2015, C.R. Bard settled more than 3,000 lawsuits for a total of $200 million
• In 2018, Boston Scientific settled around 50,000 lawsuits for a total of $189 million

Despite these settlements, thousands of vaginal mesh lawsuits remained pending against various manufacturers. In 2019, the JPML established a new MDL to handle the influx of new cases, consolidating them against multiple manufacturers, including Johnson & Johnson, C.R. Bard, and Boston Scientific.

FDA Actions and Regulatory Changes

The FDA has taken several significant steps to regulate transvaginal mesh (TVM) products in response to concerns about their safety and effectiveness:

• 2008: The FDA issued its first safety communication, warning about the rising number of complications from transvaginal mesh used in pelvic organ prolapse (POP) repair.
• 2011: The FDA updated its safety warning to state that serious complications from TVM for POP repair were not rare and questioned the long-term effectiveness of the devices.
• 2012: The FDA required manufacturers to conduct post-market surveillance studies to further assess safety and effectiveness.
• 2016: TVM devices for POP repair were reclassified from Class II (moderate risk) to Class III (high risk), requiring premarket approval (PMA).
• 2018: The FDA issued updated safety communications, highlighting severe risks such as pain, erosion, infection, and mesh migration.
• 2019: The FDA ordered manufacturers to stop selling all TVM devices for POP repair, citing insufficient evidence of their safety and effectiveness.
• 2020: An independent review panel evaluated TVM devices for stress urinary incontinence (SUI), concluding that the risks outweigh the benefits for most women.
• 2022: The FDA proposed reclassifying TVM devices for SUI from Class II to Class III, requiring premarket approval and stricter oversight before marketing. It also mandated PMA submissions for devices used in apical prolapse repair.
• 2023: Increased scrutiny and legal actions. Ongoing lawsuits continued to be filed against mesh manufacturers, with multiple settlements being reached in several large cases. New clinical studies were published, reinforcing concerns about long-term safety, leading some medical associations to issue additional cautionary guidelines about the use of TVM devices, even in SUI cases.
• 2024: Ongoing reviews and increased legal settlements. Reports of delayed complications from transvaginal mesh, such as late-onset infections and mesh erosion, led to a further rise in the number of lawsuits. The FDA began reviewing long-term patient outcomes more closely, especially in women with mesh used for SUI. In response to continued legal pressure that will not go away, manufacturers started shifting away from mesh products, focusing on alternative treatments for POP and SUI.

Vaginal Mesh Litigation in 2024

The vaginal mesh litigation is ongoing, with thousands of lawsuits pending against various manufacturers. While many cases have been resolved through settlements, some manufacturers continue to litigate and defend their TVM products in court, and victims continue to file these transvaginal mesh lawsuits.

The FDA’s regulatory actions and the increased scrutiny of TVM devices have led to significant changes in the medical community’s approach to treating POP and SUI. Many healthcare providers now opt for non-mesh alternatives for POP repair and use TVM products more cautiously for SUI treatment.

Our lawyers are seeing a resurgence in vaginal mesh litigation in 2024. Why? Vaginal mesh attorney are realizing that instead of filing a class action lawsuit, these cases can be brough individually.  The trial value of these cases – the strongest cases which are what lawyers are looking for – is high enough to justify individual lawsuits in the right cases.  The thinking is the average vaginal mesh settlement or verdict will be much higher than if it was in an MDL.

What Are the Legal Allegations in a Vaginal Mesh Lawsuit in 2024?

Vaginal mesh lawsuits in 2024 continue to assert a variety of claims against manufacturers, holding them accountable for severe harm to patients. These claims include:

1. Negligence: Manufacturers failed to properly design, test, and manufacture the mesh, causing harm rather than relief from pelvic conditions like POP and stress urinary incontinence. Patients were led to believe the mesh was a safe, effective solution, but the lack of adequate testing and design scrutiny resulted in debilitating injuries. Many women suffered intense pain, organ damage, and further surgeries to remove the faulty mesh.
2. Strict Product Liability: The mesh was inherently defective, creating unreasonable risks even when used as intended. Under strict liability, plaintiffs only need to prove that the product was defective and caused their injury. In the case of vaginal mesh, the defect was in the very structure and composition of the product, which led to tissue erosion, infection, and organ perforation in numerous patients. Companies must be held accountable for releasing this dangerous product into the market, despite knowing its inherent risks.
3. Breach of Express Warranty: The manufacturers promised in their advertising and product packaging that the mesh was safe and effective for treating pelvic organ prolapse and urinary incontinence. These promises formed the basis of patients’ trust in the product, which was tragically misplaced. When these explicit warranties were broken, patients were left to suffer physically and emotionally from the complications, making the breach of these guarantees one of the core issues in these cases.
4. Breach of Implied Warranty: Without needing explicit promises, the product should have been fit for its intended use. However, the mesh failed to meet even the basic expectations of quality and safety, causing harm instead of relief. Patients relied on the implied assurance that the mesh would work properly and safely in their bodies, but they were met with disastrous results, from chronic pain to permanent damage.
5. Misrepresentation: Companies made misleading claims about the mesh’s safety and efficacy. Women trusted the manufacturers’ narrative, which downplayed the risks and exaggerated the benefits. They were led to believe that the mesh was a reliable solution, but these misrepresentations masked the truth of its defects, leading to devastating outcomes.
6. Deceptive Trade Practices: The manufacturers engaged in deceptive marketing, providing false assurances and hiding known risks. They created an illusion of compliance with safety standards and sold a product that failed to meet the expectations set by consumers and medical professionals alike. This deliberate deceit resulted in thousands of women being unknowingly subjected to harmful procedures with defective products.
7. Failure to Warn: Even if the mesh had been properly designed, the companies did not provide adequate warnings about the potential dangers. Patients were not sufficiently informed of the risks, such as erosion and organ perforation, that accompanied the use of the mesh. This lack of warning resulted in women undergoing surgery without being fully aware of the dangers involved, which would have influenced their decisions.
8. Fraudulent Concealment: Manufacturers intentionally withheld critical information about the dangers of their product, deceiving both doctors and patients. By hiding the known risks, the companies prevented patients from making informed decisions about their healthcare. This fraudulent concealment was not just a failure to disclose, but a deliberate strategy to protect profits at the expense of patient safety.

These claims represent the wide-ranging legal challenges that vaginal mesh manufacturers face in 2024, with thousands of women seeking compensation for their suffering and irreversible damage. The lawsuits highlight the critical need for accountability in the medical device industry, particularly when companies prioritize profit over patient well-being.

Current Status of Vaginal Mesh Class Action Lawsuits

In the early days of the litigation, the transvaginal mesh lawsuits pending in federal courts were consolidated into seven separate class action MDLs. Each MDL involved claims against a specific vaginal mesh manufacturer: (1) C.R. Bard, (2) Boston Scientific Corp., (3) American Medical Systems, (4) Ethicon, (5) Coloplast, (6) Cook Medical, and (7) Neomedic. At their peak, there were around 100,000 plaintiffs with cases pending in these 7 class action MDLs. The chart below shows the number of plaintiffs in the four biggest transvaginal mesh class actions:

As of 2024, 95% of the cases pending in these vaginal mesh class action MDLs have been resolved through settlement and are no longer pending. Billions in settlement compensation have been paid out to victims. Vaginal mesh lawsuits continue to get filed as these mesh implants injure new women, but these new cases are not being handled in the class action MDLs.

Who is Eligible to File a Transvaginal Mesh Lawsuit in 2024?

Even though most of the cases in the vaginal mesh class action lawsuits have been settled, it is not too late to file a vaginal mesh lawsuit. In 2024, large numbers of vaginal mesh product liability lawsuits continued to get filed in courts across the country in federal and state courts. The current vaginal mesh plaintiffs primarily include women who had a transvaginal mesh implanted and suffered complications or injuries directly related to the implant within the last few years.

One of the primary concerns for prospective vaginal mesh plaintiffs looking to file a lawsuit in 2024 is whether the applicable statute of limitations has expired on their claim. Each state has its own statute of limitations for personal injury cases, but in most states, the statute of limitations is two or three years.

Whatever the applicable statute of limitation period is in your state, it doesn’t begin to run until your vaginal mesh injury or complication first occurs. As long as the first occurrence of your vaginal mesh complications occurred within the last 1 or 2 years, you will probably not have to worry about the statute of limitations.

Can You Join a Vaginal Mesh Class Action?

The vaginal mesh class action MDLs have mostly been settled and are now closed to new cases. However, if you were injured by complications related to a vaginal mesh or pelvic mesh, you can still file a product liability lawsuit against the implant manufacturer. Your lawsuit will not be consolidated into a class action MDL. Instead, your case would just proceed on its own against the defendant.

Who Is Eligible for a Vaginal Mesh Settlement?

Eligibility for a vaginal mesh settlement typically involves having suffered injuries due to a vaginal mesh implant and receiving treatment – typically surgery – for these complications. n These products were made with varying degrees of awfulness, so your vaginal mesh lawyer must dig out the manufacturer of your implant.

There is no question the statute of limitations for a vaginal mesh lawsuit can also come into play. Indeed, some women are otherwise eligible for a vaginal mesh settlement but cannot bring a claim because of the statute of limitations.  Some women will not bring a claim because they incorrectly assume they do not have a claim because the deadline passed, but it has not. Talking about your case with a lawyer is free and can clarify available legal options, even if you think the time limit has passed.

What specifically is our law firm looking at when we evaluate a potential transvaginal mesh lawsuit?  Four things:

1. Statute of Limitations: Our lawyers consider the potential client’s understanding of when they realized the mesh was causing issues. This can coincide with the date of a revision or repair, but sometimes the client was aware of problems well before any surgical intervention.
2. Statute of Repose: This is determined based on the date the mesh was implanted.  The statute of repose sets a deadline for filing a lawsuit based on the date of the original surgical implant, regardless of when the injury is discovered. Like the statute of limitations, the statute of repose varies state by state.
3. Manufacturers: Our law firm only accept cases involving
   • Johnson & Johnson/Ethicon
   • Coloplast
   • Boston Scientific.
4. Need for Revision or Repair: We take case where the client has or has been told to get a revision or repair of the transvaginal mesh.

Transvaginal Mesh Lawsuits Against Boston Scientific

Boston Scientific offers a range of vaginal mesh products for the treatment of pelvic floor disorders and stress urinary incontinence. Here are some of the key products they sell or have sold:

1. Advantage Transvaginal Mid-Urethral Sling System – Designed with mesh tensioning and delivery in mind, includes a centering tab to assist with alignment and tensioning.
2. Advantage Fit Transvaginal Mid-Urethral Sling System – Features a thinner needle and tighter curve for reduced insertion force and closer delivery to the pubic bone.
3. Lynx™ Suprapubic Mid-Urethral Sling System – Facilitates suprapubic device passage with a smooth transition from loop to mesh.
4. Obtryx II Transobturator Mid-Urethral Sling System with PrecisionBlue Design – Offers smooth sling placement, intra-operative adjustability, and increased physician visualization.
5. Upsylon Y-Mesh and Colpassist™ Vaginal Positioning Device – Combines low density and high durability to facilitate mesh positioning and placement while providing support for anatomical defects.
6. Capio SLIM Suture Capturing Device – Features a small profile and suture dart carrier designed for minimal space usage in the surgical field.

One of the big claims in the transvaginal mesh litigation against Boston Scientific is that the polypropylene used in these slings is unsuitable for permanent transvaginal implantation due to degradation, chronic inflammation, and mechanical mismatch with native tissues, leading to pain and nerve irritation. Experts have offered the opinion that these slings should not be placed in the vagina, a surgically contaminated field, as bacterial contamination can cause chronic inflammation and similar complications.

Another problem is that the de-tanged portion. let’s take the Obtryx mesh, for example, increases risks of complications compared to non-de-tanged mesh. The transvaginal sling’s blind implantation can cause acute and chronic injuries to nerves and muscles in the groin, resulting in conditions like obturator and pudendal neuralgia. The mechanical mismatch of the mesh can cause delayed nerve injuries, leading to life-altering pain syndromes.

In many of these lawsuits, plaintiffs are safer alternative designs existed, such as the use of sutures in a colposuspension procedure, autologous fascia sling, an allograft sling, or a sling with less polypropylene.

Boston Scientific vaginal mesh lawsuits allege the company did not adequately warn about risks in the Directions for Use (DFU), including chronic pain, neuralgia, and the need for multiple surgeries.

Contact Us About a Vaginal Mesh Lawsuit

Our national product liability lawyers are currently accepting new vaginal mesh lawsuits from women who suffered complications and injuries related to a vaginal, transvaginal, or pelvic mesh implant. Contact us at 800-553-8083 for a free consultation, or contact us online.