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.
February 26, 2024: 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: 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: 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: 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 24, 2023: 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: 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. 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.
August 14, 2023: The 8th Circuit Court of Appeals recently upheld a decision dismissing a woman’s vaginal mesh lawsuit because she filed her expert opinion too late. Had the woman gotten her expert report submitted within the deadline, this would have been a viable case. Still, the failure ultimately led to dismissing her claims because these cases cannot proceed without expert testimony.
March 24, 2023: 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: 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:
- 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
- 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
- Infection: Mesh implants can lead to infections, which may require antibiotic treatment or even surgery to remove the infected mesh
- 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
- Urinary problems: Women may develop urinary incontinence, retention, or recurrent urinary tract infections due to the mesh implant
- Vaginal scarring or shrinkage: The mesh can cause scarring or shrinkage of the vaginal tissue, leading to discomfort or pain, particularly during sexual intercourse
- 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
- 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 TVM complications, the FDA issued a Public Health Notification in 2008, warning healthcare providers and patients about the potential risks of TVM devices. The notification also urged manufacturers to provide more comprehensive information about these risks in product labeling.
In 2011, the FDA released an updated safety communication, stating that serious complications associated with TVM products for POP repair were not rare and that there was no evidence to prove that TVM was more effective than non-mesh methods for treating POP. This announcement attracted significant media attention and raised public awareness about the potential dangers of TVM devices.
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.
|$2.5 Million Verdict
|$80.5 Million Verdict
|$35 Million Verdict
|$20 Million Verdict
|$57.1 Million Verdict
|$33 Million Verdict
|$26.7 Million Verdict
|$11.1 Million Verdict
|$3.6 Million Verdict
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
In response to the ongoing concerns regarding the safety and effectiveness of TVM products, the FDA took several actions to increase regulatory oversight and improve patient safety:
- 2012: the FDA ordered manufacturers of TVM products to conduct post-market surveillance studies to assess the safety and effectiveness of their devices
- 2016: the FDA reclassified TVM devices for POP repair from class II (moderate risk) to class III (high risk), requiring manufacturers to submit premarket approval applications for these devices (no more backdoor product approvals)
- 2018: the FDA issued an updated safety communication about the risks of TVM implants, emphasizing the potential for severe complications like pain, erosion, infection, and mesh migration.
- 2019: the FDA – finally! – ordered all manufacturers of TVM devices for POP repair to stop selling and distributing their products in the United States, citing insufficient evidence of their safety and effectiveness
- 2020: the FDA convened an independent review panel to evaluate the safety and effectiveness of TVM devices for stress urinary incontinence (SUI). The panel concluded that the risks of these devices outweigh the benefits for most women.
- 2022: the FDA proposed reclassifying TVM devices used for SUI repair from class II to class III, requiring premarket approval applications. The FDA also ordered manufacturers of TVM to submit PMAs for transvaginal repair of apical prolapse. This action requires manufacturers to demonstrate the safety and effectiveness of their devices specifically for this use before they can be marketed in the United States.
Vaginal Mesh Litigation in 2024
As of today, 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.
What Are the Legal Allegations in a Vaginal Mesh Lawsuit in 2024?
The legal claims being asserted in current vaginal mesh lawsuits are essentially the same group of claims that have been at the core of the vaginal mesh litigation from the outset. Below is a summary of the various tort claims that are being pled in most vaginal mesh injury complaints these days.
The Story of Carelessness and Harm
In a world where medical advancements promise safety and healing, these companies said they could offer real relief to women. Pelvic organ prolapse (POP) and stress urinary incontinence are problems that women want to solve. This mesh, intended to offer relief and improve health, became a source of great pain and discomfort. The vaginal mesh makers’ failure to exercise due care in the design, testing, and manufacturing of the mesh has led to the suffering of countless women.
Strict Product Liability
A strict product liability claim is a legal action where a manufacturer, distributor, or seller can be held liable for placing a defective product into the hands of a consumer without the need to prove negligence or fault. Under this doctrine, the plaintiff only needs to prove that the product was defective, the defect made the product unreasonably dangerous, and the defect caused injury or damage while the product was being used as intended. The mesh was inherently defective, a fact unknown to patients at the time of implantation. This defect, a silent yet pervasive enemy, wreaked havoc on the bodies of too many American women, causing irreversible damage for many. The vaginal mesh makers should be held accountable for releasing a product into the market that was unsafe from its very conception. This is what strict liability claims are all about.
Breach of Express Warranty
The breach of warranty claim is about broken promises. Express warranties are specific, explicit promises or affirmations by the seller or manufacturer about a product. These can be found in advertising materials, product packaging, or any statement by the seller that relates to the quality or use of the product and forms part of the basis of the bargain. The companies assured the medical community and patients of the mesh’s safety and effectiveness. These assurances were not mere statements but formed the backbone of patients’ trust in the product. However, these promises were shattered.
Breach of Implied Warranty
Unspoken Guarantees Gone Awry
In this narrative, we address the unspoken guarantees – the implied warranty of the mesh being fit for its intended purpose. A breach of implied warranty occurs when a product fails to meet the standard of quality or performance reasonably expected by the consumer without the need for explicit promises by the manufacturer or seller. This claim hinges on the assumption that a product is fit for its intended use and meets the consumer’s ordinary expectations. The ordeal too many patients have endured highlights the betrayal of these implicit assurances.
The Web of Deceit
Misrepresentation in product liability claims refers to providing false, misleading, or deceptive information about a product by the manufacturer, seller, or advertiser. This can involve exaggerating a product’s capabilities, concealing its defects, or making false claims about its safety or effectiveness, leading consumers to use the product based on incorrect or incomplete information, resulting in injury or harm. The companies narrative, laced with misrepresentations, painted a false picture of safety and assurance. Patients were caught in this web of deceit, leading to decisions that would bring long-lasting agony and distress. This count unveils the manipulative tactics employed by the company to mask the true nature of the mesh’s risks.
Deceptive Trade Practices
The companies’ practices were not just negligent but deceptive.
Deceptive trade practices refer to business actions or strategies that mislead, deceive, or are unfair to consumers. These practices can include making false or misleading statements about products or services, false advertising, and other acts that misrepresent the product’s nature, characteristics, quality, or geographic origin. Here, the defendants created an illusion of compliance with safety standards and consumer protection laws, a façade that enticed unsuspecting patients into using their hazardous product.
Failure to Warn
Failure to warn refers to a legal concept in product liability where a manufacturer, distributor, or seller is held liable for not providing adequate warnings or instructions about the dangers or risks associated with using their product. This liability arises when a product has non-obvious risks or requires certain precautions for safe use, and the failure to effectively communicate these risks leads to injury or harm to the consumer.
In such cases, even if the product is flawlessly designed and manufactured – which is not the case here – the lack of proper warnings can render it legally defective due to the increased risk of harm. The companies failed to adequately warn healthcare professionals and patients of the mesh’s risks. This left women exposed to dangers they were not prepared for. This silence, a grave omission, led to uninformed decisions and subsequent suffering.
Fraudulent concealment refers to the intentional hiding or omission of vital information by one party in a situation where there is a duty to disclose that information to another party.. In the context of product liability, fraudulent concealment often involves, as we have in vaginal mesh lawsuits, a manufacturer knowingly withholding information about potential dangers or defects in their product, thus misleading consumers or preventing them from making fully informed decisions.
This concealment was not just an omission but a deliberate effort to hide the truth of the risk of these products, a truth that could have saved many women from suffering. This narrative exposes the companies’ calculated decision to prioritize huge hernia mesh profits over patient safety.
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:
|American Medical Systems
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. As of January 2024, large numbers of vaginal mesh product liability lawsuits continued to get filed in courts across the country. 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.
Potential Settlement Amounts of Vaginal Mesh Lawsuits
Based on prior settlements and verdicts in earlier vaginal mesh lawsuits and in the class action MDL settlements, we have a pretty good idea of what the potential settlement value of a good vaginal mesh case could be. Our lawyers estimate that a successful vaginal mesh injury lawsuit in 2024 would have a settlement payout value of around $150,000 to $450,000. How much your vaginal mesh case is worth and where it falls in this settlement range would depend on various factors, including the severity of the physical injuries and the age of the plaintiff.
Why are we projecting settlement amounts that were higher than women received when these injuries were treated as a mass tort? We think the compensation payouts will be higher because they are individual claims, not pooled together. These claims are generally worth more than when you have an MDL or a class action lawsuit.
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.