Complications after a transvaginal mesh implant?
If you suffered from side effects after receiving a mesh implant, you may be eligible for compensation.
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The Federal Food and Drug Administration was created to protect consumers against harm or injury from food and drugs or medical devices. However, it appears as if they did not require significant testing before they gave their approval to these transvaginal mesh devices. After being on the market for only three short years, the very first device that was approved was recalled. There were reports that it was not functioning as was fully intended and was resulting in a much higher than expected rate of vaginal erosion, according to the FDA. As a result, there have been a number of lawsuits filed against these manufacturers.
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In 2008, a warning regarding the potential complications of transvaginal mesh devices was issued by the FDA. However, their claim was that the complications were rare. In 2011, this warning was amended to state that complications were actually not rare and these devices actually put patients at a much higher risk of complications and that these devices were no more effective than any of the other procedures available.
In 2012, thirty-four pelvic organ prolapse mesh manufacturers and seven of the stress urinary incontinence mesh manufacturers were told to do 109 post-marketing studies in order to examine the safety and potential for adverse events that were related to their devices. Despite the fact that these difficulties are known, the devices have not been recalled as of right now by the manufacturers or the FDA.
There have been thousands of transvaginal mesh lawsuits filed by women and the families of these women against the manufacturers of these devices. There are many manufacturers of these devices and not all of them have been named.
2025 Settlements and News
April 11, 2025 Transvaginal Mesh Lawsuit Update: The vast majority of transvaginal mesh lawsuits have been resolved, with more than $8 billion paid in total settlements by manufacturers like Johnson & Johnson, Boston Scientific, and C.R. Bard. Most MDLs are closed or in post-settlement status, with only a handful of cases still active in state courts.
February 15, 2025 Transvaginal Mesh Lawsuit Update: A few remaining state court cases are moving forward, primarily involving women who were excluded from earlier global settlements or developed injuries after the cutoff dates. No new MDL trials are scheduled at this time.
January 4, 2025 Transvaginal Mesh Lawsuit Update: The federal MDLs for major mesh manufacturers have officially concluded, and judges have issued final orders related to administrative closure and ongoing lien resolution. Settlement programs remain active for unresolved individual claims.
November 17, 2024 Transvaginal Mesh Lawsuit Update: Settlement claims continue to be processed, particularly for claimants who experienced multiple revision surgeries or late-emerging complications. Lien resolution and Medicare compliance remain key steps before final payouts in some cases.
September 13, 2024 Transvaginal Mesh Lawsuit Update: Plaintiffs’ lawyers have shifted their focus to individual suits in state court where statute of limitations permits. Most manufacturers are no longer facing MDL-level exposure but still deal with scattered legal activity in jurisdictions like New Jersey and California.
July 22, 2024 Transvaginal Mesh Lawsuit Update: Several multidistrict litigation dockets have been formally closed. The few remaining cases involve either appeals from prior trials or late-reported injuries. Courts have urged both sides to settle any remaining disputes to conclude the litigation entirely.
May 2, 2024 Transvaginal Mesh Lawsuit Update: Final administrative orders have been issued in the MDLs for Boston Scientific and C.R. Bard. Most settlement payments have been completed, with a few still pending resolution of healthcare liens and third-party claims.
March 5, 2024 Transvaginal Mesh Lawsuit Update: With federal litigation closed, legal focus has shifted to post-settlement administration. Some plaintiffs are still disputing award amounts or requesting reconsideration due to worsening injuries.
January 9, 2024 Transvaginal Mesh Lawsuit Update: Judges overseeing the concluded MDLs confirmed that more than 99% of eligible claims have either settled or been dismissed. Law firms report that only a very small number of unresolved cases remain open in isolated state courts.
November 14, 2023 Transvaginal Mesh Lawsuit Update: The majority of transvaginal mesh manufacturers have exited litigation, following years of large-scale settlements. Johnson & Johnson’s Ethicon unit remains involved in some post-trial motions and state court appeals.
September 6, 2023 Transvaginal Mesh Lawsuit Update: Final settlements are being distributed to claimants in MDLs that have closed. Women with multiple corrective surgeries are receiving higher-tier compensation. No new filings are expected due to expiration of most statutes of limitations.
June 20, 2023 Transvaginal Mesh Lawsuit Update: Over 108,000 federal mesh lawsuits have been resolved. Several MDLs, including those for AMS, Neomedic, and Cook Medical, are officially closed with orders of final dismissal.
April 11, 2023 Transvaginal Mesh Lawsuit Update: A handful of unresolved claims against Boston Scientific and Ethicon remain, mostly involving women who were previously excluded from settlements or suffered late complications. These are being addressed individually, often in state court.
January 31, 2023 Transvaginal Mesh Lawsuit Update: With the conclusion of bellwether trials and nearly all settlements finalized, the MDL judge is issuing orders to wind down remaining proceedings. The focus is now on lien resolution and claims administration.
October 19, 2022 Transvaginal Mesh Lawsuit Update: Plaintiffs with the most severe injuries—such as erosion, chronic pain, and multiple revision surgeries—have begun receiving their final settlement payouts. Settlement distribution is handled through tier-based criteria.
July 13, 2022 Transvaginal Mesh Lawsuit Update: Ethicon agreed to resolve an additional group of claims through confidential settlements. This move follows years of jury verdicts against the company and mounting pressure to conclude remaining litigation.
April 25, 2022 Transvaginal Mesh Lawsuit Update: MDLs continue to wind down. Over 95% of mesh claims have been resolved, though some individual plaintiffs continue to pursue state-level lawsuits.
December 6, 2021 Transvaginal Mesh Lawsuit Update: A federal judge overseeing the Ethicon MDL denied a motion to reopen certain previously dismissed claims, signaling a definitive closure phase for federal mesh litigation.
August 17, 2021 Transvaginal Mesh Lawsuit Update: Several manufacturers have finalized large-scale settlement programs with tiered payouts based on injury severity. Law firms continue working with clients to complete required medical documentation.
April 15, 2021 Transvaginal Mesh Lawsuit Update: The federal court continues to dismiss resolved cases and consolidate settlement oversight. With the majority of litigation behind them, mesh manufacturers now face limited legal exposure moving forward.
March 2021: Boston Scientific will pay $188.7 million to settle claims that it deceptively marketed its surgical mesh devices to consumers.
The settlement with 47 states and Washington, D.C. was announced in March 2021. The manufacturer also agreed to describe more accurately to consumers the safety and risks of using mesh.
2020: CR Bard reached a similar agreement to pay $60 million in September.
2019: Ethicon (Johnson & Johnson) agreed to a $117 million multistate settlement over the devices.
2018: In March 2018, two plaintiffs from Indiana, Barbara and Anton Kaisera, received a $35 million compensation after a nine day trial. The nine-member jury in the United States District Court for the Northern District of Indiana awarded the couple $10 million in damages after the woman suffered from severe pelvic pain and other injuries as a consequence of being implanted with Johnson & Johnson’s Prolift mesh. The jurors also hit J&J’s sub-division Ethicon with $25 million in punitive damages after finding the manufacturer negligently designed the device and failed to properly warn the public about its serious risks.
Companies Named
Following is a list of the companies that have been named in these transvaginal mesh lawsuits.
- Boston Scientific
- Cook Medical, Inc.
- Neomedic
- American Medical Systems (a subsidiary of Endo)
- Coloplast Corp
- R. Bard
There have been over sixty thousand different transvaginal mesh lawsuits that have been combined into federal multi-district litigations, or MDLs, in the US District Court for the Southern District of West Virginia. This isn’t including lawsuits filed elsewhere. One MDL suit has reached a settlement outside of the courtroom by Ethicon, which is a Johnson and Johnson subsidiary.
There are other states and federal district courts that are currently supervising thousands of transvaginal mesh lawsuits against these manufacturers.
History of Transvaginal Mesh Lawsuits
Following is a bit of the history of the transvaginal mesh lawsuits. This list includes cases that have either already gone through trial or been settled out of court.
- 2012: C.R. Bard demanded by jury verdict to pay $5.5 million to a couple in California
- 2013: Ethicon/Johnson and Johnson by jury verdict demanded to pay $3.35 million to a woman in New Jersey
- 2013: C.R. Bard demanded via jury verdict to pay $2 million to a woman in West Virginia
- 2013: Bloomberg News announced that some of these manufacturers were in discussions to reach a settlement out of court for up to $30 thousand per claim. However, this agreement has not been officially announced.
- 2014: An agreement was made by American Medical Systems to settle around 20,000 cases for $830 million- however, if more cases are added, that total will increase.
- 2014: An agreement has been made by Coloplast to settle around 400 lawsuits for about $16 million- but the parties have been sworn to secrecy.
Manufacturer Negligence
Attorneys that are representing the victims in these cases are making claims that the manufacturers have been negligent. Following are some of the areas that negligence is being claimed.
First of all, these companies had full knowledge of the safety and efficacy of these problems and knowingly misled the FDA, the public, and medical community regarding the safety and efficacy of these devices.
Secondly, the manufacturers of these devices did not conduct significant clinical trials in order to determine whether or not they were safe and effective for treating pelvic problems in women.
The manufacturers did not establish safe, effective methods for removing these transvaginal mesh devices.
Finally, the manufacturers of these devices hid their knowledge that these devices could result in permanent and even debilitating injuries, including death, even though they had a legal and moral obligation to release such information.
At this time, there have been over forty products named in the current transvaginal mesh lawsuits and many more are expected to be filed as more women experience issues and come forward.
Information About These Devices
Since the mid-1990s, these transvaginal mesh devices have been used to treat issues of pelvic organ prolapse and stress urinary incontinence in women. These devices were supposed to be an improvement of the methods used in the past. However, instead results have been thousands of serious adverse reactions, including permanent injuries and even death.
This category of medical devices includes “slings” which is a net-like mesh that is implanted in order to suspend the bladder or uterus. This sling is implanted “transvaginally” or through the vagina instead of through traditional abdominal surgery.
Transvaginal mesh is very similar to the mesh that was used to repair hernias and other tissues that was original approved by the FDA under 510(k) status. This status allows the manufacturer to avoid having to go through rigorous and costly studies in order to prove safety and effectiveness of a product. The 510(k) program only requires that a manufacturer make a claim that the device is not substantially different than the other devices that are already on the market.
The very first device was approved based on the similarity to the medical mesh products already on the market used to repair hernias and other procedures. The transvaginal mesh devices approved after that were based on the design of the very first vaginal mesh product- which had been recalled only three short years after it was approved.
The 510(k) process of the Food and Drug Administration could be at least partially to blame for the thousands of serious adverse events that have been caused as a result of transvaginal mesh. In 2008, the Food and Drug Administration released a statement that the procedures using transvaginal mesh did not appear to be any more effective and were actually much more likely to increase the risk of Serious Adverse Events, or SAEs. Even with this opinion and the objections of many medical groups, these transvaginal mesh devices have not yet been recalled.
There have been thousands of lawsuits that have been filed by the victims and the families of those victims that have been injured or killed due to the implantation of transvaginal mesh products and this number is expected to reach over 100 thousand.
Adverse Events and Complications
The Food and Drug Administration defines a serious adverse event, or SAE, as a medical event that is a result of a medical product that results in the patient being hospitalized, birth defects, permanent injuries, or even death. The transvaginal mesh devices have required revision surgery and have resulted in permanent injury, and even death, to many victims, resulting in a number of transvaginal mesh lawsuits
Major Serious Adverse Events
There have been several serious adverse events that have been caused by the implantation of mesh devices. These SAEs include the following:
Major Erosion
The transvaginal mesh devices have eroded through the vaginal wall, which can result in perforation of organs. This results in scarring of the vaginal wall, shrinking of vaginal tissues, and even severe bleeding and/or pain. Erosion can require multiple surgeries in order to correct the damage- and in some cases, the erosion caused by transvaginal mesh could be permanent.
Perforation of Organs
When the transvaginal mesh begins to erode, it can result in the vagina or other organs to become perforated. This can result in intense pain and/or bleeding and causes a significant increase in the risk for developing an infection. Perforation of organs typically requires surgery to correct- however, in some cases, the damage is likely to be permanent.
Surgery to Correct Transvaginal Mesh Damage
Corrective surgery or even surgeries could be required in order to repair the damage that is caused by transvaginal mesh that has perforated or eroded could be required in order to address the original issue of pelvic organ prolapse or stress urinary incontinence that was not resolved by the transvaginal mesh . In some cases, one surgery will be able to correct any damages caused. However, in some cases, multiple surgeries will be required. Every surgery opens the patient up to more pain and an increased risk of infection, scarring, and excessive bleeding.
Death caused by Transvaginal Mesh Devices
In some cases, women have died due to the perforation of their organs caused by erosion of the transvaginal mesh device. Additionally, the risk of death is increased by excessive bleeding or infections caused by the device.
Other Potentially Debilitating Effects
There are a few other effects that can potentially be caused by transvaginal mesh. These effects are debilitating, but are not life-threatening.
- UTIs which become chronic and require specific medications.
- Scarring of the vagina, which can lead to thickening of the vaginal walls and therefore pain and difficulty with sexual intercourse.
- Nerve damage to the vagina and the surrounding abdominal or pelvic area that could result in significant pain or even a loss of sensation.
- Emotional disorders as a result of the pain, multiple surgeries, or even permanent disability due to damage.
If you have had a transvaginal mesh implant and are experiencing problems, you should consider speaking with an attorney to find out more about your rights. In most cases, an injury attorney will review your transvaginal mesh lawsuit for free and if you chose to move forward, you are not required to pay for representation unless you win your case.
