Pelvic organ prolapse (POP) is a condition in which tissues in the pelvic floor are weakened or stretched. It often occurs in response to pregnancy and childbirth.
Women have filed more than 104,000 vaginal mesh lawsuits against multiple medical device manufacturers. These lawsuits claim medical device malfunction caused severe side effects for thousands of patients. The majority of these transvaginal mesh lawsuits have been settled. Transvaginal mesh settlements account for roughly $8 billion in personal injury settlements. However, some cases are still pending.
Why Women Are Filing TVM Lawsuits
Thousands of lawsuits have been filed against transvaginal mesh (TVM) device manufacturers. Some lawsuits have ended in multimillion-dollar settlements.
Of those that have progressed to trial verdicts, juries have frequently found in favor of plaintiffs. Juries have awarded compensation to plaintiffs for serious complications and associated pain and suffering. Device manufacturers have contested many of these losses. Some decisions were later reversed in higher courts.
FDA Actions on TVM Devices
Surgical mesh has been used since at least the 1950s. It was initially used for hernia repair and other reconstructive surgeries. In the 1970s, some gynecologists began to use surgical mesh to treat pelvic organ prolapse (POP).
Gynecologists also used surgical mesh to treat stress urinary incontinence (SUI). As time went on, the use of gynecological mesh increased. Thousands of women received vaginal mesh implants, sometimes called bladder slings.
In 1976, the U.S. Food and Drug Administration (FDA) gained the authority to regulate medical devices. However, devices that were already on the market at the time were subject to a different classification process than new medical devices.
As such, surgical mesh was grandfathered in as a Class II medical device. Class II devices are not required to undergo premarket approval. By allowing mesh products to skip premarket approval, the FDA missed an early opportunity to recognize and prevent the many serious complications now named in multiple lawsuits.
As women began to report gynecological mesh problems, the FDA looked closer at the adverse event records. The FDA studied the thousands of reports that came in between 2005 and 2010. After reviewing the reports, the agency eventually issued a notice changing the classification of vaginal mesh from a Class II to a Class III medical device. This new distinction required premarket approval for surgical mesh devices going forward.
FDA Timeline of Urogynecological Mesh Actions
- October 2008: Public health notification about more than 1,000 reports during the preceding three years related to gynecological mesh
- July 2011: FDA safety communication update on serious transvaginal mesh complications, with more than 2,800 additional reports submitted between January 2008 and December 2010
- May 2014: FDA published a proposed order requiring premarket approval for surgical mesh used in transvaginal pelvic organ prolapse repair
- January 2017: The proposed premarket approval requirement went into effect, with updated rules published in the Federal Register
- September 2017: Another FDA safety communication related specifically to synthetic materials used to make Boston Scientific's composite mesh
- April 2018: The FDA issued a market withdrawal of all surgical mesh for transvaginal repair of pelvic organ prolapse, effectively banning new TVM sales
Current Transvaginal Mesh Lawsuits
Transvaginal mesh products are made by a number of different medical device manufacturers including:
- Ethicon (a division of Johnson & Johnson)
- Boston Scientific
- C. R. Bard
Many of the claims against these manufacturers are similar. However, Ethicon mesh lawsuits have been more prevalent than litigation against other medical device makers.
Lawsuits Against Ethicon (Johnson & Johnson)
As of May 2019, Ethicon is the subject of more than 40,759 vaginal mesh lawsuits. Many women have named the company's Gynecare TVT Abbrevo product in lawsuits. They claim the device is responsible for their injuries. The Gynecare TVT Abbrevo product is still on the market.
Ethicon has issued some transvaginal mesh recalls. However, the manufacturer has not admitted to safety concerns regarding these recalls.
Transvaginal mesh lawsuits list a variety of claims. In many cases, women who experience any severe side effects from the device have limited treatment options.
In addition to individual lawsuits, several states have filed lawsuits against Johnson and Johnson. The lawsuits claim the company marketed their pelvic mesh devices deceptively. Washington, California, Kentucky and Mississippi claim the surgeries associated with these devices ruined people's lives.
Transvaginal Mesh Lawsuit Side Effect Claims
- Infection, pain, discomfort, allergic reaction, or irritation near the surgery site
- Difficulty urinating, incontinence and involuntary urination
- Pain during everyday activities, including urination and sexual intercourse (dyspareunia)
- Organ perforation or mesh erosion into nearby organs and tissue (e.g., bowel, bladder or vaginal epithelium)
- Recurrent pelvic organ prolapse
If you experience these or any other symptoms after your transvaginal mesh surgery, talk to your doctor or healthcare provider right away to understand your treatment options.
Due to the volume of lawsuits against Ethicon, these cases have been consolidated into multidistrict litigation (MDL). U.S. District Judge Joseph R. Goodwin is overseeing the MDL. Collectively, these cases are known as MDL No. 2327. Approximately 350 cases in this MDL are still pending. Ethicon has set aside an undisclosed amount of money to cover its litigation expenses and possible settlement expenses.
Some of the composite mesh products (or similar brands like Atrium C-QUR mesh, Ethicon Physiomesh, and Composix Kugel Mesh) at the center of these legal claims are also the subject of hernia mesh lawsuits.
Boston Scientific Mesh Lawsuits
According to the company's February 2019 financial filings, there are currently more than 53,000 lawsuits in federal and state courts against Boston Scientific due to its synthetic mesh implants. Boston Scientific has settled some of the lawsuits against it. In 2015 the company paid a $119 million settlement to resolve approximately 3,000 claims. However, there are still thousands of outstanding cases pending against the company.
C. R. Bard Mesh Lawsuits
As of September 2019, C. R. Bard had more than 190 outstanding pelvic mesh lawsuits pending in federal court. The company has paid more than $200 million in vaginal mesh settlements to date related to its Avaulta brand and other products.
Foreign Mesh Lawsuits
These cases are not limited to the United States alone. A civil case was brought by 450 Australian women against Johnson & Johnson. Another 300 women have filed a class action lawsuit against American Medical Systems.
In the United Kingdom, transvaginal mesh manufacturers and the National Health Service are being sued by more than 800 women. But, regulators have recently taken steps to limit the use of these implants. The NHS announced in July 2018 that it would suspend use of any type of mesh implant for the treatment of pelvic organ prolapse or stress urinary incontinence.
If other devices are any indication, the U.S. FDA will be slow to follow its international counterparts with restrictions or bans. Thousands more class action and civil lawsuits are in progress or are expected to be filed around the world. The global cost of transvaginal mesh legal action is expected to reach billions of dollars.
Federal Pelvic Mesh Lawsuit MDLs
|Company||MDL No.||Lawsuits Filed|
|Source: MDL Statistics Report - Distribution of Pending MDL Dockets by District, January 15, 2020|
|Ethicon (Johnson & Johnson)||2327||40,860|
Two vaginal mesh MDLs closed amidst the COVID-19 pandemic.
Transvaginal Mesh Settlements and Verdicts
Some transvaginal mesh lawsuits have resulted in settlement and verdicts in favor of the plaintiffs. Some plaintiffs have received significant compensation amounts.
Suzanne Emmett - $41 million (Philadelphia, PA)
After receiving an Ethicon vaginal mesh implant in 2007, Suzanne Emmett was forced to undergo multiple revision surgeries to stop the pain and discomfort caused by the device. However, those additional medical procedures could not completely reverse the irreparable harm done by the device. Emmett and her husband sued Ethicon. In January 2019 the case went to trial, resulting in a $41 million award for the plaintiffs.
The compensation broke down into several categories:
- $15 million in compensatory damages
- $25 million in punitive damages
- $1 million for loss of consortium.
Ella Ebaugh - $57.1 million (Philadelphia, PA)
Diagnosed with urinary incontinence in 2005, Ebaugh received a TVT-Secure pelvic mesh implant in 2007. Another was implanted about two months when the first one did not resolve her medical problems. Over the next several years, Ebaugh required three additional surgeries to repair her implants, which she claims caused her pain when both sitting and standing. In 2013, Ebaugh sued Ethicon. In September 2017, the jury awarded her $57.1 million. $50 million of award was punitive damages. It is the highest jury award given in a Pennsylvania transvaginal mesh case to date.
Linda Gross - $11 million (South Dakota)
In February 2013, a jury awarded $11 million in compensatory and punitive damages to a South Dakota couple. Linda Gross required 18 surgeries (including nine to remove the mesh implant) after Ethicon's Gynecare Prolift device caused her to experience chronic pain. In March 2015, this verdict was affirmed in the Appellate Division. Ethicon petitioned for this affirmation to be reviewed. But, the company's request was denied by the New Jersey Supreme Court in December 2015.
Huskey v. Ethicon
In September 2014, $3.27 million was awarded to a woman injured by Ethicon's TVT-O vaginal mesh. The West Virginia federal jury concluded Ethicon's device was faulty, and sufficient warnings about the risks of the mesh had not been provided.
Bellew v. Ethicon
In March 2015, Ethicon settled a case relating to its Gynecare Prolift mesh device on the fifth day of the trial. Ethicon has not disclosed details of the settlement.
Cavness v. Kowalczyk et al
In October 2015, a Texas jury ruled in favor of Ethicon in the first of many lawsuits blaming its Gynecare Prosima device for pain and suffering. The jury decided a design defect was not to blame for the plaintiff's pain, despite the product having been pulled from the market by its manufacturer.
Engleman v. Ethicon
In April 2017, a Philadelphia jury awarded a New Jersey woman $2.5 million in damages. They also hit Ethicon with punitive damages of $17.5 million. The plaintiff experienced severe pain after being fitted with Gynecare TVT-Secur mesh for incontinence and required multiple surgeries to have it removed.
In its first large transvaginal mesh settlement, Ethicon paid $120 million dollars in January 2016 to resolve as many as 3,000 cases. Judge Goodwin has allegedly advised Ethicon to settle more cases in MDL No. 2317.
McGinnis v. C. R. Bard
Mary McGinnis received Avaulta and Align mesh implants, both manufactured by C. R. Bard. She claimed the implants shrank after implantation, leaving her with nerve damage, pelvic pain and virtually no sex life. When surgery failed to resolve the problems caused by her implants, McGinnis filed a lawsuit.
In April 2018, a New Jersey jury awarded Mary and her husband $33 million in compensatory damages and $35 million in punitive damages, bringing the total judgment to $68 million. C.R. Bard representatives indicated that they would appeal the decision. No appeal proceedings were pending as of February 2019.
Transvaginal Mesh FAQs
Am I Eligible to File a TVM Lawsuit?
Both women and their spouses have sought compensation for the negative impact the mesh has had on their lives, including:
- Pain and suffering
- Loss of consortium (loss of marital relations)
- Medical expenses, including surgery to remove the devices
- Loss of wages
- Lower quality of life
The statute of limitations for filing a transvaginal mesh lawsuit varies significantly between states. Plaintiffs have 1 - 10 years from the time they become aware of their injuries to file a claim, depending on product liability laws in their state.
What Compensation Can TVM Victims Receive?
Compensation in cases like these tends to vary significantly based on a number of different factors. These include:
- How long the woman suffered severe side effects of the mesh implant
- The severity of the adverse effects she experienced
- Medical costs of treatment to resolve or manage those side effects
- Any money lost because she could not work as a result of medical problems related to the device
- The state where she lives
How Much Does It Cost to Hire a TVM Lawyer?
You will not have to pay anything to file a lawsuit through a contingency agreement. This type of agreement only requires you to pay legal expenses if you win compensation for your case through a favorable verdict or settlement.