Transvaginal mesh was promoted as an effective way to address conditions called pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP is a condition where an internal organ, such as the bladder, drops from its normal place and presses against the walls of the vagina. SUI is uncontrolled urination caused by normal physical activity such as coughing, sneezing or running putting stress on the bladder.
Women who received transvaginal mesh implants thought they were receiving devices that would provide relief from these conditions. But thousands of women claim they weren’t warned that the devices could cause severe pain, organ damage and other complications.
Some women who filed lawsuits have won multimillion-dollar verdicts against mesh manufacturers.
Christine Scott and her husband won a $5.5 million jury award in 2013. It came in the first Avaulta mesh verdict in a federal multidistrict litigation (MDL). MDLs combine several — even thousands — of similar lawsuits into a single court case. MDLs are intended to save parties time and money and can move lawsuits through the legal process more quickly.
A company called Bard made the mesh in the Scotts’ case. The couple claimed it caused bleeding, pain, bladder spasms and made sex painful. It also required several surgeries to remove the mesh.
Since 2012, women who have sued companies over transvaginal mesh have won at least 20 verdicts in state and federal courts totaling around $300 million. By March 2017, multiple companies had settled thousands of claims for millions of dollars more, but 60,199 lawsuits were still awaiting some kind of action — trial, settlement or dismissal.
Why Have Women Filed Lawsuits over Transvaginal Mesh?
Women who filed transvaginal mesh lawsuits claim that mesh manufacturers “had a legal duty to ensure the safety and effectiveness of their pelvic mesh products” but instead provided patients with “false and misleading information” about how safe and effective the products supposedly were.
Lawsuits accuse mesh manufacturers of:
- Intentionally misleading the FDA, the medical community, patients and the public about the true safety and effectiveness of transvaginal mesh products
- Failing to properly test transvaginal mesh
- Failure to research the risks of surgical mesh
- Failing to create safe and effective methods to remove transvaginal mesh
- Failing to adequately warn people of potential complications and injuries
Women say mesh manufacturers never warned them that mesh can erode, or break down. They claimed this damaged their vaginal walls or internal organs and that it sometimes happened within just weeks or months after surgery. The injuries caused by mesh erosion and other complications caused them severe pain and hindered regular activities, such as sitting, walking and having sex. The complications were so bad that many women had to undergo multiple revision surgeries to remove the mesh.
Women who filed lawsuits claim the mesh implants caused:
- Extreme pain
- Dyspareunia (pain during sex)
- Recurrence of urinary incontinence
The physical and emotional harm affected women’s work, relationships and daily activities. They turned to the courts to seek compensation for these various injuries.
Women Claim Organ Damage in Transvaginal Mesh Lawsuits
In November 2014, a federal court panel combined four lawsuits filed by four different women into a single transvaginal mesh trial.
A New Jersey jury found Boston Scientific to be responsible for the injuries of 4 women – resulting in $14.5 million in compensation for injuries and $4 million in punitive damages.
Jeanie Blankenship, Carol Sue Campbell, Jacquelyn Tyree and Chris Rene Wilson had each been implanted with Boston Scientific Obtryx mesh. They claimed in their lawsuits that it eroded, damaged internal organs and caused severe pain.
A New Jersey jury held Boston Scientific responsible for the women’s medical bills and suffering. The four women split $14.5 million for their injuries and another $4 million in punitive damages.
A court can award punitive damages as a way to punish a defendant for conduct that may have been especially harmful. It may be because a company didn’t do enough research to make sure their product is safe or come up with a plan to fix any damage their product causes.
Women Claim Boston Scientific Failed to Warn of Mesh Danger
Four more lawsuits against Boston Scientific were transferred to the Southern District of Florida for trial in 2014. Margarette DuBois-Jean, Margarita Dotres, Maria Nunez and Juana Betancourt all claimed the company had been negligent in the Pinnacle mesh’s defective design. They also argued Boston Scientific failed to warn them of dangers from the transvaginal mesh.
A jury awarded each of the women more than $6 million each in November 2014, but Boston Scientific appealed.
In October 2017, the Eleventh Circuit Court of Appeals ruled in favor of the four women, upholding the $26.7 million verdict against the company.
Woman Sues Johnson & Johnson for Revision Surgeries, Pain and Suffering
Patricia Hammons won a $12.5 million award after she sued Johnson & Johnson for injuries one of its transvaginal mesh products caused.
Hammons’ Prolift implant failed, causing pain and medical problems. She was forced to have multiple revision surgeries.
During her trial, a Johnson & Johnson employee testified that the company never created a plan for how to remove the mesh from patients if it caused problems. The jury awarded Hammons $5.5 million for her injuries and $7 million in punitive damages.
Women and Husbands Seek Compensation for Mesh Injuries
Device manufacturers named in mesh lawsuits never recalled transvaginal mesh devices and never offered compensation to women their products hurt.
Women sought justice through the legal system, asking the manufacturers to pay for damages including:
- Medical expenses, including the costs of additional surgeries
- Lost wages
- Lost spousal consortium
- Lower quality of life
- Pain and suffering
Husbands of women harmed by transvaginal mesh have been included in lawsuits. They seek compensation for something the courts call loss of consortium. Loss of consortium refers to a loss of a relationship or normal marital relations.
Hundreds of ObTape Lawsuits Combined
The first transvaginal mesh lawsuits involved a device called ObTape manufactured by Mentor. Its design was based on the first transvaginal mesh approved in 1996, a bladder sling called ProteGen, which was recalled due to design flaws in 1999. Mentor sold ObTape from 2003 to 2006 and even though it caused problems for patients implanted with it, Mentor never ordered a recall.
Women filed hundreds of lawsuits against Mentor over injuries caused by its ObTape mesh.
In 2008, a federal panel, the Judicial Panel on Multidistrict Litigation (JPML), combined several of these cases into a multidistrict litigation (MDL). MDLs combine several similar lawsuits into a single case and send it to a single, federal court. MDLs can reduce costs and duplication and allow the cases to move more quickly and efficiently through the legal system.
A total of 857 lawsuits were included in this one MDL between 2008 and 2017.
Johnson & Johnson bought Mentor in 2009, and the company has settled more than 100 lawsuits involving ObTape. In 2016, the judge overseeing the MDL asked the JPML to stop adding cases to the MDL. He said the MDL had received too many lawsuits that did not have enough evidence to stand up in court and cases that had missed the time limit for filing a lawsuit.
The JPML has not closed the ObTape MDL, yet. And women seeking compensation for ObTape injuries can also still file claims in state courts.
More Transvaginal Mesh Lawsuits Combined in Federal Court
By the end of 2011, companies that manufactured transvaginal mesh products faced more than 650 lawsuits in state courts. In January 2012, lawyers for the women who had filed the lawsuits asked the JPML to combine the cases in federal court.
In February 2012, the panel agreed to consolidate cases against three companies into MDLs in the Southern District of West Virginia, where one transvaginal mesh MDL already existed.
By 2017, seven MDLs involving transvaginal mesh manufacturers had been created in federal court in West Virginia:
- October 2010 – C.R. Bard
- February 2012 – American Medical Systems
- February 2012 – Boston Scientific
- February 2012 – Ethicon (Johnson & Johnson)
- August 2012 – Coloplast
- June 2013 – Cook Medical Inc.
- February 2014 – Neomedic
The West Virginia federal court ordered the first bellwether trials in the MDLs began in July 2012. Bellwether trials are test cases. Individual lawsuits are chosen from each MDL, and the judge sets a schedule for each to go trial. The outcome of individual bellwether trials can give both sides an idea of how the remaining cases may turn out and help lawyers on each side negotiate settlements.
As of June 2017, at least 18 bellwether cases in the West Virginia MDLs had been tried, settled, dismissed or delayed.
Plaintiffs, the people who filed the lawsuits, have won verdicts totaling more than $49 million in 10 of the bellwether trials.
Johnson & Johnson subsidiary Ethicon has won the only defense verdict of any of the companies in the MDLs. Parties have settled four other lawsuits before trial and three bellwether trials have been delayed or dismissed.
Johnson & Johnson, Bard and Boston Scientific each lost multiple bellwether trials, and the MDL court has urged those companies to settle more lawsuits.
Since 2014, companies have agreed to settlements in thousands of other transvaginal cases in the MDLs including:
- May 2014 – AMS settled 20,000 claims
- January 2014 – Coloplast settled 400 lawsuits
- October 2014 – Bard settled 500 lawsuits
- January 2015 – Ethicon (Johnson & Johnson) settled four lawsuits
- April 2015 – Boston Scientific settled 3,000 claims
- August 2015 – Bard settled another 3,000 claims
- December 2015 – Neomedic settled 112 claims
- August 2017 – Remaining 22,000 AMS claims settled
Neomedic’s settlement resolved the majority of the lawsuits against the company and the court closed that MDL in January 2017.
After the wave of settlements peaked in 2015, mesh litigation made little progress in 2016. The judge overseeing the MDLs has continued to urge plaintiffs and defendants to try to settle their cases.
In August 2017, Endo International, which had acquired AMS in 2011, announced it would settle the more than 22,000 cases involving AMS mesh for $775 million. Those payments were to begin in late 2017 and be paid out through the fourth quarter of 2019.
In October 2017, the U.S. Supreme Court refused to hear an appeal by Johnson & Johnson over a $3.27 million verdict against its Ethicon subsidary’s TVT-O pelvic mesh. The Supreme Court’s decision effectively upheld the jury’s verdict in favor of the plaintiffs in the second Ethicon bellwether trial in 2014.
As of October 2017, more than 42,000 lawsuits were still awaiting some sort of action in the West Virginia MDLs, out of the more than 104,000 that had been included since the MDL was formed.
Cases in Transvaginal Mesh MDLs as of November 2017
|Company||Pending Actions||Total Actions|
|American Medical Systems||1,264||21,180|
How Could Companies Sell Dangerous Transvaginal Mesh?
Fixing transvaginal mesh complications can be painful and expensive. The damage from mesh can be permanent. Some women are unable to sit comfortably or have sex without experiencing pain.
Most transvaginal mesh devices were never tested with thorough clinical trials. The U.S. Food and Drug Administration approved the majority of them using a fast-track process called the 510(k) program. When a company creates a new, first of its kind medical device, the device has to go through a rigorous testing and approval process. But the 510(k) program allows companies to skip a lot of that process if they can show their product is “substantially similar” to another product already on the market.
In 1996, the FDA approved the first transvaginal mesh, ProteGen, made by Boston Scientific to treat SUI. Other companies were able to get their versions approved through the 510(k) process by showing their products were similar to ProteGen. But just three years after it was approved, Boston Scientific recalled ProteGen after hundreds of complaints. Even though the product was eventually pulled from the market, other companies still used ProteGen as their model to gain 510(k) approval for their own mesh products.
In 2002, the FDA approved transvaginal mesh to treat pelvic organ prolapse.
By 2008, the FDA had received thousands of complaints from patients and physicians. The mesh devices were eroding inside of women, effectively breaking down. This can lead to organ perforation — holes in organs — causing severe pain.
In 2011, the FDA updated transvaginal mesh information, saying complications were more common than expected. In 2012, the FDA ordered companies to monitor the safety of the devices.
That’s when several companies removed their transvaginal mesh products from the market.
By that time, thousands of women had already filed lawsuits against the manufacturers. The lawsuits revealed that some companies knew about the problems with the devices, but they sold them anyway.
In January 2016 the FDA reclassified the mesh from Class II (moderate risk device) to Class III (high risk device) and required manufacturers to submit pre-market approval (PMA) applications to provide more evidence of safety & effectiveness for treating pelvic organ prolapse.
Advice from a Transvaginal Mesh Lawyer
Transvaginal mesh lawsuits have become a part of one of the largest mass torts in U.S. history. A mass tort is legal action that involves multiple people suing one or more corporate defendants.
Lauren Yaeger is a lawyer who specializes in mass tort cases for Morgan & Morgan — a personal injury law firm serving clients from across the country. She has represented thousands of individuals who have been harmed by manufacturers of dangerous drugs and medical devices. Yaeger is an advocate for transvaginal mesh victims, and she has a proven track record of success in complex litigation.
“I’ve talked to hundreds and hundreds of women. They’re always very difficult conversations. You really can’t say anything to make their lives better. Their lives in some ways have been completely ruined. Even if we can get them justice — and have the manufacturers pay for their injuries — they’ll never be made whole again. That’s the most difficult part.”
- Attorney Laura Jaeger, who specializes in mass tort cases for Morgan & Morgan
Although lawyers who handle transvaginal mesh cases can’t repair the damage that mesh caused, they can help people harmed by mesh get compensation for their injuries.
“If a woman is injured from the mesh, and they would like to be compensated for their injuries, they have a certain time limit to file a claim,” Yaeger said. “If they have been harmed, they need to think about whether they want to move forward and have someone protect their interests. If they don’t do it soon, they may never be able to get compensation for their injuries.”
Terry Turner is an Emmy-winning, former television journalist. He is an associate member of the American Bar Association, the ABA’s Health Law group and a member of the Alliance of Professional Health Advocates. He holds six certificates in Health Literacy for Healthcare Professionals from the Centers for Disease Control and Prevention. As a Washington-based investigative reporter, he routinely reported on health and medical policy issues before Congress, the FDA and other federal agencies. Terry received his B.A. in Media Arts from Lyon College.