Over 100,000 vaginal mesh lawsuits have been filed against several manufacturers. The FDA has warned that serious complications are “not rare,” and may include vaginal erosion, scarring, nerve damage, disfigurement of the vagina, pelvic pain, and more. Many women have had multiple corrective surgeries and continue to suffer from complications.
Do I Have a Vaginal Mesh Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured by vaginal mesh, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
UPDATE: Kentucky AG Files Vaginal Mesh Lawsuit Seeking Millions in Penalties
August 17, 2016 — The Kentucky Attorney General has filed a lawsuit seeking millions of dollars in penalties on behalf of thousands of women who were injured by vaginal mesh. Click here to read more.
April 29, 2016 — J&J has reached a $5 million settlement with a woman who was injured by the Ethicon Gynecare Prolift vaginal mesh. Click here to read more.
April 5, 2016 — The FDA is investigating allegations that Boston Scientific imported counterfeit resin from China to use in vaginal mesh implants. Click here to read more.
February 17, 2016 — In the second big loss for Ethicon, a Philadelphia jury has awarded $13.5 million to a woman injured by Transvaginal Tape (TVT) that eroded through her vagina and required multiple revision surgeries. Click here to read more.
January 28, 2016 — J&J will pay $120 million to settle 2,000-3,000 lawsuits involving vaginal mesh, in the first big settlement out of nearly 45,000 lawsuits pending against the company. Click here to read more.
January 15, 2016 — A class action racketeering lawsuit has accused Boston Scientific of illegally smuggling counterfeit resin for vaginal mesh out of China “like a drug deal,” attorneys allege. Click here to read more.
January 4, 2016 — After receiving a significant increase in adverse events, the FDA has strengthened approval requirements for vaginal mesh and reclassified them as Class III (“high risk”) medical devices. Click here to read more.
December 21, 2015 — Ethicon has been ordered to pay $5.5 million to a woman who was injured by the Prolift vaginal mesh. Click here to read more.
October 29, 2015 — Boston Scientific has agreed to pay $457 million to settle lawsuits filed by about 6,000 women who were injured by the company’s vaginal mesh products. Click here to read more.
September 9, 2015 — About one in 30 women who get vaginal mesh to treat urinary incontinence need revision surgery within 10 years, according to a new study. Click here to read more.
August 6, 2015 — C.R. Bard has offered $200 million to settle 3,000 vaginal mesh lawsuits, or about $67,000 per case. Click here to read more.
May 28, 2015 — A jury in Delaware has awarded $100 million to a woman who was severely injured by Boston Scientific Pinnacle and Advantage Fit vaginal mesh implants, the largest-ever award to an individual in the litigation. Click here to read more.
May 12, 2015 — One week into trial, Boston Scientific has settled a lawsuit from a woman who was injured by the company’s Pinnacle vaginal mesh implant. Click here to read more.
May 6, 2015 — Attorneys for a woman who was severely injured by Boston Scientific’s Pinnacle pelvic mesh implant have presented opening arguments to a jury in California. Click here to read more.
April 28, 2015 — Boston Scientific has agreed to settle nearly 3,000 vaginal mesh lawsuits for $119 million, or an average of $40,000 per claim. Click here to read more.
March 17, 2015 — A California jury has ordered Johnson & Johnson’s Ethicon unit to pay $5.7 million to a woman who was permanently injured by TVT Abbrevo, a type of vaginal mesh. Click here to read more.
February 6, 2015 — U.S. District Judge Joseph R. Goodwin is urging counsel to come to the table and settle approximately 70,000 vaginal mesh lawsuit, warning he was going to “kick it into high gear and ask that you do the same.” Click here to read more.
January 22, 2015 — Johnson & Johnson has agreed to pay settlements in four vaginal mesh lawsuits, including one case that was set for trial this week in Missouri. Click here to read more.
January 21, 2015 — Mentor Corp., a unit of Johnson & Johnson, has agreed to pay settlements in about 111 lawsuits involving injuries from the ObTape pelvic sling. Click here to read more.
January 14, 2015 — Next month’s trial involving C.R. Bard’s Avaulta vaginal mesh will not be delayed, despite Bard’s complaints about comments made by the judge overseeing the litigation. Click here to read more.
January 8, 2015 — In response to a federal judge warning about the slow pace of settlements for about 12,000 women injured by vaginal mesh, C.R. Bard has asked to delay a trial set to begin next month. Click here to read more.
November 20, 2014 — Four women who were injured by Boston Scientific’s Obtryx Mid-Urethral Sling, a bladder sling, have been awarded $18.5 million by a federal jury in West Virginia. Click here to read more.
November 14, 2014 — A federal jury in Miami, Florida has awarded $27 million to four women who were injured by the Pinnacle vaginal mesh implant made by Boston Scientific Corp. Click here to read more.
October 9, 2014 — C.R. Bard has agreed to settle more than 500 lawsuits involving Avaulta pelvic mesh for about $21 million, or an average of $43,000 per claim. Click here to read more.
October 3, 2014 — A Texas state judge has slashed a $73 million jury verdict against Boston Scientific in half, ordering the device-maker to pay just $34.6 million in damages to a woman who was injured by the Obtryx pelvic mesh. Click here to read more.
October 1, 2014 — Endo International Plc. has agreed to settle about 10,000 lawsuits involving vaginal mesh for $400 million, or an average payout of $48,000 per plaintiff. Click here to read more.
September 9, 2014 — Bloomberg reports that a jury in Texas has ordered Boston Scientific to pay $73 million to a woman who alleges that the company’s Obtryx bladder sling is defective and caused her severe injuries. Click here to read more.
September 8, 2014 — $3.27 million has been awarded to a woman who was injured by the TVT Obturator (TVT-O), a bladder sling manufactured by Johnson & Johnson’s Ethicon unit. Click here to read more.
August 15, 2014 — The second “bellwether” trial involving Boston Scientific’s vaginal mesh is underway in Massachusetts, just weeks after the device-maker was victorious in the first trial. Click here to read more.
July 30, 2014 — Bloomberg reports that Boston Scientific has won a trial involving the Pinnacle vaginal mesh implant. The jury found that the implant was properly designed and Boston Scientific sufficiently warned about the risks. Click here to read more.
July 29, 2014 — Two law firms and C.R. Bard have agreed to an undisclosed settlement in approximately 500 lawsuits involving Avaulta vaginal mesh, according to a regulatory filing. Bard has also settled a case in federal court that was set for trial in May. Click here to read more.
July 28, 2014 — Johnson & Johnson has lost an appeal of an $11.1 million jury verdict in favor of Linda Gross, a woman who was seriously injured by the Ethicon Gynecare Prolift vaginal mesh. Judge Carol Higbee refused to reduce the punitive damages or grant Johnson & Johnson another trial. Click here to read more.
July 22, 2014 — A petition to completely ban vaginal mesh has been denied (PDF) by the FDA, but the agency has “tentatively” agreed that the implants are high-risk and should be subject to stricter approval requirements. Click here to read more.
July 11, 2014 — Covidien says it will pay $180 million in legal charges related to approximately 6,000 vaginal mesh lawsuits, as reported in a mandatory filing with the Securities and Exchange Commission (SEC). Click here to read more.
June 19, 2014 — As nearly 60,000 lawsuits involving vaginal mesh progress through the American federal court system, Scottish health secretary Alex Neil has asked health regulatory agencies to temporarily suspend implants of the device. Click here to read more.
May 21, 2014 — Surgery to remove vaginal mesh does not always improve side effects like pain and incontinence, according to two studies presented this week at the American Urological Association’s annual meeting. Click here to read more.
May 1, 2014 — Endo Pharmaceuticals and American Medical Systems have agreed to pay $830 million to settle thousands of vaginal mesh lawsuits involving Elevate, Perigee, and Apogee. Each woman who qualifies will receive a base payment of $40,000, but terms of the settlement allow women to seek higher compensation for severe injuries and multiple revision surgeries. Click here to read more.
April 30, 2014 — The FDA has proposed re-classifying vaginal mesh as a “high risk” medical device (class III) instead of “moderate” risk (class II), which would require pre-market approval. Click here to read more.
March 16, 2014 – Federal judges have announced that nearly 50,000 vaginal mesh lawsuits are currently pending in federal court. Click here to read more.
March 15, 2014 – Activists are calling for a criminal investigation into Johnson & Johnson’s destruction of documents, and they have created a website where whistleblowers can submit tips. Click here to read more.
March 6, 2014 — As part of a $16 million settlement, plaintiffs will receive an average of $40,000 for injuries caused by defective Coloplast vaginal mesh, according to Bloomberg News. The settlement resolves 400 lawsuits pending against Denmark-based Coloplast Corp. Click here to read more.
December 16, 2013 — Ethicon and Johnson & Johnson lost or destroyed hundreds of thousands of documents that could be critical for vaginal mesh lawsuits.
September 19, 2013 – C.R. Bard has agreed to settle a lawsuit filed by a woman who was injured by the Avaulta vaginal mesh implant for an undisclosed sum. Click here to read more.
August 26, 2013 – Bard agrees to a $2.2 million settlement with Donna Cission, a woman who was injured by the Avaulta. Click here to read more.
July 29, 2013 — The first federal lawsuit against C.R. Bard ended in a mistrial after an expert witness told the jury that the Avaulta implant was withdrawn from the market. A new jury has been selected and opening arguments begin today. Click here to read more.
July 18, 2013 — Judge Goodwin has chosen four cases that will be selected for the first trials against American Medical Systems (AMS). Click here to read more.
July 17, 2013 — American Medical Systems (AMS) has paid $54.5 million to settle an undisclosed number of vaginal mesh lawsuits involving the Perigee, Apogee, and Elevate implants. Click here to read more.
December 11, 2012 — Judge Goodwin has scheduled the first “bellwether” trials against AMS, Ethicon, and Boston Scientific for December 2013.
September 10, 2012 — The judge overseeing the Avaulta vaginal mesh litigation against C.R. Bard has scheduled several bellwether trials. The first trials are set to begin in February 2013. The second set are scheduled for June 2013. Click here to read more.
$5.5 Million Award in First Vaginal Mesh Lawsuit
July 20, 2012: Christine Scott and her husband, Roy, were awarded a $5.5 million award for their vaginal mesh lawsuit by a jury in Bakersfield, California. Christine was an avid runner who got the Avaulta vaginal mesh in 2008 to cure incontinence. Unfortunately, the device perforated her colon, eroded into her vagina, and caused severe pain, scarring, and tissue damage. She required multiple surgeries and now suffers pain during sexual intercourse. The jury awarded Christine $5 million, and her husband $500,000 for loss of consortium.
What is Vaginal Mesh?
Vaginal mesh (or pelvic mesh, transvaginal mesh, pelvic sling or tape) is a medical device that is implanted into a woman’s pelvis through incisions in her vagina. When placed correctly, the hammock-like device sits in the center of the pelvis and supports weakened, sagging pelvic muscles that normally support abdominal organs. This is used to treat two conditions:
- Pelvic Organ Prolapse (POP) – When abdominal organs protrude into the vagina or rectum
- Stress Urinary Incontinence (SUI) – When weakened pelvic muscles allow the urethra to open inadvertently, usually when a woman coughs, sneezes, laughs, or runs.
Vaginal Mesh and the FDA’s 510(k) Approval
Many types of vaginal mesh that are currently on the market were approved under the FDA’s 510(k) fast-track approval system. New devices that are “substantially similar” to an approved device do not have to conduct safety studies in their approval application. Although most people assume that a medical device implanted in their body has been thoroughly tested and is safe, this is not always the case.
According to Elaine Houghton, attorney for a woman who filed a vaginal mesh lawsuit, “They tested this on 12 rats, 16 rabbits, four sheep and, by their own researcher’s admission, the next living being this product went into was women.”
The FDA also continued to approve new vaginal mesh products that were “similar” to Boston Scientific’s ProteGen vaginal mesh, which was recalled due to safety concerns.
Vaginal mesh is now re-classified as a “high-risk” medical device. This means that manufacturers must conduct safety studies to keep vaginal mesh products on the market. The FDA also ordered 31 manufacturers to conduct three-year safety studies. Instead of conducting the studies, Johnson & Johnson voluntarily recalled all four of its vaginal mesh products.
Vaginal Mesh and FDA Safety Warnings
The FDA has received thousands of reports of serious complications caused by vaginal mesh. Because these reports are voluntarily submitted, they likely under-represent the total number of women who have been injured by vaginal mesh. The FDA has issues two safety warnings:
- October 20, 2008 — FDA published a Public Health Notification to warn that they had received more than 1,000 reports of vaginal mesh side effects.
- July 13, 2011 — FDA published a Safety Communication Update to warn that they had continued to receive thousands of reports of serious side effects, and these complications were “not rare.”
The FDA has never forced manufacturers to recall vaginal mesh. Some manufacturers have voluntarily stopped selling the devices, claiming the decision was prompted by declining sales and not safety concerns.
Vaginal Mesh MDLs
More than 30,000 vaginal mesh lawsuits are now pending in a federal Multi-District Litigation (MDL). Most of the lawsuits are centralized in West Virginia before Judge Joseph R. Goodwin:
- C.R. Bard, MDL No. 2187: More than 4,000 lawsuits filed.
- American Medical Systems, MDL No. 2325: More than 8,600 lawsuits.
- Boston Scientific, MDL No. 2326: More than 5,200 lawsuits.
- Johnson & Johnson, Ethicon, MDL No. 2327: More than 8,400 lawsuits.
- Coloplast Corp, MDL No. 2387: More than 680 lawsuits.
- Cook Medical, MDL No. 2440: 42 lawsuits.
For a list of types of vaginal mesh and manufacturers, click here.
Vaginal Mesh Side Effects
The FDA has warned that serious vaginal mesh side effects are “not rare.” The most common side effect is vaginal mesh erosion. Over time, the mesh can erode tissues and perforate the colon, vagina, bladder, or blood vessels. This often requires corrective surgery, but even surgery may not be able to correct permanent side effects, such as scarring, nerve damage, and pain.
Side effects of vaginal mesh include:
- Vaginal Mesh Erosion
- Chronic pelvic pain
- Pain during sexual intercourse
- Perforation of bladder, blood vessels, intestines, or vagina
- Shrinkage of mesh, which can cause shortening of the vagina
- Disfigurement of the vagina
- Severe scarring due to multiple surgeries
- Infection, which may be life-threatening or disfiguring
- Bleeding, vaginal discharge
- Recurrent incontinence or organ prolapse
- Inability to have sexual intercourse
- Emotional damage
- Decreased quality of life
- And more
Do I have a Vaginal Mesh Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Texas vaginal mesh lawsuit review.