Over 100,000 lawsuits have been filed by women who were injured by vaginal mesh. You may qualify for compensation if you were injured by vaginal mesh, pelvic tape, transvaginal tape (TVT), or a bladder sling. Severe side effects include infection, erosion, organ damage, chronic pain, additional surgery, and more.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting vaginal mesh induced injury cases and in all 50 states. If you or somebody you know has been diagnosed with a serious side effect, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
UPDATE: Ethicon TVT-O Sling Injury Lawsuit
June 2019 — A woman from Michigan has filed a lawsuit after she was injured by an Ethicon TVT-O transvaginal mesh sling. Click here to read more.
In February 2015, the federal judge overseeing more than 70,000 vaginal mesh lawsuits urged counsel to resolve the litigation, warning he was going to “kick it into high gear and ask that you do the same.” Since then, settlements have continued at a steady pace:
- January 2016 — $120 million settlement from Ethicon to resolve 2,000-3,000 lawsuits
- October 2015 — $457 million settlement from Boston Scientific for about 6,000 women
- September 2015 — $5 million settlement to one woman who was injured by the Ethicon Gyncare Prolift
- August 2015 — $200 million settlement from C.R. Bard for 3,000 cases (~$67,000 per case)
- April 2015 — $119 million settlement from Boston Scientific for nearly 3,000 cases
- October 2014 — $21 million settlement from C.R. Bard for 500 lawsuits involving Avaulta (~43,000 per case)
- October 2014 — $400 million settlement from Endo International for 10,000 lawsuits (~$48,000 per case)
- July 2014 — $180 million settlement from Covidien for 6,000 cases
- May 2014 — $830 million settlement from Endo and American Medical Systems for lawsuits involving Elevate, Perigee, and Apogee implants
- March 2014 — $16 million settlement from Coloplast for 400 lawsuits (~$40,000 per case)
- July 2013 — $54.5 million settlement from American Medical Systems for undisclosed number of cases
Before these big settlements, there were also several smaller settlements from Johnson & Johnson. The company resolved several cases just before they were set for trial in Missouri. The company also settled about 111 lawsuits involving ObTape. However, the company delayed settlements after claiming that “unscrupulous” individuals were asking women to lie about being injured by vaginal mesh to file a lawsuit.
Recent Jury Awards
- $13.5 million awarded to a woman injured by Ethicon’s Transvaginal Tape (TVT) implant that eroded through her vagina and required multiple revision surgeries.
- $12.5 million awarded to a woman who was injured by the Prolift pelvic mesh implant by a jury in Philadelphia ($5.5 million in compensation, plus $7 million in punitive damages)
- $100 million awarded by a jury in Delaware to a woman injured by the Boston Scientific Pinnacle and Advantage Fit implants, the largest-ever award to an individual in the litigation.
- $5.7 million awarded by a California jury to a woman injured by Etihcon Transvaginal Tape (TVT) Abbrevo.
- $18.5 million awarded to four women injured by Boston Scientific’s Obtryx Mid-Urethral bladder sling.
- $27 million awarded by a federal jury in Miami, Florida to four women who were injured by the Boston Scientific Pinnacle vaginal mesh.
- $34.6 million awarded to a woman injured by the Boston Scientific Obtryx (slashed from $73 million awarded by a jury in Texas)
- $3.27 million awarded to a woman who injured by the Ethicon TVT Obturator (TVT-O) bladder sling.
- $2.2 million awarded to a woman injured by the C.R. Bard Avaulta implant.
- $11.1 million jury verdict survives appeal. The plaintiff was injured by the Gynecare Prolift, in the second lawsuit to go to trial.
Studies Estimate 1 in 30 Implants Need Revision Surgery
In September 2015, a study published in JAMA Surgery warned that one in 30 women who get vaginal mesh to treat incontinence will need additional surgery within 10 years. The problem is that surgery to remove vaginal mesh does not always improve side effects like pain and incontinence, according to two other studies presented at the American Urological Association’s annual meeting.
Ethicon Lost or Destroyed Thousands of Critical Documents
In March 2015, activists demanded a criminal investigation into Ethicon’s destruction of documents. The company lost or destroyed hundreds of thousands of documents that could be critical for vaginal mesh lawsuits. The activists have created a website where whistle-blowers can submit tips.
Class Action Accuses Boston Scientific of Using Defective Materials
In January 2016, Boston Scientific was accused of illegally smuggling resin from China to make vaginal mesh, in a scheme likened to a “drug deal” by attorneys who filed a class action racketeering lawsuit. Plaintiffs say the company used questionable sources after their original resin supplier stopped selling it because it was not safe for permanent implantation in women.
FDA Reclassifies Vaginal Mesh as “High-Risk”
In January 2016, the FDA strengthened approval requirements for vaginal mesh and reclassified it as a Class III (“high risk”) medical device. The decision came nearly two years after the agency’s own experts recommended upgrading vaginal mesh from Class II to Class III. During that time, a petition to completely ban vaginal mesh was denied by the FDA. The agency also refused to temporarily suspend implants of the devices while studying safety risks.
FDA Safety Warnings
- October 2008 — The FDA published a warning after receiving more than 1,000 reports of serious side effects.
- July 2011 — The FDA published a Safety Communication after receiving thousands more reports of injuries. The agency warned that serious complications are “not rare” and the most common reported injury is erosion into the vagina.
Thousands of Lawsuits Centralized in MDL
In December 2012, federal judges centralized the litigation under Judge Joseph R. Goodwin in the U.S. District Court for West Virginia. He currently presides over more than 70,000 lawsuits involving seven manufacturers, each in their own Multi-District Litigtation (MDL)
List of Vaginal Mesh Lawsuits in Multi-District Litigation (MDL)
- C.R. Bard, MDL No. 2187
- American Medical Systems, MDL No. 2325
- Boston Scientific, MDL No. 2326
- Johnson & Johnson, Ethicon, MDL No. 2327
- Coloplast Corp, MDL No. 2387
- Cook Medical, MDL No. 2440
- Neomedic Pelvic Repair System, MDL No. 2511
- Mentor Corp. ObTape Transobturator Sling, MDL No. 2004 (resolved)
State Attorney Generals File Lawsuits
August 2016 — Attorney General Offices in Kentucky, Washington, and California have filed lawsuits seeking millions of dollars in penalties for violations of consumer protection laws. Johnson & Johnson is accused of deceptively marketing vaginal mesh and downplaying risk information. Click here to read more.
FDA Investigates Counterfeit Vaginal Mesh Sold by Boston Scientific
In April 2016, the FDA has opened a safety investigation into allegations that Boston Scientific sold vaginal mesh implants with resin that was counterfeited in China.
What is Vaginal Mesh?
Vaginal mesh is a medical device that is surgically implanted into a woman’s pelvis to treat Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). These two conditions are caused by weakened pelvic muscles, a common problem that affects hundreds of thousands of women. Transvaginal mesh is implanted into the center of the pelvis through incisions in the vagina. When placed in the pelvis, it acts like a hammock to support weakened pelvic muscles.
What is the problem?
The first vaginal mesh was created by Boston Scientific in 1996. It was called the ProteGen. Before the ProteGen, SUI and POP were treated with abdominal surgery or a device called a pessary. The FDA approved the ProteGen with a 510(k) application, which allows manufacturers of new devices to avoid conducting strict safety studies so long as their device is “substantially equivalent” to some other device that already has FDA approval. Boston Scientific’s 510(k) application cited hernia mesh as the “equivalent” device, although hernia mesh had never been used in urinary or gynecological procedures before.
Boston Scientific conducted a 90-day study of the ProteGen in rodents, and within two years, it was implanted in 17,000 women. In 1998, Ethicon gained approval for the Gynecare TVT based on a 510(k) application that cited the ProteGen as its “equivalent” device. Today, dozens of vaginal meshes can trace their design back to the ProteGen.
Unfortunately, the ProteGen was recalled in 1999 due to safety concerns. More than 500 lawsuits were filed by women who were injured. After this recall, the FDA continued approving new vaginal meshes that were “equivalent” to the ProteGen. Not surprisingly, many women with these “new” devices suffered the same fate as the women with the ProteGen — high rates of infection, erosion, and other debilitating complications.
Today, many lawsuits allege that vaginal mesh is defective, unsafe, and it was never adequately tested before it was implanted in hundreds of thousands of women. Many women are also angry at the FDA and manufacturers for failing to anticipate injuries in devices that were “equivalent” to a recalled device. In the first two lawsuits to go to trial, juries have agreed whole-heartedly and handed down multi-million dollar verdicts against manufacturers.
- Erosion into the vagina
- Perforation of intestines, bladder, vagina, or blood vessels
- Shrinkage of mesh
- Disfigurement of the vagina
- Nerve damage
- Pelvic pain
- Pain during sexual intercourse (dyspareunia)
- Recurrent urinary problems or pelvic organ prolapse
- Emotional trauma
- Decreased quality of life
- And more
Do I have a Vaginal Mesh Lawsuit?
The Schmidt Firm, PLLC is currently accepting vaginal mesh induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a side effect, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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