Thousands of women who have received transvaginal mesh surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are now living a nightmare, thanks to debilitating pain, bleeding, infection and other serious complications. According to the Sun-Sentinel, many of the women injured by transvaginal mesh claim the conditions that led to their surgeries were nothing compared to the pain and suffering they are experiencing now.
“It’s ruined my life,” Susana Franklin, 54, a Florida mother of two told the Sun-Sentinel.
According to the report, Franklin had transvaginal mesh implanted in 2007 to treat stress urinary incontinence. She has since been forced to undergo four surgeries to remove eroding pieces of mesh from her body. Franklin also told the Sun-Sentinel that she is no longer able to be intimate with her husband, and she worries her marriage is at risk. Franklin is now suing American Medical Systems, the manufacturer of the transvaginal mesh device she received.
“If you put it on a scale of 1 to 10, [my original problem] was a 10. Now it’s over 100. My quality of life will never be the same,” Franklin told the Sun-Sentinel. “I don’t want anyone else to have to go through this. If I can share what I’ve gone through, people would think twice before getting this procedure that may not be necessary.”
Transvaginal Mesh Background
As we’ve reported previously, thousands of women have received transvaginal mesh devices during surgeries to treat POP and SUI. The implants are manufactured by a number of companies, including:
- American Medical Systems: Sold under the names Elevate, Perigee and Apogee
- Boston Scientific: Sold under the names Advantage Transvaginal Mid-Urethral Sling System, Pinnacle Posterior Pelvic Floor Repair Kit, Obtryx Transobturator Mid-Urethral Sling System, Polyform Synthetic Mesh, Prefyx Mid U Mesh Sling System, Prefyx PPS System, Uphold Vaginal Support System
- C.R. Bard, Inc.: Sold under the names Avaulta, Pelvisoft BioMesh, Pelivicol Acellular Collagen Matrix, Pelvitext, and Pelvilace
- Johnson & Johnson/Ethicon: Sold under the names Gynecare, Gynemesh, Gynecare Prolift, Gynecare Prolift+M, Gynecare Prosima and Gynecare TVT
The U.S. Food & Drug Administration (FDA) allowed transvaginal mesh implants to be approved via its 510 (k) approval protocols, meaning the devices didn’t need thorough clinical human trials to prove their safety before they were put on the market. Manufacturers only needed to show a product was “substantially equivalent” to another already approved by the agency. However, the FDA has been conducting a safety review of transvaginal mesh since 2008, after reports of complications linked to the products increased. This past January, the FDA asked transvaginal mesh manufacturers to conduct post-market safety studies of their products. The agency is now considering moving transvaginal mesh for POP repair to a higher risk medical device category.
According to the Sun-Sentinel, issues with transvaginal mesh and other medical devices cleared through the 510(k) program have prompted some in Congress to call for a hearing to determine whether the FDA has been ineffective in protecting the public from defective products. Lawyers and other advocates for women injured by defective transvaginal mesh have called for a recall of such devices.
The FDA is now advising doctors to recognize that POP and SUI is usually “successfully treated” with fewer risks of complications without using mesh, the Sun-Sentinel said. Alternatives to surgical mesh include using stitches alone to support prolapsed organs, or the insertion of a removable “pressary” device to support the bladder neck in less severe cases. The FDA has also suggested that surgeons consider implanting the mesh abdominally, as that method carries far fewer risks of complications.
Transvaginal Mesh Lawsuits
Since the FDA issued its first transvaginal mesh warning in 2008, women throughout the country have filed suit against the makers of the devices, alleging the products caused serious and painful injuries. Plaintiffs further claim the device makers consistently underreported problems and withheld information about the complications associated with pelvic mesh products from federal regulators, doctors and patients.
Several hundred transvaginal mesh lawsuits that have been filed against American Medical Systems, Boston Scientific, C.R. Bard and Johnson & Johnson are currently pending in a multidistrict litigation in federal court in Charleston, West Virginia. The first bellwether trial in the West Virginia litigation, involving lawsuits against C.R. Bard, is scheduled to start on February 5, 2012. Bellwether trials will help determine how much responsibility the mesh manufacturers bear for plaintiffs’ injuries, and how much any damages are worth.
Both C.R. Bard and Johnson & Johnson are named in transvaginal mesh lawsuits in state court in Atlantic City, New Jersey. The first trial in that litigation, a case involving Gynecare Prolift made by Johnson & Johnson’s Ethicon unit, is scheduled to go to trial on November 5. American Medical Systems faces lawsuits in Delaware and Minnesota state courts over its Perigee, Apogee and Elevate surgical mesh products.