More than 100 women throughout the U.S. have filed suit against Johnson & Johnson’s Ethicon unit over injuries they allegedly sustained as a result of Gynecare Prolift transvaginal mesh. Gynecare Prolift transvaginal mesh lawsuits charge Ethicon with negligence, and claim that the device was defectively designed. Plaintiffs seek both compensatory and punitive damages.
Many transvaginal mesh products
The Gynecare Prolift device is just one of many transvaginal mesh products that have been named in lawsuits that allege injury following implantation of the devices during surgery to treat pelvic organ prolapse (POP). In addition to Johnson & Johnson, American Medical Systems, C.R. Bard and Boston Scientific have been named in similar legal claims.
Transvaginal mesh lawsuits claim women suffered a variety of complications, including mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The lawsuits further allege that transvaginal mesh complications have caused victims to suffer debilitating pain that is, in many cases, permanent.
In a safety communication released on July 13, 2011, the FDA reported that between 2008 and 2010, it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair.
The agency also noted that its review found that transvaginal POP repair with mesh does not offer any additional benefits over traditional non-mesh repair.
“It’s horrible. There are unknown amounts of the mesh still in me. I have extreme pain. It feels like the inside of my vaginal wall is on fire,” Linda Gross, 46, a plaintiff in a Gynecare Prolift lawsuit who received the implant in 2006, told ABCNews. “I wouldn’t wish this on anyone.”
Gynecare Prolift transvaginal mesh lawsuits
Gross and other plaintiffs in Gynecare Prolift transvaginal mesh lawsuits claim the device was not subjected to adequate testing before doctors began using it in POP surgery. Gross’ lawyer pointed out to ABC News that Prolift didn’t receive FDA clearance for POP until 2008, which he said means the device she and others received may have been sold without FDA clearance.
Like all other transvaginal mesh devices, Gynecare Prolift was approved for POP surgery under the FDA’s 510(k) approval process. This clearance protocol is reserved for “moderate risk” devices that are substantially equivalent to devices that have already been brought to market. 510(k) clearances do not require that medical devices undergo clinical trials involving humans be conducted before they are approved.
Transvaginal mesh devices for POP surgery be reclassified
Last month, FDA staff issued a report proposing that transvaginal mesh devices for POP surgery be reclassified and placed in the agency’s highest risk category, Class III.
This would mean that manufacturers could not utilize the 510(k) process, and would need to conduct human tests before applying to the FDA for approval. The same report also proposed requiring the makers of currently approved devices to conduct postmarketing studies to assess their safety and effectiveness in POP surgery.
However, the agency report did not propose recalling these devices while the studies are conducted, so they would be allowed to remain on the market.
Last week, during a two-day meeting to investigate the safety of transvaginal mesh in POP repair, a panel of FDA advisors backed the agency’s proposals.