A group of Canadian women has filed a class action lawsuit against Johnson & Johnson alleging the company’s transvaginal mesh devices caused them to suffer serious, life-altering injuries. The transvaginal mesh lawsuit further alleges that Johnson & Johnson, along with its Ethicon, Inc. and Gynacare units, failed to adequately warn patients and physicians of the magnitude of the risk of serious side effects when using one of their transvaginal mesh products compared to alternative treatments.
Carol Kouyoumjian, one of the Canadian women involved in the lawsuit, recently told CTV.ca that she received a Johnson & Johnson transvaginal mesh device six years ago in order to treat stress urinary incontinence. The surgery did not cure her condition, but has left her with chronic leg pain.
“I woke up from surgery and the pain was absolutely unbelievable,” she said. “If the pain scale runs from 1-10, mine was a 12. My legs were literally vibrating.”
Kouyoumjian eventually lost her job as a nurse because she is no longer able to remain on her feet for hours at a time, CTV.ca reported. Her doctors have given her no choice but to live with her pain.
“I have been advised not to have it removed because over time, it becomes part of your body and that can cause many complications,” Kouyoumjian told CTV.com
Transvaginal Mesh Complications
Transvaginal mesh devices are used in the surgical treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The devices are inserted transvaginally, and act as a hammock to support sagging pelvic organs and muscles. This past July, the U.S. Food & Drug Administration (FDA) said in a Safety Communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh products like Gynecare Prolift from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. Injuries attributed to the use of transvaginal mesh devices include
- Inflammation and infection
- Pain from mesh shrinkage
- Extrusion of mesh through the vaginal wall
- Pain during intercourse and urination
According to the FDA, even when women undergo surgery, sometimes multiple surgeries, to have defective mesh removed, complications continue because it is almost always impossible to completely remove the device.
In the U.S., most of the transvaginal mesh devices currently on the market were cleared through the agency’s 510(k) fast-track approval process, which grants access to the market without much pre-market safety testing, based on the idea that the products were similar in design to a previously-approved device. However, the FDA is considering rescinding 510(k) approvals for transvaginal mesh devices used in POP repair, and has asked the makers of such devices to conduct safety studies of the products.
Johnson & Johnson Transvaginal Mesh Lawsuits
Johnson & Johnson now faces more than 550 U.S. lawsuits filed by women who allege they sustained serious injuries following surgery with the Gynecare Prolift vaginal mesh product to treat POP and SUI. Earlier it this year, it was learned that the Gynecare Prolift device was sold on the U.S. market for two years before Johnson & Johnson filed an application for its approval.
Lawsuits involving transvaginal mesh products made by Johnson & Johnson’s Ethicon and Gynecare units have been consolidated in a multidistrict litigation in the U.S. District Court for the Western District of West Virginia. Three other transvaginal mesh litigations involving products made by American Medical Systems, C.R. Bard and Boston Scientific are also pending in the same jurisdiction.