Warnings Added to Transvaginal Mesh Labels

For approximately 15 years, transvaginal mesh (TVM) products have been used worldwide, usually to treat pelvic organ prolapse (POP) and stress urinary incontinence problems in women. Since that time, 27 clinical studies have shown that one in 12 women have suffered TVM complications. It has been estimated that 50 percent of women will have some degree of POP by the age of 50 and more than 10 percent will require surgery by the age of 80.

Boston Scientific, which includes five brands of TVM slings, has added safety labels stating the pelvic meshes and slings are considered permanent implants and that removal can be complicated or impossible reports LawyersandSettlements.com.

The U.S. Food and Drug Administration (FDA) warned doctors twice. Once in 2008 and again, in 2011, with a stronger warning regarding mesh treatment for POP.

Johnson & Johnson (J&J) alone sold 787,322 of its Ethicon TVM devices between 2008 and 2014 in the United States. Approximately 42,000 were sold in California, resulting in its latest lawsuit. One lawsuit against J&J is for alleged false advertising and deceptive marketing of its transvaginal mesh products, reports LawyersandSettlements.com.

American Medical Systems (AMS) is facing about 46,000 lawsuits. AMS was the first TVM manufacturer to resolve its product liability cases and closed its facility that sells the devices.

Boston Scientific is facing over 36,000 liability cases and their warning has come too late for too many women. A number of women have reported that their doctors said the mesh was the best thing since sliced bread and their problems “are all in your head.” Some patients blame their surgeons for mesh complications and were generally insufficiently informed about the risks involved with transvaginal mesh products.

The number of TVM lawsuits has now increased to more than 100,000 in the United States and over 135,000 worldwide, LawyersandSettlements.com reports.

This entry was posted in Defective Medical Devices, Health Concerns, Transvaginal mesh. Bookmark the permalink.

© 2005-2020 Parker Waichman LLP ®. All Rights Reserved.