Johnson & Johnson continued to sell its transvaginal mesh product for nine months after the Food and Drug Administration (FDA) told the company to stop marketing the controversial device, court records show. This discovery could lead to higher awards in the more than 1,400 lawsuits filed against Johnson & Johnson’s Ethicon unit by women who say the mesh caused organ perforation, pain, scarring and nerve damage.
In a letter dated August 24, 2007, the FDA told Johnson & Johnson to stop sales of Gynecare Prolift until the agency could determine whether the device was “substantially equivalent” to other transvaginal mesh products on the market. The agency also cited “potential high risk for organ perforation” when inserted through the vagina for the repair of pelvic floor disorders.
Despite Johnson & Johnson’s clear violation of the Federal Food, Drug and Cosmetic Act, the FDA ultimately cleared the device in May 2008 without ordering sanctions.
Transvaginal mesh is a surgical mesh product used to repair common conditions such as pelvic organ prolapse and stress urinary incontinence. The mesh is inserted through the vagina to hold up organs that have dropped, or prolapsed, causing symptoms such as urinary incontinence, pain and general discomfort.
Last year the FDA warned that the products had been associated with a fivefold jump in deaths, injuries or malfunctions when inserted vaginally, and that for many women the benefits may not outweigh the risks. An FDA advisory panel was convened to review data on the devices, and consumer groups testified that the products were defective and needed to be banned. The FDA fell short of pulling the devices, opting instead to issue stronger warnings.
According to data from the FDA’s adverse event database, Johnson & Johnson’s Prolift device received 123 complaints from 2005 until the device won clearance in 2008. Last month, Johnson & Johnson announced it would stop selling the Prolift and three other vaginal mesh implants. The company said the decision to stop selling the products was based on “their commercial viability in light of changing market dynamics,” and not due to safety issues or lawsuits.