Johnson and Johnson (J&J) continued the sale of its Gynecare Prolift transvaginal mesh implant despite a 2007 letter from the Food and Drug Administration directing them to halt sales until the FDA further reviewed the product. J&J determined that their product was “substantially equivalent” enough to another product it already had on the market, so it simply continued to sell the device despite the FDA’s warning.
The FDA eventually cleared the device about a year later; however, this does not bode well for J&J who already faces lawsuits regarding their transvaginal mesh implants. The FDA did not sanction J&J because they later complied with the FDA’s instructions to complete a new application for the device, but many believe this kind of brazen disregard for the FDA’s direct orders indicates the challenge the FDA faces when it comes to enforcing its regulations on major pharmaceutical companies.
Thousands of women have experienced severe complications from the transvaginal mesh implants including recurrence of prolapse or incontinence, severe pain, erosion of the mesh, and infection. Oftentimes, these complications require women to undergo additional painful and costly surgeries. California defective device attorneys currently represent women across the United States facing such complications from these transvaginal mesh devices.