Johnson & Johnson and the Food and Drug Administration are finding themselves under a bit of scrutiny for pushing a product through approval that perhaps shouldn't have made the cut. It's called Gynecare TVT and it's a vaginal mesh used in treating incontinence and prolapsed pelvic organ issues. And it's allegedly causing serious issues for some women.
It all started with a vaginal mesh implant created by Boston Scientific called ProteGen. A few years after ProteGen was released, it was voluntarily recalled by Boston Scientific because of the reports the company was receiving about the implant causing discomfort, pain during sex and erosion of vaginal tissue. However, Gynecare TVT and other similar products made by other companies were put on the fast track through the FDA approval process via the 510(K) system which allows the FDA to approve things based on the previous approval of similar things.
Problem is, ProteGen's FDA approval was pulled while the other products were allowed to keep theirs. And now people are having issues with those as well.
“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, of Watertown, S.D. told ABCNews.com. "I wouldn't wish this on anyone."
Gross says her body is rejecting the mesh and causing urinary complications, constant pain and swelling. She's had a dozen surgeries and still there's mesh inside her; and she's dealing with side effects. Gross and more than 100 other women are suing J&J's Ethicon for negligence and defective product design. Today all of the implants' manufacturers face more than 600 lawsuits from affected women.
And J&J? They still maintain their mesh is safe. And we trust our babies to this company?