Controversial mesh implants for women are taken off the market
Johnson and Johnson cites the overall negative publicity is the reason behind the move
Reporter: Valerie Cavazos
TUCSON (KGUN9-TV) - Controversial surgical mesh implants are being taken off the market. Johnson and Johnson plans to phase out a few of its mesh products over the next four months. The mesh is used to treat pelvic collapse in women.
KGUN 9 reported the controversy surrounding these implants on May 9th. After a raft of lawsuits were filed against Ethicon, the Johnson and Johnson unit that makes the devices, the company decided to stop selling the mesh implants and notified the FDA.
We contacted the FDA and received this emai from the Public Affairs Office:
"Ethicon notified the FDA on May 10 of their intent to stop commercializing GyneCare Prolift and GyneCare Prolift+M. The FDA is reviewing the information provided by Ethicon and will respond to the company directly."
The FDA reported last year that 10 percent of women experienced erosion or exposure of the mesh within a year of having the mesh implanted. More than half of these women required follow-up surgery to remove the mesh.
Reports say Ethicon has asked the FDA for four months to phase out the product to give patients and hospitals enough time to find alternative treatments.
KGUN9 contacted personal injury lawyer Brian Marchetti, whose firm has met with more than 150 women in Southern Arizona about alleged complications from mesh products. "Johnson and Johnson was one of the larger manufacturers and it's roughly half of the pelvic organ prolapse kits that we've seen are Johnson and Johnson," said Marchetti.
The FDA sent letters in January to 35 manufacturers of surgical mesh implants, ordering new safety studies. Marchetti says it's too early to tell the impact of Johnson and Johnson's move to phase out the mesh products, but he said, "word on the street is that other manufacturers may follow." Other manufacturers of pelvic mesh include Boston Scientific Corp., Covidien plc, CR Bard Inc. and American Medical Systems.
According to Reuters, a Johnson and Johnson spokesman says the company is phasing out its product because of the negative overall publicity about pelvic mesh devices -- not because of the lawsuits against the company.