Medical device giant Johnson & Johnson recently told a federal judge that it plans to stop sales of four of itstransvaginal mesh implants. The announcement by J&J’s Ethicon unit comes at a time when the company faces hundreds of lawsuits by women who say that these defective medical devices have caused them painful internal injuries.
Bloomberg News reports that J&J asked the U.S. Food and Drug Administration for four months to notify customers and physicians about its change in operations. The company plans on halting sales of its Prolift, Prolift+ M, TVT Secur and Prosima mesh devices, but plans to continue sales of its Gyencare Gynemesh, which can be used in the abdomen.
Surgical mesh devices are used to treat a condition called pelvic organ prolapse, which occurs when tissues in the pelvic region weaken, causing organs to slip. The surgical mesh serves to replace or support the weakened tissue, but many women have found that the mesh can slip or perforate organs. Failure of vaginal mesh implants can result in scarring, permanent tissue damage and extreme pain, among other symptoms.
Recently released documents indicate that the company rushed the medical devices to market without adequate testing. The FDA sent a letter to J&J telling it to halt sales of its vaginal mesh devices, but the company continued sales for up to nine months after the order.
“If a company knows the FDA tells them, ‘Don’t sell a device,’ they’re supposed to not sell it,” one plaintiffs attorney said. “It’s egregious that J&J was selling the device without clearance.”
“Companies know the FDA has little enforcement ability and scarce resources,” another plaintiffs attorney said. “Every woman in America who has been implanted with these devices absolutely should be outraged. They should be mad at the company because the company knew they could get away with it.”
Source: Bloomberg News, “J&J Tells Judge It Will Stop Sales Of Vaginal Implants,” Alex Nussbaum and Jef Feeley, June 5, 2012; Bloomberg News, “Johnson & Johnson kept selling vaginal mesh implants after warnings,” June 26, 2012