Posted in Defective Medical Devices on July 18, 2012
Johnson & Johnson’s Ethicon division recently announced that it plans to stop selling four types of vaginal mesh implants.
The announcement comes after approximately 600 women in California and across the country filed lawsuits after receiving defective implants.
An Ethicon spokesman told reporters that the company will stop worldwide sales of four types of mesh implants: Gynecare Prolift, Prolift+ M, TVT Secur and Prosima.
The Food and Drug Administration recently found that the company sold the Prolift mesh implants for three years without the required regulatory approval.
Vaginal mesh implants are used to treat pelvic organ prolapse, a condition which occurs when weakened tissues allow organs to slip out of place. There is evidence that Johnson & Johnson mesh devices were inadequately tested before they began being marketed to patients. Many mesh implants shrink or slip, causing patients to experience severe pain and organ damage.
FDA regulators recently noted a five-fold spike in deaths, injuries and device malfunctions connected with vaginal mesh implants. Bloomberg News reports that an advisory panel recently recommended a reclassification of mesh implants as “high-risk” medical devices that need human testing in order to be sold.
Johnson & Johnson plans to phase out its vaginal mesh implants on a regional basis. The company has also asked a district court judge overseeing the vaginal mesh personal injury litigation to give the company 120 days to notify patients and hospitals of its decision. The company plans on continuing to sell some mesh implants for abdominal uses according to a spokesman.
Source: Bloomberg News, “J&J Tells Judge It Will Stop Sales Of Vaginal Implants,” Alex Nussbaum and Jef Feeley, June 5, 2012