Johnson & Johnson Halts Transvaginal Mesh Sales
Johnson & Johnson’s Ethicon unit announced on Tuesday, June 5, 2012, that it would discontinue sales of transvaginal mesh products Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift+M. The Wall Street Journal reports that Johnson & Johnson “will be stopping sales over the next three to nine months, with the goal of completing the process by the first quarter of 2013.”
Surgical mesh products intended for vaginal insertion, including Johnson & Johnson’s Gynecare line, have attracted watchdog criticism as thousands of patients who have received vaginal mesh implants report severe medical complications. The transvaginal mesh has also resulted in several deaths due to complications.
Transvaginal mesh products are sold without clinical testing due to a loophole in U.S. Food and Drug Administration device approval policy. Device manufacturers can push a new product through the approval process without providing clinical testing data if the new product can be deemed “substantially equivalent” to an older, already-approved device. According to Consumer Reports, vaginal mesh kits sold to treat pelvic organ prolapse in women were approved because of their similarity to an “earlier mesh used to repair abdominal hernias that was sold as long ago as the 1950s, even though the kits were designed to be used in a different part of the body and inserted laparoscopically, not through open surgery.”
On April 17, 2012, the law firm of ROCHON | GENOVA LLP issued a national class action on behalf of Canadian women who were implanted with transvaginal mesh products (“TVM products”) manufactured and distributed by Johnson & Johnson and its related companies that were involved in the manufacture and distribution of these products in Canada. For information please contact: