Johnson & Johnson Halting Sales of Transvaginal Mesh After Reports of Thousands of Injuries
The four devices under scrutiny for potential lawsuits are:
- TVT Secure
- Prosima Pelvic Floor Repair System
- Prolift Pelvic Floor Repair System
- and Prolift MTM Pelvic Floor Repair System
Over 1,000 lawsuits have already been filed by injured women and the FDA has received thousands of reports of adverse side effects and injury. J&J told a federal judge in West Virginia it intends to stop selling the four implants after being sued by more than 600 women who say the products caused internal injuries (Bloomberg News).
Bloomberg also reports that an FDA "report last year found a fivefold jump in deaths, injuries or malfunctions tied to vaginal mesh for organs that slump, or “prolapse,” because of weakened support. Two months later, an advisory panel urged the FDA to reclassify the devices as “high-risk” products needing human testing."
Several things are affecting what might end up as a voluntary recall of these devices. As more information becomes available, we will post on this page.
- mesh becoming exposed or protruding out of the vaginal tissue
- pain during sexual intercourse
- urinary problems organ perforation from surgical tools
Women may need more surgery because of mesh-related complications. In a small number of women, repeat surgery may not fix the problem.
As with any potential medical situation, consult your healthcare provider immediately before taking any other action.
Information and Resources
Jury Awards Woman $7.76 Million in Damages for J&J Mesh, Reuters, March 1, 2013
A Bad Day for Vaginal Mesh Implants, The Philadelphia Inquirer, March 1, 2013
J&J Tells Judge It Will Stop Sales of Vaginal Implants, Bloomberg News, June 5, 2012
J&J to Halt Sales of Vaginal Mesh Implants, Pharmalot (Pharma Insider News Source) June 4, 2012
Johnson & Johnson's Prolift Device Was Sold for Three Years Without Proper Clearance From Regulators, New Jersey Star Ledger via Bloomberg News, March 21, 2012
FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, July 13, 2011