Surgical Mesh: Vaginal and Hernia
Transvaginal Mesh Injury, Hernia Mesh Injury and Revision Surgery Complications
Transvaginal Mesh: Manufactured by Johnson & Johnson, Ethicon brand transvaginal mesh device is implanted as a result of pelvic organ prolapse or other abdominal issues. There may be transvaginal mesh devices from other manufacturers that warrant investigation. 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
Hernia Mesh: The use of mesh to repair hernias is now used in about 90% of the surgeries. Hernia mesh can be a permanent device or an absorbable mesh that dissolves over time. Hernia mesh is manufactured by some of the same companies that make transvaginal mesh.
If you experienced adverse outcomes following the use of any of these devices contact attorneys at Sheller, P.C. at 800-883-2299 or fill out a confidential form below.
- July 30, 2014: Sheller P.C. defective medical device attorneys are investigating complications and injuries resulting from the replacement (revision) surgery performed on women who had the defective transvaginal mesh from the manufacturers listed below.
- March 1, 2013: Reuters News and the Philadelphia Inquirer are reporting that a New Jersey jury ordered Johnson & Johnson to pay punitive damages of $7.76 million to a former nurse who blames its vaginal mesh implant for years of severe problems despite unsuccessful repair surgeries.
WHAT IS THE FDA WARNING?
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.”
In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.
WHAT ARE THE SYMPTOMS THAT MAY INDICATE YOU MAY HAVE VAGINAL MESH INJURY?
- 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.
WHAT ARE THE SYMPTOMS THAT MAY INDICATE YOU MAY HAVE HERNIA MESH INJURY?
- Pain, infection, recurrence, adhesion, obstruction, and perforation
- Flu-like symptoms that do not go away
If you don’t know which device you had implanted, call your healthcare provider or speak to us and we will work with your doctor. As with any potential medical situation, consult your healthcare provider immediately before taking any other action.
INFORMATION & 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
IF YOU OR ANYONE YOU KNOW HAS HAD A TRANSVAGINAL OR HERNIA MESH IMPLANTED AND EXPERIENCED PAIN, INJURY OR COMPLICATIONS OF ANY KIND, CONTACT OUR OFFICE TO PROTECT YOUR HEALTH NOW AND IN THE FUTURE. CALL 800-883-2299 OR FILL OUT A CONFIDENTIAL FORM BELOW.