Urinary implant sales stopped

Surgical mesh implants used to treat women's pelvic organ problems will no longer be sold by Johnson & Johnson following injury claims and lawsuits.

The company's Ethicon subsidiary sent a letter saying it is voluntarily withdrawing four products from the market over the next three to nine months.

The mesh is used to treat urinary incontinence cause by muscle weakening and a condition called pelvic organ prolapse or POP, in which organs fall and press against the vaginal wall.

"Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy," the New Brunswick, N.J., company said in a statement.

The four affected products are:

• Gynecare TVT Secur System.
• Gynecare Prosima Pelvic Floor Repair System.
• Gynecare Prolift Pelvic Floor Repair System.
• Gynecare Prolift + M Pelvic Floor Repair System.

Last year, the U.S. Food and Drug Administration said the implants were associated with higher rates of pain, bleeding and infection than traditional surgery with stitches.

Take note of complications: regulator to patients

Healthcare providers should "recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications," the FDA said last July.

Symptoms of complications include: 

• Abdominal and pelvic pain.
• Urinary problems (leakage, urgency, and frequency).
• Painful sexual intercourse.
• Vaginal scarring.
• Erosion of mesh, which is the most commonly reported problem.

In 2010, Health Canada said "patients should be aware of the possible need for additional surgical procedures that may not always fully correct some potential complications."

 In January, the FDA ordered J&J and five other companies to conduct rigorous studies to track the complication rates with their products over time.

"These companies know they will never be able to prove safety and efficacy of these devices in the studies mandated by the FDA in January of this year," said Lana Keeton, a Miami resident who has undergone 17 surgeries to remove mesh that was implanted in 2001. 

Keeton is the leader of a group called Truth in Medicine, formed to lobby the FDA on the risks of mesh.

Boston Scientific Corp., Covidien plc, CR Bard Inc. and American Medical Systems also manufacture pelvic mesh.