Johnson & Johnson is stopping sales of surgical mesh products that aimed to relieve the intense pelvic pain of thousands of women but resulted in numerous reports of injury and several deaths.
The decision is the latest action by the health care giant tackling a range of problem products — such as bottles of children’s Tylenol and other popular over-the-counter medicines, as well as some contact lenses and certain hip implants — that the company recalled due to manufacturing problems.
The surgical meshes, sold by J&J’s Ethicon unit, are among a class of products made by various companies whose safety and effectiveness the Food and Drug Administration warned about in 2008. J&J’s meshes are also subject to hundreds of product-liability lawsuits, according to a May securities filing by the company.
The company is planning to halt sales world-wide of Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift+M mesh products, an Ethicon spokesman said. The company has asked the FDA to allow it to keep selling its Gynecare Gynemesh product, but for insertion through the abdomen only, rather than the vagina as is also currently allowed, the spokesman said.
J&J will be stopping sales over the next three to nine months, with the goal of completing the process by the first quarter of 2013, the company spokesman said.
“This is not a product recall and we continue to have confidence in the safety and efficacy of these products. 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 Ethicon spokesman said in a statement.
The FDA didn’t have an immediate comment.
Doctors began using surgical meshes in the 1970s to treat severe cases of a painful condition in which organs like the bladder, uterus or bowel drop down and protrude into a woman’s vagina after childbirth. Initially, doctors inserted the meshes through the abdomen to support the organs. In the 1990s, gynecologists began inserting them through the vagina.
Between 2008 and 2010, the FDA received some 1,500 reports of adverse events for meshes made by J&J and other companies. In 2008, the FDA warned about complications including erosion, pain and urinary problems.
Reported June 6, 2012 in the Wall Street Journal
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