Johnson & Johnson (NYSE:JNJ) isn’t recalling its controversial transvaginal mesh products, but is pulling them off the shelves in response to the more than 600 women who have filed lawsuits claiming personal injury as a result of having receiving the implants.
The company continues to have "confidence in the safety and efficacy of these products," according to spokesman Matthew Johnson, but will stop marketing them in consideration of "the commercial viability of these products in competitive and declining worldwide markets, the complexities of the regulatory environments in which we operate, and the availability of other treatment options for women."
The decision wasn’t made based on any safety or efficacy concerns, Johnson told Bloomberg, and the company isn’t issuing any warnings for women with the mesh already implanted.
The FDA warned patients and physicians in July 2011 that the surgical placement of mesh to repair pelvic organ prolapse may expose patients to unnecessary risk without any apparent clinical benefit over safer options.
"There are clear risks associated with the transvaginal placement of mesh to treat POP," FDA devices deputy director Dr. William Maisel said at the time. "The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh."
Since then mesh makers, including C.R. Bard (NYSE:BCR) and Endo Pharmaceuticals Holdings (NSDQ:ENDP), have been the target of hundreds of lawsuits, citizens’ petitions, Congressional attention and an FDA probe.
Late last year 3 U.S. Senators probed Bard on its management of the clamor surrounding its transvaginal mesh devices as part of a larger investigation into medical device recalls. Early this year the FDA asked a total of 33 mesh-makers to conduct 3 years of safety and effectiveness trials, collect and review all existing data on the safety and efficacy of the devices and the conduct a total 88 postmarket surveillance studies.
Johnson & Johnson subsidiary Ethicon is now pulling the mesh products off the shelves worldwide, according to Bloomberg, and will notify its customers to find alternative treatments for their patients. The company will continue selling its Gynecare Gynemesh devices with a change in labeling.
"It is heartening that these unsafe products will no longer be sold," injury attorney Lexi Hazam of the law firm Lief Cabraser Hiemann & Bernstein said in prepared remarks. "The removal from the market of certain Gynecare mesh products comes after thousands of women have filed claims over the serious, often life-altering injuries they suffered due to these products."
