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Pharmalot reports that drug maker Johnson & Johnson will halt sales of several vaginal mesh implants that have been the subject of lawsuits in which women charge that the devices led to painful and debilitating long-term complications. Ed Silverman writes:
In an unexpected move, Johnson & Johnson’s Ethicon unit will halt marketing of four vaginal mesh implants that have been the subject of lawsuits filed by approximately 1,000 women who claim the products have caused serious internal injuries. The devices treat incontinence and pelvic organ prolapse in which internal organs slump into the vagina.
The decision involves four Gynecare products – TVT Secur; Prosima Pelvic Floor Repair System, Prolift Pelvic Floor Repair System and the Proflit MTM Pelvic Floor Repair System – and was disclosed in a pair of letters sent late Monday to judges overseeing different batches of lawsuits – a federal judge presiding over multi-district litigation in federal court in West Virginia and a state judge in New Jersey.
“Ethicon has no present intention to commercialize these products in the future, but it has requested that FDA allow it 120 days to cease commercialization. This time period would permit Ethicon to notify its customers, and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients,” the J&J unit wrote the judges.
We've written about the ordeals of mesh victims like Amy Gezon, here.
Last year, Gezon testified before an FDA advisory panel about her experiences with vaginal mesh and told me after the device was implanted: “I was in the most horrendous pain I’ve ever experienced...I finally ended up in the ER after expressing a desire to end my life just to escape the pain. If I knew one-tenth of the information out there in the literature…I would have never consented to this surgery.”
Before the advisory panel hearing, the FDA issued an alert on the serious, ongoing complications associated with mesh and noted that it's unclear whether the implants for prolapse offer any benefit over traditional surgery.
In early 2012, the FDA asked vaginal mesh manufacturers, including J&J, to conduct safety and effectiveness studies.
In his report, Silverman quotes a company spokesman saying the discontinued marketing of vaginal mesh implants is not a product recall:
An Ethicon spokesman writes to “stress that this is not a product recall. 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.”
Still, J&J has had its share of troubling product snafus recently, including, among others, the mysterious disappearance of o.b. tampons.
This program aired on June 5, 2012. The audio for this program is not available.
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