Ethicon to stop selling certain vaginal mesh implants
Johnson & Johnson said its Ethicon division has informed the FDA and other regulatory bodies worldwide that it has decided to discontinue certain Gynecare vaginal mesh implants around the world.
Johnson & Johnson said its Ethicon division has informed the FDA and other regulatory bodies worldwide that it has decided to discontinue certain Gynecare vaginal mesh implants around the world.
The company said the decision was made after carefully considering a number of factors.
"On a global basis, these factors include the commercial viability of these particular 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," Ethicon said in a statement.
"This is not a product recall and Ethicon continues to have confidence in the safety and efficacy of these products. The 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 discontinuation process will be carried out over the next 3 to 9 months on a region-by-region basis. The following products will be discontinued: Gynecare PROSIMA Pelvic Floor Repair System, Gynecare PROLIFT Pelvic Floor Repair System, Gynecare PROLIFT + M Pelvic Floor Repair System, GYNEMESH M, and Gynecare TVT SECUR System. In addition to the discontinuation of these products, Ethicon said it plans to pursue an indication for use change worldwide on GYNEMESH PS, indicating it for abdominal (open or laparoscopic) use only.
The FDA has issued statements regarding the safety of transvaginal placement of surgical mesh dating back to October 2008, when the agency issued a public health notification and additional patient information on serious complications associated with transvaginally placed surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence. In a July 2011 update, the FDA indicated that "serious complications associated with surgical mesh for transvaginal repair of POP are not rare."
In January 2012, the FDA ordered postmarket surveillance studies by manufacturers of urogynecologic surgical mesh devices. The agency issued 88 postmarket study orders to 33 manufacturers of urogynecologic surgical mesh for POP and 11 postmarket study orders to seven manufacturers of single-incision mini-slings for stress incontinence.
At the time, the agency also said it was considering recommending that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse be reclassified from a class II to a class III high-risk product. According to an FDA statement, the potential change was based on assessment of Medical Device Reports submitted to the FDA, evaluation of the published literature, and a September 2011 Obstetrics-Gynecology Devices Panel meeting held regarding mesh.
Ethicon said it will continue to offer safe and effective treatment options for women suffering from pelvic disorders, including GYNEMESH PS for abdominal pelvic organ prolapse repair, the company’s full line of TVT products for the treatment of stress incontinence, and its existing products for the treatment of adhesions and abnormal uterine bleeding.
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