Philadelphia, PAJohnson & Johnson has announced it is discontinuing sales of its Gynecare mesh products in the wake of allegations of Gynecare mesh side effects. The mesh complications, similar to those linked to other transvaginal mesh side effects, reportedly include mesh protrusion into the vagina and urinary problems.
According to The Wall Street Journal (6/5/12), Johnson & Johnson's Ethicon unit told the US Food and Drug Administration (FDA) in early May that it would discontinue the product. A company spokesperson noted, however, that the product was not being recalled and that Ethicon had confidence in the safety and effectiveness of the transvaginal mesh.
Affected by the decision are the Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift+M meshes. The mesh products will likely be fully discontinued by early 2013.
Transvaginal meshes are used to relieve stress urinary incontinence and pelvic organ prolapse. Recently, the US Food and Drug Administration (FDA) issued warnings about adverse events associated with transvaginal mesh products. Among the concerns were more than 2,800 reports of adverse events for transvaginal meshes (including products made by companies other than Ethicon).
On July 13, 2011, the FDA issued a Safety Communication alerting health care providers to the risks associated with transvaginal placement of surgical mesh. That communication warned, "serious complications associated with surgical mesh for transvaginal repair of POP are not rare." The FDA had previously classified such complications as rare.
"Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk," the FDA continued.
Between 2008 through 2010, the FDA received 1,503 reports of adverse events associated with pelvic organ prolapse repairs and an additional 1,371 reports associated with stress urinary incontinence repairs. According to the FDA, the most frequent complications for pelvic organ prolapse repair include, "mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems." Many of the reported problems required medical intervention, including surgical treatment.
In some patients, the FDA warned, even multiple surgeries will not resolve erosion of the mesh through the vagina, leaving the woman with permanent pain.
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