FDA Pulls Surgical Mesh for Pelvic Organ Prolapse From the Market
The FDA has ordered all manufacturers of surgical
mesh for transvaginal repair of anterior compartment prolapse (cystocele) to
stop selling their products immediately. According to the agency, the
manufacturers Boston Scientific and Coloplast have not provided sufficient
evidence that the benefits of these products outweigh their high, class III
risks, compared with transvaginal surgical tissue repair without the use of
mesh.
Women who have received transvaginal mesh for
pelvic organ prolapse (POP) should continue routine care. However, if symptoms
arise such as persistent vaginal bleeding or discharge, pelvic or groin pain,
or pain with sex, they should promptly inform their health care providers.
Patients planning a future prolapse procedure with transvaginal mesh require
alternative treatments.
“In order for these mesh devices to stay on the
market, we determined [in 2016] that we needed evidence that they worked better
than surgery without the use of mesh to repair POP. That evidence was lacking
in these premarket applications, and we couldn’t assure women that these
devices were safe and effective long term,” Jeffrey Shuren, MD, director of the
FDA’s Center for Devices and Radiological Health, stated in a news release.
Surgical mesh made of synthetic materials can be
found in knitted mesh or non-knitted sheets and are absorbable, non-absorbable,
or a combination of both. Animal-derived mesh are absorbable.
Source: Renal & Urology News
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