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Latest News on Transvaginal Mesh
The national, nonprofit consumer advocacy organization Public Citizen which is based in Washington, D.C. is urging the FDA to recall transvaginal surgical mesh.
According to the Public Citizen media alert, the consumer advocacy group is asking the FDA to ban the marketing of all currently available non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP, to order the manufacturers of these products to recall them, and to require that any future versions be classified as a class III medical device and be subject to more stringent approval requirements.
Some of these requirements would include mandatory testing in well-designed studies with human subjects to assess whether transvaginal surgical mesh is safe and effective before being marketed for widespread clinical use.
Transvaginal Surgical Mesh Recall
The national, nonprofit consumer advocacy organization Public Citizen which is based in Washington, D.C. is urging the FDA to recall transvaginal surgical mesh.
On July 13, the FDA issued a safety announcement stating that serious complications associated with transvaginal repair of POP are “not rare” and it is “not clear that transvaginal POP repair with mesh is any more effective than traditional transvaginal surgery without mesh … and may expose patients to greater risk.”
Why would anyone prefer transvaginal mesh over a safer method? According to the Public Citizen, transvaginal mesh doesn’t have noteworthy benefits and also has high rates of serious complications, which may or may not be able to be fixed with additional surgery.
