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F.D.A. Orders Surgical Mesh Makers To Study Risks

Tue, 01/10/2012 - 6:18am

The Food and Drug Administration issued an order requiring makers of implantable surgical mesh used to treat urinary incontinence in women to study its risks.

The move Wednesday by the agency is similar to one it took last year when it ordered producers of all-metal artificial hips to undertake patient studies. The mesh products and the hips belong to a class of implantable devices that manufacturers do not have to study in patients before they are marketed or closely follow in patients afterward.

Female incontinence is often caused by two conditions. One is called pelvic organ prolapse, in which muscles that support organs like the bladder weaken, allowing them to descend and press against the vaginal wall. The other, stress urinary incontinence, is also caused by muscle weakening.

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