surgical meshFDA Says More Surgical Mesh Studies Needed

An FDA panel found that pre-approval studies are needed for new surgical-mesh products used to treat pelvic-organ prolapse, as well as research on products already on the market. The safety of transvaginal mesh products are being questioned after more than 1,500 reports of adverse effects between 2008 and 2010. Currently, transvaginal mesh products can be approved without any new research. The are products used to treat pelvic organ prolapse, an often painful condition that affects thousands of women. The mesh …

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FDA Warns About Injuries from Surgical Mesh

A type of surgical mesh used in procedures for the treatment of severe incontinence, cases of prolapsed uterus, and other women’s health problems has been linked to serious, but rare, complications, according to the U.S. Food and Drug Administration. Since 2005, more than 1,000 reports of injuries have been received regarding several types of surgical mesh used to repair pelvic organ prolapsed and stress urinary incontinence. The mesh, inserted into the vagina, can cause infection, pain including during sexual intercourse, …

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