Surgical mesh implants are designed to treat pelvic organ prolapse and stress urinary incontinence. In 2008, the FDA cautioned that the use of vaginal mesh products may lead to complications but that such incidences are rare.
However, last July the FDA warned of a fivefold increase from 2008-2010 in women suffering pain and injuries after the vaginal mesh was inserted to treat pelvic organ prolapse. In September, an advisory panel agreed with FDA staff that the agency should reclassify mesh from moderate risk to high risk and require more studies to determine if it is safe and effective.
FDA officials added the order does not include all surgical mesh products.
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