According to Bloomberg News (5/2/12), the first lawsuit will go to court in February 2013. That case could pave the way for more lawsuits, as information about the Bard Avaulta mesh—including the risk of side effects—is analyzed in court. So far, there has not been a recall of the Avaulta mesh. Instead, the US Food and Drug Administration (FDA) has issued warnings about various mesh products.
Transvaginal mesh products, which include the Avaulta mesh, are used to repair weakened or damaged tissue, especially that linked to pelvic organ prolapse and stress urinary incontinence. On July 13, 2011, the FDA issued a safety communication indicating that the use of surgical mesh for transvaginal repair of pelvic organ prolapse was of continuing serious concern. At the time, the FDA noted, "serious complications associated with surgical mesh for transvaginal repair of POP [pelvic organ prolapse] are not rare." That information was an update from a previous FDA communication that listed the risks as rare.
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"Although it is common for adverse event reporting to increase following an FDA safety communications, we are concerned that the number of adverse event reports remains high," the FDA noted (7/13/11). Among the most-reported complications were mesh erosion through the vagina, pain, infection, bleeding, organ perforation and pain during sexual intercourse. Some women who suffered adverse events after having the mesh implanted required further surgery to remove the mesh. The FDA reports, however, that in some women even surgery does not resolve the problem.