Memphis, TNNow that trial dates have been set for the first Avaulta mesh lawsuit, attorneys and critics of the Bard Avaulta mesh implant are waiting to see how many more lawsuits will be filed. So far approximately 600 federal Avaulta lawsuits have been filed, but more could be on the way.
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.
On the same FDA communication, the agency noted that it was not clear that the transvaginal pelvic organ prolapse mesh was any more effective than the traditional non-mesh repair, but that it may come with greater risks. Furthermore, as of October 20, 2008, the FDA had received more than 1,000 reports of complications linked to the surgical mesh devices. From January 1, 2008 through December 31, 2010, the FDA received 2,874 reports of complications.
"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.
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