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How Safe Are Transvaginal Mesh Products Such As Avaulta Mesh?

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Dallas, TXAs lawsuit after lawsuit regarding transvaginal mesh—including the Avaulta mesh--are filed, women are asking how safe the products really are. A recent award in an Avaulta lawsuit suggests even the courts agree the Bard Avaulta mesh is not as safe as patients were led to believe.

That lawsuit saw a jury award $5 million to Christine Scott and $500,000 to her husband in July 2012. Scott filed her lawsuit after eight procedures and nine revision surgeries—used to attempt to fix problems caused by the mesh—and after doctors determined they could not safely remove the two mesh products that were implanted. Scott's husband was awarded $500,000 because damage to her body was so extensive she is unable to have sexual intercourse.

An attorney for C.R. Bard, maker of the Avaulta mesh, has said they will appeal the decision. Bard was held 60 percent responsible for Scott's injuries while a doctor was also found partially responsible. According to Businessweek (7/25/12), the jury found that Bard knew or should have known that the doctors who implanted the devices might not be aware of the risks associated with the mesh products.

Bard faces numerous lawsuits alleging its transvaginal mesh products were unsafe and improperly tested. There are reportedly five multidistrict litigations set up with a sixth in the works.

The US Food and Drug Administration (FDA) issued a warning on July 13, 2011, about serious complications associated with transvaginal placement of surgical mesh. At the time, the FDA noted that the use of transvaginal mesh for repair of pelvic organ prolapse (POP) was an area of continuing serious concern. The 2011 warning was an update of a 2008 warning in which the FDA called serious complications associated with transvaginal mesh "rare."

"The FDA is issuing this update [in 2011] to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare [bold in original]… Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk."

From 2005 through 2008, the FDA received almost 4,000 reports of complications associated with the use of transvaginal mesh for POP or stress urinary incontinence (SUI). Among the complications were erosion of the mesh through the vagina, "the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh," the FDA reported (7/13/11; italics in original). Mesh contraction was another serious complication. Side effects associated with the adverse events include severe pelvic pain and painful sexual intercourse. In some cases, such as with Christine Scott, even multiple surgeries and procedures do not resolve the issues.

The Scott lawsuit was Scott v. Kannappan, S-1500-CV-266034-WDE, Superior Court for Kern County, California.

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