Avaulta Lawsuits Reportedly Filed

Albany, NYFor a patient, being told you have to have a device, such as the Avaulta mesh implanted in you can be daunting. No matter how well made surgical devices are, there is still a chance for something to go wrong. Now, Avaulta lawsuits have been filed, alleging patients who received the Bard Avaulta mesh implant suffered serious adverse effects caused by a defective mesh implant.

According to reports, the most recent lawsuit was filed on April 10 by Jill Dewey against C.R. Bard, maker of the Avaulta mesh. The mesh was reportedly implanted in August 2005 to treat a pelvic organ prolapse, but according to the lawsuit, the patient began suffering health problems, including physical pain, shortly after the mesh was implanted.

To be fair, the Avaulta mesh is not the only mesh device linked to serious side effects. According to the US Food and Drug Administration (7/13/11), "Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP [pelvic organ prolapse] as an area of continuing serious concern." Unlike many reports of side effects that are often referred to as "rare," the FDA took the step of warning patients that serious complications associated with surgical mesh are "not rare," a heightened warning from the FDA's previous stance.

The announcement came after a review of data from the FDA adverse events reports for surgical mesh devices. According to the FDA's news alert, from 2005 through 2007, the FDA received "over 1,000" reports of adverse events linked to the mesh devices. From 2008 through 2010, the FDA received an additional 2,874 reports of complications. The most frequent complications that resulted in reports to the FDA included "mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems." Many of the complications reported to the FDA required medical intervention including surgical treatment and hospitalization.

"The FDA's literature review found that erosion of the mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh," the FDA wrote (italics in original).

Furthermore, the FDA reported, the use of surgical mesh for pelvic organ prolapse or stress urinary incontinence did not improve results or quality of life compared with patients who received non-mesh repair. In other words, transvaginal mesh (which includes Avaulta) may not be as effective as other treatments and may have more risks.