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A Fulton County, Atlanta woman is but one of several plaintiffs suing the makers of a medical device intended to treat pelvic organ prolapse. The personal injury and product liability lawsuit was filed against New Jersey-based C.R. Bard Inc. last month in U.S. District Court in Atlanta. The suit alleges that the company made a defective device, the Avaulta Plus Anterior BioSynthetic Support System, which caused serious injuries in patients.

The Fulton County woman, Anne McVay, was an avid runner. But, she discovered, much to her own embarrassment, that when she returned from her runs, her pants were soaked. However, the wetness wasn’t caused by sweat—rather, it was caused by urinary incontinence. McVay was diagnosed with stress urinary incontinence and pelvic organ prolapse nearly two years prior. She also experienced incontinence when she laughed, coughed, or sneezed. In fact, her vaginal wall had collapsed as a symptom of pelvic organ prolapse, which contributed to her incontinence.

When McVay found out from her doctor that there was a medical device that could help with her unsightly incontinence, she decided to have the Avaulta Plus Anterior BioSynthetic Support System implanted. However, within just a few weeks she experienced worse pain than before—including bleeding and discharge. Eventually, she underwent two more surgical procedures to have as much of the mesh device removed as possible. Now, McVay and the other female plaintiffs state that they were left with severe scarring and experienced “significant mental and physical pain and suffering and have sustained permanent injury and substantial physical deformity.” C.R. Bard has not commented on the pending litigation. The suit seeks unspecified damages.

One Comment

  1. Gravatar for JILL PAUL RN

    David, thanks for your enlightening article. These women have suffered extensively with the mesh implanted in their bodies which was meant to cure their pain and suffering, not enhance it. This is one of the reasons why we must get The Medical Device Safety Act 2009 passed and do it pronto. I encourage anyone who has been injured by a faulty medical device, or, has a family member injured by such a device, to join our ongoing petition at : and leave comments why this act should be passed by Congress/Senate. I also encourage those injured to email their respective Congressmen/Women & Senators to solicit their support for this very important bill. It is imperative that we are able to take the manufacturer's of faulty medical devices to court. They should be held accountable, responsible, and liable for their products. For goodness sakes, the car manufacturers' are held liable and here we are talking about the implantation of devices into our bodies. Should the medical device manufacturers' be held to a lessor standard? Thank you.

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