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Avaulta Mesh: Attorney Update

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Newport Beach, CAThe first Avaulta transvaginal mesh bellwether trial against C.R. Bard has been set for February 5, 2013 by Chief Judge Joseph R. Goodwin in the U.S. District Court for the Southern District of West Virginia, where Bard cases have been consolidated. “The Avaulta transvaginal mesh claims are consolidated for discovery purposes,” explains attorney Brian Chase, of Bisnar & Chase Personal Injury Attorneys, LLP. “Ultimately each case is individual and if there isn’t a global Multi District Litigation [MDL] resolution, then the cases will get transferred back to their original trial courts and be tried as individual cases.”

Chase says that you can still file a claim against Bard and other transvaginal mesh manufacturers, such as Johnson & Johnson and American Medical Systems (AMS), in various state and federal courts. “But it is advantageous for plaintiffs to have their claims consolidated because you don’t want 50 judges with hundreds of different rulings,” he says, which would simply take more time and cost.

According to Bloomberg News there are about 600 cases alleging Bard mesh caused injury. Chase and his firm have more than 100 cases against various makers (there are about 31 manufacturers affected), most of which involve Bard and J&J. “We are seeing the same defects, regardless of the manufacturer,” says Chase. “The mesh problem in all these women is because of the polypropylene and it should never have been put on the market.”

Health professionals concur, and they have been voicing their concerns for the past few years. Medical expert and analyst Lana Keeton said that synthetic surgical mesh is a life-threatening device: “It is toxic, over-engineered and degrades during manufacture, shelf life and in the human body following surgical implantation." Back in 2010 Dr. Anne Weber criticized the mesh in the American Journal of Obstetrics & Gynecology (11/29/10). Finally in August 2011 the FDA determined that transvaginal mesh products were a high risk to patients and in January 2012 it required manufacturers to conduct studies related to organ damage and complications from TVM mesh.

Sadly, the FDA warnings came too late for thousands of women. So how did transvaginal mesh get past FDA scrutiny in the first place?

Chase says the problem goes back to 2005. “J&J was trying to get its vaginal mesh implant called Prolift on the market but it was never approved by the FDA,” he says. “When the drug company came up with another TVM device it said there was a predicate device on the market so their next device was fast tracked.”

(Johnson & Johnson is now facing lawsuits for at least five of its mesh products. When J&J’s Ethicon unit introduced the Gynecare Prolift device in March 2005, its annual report described the device as an “innovative and effective surgical option” for weakened pelvic muscles. It wasn’t until 2007, when the FDA required J&J to submit a so-called 510(k) application to review the Prolift, that concerns were raised.)

“The problem with all the mesh goes back to how it was first classified,” says Chase. “Avaulta mesh, like the other TVM mesh, was classified as a Class II device but it should have been designated Class III.

“The FDA places all medical products in one of three classes, depending upon how dangerous the product--whether it can produce serious complications and side effects. Class 1 products range from bandages to bedpans—anything that doesn’t require much scrutiny. The transvaginal mesh was categorized as Class II but I think it should be Class III.”

Some physicians continue to use transvaginal mesh as a treatment for women with incontinence and pelvic organ prolapse (POP). Many of these women believe the mesh should never have been approved. At the least, it should have been recalled by now.

Meanwhile, transvaginal mesh litigation progresses and the FDA continues its investigation.

Bard, based in Georgia, manufactures, distributes, and markets numerous medical devices. Brand names of Bard’s transvaginal mesh patches include:

• Avaulta Plus™ BioSynthetic Support System
• Avaulta Solo™ Synthetic Support System
• Faslata® Allograft
• Pelvicol® Tissue
• PelviSoft® Biomesh
• Pelvitex™ Polypropylene Mesh

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