A Surge in Avaulta TVM Claims and Reclassification, Lawyers and Settlements, October 6, 2011

Oct 6th, 2011 | By | Category: Legal News, Media Reports

Lawyers & Settlements reports more than 600 lawsuits have been filed against two of the largest synthetic surgical mesh manufacturers – Johnson & Johnson and C.R. Bard Inc. The Avaulta litigation was consolidated as part of multi-district litigation (MDL) in October 2010 in the Southern district of West Virginia in US District Court.

Bard representatives told an FDA panel in September that the mesh is safe and effective and injuries are rare. More than 75,000 women receive surgical mesh every year to treat pelvic organ prolapse and incontinence. It never went through the FDA pre-market approval process yet is a permanently implanted medical device.

Bard Avaulta Complications

Ever since 2005, the FDA has been collecting reports of complications with surgical mesh. They include erosion through the vaginal tissues and wall which required repeated surgeries to remove the mesh, extrusion, hardening of the prolene material, infection, nerve and tissue damage, infection and chronic pain.

At last report, the FDA said there was a five-fold increase in adverse side effects between 2008 to 2010 – 1,503 reports. However, the adverse database of the FDA is little known and likely represents just a fraction of actual events.

Mesh manufacturer, Bard, is based in Georgia and produces medical devices and several types of mesh including:

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

 

 

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.