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Transvaginal Mesh Lawsuit Update: FDA Rejects Public Citizen’s Petition to Ban and Recall TVM Devices

medical-devicesThe U.S. Food and Drug Administration (FDA) has issued its Final Response rejecting a 2011 Petition Filed by Public Citizen, a non-profit consumer advocacy organization, calling for a total ban and complete recall  of the Transvaginal Mesh® (TVM) devices used for the treatment of pelvic organ prolapse (POP).

Public Citizen also petitioned the FDA to reclassify the mesh products as a Class III device and to order the premarket approval (PMA) of the product. Public Citizen raised concerns about the “unreasonable and substantial risk of illness or injury” associated with transvaginal mesh devices, which have been used in approximately 67,500 surgical procedures. Public Citizen states that these products offer no clinically significant benefit and have high rates of serious complications, many of which require surgical intervention or inflict permanent life-altering harm.

The FDA denied Public Citizen’s requests for a ban and recall of these transvaginal mesh devices, but stated that it is taking steps to address the concerns outlined in the Petition. In September 2011, the FDA referred to the Obstetrics and Gynecological Devices Panel a proposed draft to reclassify the POP mesh products from a Class II device to a Class III device. The Panel was under the consensus that the benefit and risk profile of transvaginal mesh devices was not well-established and determined that the surgical devices should be re-categorized to a Class III device. Accordingly, the FDA issued two proposed orders to reclassify the transvaginal mesh products as Class III devices and to require such devices undergo premarket approval.

Thousands of women allege they have experienced complications from these TVM devices, including device erosion, organ perforation, intense pain, inability to have sexual intercourse, infection, and the need to undergo multiple revision surgeries. As a result, the following Multidistrict Litigations (MDLs) have been formed to manage nearly 60,000 claims against the manufacturers of transvaginal mesh devices:

  • MDL 2327 – In re: Ethicon, Inc. Pelvic Repair System Products Liability Litigation:18,501 cases
  • MDL 2187 – In re: C.R. Bard, Inc. Pelvic Repair System Products Liability Litigation: 8,667 cases
  • MDL 2325 – In re: American Medical Systems Pelvic Repair System Products Liability Litigation: 17,901 cases
  • MDL 2326 – In re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation: 12,199 cases
  • MDL 2387 – In re: Coloplast Corp. Pelvic Support Systems Products Liability Litigation: 1,506 cases
  • MDL 2440 – In re: Cook Medical, Inc. Pelvic Repair System Products Liability Litigation: 213 cases
  • MDL 2511 – In re: Neomedic Pelvic Repair System Products Liability Litigation: 74 cases

If you or a loved one has experienced serious injuries as a result of a transvaginal mesh device, please contact one of our experienced attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297. We will confidentially evaluate your case for free and without any obligation.

 

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