Transvaginal Mesh Products

Published on June 4, 2013 by Laurie Villanueva

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Over the past decade, transvaginal mesh products have been used to treat women suffering from such conditions as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). However, the implants have been named in a growing number of transvaginal mesh lawsuits alleging disturbing and long-lasting complications that are often difficult to repair through corrective surgery.

Thousands of women have already come forward to file claims over transvaginal mesh implants manufactured by such companies as C.R. Bard Inc., Johnson & Johnson’s Ethicon unit, American Medical Systems and Boston Scientific.

transvaginal mesh productsIt is noteworthy to add that many of the devices now under scrutiny by the U.S. Food and Drug Administration (FDA) and the medical community at large were able to receive approval without having to conduct any human safety testing beforehand. How can this be, you ask? Perhaps somewhat ironically, the implants were cleared through the FDA’s 510(k) program, which allows a product to bypass human testing for safety and effectiveness if its maker can prove it to be equivalent to another on the market.

Transvaginal Mesh Brands/Products

The following companies are facing a growing number of lawsuits over their transvaginal mesh brands:

American Medical Systems Inc. (subsidiary of Endo Pharmaceuticals):

  • Apogee Vault Suspension System
  • Elevate Prolapse Repair System
  • Apogee Vault Suspension System
  • Sparc Sling System
  • Monarc Sling System
  • Perigee System

Boston Scientific:

  • Uphold Vaginal Support System
  • Pinnacle Pelvic Floor Repair Kit
  • Advantage Fit Transvaginal Mid-Urethral Sling System
  • Solynx SIS Vaginal Sling System
  • Obtryx Transobturator Mid-Urethral Sling
  • Lynx Suprapublic Mid-Urethral Sling System
  • Prefyx PPS Pelvic Sling System

C.R. Bard Inc. (Avaulta Pelvic Mesh Products):

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

Ethicon Inc. (Gynecare Pelvic Mesh Products):

  • Gynecare Prolift Pelvic Mesh
  • Gynecare Prosima Pelvic Mesh
  • Gynecare Gynemesh
  • Prolene Mesh
  • Gynecare TVT Sling

In June 2012, Ethicon issued a sales suspension of the above pelvic mesh devices. While the products were taken off the market in the U.S., the company maintained its decision did not indicate a recall.

As of May 2013, approximately 8,000 vaginal mesh lawsuits were pending in U.S. courts. Claims against the above manufacturers allege the following injuries stemming from transvaginal mesh implants:

  • transvaginal mesh erosion
  • Pain
  • Urinary problems
  • Infection
  • Recurrence of prolapse and/or incontinence.
  • Bowel, bladder, and blood vessel perforation
  • Recurrence of prolapse and/or incontinence
  • Vaginal scarring
  • Pain during sexual intercourse

How to Start the Process of Filing a Transvaginal Mesh Lawsuit

If you received an implant manufactured by one of the above companies, and are now suffering extreme pain and discomfort, you may have a case against its manufacturer. Contact Bernstein Liebhard LLP for more information at .