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Product Recalls

Urgent: FDA Warns Against Use of Transvaginal Mesh

On July 13, 2011, the Food and Drug Administration (FDA) issued an urgent public notice advising patients and their healthcare providers to consider alternatives to transvaginal mesh (TVM). The advisory also noted that the FDA will be meeting to discuss a potential ban on the mesh. The FDA was prompted to issue this warning after receiving more than 3,875 injury reports associated with the mesh, three of which involved fatalities, from 2005 to 2010.

TVM is a medical device implanted surgically to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), conditions that may occur after childbirth and pregnancy. In 2010, more than 75,000 women had vaginal mesh surgery to repair POP.

Recent research shows that at least ten percent of women who have received TVM implants suffer from mesh erosion within 12 months of surgery and more than half of these patients require additional surgery to remove the mesh following complications.

Also commonly referred to as a bladder sling, transvaginal mesh was used in more than 75,000 procedures to repair pelvic organ prolapse last year. In recent years, a growing number of doctors have been recommending the surgical mesh products, despite no evidence to suggest it provides any advantages over other available methods of treating pelvic organ prolapse.

Complications from transvaginal mesh have been associated with products made by a number of different manufacturers, including C.R. Bard, American Medical Systems (AMS), Boston Scientific, Johnson & Johnson and others.

The FDA first issued a warning about transvaginal mesh problems in October 2008, indicating that hundreds of people had reported experiencing problems with products made by at least nine different manufacturers. In addition, a study published earlier this year found a high risk of problems with all transvaginal mesh implants.

Many women who have experienced painful and debilitating injuries, are now considering transvaginal mesh lawsuits against the manufacturers for failing to adequately research their products or warn about the risk complications.

Last year, Johnson & Johnson reportedly settled a number of lawsuits over Mentor ObTape vaginal mesh, which had been linked to a complication rate as high as 17% to 18%. The Mentor ObTape bladder sling was removed from the market in 2006, only three years after it was introduced.

Over the past year, a growing number of Bard Avaulta mesh lawsuits have also been filed by women who have experienced problems. All of the complaints involve similar allegations that C.R. Bard’s Avaulta Anterior and Posterior BioSynthetic Support System, which was introduced in 2007, was negligently designed and that the company failed to warn patients of possible complications that can result in severe pain and disfigurement.

Other suits over transvaginal mesh products have been filed by women who received the Ethicon Gynecare Gynemesh, Prolene Mesh, Prolift and TVT sling products, as well as the AMS Sparc, Elevate, Apogee, Perigee and Monarc sling systems.

If you or someone you know has suffered damage from the use of a vaginal mesh during surgery, please contact Avera & Smith. You may speak to our nurse or a female attorney on our staff if you wish.