The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph R. Goodwin has scheduled the first trial for February 5, 2013.
The Bard Avaulta transvaginal mesh MDL was established in 2010. This past February, lawsuits against other pelvic mesh makers, including, Johnson & Johnson and American Medical Stems, were consolidated by the U.S. Judicial Panel on Multidistrict Litigation and transferred to Judge Goodwin’s courtroom. The complaints allege that transvaginal mesh products used in pelvic organ prolapse (POP) and stress urinary incontinence (SUI) repair surgeries caused women to suffer serious complications, including organ damage. The MDL’s bellwether trials will help determine how much responsibility the mesh manufacturers bear for plaintiffs’ injuries, and how much any damages are worth.
Transvaginal Mesh Background
According to Bloomberg, more than 75,000 women a year have transvaginal mesh devices implanted to treat SUI and POP. The U.S. Food & Drug Administration (FDA) has been conducting a safety review of transvaginal mesh since 2008. Last July, the agency said in a Safety Communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh products made by Johnson & Johnson and other companies from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. According to the FDA, even when women undergo surgery, sometimes multiple surgeries, to have defective mesh removed, complications continue because it is almost always impossible to completely remove the device.
Injuries attributed to the use of transvaginal mesh devices include
- Inflammation and infection
- Pain from mesh shrinkage
- Extrusion of mesh through the vaginal wall
- Pain during intercourse and urination
In January, the FDA asked transvaginal mesh manufacturers to conduct post-market safety studies of their products. The agency is considering moving transvaginal mesh for POP repair to a higher risk medical device category.
Transvaginal Mesh Lawsuits
In addition to the federal MDL, transvaginal mesh lawsuits are pending in various jurisdictions around the country. According to Bloomberg:
- Both C.R. Bard and Johnson & Johnson are named in transvaginal mesh lawsuits in state court in Atlantic City, New Jersey. The first trial in that litigation, a case involving Gynecare Prolift made by Johnson & Johnson’s Ethicon unit, is scheduled to go to trial on November 5.
- American Medical Systems faces lawsuits in Delaware and Minnesota state courts over its Perigee, Apogee and Elevate surgical mesh products.