Attorney Henry Garrard III of Georgia’s Blasingame, Burch, Garrard & Ashley, P.C, says that medical organizations are recognizing that the risks of the use of surgical mesh to treat pelvic organ prolapse outweigh any potential benefits for most patients.
Athens, GA (PRWEB) December 03, 2011
Garrard, managing partner of the Georgia product liability law firm of Blasingame, Burch, Garrard & Ashley, P.C., was referring to the joint opinion of the American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUS). The opinion recommends limiting the use of POP vaginal mesh repair “to high-risk women for whom the benefit may justify the risk.”
In a news release, a spokesman for the groups said that a significant number of women who have had surgery to implant the mesh have experienced permanent and life-altering problems.
These problems include pelvic pain and painful sexual intercourse due to the mesh eroding through the vaginal wall – some of the women have needed additional surgery, the spokesman said.
“I can’t offer a medical opinion, but based on the numerous problems with transvaginal mesh products that our law firm has observed, including the complications cited in this joint opinion, I find it hard to believe there is any situation in which the benefits of using mesh would outweigh the risks,” Garrard said.
“It seems clear that all alternatives should be strongly considered by any woman seeking treatment for pelvic organ prolapse, including high-risk patients,” he said.
The U.S. Food and Drug Administration (FDA) cleared surgical mesh for the repair of POP in 2001 under the 510(k) process based on its “substantial equivalence” to surgical mesh used in hernia repairs.
The 510(k) process does not require pre-market clinical studies to show that a medical product is safe and effective for the market. Instead, the manufacturer simply has to show that the medical product is “substantially equivalent” to a medical product already on the market.
However, due to reported complications, the FDA issued a safety communication in July 2011 in which it called the use of surgical mesh for POP treatment an issue of “continuing serious concern.”
Since 2006, Garrard and his law firm have been at the forefront of nationwide transvaginal mesh litigation, representing hundreds of women – and in some cases, their husbands – in actions against manufacturers of the mesh products.
Garrard currently serves as lead counsel for the plaintiffs in the In re Avaulta Pelvic Support Systems Product Liability Litigation (MDL No. 2187) in the U.S. District Court for the Southern District of West Virginia.
The case involves several pelvic mesh products sold by C.R. Bard, Inc., and designed and manufactured by one or more subsidiaries of Covidien, plc. They include the Avaulta Biosynthetic, Avaulta Plus, Avaulta Solo, Pelvicol, PelviLace, PelviSoft, Pelvitex, Uretex and/or Align products that were implanted in women’s pelvic region for the treatment of POP or stress urinary incontinence (SUI). Garrard and his firm are actively involved in other litigation against several other manufacturers of transvaginal mesh products, as well.
“We urge any patient considering use of a transvaginal mesh product to get a second and third opinion about their condition, and to weigh this procedure very carefully,” Garrard said.
The joint opinion by the ACOG and AUS – Committee Opinion #513, “Vaginal Placement of Synthetic Mesh for Pelvic Organ Placement” – will be published in this month’s issue of Obstetrics & Gynecology.
Garrard said he agreed with several other recommendations set out in the statement, including limiting the adoption of new mesh products and devices to only those “with clinical long-term data demonstrating equal or improved safety and efficacy compared with existing products and services.”
“Our ultimate goal is to protect the health of women across the country,” Garrard said.
About Blasingame, Burch, Garrard & Ashley, P.C.
Blasingame, Burch, Garrard & Ashley, P.C. is an Athens, Georgia-based law firm that has been widely recognized for its ethics, skill and professionalism by Martindale-Hubbell®, The Best Lawyers in America, American College of Trial Lawyers, Super Lawyers and Law & Politics Media/Atlanta Magazine. Since 2006, the firm’s defective medical device and product liability lawyers have pursued claims involving defective transvaginal mesh products, including handling attorney referrals from co-counsel across the country. For more information, call the firm at (866) 354-3544 or use its online contact form.
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Josh B. Wages
Blasingame, Burch, Garrard & Ashley, P.C.
(866) 354-3544
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