New Study Finds Patients Who Receive Vaginal Mesh Implants Have Higher Reoperation Rate

Dec. 28, 2011 - PRLog -- Los Angeles, CA, December 28, 2011 – A new study forthcoming in the January issue of the American Journal of Obstetrics and Gynecology found that women who are fitted with a vaginal mesh device to treat pelvic organ prolapse typically require additional surgery more often than women who are treated using other methods. Pelvic organ prolapse (POP) is a condition that causes a weakening of the pelvic floor muscles in certain women. Depending on its severity, POP can cause the internal organs to bulge or sag outward through the vagina.

The study looked at post-treatment outcomes for 32 women who received a mesh implant and 33 women who underwent traditional prolapse repair methods. Researchers found that 15.6 percent of the women who received a transvaginal mesh device required additional surgery within one year of the initial treatment. They also concluded that women who were treated using other methods saw a comparable reduction in prolapse symptoms compared with mesh recipients.

Vaginal mesh was first approved by the U.S. Food and Drug Administration in 1996 when Boston Scientific began marketing its Protogen mesh system. This device has since been recalled. Johnson & Johnson was later able to secure approval for its Ethicon Gynecare mesh system using Protogen as its predicate under the FDA’s 510(k) rule, which requires medical device manufacturers to simply prove that a similar device is already on the market. Johnson & Johnson is currently facing 600 lawsuits from women who claim the Ethicon mesh implants caused severe pain, infection, tissue damage, swelling and other complications. The first trials in these cases are scheduled to begin in a New Jersey court in November 2012.

Since 2008, the FDA has received nearly 3,000 adverse event reports from women who claim they were injured by a vaginal mesh device. In addition to the injury lawsuits faced by Johnson & Johnson, liability claims have also been filed against American Medical Systems and C.R. Bard, which manufactures the Avaulta mesh system.

Consumer advocacy groups are calling for a recall of all vaginal mesh products. Women across the country who’ve been injured by one of these devices are being urged to contact a personal injury lawyer to discuss their claim. Prominent national law firm Nadrich & Cohen LLP is currently investigating claims from women in all 50 states and has developed an online mesh resource center to provide the latest news, updates and information on the ongoing litigation. Free initial case evaluations are available by calling 1-800-722-0765 or by visiting www.VaginalMeshLegalClaims.com.

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Nadrich & Cohen LLP is a national law firm specializing in representing clients in every state who’ve been injured by defective medical devices, harmful prescription drugs, faulty products, car accidents, motorcycle accidents and dog bites.