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Woman File Suit Over Johnson & Johnson Transvaginal Mesh | cialis online

Woman File Suit Over Johnson & Johnson Transvaginal Mesh

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Following pelvic organ prolapse (POP) repair, a woman has filed a lawsuit against transvaginal mesh maker, Johnson & Johnson. Linda Gross, 46, suffered from a condition in which her pelvic organs prolapsed into her vagina; she alleges her surgery led to even more complex, long-term, and serious medical issues.

POP occurs when the pelvic floor muscles weaken and slide into the vagina. To correct Gross’ POP, her physician inserted a new vaginal mesh—the Gynecare Prolift—into her vagina via incisions in 2006. Since, Gross says she has suffered from a variety of adverse reactions, including urinary complications and ongoing body pain and swelling in response to her body continuing to attempt to reject the device. She also said she is unable to sit for more than 20 minutes at a time, is unable to engage in sexual relations with her husband, and cannot be active more than a few moments. Twelve follow-up surgeries have been unable to correct the Gynecare Prolift complications.

Gross is not alone. The U.S. Food and Drug Administration (FDA) reportedly received 1,503 injury, infection, malfunction, and death reports between 2008 and 2010, a significant rise from prior years that followed with the FDA issuing a warning to medical professionals. The FDA is now looking into pulling vaginal mesh, pending additional safety information, recently convening a two-day meeting of the Obstetrics and Gynecology Devices Panel to discuss potential regulatory steps.

Gross and 100 other women are suing Johnson & Johnson’s Ethicon, claiming negligence and defective product design and for compensatory and punitive damages. A number of complaints concerning vaginal mesh defects have been received nationwide with about 500 other lawsuits filed since last year.

C.R. Bard, Boston Scientific, and American Medical Systems are also facing lawsuits that allege that mesh makers knew of safety risks, but neglected to disclose those risks and that the products were defective.

Approximately 300,000 women in the United States underwent POP surgeries in 2010; more than 70,000 of these women received transvaginal mesh.

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