South Dakota Woman Sues Johnson & Johnson after Failed Transvaginal Mesh Surgery

Johnson & Johnson has been named in another lawsuit over its Gynecare Prolift transvaginal mesh. Linda Gross, 46, of Watertown, South Dakota, alleges she was left with urinary complications and constant pain after her body rejected the Gynecare Prolift transvaginal mesh device doctors implanted in her back in 2006.

According to a report published by Bloomberg last month, about 270 lawsuits are pending against Johnson & Johnson, the global leader in transvaginal mesh, over similar injuries. Other companies facing <"">transvaginal mesh lawsuits include C.R. Bard, Boston Scientific, and American Medical Systems. Such lawsuits allege that mesh makers knew of safety risks and failed to disclose them and that the products were defective. It has been estimated that approximately 500 lawsuits have been filed against various transvaginal mesh manufacturers since 2010.

Legal claims against transvaginal mesh makers began to spike after the U.S. Food & Drug Administration (FDA) issued a safety alert for such devices on July 13. A t the time, the agency said that between 2008 and 2010, it had received 1,503 reports of serious complications associated with transvaginal mesh used in pelvic organ prolapse (POP) repair. These included mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.

Just last month, an FDA advisory panel backed a proposal by agency staff to reclassify transvaginal mesh as a Class III (high risk) medical device. Currently, the devices are classified as moderate risk (Class II), making them eligible for the 510(k) approval process, which does not require human trials before a device is brought to market.

According to Gross’ lawsuit, she received Gynecare Prolift in 2006 to repair POP. Today, Gross says she cannot sit for longer than 20 minutes, cannot have sex with her husband, and she can’t be active for more than a few minutes at a time. She has had twelve additional surgeries to correct the complications, but none have helped.

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