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Boston Scientific Named In 300 Transvaginal Mesh Lawsuits

Device maker, Boston Scientific, has been named in 300 transvaginal mesh lawsuits. The controversial devices are typically used during surgical procedures to treat pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI). Sadly, patients describe horrific pain and infections that worsen even after corrective surgery is attempted, leaving these women with limited options and debilitating health responses.

Transvaginal mesh devices were approved through the U.S. Food & Drug Administration’s (FDA) 510(k) fast-track approval process. The 501(k) enables a device access to the market with reduced pre-market safety testing if that device is similar to a previously approved device. Because of the significant outpouring of adverse reactions reports associated with these devices, as well as mounting lawsuits, the agency is considering rescinding 510(k) approvals for transvaginal mesh devices used in POP repair. As a matter-of-fact, the FDA recently asked transvaginal mesh device makers to conduct safety studies of their products. (more…)

FDA Seeks Transvaginal Mesh Studies from 33 Firms

Makers of transvaginal mesh products have been ordered by U.S. regulators to conduct studies. Today, the devices are the focus of many hundreds of lawsuits involving dozens of manufacturers. According to Bloomberg, manufacturers of such devices are facing more than 600 lawsuits over alleged transvaginal mesh complications.

Johnson & Johnson, C.R. Bard, Endo Pharmaceuticals Holding Inc., and Boston Scientific Corporation, among others, have just been ordered by the U.S. Food and Drug Administration (FDA) to study links between their vaginal mesh implant products and organ damage, infection, and painful sex rates, said Bloomberg News. Device makers—33 in all—received FDA letters this week, asking them to compile three years of data on implant safety and efficacy, William Maisel, deputy director of science for the FDA’s device-approval center, told Bloomberg News. (more…)

Woman File Suit Over Johnson & Johnson Transvaginal Mesh

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. (more…)

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