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Public Citizens Asks FDA to Recall Transvaginal Mesh | cialis online

Public Citizens Asks FDA to Recall Transvaginal Mesh

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Transvaginal mesh products made by Johnson & Johnson and Boston Scientific Corp., typically used treat pelvic organ prolapse in women, have led to painful side effects in many, according to watchdog group, Public Citizen.

The transvaginal mesh products are made of a nonabsorbable synthetic material that can erode, leaving the patient in pain and suffering from urinary incontinence and painful bladder infections, said Bloomberg News.

Somewhere between 30-to-50 percent of all women over 50 will experience some type of pelvic organ prolapse, a condition in which pelvic muscles and tissues weaken. This can allow organs—including the uterus and bladder—to prolapse, or drop, according to a recent report from Newsinferno.

Transvaginal mesh is implanted via incisions into the vaginal wall and reinforces the areas around the pelvic organs, noted Bloomberg News. According to Public Citizen, some 67,500 women have been implanted with nonabsorbable mesh and the U.S. Food and Drug Administration (FDA) has received 1,503 reports of complications concerning the mesh from January 2008 to December 2010, said Bloomberg News, citing a July 13 FDA safety warning.

“Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately,” Michael Carome, deputy director of Public Citizen’s Health Research Group, said in a statement, reported Bloomberg News. The FDA said the efficacy of the surgery remains unknown.

Public Citizen is seeking a mandatory recall from the FDA for nonabsorbable transvaginal mesh devices and is also asking that future versions be subject to more stringent approval mandates, said Bloomberg News.

The FDA issued its first warning for transvaginal mesh complications in 2008. Last month, the agency issued a second warning that revealed that transvaginal mesh product complications are not rare, said NewsInferno. The recent warning indicated that the FDA stated it received more than 2,800 complaints about transvaginal mesh complications since 2009; over 1,500 were associated with pelvic organ prolapse repair and three involved death.

Dozens of lawsuits are currently pending against the makers of transvaginal mesh.

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