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FDA Seeks Transvaginal Mesh Studies from 33 Firms

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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.

The move followed an FDA report this summer in which a five-fold increase was seen in transvaginal mesh deaths, injuries, and malfunctions, said Bloomberg News. According to NewsInferno, the FDA warned that the devices were linked to serious and painful complications, specifically when used in pelvic organ prolapse (POP) repair. At that time, the FDA said it had received over 2,800 complaints about transvaginal mesh complications since its warning in 2008; women died in three of those cases.

POP occurs when pelvic floor muscles supporting the uterus, bladder, urethra, small intestine, rectum, and the top of the vagina are weakened due to childbirth and other issues. POP can cause no symptoms or can cause pelvic pressure, lower back pain, urinary incontinence, sexual difficulties, or bowel movement issues, said NewsInferno. Some 350,000 women undergo surgery for POP in the U.S. every year.

Transvaginal mesh is a “hammock-like” device that is surgically threaded in the body via a vaginal incision, explained Bloomberg News. According to the FDA this July, studies could not clearly confirm if the devices offered increased benefits over older treatments; however, mesh devices have been linked to mesh fiber edges constricting or cutting into internal organs after implantation, as well as infection, according to studies, said Bloomberg News.

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