FDA or­ders pelvic sur­gi­cal mesh off the mar­ket

The Buffalo News - - NATIONAL NEWS - By Lau­rie McGin­ley

The Food and Drug Ad­min­is­tra­tion on Tues­day or­dered man­u­fac­tur­ers of sur­gi­cal mesh used for re­pair­ing a con­di­tion called pelvic or­gan pro­lapse to im­me­di­ately stop sell­ing their prod­ucts, the lat­est turn in a years­long bat­tle over the safety of the im­plants.

The FDA said the com­pa­nies, Bos­ton Sci­en­tific and Colo­plast, had not demon­strated a “rea­son­able as­sur­ance” of safety and ef­fec­tive­ness for the de­vices over the long term, and will have 10 days to sub­mit plans for with­draw­ing them from the mar­ket.

The FDA ac­tion specif­i­cally af­fects sur­gi­cal mesh used for the transvagi­nal re­pair of pelvic or­gan pro­lapse, which oc­curs when the mus­cles and tis­sues sup­port­ing the uterus, blad­der or rec­tum be­come weak or loose. That can al­low or­gans to drop or press into the vagina. The reg­u­la­tory ac­tion does not ap­ply to mesh used for other con­di­tions, such as her­nias or stress uri­nary in­con­ti­nence.

The FDA move, its tough­est ac­tion yet against the de­vices, comes af­ter tens of thou­sands of women have filed law­suits against mesh man­u­fac­tur­ers claim­ing in­juries, bleed­ing and pain. It said there has been an in­crease in re­ports of ad­verse events in the past sev­eral years in­volv­ing the de­vices.

In 2016, the FDA re­clas­si­fied the prod­ucts as high-risk de­vices – sub­ject­ing them to the agency’s most strin­gent path for de­vice over­sight – and re­quired man­u­fac­tur­ers to ob­tain ap­proval to con­tinue to mar­ket them. Many man­u­fac­tur­ers with­drew from the mar­ket amid the height­ened reg­u­la­tory scru­tiny and the grow­ing num­ber of law­suits.

“In or­der for these mesh de­vices to stay on the mar­ket, we de­ter­mined that we needed ev­i­dence that they worked bet­ter than surgery with­out the use of mesh to re­pair pelvic or­gan pro­lapse,” said Jeffrey Shuren, di­rec­tor of the agency’s Cen­ter for De­vices and Ra­di­o­log­i­cal Health. “That ev­i­dence was lack­ing in these pre­mar­ket ap­pli­ca­tions, and we couldn’t as­sure women that these de­vices were safe and ef­fec­tive long term.”

Pub­lic Ci­ti­zen, which first pe­ti­tioned the FDA in 2011 to ban the prod­ucts, wel­comed the move, but it said it came “too late for the thou­sands of women who have been ir­repara­bly harmed by these de­vices.” The group said it has been clear for sev­eral years that the prod­ucts “are un­safe for treat­ing pelvic or­gan pro­lapse and lack any clin­i­cally sig­nif­i­cant ben­e­fits in com­par­i­son to non­mesh prod­ucts.”

Bos­ton Sci­en­tific said the com­pany was “deeply dis­ap­pointed” by the agency’s de­ci­sion, adding that “pa­tient safety is al­ways our high­est pri­or­ity.” The com­pany said the FDA ac­tion will “se­verely limit” op­tions for women seek­ing treat­ment for pelvic or­gan pro­lapse. Colo­plast de­clined to com­ment.

About 1 in 8 women have surgery to re­pair the con­di­tion, and a sub­set of the pro­ce­dures use the mesh, the agency said. It added that the pro­por­tion of women un­der­go­ing the mesh pro­ce­dures de­creased af­ter the FDA be­gan is­su­ing warn­ings.

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