FDA puts restric­tions on birth con­trol im­plant but no re­call

South Florida Times - - HEALTH - FDA Com­mis­sioner, Scott Got­tlieb MATTHEW PERRONE AP Health Writer


WASH­ING­TON - U.S. health of­fi­cials on Monday placed new restric­tions on a per­ma­nent con­tra­cep­tive im­plant that has been sub­ject to re­ports of painful com­pli­ca­tions from thou­sands of women. But the metal im­plant, called Es­sure, will re­main on the mar­ket.

The Food and Drug Ad­min­is­tra­tion said only women who read and sign a brochure about the risks of the de­vice will be able to re­ceive the im­plant made by Bayer. The check­list of risks must also be signed by the woman's doc­tor. The new re­quire­ment comes al­most two years af­ter the FDA added its strong­est warn­ing to Es­sure, cit­ing prob­lems re­ported with the nickel-ti­ta­nium im­plant. The agency also or­dered Bayer to con­duct a study of the de­vice's safety.

Pa­tients have re­ported cases of pain, bleed­ing, al­ler­gic re­ac­tions and cases where the im­plant punc­tured the uterus or shifted out of place. Those re­ports are sub­mit­ted to the FDA by pa­tients, physi­cians and the man­u­fac­turer.

“De­spite pre­vi­ous ef­forts to alert women to the po­ten­tial com­pli­ca­tions of Es­sure, we know that some pa­tients still aren't re­ceiv­ing this im­por­tant in­for­ma­tion,” said


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