The U.S. Food and Drug Ad­min­is­tra­tion expects to release new guidance by the end of Fe­bru­ary on a form of birth con­trol that has been linked to more than 15,000 ad­verse events, in­clud­ing at least a dozen deaths.

Modern Healthcare - - LATE NEWS -

Es­sure, a per­ma­nent con­tra­cep­tion pro­ce­dure, is a small, soft, flex­i­ble coil made of nickel that, when in­serted into each fal­lop­ian tube, pre­vents eggs from get­ting into the uterus. In its an­nounce­ment last week, the FDA called its re­view of the safety and ef­fi­cacy of Es­sure a “high pri­or­ity,” and said it is work­ing ex­pe­di­tiously to con­duct an ev­i­dence­based re­view of the avail­able in­for­ma­tion. It plans to com­mu­ni­cate its ac­tions pub­licly within the next three months. Bayer has con­tin­ued to firmly sup­port the prod­uct, say­ing it is sup­ported by more than a decade of re­search, the FDA and real-world ex­pe­ri­ence.

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