Bayer re­vealed it has re­ceived more than 17,000 ad­verse-event re­ports from women around the globe who had used its fe­male con­tra­cep­tive Es­sure.

Modern Healthcare - - LATE NEWS -

That’s over 11,000 more than the 5,093 re­ports cap­tured by June of this year on the Man­u­fac­turer and User Fa­cil­ity De­vice Ex­pe­ri­ence data­base, an FDA web­site for pa­tients and clin­i­cians to sub­mit com­plaints. Health pol­icy and qual­ity and safety lead­ers say the vol­un­tary re­port­ing sys­tem does not pro­vide the rig­or­ous post-mar­ket sur­veil­lance needed to cap­ture ad­verse events be­fore prob­lems be­come wide­spread.

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