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US to require safety warnings for Essure sterilization device

BMJ 2016; 352 doi: https://doi.org/10.1136/bmj.i1283 (Published 03 March 2016) Cite this as: BMJ 2016;352:i1283
  1. Michael McCarthy
  1. Seattle

New warnings must be printed on the labels of the implantable sterilization device Essure after reports of serious side effects, the US Food and Drug Administration (FDA) has announced.

The administration has also ordered the device manufacturer, Bayer, to conduct a postmarket surveillance study to compare adverse events with Essure with those seen with tubal ligation.

“The actions we are taking today will encourage conversations between women and their doctors to help patients make more informed decisions about whether Essure is right for them,” said William Maisel, deputy director for science …

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