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FDA places “unique” restrictions on contraceptive implant Essure

BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k1650 (Published 12 April 2018) Cite this as: BMJ 2018;361:k1650
  1. Owen Dyer
  1. Montreal

The US Food and Drug Administration will apply unprecedented restrictions on the use of Bayer’s contraceptive implant Essure after finding that previous warnings did not do enough to inform patients about the device’s potential risks.

Effective immediately, the only healthcare facilities allowed to implant the device will be those that agree that, in every case, a healthcare professional will guide prospective recipients through a 20 page, FDA approved brochure laying out potential adverse effects.1

Informed …

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