FDA Mandates Boxed Warning, Patient Checklist for Essure


The U.S. Food and Drug Administration (FDA) recommended on Nov. 15 a boxed warning and a patient checklist that highlights possible adverse events associated with the use of Essure, Bayer’s permanent contraception device.

The adverse events listed in the new FDA recommendation include:

  • Perforation of the uterus or fallopian tubes
  • Device migration
  • Hypersensitivity reactions
  • Persistent pain

Adverse Events Related to Essure

Over the past several years, the FDA has been investigating a growing number of adverse events associated with Essure. This review led the FDA to convene a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on Sept. 24, 2015 to hear expert opinions as well as patient experiences related to the risks and benefits of Essure.

On the basis of this meeting and the comments received, the FDA concluded that some women are not receiving information explaining the risks or benefits of permanent birth control implants like Essure, and as a result, issued the boxed warning and decision guide.

History of Essure

The FDA approved Essure – permanent birth control without surgery – in 2002. It consists of a delivery system and nickel-containing permanent implants. Two metal coils are inserted through the vagina and implanted within each fallopian tube. Once implanted, the coils stimulate the growth of scar tissue, resulting in sterilization.

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