On Monday, the U.S. Food and Drug Administration introduced new sale restrictions on the popular sterilization tool, Essure. The device, a metal coil implanted in the fallopian tube to prevent pregnancy, allows patients to avoid major surgical procedures to achieve permanent sterilization.
The distribution of Essure will now be limited to health care providers who provide full risk information to their patients. Potential recipients of Essure are required to receive and read through the “Patient-Doctor Discussion Checklist — Acceptance of Risk and Informed Decision Acknowledgement,” a two-page checklist of dangerous side effects and general advisory. Only after both parties sign the document can Essure be made available.
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“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” said FDA Commissioner Scott Gottlieb, MD. “Despite previous efforts to alert women to the potential complications of Essure, we know some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”
Though available on the market since 2002, Essure has gone through rigorous examination from the FDA. This new constraint comes on the heels of another warning label issued by the FDA in February 2016, when thousands of women who had turned to Essure came forward with extreme adverse reactions. Many claimed their doctors had not completely advised them about the dangers of using the product.
The FDA has since ordered Bayer, Essure’s manufacturer, to conduct an extended post-market study to continually appraise the safety of the tool. In November of the same year, a black box warning was issued, placing a cautionary label on the product packaging that serves as the strictest warning label the FDA can enforce.
The FDA will continue to monitor the safety of Essure through information generated by Bayer’s ongoing study of product effectiveness and safety.
