SUMMARY:

The FDA was notified on July 20, 2018 that Essure permanent birth control will no longer be sold or distributed in the US after December 31, 2018.  This notification follows earlier actions on the part of the FDA related to this device.

In 2017, the FDA provided guidance, a ‘black boxed warning’ and a patient decision checklist to ensure all women were aware of potential risks associated with Essure.  On April 9, 2018, the FDA concluded that some women were not being adequately informed. Therefore the FDA initiated a unique type of restriction that limited the sale and distribution of Essure, with the imposition of additional requirements.

Essure Restrictions

• Essure can only be used by healthcare providers and facilities that provide information to women about the risks/benefits
• Information is to be provided using the “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”  (see ‘Learn More – Primary Sources’ below)
• The above ‘Checklist’ requires
  • Signature of physician implanting the device
  • Signature and acknowledgement of patient

FDA labeling requirements

• Black Boxed Warning: The FDA included an example of a ‘black boxed warning’ which would include the reported adverse events, such as perforation of the uterus and/or fallopian tubes, as well as identification of inserts in the abdominal or pelvic cavity, persistent pain and suspected allergic reactions. In addition to the above, the patient would also be alerted that management of an adverse event could entail further surgery.
• Patient Decision Checklist: The checklist, requiring initials and signatures, appears at the end of the patient brochure and includes
  • Birth control options
  • Contraindications
  • Importance of follow up after placement, including confirmatory placement test and use of alternative birth control for 3 months
  • Pregnancy risks (<1% risk of unintended pregnancy at 5 years)
  • What to expect during the procedure and days afterward
  • Long term risks

Patients Currently Using Essure

The FDA statement that addresses this notification on the ending of the sale and distribution of Essure includes the following information

Women who’ve been using Essure successfully to prevent pregnancy that they can continue to do so. Those with Essure who suspect they may be having symptoms related to the device, such as persistent pain, should consult with their doctor on what steps may be appropriate for them to take. Device removal has its own risks. Patients should discuss the benefits and risks of any operation or procedure with their health care providers before deciding on the best option for them.

For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA. We expect Bayer to meet its postmarket obligations concerning this device.

Learn More – Primary Sources:

FDA Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales

Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed

FDA News Release: FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information

Bayer Information Booklet Including Patient – Doctor Discussion Checklist and Black Boxed Warning

ACOG Commentary: Hysteroscopic Sterilization With Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance

ACOG Practice Bulletin 133: benefits and risks of sterilization

Related ObG Topics:

CDC Guidance: Contraception in Women with Medical Conditions

Hormonal Contraception Benefits – Beyond Pregnancy Prevention

Optimizing Contraception for the HIV-positive Woman