Background
Essure is a form of permanent birth control that requires the implantation of a small device within the female reproductive system. It was originally approved by the FDA in 2002, and approximately 750,000 women worldwide have received Essure since its approval. Given that the device is meant to be permanent, it is not typically removed unless necessitated by complications.
Bayer is the manufacturer of this contraceptive device, and has received pressure from the U.S. Food and Drug Administration to increase warnings for Essure in light of the increasing number of adverse event reports that have been submitted within the past several years.
Previous Warnings
On November 15, 2016, the FDA approved a revised label for Essure that included a boxed warning and a Patient Decision Checklist (p. 19 of linked document). A boxed warning, sometimes called a “Black Box Warning” is the most serious warning that can be included with a product.
This new Essure warning reads:
WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during discussion of the benefits and risks of the device. [Emphasis added]
By adding this warning and including the checklist, the FDA hoped to ensure that women were adequately informed of the possible risks of undergoing implantation of this medical device. However, they recently determined that some women are still not being thoroughly informed of the risks, and decided further action was necessary.
New Requirements
On April 9, 2018, the FDA restricted the sale of Essure, and sent a letter to Bayer requiring them to make further changes to the current label for this contraceptive device.
Per the new FDA requirements, women must now read and sign a brochure that provides detailed information on the risks of Essure before they can undergo the implantation procedure.
Furthermore, sale and distribution of Essure is limited to healthcare providers who agree to review the “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement” with patients. Both the patient and their doctor must also sign the checklist before the Essure implantation procedure can take place.
Given that Essure sales dropped 70% after increased warnings were required by the FDA in 2016, and Bayer stopped selling Essure outside of the U.S. last year for “commercial reasons,” it will be interesting to see if the product will vanish from U.S. markets in the wake of these new warnings and requirements.
We will continue to monitor the medical literature for updated information on Essure and its associated risks, and report on significant developments.
In the meantime, we encourage you to complete a Free Essure Case Evaluation if you or someone you know has experienced severe complications as a result of the Essure permanent contraceptive device.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P. A.
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