The Food and Drug Administration (FDA) has taken the unusual step of limiting and restricting sales of the birth control medical device, Essure®, to healthcare providers who provide adequate risk versus benefit discussions with patients. Bayer’s Essure® is a system for permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes. Some users report 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. Removal of the device usually requires surgery.

On April 9, 2018, FDA issued a safety announcement restricting sales of the Essure® device to only doctors and healthcare facilities that use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement.” Sale and distribution of Essure® is now limited to healthcare providers who agree to review this checklist with patients and give them the opportunity to sign it before Essure® implantation. FDA believes this new safety measure is needed to ensure that the device meets standards for a reasonable assurance of safety and effectiveness.

Along with this new safety measure, FDA has approved Bayer’s new labeling which includes a statement that the sale and distribution of the device is "restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer.” The labeling also refers to Bayer’s Patient-Doctor Discussion Checklist, “Acceptance of Risk and Informed Decision Acknowledgement,” which is part of the patient information booklet, which has key information about the device, its use, and safety and effectiveness outcomes, of which the patient should be aware as she considers permanent birth control options.

FDA has always taken a hands-on approach to patient safety for contraception with informed risk versus benefit information. For example, FDA regulations already require a patient package insert with oral contraceptives.  (21 CFR 310.501) Restricting the sale of this device to healthcare providers who are mandated to provide adequate risk versus benefit discussions comes on the heels of thousands of adverse event reports and costly product liability litigation.

You can read the full FDA announcement