Sales of the permanent birth control device Essure have been restricted by the Food and Drug Administration (FDA) for only doctors and health care facilities that agree to go over a checklist with women before the device is implanted explaining possible risks. The action comes more than a year after the FDA ordered manufacturer Bayer to update the safety label of Essure to include a black box warning about potential injuries associated with use.
Essure was approved by the FDA in 2002. It consists of two nickel alloy coils that are inserted into the each of the fallopian tubes. Over time, scar tissue builds up around the coils, forming a permanent barrier preventing sperm from reaching the egg.
In recent years, Bayer was hit with thousands of reports of complications with Essure, including allergic reactions, autoimmune reactions, abdominal pain, unusual bleeding and unintended pregnancy. The coils can also migrate and puncture the Fallopian tubes or uterine wall. Some women who reported complications have had surgery to remove the device.
“The FDA is aware that some women have received the Essure device without being adequately informed of Essure’s risks,” the FDA said in a Safety Communication. “In order for this device to meet reasonable assurance of safety and effectiveness, all women considering Essure should receive this important information.”
The agency is requiring doctors to use an FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgment,” and sign it before being implanted with the device.
Bayer has also updated the label of Essure to include the following statement: “The sale and distribution of this device are 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.”
FDA Safety Communication