FDA Mandates New Warning for Essure Birth Control Device


The United States Food and Drug Administration has said it will require a new “black box warning” on Essure, an implanted permanent contraceptive device. A black box warning on the device is supposed to “call attention to serious or life-threatening risks,” according to their website.


The announcement made February 29th, 2016 comes after more than 5,000 women filed complaints with the Food and Drug Administration (FDA) from November of 2002 and May of 2015. The grievances showed women complained about unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding after Essure implantation.

Initially approved by the FDA in 2002, Essure is a permanent form of birth control in which a coil is non-surgically implanted in a woman’s fallopian tubes. Scar tissue is supposed to form around the implant to prevent sperm from reaching the egg and hence, preventing pregnancy.

The FDA also called upon Bayer, the maker and marketer of Essure, to conduct surveillance that will determine the “risks of the device in a real-world environment,” and it said the agency will use these results of the study to “determine what, if any, further actions related to Essure are needed to protect public health.” Bayer is to track more than 2,000 women for at least three years.

The study won’t be strictly limited to women being implanted with Essure, but will also be comparing women with Essure to women who elect other methods of sterilization, such as a tubal ligation.
According to Dr. William Maisel, FDA deputy director for science, the Food and Drug Administration expects Bayer to submit a study protocol within 30-days and the company is also required by law to start the study within 15 months. If Bayer doesn’t comply, the FDA can declare the device misbranded and remove it from the market.

Bayer will also be required to submit interim reports on the study including any data and analysis done. The FDA requires the first of these reports to be made available in the next few months, when the trial starts.

When the press reached Bayer for a comment they had the following response: “Essure is an important permanent birth control option with a positive benefit-risk profile. Bayer will continue to work closely with the FDA to support the continued safe, effective and appropriate use of Essure.”

Reactions to the announcement made by the Food and Drug Administration were rapid and disparaging.
Essure Problems, a support group for women who say they have been affected by the implant said, “We are outraged that it appears as if the FDA is going to leave Essure on the market. Take the device OFF the market and revoke PMA (premarket approval). Do not continue to allow more women to be harmed.”

Republican Rep. Mike Fitzpatrick from Pennsylvania, who has called for the FDA to revoke Essure approval stated, “It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market. It’s been done. The evidence is all there: tens of thousands of injured women and hundreds of fetal deaths.”


While the FDA has changed its mandates regarding the Essure device, it’s important that as a woman, you educate yourself to the risks and benefits associated with this device and to make the best decision for you.


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