According to a recent announcement, the Bayer Co. has decided to stop selling its permanent birth control coils known as Essure effective Jan. 1, 2019 in the U.S.

Globally, there have been thousands of complaints of Essure injuries and, in this country alone, Bayer is facing 16,000 lawsuits from women. Bayer has already stopped distribution of Essure in Canada, Europe, South America, South Africa, and the United Kingdom (U.K.).

What are Essure Coils?

Essure coils are made of nickel, titanium, and polyester and are implanted during a doctor visit into the bilateral fallopian tubes through a woman’s cervix. They are designed to promote the growth of scar tissue gradually over a three-month period—scar tissue which is supposed to obstruct the union of sperm and egg, helping prevent unwanted pregancies.

The effectiveness of this obstruction needs to be verified by a radiological procedure using a contrast material prior to solely relying upon it as birth control. Prior to having this test, women have been encouraged to use a back up contraceptive method with their sexual partners.

Package Warning and Reported Essure Injuries

On the original packaging, women were warned of the potential of experiencing an allergic reaction to Essure coils mainly due to the nickel used in the product. Symptoms of allergic reaction on the label included but weren’t limited to hives, rash, itching, and inflammation.

In the thousands of worldwide complaints of Essure injuries, women have attributed a variety of distressing physical conditions to the coils such as frequent headaches, unexplained weight gain, and rapid changes in mood. The U.S. Food and Drug Administration (FDA) lists them in labeling dated from April 2016. with the caveat that it is unknown whether the symptoms are Essure-related or not.

Consideration of the complaints of Essure injuries spurred the FDA to require Bayer to begin new clinical trials on the device. A checklist of potential side effects was also developed as of May 2018 that physicians are required to review with patients prior to implantation.

Bayer insists that its withdrawal of Essure from the market is due to declining interest, not to the many reports of Essure injuries.

Coincidentally, a new documentary released on Netflix on July 27, called The Bleeding Edge, details the experiences of women who had Essure birth control implanted. The documentary also reports that protesting women called for Essure coils to be discontinued by the FDA. The release of this film where women talk about their Essure injuries and announcement of Bayer’s decision seem to be intertwined in time.

Were you or a loved one implanted with coils and then suffered Essure injuries? You may have a legal claim. Fill out our form to request a consultation with a medical products attorney.