Mar 11, 2024

FDA Announcement Requires New Warning Label and Clinical Trial for Essure

black box warning label birth control

Tens of thousands of women around the country have been waiting for this moment for months: the Food and Drug Administration has announced the findings of its review of the permanent birth control product Essure.

The investigation was announced in September following public outcry against the product by women who experienced adverse side effects after having the Essure procedure done.

Essure is a permanent, non-surgical form of birth control that consists of two flexible metal coils that are inserted through the vagina into the fallopian tubes. Scar tissue then develops around the coils preventing sperm from entering the tubes.

The major outcome of the FDA’s review is that Essure will now contain a “black box” warning of possible side effects, and the product’s manufacturer, Bayer, will have to conduct a new clinical study to determine the heightened risks for particular women.

The FDA also announced that a Patient Decision Checklist would be written in order to increase patient and physician understanding of the potential risks associated with Essure. In order for the public to have an opportunity to comment on the proposed language for the checklist and new label, the FDA issued a draft guidance. The FDA will take comments for the next 60 days in order to craft a comprehensive warning label and checklist so that women are able to make the most informed decision possible before having the procedure to insert Essure.

Despite the new warnings on Essure labels, the “e-sisters” who have already been hurt by the medical device were deeply disappointed by the FDA’s decision.

The e-sisters are the tens of thousands of women who’ve banded together to share their Essure horror stories to ensure other women don’t have to go through a similar experience. They had hoped that the FDA would issue a recall based on the living proof they represent of the product’s failure.

However, the FDA disagreed and found that the device was safe for the majority of women and the new warnings would facilitate a dialogue between women and their doctors to better determine if Essure is suitable for them.

Since Essure was approved by the FDA in 2002, the agency has received more than 10,000 complaints regarding the product. The e-sisters Facebook group has over 27,000 members which suggests that even more women than just those who have filed adverse event reports with the FDA have experienced negative side effects.

The side effects women have reported include abdominal pain, menstrual irregularities, headaches, fatigue, weight fluctuations, hair loss, device migration, allergic reactions, and device breakage.

If you or someone you know has experienced one of these side effects from Essure, the attorneys at Morgan & Morgan would like to hear from you. We are currently pursuing a mass tort against Bayer Healthcare for the product Essure. Morgan & Morgan attorneys have decades of experience fighting for the rights of victims who encountered surprising and unwanted side effects from drugs and medical devices.

To find out if you are eligible to file a lawsuit contact Morgan & Morgan by completing our case review form, and you will be able to speak with our team for a free consultation.