1-in-5 Women Affected By Essure's Allergic Reactions: FDA

1-in-5 Women Affected By Essure's Allergic Reactions: FDA

Introduction

Food and Drug Administration's (FDA) ongoing study over Essure indicates that more than 20% of women implanted with the birth control device may be suffering from allergic or hypersensitivity reactions, which increases the risk of chronic abdominal pain, abnormal bleeding, and higher rates of gynecological surgical procedures.

The preliminary results were issued in a press release on July 8, confirming several serious problems associated with Bayer's birth control device, which is no longer available in the market.

Essure was suspended from the market in most of the countries since 2017, but Bayer continued to sell the device in the U.S. until the end of 2018. In July 2018, Bayer announced to remove all the Essure devices from the U.S. market by December 31, 2018. Following the removal, the FDA required Bayer to extend the postmarket surveillance study and take measures to ensure long-term Essure supervision.

The previous reports of the FDA prove that women using Essure have a higher tendency to develop chronic lower abdominal pain and abnormal uterine bleeding in comparison to women who use laparoscopic tubal ligation for birth control. Also, women who have implanted Essure have to go through various gynecologic surgical procedures as compared to patients who bring tubal ligation in use for birth control. The pregnancy risk rates are also found to be similar to Essure and tubal ligation. 

Meanwhile, FDA has recommended the continuation of going with Essure to women who have been using it without any complication. However, if Essure patients come across any pain, they should consult with their doctor and take guidance to take further steps. Also, before deciding on birth control device removal, it is necessary to understand the risk associated with it by discussing it with health care providers. 

The FDA has taken necessary actions to monitor the safety of Essure. The agency has been updating people about the risk of this birth control device and they will continue to show full cooperation to patients in making them aware of the post-market safety of Essure. 

Bayer is currently facing 18,000 lawsuits nationwide, each claiming that the Essure birth control coils were dangerous and defectively designed and the women experienced painful and debilitating complications, including migration injuries, perforations, severe reactions, and other problems.

Worldwide 750,000 women have been implanted with the device, of which 70% are from the U.S. as estimated by Bayer. The FDA is taking several actions to monitor the safety of Essure and is updating the public about it regularly.