Women Outraged as Essure Remains on the Market
FDA Receives Nearly 10,000 Essure-Related Complaints
In the 13 years since Essure’s approval, the FDA has received roughly 10,000 complaints from consumers citing a slew of problems, ranging from pain and menstrual irregularities to device breakage.
Federal regulators have confirmed five fetal deaths in connection with the device, but analysts say that number is likely underestimated. Additionally, four adult deaths have been attributed to Essure-related issues like infection and uterine perforation. At a September 2015 meeting of the FDA’s Obstetrics and Gynecology Devices advisory panel, the agency stated they had observed a spike in complaints filed over Essure of nearly 1,400% in the past three years.
At this hearing, one of Bayer’s directors informed the panel they had received 17,000 adverse event reports. Furthermore, an October 2015 study discovered that a woman who chose the Essure implant over laparoscopic sterilization was more than 10 times as likely to require post-procedure surgery.
FDA Announces Stricter Labels
On Monday the FDA announced they would be adding their strictest warning to the label of Essure, and that a black-box warning had been recommended to call greater attention to the potential for serious or life-threatening reactions.
They have also told Bayer to include a “patient decision checklist” within Essure’s packaging so women will have more information available regarding the benefits and risks of using the device. In addition to this, the company has been ordered to initiate a three-year clinical study comparing women who receive the Essure implant and those who utilize alternative methods.
Essure was granted 30 days to submit a study protocol and must begin the study within the next 15 months. If the company fails to comply with these demands, the FDA can declare the device misbranded.
Women Voice Discontent with FDA Decision
For those who have experienced the often devastating side effects of this device, these mandates are seen as insufficient and careless of the countless women who are still at risk from the device while it remains available.
These women have complained of chronic pain, allergic reactions, perforated organs, migrating coils, and fetal disfigurement and death due to Essure.
The FDA has been considering the issue since last September, yet when they finally make a decision it was limited to two recommendations. Many consumers feel the regulator made no enforcement measures and simply asked the company to conduct another study while leaving Essure on the market.
The studies will take several years, and the FDA decision to allow the device to stay on the market exposes women to its depredations. These women, who have banded together on the Facebook page “Essure Problems”, have declared that they will push Congress to take action on their behalf if the FDA doesn’t revoke the devices pre-market approval and remove it from the market.
Rep. Mike Fitzpatrick reflects this desire; he introduced the “E-free” act to Congress last November to call for a total market removal.