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Essure Victims Can't ‘Bayer’ FDA’s Cop Out on Essure

Holly Ennis March 8, 2016

03/8/2016 - Last week the FDA issued a much-anticipated announcement regarding the fate of the Essure Sterilization Device. After 5 months of deliberation, the best the FDA could muster is to require a “black box” warning on the device’s labeling and a Patient Decision Checklist to help ensure women receive and understand the dangers and benefits of the Essure device. Finally, despite an abundance of information made available to the FDA and Bayer concerning “real-world” risks and injuries supplied by thousands of women, the FDA ordered Bayer to conduct a new study to collect more information regarding Essure’s risk in the real world. The FDA gave Bayer 15 months to even commence the study, which will take another few years to complete. Meanwhile, the device remains on the market, potentially injuring thousands more women while Bayer and the FDA further “study” the harmful effects.

The FDA’s actions fall woefully short of addressing the significant health issues caused by the Essure device. At a minimum, Essure should be removed from the market, while Bayer undertakes the additional studies to prevent risk of harm to innocent women. The black box warning will not be discernible by many women, as they typically do not see the packaging and device prior to insertion. They must rely on their physicians to relay all of the safety information, and implanting physicians profiting from the procedure may not be so forthcoming with all information. Furthermore, most of the proposed warnings already exist in some fashion, but are either downplayed or not fully explained to the patient prior to the procedure.

The FDA is also requiring a Patient Decision Checklist designed to highlight key risk and benefit information and it is intended to be reviewed and signed by both the patient and the physician prior to making the decision regarding Essure. It is unclear at this time, who will draft the Patient Decision Checklist and whether physicians will be required to use a mandatory, uniform checklist without alteration or modification to the language. However, to be effective, the checklist must be completed prior to sedation and preferably completed prior to the day of surgery.

The FDA is also requiring Bayer to conduct a new clinical study designed to provide information about the benefits and risks of the device in a real world environment. Bayer will be required to enroll more than 2000 patients and to collect data on women receiving the Essure device as well as women choosing an alternative method of sterilization and follow them for at least three years. The FDA did not advise how many women were to be implanted with Essure versus an alternative sterilization method, it did not discuss which model of the Essure device should be used in the study nor which confirmation test should be implemented. However, similar studies have been recently undertaken and as reported in the British Medical Journal, women undergoing the Essure procedure have a 10-fold higher risk of undergoing reoperations compared to women undergoing laparoscopic sterilization. Other studies have also indicated a higher pregnancy rate with Essure than with laparoscopic surgery.

Since there have been other reputable studies and real world experiences of over 25,000 women, it is unfathomable that the FDA wants yet another study. Additionally and most disturbing is this new clinical trial does not have to be started for 15 months and will require at least three years to complete. This means at least 4 more years of this dangerous device being left on the market injuring potentially thousands of women while Bayer and the FDA continue their “studies.” This is both unconscionable and unacceptable. Bayer and the FDA admit there are serious complications, which occur in some women, but believe Essure should remain an available option for women. However, it is impossible to predict which women will suffer these serious and potentially life-threatening injuries. Is the FDA playing Russian roulette with women’s health?

Congressman Mike Fitzpatrick was also outraged by the FDA’s decision and 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.” Fitzpatrick continued stating, “Frankly, I’d contend that the 25,000 women harmed by Essure are the post-market study that FDA is ordering. It’s been done. The evidence is all there: tens of thousands of women and hundreds of fetal deaths.”

Fitzpatrick is continuing his efforts for the House and Senate to pass the E-Free Act and revoke the FDA approval of Essure. He is also introducing new legislation to eliminate the blanket civil liability protections that device manufacturers enjoy for non life-saving devices because individuals harmed deserve a voice in court. Women affected by the device are understandable outraged by the FDA’s decision and are urged to submit their comments and suggestions to the FDA here:!searchResults;rpp=25;po=0;s=FDA-2016-D-0435;fp=true;ns=true