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Essure Victims Call For William Maisel’s Resignation

Holly Ennis March 12, 2016

03/12/2016 - Proponents from the Essure Problems Activist Group have forwarded a letter to William Maisel, Deputy Director for Science and Chief Scientist at the FDA’s Center for Devices and Radiological Health, demanding his resignation from the FDA. The formidable E-Sisters as they are known, are outraged regarding the FDA’s recent rulings concerning the Essure sterilization device. The FDA clearly should have revoked the premarket approval (PMA) granted to the device and Essure should no longer be offered for sale in the United States.

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 E-Sisters were particularly incensed that the William Maisel and the FDA still maintain that Essure is a safe and effective option for women, given the overwhelming amount of evidence presented to the FDA, proving that the device injured thousands of women. According to the letter, Mr. Maisel made it perfectly clear that he and the FDA would rather stand by Bayer, despite the harm inflicted upon these women. Mr. Maisel is now as much to blame for continuing the harm, as is Bayer. The FDA has long been plagued with a history of bias toward industry, conflicts of interests and corruption and it appears that Mr. Maisel is carrying on with this tradition, according to the letter.

The group is demanding Mr. Maisel resign as it believes there is no scenario, which would cause Mr. Maisel and the FDA to do the right thing and revoke the PMA. There are now over 10,000 adverse event reports documenting problems in the FDA MAUDE database and over 16,000 other complaints, which were turned over to the FDA from the manufacturers. At a prior meeting with the FDA, William Maisel was asked point blank how many women must be injured before the FDA does the right thing. Was it 5,000? 20,000? 50,000? Despite Maisel’s assurances that, “even one woman harmed is too many,” it is clear the number of women whose lives have been and will continue to be impacted is irrelevant to Maisel, the FDA and Bayer.