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Response from Essure Problems Administrators to the Statement on Essure from FDA Commissioner Scott Gottlieb, M.D.

By December 21, 2018Uncategorized

Response from Essure Problems Administrators to the statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. Sales:

Prior to today’s announcement from Commissioner Scott Gottlieb, Essure Problems Administrators voiced serious concerns regarding the validity and feasibility of the 522 postmarket clinical study on Essure. We knew that Bayer meeting the enrollment requirement was going to be a significant issue as awareness about the dangers of the Essure device is everywhere now, especially since the Netflix release of The Bleeding Edge.

While we agree with the FDA  taking steps to lengthen the time frame to study the clinical trial participants from three to five years and ordering more specific blood tests to look at autoimmunity factors, the fact of the matter is that Bayer is still running the show and has a vested interest in providing favorable results. The FDA has permitted Bayer to significantly reduce the enrollment numbers of Essure patients and once again Bayer can escape violation of the study order. So, yet again, the sample size of women implanted with Essure in this study will be small. We simply cannot comprehend why the FDA continues to bend over backward for industry while women continue to be implanted and potentially harmed without holding Bayer accountable. The FDA has the authority to order all (Essure) kits off the shelves while women who have already been implanted are independently evaluated and studied, yet it refuses to do so.  

We have been contacted by two women who assert they were dropped from this 522 study soon after reporting problems with their Essure implants to their study coordinators.  Another valid concern which we have previously voiced to the FDA is that some of the clinical investigators retained on for this study are known, highly paid consultants to Bayer, one of which was cited by the FDA for various protocol deviations during a previous study. Furthermore, we have received multiple complaints from women who were implanted after the FDA’s April 9, 2018 announcement making Essure a restricted device, advising they were implanted with the Essure device without the requisite informed consent, nor the patient decision checklist.

Also concerning is that the FDA appears to be insinuating that plaintiffs’ attorneys are primarily responsible for the reporting of adverse events in recent years. Today and during the April 9th FDA announcement, Commissioner Gottlieb was sure to point out most reports came from cases that were made available by plaintiff attorneys as part of litigation against the manufacturer Bayer. However, when a lawsuit is filed, Bayer has a duty to report to the FDA as required. Regardless of who initiates a report of injuries caused by a device, the critical point is that the Essure device injured a woman and this injury is being reported to the FDA for the FDA to take the necessary action to remedy the situation.

Ironically, we’ve heard multiple reports from women being told by their physicians not to google the side effects of Essure because the problems being reported on social media are fueled by the lawyers and the lawsuit. This is a dangerous practice on behalf of Bayer and puts women at risk of not getting the full scope of information needed to make an informed decision. These doctors are violating the FDA requirements that all patients receive adequate informed consent, including disclosing that Essure has a black box warning and going over the patient decision checklist.