FDA Commissioner Gottlieb Totally Misses the Mark on Essure

The FDA once again angered thousands of women yesterday when its chief officer defended the Essure device, despite mounting evidence of injuries caused by the device.  Commissioner Scott Gottlieb penned an industry friendly response attempting to justify the weak actions taken by the FDA, despite his acknowlegement that, "the agency also recognizes that serious problems have been associated with its [Essure's] use.”  Unfortunately, Gottlieb's response was not entirely accurate in many of its assessments.  For example, Gottlieb notes that Bayer, "estimates that more than 750,000 women worldwide have received the device implant since it was first approved." Bayer has used the 750,000 number for nearly five years now and states it is the number of devices sold, but not necessarily implanted. Many women were implanted with mutiple devices, many kits are still sitting on shelves, and other kits have likely expired. Accordingly, neither Bayer nor the FDA, has any idea of how many women were actually implanted with Essure, making all data collected inaccurate as the baseline number of women implanted has not been determined. 

Commissioner Gottlieb next maintains that the FDA has monitored the device for years and has taken affirmative steps such as instituting a black box warning and a patient decision checklist to make certain that women considering Essure recieve full access to information regarding the benefits and risks of Essure prior to being implanted.  However, as was fully explained to Commissioner Gottlieb (and presumeably to a select group of his staff who are former Sidley Austin attorneys, the lawfirm who coincidentally represents Bayer on all of the nationwide Essure litigation) since the FDA chose to make these a 'guidance' and not a 'mandate', doctors are blatantly refusing to inform the patients concerning the black box warning or go over the patient- decison checklist.  Out of 517 women who have joined the Essure Problems Facebook Group since the black box warning was implemented, 506 never received the warning nor was a patient decision checklist discussed.

Commissioner Gottlieb also noted that in February 2016, the FDA ordered the manufacturer of Essure, Bayer to conduct a post-marketing 522 study to better evaluate the safety profile of this device when used in the real world. Does it seem reasonable for the company making a profit from the manufacture and sales of the device to undertake, run and control a post-market study on the safety of the device? Are we truly expecting the results of the post-market study run by physicians paid by Bayer who already have a financial stake from implanting the device to fully portray the potential problems caused by the device?  Additionally, the study is not scheduled to be completed until 2023.  How many hundreds, if not thousands of women will be implanted and may be injured before the study is completed?  Doesn't it make even a modicum of sense to suspend the device from the market pending the outcome of the current clinical trials?  The rest of the world seems to think so.

Commissioner Gottlieb also noted that there were approximately 12,000 adverse reports received in 2017 for Essure and more than 90% mentioned issues involving potential device removal. Commissioner Gottlieb was provided information during the meeting with the Essure Problems Group that according to the FDA's own database, there were nearly 18,000 adverse event reports concerning device removals.  How many women must undergo hysterectomies to remove the dangerous devices from their bodies before it is enough?  Is it 20,000, 30,000 or even 50,000?  What is the magic number to say enough is enough?

Finally, Gottlieb noted that, "The FDA, ...protects the public health by assuring the safety, effectiveness and security of human drugs...and medical devices."  In no way has the FDA assured the safety of the Essure device for the 26,000 women who have reported Essure related injuries to the FDA.  At least 18,000 of these women have been required to undergo removal surgeries and it is well known that FDA adverse events are grossly under-reported. So unfortunately, the FDA's "assurances" of the safety and effectiveness of Essure is anything but reassuring.