Holly Kelly Ennis
Essure's Suspension Lies in Hands of FDA: Will They Take Action?
A tenacious group of Essure Problems Group administrators, attorneys and data specialist met yesterday with FDA Commissioner, Scott Gottlieb, and ten additional FDA employees to discuss the significant ongoing problems with Essure, the controversial sterilization device. It is the latest in a series of meetings with the FDA that have left the Essure opponents frustrated, but determined. The highest priority for the meeting was to persuade the FDA to suspend the PMA approval granted to the device and pull it from the market, pending the outcome of the current clinical trials which are scheduled to conclude in 2023. During these next five years the women argued, hundreds, if not thousands of women, will continue to be implanted with the dangerous device without adequate warnings of the associated risks. .
The meeting opened with Dr. Gottlieb explaining why the Essure Problems Group administrators were previously excluded from the recent meeting with Dr. Gottlieb and Congresswomen DeLauro, Slaughter and Schakowsky. He asserted that this was based upon a long-standing policy of not having consitutents meet with the FDA along with members of Congress, due to perceived political influences and conflicts. The group's presentation than began with Essure Problems' founder, Angie Firmalino. Angie argued that following the 2015 FDA hearing, the FDA strongly agreed with the panel members that there were serious concerns with the device and ordered that a black box warning and a patient decision checklist be instituted, as well as requiring Bayer to undertake another clinical trial, which will not be completed until 2023 (and again will only show three years of data). Meanwhile, the black box warning and the patient decision checklist are NOT being given, so this remedial measure instituted by the FDA has clearly failed. She strongly requested that Essure be suspended until the manufacturer's post market study is complete. Then, if it is decided that Essure can return to the market, it was requested that the FDA mandate the black box warning and checklist. She concluded leaving Commissioner Gottlieb to ponder why the FDA finds it so important to keep this device on the market when it is so clear that the risks are heavily outweighing the benefits, especially for a non life-saving device.
Next, Madris Tomes from Device Events spoke and updated the FDA with data (from the FDA's own website) which the FDA did not seem to be aware of. She explained how difficult it is to search and obtain data through the FDA MAUDE (Manufacturer and User Facility Device Experience) database, so that the public and physicians have difficulty in accessing data. Madris provided data showing how complaints concerning Essure have spiked significantly over the past two years. It was noted that there have been over 18,000 reports of women undergoing either full or partial hysterectomies. Also noted were over 5,000 reports of pregnancy. However, as of the 2015 FDA Essure hearing, the FDA only noted 631 reports of pregnancies. Clearly, the MAUDE system is failing as well. (In fact an article released today in the Washington Examiner, "FDA must make medical device complaints transparent", coincidently addresses this very issue. The article noted that adverse event reports "can be so difficult to access, and so nearly impossible to put in perspective, that FDA regulators themselves are often unaware of the full stories they tell." What's worse, only a fraction of problems — one study says as few as 1 percent — actually end up in the database, according to medical journalist Jeanne Lenzer, author of The Danger Within Us.)
Tess Schulman spoke next and reiterated to Commissioner Gottlieb that approximately 95% of the women implanted after November 15, 2016 when the black box warning became effective, were never advised of the black box warning and were never advised of nor shown the patient decision checklist. The women were also not advised that the product was in current FDA mandated clinical trials which will not be completed until 2023. In many cases women were advised that this was their only sterilization option, particularly in the military. Tess noted that often in cases where the warning was actually given, it was downplayed by the physician.
Next, attorney Holly Ennis presented on why Essure's PMA should be suspended during the pendency of the current post market study. She noted that several panel members during the 2015 FDA hearing, as well as a New England Journal of Medicine article sharply criticized the original PMA approval study for following far too few women for too short a time frame and were based upon two nonrandomized, nonblinded studies which do not constitute proper clinical trials. It was noted there was sufficient evidence of altering clinical trial participants' medical records as well as allowing a physician who was cited by the FDA for altering medical records to participate in the current clinical trials. Ms. Ennis also noted that at the FDA hearing, several panel members were outraged that the nickel contraindication was removed from the product labeling and yet Bayer had no data regarding nickel allergies. Bottom line, Ms. Ennis argued, is that the product is not working: there are over 26,000 reports of malfunction and injuries in the FDA database and over 18,000 removal surgeries. This does not include the 32,000 complaints previoulsy received by Conceptus. We are the only country in the world that still has it on the market. The duty of the FDA is to protect the consumer from dangerous medical devices and to accomplish this, the product's PMA needs to be suspended until the clinical trials are complete.
In closing, Amanda Dykeman reiterated the group's position regarding suspending the device and holding Bayer accountable. She noted the FDA has often turned a blind eye to violations by the manufacturer without consequences. In order to uphold the integrity of the office, it is imperative the FDA do the right thing and suspend Essure's PMA until such time as the clinical trials are completed. This is a pivitol moment and Commissioner Gottlieb has the unique opportunity to do the right thing. He can make his mark as a Commissioner with the integrity to uphold the FDA mission to protect consumers from dangerous medical devices or he can join a legion of former commissioners with strong ties to industry and the public be dammed.