Ennis & Ennis, P.A.
FDA Panel Hears Testimony Regarding Essure
09/28/2015 - The FDA held a 12 hour emotionally charged hearing on Thursday to evaluate the risks and benefits of the Essure Sterilization device after receiving complaints from thousands of women who have been harmed by the device. The Panel gave some initial recommendations after hearing presentations from Bayer, FDA representatives, patient advocates and patients harmed by the device. The most common refrain from panel members was that much more information and data was needed regarding the device.
Some of the panel members, particularly Richard Chappell of the University of Wisconsin, were quite critical of the FDA for conditionally approving the device in 2002, without having the gold standard, randomized clinical trial before approving Essure. The clinical trials were grossly inadequate both in size and in scope. A recent article in the The New England Journal of Medicine also sharply criticized the premarketing approval of Essure based on the two nonrandomized, nonblinded prospective studies that lacked a comparator group and enrolled a total of only 926 women. Just 197 (25%) of the women were followed for effectiveness at 2 years, despite the fact Essure is designed to remain in place permanently.
Dr. Diana Zuckerman, president of the National Center for Health Research, was also critical of the initial clinical trials concerning Essure. “Women are telling us that if they reported pain during a study they were thrown out of the study.” Her center conducted its own study of more than a thousand women with severe symptoms and over 86% of them reported pain. Two Essure patients also testified and accused the manufacturer of falsifying their medical records from clinical trials and provided examples of the falsified records. The FDA downplayed these accusations claiming possible medical record tampering was sporadic and there, “was not a pattern of discordant reporting.”
The most provoking and emotional testimony came from the women implanted with Essure who have suffered debilitating injuries from the device. Angie Firmalino, creator of the Facebook page EssureProblems, which has over 21,000 members presented moving testimony on behalf of the group members. “We’ve watched mothers have to bury their babies, after essure coils perforated the infant’s amniotic sac. We’ve had to mourn the loss of women in our group. We’ve seen suicides, and we’ve seen death during or after Essure related surgery. We watch surgery after surgery every single day in our group, and the complications that come with them. We’ve seen coils in the spine, in the colon, in the kidney, in the cervix. Husbands walking out on families because we can no longer have sex due to excruciating pain. We’ve watched mothers cry in despair because they cannot take care of their children anymore, we watch women lose their careers, all because of problems from Essure. There are patterns of autoimmune diseases, cancers, pelvic adhesive disorder, PID, and other recurrent infections that will JUST not go away. These side effects are extreme. This is not just “period type cramping. “ The allergies some are experiencing are not just “simple dermatitis”. These are life altering side effects that stop you from functioning as a person.” Other patients’ testimonies were similar and heart wrenching.
The panel had various initial recommendations to the FDA including:
- that the insertion of the device be labeled a surgical procedure;
- that patients be provided much more extensive information prior to the implantation including the device contents, possible side effects and the possible necessity of removal;
- that the patients be required to sign an informed consent;
- that a registry be established to more accurately track patients with the procedure to - study any negative side effects for at least 5 years;
- that clear guidelines be established for when the implants should be removed;
- that there should more data obtained on patients who develop hypersensitivity to metal or autoimmune disorders following the procedure.
Although these recommendations are clearly small steps in the right direction, for most of the injured women, nothing short of a recall or revoking the PreMarket Approval for the device will suffice. For them, it is clear that the risks of the device clearly and significantly outweigh the benefits. Also clear is that due to grave irregularities in the clinical trials, and the entire premarket approval process, this device should never have received conditional approval in the first place. The FDA is accepting public commentary on this issue up through October 24, 2015. All persons with views regarding the Essure device should post comments at the following site: http://www.regulations.gov/#!submitComment;D=FDA-2014-N-0736-0015
If you or a loved one has been injured by an Essure device, contact attorney Holly Ennis at Ennis & Ennis, P.A. for a free confidential consultation.