Holly K. Ennis
Essure Advocates Seek Answers From FDA Regarding Black Box Warning
Last week two administrators from the Essure Problems Group, Angie Firmalino and Amanda Brooke Dykeman, along with attorney Holly Ennis and medical device specialist, Madris Tomes met with several key members of the Food and Drug Administration (FDA) regarding the long anticipated black box warning to be placed on the Essure permanent sterilization device. The Essure Problems Group has long been advocating for the FDA to revoke the controversial device due to the thousands of women who have been seriously injured by the device, requiring complete hysterectomies to remove the dangerous coils. The FDA announcement on February 29, 2016 that it would be requiring the black box warning was bittersweet to the women who pushed to have the device recalled, particularly as the warning has yet to implemented on the packaging.
The group sought specifics from the FDA such as when Bayer must implement the warnings, the specific language of the warnings and where the warnings will be placed on the packaging. It also queried whether it will be required on patient brochures and pamphlets as well since the actual packaged product is sent directly from the manufacturer to the physician or hospital meaning few, if any, women will actually see the product with the requisite warnings. The FDA was, not surprisingly, close-mouthed and hesitant to provide any real information or details concerning any aspect of the black box warnings other that it was “working on it” and that the warnings “remain a high priority for the FDA.”
The Group also questioned the FDA members regarding the proposed Patient Decision Checklist wanting to elicit information regarding the final proposed wording of the checklist, when it will be available to the physicians and whether the checklist language will be mandatory or modifiable by the physicians. The Group expressed concerns that there is not procedure in place to ensure compliance by the physicians. It was also recommended the patient checklist be required to be presented at the initial consultation for the procedure, not directly before the procedure begins, often while the patient has already been sedated as often occurs. Again, the FDA acknowledged the Group’s concerns but provided no real information regarding the final language of the Patient Checklist, when the checklist will be implemented nor if there were any procedures in place to ensure physician compliance.
The Group also discussed the Bayer’s upcoming 522 clinical trial, which has been ordered by the FDA. Again and unfortunately most of the questions were left unanswered. We queried, where will the new trial be held? Will the participants be informed there is a black box warning? What model number of the device will be used in the trials? Will the trials exclude women with known contraindications such as metal allergies and autoimmune issues? If so, would that now skew the data regarding adverse events? Will dental records and blood work be obtained prior to implanting the device? Can the participants have the device removed if requested? Do they have only physicians who are “experts in hysteroscopy” participating? We were told most of this information would be available pursuant to a Freedom of Information Act (FOIA) requests, although it would be largely redacted.
Overall, the meeting was an exercise in frustration. We are confident that a black box warning and patient decision checklist will be implemented but have no indication of when this will occur. Women interested in the black box warning should email the FDA and request this action be given the highest priority. Should anyone have any questions concerning the black box warning, patient decision checklist or upcoming clinical trial, please contact Holly Ennis at 800-856-6405 or visit us online at www.ennislaw.com.