Holly Kelly Ennis
Essure’s Black Box Warning: Lipstick On A Pig
This week the Food and Drug Administration (FDA) announced that it has approved Bayer’s new labeling for the Essure sterilization device which will include a black box warning concerning certain risks associated with the device, including device migration, perforation, pain and allergic reactions. Although Bayer has not yet released the black box warning, FDA sources confirm that the boxed warning on the new label is identical to the final FDA guidance. The black box warning will state as follows:
WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.
It is axiomatic that the warning falls woefully short. It fails to address many of the other severe and significant injuries, including: chronic inflammation and foreign body reaction, chronic joint and back pain, chronic headaches, increased risk of autoimmune issues (including Lupus, MS, thyroid issues and Fibromyalgia), severe bloating/distended abdomen, hair loss, increased risk of ovarian, uterine and fallopian cysts and brain fog/cloudiness/confusion. Such concerns have been continually raised with the FDA as recently as September 2016 when representatives from the Essure Problems Group, Angie Firmalino and Amanda Brooke Dykeman, along with attorney Holly Ennis and medical device specialist, Madris Tomes voiced their concerns regarding the proposed warnings.
Bayer has also yet to release the Patient Decision Checklist it intends to provide to physicians. There has been no confirmation that the wording of the checklist is identical to the final proposal by the FDA, only that it adequately conveys safety and effectiveness information concerning the device. There are also no oversight procedures in place to ensure that physicians will comply and follow through with the appropriate consultations with the patients. However, according to the FDA, “Bayer will issue a letter to health care providers to inform them of the updated labeling and to explain the labeling changes in the instructions for use and patient information brochure, both of which will now include the boxed warning and Patient Decision Checklist. Bayer will also train sales representatives on the updated labeling and on the importance of doctors providing patients with the Patient Decision Checklist. “
Bayer plans to provide updated patient information in health care offices, including both print and digital marketing materials, which includes the necessary risk information to both providers and patients. Bayer must have the updated patient and physician labeling in place within 30 days.
The FDA also noted that with the approval of the new Essure labeling, it has concluded its evaluation of a trade complaint initially made in a Citizen’s Petition. The agency provided that, “With the approval of Bayer’s labeling changes for Essure, the FDA considers its investigations of the trade complaint completed. The FDA will ensure that Bayer’s revisions to their marketing and promotional materials are consistent with the new, approved labeling.”
Since the September 24, 2015 FDA hearing regarding the safety of Essure, the Essure Problems Facebook Group has grown to over 31,000 members. There have been over 1,907 reported removal surgeries, primarily hysterectomies, to remove the Essure devices, just since the September hearing. This number is expected to grow exponentially as more women connect their symptoms to the dangerous device. The number of reported pregnancies also continues to rise.
Bayer’s black box warning regarding Essure is like putting lipstick on a pig. Essure is still a pig, but with prettier packaging. The prudent thing would have been to pull Essure from the market pending the outcome of Bayer’s upcoming clinical trials determining the safety of the device. Essure is not a life saving device and there are a variety of other birth control options available. However, until such time as the FDA puts the safety of patients before the profits of the pharmaceutical and device industry, we’re stuck with a prettier pig.
If you have questions concerning any Essure issue, 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.