FDA Hits Essure With “Black Box” Warning

FDA WANTS STRONGER WARNINGS ON ESSURE Here's What The Agency Has Proposed BLACK BOX WARNING FDA "intends to require" a new black box warning "to better communicate to patients and providers the significant side effects or adverse outcomes associated with" Essure. In a Draft Guidance, FDA suggested the following language: WARNING: Some patients implanted with the Essure System for Permanent Birth Control have reported adverse events, including perforation of the uterus and/or fallopian tubes, intraabdominal or pelvic device migration, persistent pain, and allergy or hypersensitivity reactions. Some of these reported events resulted in device removal that required abdominal surgery. This information should be shared with patients considering sterilization with the Essure device during discussion of the benefits and risks of the device. Note that this language is only a proposal from the FDA, and may differ from any warning eventually put into effect by Bayer. PATIENT DECISION CHECKLIST FDA "believes that a patient decision checklist highlighting key risk and benefit information should be included at the end of the patient labeling brochure": POSTMARKET Essure is permanent STUDY Alternative forms of M birth control No form of birth control is M 100% effective Risks of Essure on a developing fetus have not been established Side effects Ordered Bayer to conduct In some patients, the Essure device can movoe after a new study on Essure's placement benefits and risks: Surgery is required to remove the implants "more clinical data is needed to better define and understand Each statement will be followed by a certain outcomes and events space for a patient's initials. After associated with or reported to be completing the checklist, a patient will have signed it 14 times. assoclated with Essure" NEARLY 10,000 SIDE EFFECT REPORTS Between November 4, 2002 and December 31, 2015, FDA received 9,900 side effect reports related to Essure. Most of these reports listed more than one problem. Pain / abdominal pain 6,989 (70.6%) Irregular menstruation | 3,210 (32.4%) Headache 2,990 (30.2%) † 2,159 (21.8%) 2,088 (21.1%) 2,016 (20.4%) | 854 (8.6%) Abnormal fatigue Welght fluctuations Patient / Device Incompatibility (possible nickel allergies are frequently reported) Device migration Device breakage 429 (4.3%) li 280 (2.8%) I 199 (2%) If 187 (1.9%) Difficulty removing device Most of the reports since 2013 have been voluntarily submitted Device incorrectly positioned by women with Essure implants. Difficulty inserting device 631 REPORTS OF PREGNANCY IN PATIENTS AFTER ESSURE IMPLANTATION: 150 294 204 23.8% 46.6% 32.3% LIVE BIRTH PREGNANCY LOSS 96 (32.7%) Ectopic pregnancy 43 (14.6%) Elective terminations of pregnancy 155 (52.7%) Other Out of 32 REPORTS Of the remaining reports: coded as death, the FDA judged 6 (18.8%) 2 INFANT DEATH AFTER LIVE BIRTH 15 PREGNANCY LOSS to be "incorrectly coded, as ADULT DEATH there was no indication of death in the report." *1. We have paraphrased the statements proposed by FDA. To read the full text, visit http://www.fda.gov/downloads/MedicalDevices/DeviceRegula- We urge you to visit Regulations.gov, read the tionandGuidance/GuidanceDocuments/UCM488020.pdf *2. Of the 26 remaining reports of death, several pertained to the same patient, according to FDA. We've chosen to simplify these numbers, entire Draft Guidance and presenting only unique reports, and the numbers listed will not add up to 26. comment with your References: thoughts and suggestions! http://www.fda.gov/downloads/MedicaDevices/DeviceRegulation- andGuidance/GuidanceDocuments/UCM488020.pdf http://www.fda.gov/MedicalDevices/ProductsandMedicalProce- Dures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm45 2254 htm DESIGNED BY BIRTHCONTROLPROBLEMS.COM OUR ESSURE LAWYERS WANT TO HELP https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm https://www.regulations.gov/#ldocumentDetail:D=FDA2016D04350001.