FDA Drags Feet On Essure Black Box Warning
Aug. 10, 2016
On September 24, 2015, the FDA held a 12 hour emotionally charged hearing 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 and promised to provide its ruling and recommendations to the public.
The FDA indicated these concerns would be given high priority within the agency. It claimed that, “Patient health and well-being is our first priority regarding this device and all-medical devices This is a high priority issue for the agency, and we are working expeditiously to conduct an evidence-based review of the available information and identify appropriate next steps.”
Five months later, on February 29, 2016, the FDA finally rendered its decisions concerning Essure and (1) Ordered Bayer to conduct yet another post market surveillance study to obtain more data regarding Essure’s benefits and risks; (2) Required that a black box warning and Patient Decision Checklist be added to the product packaging/labeling to assist women in understanding the risks of the device and (3) and announced that the FDA will complete its evaluation of trade complaints regarding the device.
It is readily apparent that these FDA actions are woefully insufficient to address the needs of thousands of women who have been injured by the device, forced to undergo needless surgeries and/or have been left with debilitating autoimmune issues. Additionally, not only are the actions insufficient, they have STILL yet to be implemented six months later. As a result of this delay, there have been well over 1,652 removal surgeries since the September 2015 FDA hearing and hundreds more surgeries are being scheduled in the coming months. Women from the Essure Problems Group wrote to the FDA on June 8, 2016 indicating, “Although we can not stress enough the importance of removing the device from the market, the FDA has been recalcitrant in its refusal to do so. According, to fulfill the FDA obligation to protect the public, and not pharmaceutical companies, we believe it absolute imperative that certain warnings be added to the proposed black box warnings.”
The Group stressed that the following warnings are an absolute necessity and must be included on the packaging, indicating that, “we are hopeful, but not convinced, that these warnings will be provided to the women by their implanting physicians, since few if any, women, ever see the product packaging.” Such warnings include risks of the following:
Severe cramping and abdominal/pelvic pain
Heavy, painful periods (Dysmenorrhea)
Painful intercourse (Dyspareunia)
Severe bloating/distended abdomen
Chronic inflammation and foreign body reaction
Chronic back, joint and muscle pain
Weight and mood changes
Brain fog, confusion, and cloudiness
Increased risk of ovarian, uterine and fallopian cysts
Increased risk of developing autoimmune disorders including Lupus, Fibromyalgia, MS, Chronic Fatigue Syndrome, and Thyroid issues. (Also Essure should never be placed in women previously diagnosed with any autoimmune condition.)
Risks associated with polyvinylpyrrolidone (PVP) and the lubricious coating used on Essure. The FDA has published warnings regarding this exact coating for other devices.
Risks associated with Ablation. Ablation should not be performed at the time of the Essure implant procedure nor after the device has been implanted.
Two months have elapsed and the FDA has neither responded to the letter written by the Essure Problems Group nor issued the black box warning to be displayed on the Essure packaging. Next month will mark one year since the FDA hearing and still no action by the FDA, begging the question, why is the FDA failing to implement its own requirements for a black box warning and patient checklist regarding the dangers and risks of the Essure device? Women should contact the FDA demanding such warnings be issued to keep unsuspecting women from being irreparably harmed by the device.
Women who have been harmed by the device should contact the attorneys at Ennis & Ennis, P.A. for a free confidential consultation.