Ennis & Ennis, P.A.
Essure Victims Prepare For Battle With FDA
09/22/2015 - Right now, women are traveling from around the country to Washington, DC to take on the FDA over the serious and debilitating injuries caused by the birth control/sterilization device Essure. Thousands of women have waged a battle against Bayer, the manufacturer of Essure, for years to have Essure banned from the market over its dangerous side effects. On Thursday September 24th health experts and other FDA officials will review the potential risks of the Essure device and consider whether its use should be restricted or possibly withdrawn from the market.
Over 20,000 women have voiced complaints regarding the device. The FDA will be asked to discuss potential changes to the product’s label and whether further clinical studies should be conducted. It should be noted that the FDA has logged a nearly 1,400% spike in complaints regarding Essure in the last three years as more women have become educated in the myriad of symptoms and injuries that can be associated with the device. Women implanted with Essure have suffered numerous side effects including severe joint pain, weight gain, chronic fatigue, hair loss, debilitating headaches and abdominal pain, painful periods and intercourse. Other serious injuries include device migration and perforation, unintended pregnancies, which are often ectopic pregnancies and severe nickel allergies. Many young women are opting for hysterectomies, just to be rid of the Essure device.
Bayer is also alleged to have made false representations regarding the safety and effectiveness of Essure. Diana Zuckerman, who heads the National Center for Health Research, a Washington-based watchdog group that has been studying Essure, noted that “This device has been sold to tens of thousands-probably hundreds of thousand of women as a very safe and easy way to permanently end any concerns about pregnancy. We know that’s not accurate.” Zuckerman says that Bayer failed to fully inform the FDA concerning the problems the device can cause when it obtained its conditional approval in 2002. Further, although Bayer claims the device is 99% effective, Zuckerman noted that research suggests Essure may actually fail about 10% of the time.
Bayer spokesman, Edio Zampaglione, claims that for most women, getting sterilized with Essure is quick, safe and totally reliable. “What we believe and feel is that these women represent the small percentage of women who have had a bad experience with it. There’s nothing that we do or take in the medical world that is 100 percent adverse-event free,” he says. Zampaglione acknowledges that the device can cause complications, but says they only occur rarely. Tell that to the 20,000 ‘rare’ women who have suffered complications, often debilitating ones, from Essure. The September 24th hearing will be a pivotal and crucial time for the FDA. It has the power to do the right thing. Let’s see if it has ethical courage to do it and revoke the PMA it erroneously granted to Essure in 2002.
If you or a loved one has been injured by Essure, fill out a MedWatch form and contact the attorneys at Ennis & Ennis, P.A. for a free confidential consultation