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The Evolution of the [E]ssure Sisters

Ennis & Ennis, P.A. May 26, 2015

05/26/2015 - It is known that tiny droplets of water can eventually break down even the hardest of stone. In the case of the thousands of women, who have been injured by the Essure sterilization device, the drops of water have turned into a virtual tsunami. What started out as a single Facebook page by Angie Firmalino, seeking to share her painful journey and warnings, has evolved into a Facebook group of over 17,000 strong supportive women, fondly known as the E-Sisters. These women have Bayer in their crosshairs and will not stop until Essure is pulled from the market, the FDA rescinds the classification of Essure as a Class III medical device and federal preemption is deemed inapplicable to the Essure device based upon fraud in the pre-market approval process. There is no doubt that these amazing women will accomplish these goals.

Words cannot accurately depict all of the heart-wrenching personal stories and photographs of what thousands of ladies have endured as a result of the Essure device. Every single day women are fighting to undergo hysterectomies to have the devices removed. They battle reluctant doctors and insurance companies, determined to have the destructive coils removed from their battered bodies. Imagine the pain and misery, which would make one desperate enough to plead for major surgery to have two 4-centimeter coils removed, commonly referred to as ‘e-viction’ or ‘e-free.’ The suffering affects not only the women, but their families, particularly the children who watch their mothers endure a variety of injuries including abdominal pain, Ovarian and Uterine cysts, Uterine perforation, Endometriosis, PID, bleeding, unwanted pregnancy (often ectopic), Fallopian Tube Fibroids, Cervical Cancer and many other serious side effects.

Due to years of relentless efforts by the E-Sisters through Facebook, letters to Congressmen, visits and petitions to the FDA, rallies, fundraisers, and other awareness activities, their concerns are finally starting to be heard and acknowledged. Even Erin Brockovich has championed their cause and they are gaining serious traction. The group is extremely well organized, thoughtful and helpful to all women with Essure and women who are considering having the device implanted. They are extraordinarily informative and can assist in everything from how to file an adverse incident report to locating a doctor in a geographical area who performs removal procedures. However, what really affects and impresses is the compassion and closeness the group shares. The support and comfort the group emits is palpable

The group is making strides. A recent New York Times article brought to light the numerous problems and health concerns caused by the device and local news stations across the country have run reports featuring affected women. Additionally, doctors and certain watchdog agencies are also taking note. The Health News Review, a health news watchdog recently published an article indicating the Bayer had “glossed over” and downplayed the dangers of Essure with its incomplete and one-sided five-year follow-up study. The article noted that Bayer’s news releases, “ was unacceptably one-sided as it never mentioned that nearly a third of the women originally enrolled in the study dropped out for reasons that may reflect a bad experience, underestimates the levels of pelvic pain reported by the women and never discloses that the study’s lead author is a paid Bayer consultant.” The release also fails to note that the FDA has received more than 4,000 adverse event reports on Essure, that the original manufacturer, Conceptus, received more than 16,047 complaints and that a Petition, signed by more than 2,100 women has been filed with the FDA, asking the Essure be taken off the market.

Although great strides have been made by the E-Sisters, they will not, and should not rest until the device is removed from the market and the injured compensated for their suffering. If you or a loved one has been injured by Essure, contact Holly Ennis at Ennis & Ennis, P.A. for a free confidential consultation.