Ennis & Ennis, P.A.
Formidable Essure Problems Group Returns To Washington
01/07/2016 - The indomitable E-Sisters will return to Washington in early February to continue their fight to have the Essure Sterilization Device removed from the market. The Essure Problems Group, now over 25,000 strong, is resolute in its determination to ensure the device will no longer be implanted in unsuspecting women and that women previously injured by the device can seek compensation for those injuries. Group representatives, including Angie Firmalino, Amanda Dykeman, Kim Hudak, Kim Myers, Amanda Rusmisell, Tess Schulman and attorney Holly Ennis will be meeting with various Representatives and Senators to discuss H.R. 3920, the E-Free Act.
The E-Free Act provides that: Not later than 60 days after the date of enactment of the Act, the Commissioner of Food and Drugs shall issue an order under section 515(e) of the Federal Food, Drug and Cosmetic Act (21 U.S. C. 360e(e) withdrawing approval for Essure System. The Essure Problems representatives will continue to garner support for the Bill as well meeting with Subcommittees of the Energy and Commerce Committee. Essure is a nickel based metal coil, wrapped in PET fibers that causes blockage of the fallopian tubes, thereby preventing pregnancy. It was erroneously approved in an expedited premarket approval process. There were inadequate clinical trials performed, altered clinical trial records and no premarket studies performed regarding potential allergic and hypersensitivity reactions to the nickel in the device.
Recent well-respected studies have shown that women implanted with Essure were 10 times more likely to need re-operations within the first year of the procedure. Another Yale study indicated that nearly 9.6% of women could become pregnant with 10 years of having Essure; a rate that is nearly four times the estimated risk after a laparoscopic tubal ligation, the more traditional method.
The group also plans to reach out to certain key Senators to discuss concerns regarding the controversial 21 Century Cures Act, which was recently passed by the House and is awaiting a vote by the Senate. The 21 Century Cures Act has been touted as an innovative way to get needed drugs and devices to the market quicker. However, the Act is fraught with landmines insofar as the Act allows the FDA to approve such devices, not based on randomized controlled clinical trials which is the gold standard for determining safety and efficacy; but rather on less scientific, anecdotal evidence such as case histories. One can only imagine the widespread medical disasters which could occur from such a cavalier approval process. Not surprisingly, recent documents and emails revealed the FDA worked closely together with device industry trade groups on proposed language for the majority of the device provisions. The FDA is a supposedly neutral regulator looking out for the public’s health and safety not, for the device industry.
The Essure Problems representatives are advocating for tens of thousands of women who have been adversely affected by the Essure device. They volunteer their time and effort and fund their own trips to Washington in order to effect the necessary change. Anyone seeking to support this worthy effort is urged to visit the you caring page at https://www.youcaring.com/firmalino-dykeman-myers-hudak-rusmisell-schulman-497742 and make a donation to help fund the trip.
Anyone who has been injured by the device and would like a free confidential consultation, contact attorney Holly Ennis at 1-800-856-6405 or visit us online at www. EnnisLaw.com and fill out an online form.