Essure Opponents Pursue Congressional Hearing
04/26/2016 - A representative group from the Essure Problems Group, better known as the E-Sisters returned to Congress last week to garner support for the E-Free Act and to strongly pursue a congressional hearing into the deceitful and inappropriate actions of Bayer and the FDA concerning Essure. The fight against the highly controversial sterilization device, Essure is gaining traction. The Group presented Congressman Jason Chaffetz with compelling reasons why a congressional hearing is warranted and imperative that the hearing be called quickly due to the continued danger to thousands of unsuspecting women. The request to Congressman Chaffetz can be reviewed in its entirety at http://essureproblems.webs.com/congressionalhearing-request-2.
Members from the group, including Kim Hudak, Kim Myers, Cecilia Bogle, Kim Hughes and Tess Schulman, worked tirelessly for two days, meeting with as many representatives and senators as could be scheduled. Also lobbying with the group were attorney Holly Ennis, who represents many individual clients harmed by the device and Madris Tomes, from Medical Device Events, who has been invaluable and instrumental in uncovering crucial data from the FDA Maude database regarding injuries and pregnancies intentionally hidden within the vast adverse event reporting system. The Group has been systematically meeting will each Congressional office to educate congressmen regarding the dangers of the device, why the E-Free Act is necessary to protect thousands of women and more importantly, why a congressional hearing is mandated at this time.
The bill seeks to revoke the pre-market approval (PMA) status originally granted to Conceptus in 2002. Bayer acquired Conceptus in 2013. If passed the legislation would require the Commissioner of Food And Drugs to issue an order withdrawing approval for the Essure System. The Act, entitled the “E-Free Act” states: “Not later than 60 days after the date of enactment of this 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. 360 e (e)) withdrawing approval for Essure System.” The bill presents a new and unconventional method to force the FDA to act. However, the FDA has been reluctant to address the injuries of thousands of women harmed by this device. Congressman Fitzpatrick noted the necessity of this bold move and stated, “If the FDA or manufacturers aren’t willing to act in the best interest of these women, Congress must.”
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. Recent well-respected studies have shown that women implanted with Essure were 10 times more likely to need reoperations with the first year of the procedure. Another Yale study indicated that nearly 9.6% of women could become pregnant within 10 years of undergoing the Essure procedure; a rate that is nearly four times the estimated risk after a laparoscopic tubal ligation, the more traditional method.
It is imperative that a congressional investigation be opened into the FDA’s actions concerning Essure. This is an urgent situation because on February 29, 2016 the FDA announced their irrational and illogical decision to leave Essure on the market while simultaneously ordering new clinical trials from the manufacturer for the device and placing a black-box warning on the packaging. The FDA has willfully ignored the advice of the experts on its own advisory panel. Not only has the FDA tasked Bayer with managing these new clinical trials (which is unreasonable because of their financial conflicts of interest), but the FDA also gave them an additional 15 months to start conducting them while the device continues to be sold to the public. As such, the FDA oversight of this device is an epic failure and women nationwide are bearing the costs of these failures. It is up to Congress to rectify this situation.