Ennis & Ennis, P.A.
Essure Opponents Return To Washington
02/10/2016 - 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, introduced by Representative Mike Fitzpatrick. The fight against the highly controversial sterilization device, Essure is gaining traction. 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 women worked tirelessly for two days, meeting with as many representatives and senators as could be scheduled as well as meeting with key figures from the FDA to further discuss concerns regarding the safety of the Essure device. 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
While certain E-Sisters met with key legislators to obtain support for the E-Free Act, other members of the group met with FDA officials to discuss potential FDA action regarding Essure. The group noted its concerns regarding clinical trial irregularities, inaccurate MAUDE data, proposed panel recommendations and potential testing protocols. Further exchange of information and additional meetings are expected to occur. The Essure Problems group is willing to assist the FDA in any way to provide accurate factual data to assist the FDA in making the appropriate decisions regarding Essure.
One thing is for certain. The tenacity of the Essure women is historic and they will not stop until the PMA for Essure is revoked, or the product is effectively withdrawn from the market. Women who have been harmed by Essure and need legal advice can contact attorney Holly Ennis from Ennis & Ennis, P.A., for a free confidential consultation or visit us online at www.Ennislaw.com and fill out an online form.