Ennis & Ennis, P.A.
Essure Victims Lobby House Members To Revoke Essure Sterilization Device
A group of women who have been gravely injured by the Essure sterilization birth control device met with several members of the House of Representatives this week to urge support for an upcoming Bill, which would require the FDA to revoke the Premarket Approval granted to the Essure device in 2002. The Bill, which is being co-sponsored by Congressman Mike Fitzpatrick and Congresswoman Rosa DeLauro, will require the Food and Drug Administration to revoke the premarket approval for the Essure permanent sterilization device within 60 days of the passage of the Act. The Bill is scheduled to be introduced on November 4, 2015, the 13th anniversary of Essure’s approval by the FDA.
Since the device was first approved in 2002, thousands of women have endured serious complications and injuries. The FDA has received more that 5,000 complaints regarding injuries caused by the device. Bayer, the current manufacturer of the device had previously received over 16,000 Essure related complaints. Essure has caused at least five fetal deaths and the deaths of four women arising from complications with the device. Thousands of other women have suffered debilitating injuries such as severe pelvic pain, migration resulting in perforation of the fallopian tubes, uterus or other organs, severe allergic and autoimmune reactions to the nickel component of the device, loss of teeth and hair, fatigue and severe migraines.
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. The approval process was replete with questionable conduct on behalf of the manufacturer. There were inadequate clinical trials performed, altered clinical trial records and surprising no premarket studies performed regarding the potential severe allergic and hypersensitivity reactions to the nickel in the device. Further, compounding the fact that there were far too few clinical trial participants to begin with, 30% of the clinical trial participants were “lost to follow up”.
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.
The women are counting on the members of Congress to take the necessary action to require the FDA to do what is right and just for thousands of women nationwide. They personally delivered a copy of the proposed Bill to each and every one of the 435 members of the House of Representatives and will seek similar support from the Senate when the Bill clears the house. The tenacity of the Essure women or E-Sisters is historic and they will not stop until the PMA for Essure is revoked. If you or a loved one has suffered an injury from Essure, contact the attorneys at Ennis & Ennis, P.A. for a free confidential consultation at 1-800-856-6405 or visit us online at www.EnnisLaw.com and fill out an online form.
Holly Ennis is a partner at Ennis & Ennis, P.A. and has been practicing law for over 25 years. She concentrates her practice representing plaintiffs against pharmaceutical and medical device manufacturers. She has represented plaintiffs who have participated in settlements involving Yaz birth control, Ortho Evra, Transvaginal Mesh, Pradaxa, NuvaRing, Metal Hip Manufactures and many more. Holly is a graduate of the University Florida College of Journalism and College of Law. To learn more about Holly Ennis, visit us online at www.EnnisLaw.com or contact Holly directly at 1-800-856-6405.