Ennis & Ennis, P.A.
FDA Announces New Information Regarding Essure
06/25/2015 - In a highly anticipated “announcement” the FDA updated its Essure Web Page to add important information regarding Essure. Most importantly, the FDA indicated that it had been meeting with patients and patient advocates learning more about patients’ issues and experiences with Essure. As a result of such information, the FDA plans to convene a public meeting of the Obstetrics and Gynecology Devices Panel on September 24, 2015 to discuss scientific data regarding Essure. The panel will also hear feedback from presenters, panel members and the public and consider recommendations regarding the future of Essure.
The FDA noted that it had received over 5,000 Manufacturer and User Facility Device Experience (MAUDE) reports outlining different injuries and problems associated with the device. It is highly important that women affected by Essure complete and file reports with the FDA MedWatch to ensure the FDA has an accurate depiction of the thousands of women adversely affected by this device. 81% of the adverse event forms have been filed since October 26, 2013. The forms can be accessed at: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm2007306.htm.
The FDA also updated its website to include the risks associated with Essure. Besides pain during and immediately after the placement, short-term risks include cramping (often severe), vaginal bleeding and pelvic or back pain. Some of the long-term risks are ectopic pregnancy, pelvic pain, device migration into the lower abdomen or pelvis, perforation of the uterus or fallopian tubes and rash and itching associated with a possible nickel allergy. The FDA is still determining whether there is an increased risk of neonatal or pregnancy complications for women who become pregnant following Essure placement.
The updated web page also provides some limited information regarding the regulatory history and how Essure was approved and marketed. It noted the important label changes over the years including physician labeling to substitute a warning for contraindication related to nickel as patients may have an allergic reaction to the nickel in the device. In 2012, the labeling was updated to include the results of a 5-year follow-up of subjects in Phase II and pivotal trials and information regarding pregnancies after Essure. In 2013, a warning label was finally changed to include risks of chronic pain and device migration. The current patient information handbook is also included on the updated page.
The changes to the FDA Webpage and upcoming meeting come as a result of a resilient group of women injured by the device and determined to have the device removed from the market to prevent future harm. If you or a loved one has been injured by Essure, fill out a MedWatch form and contact the attorneys at Ennis & Ennis, P.A. for a free confidential consultation.