FDA May Require Black Box Warning For Essure

162017_132140396847214_292624_nThe FDA announced on February 29, 2016 that its intends to require changes to product labeling for the Essure implantable form of sterilization, including a boxed warning and a Patient Decision Checklist to help to ensure women receive and understand information regarding the benefits and risks of the device.

The FDA is also requiring Essure’s manufacturer to conduct a new, mandatory clinical study for Essure to determine heightened risks for particular women.

Essure was approved by the FDA in 2002 as a permanent form of birth control that involves the insertion of flexible coils through the cervix and vagina into the fallopian tubes. Over a period of about three months, scar tissue forms around the inserts and creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. While the scar tissue is forming, women must use an alternative form of birth control.

The FDA reportedly received more than 5,000 complaints regarding Essure through May 2015 (80% of the complaints were received since late October 2013). Some of the complaints included deaths of patients, deaths of fetuses, and patients who required abdominal surgery to remove the Essure device. An FDA advisory panel recommended regulatory measures in September 2015, some of which the FDA will be implementing.

In announcing its regulatory actions regarding the Essure device, the FDA stated that it believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, but that some women may be at risk for serious complications, such as persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding, and allergy or hypersensitivity reactions.

The FDA intends for the black box warning to explain the adverse events that have been associated with implantable forms of sterilization devices, including their insertion and/or removal procedures, in order to increase patient and physician understanding of the potential risks associated with the devices.

The FDA’s proposed “patient decision checklist” would provide guidance for physicians in discussing with patients the risks associated with Essure and the importance of undergoing a confirmation test three months after the device is implanted to determine whether the implants are properly placed and that scar tissue has formed to prevent pregnancy. The FDA proposes that the checklist should be completed and signed by the patient and physician prior to proceeding with a permanent hysteroscopic sterilization procedure, such as Essure.

The FDA has ordered that Bayer, the manufacturer of Essure, develop and conduct a new postmarket surveillance study to provide the FDA with data to better understand the risks associated with Essure and compare them to laparoscopic tubal ligation. The study will include the rates of complications including unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the Essure device. The study will also evaluate how much these complications affect a patient’s quality of life, and will collect information to identify reasons for why some patients do not have a confirmation test to ensure that Essure has been properly placed three months after insertion. The results of the study will be used by the FDA to determine what, if any, further actions related to Essure are needed to protect public health.

Source

If you or a loved one had the Essure device implanted and suffered unexpected pain, bleeding, perforation of the uterus or fallopian tubes, or other complications, you should promptly seek the  advice of a medical device claim lawyer in your U.S. state who may investigate your Essure claim for you and represent you in an Essure claim, if appropriate.

Visit our website to submit a short, secure form, or call us toll-free in the United States at 800-295-3959, to find Essure attorneys who may assist you.

Turn to us when you don’t know where to turn.

This entry was posted on Wednesday, March 16th, 2016 at 5:12 am. Both comments and pings are currently closed.

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