FDA Announces Actions to Warn of Serious Essure Risks

Categories: Medical device litigation

The U.S. Food and Drug Administration (FDA) just announced actions to provide important information about the risks of using Essure, an implantable permanent contraceptive device. According to the FDA, the purpose of these actions is “to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization.” As reported by CNN, this announcement comes after more than 5,000 women filed grievances with the FDA between November 2002 and May 2015, complaining of unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding after an Essure implantation.

The FDA announced that it will require a “black box warning” label for Essure, as well as a Patient Decision Checklist to help to “ensure women receive and understand information regarding the benefits and risks of this type of device.” According to the FDA, a black box warning in the labeling of products is “designed to call attention to serious or life-threatening risks.” The FDA also issued a new, mandatory clinical study to examine the heightened risks.

As described by the FDA, Essure is 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. Unfortunately, women may be at risk for serious complications including persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions.

For more information about this FDA announcement or the Essure litigation, feel free to contact Pharmaceutical/Medical Device Litigation Attorney Pamela A. Borgess of Borgess Law, LLC at (567) 455-5955 or toll-free at (844) LAW-9144. You can also contact Borgess Law, LLC by submitting an online inquiry or emailing Attorney Borgess directly at pborgess@BorgessLaw.com.  Borgess Law never charges a fee for an initial consultation.