Essure, a medical device which provides permanent sterilization for women,has been found to cause significant injuries and side effects. Marketed by Bayer HealthCare, Essure has been the subject of adverse event reports which reveal a trend of unanticipated side effects. The device is now under FDA scrutiny in order to track the prevalence of serious Essure problems, and is accompanied by a Black Box warning. Meanwhile, thousands of American women have signed a Citizens' Petition, urging the FDA to call for an Essure recall.
First approved by the FDA in 2002, Essure was originally a product of the medical device company Conceptus, Inc. Conceptus was acquired by Bayer in 2013. Approximately 750,000 American women have been implanted with Essure for sterilization. This page provides information on filing an Essure side effects lawsuit from attorneys handling Essure claims for women and families from around the United States.
According to adverse event reports gathered by the FDA, Essure side effects include persistent abdominal and pelvic pain, Essure perforation of the uterus and fallopian tubes, abnormal uterine bleeding,and hypersensitivity reactions and allergic reactions to Essure. Some patients have been forced to undergo one or more serious gynecologic surgery as a result of Essure injuries or to have the device removed. Finally, women report becoming pregnant despite having the device implanted. All of these side effects were incorporated into the new FDA Essure warning - a Black Box warning which was added in November of 2016.
As a result of a significant number of adverse event reports, the FDA has initiated an ongoing investigation into Essure problems. In 2015, the FDA convened an Advisory Committee on the matter, at which testimony was heard from medical professionals and patients. Then, in 2016, an Essure FDA warning was issued, adding a Black Box label with new Essure side effects information and announcing the launch of a postmarket surveillance study to track Essure problems. The study is tracking 2,800 women implanted with Essure in the United States and tracking Essure defects and problems including pelvic and abdominal pain, abnormal bleeding, allergic and hypersensitivity reactions, and the need for invasive gynecologic surgeries as a result of the device.
Despite the prevalence of Essure problems reports, the FDA has not called for an Essure recall. Bayer voluntarily stopped marketing the device in every other country, but the company was careful to say the decision was guided by changing consumer preferences (likely a result of all the negative press on Essure problems) rather than outcomes or safety concerns. Thousands of women in the United States have signed on to a Citizen's Petition to demand the device be recalled as a result of the serious side effects caused by Essure that are not listed in the product's warning label. The Essure petition asserts that trial results were altered to conceal adverse events caused by the medical device. To date, the FDA has not granted the demands of the petition and no Essure recall has been issued in the United States.
Attorneys handling Essure lawsuits nationwide believe that women and the family members of women who have suffered from Essure side effects may be entitled to significant compensation through filing an Essure lawsuit against Bayer. Essure lawyers are currently offering a free, no-obligation Essure problems case review.