When the U.S. Food and Drug Administration (FDA) issued a black box warning for the Essure contraceptive device this past February, many critics felt disappointed. Women harmed by the device have called for its recall from the market since 2013, so only issuing a warning felt like a light sentence. In addition to the black box warning, the FDA also required the manufacturer, Bayer AG, to conduct a post-market study regarding the safety and efficacy of the device, but the post-market study will not be due to the FDA until 2023.
Between November 2002 and the end of 2015, the FDA received nearly 10,000 reports of adverse event related to the Essure device. Despite the overwhelming number of reports, the FDA is not requiring drug manufacturer Bayer AG to provide answers about Essure anytime soon.
Representative Mike Fitzpatrick sponsored a Bill requiring the FDA to pull Essure off the market, and he is particularly outraged by the FDA’s slow response. Mr. Fitzpatrick believes it is “unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market … If the FDA is going to order another study, then at the minimum they should take Essure off the market during that time.”
Essure Side Effects
More than 25,000 women claim to have been harmed by the Essure device. Side effects of the device include chronic abdominal and pelvic pain, allergic reactions, autoimmune reactions, fatigue, nausea, abnormal bleeding, and even fetal death.
Bayer maintains the benefits of its device far outweigh the risks, but thousands of women disagree. Lawsuits against the company have had a rocky start, with many being dismissed due to a federal preemption law protecting device manufacturers from lawsuits. But the tide has turned on the company. In early August, a California judge ruled 14 lawsuits against the company could proceed, and since then, hundreds of lawsuits have been filed around the country.