One of the key responsibilities of the Food and Drug Administration (FDA) is to protect the public health by ensuring the safety and efficacy of pharmaceuticals and medical devices.  While it is the responsibility of a manufacturer to perform safety testing, the FDA approves a drug or device based on the safety studies conducted and reported by the manufacturer. In instances where a safety issue does not become apparent until after a drug or device is already on the market, and the side effects are serious and life-threatening, short of removing it from the market, the FDA will require the manufacturer to add a boxed warning, or “black box warning” to the package insert/and or label. A black box warning is the most extreme warning required by the FDA and is intended to draw attention to the severity of the side effect. In February of 2017, the FDA issued a black box warning for Bayer HealthCare’s Essure, which was later amended in April of 2018, restricting sales of the device to doctors and facilities who use an approved checklist. Considering the horrible conditions caused by Essure, some individuals are outraged the product remains on the market, regardless of the existence of a black box warning.

When Essure was first cleared for women to use in the United States in November of 2002, a black box warning was not included as a protective measure by the FDA.  The reason for this being that, based on the safety and efficacy data originally presented by Bayer to the FDA, one was not needed. However, the safety and efficacy of Essure became questionable as adverse events were increasingly reported by women and physicians having used the device. A few of the terrible reactions women experienced, included: uterus and fallopian tube perforation; unintended pregnancies; device migration; and serious allergic reactions. Consequently, countries such as Brazil, The United Kingdom and Canada, have all banned the implantation of Essure altogether. Surprisingly, the United States is now the only country in the world where Essure is still being sold.

Despite current understandings, Bayer maintains that the benefits of Essure outweigh any risk and continue to promote the device as a safe and effective form of permanent birth control.  Equally, victims and consumer advocates alike believe the FDA chose to protect the makers of Essure instead of the endangered population. In efforts to resolve this discrepancy, the FDA added the “Patient Decisions Checklist” as a prerequisite to all Essure procedures.  As such, if a physician is considering implanting Essure in a particular patient, the physician is required to review a four-page, FDA-approved checklist, with the patient, prior to doing so. But as women continue to discover the link between Essure and their injuries, the requirement of an “approved checklist” still falls short, as the majority of the population believe that the risks exponentially outweigh any potential benefit. Meaning, the only resolution is to completely pull the device from the market in the United States.

It is clear that the problematic choice made by both Bayer Pharmaceuticals and the FDA to keep Essure on the market will continue to hurt women. As more can be done to ensure a woman’s safe access to birth control, our experienced lawyers continue to be the voice for those women who have been harmed by defective products. If you or someone you know has been injured as a result of the Essure device, the attorneys at the Yost Legal Group may be able to help you obtain the compensation you deserve. For a free consultation, please call us at 1-800-YOSTLAW.