Essure is a birth control device made by Bayer. Many women opted for this form of birth control based on claims from the company that it was safe, there are now nearly 20,000 lawsuits pending in courts across the country claiming Essure exposed users to serious side effects.
According to Bayer, Essure offers permanent birth control that is safe, quick, and effective. Unfortunately, many women found at least two of those claims to be misleading.
Essure users experienced severe side effects that left them with long-term and in some cases permanent damage. These women claim that despite knowing these side effects were possible, Bayer failed to share the potential risks with doctors and patients, and even went as far to market their product as completely safe.
Essure Side Effects
A variety of complications are present with Essure, but some of the most common include:
- Development of autoimmune disorders
- Device migration
- Unintended pregnancy
According to claims against Bayer, the company failed to inform doctors and patients of the potential for serious side effects. Some Essure users even had to undergo operations to correct problems with their devices. Others experienced organ perforation, and still others are dealing with ongoing pain and suffering because the problems caused by their Essure devices cannot be corrected.
These women are seeking damages for physical, mental, and emotional anguish as a result of their Essure use. Some are also seeking punitive damages based on the fact that Bayer knew of the risks associated with the birth control device and failed to inform the public.
FDA Takes Action on Essure Birth Control
Problems with Essure were serious enough that the FDA eventually had to take action after receiving tens of thousands of adverse event reports.
The agency ordered the restriction of sales of Essure devices to women who reviewed a list of potential complications, signed off on their awareness of the risks, and still chose to go ahead with implantation of the device. This at least ensured that those using Essure were aware or the risks before device placement.
Bayer continues to defend the safety of its device, despite the legal claims filed against the company and despite its also acknowledging that some women have experienced problems. The company claims that the benefits of using Essure still outweigh any potential risks. Bayer also claims that it did indeed reveal the risks associated with the device and it continues to encourage women to be “wary” of all birth control options due to the various side effects that exist.
Essentially, Bayer said “buyer beware” in stating its birth control device is no more of a risk or any safer than any other on the market.
Netflix Documentary Calls Safety of Essure into Question
Bayer discontinued Essure in the summer of 2018, still claiming the device was effective but stating the market in the United States had dried up. In its announcement, the company stated that Essure sales had suffered from “inaccurate and misleading publicity.”
In part, it claimed the Netflix documentary “The Bleeding Edge” contributed to the decline in sales of its device.
The documentary follows a woman implanted with the Essure device, describing her adverse side effects and the problems she suffered after implantation. The documentary also looks at the medical device industry in general and how patients have been harmed by products marketed as safe and effective.
In addition to the documentary, a Facebook group called Essure Problems created by Essure users allows women to discuss their challenges and side effects with their Essure devices. Members also share news updates and advancements in their individual lawsuits against Bayer.
In March 2019, a federal appeals court tossed Bayer’s request to force a North Carolina woman to litigate her claim in federal court. Bayer had claimed the lawsuit should move out of a state court to a federal one because the device is regulated by the FDA – a federal agency.
This decision comes after the FDA approved an updated protocol for an ongoing Essure post-market surveillance study in December 2018. Based on the updates, patients will now be followed for five instead of three years and will undergo additional blood testing. There were also amendments made to various inclusion and exclusion criteria for enrollment in the study.