Essure Devices Discontinued

Essure, a non-surgical female birth control device, has been in the news since 2018 when it was announced that its manufacturer, Bayer, would no longer sell the device. Essure is a permanent form of birth control that works by placing two metal spring-like devices constructed of nickel, titanium, stainless steel and PET fibers into each fallopian tube. An estimated 750,000 women use the device worldwide, with roughly 70% being from the United States. Originally approved by the U.S. Food and Drug Administration in 2002, it has been all downhill since.

Why is Essure being Discontinued?

Thousands of women throughout the united states and other countries have experienced severe negative side effects since using Essure, resulting in over 17,000 lawsuits against Bayer. Some claimed that the device moved out of the fallopian tubes and cut into nearby organs, while others say the device broke into pieces causing extreme discomfort.

After the FDA placed sale restrictions and black box warnings on Essure, the manufacturer Bayer decided that it would stop selling the product in the United States on December 31st, 2018. Although Bayer made the decision to stop selling Essure, the company held firm in their stance that the product was fully safe for the public.

Bayer’s Legal Response

Additionally, Bayer plans to defend themselves against the continuous flow of lawsuits that are being filed. Baylor has been using a legal defense called preemption to protect themselves throughout the process, a complex defense that boils down to the idea that Bayer was compliant with the FDA’s requirements. Bayer argues that since the FDA approved Essure at the federal level, Baylor is exempt from the claims that it failed to warn the public of its potential risks. In other situations, judges have dismissed cases for failing to meet court requirements.

In September 2019, Bayer made the decision to recall all units of Essure that had not been implanted, with the hopes of recovering all unused product by the start of 2020.

Retain Legal Assistance Today

Those who have suffered injuries due to their Essure product malfunctioning should take the steps necessary to hold the liable parties accountable for their negligence. Although victims are within their rights to file an injury claim against the at-fault party, victims should make sure to speak with an attorney before taking any legal action. An experienced attorney at Price Benowitz could take a closer look at your situation in order to determine what strategies are applicable to your case, who should be held responsible, and how much you should be compensated. To get started, or to learn more about the injury claims process, be sure to schedule a consultation today.