Women who received the Essure birth control implant have filed lawsuits against the maker of Essure after concerns were raised about the implant’s safety. Among the reported Essure problems is a risk of the device migration, device breakage, and patient/device incompatibility (such as allergies).

Women who filed lawsuits say they have suffered severe pain and other Essure side effects and did not receive proper warnings about the risks of adverse events. Meanwhile, concerns regarding Essure were strong enough that the Food and Drug Administration (FDA) convened an advisory panel meeting on the issue.

The following is a timeline of Essure’s history with the FDA from device approval to the current situation.

November 4, 2002: The FDA Approves Essure

Developed as an alternative to surgical options for permanent birth control, Essure is approved by the FDA after a clinical study conducted by then-manufacturer Conceptus. The clinical study lasted only one to two years, but when the FDA gave Essure pre-market approval (PMA), it gave it with the condition that Conceptus continue to study the birth control implant in two clinical studies that would follow trial participants for five years.

As a condition of its PMA, any changes made to Essure in the months and years to follow would have to be approved by the FDA after the manufacturer submitted a PMA supplement. Since then, Essure has done so several times, generally for updated warning labels.

April 1, 2008: Essure’s Post-Approval Study is Submitted to the FDA

In keeping with the PMA requirements, Conceptus submits the results of their five-year follow-up study to the FDA. The study is done internationally, with sites in the United States, Australia, Belgium, and Spain, but there is no control group for the study.

The five-year study found that adverse effects after Essure implantation occurred in 9 percent of participants. These adverse effects included period pain, perforations, an expulsion of the device, and a retained micro-insert fragment, among others.

Of the seven women who suffered perforations in the five-year trial, one was not identified until 18 months after the Essure device was implanted. In another case, the perforation was not discovered until an exam following the removal of the Essure implant due to pain. One of the perforations was only found during a hysterectomy.

Critics of the five-year follow-up study point to its focus on pregnancy rates, and on the fact that five years of study on a device intended to be worn for the remainder of one’s life may be insufficient, especially given that it is not uncommon for women in their 30s to get the Essure device, potentially translating into 40 years or more of having the implant in place.

September 24, 2015: The FDA Holds a Public Advisory Meeting on Essure

With nearly 10,000 reports of adverse affects stemming from the Essure birth control device (by then manufactured by Bayer), the FDA decides to hold a public advisory meeting with experts, physicians, industry advocates and patients to discuss both the data available on the implant and the complaints filed against it.

During the advisory meeting, numerous women speak about the painful, and debilitating effects they feel are a result of choosing Essure for their permanent birth control. They touch on the changes to the lives, both at work and at home, and on the regret, they feel about their decision to choose the device.

Concerns are also raised about the risks that can arise during removal of the device, especially in the case of doctors who have not been trained on the procedure (unlike most of the doctors in the clinical studies).

The advisory meeting would be a key factor in new requirements from the FDA about Essure.

February 29, 2016: The FDA Announces Revised Essure Requirements

Taking into account the emotional public advisory meeting, the FDA issues a new, mandatory clinical study for Bayer to conduct on Essure. The aim of the study is to determine if there are heightened risks with the birth control implant for certain women.

At the same time, the FDA announced its intention to require Bayer to change the labeling of Essure, adding a boxed warning and utilizing a Patient Decision Checklist that would ensure women are fully aware of both the benefits and risks of Essure (and other permanent birth control devices) before selecting one.

Physicians are required to complete the Checklist with patients considering having Essure implanted.

March 29, 2016: Bayer Submits Study Plan Report

Per the requests made by the FDA after the public advisory meeting, Bayer submits their study plan report for another post-market study on Essure. In this study, 1,400 women with the Essure implant will be followed for seven years, while another 1,400 women who have undergone laparoscopic surgery for sterilization are studied during the same time span.

The first report of this study—a 6-month report—is due on March 3, 2017.

November 15, 2016: Essure Labeling is Updated to Reflect Risks

Several months after the FDA calls upon Bayer to update its labeling for Essure, the company does so, with a new boxed warning that includes safety statements about the serious side effects that may come with the permanent birth control. The new labeling also informs patients about the potential need for removal of the device.

Additional labeling for physicians discusses patient counseling and device removal—an area that many Essure users mentioned at the public advisory meeting.

What is the Situation Now?

Numerous lawsuits have been filed against Bayer for the adverse effects of Essure, and more continue to be filed. Additional studies are underway to shed more light on the link between the implant and the life-altering effects experienced by some patients.

If you or a loved one have or had the Essure implant and encountered adverse effects, contact Patterson Dahlberg for a free evaluation of your case and information on your rights. Our attorneys are experts in personal injury litigation and will provide the best possible representation for our clients.