Essure birth control has long been marketed as a safe, permanent and non-surgical method of birth control.

However, recent questions about the validity of the Essure research trials have patients and doctors wondering about the safety of the devices.

The Obstetrics and Gynecology Devices Panel was reconvened by the Food and Drug Administration in September 2015. Nineteen women’s health experts gathered together to take a closer look at the Essure device.

What is Essure?

Essure is a form of permanent female sterilization that has had a controversial past.

First approved in 2002, Essure went through a fast-track procedure for approval which is one of the reasons why the Essure research trials have been called into question.

Essure is made up of two flexible coils made of metal and polyester. During the procedure, they are inserted through the vagina and implanted into the fallopian tubes.

Tissue begins to grow and develop around the coils, essentially blocking the tubes and thereby subverting conception.

Essure patients are checked three months after implantation to verify that the procedure worked. The Essure process has been marketed as being safer than tubal ligation.

Essure Research Trials

When the FDA reconvened the group of women’s health experts late last year, the group was tasked with the purpose of researching the safety of the device as well as looking at the Essure research trials conducted before the device was approved 13 years prior.

When the FDA approved Essure, its approval was based on two Essure research trials. Many think these trials were limited in their scope. Fewer than 1,000 women participated in the the trials. But a couple hundred enrollees weren’t even included in the final conclusions.

The findings were based on only 664 participants. Nearly 300 participants’ results were not reported.

Of the nearly 300 missing reports, some chose not to undergo the Essure procedure. Some failed to meet the screening requirements. But many were excluded from the conclusions after the procedure failed or after they did not show up for the follow-up appointment.

After the first year of the Essure research trials, only 632 of 745 women with whom the procedure was attempted were followed by the study. After the second year, only 25% of the women were still being tracked.

What is alarming is that so few women in the trials were followed for long term effects.

One editorial in JAMA noted that although Essure is meant to be a permanent and life-long birth control method, “few women in the [preapproval] studies [had been] followed more than a year – a limitation that precludes conclusions about longer-term risks.”

Now, however, there has been time to look at the long term risks of Essure. Since its inception, more than 5,000 adverse side effect reports have been reported to the FDA.

Also, the efficacy of the device has been called into question. At one time, Essure was thought to prevent pregnancy in 99.83% of women.

A recent study found that Essure may result in pregnancies for up to 9.6% of women. It may even be less effective than tubal ligation. Tubal ligation is over 99% effective.

Essure Side Effects

Some participants in the Essure research trials reported side effects such as constant pain, severe menstrual cramping and pelvic tenderness.

One participant reports that when she received a report of her symptoms, some of her own notations had been altered, crossing out the word “severe” next to her description of pain and changing her comfort level to “excellent.”

If you or a loved one have experienced Essure complications, you may have a legal claim. Fill out the form on this page now for a FREE and confidential case evaluation.