The Essure Device: ‘Safe and Effective?’

Written by admin on September 24, 2013

According the the Food and Drug Administration, Essure is a safe and effective form of permanent birth control for women. Similar to an intrauterine device, or IUD, it consists of two metal coils that are inserted in the Fallopian tubes. Scar tissue that build up around the coils provides a permanent barrier to sperm.

Hundreds of women are now coming forward to say that coils have caused them years of agonizing pain, an NBC station in New York City reported. Some women have even required hysterectomies to alleviate the symptoms caused by the device.

What Does the FDA Means When It Says ‘Safe and Effective?’

The FDA website reports that there have been 741 adverse event reports for Essure since it was introduced in 2002. That means 741 women out of the 750,000 who have had the device inserted have experienced complications. That translates to less than a 0.1% adverse event rate.

Pre- and post-market studies found that Essure was safe and effective, with a very low rate of complications. But explain that to the 741 women whose lives have been impacted by Essure. It’s also likely that many other women have suffered pain that goes unreported.

The lesson: no medical device is completely risk-free. When the FDA says “safe and effective,” it means “safe and effective for the majority of women.”

Essure is Not Safe for All Women

An important part of mitigating your risk of having complications is understanding what factors increase that risk. In the case of Essure, the FDA and the manufacturer may have failed to give women the information they needed to make an informed decision. When it was released in 2002, the packing of Essure warned about its nickel content. But in the last decade, health regulations have relaxed warnings about nickel on the product’s package. In 2011, hypersensitivity to nickel was completely removed as a contraindication for patients, as was the recommendation for patients to undergo a skin test to check for an unknown nickel allergy. While information on nickel allergies can still be found in the Essure patient information materials, physicians are not required to discuss the possible risk with their patients.

The result? Women with nickel allergies had coils made partly of nickel inserted into their bodies without their knowledge. This  nickel may be to blame for many of the serious adverse events caused by Essure.

A Lawsuit in the Making?

A class-action lawsuit is in the works for women harmed by the Essure device. They face the challenge, however, of demonstrating negligence on the part of Bayer, which markets the device. In order to sue the manufacturer of an FDA-approved device, lawyers have to demonstrated that the company intentionally withheld information from the public and health regulators, leading to the harms inflicted by the device.