FDA Expected to Announce Results of Essure Investigation

A number of women are awaiting an announcement from the U.S. Food and Drug Administration (FDA) regarding Essure, a permanent birth control device sold by Bayer. The agency is expected to release the results of its investigation, which was launched following complaints from users.

Essure consists of two metal coils that are inserted into each fallopian tube to prevent pregnancy. It is marketed as a non-surgical alternative to female sterilization. However, safety concerns arose after thousands of women said the device led to various problems. One of them is Amanda Dykeman, who runs the online group “Essure Problems”. She told KWQC, “My hair was falling out, I had bloating out to where I looked 8 months pregnant, I was tired all the time.” Dykeman has been trying to get Essure taken off the market for several years. She and other advocates say they will continue to push forward, even if the FDA does not issue a favorable decision. “I think what the FDA is probably going to do is maybe give them a slap on the wrist,” she said.

According to Dykeman, an increasing number of women are coming forward with Essure problems. “Just over the last two years we’ve tracked over 4,000 device removal surgeries.” she said. She has passed those stories along to advocates in Washington who have been meeting with individuals involved in the Essure investigation.

Dykeman and other advocates intend to push for reform, even if the FDA does not take action; recently introduced legislation known as the “E-Free Act” would ban Essure. “We need to re-evaluate what we can do to make something work in the future,” said Dykeman.

Bayer insists that Essure is safe and effective and “supported by more than a decade of science and real world clinical experience.” Some doctors continue to use the device, and others are awaiting the results of the investigation.