US FDA asks outside panel to review Essure safety

Bayer’s Essure is the only FDA approved non-surgical permanent birth control device. Approved in 2002 and sold to up to hundreds of thousands of women, the FDA recently called for an outside panel to review Essure’s safety after thousands of women complained of various complications.

The FDA is scheduled to have a follow up meeting on Thursday to discuss the safety of the device after numerous women have said they faced debilitating side effects.

“Over the past several years, the Agency met with patients and patient advocates to better understand patient issues and experiences after Essure placement,” the FDA said in a statement on Monday. “We will continue to work with these individuals as we continue our efforts to better understand their experiences with this device.”

While Bayer, which produces Essure, has acknowledged side effects including pelvic pain, migration of the device or rash, women have said they have experienced other unlisted side effects.

The FDA said it found 20,000 complaints from women who shared their stories on Facebook and Twitter. In a review of the device before this week’s planned meeting, the FDA said “significant limitations must be taken into account when reviewing the data,” on the device.

The agency also reported that “over the past 2 years, FDA has seen a dramatic increase in the number of adverse events submitted in relation to the Essure device.”

Bayer officials have said they appreciate the opportunity to discuss the matter with the FDA.

“While there are risks with all medical devices and procedures, Bayer’s highest priority is patient safety, and we sympathize greatly with any woman who has experienced problems with Essure,” the company said in a statement on Monday. “We continue to be committed to maintaining an open dialogue with any patient who has questions or concerns about Essure.”

The company said 10,000 women were studied with the device before it was approved.

Agencies/Canadajournal