FDA to take 2nd look at Essure contraceptive

WPVI logo
Sunday, July 19, 2015

WASHINGTON, D.C. (WPVI) -- The Food and Drug Administration is taking a second look at a controversial contraceptive.

The agency has called a public meetingfor September 24th, to hear from supporters and critics on the Essure contraceptive coil.

The small metal coil, placed into the Fallopian tubes by catheter, was approved by the agency in 2002.

It remains the only permanent birth control device approved in the U.S.

Thousands of women have complained to the FDA, saying they've suffered pain, headaches, fatigue and other problems due to the device.

Some of them shared their stories with Action News in 2013.

The complaints include breakage, 'migration,' of bad positioning of the coil or had hysterectomies because of the implanted device.

More than 18,000 belong to a Facebook group, and call themselves 'E-sisters.'

In a release posted on its website, the FDA said it completed two studies reviewing "postmarket surveillance data."

The September meeting will be to discuss the findings and decide on "next steps" regarding the device

Bayer, which makes Essure, says the product passed a detailed analysis by the FDA.

There have also been several deaths of women potentially linked to Essure, the agency said, and five reports of fetal death after women became pregnant while using the contraceptive device.