FDA requires new study, black box warning for Essure

Courtesy of WRIC

RICHMOND, Va. (WRIC) — The U.S. Food and Drug Administration on Monday announced new actions to further regulate the controversial birth control product Essure.

The FDA is calling for a new, mandatory clinical study of the birth control device and a black box warning. A black box warning is the strictest medical warning put on the label of any medical device or prescription drug.

Click here to read the full release from the FDA.

A group of women known as the ‘E-Sisters,’ who have been pushing for months to have Essure removed from shelves, are not satisfied. They say they’ve provided sufficient evidence that Essure is unsafe and should be pulled from the market.

In response to Monday’s developments from the FDA, the E-Sisters posted the following statement on their website:

We are outraged that it appears as if the FDA is going to leave Essure on the market while it implements a draft guidance and labeling recommendations within a black boxed warning as well as ordering new clinical studies. Clearly Essure’s PMA should be revoked and the device should be pulled from the market. These studies could take several years, and leaving the device on the market will only put more women’s lives at risk.

We have provided the FDA with enough relevant data to prove that Essure is unsafe. Take the device OFF the market and revoke PMA. Do not continue to allow more women to be harmed. Unless the FDA takes those steps, we intend to push for Congress to force the hand of the FDA.  We will not be stopped or silenced.

While we continue to encourage women to file their adverse event reports with the FDA, our focus will be on Congress and the E-Free Act. We are disappointed but not surprised the FDA has once again chosen to side with industry rather than protect patients of a failed medical device.

Essure is just birth control. It will not save your life, but it can certainly take your life or the life of your unborn child. The risks do NOT outweigh the benefits!

The maker of Essure, Bayer, also issued a statement saying, in part, that it will, “continue to work with the FDA to implement measures to support the continued safe, effective and appropriate use of Essure.”

“Patient safety and appropriate use of Essure are our greatest priorities,” said Dario Mirski, M.D., senior vice president and head of medical affairs Americas at Bayer. “A woman’s decision to choose a birth control method is a very important and personal one, and Bayer is committed to providing physicians with resources, tools and information to help them counsel women about Essure.”

Bayer encourages anyone who has questions about Essure to speak directly with a trained Essure medical specialist. Individuals can call 1-877-ESSURE1 if they have questions.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s