13 Investigates


FDA restricts contraceptive Essure

Posted at 3:50 PM, Apr 09, 2018
and last updated 2018-11-21 16:56:31-05

Thousands of women have reported serious problems with what was once a popular choice for birth control. Contact 13 has new information that's supposed to protect women from harm. 

It was advertised as surgery-free, hormone-free and worry-free. But Contact 13 started investigating claims back in 2013 from women who say they endured serious medical complications due to a contraceptive device called Essure. 

On Monday, the FDA is taking action, saying it's simply unacceptable that women are not being told about all the risks.  

Las Vegas women, and many more across the country, shared their stories of pain, confusion and denial.  Life-changing symptoms they linked to Essure -- a tiny coil inserted in the fallopian tubes to prevent pregnancy.   

Since our investigation nearly 5 years ago, the total reports the FDA has received about Essure is 26,773 -- as of Dec. 31, 2017.

They've taken steps to require warnings, but now the federal agency is imposing a unique type of restriction involving sales and distribution -- forcing manufacturer Bayer to only sell the device to doctors who can verify that they're telling patients about all the risks. 

Based on a growing body of evidence, the FDA says Essure requires additional, meaningful safeguards to ensure women can make informed decisions about risk when considering Essure.

According to the FDA, Essure sales dropped 70 percent in 2016 after they required Bayer to include a warning and checklist.  This new action comes after the feds found some women were still not getting all the information they should. 

Bayer provided the following statement:

Whippany, N.J., April 9, 2018 – Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved a label update for the Essure® System for Permanent Birth Control requiring healthcare providers to use the Patient-Doctor Discussion Checklist in order to purchase the product. The label now states that the sale and distribution of Essure is restricted to healthcare providers who counsel patients according to the approved label. The benefit/risk profile of Essure has not changed and remains positive.

Patients deserve the most accurate and comprehensive information to help them make their healthcare decisions, and Bayer has educated and continues to educate healthcare providers about the importance of appropriately counseling each patient on the benefits and risks of Essure. The FDA requested we update the label to emphasize this point.

The Patient-Doctor Discussion Checklist, which was added to the Essure label in November 2016, now includes the sub-title “Acceptance of Risk and Informed Decision Acknowledgement” to emphasize the importance of this tool. Bayer will continue to reinforce the use of the Checklist with healthcare providers and will inform them about this important label update.

Choosing a birth control method is a very important and personal decision. Bayer is deeply committed to providing women with safe and effective healthcare options that meet their individual needs, and is dedicated to ensuring the continued safe, effective and appropriate use of Essure as an important option for permanent contraception. As the FDA has repeatedly determined – after a rigorous review of the scientific evidence – Essure, the only non-incisional option available for those who seek permanent birth control, is a safe and effective medical device that benefits women by providing them with a valuable contraception option.

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