FDA ordering that sale of Essure be restricted, some still call for it to be taken off market

(WXYZ) - For years, the 7 Investigators have been investigating the controversial birth control device called Essure. Now the FDA is ordering that sale of Essure be restricted.

“To me, it’s almost like a death sentence,” said Darlene Taylor back in 2013 about the side effects from Essure. She still feels the same today.

Taylor and thousands of other women have been battling to have their voices heard. They want the feds take the permanent birth control device called Essure off the market.

But now, the U.S. Food and Drug Administration is issuing an order restricting the sale and distribution of Essure. That means only doctors who commit to having patients sign a form acknowledging that they’ve been warned about possible side effects can implant Essure.

Essure is marketed as permanent birth control without surgery, as an alternative to tubal ligation. During the procedure, two metal coils are placed inside the fallopian tubes to block conception.

There had been 26,773 adverse events with Essure reported to the FDA as of December 2017, though it’s not clear if any of those are duplicate reports. For several years, women have been reporting side effects such as bloating, rashes, chronic pelvic pain, and miscarriages.

“The Essure coil broke inside of me, they recovered 1.5 cm of the Essure and I suffer now with fragments inside,” said Taylor on Tuesday.

The mother of four from Detroit says she had Essure implanted back in 2008 and ultimately had to have a hysterectomy.  Taylor is grateful for the new restrictions on the sale of Essure, but says the FDA needs to do more.

“No matter how many stipulations, no matter how many regulations you change or put on, it’s still just not a good idea.   It needs to be off the market today,” Taylor told 7 Investigator Heather Catallo.

Two years ago, the FDA ordered Essure’s manufacturer, Bayer, to add a black box warning label on the device about potential problems.  

Even though a Bayer spokesman says Essure is safe and effective, sales have now declined 70%. And the voices of the 36,000 women who call themselves E-sisters on Facebook have now been heard.

“They finally saw your news stories and connected the dots and said, I’m literally not crazy.  It’s literally not in my head, it’s in my body, and it’s called Essure,” Taylor told Catallo.  “You’ve led a lot of women to a bunch of help!”

A Bayer spokesman released this statement on Monday:

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.

If you have a story for Heather, please call 248-827-4473 or email her at hcatallo@wxyz.com.

Print this article Back to Top