FDA's Essure Black Box Warning Criticized

Chris Newmarker

October 31, 2016

3 Min Read
FDA's Essure Black Box Warning Criticized

Some patient advocates say it doesn't go far enough when it comes to warning about Bayer's controversial birth control device. 

Chris Newmarker

Updated November 1, 2016


FDA on Monday issued its final guidance for a black box warning for Bayer's controversial Essure sterilization device.

Some activists--already critical at what they said was foot-dragging by the agency--now complain that the warning doesn't reflect the actual dangers associated with Essure.

About 750,000 women have had Essure implanted since FDA approved it in 2002, according to The Associated Press. But reports of serious complications have increasingly dogged the device, which is meant to be a less-invasive alternative to tubal ligation. As of early this year, FDA had received nearly 6000 reports of problems related to Essure.

FDA acknowledges in its new guidance that its official believe some women are not receiving or understanding information regarding the risks and benefits of permanent tubal implants for sterilization.

Here's the example FDA provides of an Essure black box warning:

"WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device."

Rep. Mike Fitzpatrick, R-PA, a major medical device safety advocate in Congress, said the warning doesn't go far enough, and highlights why a law needs to be passed to revoke Essure's approval. "A boxed warning and patient checklist highlight the severe risks of Essure--but they're not legally enforceable requirements. Tens of thousands of women have been harmed by this unsafe medical device, including hundreds of fetal deaths," Fitzpatrick said. 

Holly Kelly Ennis of Ennis & Ennis P.A. (Miami, FL), one of the law firms involved in Essure litigation, complains that the warning "fails to address many of the serious and significant injuries caused by the device."

"While thousands of women affected by the device feel a BBW is mandated, the proposed warning falls woefully short; failing to address many of the other severe and significant injuries, including: chronic inflammation and foreign body reaction, chronic joint and back pain, chronic headaches, increased risk of autoimmune issues (including Lupus, MS, thyroid issues and Fibromyalgia), severe bloating/distended abdomen, hair loss, increased risk of ovarian, uterine and fallopian cysts and brain fog/cloudiness/confusion," Ennis writes in a blog post.

The FDA guidance also includes an example of a patient decision checklist. The checklist, for example, mentions that Essure includes nickel, titanium, iron, chromium, and tin, as well as a material called polyethylene terephthalate (PET)--and that rash and itching may occur even among people who have not had allergic sensitivities to such materials in the past. 

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

Like what you're reading? Subscribe to our daily e-newsletter.

[Essure image courtesy of Bayer]

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like