FDA Recommends Stronger Warnings for Essure

Brian Buntz

February 29, 2016

3 Min Read
FDA Recommends Stronger Warnings for Essure

Facing pressure from politicians and patients advocates, the agency is recommending more testing for the controversial Essure birth control product as well as a restrictive warning.

Qmed Staff


Bayer AG to perform more studies on its Essure birth control device, a coil-based fallopian tube implant. FDA is also recommending that the product carry a black box warning (describing the possibility of possible serious or life-threatening injuries) and that doctors use a patient-decision checklist to make sure that women treated with the device understand its potential risks.

"The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them," William Maisel, MD, deputy director for science and chief scientist at the FDA's CDRH said in a statement. In a press meeting, Maisel stated that the agency believes that "informed women should have [Essure] as an option available to them."

While the FDA statement doesn't go into detail, it does mention that the agency believes that certain women may face a heightened risk for complications and that "more rigorous research is needed" to determine which women are.

The device has been promoted as as a less invasive alternative to tubal ligation. Scar tissue forming around the device after implantation is intended to prevent fertilization from occurring.

The aforementioned patient checklist would include criteria to determine if a "confirmation" test  is required to determine if scar tissue around the implant has indeed formed to prevent pregnancy.

While the FDA believes that Essure is an appropriate treatment option for many women, some patients treated with the device have reported problems like chronic pain, bleeding, allergies, or autoimmune disorders that have persisted even after the device is explanted. Some women also

In September, FDA had instructed Bayer to perform more thorough post-market surveillance of the product. The agency plans on using this study to determine if further regulations are required.

The agency is accepting comments on the guidance document over the course of the next 60 days.

FDA has received thousands of adverse events linked to the devices. Recently, Rep. Michael Fitzpatrick, R-PA, has accused FDA of underreporting the number of adverse events related to the device, stating that the company counted had counted five fetal deaths linked to the device when there were really 303 fetal deaths. Bayer disagreed: "It is not true that an investigation revealed 'unreported' deaths with Essure," a Bayer spokesperson said in a statement.

Fitzpatrick clearly didn't like FDA's recent decision. "It's unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and [to] ask the manufacturer to perform another study while leaving Essure on the market," he was quoted saying in the Washington Post.

Fitzpatrick is the sponsor of the H.R.3920 - E-Free Act, legislation that would require FDA to pull Essure from the market.

In a Philly.com article, Fitzpatrick had criticized FDA's response time at dealing with injuries caused by dangerous devices to be "excruciatingly slow and ineffective in withdrawing something from the market."

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