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FDA Finalizes Guidance on Boxed Warning, Patient Decision Checklist for Essure Devices

Posted 31 October 2016 | By Michael Mezher 

FDA Finalizes Guidance on Boxed Warning, Patient Decision Checklist for Essure Devices

The US Food and Drug Administration (FDA) on Friday finalized its guidance requiring a boxed warning and patient decision checklist for Bayer's permanent implantable birth control device Essure.

While the final guidance retains most of the recommendations made in the draft version, both the language of the boxed warning and patient decision checklist have been updated.

However, these changes are unlikely to settle concerns from patients who say they have been harmed by Essure, as many called for FDA to remove the device from the market in comments submitted to the draft guidance. In total, FDA received more than 1,300 comments on the draft guidance, the vast majority of which were from patients and patient advocates.


Essure is marketed as a non-surgical alternative to tubal ligation and consists of a pair of coils that are inserted into the fallopian tubes, prompting scarring which physically blocks a woman's eggs from being fertilized.

Essure has been the subject of controversy in the US, where the Facebook group Essure Problems has drawn attention to the device, citing patient complaints of pain, inflammation, menstrual irregularities, hair loss, fatigue and allergic reaction after implantation with Essure.

These complaints prompted FDA to convene its Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee in October 2015 to hear patient and expert testimony about the device.

Then, in February 2016, FDA announced it would require Bayer to conduct a large postmarketing study comparing outcomes for patients with Essure and patients who underwent tubal ligation to identify the risks to women posed by the device. At the same time, FDA released its draft guidance proposing a boxed warning and patient decision checklist for hysteroscopically-placed tubal implants such as Essure (notably, Essure is the only device of this type currently on the market).

Last month, FDA signed off on Bayer's study plan, an open-label, non-randomized, prospective observational study of 2,400 women that aims to evaluate reports of chronic abdominal and pelvic pain, abnormal bleeding and allergic reactions, as well as surgical removal of the device.

Boxed Warning and Patient Decision Checklist

The final version of the guidance includes minor changes in the language of the boxed warning.

First, FDA has changed the first sentence of the warning to note that patients have experienced the numerous adverse events listed in the warning. In the draft guidance, the agency merely stated that adverse events had been reported.

The second change involves the statement regarding surgical removal of Essure. In the draft guidance, the warning was made in the past tense, stating that some patients had Essure removed as a result of adverse events, whereas the final version cautions patients that "if the device needs to be removed to address such an adverse event, a surgical procedure will be required."

FDA has also revised the patient decision checklist proposed in the draft guidance to make it easier to follow in response to comments calling for the checklist to be simplified.

"We urge the FDA to consider condensing the information so that the checklist is more concise and manageable for both the patient and the provider, while still including the essential information," Planned Parenthood said in its comments.

Now, in the final version of the guidance, the checklist is broken up into sections grouping relevant topics, such as other birth control options, pregnancy risks and long-term risks. The new version is also about half a page shorter than the one proposed in the draft guidance due as a result of simplified and more direct language.

However, contrary to requests from Planned Parenthood and the Patient, Consumer, and Public Health Coalition, FDA did not add a reference to the boxed warning to the checklist.

FDA also received comments from two healthcare practitioner groups that opposed the boxed warning and patient decision checklist—the Association of Reproductive Health Professionals (ARHP) and the American College of Obstetricians and Gynecologists (ACOG). Both groups argued that the information presented in both the warning and checklist are based on anecdotal evidence, rather than clinical data.

"ACOG strongly recommends that the proposed black box warning language for hysteroscopic sterilization devices be revised to reflect only supported clinical data, or eliminated from the labeling requirements. We also strongly recommend that the Patient Decision Checklist be abandoned as a patient informed decision making tool for hysteroscopic sterilization devices," ACOG said in its comments.

FDA spokesperson Deborah Kotz told Focus the agency feels these checklists can help patients understand benefit-risk information about devices.

"The FDA recognizes the importance of patient-centered decision-making related to medical devices and strives to ensure that patients fully understand the benefits and risks of a medical device in order to make an informed decision on whether to use it," Kotz said.



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