FDA Takes Steps to Ensure Patients are Informed of Safety Risks Associated with Essure

Additional information on FDA's review of Essure is available in our previous FDA News article entitled "Coming Soon: FDA Safety Review of Essure"

On Monday, February 29th, FDA announced that it will require Bayer, the manufacturer of the Essure permanent birth control device, to conduct a new postmarketing study to look into the safety of the device. In addition, FDA also stated that it “intends to require changes to product labeling, including a boxed warning and a Patient Decision Checklist to help ensure women receive and understand information regarding the benefits and risk of this type of device.”

Background

Essure is an FDA-approved permanent birth control device (female sterilization). The device is a small, flexible metal coil made of titanium and nickel, which works when the coils are inserted into each Fallopian tube. This causes the formation of scar tissue, which then blocks contraception by preventing sperm from reaching the eggs.

The device was originally developed by Conceptus, Inc., and was approved by the FDA in 2002; and in 2013, after being acquired by Bayer, nearly 17,000 adverse events were uncovered that had not been reported during the approval process, causing the FDA to dig a little deeper. After reviewing thousands of adverse event reports, the FDA decided to conduct another review of the device in 2015.

In a recent press release, the FDA stated that, although the Agency still “believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications.” As such, on February 29th the FDA issued a draft guidance regarding the potential risks of Essure and required Bayer to conduct an additional clinical study “to determine heightened risks for particular women.”

Draft Guidance

FDA’s draft guidance regarding the use of Essure “aims to increase patient and physician understanding of the potential risks associated with this type of device.” When finalized, the draft guidance will mandate Bayer to include a box warning on Essure, explaining the adverse events that have been associated with the use of the device. The warning includes those adverse events related to insertion and/or removal procedures.

In addition, “the draft guidance provides the public an opportunity to comment on the language that once finalized, will be included in the product labeling to communicate to health care practitioners and patients the potential serious complications that can occur in some women.”

Furthermore, “the draft guidance also includes proposed language for the ‘patient decision checklist,’ for doctors to discuss with patients to better communicate risks and help to ensure an informed decision-making process.” The checklist is intended to help doctors communicate the importance of undergoing a “confirmation” test three months after the device is implanted, which will determine whether or not the device is working properly.

Postmarket Study

In addition to the draft guidance, FDA is ordering Bayer “to conduct a new postmarket surveillance study designed to provide important information about the risks of the device in a real-world environment.” The FDA is requiring the study be conducted in an attempt to better understand the risks associated with Essure as compared to the risks of laparoscopic tubal ligation.

The Agency’s press release states that “the study will also evaluate how much these complications affect a patient’s quality of life. Additionally, it will collect information to identify reasons for why some patients don’t have a confirmation test to ensure that Essure has been properly placed three months after insertion. The FDA will use the results of this study to determine what, if any, further actions related to Essure are needed to protect public health.”

FDA is seeking feedback on the draft guidance and is asking the public to submit comments electronically or in writing by April 29, 2016.

Do you have a medical product that is already developed or in the process of being developed? We can help you verify that your device is compliant with applicable FDA regulations, as well as assist in the approval of your product. For more information on our services and how we can help you, contact us today.