EXECUTIVE SUMMARY
The Food and Drug Administration has taken steps to ensure the safety of the Essure method of permanent birth control. The agency has issued a new, mandatory clinical study for the device to determine heightened risks for particular women.
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The agency also plans to change product labeling to include a boxed warning and a patient decision checklist to help to ensure women receive and understand information regarding the device’s benefits and risks.
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The action follows a September 2015 meeting of the agency’s Medical Devices Advisory Committee’s Obstetrics and Gynecology Devices Panel. The meeting included expert scientific and clinical opinions, as well as reports from women who have used the device. The panel meeting was called to weigh all evidence following complaints regarding the sterilization option.
The Food and Drug Administration (FDA) has taken steps to ensure the safety of the Essure method of permanent birth control. The agency has issued a new, mandatory clinical study to determine heightened risks for particular women. It also plans to change product labeling to include a boxed warning and a patient decision checklist to help to ensure women understand information regarding the device’s benefits and risks.
Essure is commercially available in the United States, Canada, Australia, and several European, Latin/South American, and Asia Pacific countries. About 1 million Essure systems have been distributed worldwide, according to information presented at the FDA hearing.
The Essure System includes an implantable insert and a delivery system for the placement of the insert. In contrast to other permanent sterilization procedures, Essure inserts are placed into each fallopian tube through the cervix using a hysteroscope. Once in place, the fibers within the insert elicit a local, fibrotic reaction, which causes fibrous tissue to grow in and around the implant, thus blocking the fallopian tubes.
As part of the Essure procedure, patients undergo a radiologic confirmation test via hysterosalpingography or ultrasound three months after insert placement to ensure the proper placement and/or occlusion of the fallopian tubes. Women are advised to use alternate contraception for the first three months until the confirmation test ensures tubal occlusion.
The Essure System was approved by the FDA in 2002 as a permanent birth control option for women who have completed their families. Originally brought to market by Conceptus of Mountain View, CA, Essure was acquired by Bayer in June 2013. According to the FDA, in late 2013, it received a significant increase in the number of adverse event reports related to Essure, particularly from patients who had received the device.
The 2016 regulatory action follows a September 2015 meeting of the FDA Medical Devices Advisory Committee’s Obstetrics and Gynecology Devices Panel. The meeting included expert scientific and clinical opinions, as well as reports from women who have used the device. The panel meeting was called to weigh all evidence following complaints regarding the sterilization option.
While the FDA officials say Essure remains an appropriate option for most women seeking a permanent form of birth control, some women might be at risk for serious complications, according to its February 2016 announcement. Such complications may include persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding, and allergy or hypersensitivity reactions.
How will the proposed patient checklist help with counseling women about the risks and benefits of the device?
“FDA intends to require a boxed warning and Patient Decision Checklist be added to the Essure product labeling to help to ensure that a woman receives and understands information regarding the benefits and risks of this type of device,” says Deborah Kotz, an FDA press officer. “The FDA has issued a draft guidance to provide the public an opportunity to comment on the proposed language to be included in these warnings.” (The draft guidance issued on March 4 is available at http://1.usa.gov/1U2pmeV. Comments are being accepted for 60 days.)
The decision checklist should be provided by doctors to patients to better communicate risks to support an informed decision-making process, says Kotz. The FDA recommends that the checklist be completed and signed by the patient and physician prior to proceeding with a permanent hysteroscopic sterilization procedure, such as Essure, she notes.
“The FDA believes that significant improvements in patient counseling are necessary and may be accomplished through the decision checklist and other information disseminated through professional medical societies, patient advocacy groups, and minority health organizations,” states Kotz. “Patients should be informed of all their birth control options, including all forms of sterilization techniques, before making the decision to use Essure.”
In its February 2016 announcement, the FDA also ordered Bayer HealthCare Pharmaceuticals of Wayne, NJ, the company that manufactures Essure, to conduct a new postmarket surveillance study on the device.
The study will provide data to help the agency to better understand the risks associated with Essure and compare them to laparoscopic tubal ligation, including rates of complications such as unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the Essure device. The study also will examine how much these complications affect a patient’s quality of life, as well as 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 the device are needed to protect public health.
Dario Mirski, MD, senior vice president and head of medical affairs Americas at Bayer, states, “Physicians who perform the Essure procedure will receive a communication from Bayer outlining the FDA action items and will continue to receive updates as we proceed. We will also continue to inform physicians on any labeling changes through our field personnel and other outreach.”
