FDA Recommends Boxed Warning, Decision Guide for Essure

Megan Brooks

Disclosures

October 28, 2016

The US Food and Drug Administration (FDA) has called for a boxed warning on labels for Essure (Bayer) permanent contraception (and similar products), as well as a patient checklist that highlights possible adverse events, such as perforation of the uterus or fallopian tubes, device migration, hypersensitivity reactions, and persistent pain.

Marketed as a nonsurgical alternative to tubal ligation, Essure is a small flexible metal coil implanted into each fallopian tube through the cervix and uterus. Within 3 months, tissue builds up, which creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. Until that time, the patient must use another form of contraception. Essure is considered a permanent form of birth control and therefore is not intended to be removed.

Over the past several years, the FDA has been looking into a "growing number" of adverse event reports associated with the use of Essure. These include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgery to remove the device.

This led the FDA to convene a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015, to hear expert scientific and clinical opinions and patients' experiences regarding the benefits and risks of Essure. They also solicited and reviewed more than 2800 comments on the device.

On the basis of the panel meeting and comments received, the FDA concluded that some women are not receiving or understanding information regarding the risks and benefits of permanent, hysteroscopically placed tubal implants that are intended for sterilization.

Therefore, the agency said today it believes that a boxed warning should be part of labeling for these products.

The boxed warning should note the types of significant and/or common adverse events that may be associated with the device and its insertion, use, and/or removal procedure, including those noted in clinical trials, as well as those reported in other device use experience, the FDA says. It should also include a statement noting that these risks should be conveyed to the patient during the decision-making process.

The FDA also recommends that products include a patient checklist to highlight key risk and benefit information, including key items related to the device, its use, and its safety and effectiveness. The checklist should be printed, reviewed, and signed by the patient and physician.

The FDA believes these actions "will help to ensure a woman receives and understands the benefits and risks associated with her contraceptive options so that she can make an informed decision as to whether a permanent hysteroscopically-placed tubal implant intended for sterilization is the right choice for her."

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