FDA to require Black Box warning for Essure birth control device
The agency will require Bayer to conduct clinical studies examining Essure's benefits and harms.
The FDA will require changes to the product labeling of the permanent birth control device Essure, which will include a “Black Box” warning detailing associated adverse events, as well as a patient decision checklist to help clinicians better inform their patients.
The agency has also ordered the manufacturer, Bayer, to conduct a clinical study to shed further light on the device's benefits and risks.
“The actions we are taking today will encourage important conversations between women and their [clinicians] to help patients make more informed decisions about whether or not Essure is right for them,” said William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”
Essure involves the insertion of flexible coils through the cervix and vagina into the fallopian tubes. After about 3 months, scar tissue forms around the inserts and creates a barrier that keeps sperm from reaching the eggs, preventing conception. Although the scar tissue forms, women must use an alternative form of birth control.
Since Essure's approval in 2002, the FDA has reviewed a significant amount of research regarding its use. Although the FDA believes that 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," the agency stated. "These may include persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding, and allergy or hypersensitivity reactions.”
The FDA's draft guidance provides an opportunity for the public to comment on the language that will ultimately be included in the product labeling to communicate to health care practitioners and patients the potential serious complications that can occur in some women.
The patient decision checklist will help clinicians discuss the importance of undergoing a “confirmation” test 3 months after the device is implanted to determine whether the implants are properly placed and that scar tissue has formed to prevent pregnancy. The FDA intends for the checklist to be completed and signed by the patient and physician before proceeding with a permanent hysteroscopic sterilization procedure, such as Essure.
The FDA will also require Bayer to develop and conduct a postmarket study, which will allow the agency to better understand the risks associated with Essure and compare them with laparoscopic tubal ligation. Data will include the rates of complications such as unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the Essure device. The study will also evaluate how these complications may affect a patient's quality of life. The FDA will use the study results to determine if further action is needed to protect public health.
- FDA takes additional action to better understand safety of Essure, inform patients of potential risks [news release]. Silver Spring, MD: U.S. Food and Drug Administration. Published February 29, 2016. Accessed February 29, 2016.