3 Things to Know About Essure Birth Control Labeling Changes
Essure received approval in 2002 and is a permanently implanted birth control device for women that is not intended to be removed.
Essure received approval in 2002. It’s a permanently implanted birth control device for women that not intended to be removed. Based on adverse event reports, the FDA recommended certain updates to the approved labeling.1 Also, the FDA’s 2015 panel meeting revealed that women may not be receiving or understanding the risks and benefits of Essure. Pharmacists can collaborate with physicians to assist with Essure safety patient education. These 3 facts will help to serve as counseling points for patients inquiring about Essure birth control.
- Essure now includes a boxed warning1
The FDA approved the new boxed warning in November 2016, which will be made publically available within 30 days by the manufacturer Bayer. This includes the most significant adverse reactions associated with the device and its insertion. The FDA provided guidance that it can include reports of perforation of the uterus or fallopian tubes, persistent pain, and suspected allergic or hypersensitivity reactions. If Essure must be removed due to an adverse reaction, then surgery is required. Physicians should counsel patients about the risks and benefits of Essure.
Patients may ask pharmacists questions about Essure as a form of birth control, so it’s important to be up-to-date with the product. Let patients know that the Essure insert contains metals, including nickel, titanium, iron, and chromium, among others.2 Patients who are allergic to these materials can have a reaction following implantation. Symptoms of an allergic reaction include rash, itching, and hives. Pharmacists can communicate with physicians if patients are experiencing signs or symptoms of an allergic reaction to the Essure device.
- Labeling includes a patient decision checklist1
The Essure labeling now includes a patient decision checklist to highlight key risk and benefit information. The checklist should be reviewed and signed by the patient and physician. The document emphasizes that Essure is a permanent form of birth control. Other birth control options that are not permanent (eg, oral contraceptives, condoms) should be discussed with the patient. The document also states possible adverse effects that may result from the Essure placement procedure, which include cramping, pain, nausea, vomiting, dizziness, and vaginal bleeding.
The checklist also discusses steps to take after Essure placement. Pharmacists can play an important role in counseling patients to use an alternative form of birth control for at least 3 months.1,2 Patients must also schedule a confirmation test to verify that the Essure device is placed correctly before the alternative form of birth control can be stopped.
- Report adverse reactions to the FDA
Pharmacists and physicians should report any adverse effects associated with Essure to the FDA’s MedWatch program to assist with the monitoring of the device. The FDA is also requiring Bayer to conduct a new postmarket surveillance study to assess the risks of the Essure device in clinical practice.
- Labeling for permanent hysteroscopically-placed tubal implants intended for sterilization. FDA website. www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM488020.pdf. Accessed November 15, 2016.
- What women should know about Essure permanent birth control. FDA website. www.fda.gov/ForConsumers/ConsumerUpdates/ucm529208.htm. Accessed November 15, 2016.