The Food and Drug Administration will require the Essure permanent birth control system to carry a boxed warning about the device’s reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions.
The boxed warning should also state that if the device needs to be removed to address an adverse event, surgery will be necessary.
FDA officials released the final guidance Oct. 28 on labeling for permanent hysteroscopically placed tubal implants intended for sterilization, following the publication of draft labeling requirements in February 2016.
The guidance includes a Patient Decision Checklist to be signed by the patient and the physician, acknowledging that the risks and benefits of the device were discussed. The checklist is divided into sections detailing other birth control options, requirements for Essure placement (including contraindications), pregnancy risks with the device, what to expect during and after the procedure based on clinical studies, and long-term risks.
The new labeling requirements follow years of controversy about the device, which is currently the only permanent contraception option for women that can be performed without surgery.
In September 2015, the FDA Obstetrics and Gynecology Devices Panel reviewed the safety of the device after receiving more than 5,000 complaints of adverse reactions. Consensus from the 19-member panel was that there was a lack of data about the risks of the device and that patients needed better counseling before choosing it as a birth control option.
The final labeling guidance document seeks to address some of those concerns, according to the FDA.
“FDA believes this 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,” according to the guidance document.
In September 2016, the FDA approved a postmarket surveillance study plan from Essure’s manufacturer, Bayer. The 3-year study will compare safety and effectiveness between women who undergo hysterocopic sterilization with Essure and those who have laparoscopic tubal sterilization.
mschneider@frontlinemedcom.com
On Twitter @maryellenny
