FDA Expert Panel Recommends Label Changes Better Guidance for Essure Birth Control DeviceSep 29, 2015
After collecting evidence from scientists and clinicians and hearing accounts from affected women, a Food and Drug Administration (FDA) advisory panel has recommended that the Essure birth control system should have more comprehensive instructions for insertion and follow-up monitoring.
At its September 24 meeting, the FDA's Obstetrics and Gynecology Devices panel reviewed post-marketing data, peer-reviewed studies, and hours of patient comments about the Essure device, before offering recommendations to the agency for best practices, stronger patient education, and increased collection of data, Medpage Today reports.
The panel called for:
- Developing a protocol that includes imaging during insertion to ensure correct device placement
- Establishing guidance for practitioners to be able to identify long-term complications earlier
- Supporting early intervention analysis if abnormal bleeding occurs following the procedure
- Requiring a checklist or signed informed consent form to ensure clinicians discuss risks, benefits, and alternatives
- Developing a patient registry for tracking the rate of pregnancies and adverse events
- Strengthening training programs for device implantation and placement
- Developing training for removal
The panel recommended label changes to indicate that the implantation is a "surgical" rather than "nonsurgical" procedure, as currently stated. The label should also indicate that the procedure may be more dangerous for the small percentage of women whose fallopian tubes are not "straight shots" but "tortuous," said Dr. Charles Coddington III, a gynecological surgeon at the Mayo Clinic.
Essure was developed by the California company Conceptus (acquired by Bayer Health in 2013), and approved in 2002 as a minimally invasive permanent birth control implant. Small, flexible nickel-titanium coils are inserted into the fallopian tubes to trigger the growth of scar tissue that blocks the tubes and prevents pregnancy. Follow-up imaging is required at three months to confirm that the fallopian tubes are blocked. Women are urged to continue using alternative contraception until the blockage has been confirmed.
The FDA has received more than 5,000 reports of adverse effects in women implanted with Essure. During the public discussion portion of the panel meeting, more than 30 patients described such side effects as severe abdominal pain, bleeding irregularities, migraines, painful sex, autoimmune disorders, extreme fatigue, psoriasis, and perforation of the uterus. The women attributed the symptoms to the Essure device. Some women said they became pregnant despite the device, Medpage Today reports.
Dr. Cheryl Iglesia, a surgeon at MedStar Washington Hospital Center, summarized the panel's consensus that the device was appropriate for patients who wanted permanent birth control and who had thoroughly discussed the device's advantages and potential harms with a physician. Iglesia said the device may not be appropriate for patients with chronic pelvic pain, autoimmune disorders, hypersensitivity to nickel or other metals, pelvic inflammatory diseases, or a history of abnormal uterine bleeding, according to Medpage Today.
The committee also recommended better monitoring of women who have had Essure implanted and earlier removal of the device when it causes problems.