FDA Mandates New Clinical Study and Boxed Warnings for Essure Birth Control Device

On February 29, 2016 the Food and Drug Administration (FDA) announced the actions it would take to address the risks associated with Essure permanent birth control device.

A news release on the FDA website indicates that the FDA ordered Bayer, the manufacturer, to conduct a clinical study evaluating real-world side effects and complications associated with Essure. In addition, the FDA plans to require a boxed warning, the agency’s strongest type of FDA warning, explaining the adverse events that have been associated with Essure. A “Patient Decision Checklist” will ensure women receive and understand information about the benefits and risks of using Essure. The FDA is requiring a new clinical study to determine Essure’s risks for particular women. A 60-day comment period will give doctors, the public, and the device industry the opportunity to comment on the proposed actions.

Essure is a permanent form of birth control—a non-surgical alternative to standard sterilization surgery, which is done with small abdominal incisions. The Essure device consists of a small pair of flexible metal coils that are inserted through the vagina into the fallopian tubes. Essure creates scar tissue that blocks the tubes and prevents pregnancy. Essure can be inserted in a procedure in a doctor’s office, without the anesthesia and incisions required in surgical sterilization. But thousands of women who have had Essure inserted since its approval in 2002 have suffered complications. These include:

  • Persistent pain
  • Device migration
  • Perforation of the uterus or fallopian tubes
  • Abnormal bleeding
  • Painful sex
  • Allergy or hypersensitivity reactions
  • Unplanned pregnancy

In September 2015, in response to the many complaints, the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel to gather scientific and clinical information about Essure and to hear from affected women about their experiences with Essure.

William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said the FDA’s actions “will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them.” The actions “also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications,” Maisel said.

Bayer will be required to develop and conduct a study that will provide data to help the FDA better understand the risks associated with Essure and compare those risks to laparoscopic tubal ligation, the standard sterilization procedure. Bayer must include the rates of complications, including unplanned pregnancy, pelvic pain and other symptoms, and the number of surgeries to remove Essure. The study must also evaluate how Essure these complications affect women’s quality of life. The FDA will use the study results to determine what, if any, further actions related to Essure are needed to protect women’s health.

 

 

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