Essure Procedure Risks Result in Boxed Warning About Migrations, Perforations, Allergic Reactions

Following months of speculation about how the FDA would address growing reports of problems with Essure sterilization procedures, the federal health regulators announced this week that a new “black box” warning will be required about the risk that the birth control implant may perforate organs or migrate out of position.

In a press release issued February 29, the FDA indicated that it will require stronger warnings about the potential Essure procedure risks, and is indicates that the manufacturer must conduct additional studies to better understand the safety of the implanted coils.

The announcement also indicates that doctors will be urged to have women fill out a “Patient Decision Checklist” before having receiving the implant, to ensure they understand the risks before undergoing the procedure.

Essure is a permanent form of birth control, which is offered as an outpatient procedure where the doctor inserts bendable coils into the fallopian tubes. This process causes scar tissue to form around the coils over several months, which is supposed to block the tubes and prevent pregnancy.

Over the past few years, there have been mounting concerns about Essure procedure risks, with thousands of women submitting adverse event reports to the FDA involving painful and debilitating complications where the device migrated out of position, perforated the fallopian tubes, caused allergic reactions or other problems.

The announcement issued this week comes following a lengthy Essure safety review conducted by the FDA, which included an advisory panel meeting and testimony from women who have undergone the procedure and suffered devastating complications. In many cases, women have required a total hysterectomy for Essure removal after experiencing severe and debilitating pain.

While some critics had hoped that the FDA would require an Essure recall, arguing that the risks outweigh the benefits provided by the device, the agency has decided to leave the product on the market, opting instead for a black box warning; the strongest label warning the agency can require.

According to a draft guidance (PDF) issued on February 29, the warning should state:

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have reported adverse events, including perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, persistent pain, and allergy or hypersensitivity reactions. Some of these reported events resulted in device removal that required abdominal surgery. This information should be shared with patients considering sterilization with the Essure device during discussion of the benefits and risks of the device.

The guidance also details the patient checklist, which is intended to be reviewed and signed by both patients and doctors. The guidance notes that the FDA realized at a recent advisory committee hearing that some women are not receiving adequate information on Essure health risks or benefits.

“The action we are taking today 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,” Dr. William Maisel, deputy director for science and chief scientist at the FDA Center for Devices and Radiological Health, said in the press release. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”

The move comes as a growing number of women are now pursing Essure procedure lawsuits against the manufacturer, alleging that Bayer failed to adequately warn women of the risks of ectopic pregnancy, migration, organ perforation and infections.

The new boxed warning could spark more Essure complaints and will likely serve as a fixed point around which much of the Essure litigation will coalesce.