In February 2016, the U.S. Food and Drug Administration (FDA) requried the Bayer Company to include a new Essure boxed warning with this permanent birth control method.

This Essure boxed warning is meant to act as a guide to help women in conjunction with their physicians determine whether tubal ligation or Essure, a permanent sterilization method made of metal coils, is the best choice for them.

The FDA also required the Bayer Company to pursue a post-market study on Essure. This study was supposed to sign up 2,000 women over a three-year period with the aim that Essure patients and tubal ligation patients would then be compared to determine just what risks the coils presented to women.

According to the Regulatory Affairs Professionals Society (RAPS) in an article dated February 2016, the study allegedly was to begin within 15 months, with a plan submitted 30 days after notification.

According to a more recent RAPS article dated in late October 2017, three congressional representatives are questioning the progress of both the Essure boxed warning and the post-market study.

Representatives Rosa DeLauro, Jan Schakowsky, and Louise Slaughter from the states of Connecticut, Illinois, and New York, respectively, have sent a recent urgent communication to Dr. Scott Gottlieb, commissioner of the FDA.

The representatives’ letter addressed to the commissioner holds him accountable for allowing Essure to remain on the market despite numerous adverse event reports on the device.

The representatives further questions whether there has been any push to ensure that Bayer has made progress on enrolling women in its study. The representatives note that the FDA website indicates only one enrollee in the study with 60 approved sites after 20 months.

The representatives are very distressed at what appears to be a failure by the FDA to follow-up with the pharmaceutical and medical device giant and hold them to any standard.

This allegedly is occurring while many women are suffering inordinately. The Essure black box warning is indicative of many of the adverse medical events that women have supposedly experienced:

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, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during discussion of the benefits and risks of the device.

The three representatives refer to over 18,000 reports of problems that poured into the FDA regarding this device while Bayer seems to be successfully stalling at meeting the requirement posed by the regulatory agency.

Essure coils allegedly work by occluding the fallopian tubes with scar tissue that prevents egg and sperm from connecting. The coils take three months to induce this level of scar tissue, and sterilization is not guaranteed until a radiologic test with contrast is performed within this time window.