Essure birth control complications are serious concerns for women across the United States who have the Essure device implanted. Bayer HealthCare has allegedly fallen behind schedule in its post market study regarding the safety of the medical device.

Consumer advocates state the Essure contraceptive device should not have been released into the market and that further inquires are needed to properly evaluate the likelihood of Essure birth control complications.

Bayer HealthCare insists that the Essure contraceptive is a safe and effective alternative to traditional tubal ligation and is a “valuable contraceptive option” for women.

The FDA is stuck in the middle of the debate in trying to determine if the Essure contraceptive device  is unreasonably dangerous to patients. FDA press representatives point out different post market surveillance studies for Essure which have examined the outcomes for both Essure patients and patients undergoing tubal ligation.

This study is not randomized but is open label, and currently has 136 participants at 44 different locations.

According to Bayer HealthCare, the company announced it would stop Essure sales in September 2017 outside of the United States for “commercial reasons.” Consumer advocates believe there were other reasons behind this decision, with House Democrats sending a letter to FDA member Dr. Scott Gottlieb alleging the agency was being too lenient with the pharmaceutical company.

More specifically, the letter stated Bayer was “[dragging] its feet” on a post market study that was supposed to be conducted to analyze the Essure birth control complications. The study Bayer HealthCare is conducting should be ready in September 2023.

Overview of Essure Study

Members of Congress and an independent research team are calling for another inqury to be conducted. Dr. Aileen Gariepy of Yale School of Medicine is teaming up with the Patient-Centered Outcomes Research Institute (PCORI) to determine the risk-benefit ratio for Essure birth control complications.

Dr. Gariepy believes that part of the problem may have originated around the initial excitement of the Essure contraceptive and in the fact that it was the a far less invasive alternative to traditional female sterilization.

The Essure contraceptive device consists of two metal coils which are implanted into each fallopian tube. New tissue grows around the coils and ultimately blocks sperm-to-egg fertilization.

However, these coils have been allegedly inducing allergic reactions and other problems in thousands of patients.

In addition to the alleged Essure birth control complications, Dr. Gariepy stated the Essure procedures she conducted had caused “more problems.” These Essure injury reports have spurred major concern in the medical community, with Dr. Gariepy leading the independent study.

The PCORI study will examine California Medicaid claims data from 2008 to 2013, analyzing women who either underwent tubal ligation or had the Essure contraceptive implanted. The researchers will analyze the rate of success for both female sterilization methods, as well as the rate of complications including chronic pain, depression, allergies and adverse immune system reactions.

Almost 9,000 women who have had the Essure contraceptive device implanted and over 14,000 women who have had laparoscopic sterilizations are expected to participate in the study. Dr. Gariepy stated the preliminary results should be available in the spring of 2019, and the study is scheduled to conclude in July 2020.