From the time of the FDA approval, there have been clinical study requirements that were attached to the initial review and final approval of the product. This was due to the fact the initial study that was submitted to the FDA was rather short (2 years) and did not involve a large number of participants (745 women). The FDA stipulated that Conceptus would be required to conduct two post-approval studies. The first was to “gather five-year follow up information on the participants in the two premarket clinical trial patient cohorts” and the second consisted of evaluating the rates of bilateral placement by newly trained physicians (FDA, 2018).

2013- Bayer AG of Germany acquired Conceptus. In this same year, patient labeling of the Essure product was updated to include risks of chronic pain and device migration. This was due to increasing concerns among thousands of women that were experiencing severe side effects and surgical removal of the devices.

2014- Bayer sales reportedly topped out over $47 billion.

2016- The FDA required physician and patient labeling changes as well as the requirement of a Patient Decision Checklist (FDA, 2016). A box warning included information about patients having experienced numerous adverse events (persistent pain, perforations of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen) and that surgical removal would be necessary to stop these. In the same year, the FDA announced that they were ordering Bayer to conduct post-market studies to determine the benefits and risks associated with the use of Essure.

2017- The European Union suspended the commercial license of Essure for a minimum of three months (Legal Reader, 2017). As a result of this action, authorities in France and Ukraine recalled the device and Bayer voluntarily recalled all implants in Canada, United Kingdom, Finland, and the Netherlands. The FDA also reported in this same year that they had received nearly 12,000 reports of adverse effects related to Essure (Reuters, 2018).

April 2018- The FDA update the physician and patient labeling again. This time, to include a restriction on the sale and distribution of Essure. This product would be restricted to only doctors and hospitals that reviewed the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement” with their patients and got signed consent prior to implanting Essure devices (FDA, 2018). In a letter to Bayer, the FDA stated that they “determined that these restrictions on sale and distribution are necessary to provide reasonable assurance of the safety and effectiveness of the device” (FDA, 2018).

July 2018- The FDA issued a press release stating that the maker of Essure, Bayer, announced that they would halt sales of Essure in the US. The commissioner of the FDA stated that they had been notified by Bayer and “that the Essure permanent birth control device will no longer be sold or distributed after December 31, 2018” (FDA, 2018). Bayer stated that they would withdraw Essure from the US market. The reasoning was not due to safety concerns, but because of declining sales.