Essure (P020014) was approved November 4, 2002. At the time of approval, Essure was manufactured and marketed by Conceptus, Incorporated (Bayer acquired Conceptus on June 5, 2013). Essure is a Class III device and received the FDA’s most stringent review prior to marketing, using the Pre-market Approval process. As a condition for the original Premarket Approval, the FDA required Conceptus to conduct two Post-Approval Studies.
Post-Approval Study I was conducted to gather five-year follow up information on the participants in two groups of patients that were part of premarket clinical trials (known as Phase 2 trial and Pivotal Trial). The study evaluated:
- how well Essure prevented pregnancy;
- the safety of the procedure used to place Essure; and,
- the safety of Essure once implanted, including patient comfort.
Post-Approval Study II was conducted to evaluate bilateral placement rate (insert placement in both the right and the left Fallopian tubes at first attempt) for newly trained physicians in the U.S. Data from this study were used to evaluate the training procedures and to update labeling. You can view a summary of Essure Post-Approval Study results for the two studies ordered in conjunction with the Premarket Approval Application approval, which have been extracted from the Post-Approval Study Status web page.
In February 2016, the FDA ordered Bayer to conduct a postmarket surveillance study to obtain more data about Essure's benefits and risks.
After the FDA approves a Premarket Approval, an applicant generally must obtain the FDA's approval to make any change (including device design, manufacturing and/or labeling changes) that could affect the safety and effectiveness of the device by submitting a PMA supplement. A list of all Premarket Approval supplements reviewed and approved by the FDA is available on the FDA website.
Since Essure's approval, numerous Premarket Approval supplements have been reviewed and approved by the FDA, some resulting in labeling changes, notably:
- 2011: physician labeling updated to substitute a warning for a contraindication related to nickel. Current Essure labeling includes a nickel sensitivity warning.
- 2012: patient and physician labeling updated to include results of 5-year follow-up of subjects in Phase II and pivotal trials and information on pregnancies that have occurred in the commercial setting (that is, outside of clinical trials).
- 2013: patient labeling updated to include risks of chronic pain and device migration.
- 2016: physician and patient labeling updated to include boxed warning and Patient Decision Checklist.
- 2018: physician and patient labeling updated to include a restriction on sale and distribution of Essure to limit it doctors and hospitals that review the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement” with patients and obtain their signature before implanting the device. The FDA has approved this new safety measure to ensure that the device meets our standards for a reasonable assurance of safety and effectiveness.