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 FDA’s most stringent review prior to marketing, using the Pre-market Approval (PMA) process. As a condition for the original PMA approval, the FDA required Conceptus to conduct two Post-Approval Studies to 1) gather five-year follow up information on the participants in the two premarket clinical trial patient cohorts (Phase 2 trial and Pivotal Trial) and 2) evaluate bilateral placement rate for newly trained physicians. In February 2016, the Agency ordered Bayer to conduct a postmarket surveillance study to obtain more data about Essure's benefits and risks.
After FDA approves a PMA, an applicant generally must obtain 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. Since Essure's approval, numerous PMA 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 (i.e., 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.
A list of all PMA supplements reviewed and approved by the FDA is available on the FDA website.