Medical Devices

Regulatory History

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.
  • 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.
  • A list of all PMA supplements reviewed and approved by the FDA is available on the FDA website.


Page Last Updated: 04/09/2018
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