FDA's Review of Medical Device Reports Related to Essure Removal Between January 2017 to June 2018
The FDA relies on a variety of postmarket surveillance data sources to monitor the safety and effectiveness of medical devices. The FDA continues to review the available information about Essure and the experiences of patients who have had Essure since the FDA approved it in 2002. Between January 2017 and June 2018, there were 11,854 medical device reports related to Essure in 2017 and 3,167 reports in 2018. Of those reports, eighty-five (85) percent referenced an instance in which the device was removed from a patient (referred to as "device removal reports" from here after).
- Eighty-three (83) percent of the device removal reports cite litigation.
- The top six reported reasons in the device removal reports were:
- Pain (57 percent),
- Device dislocation/migration/expulsion (11 percent),
- Genital hemorrhage (8.5 percent),
- Perforation (8.5 percent),
- Device breakage (2 percent), and
- Suspected allergy to metals (2 percent).
- Seventy-one (71) percent of the device removal reports did not provide information regarding patients' outcomes after device removal (or the outcome was unknown).
- Of the device removal reports that did provide information about patients' outcomes (29 percent):
- Fifty-four (54) percent stated patient symptoms resolved after device removal;
- Thirty (30) percent stated patient symptoms partially resolved (meaning only some of the symptoms resolved or symptoms were in the process of resolving); and
- Sixteen (16) percent stated patient symptoms were not resolved or improved.
- Ten (10) percent of the device removal reports suggest complications directly related to device removal. The most commonly reported complications related to Essure device removal which were reported in approximately half of the complications identified were:
- Device breakage,
- Coil migration and
- Device fragments remaining in the patient,
- Other complications reported include procedural or post-procedural hemorrhage, and uterine or fallopian tube perforation.
- Sixty (60) percent of the device removal reports specified a date in which the device was removed. Device removal reports included explant dates ranging from the year 2003 to 2018.
- Forty-nine (49) percent of the device removal reports provided both an implant and an explant date. In these reports, the mean and median time from implant to explant were both approximately 4 years.
The FDA will continue to evaluate medical device reports related to Essure removal and will keep the public informed if significant new information becomes available. While such reports are a valuable source of information, this type of reporting system has notable limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. Adverse event reports alone cannot be used to establish or compare rates of event occurrence. Additionally, we may receive multiple reports related to the same event, making it difficult to determine actual numbers of events.