An Epidemico update on Essure
Essure, an implantable permanent birth control device, was introduced to the market and granted early approval by the FDA in November 2002. Reports of adverse events among women implanted with Essure surfaced shortly thereafter, increasing over time, principally over the past two years. As a result, the FDA’s Medical Devices Advisory Committee met on September 24, 2015 to discuss the risks and benefits of Essure, seeking expert scientific and clinical opinion, as well as hearing patient testimonials.
The Advisory Committee meeting focused on providing patients more information pre-procedure, guidelines for implants removal, and collecting more data on patients who develop a metal allergy or autoimmune disorders following the procedure. At this meeting, the FDA presented data from the 5,093 adverse event reports received from 2002 through May 31, 2015. Also noteworthy, the FDA Review Document included a summary of 350,000 social media posts from Twitter, Facebook, and select patient forums collected through Epidemico’s MedWatcher Social tool between September 2013 and July 2015. Please see infographic below to view frequently reported adverse events.
Epidemico has been collecting adverse event reports on Essure through the MedWatcher app since 2013, long before the Advisory Committee meeting. This Web and mobile app, developed by Epidemico in partnership with the FDA, allows the public to report adverse events directly to the FDA for streamlined and more transparent post-market surveillance. In August 2015 the Epidemico team, with Essure patient group representatives, published a study in Pharmaceutical Medicine analyzing the 1,349 reports received over 20 months, from May 2013 to Dec 2014. This study found that coupling an easy-to-use mobile tool with online community outreach yielded a high volume of well-documented reports.
Since the study period, we have received 2,916 more reports as of November 2, 2015, for a total of 4,255 adverse event reports over a two and a half year period. The number of reports received through the MedWatcher app continues to increase annually; out of the 4,255 reports received from 2013 to 2015, 4% were collected in 2013, 30% in 2014, and 65% so far in 2015. When asked about health outcomes as part of the report, approximately 78% of reports indicated at least one serious health outcome. While the large number of reports describing serious health outcomes is concerning, it is also important to note that there were many external factors that may have contributed to the increased number of reports and that these patient reported outcomes are not medically validated. View the below infographic for a more detailed timeline.
Regardless, these adverse events are no doubt a concern to patient safety, and the FDA recently announced they are reviewing the Advisory Committee meeting materials, and anticipate communicating their actions at the end of February 2016. We at Epidemico will continue to collect, analyze, and share data on adverse events reported through the MedWatcher app. With the public’s help in submitting reports, we can help make medical products safer, sooner.
FDA REVIEW DOCUMENT: REVIEW OF THE ESSURE SYSTEM FOR HYSTEROSCOPIC STERILIZATION. 2015. AVAILABLE AT:HTTP://WWW.FDA.GOV/DOWNLOADS/ADVISORYCOMMITTEES/COMMITTEESMEETINGMATERIALS/MEDICALDEVICES/MEDICALDEVICESADVISORYCOMMITTEE/OBSTETRICSANDGYNECOLOGYDEVICES/UCM463486.PDF
BAHK C, GOSHGARIAN M, DONAHUE K ET AL. INCREASING PATIENT ENGAGEMENT IN PHARMACOVIGILANCE THROUGH ONLINE COMMUNITY OUTREACH AND MOBILE REPORTING APPLICATIONS: AN ANALYSIS OF ADVERSE EVENT REPORTING FOR THE ESSURE DEVICE IN THE US.PHARM MED. 2015:29(6):331-340.