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# Essure Medical Device Reports Doubled in 2017
- URL: https://www.fdaweb.com/essure-medical-device-reports-doubled-in-2017/
- Published: 2018-03-07T12:00:00.000Z
- Updated: 2026-09-14T23:28:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140927

FDA says it received 11, 854 medical device reports related to Bayer’s Essure contraception device in 2017, more than double the 5,019 reports received in 2016\. “The nature and severity of the reports remain consistent with prior years,” an FDA Essure activity [update](https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm?ref=fdaweb.com) says. “However, in 2017, 78% of all manufacturer-submitted reports cited litigation, and may be referencing reports previously submitted to FDA.”

Also in 2017, the update says, 92.7% of all reports received used terms related to device removal, but some of the reports might not indicate that the device was removed or the date of removal. The agency says it is currently evaluating individual reports to better understand reasons for the device removal and patient outcomes where that information is provided.

Through 12/31/17 there were 48 reports coded by the submitter as death. Eight of them were incorrectly coded, the agency says, as there was no indication of death in the report. Of the remaining 40, 10 reports related to eight adult deaths; 23 reports related to 20 incidences of pregnancy loss; four reports related to four incidents of a death of an infant after live birth; two reports related to two incidences of ectopic pregnancies; and one report specified a death but did not indicate whether the death was before or after birth. “It is difficult for FDA to determine whether the device caused the death with only the information provided in the report,” the update says.

In a statement on the update, FDA commissioner **Scott Gottlieb** [says](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm600052.htm?ref=fdaweb.com) the agency is working to develop whether the cases reported in 2017 reflect new safety concerns, as well as the extent to which they represent entirely new reports to FDA or may have been reported in a prior safety filing. “We’ll provide updates on our evaluation of these data,” he says. “FDA will use the new information to continue to inform our assessments of the benefits and risks of Essure. We also rely on peer-reviewed medical studies to inform our thinking on Essure…. While FDA continues to believe that Essure may be appropriate for some women, based on our current information, the agency also recognizes that serious problems have been associated with its use.”