Regulatory Focus™ > News Articles > 2019 > 5 > FDA Updates on Essure Postmarketing Study

FDA Updates on Essure Postmarketing Study

Posted 15 May 2019 | By Michael Mezher 

FDA Updates on Essure Postmarketing Study

Months after Bayer ended US sales and distribution of its permanent birth control device Essure, the US Food and Drug Administration (FDA) on Wednesday provided an update on the ongoing postmarketing safety review of the device.
“Even though this device is no longer sold, I want to reiterate the FDA’s commitment to regularly communicating with patients and health care professionals about Essure as more information is made available,” said Center for Devices and Radiological Health (CDRH) Director Jeff Shuren.
In February 2016, FDA announced it would require a new Section 522 postmarketing study and a boxed warning for Essure following thousands of complaints from patients that the device caused abdominal pain, menstrual irregularities, headache and fatigue, and in some cases unplanned pregnancies and miscarriages.
In July 2018, Bayer announced it would discontinue sales and distribution of Essure in the US at the end of the year, following the company’s decision to pull the device from international markets in 2017. In its announcement, Bayer cited declining sales as the reason for discontinuing sales of the device and said it stood by the product’s safety and efficacy.
In response to the company’s decision to end sales of the device, FDA announced changes to the ongoing postmarketing safety study as Bayer struggled to reach the study’s sample size.
FDA also said that the study will follow women for five years rather than the three years the study initially called for, and will feature additional blood testing in an effort to better understand patients’ immune reactions to the device.
In the update posted Wednesday, FDA said that Bayer had enrolled 891 patients in the postmarketing study as of 1 April 2019. Of those patients, 307 are women in the Essure arm of the study and 584 are women in the control group who elected to undergo laparoscopic tubal ligation.
Prior to the revised study protocol, FDA had expected Bayer to enroll 1,400 participants in each arm.
FDA said it considers the company’s progress on the study “to be adequate.”
Another update on the interim study results is expected once the enrollment of the Essure arm of the study is completed. Because the device has a shelf life of one year it is expected that women may continue to be enrolled in the study through December.
FDA also provided an update on the medical device reports it received related to Essure in 2018. FDA said it received 6,000 medical device reports concerning Essure in 2018, roughly half of the number it received in 2017.
“As in 2017, most of the reports received by the FDA in 2018 were submitted by Bayer and are related to litigation against the company, and most of the reports mention potential device removal,” FDA said.
From Essure’s approval in 2002 through the end of 2018, FDA said it has received nearly 33,000 medical device reports for the device, including 57 reports “coded by the submitter as death.”
FDA said that eight of these reports were improperly coded and did not indicate a death within the report. Seventeen of the reports relate to 15 adult deaths, with the remaining reports citing either loss of pregnancy, ectopic pregnancy or the death of an infant. However, FDA notes that it is difficult “to determine whether the device caused the death[s],” cited in the reports.
FDA also said it has received 2,230 reports of pregnancies, 454 of which cited live births. The remaining reports either did not specify the result of the pregnancy (704 reports) or reported loss of pregnancy (1055 reports).
Statement, FDA


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.