FDA Commissioner Scott Gottlieb said the action follows a “series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use,” according to an FDA release.
“For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA. We expect Bayer to meet its postmarket obligations concerning this device,” Gottlieb said in a prepared statement.
In April, the federal watchdog put restrictions on US sales of Essure, a small metal coil that’s placed in the fallopian tubes via catheter, after concluding that some patients were not adequately warned of its risks.
The controversy around Essure has grown in recent years under an increasingly vocal patient advocacy campaign. As product liability lawsuits mounted so did the volume of Bayer’s self-reported adverse events; most of the reports filed last year came from the manufacturer, according to the FDA.
The FDA said that estimates indicate that Essure has been used by more than 750,000 patients, and has been “associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen.”
In its notice released today, the FDA compiled a list of all the official actions it engaged in related to Essure, dating back to Sepetember 2015 when it convened a panel of experts exploring how to investigate patient complaints. The following February, the agency ordered a postmarket study of the device, and in October 2016 updated the labeling.
In February 2018, the FDA said its officials met with women implanted with the device to listen to their concerns. The next moth, the FDA said it reported a rise in medical device reports from events in 2017, and in April it restricted the sale of the device.
“I want to stress that, even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events reported to our database, as well as other data sources. And we’ll communicate publicly on any new findings or concerns,” Gottlieb said in an FDA posting. “I also want to reassure women who’ve been using Essure successfully to prevent pregnancy that they can continue to do so. Those with Essure who suspect they may be having symptoms related to the device, such as persistent pain, should consult with their doctor on what steps may be appropriate for them to take.”