FDA announces halt to U.S. Essure sales by Bayer

The FDA said today that Bayer will no longer sell or distribute its Essure permanent birth control device in the US, effective December 31. 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 enga...
Source: Mass Device - Category: Medical Devices Authors: Tags: Regulatory/Compliance Women's Health Bayer Source Type: news