FDA received 12k MDRs for Bayer ’ s Essure contraceptive in 2017

The FDA this week updated on its monitoring and investigations into issues related to Bayer‘s (ETR:BAYN) Essure contraceptive, saying it is currently evaluating approximately 12,000 reports received in 2017 related to the device, but that still believes the device to be appropriate for some women. The agency said the total number of medical device reports it received in 2017 was 11,854, though it specified that the majority of those reports were submitted by the manufacturer. “At the current time, the FDA is actively evaluating a significant collection of new medical device reports submitted to FDA on the Essure device. Of the nearly 12,000 reports received in 2017 for Essure, the majority were sent to the FDA in the last quarter of the year,” FDA head Dr. Scott Gottlieb said in a press release. “We’re working to evaluate whether these cases reflect new safety concerns, as well as the extent to which they represent entirely new reports to the FDA or may have been reported in a prior safety filing.” The total number of MDRs the FDA has received related to the Essure contraceptive device is up to 26,773, according to an agency press release. In 2016, the FDA said it received a total of 5,019 reports. The federal watchdog said that 78% of reports submitted last year by the manufacturer cited litigation, and that they may be referencing previously submitted reports. A total of 92.7% of the nearly 12,000 reports submitted last year were related ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Women's Health Bayer Source Type: news