Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said last year that in the 13 years since Essure’s approval, the agency had received 5,093 complaints, including for pain or menstrual irregularities after using the device, and complaints of the device breaking. In addition to 5 fetal deaths, there were 4 reports of adult deaths for reasons such as infection and uterine perforation, the FDA said.
Updated guidelines from the FDA will require a patient checklist to avoid possible adverse events and a boxed warning as labeling for these devices from now on, according to releases posted this week by the federal watchdog.
Boxed labeling will be required to display types of significant or common adverse events associated with the device and its application, the FDA said, including those from clinical trials and “those reported in other device use experience.”
Labeling will also be required to include a statement noting that “these risks should be conveyed to the patient during the decision making process,” according to the new FDA release.
The required checklist will highlight key risk and benefit information about the device and procedure, which will be required to show detailed probability rates for events within individual checklist items.
Alternative options, signs or symptoms of device-related complications and device materials are included as points on the checklist, according to the FDA release.
The FDA mandated a new study and new labeling of the device earlier this year.
In August, the FDA said it completed a review of a trade complaint which alleged that Bayer was engaged in clinical trial misconduct and altering data, saying it found no signs of manipulation.
The agency set out to review the allegations, which accused Bayer of clinical trial misconduct, “notably that clinical trial participants’ medical records were altered to reflect more favorable data about participants’ experiences, and that the sponsor violated the terms of the PMA approval order and violated laws that relate to the manufacturing and marketing of Essure,” according to an FDA release.