- Makers of permanent sterilization devices, including Bayer’s controversial Essure, should include a boxed warning as well as a patient decision checklist in the package labeling, according to FDA final guidance issued this week.
- The FDA plans to require the new safeguards in future premarket approval applications and supplemental applications for devices already on the market.
- Possible health complications and clinical trial issues involving Essure have led to thousands of reports to the FDA’s Manufacturer and User Facility Experience, or MAUDE, database.
The boxed warning should note the types of significant or common adverse events associated with the device and its insertion, as well as a statement noting the patient should be informed of the risks when considering the device. The checklist, which highlights the device’s risks and benefits, would need to be signed by the patient and doctor before the procedure is done.
Bayer said it would change Essure’s labeling to reflect the guidance, Modern Healthcare reports.
In September 2015, the FDA called for an outside panel to review Essure’s safety. The device, a small coil placed in a woman’s fallopian tubes to prevent conception, has been linked to a host of adverse events, including heavy bleeding, pain, organ perforation, device migration, depression, hair loss, and fatigue.
That same month, an FDA advisory committee held a public meeting to discuss concerns about Essure’s safety and clinical trials used to support the device’s approval. A number of women alleged their side effects were soft-pedaled or attributed to other health issues, and that Bayer altered the reports they submitted.
More than 1,300 organizations and individuals commented on the draft version of the FDA guidance, which was published in March, including women who claimed they were injured by Essure.
Since Essure’s approval in November 2002, nearly 10,000 adverse event reports have been logged with the MAUDE database. The device is the subject of numerous lawsuits in state and federal courts.