FDA and Essure
Between November 4, 2002 and May 31, 2015 the FDA received 5,093 complaints related to Essure.1 The majority of these reports were received from women who suffered injuries from their Essure implants.
The most common problems were pain (3353), problems with menses (1408), headache (1383), fatigue (966), and weight fluctuations (936). There were also five reports of fetal deaths that occurred in women who became pregnant following placement of the Essure device. In addition, four adult deaths were reported.
The FDA presented evidence at this hearing about the high rates of adverse events such as the need for additional surgery, device perforation/migration, chronic pelvic pain and nickel allergies. At the end of a lengthy hearing, the panel voiced concerns about Essure :
- Concern about the lack of studies to determine allergies to the materials used to make Essure
- Concern about whether physicians were properly trained not only to implant the Essure device, but also if physicians knew how to remove Essure
- Concern about whether physicians know when Essure is not right for a patient. The panel also suggested that “patients with a known hypersensitivity to metal, autoimmune disease, history of pelvic inflammatory disease and those with a history of abnormal uterine bleeding may be less suitable candidates for the Essure system.”
- Concern about the need for additional studies to better understand complications, including complications up to ten years after implantation3
FDA Orders Bayer into Action
On February 29, 2016, the FDA reported the next steps Bayer must take for Essure to stay on the market. The FDA stated in this report that Bayer must perform the following actions:
- Mandatory clinical study to determine the real world implications of Essure and its heighten risks in women (a post market surveillance study)
- Black box warning that contains a “patient decision checklist”
- A proposed checklist informed consent document4
A black box warning is the strongest FDA warning, suggesting that serious injury or death can result from the device. William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health stated that this February 2016 publication “will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them.”5