UPDATED November 18, 2016 // The US Food and Drug Administration (FDA) announced today it has approved a new label for Essure (Bayer) permanent contraception that includes a boxed warning about the risk for implant perforation, device migration, allergic reaction, pain, and other possible adverse events.
The label change has been long in the making, and it has yet to reach official closure. The FDA recommended a boxed warning in February after receiving thousands of complaints about the device since its approval in 2002 and weighing the recommendations of an advisory panel in September 2015. Last month, the FDA issued final, nonbinding guidance on both the boxed warning for Essure and a patient checklist that reviews possible risks such as the metal coil perforating the uterus or the fallopian tubes, where it is implanted.
In a document posted on its website today for both patients and clinicians, the FDA said it had approved new Bayer labeling "which is consistent with the recommendations of the final guidance."
"The FDA expects Bayer to make the updated Essure product labeling available within 30 days following the FDA's approval decision," the agency said. "A link to the new, approved labeling will be provided on this website as it becomes available on Bayer's website." (Today Bayer provided Medscape Medical News with a link to the new label: https://labeling.bayerhealthcare.com/html/products/pi/essure_ifu.pdf.)
Medscape Medical News asked both the FDA and Bayer for the official Essure label approved by the agency, but did not receive it. An FDA spokesperson, however, said that the boxed warning on the new label is identical to the example in the final FDA guidance. That example points out that some patients implanted with the Essure system have experienced adverse events such as perforation of the uterus and fallopian tubes and device migration into the abdominal and pelvic cavity.
"If the device needs to be removed to address such an adverse event, a surgical procedure will be required," the recommended boxed warning states.
The FDA said that, with the approval of the new Essure label, it has wrapped up its evaluation of a citizens' petition alleging, among other things, that Bayer had deceived the public and the FDA about the device's safety and efficacy by falsifying clinical-trial records. The petition was filed in 2015 by the Fort Lauderdale, Florida, law firm of Koch Parafinczuk & Wolf, which is representing hundreds of women who have sued Bayer alleging they were injured by Essure. Earlier this year, the FDA determined that, although a tiny percentage of patient records had been altered, there was no evidence that Bayer had purposefully modified data to make Essure look better.
More information on today's FDA announcement is available on the agency website.
To report any problems with Essure permanent contraception, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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Cite this: FDA Approves Boxed Warning for Essure - Medscape - Nov 15, 2016.