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Added a boxed warning and patient checklist in 2016
Restricted the Sale and Distribution of Essure in 2018
Received 26,773 medical device reports related to Essure from its approval date through 2017.
Most Reported Problems To The FDA Regarding Essure:
Dislodged or dislocated device
Device not operating as expected
Device difficult to remove/insert
Malposition of the device
Unintended pregnancies (ectopic pregnancies)
Death (adult and infant)
Heavier Menses/menstrual irregularities
Patient-Device Incompatibility (allergies-nickel)
Migration of the device or Device component
2011: Physician labeling updated to substitute a warning for a contraindication related to nickel. Current Essure labeling includes a nickel sensitivity warning.
2012: Patient and physician labeling updated to include results of 5-year follow-up of subjects in Phase II and pivotal trials and information on pregnancies that have occurred in the commercial setting (i.e., outside of clinical trials).
2013: Patient labeling updated to include risks of chronic pain and device migration.
2016: Physician and patient labeling updated to include boxed warning and Patient Decision Checklist.
2018: Physician and patient labeling updated to include a restriction on sale and distribution of Essure to limit it doctors and hospitals that review the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement” with patients and obtain their signature before implanting the device. The FDA has approved this new safety measure to ensure that the device meets our standards for a reasonable assurance of safety and effectiveness.
2018: Bayer announced they will halt sales of Essure in the United States at the end of 2018