Essure Birth-Control Device Hit With New Restrictions From US FDA
US FDA is placing more restrictions on the sale of Bayer's Essure permanent contraception device by requiring both patients and providers to read and sign off on a patient checklist highlighting adverse events.
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The US FDA says Bayer has successfully recovered unsold Essure units and completed enrollment in a Sec. 522 postmarket study, fulfilling deadlines set at a year from the date the devices were taken off the US market.
A US House representative and two co-sponsors have reintroduced the Medical Device Safety Act, which would remove the defense against state product liability suits for premarket-approved devices from the Federal Food, Drug, and Cosmetic Act (FDCA).
With increased pressure on US FDA surrounding its approach to safety and growing concerns with Bayer's Essure birth control device, the agency is now requiring the manufacturer to extend a mandated post-market study of women who have been implanted with the product, among other requirements.