The U.S. Food and Drug Administration (FDA) is opening an investigation into Bayer’s new permanent birth control device Essure. The FDA reports that it has received allegations that Bayer “falsified and altered medical records during clinical trials, failed to report adverse events, deceived the public and the FDA about the device’s safety and efficacy, and used defective materials in manufacturing,” in a petition filed on behalf of hundreds of women.
The women complained of several Essure complications, including pain, organ perforation, and device migration out of the fallopian tubes. The FDA Office of Compliance has agreed to take necessary actions to review and investigate allegations against the device’s manufacturers.
The Essure device was acquired by Bayer when it purchased its original manufacturer Conceptus in 2013, and causes permanent contraception after it causes the fallopian tubes to inflame about 3 months after insertion. The small, flexible coil is inserted by a doctor through the cervix and uterus, though women have alleged that the device migrated.