FDA Discovers No Evidence of Trial Misconduct in Bayer Essure Study

An FDA investigation into complaints that Bayer manipulated data in its clinical trials of the controversial Essure contraceptive implant device has found no evidence to back up those claims.

The investigation was prompted by a trade complaint in a citizen petition that alleged the company engaged in clinical trial misconduct by altering clinical records to cast the device in a more positive light.

“Although modifications to the case report forms were identified, our analysts did not find evidence the sponsor purposefully modified patient responses to reflect more favorable data for Essure,” the agency said in its report released Sept. 6. — Tamra Sami