FDA Approves Labeling Changes for Essure

The FDA has completed an investigation of a trade complaint against Bayer Healthcare LLC alleging that the company altered medical records supporting the premarket approval application for its Essure permanent birth control device.

The complaint alleged that Bayer altered the medical records of clinical trial participants, violated the terms of the PMA approval order, and violated manufacturing and marketing laws.

After conducting an inspection, the FDA found that Bayer had committed some violations related to the clinical trials but had not harmed any patients. It now requires the firm to use new labeling that includes a boxed warning and a patient decision checklist. — Jeff Kinney