Bayer Healthcare, LLC – FDA EIR, Jan 6, 2011

An FDA inspection of Conceptus, Inc., a medical device dealer located in Mountain View, CA, was conducted between December 8, 2010, and January 6, 2011. The inspection focused on the Essure permanent birth control system, gathering documentation on interstate commerce and product complaints. Significant issues identified included discrepancies in product labeling, where collected labels for the Essure device did not consistently match the lot numbers of shipping records, suggesting potential challenges in maintaining precise lot-specific documentation. More critically, the inspection documented numerous serious patient complaints regarding the Essure device. These adverse events included reports of bowel perforation during device placement procedures and instances where the device's coil migrated into the peritoneal cavity, leading to pain and necessitating surgical removal. While this document is a Collection Report, it references an associated Establishment Inspection Report (EIR) and an FDA Form 483. These companion documents would detail specific regulatory observations and outline the corrective actions Conceptus, Inc. was required to implement. The findings underscore the critical importance of stringent quality control, accurate labeling, and comprehensive adverse event reporting within the medical device industry under FDA oversight.