FDA EIR - Mentor Worldwide LLC - February 07, 2019

An FDA For Cause inspection of Mentor Worldwide LLC, located in Irvine, CA, was conducted from February 4-7, 2019. The inspection aimed to address allegations regarding the implantation of the company's MemoryGel Silicone breast implant (approved under PMA P030053) without patient knowledge or informed consent. The regulatory framework guiding this inspection was CP 7348.810, focusing on Sponsors, Contract Research Organizations, and Monitors.

The investigation specifically reviewed the post-approval study for the MemoryGel implant, scrutinizing consent procedures. While an April 2007 protocol amendment allowed commercial implantation without mandatory study consent, patients participating in the post-approval study were required to provide consent. Following a comprehensive review of the firm's records, including electronic Case Report Forms, the FDA investigator determined that all documented implantations for study participants were performed with proper informed consent. Consequently, no significant deficiencies were observed, and no FDA Form 483 was issued. Therefore, no regulatory violations were found, and no specific corrective actions were required from Mentor Worldwide LLC based on this inspection.