-centered Mentor withheld safety data about its silicone breast implant application intentionally.

All rights reserved.. Advocacy group asks FDA to release criminal investigation of allegedly withheld data on silicone breasts implant application The consumer advocacy group Public Citizen on Thursday sent a letter to acting FDA Commissioner Andrew von Eschenbach asking the agency to conduct a criminal investigation into whether Santa Barbara, Calif.-centered Mentor withheld safety data about its silicone breast implant application intentionally, the Washington Post reports.However, the outcomes of numerous studies and systematic reviews have been contradictory.19-23 The studies have already been tied to the enrollment of small, heterogeneous study populations and the usage of several factor VIII products, and comparisons among studies have already been difficult because of different study designs.22,24 The inclusion of minimally treated sufferers and sufferers who were still at risk for subsequent advancement of inhibitory antibodies has resulted in an underestimation of the incidence of inhibitor advancement.25 Furthermore, prospective postmarketing studies could not include high-risk children who started bleeding at an early age, which meant that the chance of inhibitor advancement was underestimated.