CONCEALING FROM FDA FRAUD/MISREPRESENTATION MISCELLANEOUS - RECKLESS/CONSCEOUS DESREGARD

"Internal Audit and Corrective Action Plan" prepared by Dow Corning of its Toxicology Laboratory. The audit uncovered four studies in which a former Dow Corning employee (Mark Bejarano) created false data and violated Good Laboratory Practices (GLP). The studies which were falsified are a lifetime breast implant gel study in rats, a biodurability study of elastomer in orthopedic devices, a breast implant elastomer study.

The falsification involved the technician, Bejarano. who created multiple slides from a single animal and labeled them as though they had come from different animals. The report states, "It has been acknowledged by Mr. Bejarano that he: did create multiple slides, made a mistake, acted on his own, acted contrary to his Dow Corning training, and did not tell his supervisor or anyone else what he had done." (p.4 or Temporary Dow Corning Bates Number 411) Dow Corning claims that none of the four studies were published or relied on for data on the safety of breast implants, that an outside audit will also be done, and that Dow Corning will examine its operating procedures for the toxicology laboratory to make sure it complies with applicable regulatory requirements.

 Appendix A is a list of studies in Dow Corning's PMAA master file and a list of studies ; in Dow Corning Corporation's blue book.

Appendix B is a list of studies containing duplicate slides created by Mark Bejarano.

Appendix C is qualifications of the consultant.