You are on page 1of 1
oe ¢ DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Silver Spring, MD 20983, ‘The Honorable Mike Fitzpatrick House of Representatives | Washington, D.C. 20515-3808. MAR 29 2016 Dear Mr. Fitzpatrick: Thank you for your letter of December 18, 2015, to George Karavetsos, Director of the Food and Drug Administration’s (FDA or Agency) Office of Criminal Investigations (OCI), requesting that the ageney conduct an investigation regarding the use of Laparoscopic Power Morcellators and incomplete Medical Device Reporting (MDR), The Ageney takes these issues very seriously, arid in recent months, we have conducted | inspeotions of hospitals highlighted in your letter, including Brigham and Women’s Hospital, Rochester General Hospital, and the University of Rochester Medical Center, However, in order to protect the integrity of the investigative process, it is FDA’s policy not to ‘confirm or deny the existence of a crintinal investigation, Therefore, while the Agency acknowledges your request for an investigation, FDA cannot comment on the questions posed in your letter at this time. As you know, the Agency Wams against the use of laparoscopic power morcellators in the | renioval of the uterus (hysterectomy) or fibroids from the uterus (myomectomy) in the vast majority of women. FDA will continue to consider steps that may further heip to reduce the risk of spreading unsuspected cancer, such as encouraging innovative ways to better detect uterine cancer and containing potentially cancerous tissue. : FDA appreciates your interest in this issue and we will continue to keep you and your staff a apprised of any updates, Sincerely, Dayle dene Acting Associate Commissioner for Legislation