For several years, the Food and Drug Administration (FDA) has been aware of the apparent illegal distribution, sale, and promotion of the LipoTron medical device without the approval or clearance of the FDA. Public Citizen obtained documents from a whistleblower that indicate that the apparently illegal marketing and promotion of this potentially dangerous device was brought to the attention of the FDA’s Office of Criminal Investigations more than two and a half years ago, but the FDA has failed to take action against the manufacturer and other entities involved in the distribution, sale, and promotion of the device, which is now being widely used throughout the U.S.
August 3, 2012 letter from an attorney representing Advanced Aesthetic Concepts (AAC) – the distributor of the LipoTron device – demanding that Public Citizen cease and desist all communications about AAC’s activities involving the marketing and promotion of the LipoTron device and threatening to file a lawsuit against Public Citizen unless it complied with this demand. (PDF)
August 22, 2012 letter from Public Citizen rejecting the demand from AAC’s attorney. (PDF)