FLORIDA — An Orlando doctor has been indicted on charges involving the use of an adulterated device in an unapproved medical procedure, according to federal prosecutors.
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Nhan Pham, 54, of Orlando, is facing three counts of violating the Federal Food, Drug, and Cosmetic Act for allegedly receiving liquid silicone in interstate commerce and offering to inject it for a gluteal augmentation procedure.
The indictment also accuses Dr Pham of misbranding the device after its shipment and failing to register as a device manufacturer.
If convicted, Pham faces up to three years in federal prison for each count. The U.S. Attorney’s Office for the Middle District of Florida has stated that the United States plans to seek forfeiture of any adulterated or misbranded devices, property used in connection with the violations, or proceeds derived from the alleged crimes.
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According to the indictment, the incident occurred in October 2019 when Dr Pham allegedly obtained liquid silicone and offered to inject it into a person’s body for the augmentation. The FDA has not approved injectable silicone for body contouring due to its potential to cause severe injury or death, authorities said.
“Injectable silicone for body contouring is not FDA-approved and can cause serious injury and even death,” said Special Agent in Charge Justin C. Fielder of the FDA’s Office of Criminal Investigations, Miami Field Office.
“We will continue to investigate and bring to justice those who place American consumers at risk.”
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The FDA Office of Criminal Investigations and the Metropolitan Bureau of Investigation investigated the case, with help from the Pasco Sheriff’s Office and the United States Marshals Service. Assistant United States Attorney Diane Hu is prosecuting the case.
An indictment is a formal charge that a defendant has committed one or more violations of federal criminal law. Every defendant is presumed innocent unless and until proven guilty.
