July 26, 2018: Miami-Dade Resident Charged in Connection with Performance of Illicit Silicone Injections
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Food and Drug Administration
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U.S. Department of Justice Press Release
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For Immediate Release |
United States Department of Justice Southern District of Florida |
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A Miami-Dade Resident has been arrested and charged with performing illicit silicone injections.
Benjamin G. Greenberg, United States Attorney for the Southern District of Florida, and Justin D. Green, Special Agent in Charge, U.S. Food and Drug Administration, Office of Criminal Investigations (FDA-OCI), Miami Field Office, made the announcement.
Kerlys Mercedes Chaparro, 39, of Miami-Dade County, Florida, is charged by indictment with delivery for pay of an adulterated and misbranded device received in interstate commerce with intent to defraud and mislead, in violation of Title 21, United States Code, Sections 331(c) and 333(a)(2).
The indictment alleges that on or about July 27, 2016, Chaparro received a device (a silicone substance) that she intended to inject into the human body of another individual in exchange for payment. Chaparro was not a licensed medical practitioner. The silicone substance was allegedly misbranded, in that it had false and misleading labeling. Chaparro intended to inject this silicone substance, that had not been approved by the FDA, into the other individual’s body for contouring purposes.
The indictment further alleges that injections of silicone for body contouring purposes, especially deep tissue injections into the buttocks of the large amounts of silicone that would be required to achieve visible buttocks augmentation and enhancement, presented serious risks and dangers. Included among the risks of such injections were the potential of injection into a blood vessel resulting in embolism, migration of injected silicone to other bodily regions and resultant interference with organs and bodily systems, serious sepsis infection and infection-related disorders, silicone-filled scar tissue formations (“granulomas”), necrosis, skin discoloration, immune system hyperactivity and related adverse systemic conditions, disfigurement, discomfort, and pain.
Chaparro appeared in court today for her initial hearing in this matter. Her arraignment is scheduled for August 6, 2018 before U.S. Magistrate Judge Andrea M. Simonton.
Individuals in the South Florida area who have undergone buttocks injection procedures from Kerlys Mercedes Chaparro and are concerned about their health and safety, regardless of how far in the past, are urged to contact gluteal.injections@fda.hhs.gov(link sends e-mail) in order to receive additional information, address individual concerns, and to receive information concerning their status and rights as potential victims.
An indictment is a formal charging document notifying the defendant of the charges. An individual charged by indictment is presumed innocent until proven guilty beyond a reasonable doubt in a court of law.
Mr. Greenberg commended the investigative efforts of the FDA-OCI and the Miami-Dade Police Department Medical Crimes Unit. This case is being handled by Assistant U.S. Attorney Miesha Darrough.
Related court documents and information may be found on the website of the District Court for the Southern District of Florida at http://www.flsd.uscourts.gov or on http://pacer.flsd.uscourts.gov.
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