March 2, 2018: Woman Sentenced for Injecting Adulterated Liquid Silicone
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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 District of Puerto Rico |
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SAN JUAN, P.R. – Senior US District Court Judge Daniel Domínguez sentenced Rosa Betancourt-Farfán to 15 months in prison and one year of supervised release for injecting liquid silicone, an adulterated and misbranded device used for body-contouring, announced US Attorney for the District of Puerto Rico, Rosa Emilia Rodríguez-Vélez. Betancourt-Farfán was arrested and indicted in December 2016 and pled guilty on May 12, 2017. The US Food and Drug Administration’s (FDA’s) Office of Criminal Investigations (OCI) was in charge of the investigation.
According to the information gathered during the investigation, liquid silicone is sometimes injected into the body to “augment” tissues, such as the buttocks or breasts. When intended for tissue augmentation, liquid silicone is a “device” under the Federal Food, Drug, and Cosmetic Act, and is subject to FDA approval before it can legally be distributed and used for such use in the United States. FDA has not approved any liquid silicone products for injection to augment tissues anywhere in the body. In addition, the injection of liquid silicone into the body for tissue augmentation can result in serious adverse health consequences, including hardening of tissue at the injection site, embolization, and even death.
On or about May 23, 2016, Puerto Rico Board of Health, Legal Division, contacted the FDA-OCI to advise of a complainant who received medical procedures from a female individual who claimed to be a nurse. It was further indicated that the complainant received treatment to enlarge his/her buttocks and that the female individual was identified as “Rosa from Venezuela” (later identified as Rosa Betancourt-Farfán).
The complainant was interviewed by FDA-OCI agents and indicated that she had been injected in both glutes with one (1) vial by Betancourt-Farfán, for which she paid twelve hundred dollars ($1,200.00) in cash, but was having health problems during the summer of 2013. These problems consisted first with trouble breathing and back pain. Her health condition worsened on or about 2015, when she was hospitalized with tendonitis and back spasms.
“Your life is in danger if you have received any of these adulterated treatments. We urge people not to trust those who claim to be medical professionals and offer treatments outside of certified medical offices victimizing patients. The US Attorney’s Office is committed to protecting patients from medical frauds,” stated Rosa Emilia Rodríguez-Vélez, US Attorney for the District of Puerto Rico.
“Liquid silicone injected into individuals’ bodies can cause serious harm and even death, and FDA has not approved any such product for body contouring,” said Justin D. Green, Special Agent in Charge, FDA’s Office of Criminal Investigations’ Miami Field Office. “We will continue to aggressively pursue and bring to justice those who endanger American consumers by offering these hazardous procedures.”
Assistant U.S. Attorney Myriam Fernández prosecuted the case. The case was investigated by the FDA, with assistance from Homeland Security Investigations.
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Topic(s):
Health Care Fraud