Inspections, Compliance, Enforcement, and Criminal Investigations

December 2, 2016: Woman Arrested For Injecting Adulterated Liquid Silicone

 

 

 

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Food and Drug Administration 
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             U.S. Department of Justice Press Release

 

 

For Immediate Release
December 2, 2016

United States Department of Justice

District of Puerto Rico  

 

 

 

 

 

San Juan, Puerto Rico– Today, U.S. Magistrate Judge Silvia Carreño-Coll authorized a complaint charging Rosa Betancourt-Farfán, with the injection of a device into a human body, after shipment in interstate commerce, having the device been adulterated or misbranded, all in violation of Title 21, United States Code, Sections 331 (k), 333(a)(1), and 351(f)(1)(B), announced U.S. Attorney for the District of Puerto Rico, Rosa Emilia Rodríguez-Vélez. The Food and Drug Administration (FDA) is 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 FDCA, 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, San Juan Resident Office, 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 agents and indicated that she/he had been injected on both glutes one (1) vial by Betancourt-Farfán, for which he/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. His/her health condition worsened on or about 2015, when he/she was hospitalized with tendonitis and back spasms.

 

A second victim indicated that he/she received treatment for butt augmentation with Betancourt-Farfán who had injected him/her with stem cells. According to the second victim, the first time he/she received the cosmetic treatment by the defendants, there were more than ten (10) individuals at a residence in Bayamón waiting to receive treatment. This second victim is presenting serious health issues and is receiving medical treatment with a doctor outside of Puerto Rico.

 

“If you or a person you know have been treated by the defendant, please call the Junta de Licenciamiento y Disciplina Médica y Oficina de Reglamentación y Certificación de los Profesionales de la Salud al 787-765-2929, ext. 6589.  Your life is in danger if you have received any of these adulterated treatments,” stated Rosa Emilia Rodríguez-Vélez, US Attorney for the District of Puerto Rico.

 

This case is being prosecuted by Assistant U.S. Attorney Myriam Fernández. The case was investigated by the FDA.

 

A criminal complaint is an accusation of criminal conduct, not evidence. A defendant is presumed innocent unless and until proven guilty.

 

USAO - Puerto Rico

 

Topic: 

Consumer Protection

 

 

Page Last Updated: 01/31/2018
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