Inspections, Compliance, Enforcement, and Criminal Investigations

February 14, 2017: Two Miami-Dade Women Charged in Connection with Their Operation of a Spa Performing Illicit Silicone Injections

 

 

 

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             U.S. Department of Justice Press Release

 

 

For Immediate Release
February 14, 2017

United States Department of Justice

Southern District of Florida  

 

Wifredo A. Ferrer, United States Attorney for the Southern District of Florida, Justin Green, Special Agent in Charge, U.S. Food and Drug Administration, Office of Criminal Investigations (FDA-OCI), Miami Field Office, Mark Selby, Special Agent in Charge, U.S. Immigration and Customs Enforcement, Homeland Security Investigations (ICE-HSI), Miami Field Office, and Juan J. Perez, Director, Miami-Dade Police Department (MDPD), announced the arrest today of Maribel Jimenez and Magaly Del Rosario, both Miami-Dade residents, on charges contained in a twenty-count federal indictment.

 

According to allegations contained in the indictment:

Jimenez and Del Rosario are charged with conspiring, from 2008 through August 2015, to receive and deliver an adulterated and misbranded medical device in connection with their unlawful receipt and use of silicone smuggled into the U.S. from Colombia and eventually injected into hundreds of clients seeking augmentation of their buttocks, as well as their administration of injections of misbranded prescription drugs, including lidocaine and Botox, at Bella Beauty Spa (“Bella Beauty”), a business owned by Jimenez, located at 8360 West Flagler Street, Miami, Florida (Count 1). The defendants are also charged with conspiring to commit wire and mail fraud arising from their fraudulent misrepresentations to these same clients regarding the true nature of the substance which would be utilized in the clients’ buttocks injections and concealing the fact that the injected substance was, in fact, health-threatening silicone (Count 2). In addition, the defendants are charged with delivery for pay of a misbranded and adulterated medical device with intent to defraud and mislead (Counts 3-9). Jimenez is also charged with smuggling offenses (Counts 10-14) and false statement offenses (Counts 15-20).

Jimenez, with assistance from Del Rosario, a manager of Bella Beauty, administered deep tissue buttock injections of substantial quantities of silicone, an adulterated medical device when used and intended to be used in this manner, to hundreds of Bella Beauty clients.

The silicone which was unlawfully injected into Bella Beauty clients was clandestinely smuggled into the United States by Jimenez and co-conspirators by means of approximately 170 separate DHL air carrier shipments. To avoid the scrutiny of Customs and Border Protection, upon importation into the United States, each bottle contained false labelling stating in Spanish that the contents consisted of “Depilatory Wax” and alleged instructions on how to apply this purported rosin-based substance in a manner consistent with hair removal.

After the injections, Jimenez had been informed by a number of Bella Beauty Spa clients that they were experiencing adverse health related symptoms. Jimenez and Del Rosario failed to advise the clients that silicone had been injected into their bodies. The defendants also intentionally concealed the potential health consequences arising from the injection of silicone into their clients’ bodies.

Attorney Ferrer stated, “Criminal conduct that poses a significant health risk to the general public is of grave concern to the U.S. Attorney’s Office. Federal prosecutors and our law enforcement allies are committed to disrupting illicit operations that hold themselves out to be legitimate medical facilities while endangering lives for profit. To best protect yourself, individuals who are considering body augmentation should do their due diligence to ensure that the procedures are performed by reputable persons and do not contain hazardous materials.”

“Serious harm, including death, can occur when individuals have liquid silicone or other substances injected into their buttocks to increase their size. The FDA has not approved liquid silicone or other injectable substances to increase the size of the buttocks,” said Justin D. Green, Special Agent in Charge, FDA-OCI Miami. “Our office will continue to pursue and bring to justice those who offer this hazardous procedure to the public.”

“The suspects in this investigation put their own financial enrichment well above the health and safety of the hundreds of people who trusted them,” said Mark Selby, Special Agent in Charge of HSI Miami. "At HSI we will continue to work with our federal, international and local law enforcement partners to put an end to this dangerous practice."

Defendants Jimenez and Del Rosario appeared in court today for their initial hearings. Jimenez is scheduled for a pre-trial detention hearing on Friday, February 17, 2017.

Individual clients of Bella Beauty Spa who have undergone buttocks injection procedures, regardless of how far in the past, are urged to contact bellabeautyinjections@fda.hhs.gov 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 documents notifying the defendant of the charges. All persons charged by indictment are presumed innocent until proven guilty in a court of law.

Mr. Ferrer commended the investigative efforts of each of FDA, MDPD and ICE-HSI. Mr. Ferrer thanked Christopher D. Maston, Port Director for Miami International Airport, U.S. Customs and Border Protection (CBP), Luis Sierra, Country Attaché HSI Andean Region, HSI International Operations, and the Colombian National Police for their assistance with the investigation. This case is being handled by Assistant U.S. Attorneys Peter Outerbridge and Brooke Watson.

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.

USAO - Florida, Southern

 

 

 

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