Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
January 14, 2011
United States Attorney
Southern District of New York
Public Information Office
Boston Scientific Subsidiary Sentenced to Pay Criminal Penalty of More Than $296 Million and Three Years Probation
PREET BHARARA, the United States Attorney for the Southern District of New York, JANICE K. FEDARCYK, the Assistant Director-In-Charge of the New York Office of the Federal Bureau of Investigation (“FBI”), and MARK DRAGONETTI, Special Agent-in-Charge of the New York Field Office of the Food and Drug Administration's Office of Criminal Investigations (“FDA”), announced the arrest today of WHALESCA CASTILLO on charges that she administered illegal injections of liquid silicone for cosmetic purposes, as part of an underground business she ran out of her Bronx home. The Complaint alleges that CASTILLO, who does not have a medical license, charged over $1,000 in some instances for each round of shots.
Manhattan U.S. Attorney PREET BHARARA said: “As we allege, Whalesca Castillo put the health of unsuspecting women at risk, all to make a quick buck. She compounded the danger in which she placed her clients by allegedly discouraging at least one woman from seeking medical attention after she developed complications from the injections. We will continue to work with our partners at the FBI and the FDA to expose and prosecute such underground operations that seek to profit by offering unsafe treatments at the expense of public health and safety.”
FBI Assistant Director-in-Charge JANICE K. FEDARCYK stated: “Castillo allegedly performed procedures she was not licensed to perform, using substances unapproved for that purpose. She knew what she was doing was illegal, as she told one of her customers. In her thirst for profit, she put lives in peril. The mission of the FBI Health Care Fraud Task Force is not only to minimize the monetary effects of fraud, but to protect the health and safety of the public from unscrupulous practitioners.”
FDA Office of Criminal Investigations Special Agent-in-Charge MARK DRAGONETTI said: “FDA's regulatory requirements are designed to ensure the safety and quality of the medical devices and drugs distributed to American consumers. We will continue to work with our law enforcement partners to investigate and prosecute those who disregard regulatory requirements and jeopardize the public health by engaging in the distribution of unapproved and misbranded products.”
According to the Complaint unsealed today in Manhattan federal court:
Although the FDA has approved certain forms of silicone for cosmetic use, it has prohibited the injection of liquid silicone or silicone gel to fill wrinkles or augment tissues anywhere in the body for public and health safety reasons. Tissue augmentation using injectable fillers such as silicone has resulted in death and serious injuries in both the United States and abroad, especially when injections are performed by unlicensed practitioners and outside a clinical setting. Risks associated with such injections include permanent lumps within the skin, infection, skin ulceration, and potentially fatal pulmonary blood clots.
Since at least 2009, CASTILLO, who does not hold a medical or nursing license of any kind in New York State, has imported liquid silicone from the Dominican Republic, and administered injections of it to women for breast and buttocks enhancement. She has administered these injections in her Bronx home, telling women that the injections are safe, and charging them hundreds of dollars per injection. One woman, who paid CASTILLO $1,000 for injections, experienced pain and shortness of breath following the procedure, and fainted within hours of the procedure. After being revived by her boyfriend, the woman called CASTILLO to report her medical symptoms. CASTILLO discouraged the woman from seeking proper medical attention, saying that a hospital would not help her because the procedure was illegal.
In November and December 2010, federal agents, working together with the New York City Police Department and the New York City Department of Sanitation, Environmental Police Haz-Mat Unit, recovered numerous trash bags in the vicinity of CASTILLO's home. The trash bags contained over one hundred bottles, some of which were tested and had silicone residue on them, syringes, needles, bloodied gauze, and dozens of tubes of Krazy Glue, which unlicensed practitioners sometimes use to seal puncture wounds.
CASTILLO, 36, of Bronx, New York, is charged with one count of distributing an adulterated or misbranded product. She faces a maximum of three years in prison on that charge.
Mr. BHARARA praised the Federal Bureau of Investigation, the U.S. Food and Drug Administration Office of Criminal Investigations, the New York City Police Department, and the New York City Department of Sanitation for their work in investigating this case. He also said that the investigation is continuing.
The FBI has set up a hotline, in English and Spanish, that individuals can call if they received liquid silicone injections from WHALESCA CASTILLO or anyone else. That number is (212) 384-2400.
This case is being handled by the Office's Complex Frauds Unit. Assistant U.S. Attorney SARAH LAI is in charge of the prosecution.
The charges contained in the Complaint are merely accusations, and the defendant is presumed innocent unless and until proven guilty.