Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
January 15, 2010
United States Attorney
Western District of Washington
Contact: Emily Langlie
Public Affairs Officer
Bellevue Cosmetologist Injected Women with Unknown Substance She Claimed was 'Restylane'
XIN HE, aka FAITH HE, 46, of Issaquah, Washington, was sentenced today in U.S. District Court in Seattle to 13 months in prison and one year of supervised release for a felony count of Misbranding of a Drug While Held for Sale and two misdemeanor counts of Receipt & Proffered Delivery of Adulterated Device. HE was convicted at a bench trial October 30, 2009. She was ordered into immediate custody by U.S. District Judge Marsha J. Pechman. Today Judge Pechman observed that HE persisted in "risky and dangerous behavior," offering unlicensed treatments despite warnings from employers, regulators, agents and others.
According to testimony at trial and records filed in the case, FAITH HE used counterfeit Botox© and Restylane© on customers at her Bellevue beauty salon. FAITH HE was not a medical doctor licensed to use injectable treatments for wrinkle removal such as Botox and Restylane. According to the indictment, as early as 2004, FAITH HE injected a substance that she later represented was Restylane into the face of a Snohomish, Washington, woman. Court records indicate the woman's face became inflamed and she sought treatment from a dermatologist. The material injected into the woman's face was confirmed later not to be genuine Restylane. The Washington State Department of Health investigated and issued a cease and desist order to FAITH HE in July 2006. The order was issued after HE offered to inject an undercover agent with what she claimed was Botox at HE's Issaquah home. Despite that order, in April 2008, FAITH HE was once again injecting patients in a Bellevue salon. A Bothell woman had to be treated by a plastic surgeon after the locations FAITH HE had injected became hard and swollen.
In court today Assistant United States Attorney Kathryn Warma urged the court to reject the defense request for a probationary sentence saying, "This defendant cannot be trusted. She is a liar and manipulator. (By injecting unknown substances), she was exposing every person she treated to risk of death." Ms. Warma noted that until the court ordered HE into custody, "No one, nothing, had stopped her before."
Each year in the United States, including the State of Washington, consumers are injured by individuals who are neither licensed or trained to perform medical procedures. Oftentimes, the people performing these cosmetic treatments use drugs and devices not approved by the FDA for use in the United States. The injuries range from severe burns, infection and permanent scaring. The FDA has investigated cases where some consumers have died after receiving such treatments from individuals not licensed to perform such procedures.
This was a joint investigation between the FDA Office of Criminal Investigations and U.S. Immigration and Customs Enforcement (ICE). Both the Washington State Department of Health and the Washington State Department of Licensing assisted with the investigation.
The case is being prosecuted by Assistant United States Attorneys Kathryn Warma and Kathryn Kim Frierson.