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THREE INDICTED IN CONNECTION WITH UNLICENCED COSMETIC TREATMENTS
Bellevue Woman Offered Bad Botox; Burien Couple Tried to Bribe FDA Officer

FOR IMMEDIATE RELEASE
August 25, 2009

Three people were arrested late yesterday in a crackdown on unlicenced cosmetic surgery practices that put the public at risk. In each case, the defendants were using or attempting to use devices that had not been approved by the U.S. Food and Drug Administration. The three defendants, XIN HE, aka FAITH HE, 46, of Issaquah, Washington, and TOAN LE, 51, and HANG HO, 41, both of Burien, Washington, will make their initial appearances in U.S. District Court in Seattle today at 2:30, in front of Magistrate Judge James P. Donohue. The courtroom is on the 12th floor at 700 Stewart Street.

According to a three count indictment returned by the grand jury, FAITH HE has been using counterfeit Botox© and Restylane© on customers to her Bellevue beauty salon. FAITH HE is a licensed esthetician and manicurist, but is 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 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 came from a vial with Chinese characters on it. The Washington State Department of Health investigated and issued a cease and desist order to FAITH HE in July 2006. However, the indictment alleges that 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 LE had injected became hard and swollen. Investigators served a search warrant on the NATURAL BEAUTY salon located at 11004 NE 11th Street, Suite 109, Bellevue, Washington, and obtained numerous vials of injectable substances labeled in Chinese characters.

In a second unrelated case, the operators of a Burien salon have been indicted for two counts related to a conspiracy to bribe a public official. TOAN LE and HANG HO own Crystal Nails beauty salon. Last month they attempted to import, into the United States, medical devices that had not been approved by the Food and Drug Administration. One of the items was a laser type device for skin treatment. The device emitted radiation at unknown levels. When the FDA Consumer Safety Officer made an inspection, the indictment alleges she was offered first $500 and later $800 to allow the couple to keep the adulterated goods. According to the indictment, on July 13, 2009, in Tukwila, the couple delivered an envelope containing $800 to the Consumer Safety Officer. The officer was cooperating with law enforcement.

If convicted, HE faces up to three years in prison and a $10,000 fine. LE and HO face up to fifteen years in prison and a $250,000 fine.

The charges contained in the indictment are only allegations. A person is presumed innocent unless and until he or she is proven guilty beyond a reasonable doubt in a court of law.

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 Mary K. Dimke

For additional information please contact Emily Langlie, Public Affairs Officer for the United States Attorney’s Office, at (206) 553-4110 or Emily.Langlie@USDOJ.Gov.

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