By James Limbach
ConsumerAffairs.com
January 20, 2010
An Issaquah, Washington, salon owner is going to prison for 13 months for a felony count of misbranding of a drug while held for sale and two misdemeanor counts of receipt & proffered delivery of an adulterated device.
Xin He, aka Faith He, must also undergo one year of supervised release. U.S. District Judge Marsha J. Pechman noted 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. She is not a medical doctor licensed to use injectable treatments for wrinkle removal such as Botox and Restylane.
The indictment charges that as early as 2004, 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 the case and issued a cease and desist order to He in July 2006 after she offered to inject an undercover agent with what she claimed was Botox. Despite that order, in April 2008, He was once again injecting patients in a Bellevue salon. A Bothell woman had to be treated by a plastic surgeon after the body parts in which she locations became hard and swollen.
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." Warma noted that until the court ordered He into custody, "No one, nothing, had stopped her before."
Each year in the United States, consumers are injured by individuals who are neither licensed nor 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. In some cases consumers have died after receiving such treatments from individuals not licensed to perform such procedures.
Even the real Botox has been blamed for problems.
• Terri of Elmsford, NY tells ConsumerAffairs.com that she received Botox injections in her face in May of 2007, something she had been doing for ten years. This time was different though. "About an hour and a half after the procedure, I developed very disturbing symptoms. I felt as if I was paralyzed. My speech became slurred. I could not walk. The only thing I could do was get in bed. I stayed there for days." She says a representative of the company that makes Botox told her he had never heard of such a reaction.
• Kelly of Fishers, IN says immediately after she received a Botox treatment she experienced shortness of breath and a bad consistent cough. "I went back to my plastic surgeon," she writes ConsumerAffairs.com, "who told me that there is no way that it could be from the Botox. After approximately three months of consistent trouble breathing I got it again, and it got worse. I was told again that it could not be the Botox." Kelly says even the doctors at the Mayo Clinic told her that the Botox injection does not cause that symptoms. "They did other tests on me and found nothing wrong."
