A woman who operated a Tulsa spa was sentenced today in federal court for using medical devices on her patients that were not approved by the U.S. Food and Drug Administration, announced Acting U.S. Attorney Clint Johnson. The devices are also known as cosmetic fillers.
U.S. District Judge Gregory K. Frizzell sentenced Elisa Kaye Sanders, 62, of Tulsa, to three years of probation. As a condition of her probation, Sanders cannot apply for reinstatement of her nurse’s license for the duration of her sentence. Sanders was further ordered to pay a fine of $25,000.
“U.S. consumers rely on FDA oversight to ensure that the drugs and devices they receive are safe and effective. Rogue health care professionals who obtain foreign unapproved medical products and then dispense and administer them to their patients, put the health of those patients at significant risk,” said Special Agent in Charge Charles L. Grinstead, FDA Office of Criminal Investigations Kansas City Field Office. “We will continue to investigate and bring to justice those who choose to put the public’s health at such risk.”
Sanders was a majority owner and operator of L’Chaim Medical Spa, previously known as Enhance Skin and Body Medical Spa. She was originally charged in a 13-count indictment in January 2020 alleging Sanders defrauded clients seeking treatment from her spa; her staff; and state and federal regulatory agencies responsible for the oversight of the spa.
Sanders pleaded guilty on April 30, 2021, to misdemeanor fraud relating to misbranded devices. The defendant admitted that on March 10, 2017, she administered the medical devices Juvederm® Ultra 4 and Juvederm® Ultra with Lidocaine to a patient who, as a result, suffered adverse reactions. These specific devices are not approved by the FDA for distribution in the United States and are considered adulterated under the Food, Drug, and Cosmetic Act. Sanders failed to tell the patient she was using unapproved fillers. The defendant purchased the fillers from unauthorized sources after previously being advised by the FDA that purchasing these prescription devices from unauthorized sources was illegal.
L’Chaim Medical Spa is no longer in operation.
The Food and Drug Administration Office of Criminal Investigations conducted the investigation. Assistant U.S. Attorney Shannon Cozzoni prosecuted the case.
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