A Tulsa woman has pleaded guilty to misbranded medical devices after administering unapproved cosmetic fillers to a patient.
Elisa Kaye Sanders, 61, of Tulsa, pleaded guilty to misdemeanor fraud relating to misbranded devices.
Sanders admitted that on March 10, 2017, she administered the medical devices Juvederm® Ultra 4 and Juvederm® Ultra with Lidocaine to a patient. 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. According to court documents, Sanders purchased the fillers from unauthorized sources and was previously advised by the FDA that purchasing these prescription devices from unauthorized sources was illegal.
Sanders was a majority owner and operator of L’Chaim Medical Spa, previously known as Enhance Skin and Body Medical Spa. The business is no longer in operation.
The Food and Drug Administration, Office of Criminal Investigations conducted the investigation. Assistant U.S. Attorneys Shannon Cozzoni and Scott Proctor are prosecuting the case.
Sanders’ plea will be considered at a later date.
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Key Facts
- State: Oklahoma
- Category: Fraud & Financial Crimes
- Source: DOJ Press Release â†â€â€
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