Center Valley, Pa. — Young Medical Spa, based here, has been cited by the Food and Drug Administration for several violations, including some related to the use of adult stem cells for breast augmentation.
The FDA’s Center for Biologics Evaluation and Research sent a warning letter to Thomas E. Young, M.D., owner and medical director of the spa, saying the facility had radically altered adult stem cells when converting them from adipose tissue, MedCity News reports.
Companies may derive adult stem cells from certain tissues as long as harvesting these cells doesn’t significantly change the structure of the cells. Stem cells may be injected back into the tissue of the person from whom the cells were derived. If regulators conclude that the process significantly changed the adipose tissue, then the tissue is considered a biological product, and must meet a more demanding set of criteria.
“Specifically, your processing alters the relevant characteristics of the adipose tissue relating to the tissue’s utility for reconstruction, repair or replacement. Therefore, the processing would not meet the definition of minimal manipulation for structural tissue such as adipose tissue,” the letter stated.
During a two-month factory inspection of the practice’s offices in Lansdale and South Center Valley, Pa., ending in January, regulators allegedly found numerous violations of good manufacturing and good tissue practices and failure to keep a record of investigations into cases in which patients suffered adverse reactions. The letter also noted a lack of appropriate laboratory testing of each batch of drug product.
According to MedCity News, there were at least six cases in which the company failed to investigate adverse reactions following surgical procedures.
If the practice does not adequately respond to the FDA’s letter, regulatory action, including seizure or injunction, may be taken without further notice.
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