The U.S. Food and Drug Administration has cited a plastic surgery practice over several violations tied to its use of adult stem cells for breast augmentation and other procedures to manufacturing violations.
In a warning letter to Dr. Thomas E. Young, the owner and medical director of Young Medical Spa, the FDA’s Center for Biologics Evaluation and Research said the company had significantly altered adult stem cells as part of the process of converting them from adipose tissue.
The FDA allows companies to derive adult stem cells from structural and adipose tissue on condition that the structure of the stem cells is not significantly changed. It permits the use of stem cells to be derived from adipose tissue from one person and injected back into the same person. If the regulator concludes the process significantly changes the adipose tissue, it considers it a biological product that has a much more rigorous set of criteria to meet.
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“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 said.
The company singled out a product it uses in breast augmentation procedures containing adipose-derived stem cells as a violation of the regulator’s rules.
During a factory inspection of the practice’s Lansdale, Pennsylvania and South Center Valley, Pennsylvania offices between December 2011 and January this year, the regulator said it found numerous violations of good manufacturing and good tissue practices. Among the violations listed in the letter were its failure to keep a record of investigations into cases in which patients experienced adverse reactions. It also did not ensure appropriate laboratory testing of each batch of drug product required to be free of objectionable microorganisms, the letter posted on the regulator’s website said.
In at least six cases, the letter said, the company failed to investigate adverse reactions such as fever, redness, soreness, cyst formation, mastitis and infection following the procedures.
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If the company fails to adequately respond to the FDA’s letter, it could lead to regulatory action being taken without further notice. That action could include seizure and/or injunction, the letter said.
The FDA’s action follows a letter sent to New York-based IntelliCell BioSciences in March raising some of the same concerns with the stem cell company and would seem to reflect a crackdown by the regulator.
