US FDA warning letter for illegally marketing unapproved device

The U.S. Food and Drug Administration issued a warning letter to Mark Berman, M.D., of Beverly Hills, California, for illegally marketing an unapproved implantable device, the Pocket Protector, that Dr. Berman claims can prevent and treat a complication of breast implants known as capsular contracture, or tightening of scar tissue. The warning letter also notifies Dr. Berman of significant deviations from the FDA’s quality system requirements and current good manufacturing practices (CGMPs), including deviations from manufacturing processes intended to keep implants sterile.

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