FDA Issues Warning Letter on Unapproved Breast Implant Device

February 19, 2019 | Steven Shapiro | FDA | Litigation | Medical Devices and Wearables

Last week, the U.S. Food and Drug Administration (FDA) announced that it issued a warning letter to Mark Berman, M.D., a Beverly Hills, Calif., cosmetic surgeon, for illegally marketing an unapproved implantable device. Dr. Berman claims that the “Pocket Protector” can prevent and treat capsular contracture (tightening of scar tissue), a complication of breast implants.

In the letter, the FDA stated that it is “not aware of an implantable device intended for use with breast implants . . . that is legally marketed for this use.” Therefore, the device requires premarket approval as a class III medical device.

In addition to the violations noted in this warning letter, Dr. Berman is currently the subject of a separate federal enforcement case pertaining to marketing of other FDA-regulated products without FDA approval. In that case, the U.S. is seeking a permanent injunction against Dr. Berman and his California Stem Cell Treatment Center to stop them from marketing unapproved stem cell products.

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