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Medical Devices / Regulatory Affairs

FDA Issues Warning Over Unapproved Breast Implant Device

Feb. 19, 2019
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The FDA ordered a Beverly Hills plastic surgeon to stop marketing an implantable pouch that the doctor says can help prevent tightening of scar tissue after breast augmentations.

Mark Berman has been marketing what he calls the Pocket Protector, a pouch made of two sheets of polytetrafluorethylene held together by silicon rubber cement.

The FDA said that Berman has been advertising the unapproved device on his web site with such claims as, “Within three months, there’s no tissue reaction to the material and it is safely incorporated into one’s body essentially as a synthetic scar.”

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