Meet Dr. Mark Berman of California. The plucky surgeon had already run into trouble with the FDA and US Dept. of Justice for “allegedly offering unproven stem cell treatments,” and now he finds himself the recipient of an official FDA warning letter for just outright making his own breast implants.

According to the FDA, when he wasn’t trying to grow his hair into the perfect accidental parody of artist Bob Ross, Dr. Berman marketed a breast implant device called the “Pocket Protector,” essentially some sheets of polymer mesh glued together with silicon rubber. This would then be implanted into the breast, in front of the actual silicone implant, to improve the appearance and reduce scarring.

The only problem is that Berman isn’t, you know, a medical device manufacturer. The FDA alleges multiple potentially illegal acts by Berman, as a result, including that he never submitted the product for pre-market approval (PMA), and that his operation lacked basic manufacturing controls like equipment calibration, sterility processes, woefully poor incoming inspection of raw materials, and no required device history records or device master record. It sort of sounds like he glued a few pieces of plastic together and started sticking them inside women — but I leave that up to the FDA and DOJ to figure out.

The problem was so severe, it prompted the FDA’s Commissioner to make a public statement, declaring:

Dr. Berman unlawfully marketed the unapproved product via a website and through promotional videos telling the public that the Pocket Protector was safe and beneficial for treating or preventing capsular contracture, even though the product has never been evaluated by the FDA for safety or efficacy for that or any use.

Berman’s website is now entirely shut down, and I suspect his passport suddenly has some weird looking stamps on it.

 

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    About Christopher Paris

    Christopher Paris is the founder and VP Operations of Oxebridge. He has over 30 years' experience implementing ISO 9001 and AS9100 systems, and is a vocal advocate for the development and use of standards from the point of view of actual users. He is the author of Surviving ISO 9001:2015. He reviews wines for the irreverent wine blog, Winepisser.