A A A

Welcome! Read this first! Then, feel free to introduce yourself here! And if you need to adjust the font size, click the A A A symbols at top right!

Avatar
Please consider registering
Guest
Search
Forum Scope




Match



Forum Options



Minimum search word length is 3 characters - maximum search word length is 84 characters
Register Lost password?
sp_Feed sp_PrintTopic sp_TopicIcon
California Surgeon Thought He Could Make His Own Breast Implants and No One Would Notice
sp_BlogLinkWhite Read the original blog post
Avatar
Christopher Paris
Admin
Forum Posts: 625
Member Since:
5 December, 2012
sp_UserOfflineSmall Offline
1
13 March, 2019 - 3:21 PM
sp_Permalink sp_Print

Image EnlargerMeet 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.

 

Forum Timezone: America/New_York
Most Users Ever Online: 64
Currently Online:
5
Guest(s)
Currently Browsing this Page:
1 Guest(s)
Top Posters:
Mu Beta: 54
dozza: 32
royplchan: 28
jo9977: 23
KH: 20
annie: 17
wayintense: 14
jdgill1963: 13
Richard Billings: 12
ckoski: 9
Newest Members:
gs1694
Jack97116
PerryGayon
Redswitches
MRCAS
loadupvape
svara
Richard Billings
Danny Ha
adinamuskat
Forum Stats:
Groups: 13
Forums: 43
Topics: 712
Posts: 1513

 

Member Stats:
Guest Posters: 1
Members: 1654
Moderators: 1
Admins: 1
Administrators: Christopher Paris
Moderators: OQRI