Posts Tagged San Diego Ambulatory Center LLC
The U.S. Food and Drug Administration today announced that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, an FDA-approved device used for weight loss in obese adults. The FDA issued Warning Letters to Bakersfield Surgery Institute Inc.; Beverly Hills Surgery Center; Palmdale Ambulatory Center; Valley Surgical Center; Top Surgeons LLC; Valencia Ambulatory Center LLC; Cosmopolitan Plastic & Reconstructive Surgery; San Diego Ambulatory Center LLC; and to 1-800-GET-THIN because Lap-Band is a restricted medical device that is misbranded as a result of misleading advertising by these groups. In the letters, the FDA warns that billboards and advertising inserts used by recipients of the Warning Letters to promote the Lap-Band procedure fail to provide required risk information, including warnings, precautions, possible side effects and contraindications. The FDA also is concerned that the font size of information related to risks on the advertising inserts is too small to be read by consumers.
We have blogged on 1-800-Get-Thin and Lap-band surgery in general before.
Lap-band surgery like any surgery on the obese has not insignificant risks. The FDA apparently believes that these risks are not appropriately featured in the 1-800-Get-Thin advertising. It is interesting that the FDA has jurisdiction here due to the fact that the Lap-band is a registered medical device.
There was a time in which advertising for procedures was considered inappropriate in medicine. Advertising by its very nature is meant to encourage behavior in such a way as to benefit the advertiser. To expect advertisers to be forthcoming about negatives is probably expecting too much. Then again expecting the FDA not to investigate when there have been deaths associated with Lap-band surgery and 1-800-Get-Thin is probably also expecting too much.
This is amongst the reasons for my usual recommendation that potential surgical patients obtain physician referrals from less biased channels. In my opinion, patients should concentrate on choosing the right surgeon and evaluating him or her and their chosen procedure carefully before proceeding.
What do you really expect from an ad anyway?
John Di Saia MD