FDA WARNING_LETTER - oBand Centers Westwood, CA - November 02, 2012

The FDA issued a Warning Letter to oBand Centers on November 2, 2012, for marketing the LapBand gastric banding system in violation of the Federal Food, Drug, and Cosmetic Act. The LapBand is a restricted device, approved with conditions requiring prescription-only sale and distribution.

The FDA's review of oBand Centers' website (www.obandcenters.com) on October 25, 2012, revealed that the promotional materials misbrand and adulterate the LapBand. Specifically, the website's "Risks" section on www.obandcenters.com/right_risks.asp significantly understates the device's risks by failing to mention serious complications like death, organ damage, lung problems, blood clots, infection, gastric perforation, esophageal dilatation, severe vomiting, and the high rate of revision surgery. It also omits that surgical risks are higher for obese patients or those with underlying medical conditions.

Furthermore, a video on www.obandcenters.com/right_procedure.asp, while including a disclaimer of indications, contraindications, warnings, and adverse events, renders this information illegible due to brief appearance, tiny, and blurry print. These omissions and illegible disclosures make the promotional materials misleading under Section 201(n) and misbrand the LapBand under Section 502(q) of the Act.

The FDA demands oBand Centers immediately cease marketing the