Wednesday, January 16, 2013
Lap Band Facility gets a Warning Letter
An FDA Warning Letter says that oBand Centers in Marina Del Rey, CA, is making misleading claims in its promotional materials for the Lap-Band, a device indicated for weight reduction in certain severely obese adults.
According to the letter, the company's website fails to reveal material facts about Lap-Band risks. The letter also says that a web video that is intended to convey indications for tse, contraindications, warnings and adverse events is not accessible to viewers, due to the brief appearance of the information and tiny, blurry print that renders the content illegible.