Lap-Band gets FDA Warning Letter

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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 use, 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.

Earlier in 2012, FDA warned Lap-Band VIP about marketing the Lap-Band gastric banding system in TV spots and billboards that lacked information on the device's use and relevant warnings, precautions, side effects, and contraindications. In 2011, the agency sent five related Warning Letters to weight-loss centers promoting the Lap-Band.

OBand Centers was told to correct the violations and to respond with a list of specific steps taken, documentation of the steps, and a timetable for their completion.
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