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13 Dec 2011 06:35 PM

Stop Misbranding Lap-Band In Your Advertising, FDA Warns Companies

1-800-GET-THIN LLC has been warned, along with eight surgical centers in California, to stop misleading people in their advertising about the Lap-Band, a medical device approved by the FDA to help obese adults lose weight. The Food and Drug Administration (FDA) accused the advertisers of omitting important negative data on the Lap-Band, such as contraindications, warnings, precautions, and potential side-effects.

The following have been sent warning letters by the FDA:

  • 1-800-GET-THIN

  • Bakersfield Surgery Institute Inc

  • Beverly Hills Surgery Center

  • Cosmopolitan Plastic & Reconstructive Surgery

  • Palmdale Ambulatory Center

  • San Diego Ambulatory Center LLC

  • Top Surgeons LLC

  • Valencia Ambulatory Center LLC

  • Valley Surgical Center

The thrust of the message is that the Lap-Band, being a restricted medical device, is being misbranded due to misleading advertising.

The FDA also mentioned that any negative information regarding the device that appears on the advert is in too-small-a-font size.

Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health, said:

"The FDA takes seriously its responsibility to protect consumers from products promoted without adequate warnings. It's particularly troublesome when advertisements don't communicate the serious risks associated with medical devices."

The companies have been told by the FDA that they could face fines or product seizure if they do not address the concerns included in the Warning Letters.

What is the Lap-Band?

The Lap-Band, also referred to as a (Laparoscopic) Adjustable Gastric Band, is an inflatable silicone medical device that is surgically placed around the top portion of the stomach - it is used to treat patients with a BMI (body mass index) of 30 to 40 (obese).

Adjustable Gastric Band

The Lap-Band, also known as the Adjustable Gastric Band

The obese patient candidate for the Lap-Band often also has an obesity related medical condition, such as high blood pressure (hypertension) or diabetes type...
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