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FDA reprimands surgical centers for misleading advertising of Lap-Band

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The FDA today announced that it has issued warning letters to eight California surgical centers and a marketing firm for misleading advertising of Lap-Band.

The FDA issued warning letters to Bakersfield Surgery 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 the marketing firm 1-800-GET-THIN because these groups misrepresented Lap-Band (Allergan), which is a restricted medical device, according to the press release.

In the letters, the FDA warns that billboard and advertising inserts used by the groups to promote the Lap-Band procedure fail to provide required risk information, including warnings, precautions, possible side effects and contraindications. Further, the FDA expressed concern that the font size of information related to risks on the advertising is too small to be read by consumers.

“The FDA takes seriously its responsibility to protect consumers from products promoted without adequate warnings,” Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health, said in a press release. “It’s particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices.”

If the companies do not amend their advertising and promotion strategies, the agency may take further action, such as product seizure or civil money penalties, the release stated.

“The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider,” Kimber Richter, MD, deputy director for medical affairs in the Office of Compliance in the FDA’s Center for Devices and Radiological Health, said in the release. “It is important for the patient to fully understand both the risks and the benefits of the procedure and for the health care provider to be sure the procedure is appropriate for the patient.”

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