FDA Tells Lap-Band Surgical Centers They Need More Truth in Their Advertising
"Let your new life begin, call 1-800-GET-THIN!" We've heard that jingle on television and radio for some time now, and seen the billboards along local roads. Now the U.S. Food and Drug Administration has announced they have issued warning letters to eight California surgical centers and the marketing firm 1-800-GET-THIN LLC because their advertising for the Lap-Band surgical device is misleading.
The warning letters went to the following businesses who provide the gastric banding service to their clients: Bakersfield Surgery Institute 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 to 1-800-GET-THIN.
The FDA believes those companies have misbranded the Lap-Band through their advertising, and that they need to put truth in their advertising, namely to provide "required risk information, including warnings, precautions, possible side effects and contraindications." The FDA also says the warning information currently provided to consumers is too small to read.
So what are the consequences of these warnings? The FDA says they are "prepared to take further action, which could include product seizure or civil money penalties."
In Los Angeles County, concerns about misleading or incomplete information in the 1-800-GET-THIN ads were raised previously, and today's announcement regarding warning letters "comes one year after Los Angeles County's public health chief, Dr. Jonathan Fielding, asked the FDA to take action," notes the L.A. Times Money & Company blog. In September, an Orange County woman was the fifth fatality following Lap-Band surgery from an affiliated provider. Both clinics, Valley Surgical Center and Beverly Hills Surgery Center, where all five victims underwent their Lap-Band procedures, were included in the FDA warning.
