Lap Band Side Effects, Misleading Ads, and Other Stuff: The United States Food and Drug Administration has asked eight California surgical centers to correct their “misleading” ads for the Lap-Band weight-loss device, the agency announced on Dec. 13.
The FDA said it sent letters to the eight surgical clinics, warning them that their advertising for the Lap-Band failed to provide required risk information, including warnings, precautions, possible side effects and contraindications.
A marketing firm, 1-800-GET-THIN, also got a warning letter, the FDA said.
The agency also warned the companies that if they did not change the advertising and promotion strategies to address these concerns, it would take further action, which may involve seizing products or imposing civil money penalties.
The eight clinics are:
• 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
The Lap-Band is a gastric band, a medical device implanted surgically around the top of the stomach to produce weight loss in obese adults. It is only one of many forms of obesity or bariatric surgery.
Lap bands and bariatric surgery have become popular over the past three decades, as obesity rates began to rise.
“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 statement.
“It’s particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices,” he said.
In its letter, the FDA also said advertising inserts used by the eight surgical centers and the marketing firm to promote the Lap-Band procedure had risk warnings printed in type size too small to be read by consumers.
Lap Band Side Effects and Risks
Gastric bands helps reduce weight in people who have them inserted by effectively restricting the stomach—by dividing the stomach into a smaller stomach and an isolated pouch on top.
With a smaller stomach, a person’s feels full on smaller amounts of food, thus decreasing the overall amount of food a person eats for as long as he or she is outfitted with a gastric band.
More Lap Band Side Effects after the jump.