South Carolina Consumer Protection Attorneys
The U.S. Food and Drug Administration recently announced that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, an FDA-approved device used for weight loss in obese adults.
The marketing company reportedly used misleading advertising for the weight loss surgery through billboards, radio and television ads that underplayed the serious risks to patients.
The billboards, which were plastered all over Southern California freeways, showed smiling faces of thin people and catchy phrases about the benefits of Lap-Band surgery. Although the billboards did include warnings about the risks, they were written in such small typeface that they were not legible from the road.
On the radio, the company promotes the surgery with its own jungle and has recently been endorsed by celebrity doctor Drew Pinsky.
In the warning letters, the FDA said the advertisements failed to adequately convey warnings, precautions and possible side effects. If the affected companies do not change the advertising and promotion strategies to address the concerns raised by the FDA, the agency is prepared to take further action, which could include product seizure or civil money penalties.
The FDA’s announcement comes one year after Los Angeles County’s public health chief, Dr. Jonathan Fielding, asked the FDA to take action.
In a December 2010 letter, Fielding said “advertising of this medical device by 1-800-GET-THIN … inadequately informs consumers of potential risks.”
An attorney for 1-800-GET-THIN then fired back with a complaint against Fielding, arguing that the LA official had a conflict of interest since he was he’s a former executive and a shareholder of Johnson & Johnson, which competes with Lap-Band manufacturer Allergan Inc. in the gastric-band market.
Since 2009, five patients have died following surgeries at centers associated with the ad campaign. A series of lawsuits blamed the deaths on mistakes by the surgery centers and doctors who performed the procedures.
Experts say these crackdowns could lead to less people choosing the Lap-Band surgery as an option because it’s exposing risks and information that people otherwise may not have had access to.
The Lap-Band is a silicone ring surgically implanted around the stomach to discourage overeating. The surgeries vary in cost and can range between $12,000 to about $20,000, according to Allergan. The Lap-Band is often covered by insurance.
Gastric banding is used when non-surgical weight loss methods, such as supervised diet and exercise, have not worked. Patients thinking about gastric banding need to be willing to make major changes in their eating habits and lifestyle in order for the surgery to be successful.
Health care providers who choose to support the gastric banding surgery are required to educate patients about the risks involved, which must also be included in any advertising and promotional resources. Patients considering the surgery should read the patient information provided by their doctor and should ask any questions they have about gastric banding before having surgery.
By: Pete Strom, South Carolina Consumer Protection Attorney
