Feds Warn Against Misleading Lap-Band Ads

The marketing firm 1-800-GET-THIN and eight California surgical centers are being warned that their advertising is misleading and doesn't provide enough information about possible side effects of the Lap-Band, a surgical procedure for weight loss in obese adults.

Several Californians have died following surgery related to the 1-800-GET-THIN advertising campaign, according to The Los Angeles Times.

Her husband, John, said Ms. Faitro became interested in the surgery after seeing television commercials for1-800-GET-THIN. But a few days after the surgery, she was hospitalized with an infection and later died.

Warning letters

The U.S. Food and Drug Administration sent warning letters to the marketing group and to  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; and San Diego Ambulatory Center LLC.

In the letters, the FDA warns that billboards and advertising inserts the centers are using fail to provide required risk information, including warnings, precautions, possible side effects and contraindications.

The FDA said it is also concerned that the font size of information related to risks on the advertising inserts is too small to be read by consumers.

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

Action threatened

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 Lap-Band is a gastric band, an implanted medical device used in a surgical procedure for weight loss in obese adults who have a body mass index (BMI) of 30-40, with one or more obesity-related medical conditions (such as type II diabetes and hypertension), or in patients with a BMI of 40 or over with or without an obesity-related medical condition.  Gastric banding is used when non-surgical weight loss methods (such as supervised diet, exercise and behavior modification) have not been successful. Patients considering gastric banding must be willing to make major changes in their eating habits and lifestyle.

“The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider,” said Kimber Richter, M.D., deputy director for medical affairs in the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “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.”

The Lap-Band has not been approved for use in children younger than 18. Only those who are able and willing to follow dietary and other health and lifestyle recommendations should consider the procedure. It’s important that patients and their physicians are aware of and understand the limitations of gastric banding, the FDA said.

Health care providers who choose to promote the gastric banding procedure are required to educate patients about the risks involved, which must also be included in any advertising and promotional materials. 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.