FDA Warns Lap-Band Weight-Loss Firms on 'Misleading' Ads
The Food and Drug Administration said Tuesday that it has taken action against nine groups, mostly surgical centers in California, for misleading advertising of the Lap-Band, an FDA approved device used for weight loss in obese adults.
The FDA said the notified companies could be punished if Lap-Band advertisements are not corrected within 15 working days.
The agency sent warning letters to eight California surgical centers and the marketing firm 1-800-GET-THIN LLC for failing to provide required risk information of the range of side-effects, from nausea to death from surgery, of the Lap-Band device, and that the font size for the risk information 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 said in a statement. “It's particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices."
FDA began to investigate the promotion of Lap-Band after the Los Angeles County Public Health Department submitted a request, Morgan Liscinsky, a spokesperson for the FDA told Medical Daily.
John Faitro filed a lawsuit in February 2011 against Valley Surgical Center, 1-800-GET-THIN LLC, Simi Valley Hospital when his wife died five days after undergoing Lap-Band surgery. Faitro claims that his wife became interested in the weight loss surgery after seeing advertisements for the 1-800-GET-THIN that failed to provide adequate risk information, according to court documents.
A health officer for the Los Angeles County then requested on December 7, 2010 that FDA investigate the Defendants’ advertising of Lap-Band surgeries because the advertising “inadequately informs consumer of potential risks” and “fail[s] to provide the relevant warnings, precautions, side effects, and contraindications related to the procedure.”
“The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider. 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,” said Kimber Richter, the deputy director for medical affairs in the Office of Compliance in the FDA’s Center for Devices and Radiological Health in the statement.
Five people have died after Lap-Band surgeries at clinics associated with the 1-800-GET-THIN LLC campaign since 2009, according to the LA Times.
“The FDA issued Warning Letters 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; San Diego Ambulatory Center LLC; and to 1-800-GET-THIN because Lap-Band is a restricted medical device that is misbranded as a result of misleading advertising by these groups,” the FDA said in the statement.
1-800-GET-THIN LLC could not be reached for a comment.