Weight loss surgical centers affiliated with the 1-800-GET-THIN marketing campaign have been accused by the U.S. Food and Drug Administration of misleading consumers about the risks of the Lap-Band device used to treat obesity.
On Tuesday, the FDA announced that it has taken action against eight California centers by issuing warning letters because Lap-Band is a restricted medical device that is being misbranded because of allegedly deceptive advertising by the centers.
In a news release, the FDA announced that it warned that the organization’s billboards and advertising inserts used by recipients of the warning letters “to promote the Lap-Band procedure fail to provide required risk information, including warnings, precautions," and possible side effects.
Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health, said in a statement: “The FDA takes seriously its responsibility to protect consumers from products promoted without adequate warnings. It's particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices."
Five people have died since 2009 after Lap-Band surgeries at clinics affiliated with the 1-800-GET-THIN campaign, according to lawsuits, autopsy reports and interviews.
In all, the FDA sent 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 1-800-GET-THIN LLC.
[Updated at 11:53 a.m.: 1-800-GET-THIN, the ubiquitous marketing campaign on billboards, television and the Internet, has led to a surge of Lap-Band weight-loss surgeries in Southern California. More than 100,000 people called 1-800-GET-THIN in its first 15 months of business, leading to more than 10,000 scheduled surgeries, the marketing company said in a trademark lawsuit.
The Lap-Band, manufactured by Irvine-based Allergan Inc., is a silicone ring that is surgically implanted around the stomach to discourage overeating. The surgeries vary in cost — ranging from $12,000 to about $20,000 by some accounts — and often are covered by insurance.
The patients' deaths and injuries have led to a series of wrongful-death and personal injury lawsuits against 1-800-GET-THIN, its affiliated surgery centers and doctors who performed the procedures. Allergan is not affiliated with 1-800-GET-THIN.
Another lawsuit, seeking class-action status, accuses 1-800-GET-THIN of false advertising, saying the ads failed to provide adequate warnings about the risks of the surgery. Wrongful death lawsuits allege that two brothers, Julian and Michael Omidi, were part of a "joint venture" that included the surgery centers and the 1-800-GET-THIN marketing firm.
Both Omidis have been disciplined by the state medical board over issues unrelated to 1-800-GET-THIN, according to state records.
Michael Omidi did not return a telephone call seeking comment. His attorney, Robert Silverman, also did not immediately comment.
1-800-GET-THIN and the Omidi brothers have filed a series of lawsuits against The Times, its journalists and website commenters over past coverage of the surgery deaths. Judges have dismissed three of the lawsuits and ordered the plaintiffs to pay The Times' legal expenses and fees in two of the cases.]
Lap-Band clinic sued over death
Another patient dies after Lap-Band surgery
Tighter scrutiny for outpatient surgery centers
-- W.J. Hennigan and Stuart Pfeifer
twitter.com/wjhenn and twitter.com/spfeifer22
Photo: The 1-800-GET-THIN marketing firm promotes Lap-Band surgeries on Southern California billboards as well as on TV, radio and the Internet. Above, a pair of billboards in 2010. Credit: Glenn Koenig / Los Angeles Times