FDA's 1-800-GET-THIN warning follows L.A. County official's complaint
The Food and Drug Administration has ordered 1-800-GET-THIN, the company behind the ubiquitous advertising campaign for Lap-Band weight-loss surgery, to take better steps to warn consumers about risks associated with such procedures.
The move, in an FDA letter to eight California surgical centers and the marketing firm 1-800-GET-THIN, 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."
Since 2009, five patients have died following surgeries at centers affiliated with the ad campaign. A series of lawsuits blamed the deaths on mistakes by the surgery centers and doctors who performed the surgeries.
An attorney for 1-800-GET-THIN filed a complaint against Fielding with the county, contending that the county official had a conflict of interest because he's a former executive and a shareholder of Johnson & Johnson, which competes with Lap-Band manufacturer Allergan Inc. in the gastric-band market.
Fielding said he wasn't aware when he wrote to the FDA that Johnson & Johnson, where he worked in the 1980s, makes gastric bands. Regardless, he said, he would delegate any issues related to weight-loss devices to members of his staff.
Photo: Paula Rojeski died Sept. 8 after having Lap-Band weight-loss surgery at an outpatient clinic in West Hills, officials said. She was the fifth person to die in the last two years after having surgeries at clinics that, according to wrongful-death lawsuits, are affiliated with the 1-800-GET-THIN ad campaign. Credit: Marni Rader