The controversy around a surgically implanted device to help people lose weight has been festering in the Los Angeles area for months. Opponents of the "Lap-Band" a ring that is surgically implanted around the stomach to discourage overeating have questioned the effectiveness and safety of the device, as well as its marketing claims.
The 1-800-GET-THIN weight-loss surgery billboard campaign is ubiquitous along Southern California freeways--in a town known for its obsession with physical appearance. Local opponents have questioned the "aggressive marketing" of the device through the freeway billboards, radio, television, direct mail and the Internet. Two former employees have accused 1-800-GET-THIN and its affiliated surgery centers of operating in unsanitary conditions, improperly billing insurers and putting an emphasis on profits over patient safety.
And now, the opposition is getting a national sponsors in U.S. Rep. Henry A. Waxman (D-Beverly Hills) and two other House members who are calling for congressional hearings to examine whether the sponsors of the ad campaign, their affiliated clinics and the device's manufacturer are improperly promoting a potentially dangerous surgery. Waxman wants Congress to subpoena documents from 1-800-GET-THIN and Lap-Band manufacturer Allergan Inc.
"We believe the Committee should hold hearings to examine whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices like the Lap-Band," said Waxman and Reps. Diana DeGette (D-Colo.) and John D. Dingell (D-Mich.) in letter.
The Los Angeles Times reports that five patients have died in Southern California since 2009 after Lap-Band surgeries at clinics affiliated with 1-800-GET-THIN, according to lawsuits, autopsy reports and other public records.
For its part, the Food and Drug Administration has sent warning letters to 1-800-GET-THIN and some of its affiliated surgery centers, saying that its advertisements were misleading because they did not adequately disclose dangers of the surgery. The company has agreed to change the ads to address the FDA's concerns.
"The fundamental mission of the FDA is to ensure the safety and effectiveness of medical devices," Congressman Waxman is quoted as saying. "That is why it's critical that we understand how unsafe devices get on the market and how to protect patients from these risks."