Rep. Henry Waxman (D.-Calif.) and two other House members have sent a letter to the House Energy and Commerce Committee calling for investigations into 1-800-GET-THIN weight-loss advertisements and the safety and effectiveness of the Lap-Band device, the Los Angeles Times reports.
The 1-800-GET-THIN campaign markets the Lap-Band procedure, which is used to treat obesity by surgically implanting a ring around the stomach to discourage overeating.
In December 2011, FDA sent warning letters to 1-800-GET-THIN and its affiliated surgery centers about ads that were misleading about the procedure.
The company later added a disclosure to its website, saying the surgeries can result in death.
Since 2009, five Southern California patients have died after having the Lap-Band procedure, according to autopsy reports, lawsuits and public records.
Los Angeles County supervisors are examining whether the county can regulate weight-loss ads.
Details of the Letter
The letter -- which was signed by Waxman, ranking member of the House Energy and Commerce committee, and Reps. John Dingell (D-Mich.) and Diana DeGette (D-Colo.) -- calls for congressional hearings to examine if the sponsors of the 1-800-GET-THIN campaign, the Lap-Band manufacturer Allergan and affiliated clinics are improperly promoting a surgery that is potentially dangerous.
The letter also seeks an investigation into the effectiveness of the procedure, citing media reports and studies that question the Lap-Band's long-term effectiveness (Pfeifer, Los Angeles Times, 1/20). The letter also calls for hearings into a urogynecologic surgical mesh device (Ethridge, CQ Today, 1/20).
Waxman said that "the evidence is clear that there are devices on the market today that pose dangerous risks" (Los Angeles Times, 1/20).
The letter comes as Congress prepares to review an expiring law that helps provide funding for FDA's review process of medical devices (CQ Today, 1/20).
Response to the Letter
Naziah Lasi-Tejani -- a spokesperson for Irvine-based Allergan -- said the Lap-Band device is safe and effective if it is "inserted by an experienced and qualified bariatric surgeon who offers the patient appropriate follow-up care."
Robert Silverman, president of 1-800-GET-THIN, did not respond to a request for comment (Los Angeles Times, 1/20).
Debbee Keller, a spokesperson for the committee's Republican majority, said the committee is "thoroughly examining" medical device regulations and plans to hold a hearing Feb. 15 (Nussbaum, Bloomberg Businessweek, 1/23).