By Stuart Pfeifer, Los Angeles Times –
LOS ANGELES — Members of Congress are calling for an investigation into the 1-800-GET-THIN weight-loss surgery marketing campaign and the safety and effectiveness of the Lap-Band device.
Rep. Henry A. Waxman, D-Calif., and two other House members called 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.
In a letter sent Friday to the chairman of the House Energy and Commerce Committee, Waxman said Congress should subpoena documents from 1-800-GET-THIN and Lap-Band manufacturer Allergan Inc.
The letter cited a series of articles in The Los Angeles Times about patient deaths and recent studies that have questioned the long-term effectiveness of the Lap-Band, a ring that is surgically implanted around the stomach to discourage overeating.
“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,” Waxman and Reps. Diana DeGette, D-Colo., and John D. Dingell, D-Mich., said in the letter.
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.
Robert Silverman, president of 1-800-GET-THIN, did not respond to a request for comment. Neither did Michael and Julian Omidi, brothers who, according to a recent lawsuit, run the Lap-Band surgery business from offices in Beverly Hills, Calif.
A spokeswoman for Lap-Band manufacturer Allergan of Irvine, Calif., said the device is safe and effective, if “inserted by an experienced and qualified bariatric surgeon who offers the patient appropriate follow-up care.”
Allergan spokeswoman Naziah Lasi-Tejani also questioned a study that Congress members cited in the letter as evidence that the Lap-Band often has long-term complications. That study examined the effectiveness of an earlier version of the Lap-Band and surgical techniques that are no longer used, she said.
In addition to the effectiveness of the Lap-Band, Waxman and his colleagues questioned “aggressive marketing” of the device through 1-800-GET-THIN ads on freeway billboards, radio, television, direct mail and the Internet.
Last month, the Food and Drug Administration sent warning letters to 1-800-GET-THIN and some of its affiliated surgery centers, saying the ads were misleading because they did not adequately disclose dangers of the surgery. The Los Angeles County Board of Supervisors has asked its legal team to determine whether the county can regulate the advertising.
The company responded by adding a disclosure to its website that said Lap-Band procedures can result in death. Silverman later told supervisors that the company planned to change its ads to address the FDA’s concerns.
Waxman, in a statement to The Times, said he hopes the House committee holds the hearings because “the evidence is clear that there are devices on the market today that pose dangerous risks.” The issue is important, he said, because this year Congress is expected to re-evaluate how medical devices such as the Lap-Band are regulated.
“The fundamental mission of the FDA is to ensure the safety and effectiveness of medical devices,” he said. “That is why it’s critical that we understand how unsafe devices get on the market and how to protect patients from these risks.”
Kathryn Trepinski, an attorney who has filed a wrongful-death lawsuit against 1-800-GET-THIN on behalf of relatives of a woman who died following Lap-Band surgery, said she welcomed congressional scrutiny.
“I’m pleased to see increased action on a federal level,” Trepinski said. “I would like to see Allergan and its product, the Lap-Band, put under a microscope and examined.”
The congressional concern comes three days after two former employees filed a whistle-blower lawsuit in Los Angeles that 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.
The lawsuit also said workers affiliated with the companies persuaded patients to have surgeries they did not need, including hysterectomies and other organ removals, in order to drive up profits.
Company officials did not respond to The Times about the lawsuit’s allegations.