The maker of the Lap-Band will no longer sell its product to clinics affiliated with the 1-800-GET-THIN marketing company — a blow to Southern California surgery centers that have built an empire implanting the weight-loss devices in people looking to shed pounds.
said in a statement that it has "made the decision to presently discontinue the sale of the Lap-Band … to all entities affiliated with 1-800-GET-THIN."
The Irvine company's action Thursday comes amid state and federal investigations of surgery centers affiliated with 1-800-GET-THIN, which touts the Lap-Band procedure on Southland freeway billboards and on TV, radio and the Internet.
A representative for the surgery centers issued a statement saying the clinics were disappointed with Allergan's decision but would continue working with patients who want to
"Our surgery centers are staffed with experienced bariatric surgeons, trained by Allergan on the proper procedures for implanting the Lap-Band," the statement said. "Patients interested in weight loss solutions have a range of options, of which the Lap-Band is only one. We will continue to work with our patients to find the best healthcare options for their medical needs."
Five Southern California patients have died since 2009 after undergoing Lap-Band surgeries at clinics affiliated with 1-800-GET-THIN, according to lawsuits, autopsy reports and other public records. Each of the patients had been treated at surgery centers in Beverly Hills and West Hills tied to the ad campaign, according to the records.
Allergan is the world's top manufacturer of surgically implanted bands that constrict the stomach to limit food intake. It controls more than 80% of the market, according to the company.
1-800-GET-THIN has featured the Lap-Band prominently in its advertising.
Allergan spokeswoman Caroline Van Hove declined to elaborate on the device maker's decision to cut off a major group of customers. "We do not discuss our customer relationships with third parties," she said.
Allergan has said in previous comments to The Times that it was legally prohibited from banning sales to the surgery centers tied to 1-800-GET-THIN. It did not explain why it was able to take that step now.
In recent months, local, state and federal regulatory agencies have been examining the 1-800-GET-THIN affiliates amid questions about the advertising, surgery-related deaths and accusations of insurance fraud.
The California Department of Insurance is investigating the surgery centers for alleged insurance fraud, said David Althausen, a spokesman for the state agency.
In December, the
warned 1-800-GET-THIN and the surgery centers that the ads were misleading because they failed to adequately disclose risks of the surgery.
Allergan's decision could prove challenging to 1-800-GET-THIN because its marketing campaign is so closely tied to the Lap-Band brand, said Lars Perner, assistant professor of clinical marketing at the USC Marshall School of Business.
Lap-Band procedures typically cost between $12,000 and $20,000, according to Allergan.
Publicity about the Southern California deaths and investigations of 1-800-GET-THIN have hurt at least one surgeon who performs Lap-Band surgeries but who is not connected to the marketing company.
"Our Lap-Band business has come to a screeching halt," said Dr. Carson Liu, a Santa Monica bariatric surgeon who praised Allergan's decision. "I've been trying to get the word out that there's a difference between the Lap-Band and 1-800-GET-THIN."
Alexander Robertson, a Westlake Village attorney who has filed several lawsuits against 1-800-GET-THIN and its affiliated surgery centers, applauded Allergan's decision.
His clients include relatives of patients who died after Lap-Band surgeries and former employees who accused the surgery centers of performing unnecessary surgeries and of billing insurers for procedures that were not performed.
"Allergan is the only manufacturer of the Lap-Band device. So this means the 1-800-GET-THIN surgery centers may be out of the Lap-Band business," Robertson said. "Hopefully, it's going to result in saving lives and preventing further tragic outcomes."
The 1-800-GET-THIN ad campaign had been a marketing success story. In a court filing last year, the company said its advertising had led to 10,000 scheduled surgeries within its first 15 months of business.
Word of the patient deaths and allegations of insurance fraud prompted regulatory scrutiny.
Last month, members of Congress called for an investigation into the 1-800-GET-THIN campaign and the safety and effectiveness of the Lap-Band device.
(D-Beverly Hills) 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 were improperly promoting a potentially dangerous surgery.
On Wednesday, Allergan representatives met with Waxman's staff to update him on the company's plans.
Waxman said in a statement Thursday that he was pleased with Allergan's decision. But he wants Congress to examine whether the FDA is properly policing devices such as the Lap-Band.
"This extraordinary step underscores the need for the committee to hold balanced hearings to examine whether FDA device regulation is adequate," he said in the statement.
Also on Thursday, Allergan reported fourth-quarter earnings had climbed more than 6% amid increased sales of its eye drugs.
But, it said, its
-intervention segment sales declined 23% to $46.9 million.
In the earnings call, Allergan's chief executive, David E. I. Pyott, said the company held 83% of the band market and is stepping up its efforts to sell the product.
Allergan's stock dropped nearly 3% to $84.84 a share.