Allergan Stops Lap-Band Sales to '1-800-Get-Thin' Surgeons

February 04, 2012

February 4, 2012 — Medical device maker Allergan announced February 2 that it will no longer sell its gastric-banding device to a group of Southern California weight-loss surgery centers that are under intense scrutiny for their safety record, billing practices, and advertising.

The advertisements in question, found on billboards, bus placards, television, and radio, tout the benefits of weight-loss surgery with Allergan's Lap-Band Adjustable Gastric Banding System. The ads, which have swamped Southern California, bear the telephone number 1-800-Get-Thin and testimonials from men and women who say they have lost as many as 130 pounds through the procedure. Individuals calling the telephone number are referred to an affiliated surgery center.

In December, the US Food and Drug Administration (FDA) warned the marketing firm called 1-800-Get-Thin and 8 affiliated surgery centers that the ads are misleading because they fail to spell out the risks of the surgery. The agency ordered the businesses to change the ads immediately.

In an ongoing investigation, the Los Angeles Times has reported that at least 5 patients have died since 2009 after undergoing gastric banding at the surgery centers in question. The centers, along with the 1-800-Get-Thin marketing firm and individuals said to control these different businesses, have been hit with 2 wrongful-death suits as well as a whistleblower suit filed by ex-employees and patients. The whistleblower suit alleges unsanitary operating rooms, broken surgical equipment, billing fraud, and the cover-up of a patient death. Konrad Trope, an attorney for the surgery centers, has called the suit's accusations untrue.

The California Department of Insurance is investigating the allegations of billing fraud, and the Los Angeles County Board of Supervisors is seeking legislation to more tightly regulate bariatric surgery centers. Several members of Congress have called for hearings into the relationship of the surgery centers, 1-800-Get-Thin, and device-maker Allergan, and how they have responded to adverse events.

Allergan has stated that it has no financial ties to 1-800-Get-Thin and no control over how physicians market its Lap-Band device. On February 2, the company issued a statement saying that it has stopped selling the system to surgery centers affiliated with the 1-800-Get-Thin advertising campaign. The statement did not give any reasons for the decision.

Trope, the attorney for the surgery centers, did not respond to a request for comment on the Allergan decision. Robert Silverman, the president of 1-800-Get Thin, said in an email that his company is waiting to hear from the FDA in regard to its earlier warning letter.

"There will be no marketing of any restricted medical device until such time that the FDA approves an appropriate risk disclosure," Silverman said. "The decision by Allergan is a nonissue until such time that the FDA either approves a risk disclosure statement or provides further guidance."

The Lap-Band is 1 of 2 gastric banding devices approved by the FDA for weight loss. The other device is the Realize Adjustable Gastric Band sold by Ethicon, a subsidiary of Johnson & Johnson. Ethicon spokesperson David Shaffer told Medscape Medical News that his company has no business relationship with the surgery centers behind the 1-800-Get-Thin ads, nor does it have plans to sell them its gastric banding device in the future.

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