FDA Warns Surgery Centers to Drop 'Misleading' Lap-Band Ads

December 13, 2011

December 13, 2011 — Eight California surgical centers and an affiliated marketing firm have been warned by the US Food and Drug Administration (FDA) to drop "misleading" ads for laparoscopic adjustable gastric banding (LAGB) that fail to inform patients about the risks of the weight-loss procedure.

The Los Angeles Times reports that since 2009, at least 5 individuals have died after they underwent the procedure at clinics targeted by the FDA.

The marketing firm in question, 1-800-Get-Thin, has swamped southern California with highway billboards, bus placards, and advertising inserts touting LAGB performed with the Lap-Band Adjustable Gastric Banding System (Allergan). The advertising features trim, smiling men and women who testify to losing as much as 130 pounds through the procedure, described as "Safe, 1-Hour, FDA Approved."

The Lap-Band is one of 2 devices approved by the FDA for gastric banding. Both bands wrap around the upper part of the stomach to form a pouch. The narrowed opening can be adjusted to control the flow of food into the main part of the stomach. The band limits how much a person can eat and thereby helps create a sense of fullness that curbs appetite.

The Lap-Band is indicated for adults age 18 or older who have not lost weight with nonsurgical methods and have either a body mass index (BMI) of at least 40 kg/m2 or a BMI of 30 kg/m2 or more and at least 1 health problem related to obesity.

The FDA announced today that it had issued its warning letters to 1-800-Get-Thin and the surgical centers earlier this month. In those letters, the FDA complains that the Lap-Band advertising omits warnings, precautions, contraindications, and possible side effects of the procedure. The warnings in some of those ads that instruct would-be patients to consult their physicians about risks and to read online safety information "may be so small as to render the information illegible," the agency added.

The risks of the surgery, which include death, are heightened for obese individuals, according to the FDA. Risks after the Lap-Band procedure include nausea and vomiting, difficulty swallowing, gastroesophageal reflux disease, stretching of the stomach pouch, and the need for further surgery when the band shifts position or erodes into the stomach.

"FDA's concern is that these ads glamorize the Lap-Band without communicating any of the risks," Steven Silverman, director of the Office of Compliance in the agency's Center for Devices and Radiological Health, said in a press release.

The warning letters instruct 1-800-Get-Thin and the 8 surgery centers to immediately cease marketing the Lap-Band with "misleading" ads. If they fail to comply, the agency said it may resort to "product seizure" and civil penalties.

An attorney for 1-800-Get-Thin did not respond to a request to comment on the warning letter as of press time.

Allergan, the maker of the Lap-Band system, did not receive an FDA warning letter. Company spokesperson Caroline Van Hove told Medscape Medical News that Allergan has no financial ties to 1-800-Get-Thin and no control over how Allergan customers — namely bariatric surgeons — promote Lap-Band surgery.

More information about today's FDA announcement is available on the agency's Web site.

To report adverse events related to the Lap-Band system, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....