Health

FDA Asked to Rein in 'Get Slim' Surgery Ads

Wednesday, February 23, 2011

Southern California billboard ads are criticized for their casual portrayal of Lap-Band weight-loss surgery in light of recent deaths linked to the surgery. On Feb. 16 the FDA approved the surgery for lower weight people.

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Billboards May Not Meet Government Regs

Los Angeles Department of Public Health Director Jonathan E. Fielding has asked the Food and Drug Administration to determine whether advertisements such as the 1-800-GET-THIN billboards prevalent in some parts of Southern California are consistent with government regulations that require consumers to have adequate information about potential surgical risks.

"The Lap-Band procedure, like other bariatric procedures, while effective for many patients, can cause serious complications," Fielding said in a press statement on Jan. 27.

Fielding said that marketing information doesn't adequately convey the potential complications or make clear that surgery isn't appropriate for the vast majority of individuals.

The marketers behind the 1-800-GET-THIN billboards are just one of a handful of companies that promote the surgery with language that could also be used to shill the latest fad diet.

Newer billboards have a disclaimer at the bottom, according to attorney Silverman. "We only work with pre-screened, fully inspected and accredited facilities," the billboards state, along with a gold seal with the words, "We are committed to patient safety at the highest level."

Allergan's Chief Executive Officer David E.I. Pyott distanced his company from the independently-produced billboards.

On Feb. 3, he told the Los Angeles Times he doesn't support the ad campaign and that Allergan is in the process of devising guidelines for surgeons that require the risks associated with gastric banding be stated clearly on any advertisement.

Since its FDA approval in 2001, gastric banding has been aggressively marketed as a safer and more effective alternative to gastric bypass, its weight loss surgery predecessor.

Magic With Numbers

Dr. Edo Aarts, a bariatric researcher from Rijnstate Hospital in the Netherlands is skeptical.

"Everybody is doing magic with numbers here," he told Women's eNews in a recent phone interview.

Only deaths that occur within 30 days of surgery figure into statistical mortality rates, Aarts said. That doesn't count patients such as Delango, whose initial complications turn fatal weeks or even months after the surgery.

Even deaths within a 30-day period aren't necessarily attributed to the Lap-Band. Deaths from sepsis, cardiac arrest or electrolytic imbalance could be from Lap-Band complications, but coroners' reports don't always pin the cause of death on the device, further skewing statistics, Aarts said.

The death rate also doesn't account for patients lost to follow up--and therefore the ones who don't receive any post operative-care, who Aarts says tend to fare the worst--and those who get the procedure done out of the country to avoid insurance company red tape and long waiting periods.

Advocates for gastric banding say that as with any surgery, the Lap-Band carries inherent risk and complications that are more likely when patients don't comply with strict diet and lifestyle changes. Those opting for "surgery mills," or unaccredited surgical centers, also put themselves at risk.

The safe route, according to bariatric professionals, is hospitals and surgical centers sanctioned as "centers of excellence" that meet requirements outlined by the American Society for Metabolic and Bariatric Surgery. Bariatric centers must have a mortality rate of less than 1 percent and provide proper follow-up care to be deemed excellent.

Some "excellence" centers, however, perform up to 20 operations a day and the sheer number of patients makes it difficult for many--like Delango, who was operated on at a hospital that met American Society for Metabolic and Bariatric Surgery criteria--to get quick appointments for adequate follow-up care.

There is no exact science in figuring out how the body will react to a foreign device cinching an essential organ, said Aarts, making it difficult to determine who will react negatively to surgery.

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Alizah Salario is a freelance journalist based in Chicago. Her work has appeared in The Daily Beast, Ms. Magazine and elsewhere. You can read more at www.alizahsalario.com or follow her on Twitter at http://twitter.com/Alirosa.

 

For more information:

"Allergan CEO criticizes Lap-Band billboards," Los Angeles Times:
http://www.latimes.com/business/la-fi-lap-band-20110203,0,5462230.story

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