surgery

FDA issues warning to 8 bariatric surgery centers following multiple confirmed fatalities

Thursday, December 15, 2011 by: Tara Green
Tags: bariatric surgery, warning, fatalities

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(NaturalNews) After four confirmed fatalities since 2009, the FDA is finally taking action against eight California surgical centers and a marketing firm for providing misleading information while advertising lap-band surgery.

Death and advertising

The L.A. County Department of Public Health last year asked the FDA to investigate the advertising campaign promoting lap-band surgery as a relatively simple weight loss solution. Ads and billboards display a fit-looking woman on a scale, with her fist raised as if in victory, beneath the caption "Let Your New Life Begin," and the helpful suggestion that the surgery is "covered by most PPO insurance." The FDA concluded that the clinics' 1-800-GET-THIN ads fail to explain the risks and side-effects of the procedure they are promoting.

The FDA issued warning letters to Beverly Hills Surgery Center, Palmdale Ambulatory Center, Bakersfield Surgery Institute Inc., Valley Surgical Center, San Diego Ambulatory Center Valencia Ambulatory Center, Top Surgeons and Cosmopolitan Plastic & Reconstructive Surgery. The agency said the font size of information related to risks on the advertising inserts is too small to be read by consumers.

"It's particularly troublesome when advertisements don't communicate the serious risks associated with medical devices," said an FDA representative. "If the affected companies do not change the advertising and promotion strategies to address the concerns raised by the FDA, the agency is prepared to take further action, which could include product seizure or civil money penalties." The companies involved have 15 days to respond to the FDA warning. The maker of the Lap-Band device, Allergan, did not receive an FDA warning letter.

Four people died after undergoing lap-band procedures at clinics associated with the misleading ads. A coroner's ruling is still pending on the death of a fifth patient, who was rushed to the hospital immediately after receiving bariatric surgery at one of the clinics. Articles in the LA Times have pointed out inadequate sanitary and safety conditions at these clinics. Since bariatric surgery facilities such as these are officially categorized as performing a minor cosmetic service rather than major surgery, they fall into what the Times calls a "regulatory grey zone." Another bariatric surgeon in the LA area described the situation as "the Wild Wild West out there when it comes to bariatric surgery."

Thin promises

Bariatric surgery involves the placement of gastric bands via laparoscopic incision. Although the procedure involves a relatively small incision and is guided by a camera, it carries many risks, including death. After surgery, patients may also experience vomiting, blood clots in the legs, gastric reflux, iron deficiency anemia, difficulty swallowing, narrowing of the opening between the stomach and small intestine, gallstones, vitamin D deficiency, kidney stones, hair thinning or hair loss and pain. A 2008 study also found bariatric surgery patients were 5-10 times more likely to commit suicide as compared with the general population (http://www.naturalnews.com/022994_surgery_ba... ). Nor are the promised results guaranteed: the stomach can stretch resulting in the band no longer limiting food intake, or the bands may shift.

It is sad that so many people define wellbeing solely through appearance so that they are willing to risk their lives to become thin. Bariatric surgery alone cannot improve measures of health such as blood sugar levels, cholesterol levels and blood pressure. Unfortunately this mistaken attitude is supported in at least some quarters of the mainstream health care field. NaturalNews reported in 2008 on a study published in The American Journal of Managed Care claiming that bariatric surgery can "pay for itself" by diminishing the number of insurance claims filed by people who are grossly overweight (http://www.naturalnews.com/024511_surgery_ga...). The clinics' billboard advertisements noted that the procedures were often covered by insurance; there is no mention in any of the articles relating to the fatalities of the insurance companies terminating their relationship with the facilities in question.

Sources:

http://www.nationaljournal.com/healthcare/fd...

http://www.latimes.com/health/la-fi-hiltzik-...

http://jezebel.com/5867887/after-five-fatali...

http://www.istockanalyst.com/business/news/5...

http://www.istockanalyst.com/business/news/5...

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