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.

(WOMENSENEWS)--Danielle Delango expected weight loss surgery to change her life, not take it.

The 25-year-old mother underwent Lap-Band surgery at Lawrence Hospital Center for Advanced Surgery in Bronxville, N.Y., in January 2008.

Allergan, the Irvine, Calif., pharmaceutical giant, produces the Lap-Band, one of the most popular gastric bands on the market. The surgically-implanted device cinches the stomach and severely restricts food intake, making patients feel full quicker.

Lap-Band manufacturers and bariatric surgeons insist the device saves more lives than it takes, but mounting evidence suggests that the dangers of the procedure aren't adequately known.

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On Feb. 16 the Food and Drug Administration lowered the weight requirement for the procedure, expanding Allergan's potential customer base by 26 million, according to The New York Times. The lower restrictions apply only to those with conditions such as diabetes, which are more threatening when combined with excess weight.

Before the expansion, overweight individuals with a body mass index (BMI) of 40 or above or a BMI of 35 with an existing obesity-related health problem such as diabetes qualified for surgery. Under the new guidelines, prospective patients can qualify with a BMI as low as 30 if an underlying complication is present. A person who is 5 feet 6 inches tall and weighing 186 pounds, for example, has a BMI of 40.

Though Delango suffered from severe constipation after the operation, she couldn't immediately get a follow-up appointment.

Over the phone, doctors advised her to take laxatives and an enema. Delango collapsed five weeks after her surgery, just days before her scheduled appointment. She suffered a 104 fever due to extreme infection and died six days later on March 3, 2008. Delango's official cause of death was a "fever of unknown origins followed by Lap-Band."

"She wasn't morbidly obese or suffering from life-threatening health issues," said Delango's mother, Joan Delango.

Joan Delango said her daughter had struggled with her weight since junior high school, but insists she wasn't heavy enough to qualify for surgery. She is unsure of how her daughter qualified for the surgery, unless her medical records were incomplete or erroneous.

"The tragedy is that she didn't need the surgery in the first place," said Joan Delango.

Other Women Impacted

Other women have suffered fatal complications from the restrictive--and increasingly popular--weight loss procedure.

"I feel strongly that it's a bad procedure and there's too much risk even with the most knowledgeable and compliant of patients," said Karen Parks, whose 38-year-old daughter, Leslie, died just three weeks after getting the surgery in Houston.

In view of the complications associated with the Lap-Band, some health officials criticize any marketing that promotes the procedure without serious disclaimers about the associated risks.

A 2007 study funded by Allergan and published in the American Journal of Surgery found that up to 76 percent of patients developed complications over three years. While some deaths are directly related to surgery, many more are connected to Lap-Band failure over time.

In Southern California numerous 1-800-GET-THIN billboards, some featuring a slender woman in a bikini, are produced by a marketing company that directs prospective patients to surgical centers that use the Lap-Band weight loss device.

Ana Renteria, 33, suffered a severe infection and died 10 days after getting the Lap-Band, and 52-year-old Tamara Walter stopped breathing two hours after surgery and was taken off life support four days later. (Walter's death is not officially attributed to the Lap-Band.)

Both underwent the procedure at the Beverly Hills Surgery Center, one of 11 Southern California weight loss facilities where prospective clients are referred to when they call 1-800-GET-THIN.

"My clients are fully dedicated to providing the highest level of patient care and safety. An overwhelming majority of individuals have experienced positive results which all prior reports have failed to mention," said attorney Robert Silverman, who represents 1-800-GET-THIN and the Beverly Hills Surgery Center. "In full consideration of all of these factors and others, independent review will confirm that not all of these incidents are related to the Lap-Band or the safety of the facilities and doctors providing this service."

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Lap-Band Critics Decry Excess Rhetoric on Weight


FDA Panel's OK for Lap-Band Surgery Stirs Critics

Brand new lap band surgical procedure guidelines have been issued by the Food and drug administration. Lap band studies certain the Food and Drug Administration to suggest that patients with a lower body mass index than was recommended before ought to be considered eligible if they have health issues linked to obesity. About 26 million more overweight Americans could be more effortlessly approved for lap band surgical procedure under new FDA recommendations.