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

By Alizah Salario

WeNews correspondent

Wednesday, December 8, 2010

Women's health advocates are unhappy about a FDA advisory panel's support last week for increasing the eligibility scope of a weight-reduction implant used by far more women than men. They say the risks are too clear and the data too limited.

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Study Backs Failure Rates

While representatives from the company say that surgical improvements have decreased ex-plants, a 2010 Dutch study reveals similar rates to previous studies.

"You've already inherited 1 million [American] patients with a Lap-Band that has a failure rate of 50 percent," said Dr. Edo Aarts, a leading Dutch obesity researcher who cautioned panelists against the expansion.

Aarts followed 201 Lap-Band patients for an average of 10 years and found that weight loss peaked after two years. Only one-third of participants maintained a functioning Lap-Band by the end of the 10-year study.

Aarts also said that in Allergan's study, shedding 30 percent of excess weight was defined as "meaningful" weight loss.

Based on Allergan's criteria, a patient with a BMI of 30 who is approximately 40 pounds overweight must lose just 12 pounds to be considered successful. The advisory panel did not include any experts on diet and exercise as a means of losing weight.

Last month, Allergan recalled 152,000 bands because of a defect in the port, the portion of the device connected to the skin and susceptible to infection. The recall was not mentioned at the FDA advisory meeting.

Allergan is the nation's largest manufacturer of gastric bands and has the majority of the market share. The company's third-quarter earnings for all product sales were $1.192 billion, and its stock was up 3.4 percent to $71 in after-hours trading on the day of the vote.

Not all insurance companies that cover the Lap-Band will pay for a second operation. Many patients end up paying out-of-pocket or have to make an emergency room visit to get the device removed. Aarts warned that a dramatic increase in the number of patients needing surgical revisions could put a tremendous burden on the health care system.

"You are really creating a very big problem for the future," he said.

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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 follow her on Twitter at http://twitter.com/Alirosa.

For more information:

National Women's Health Network:
http://nwhn.org/

National Research Center for Women and Families:
http://www.center4research.org/

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1 COMMENTS | Login or Sign Up to post comments

Excellent article, including that more than half of the panel members had a conflict of interest, those members should have abstained from the vote and not been in the room when the vote was taken; that includes the chair person should also have left the room and not given advice about voting direction before she left the room. Another significant problem ignored by the committee is the volume and seriousness of the research findings against the safety of this procedure in the years after the procedure is done. Thus prospective patients can be under an incorrect assumption given by their physician, if shown examples of low problem rates in one or two years after the procedure.