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Concerns build as more teens undergo gastric banding Add to ...

After one patient died and others suffered serious complications following Lap-Band surgery, Dr. Neelu Pal had seen enough. A petite surgical resident now aged 40, she began quietly calling patients about to undergo the weight-loss procedure at New York University's Medical Center, telling them she feared for their safety.

Dr. Pal had previously raised her concerns with hospital officials, complaining - to no avail - about the lack of care given after surgery and incomplete or inaccurate medical forms that were taken prior to surgery.

She was fired weeks after hospital authorities learned she had contacted patients in January 2006. She has filed a wrongful termination lawsuit (the case is pending) and enrolled in law school. Dr. Pal, who came to the United States from India a little over a decade ago to practice medicine, says she has been blackballed from her chosen profession.

The NYU bariatric surgery practice where she worked is widely considered one of the world's most experienced. But in an interview with Reuters, Dr. Pal described the facility as a hectic Lap-Band factory.

"My impression at the time was that the practice was disorganized, but once I knew more about the system, I could see what they were trying to do was get as many patients on to the operating table as possible," she said.

During her three months at NYU Langone Medical Center's Surgical Weight Loss Program in late 2005 and early 2006, two surgeons - Dr. Christine Ren and Dr. George Fielding, who are married - implanted gastric bands into as many as 20 patients in a single day, according to Dr. Pal.

Known as pioneers in the field, Dr. Fielding and Dr. Ren are also paid consultants of Allergan Inc, the Botox and breast implant maker which is the leading manufacturer of the gastric band. Though rivals have been gaining, Allergan's Lap-Band still commands more than two-thirds of a $300-million to $400-million market (all figures U.S.).

To critics, Dr. Pal's allegations - some of which were corroborated by a New York State Health Department investigation around that time - underline the potential risks that go along with the industry's rapid growth.

And the business could soon swell even more if U.S. regulators grant permission to perform the procedure on the nation's bulging ranks of overweight teens.

Dr. Ren was an investigator in an Allergan-sponsored clinical trial studying the use of bands on teens, and the company has an application with the U.S. Food and Drug Administration seeking approval to market the device to teens as young as 14. A decision could come any time.

Winning regulatory approval for the gastric band in teenagers would allow the companies that make the devices - Allergan, Johnson & Johnson and others - to target that specific age group.

Today, regulators consider performing the procedure on teens "experimental" as it has not been approved for that age group. But, like any device, it may be used on teens at a doctor's discretion.

Allergan declined to comment on Dr. Pal's lawsuit or disclose how much it pays the surgeons, though the company did confirm that both remain on the payroll.

Through a NYU spokeswoman, Dr. Ren and Dr. Fielding - who have been the subject of some controversy - declined to be interviewed for this article, also citing the lawsuit.

But in some medical circles, concern over gastric banding for teenagers is growing nearly as fast as American waistlines. In particular, some doctors worry about the device's long-term safety and effectiveness.

COMPLIANT TEENS

Gastric banding demands that teens do something they often aren't very good at - sticking to a rigorous follow-up routine.

Dr. Roberta Maller Hartman, a psychologist and Lap-Band patient herself, counsels teens and adults after receiving the gastric band.

"I've worked with a lot of high school students and they just want to be like everyone else and go out and eat pizza with their friends," she said. "They can, but they have to take little bites and chew a lot."

Success depends most on a patient's ability to modify their behavior. "The band doesn't reduce the desire to eat emotionally. That has to be addressed," said Dr. Maller. "Teens tend to need more hands-on, one-to-one support."

Indeed, there are many success stories of obese teens losing weight, keeping it off and staving off a host of related illnesses, such as diabetes, arthritis and high blood pressure. Surgery - banding or bypass - has been shown to produce the most sustainable results when compared with diet and exercise.

Nevertheless, critics abound. Dr. Susan Woolford, Medical Director of the Pediatric Comprehensive Weight Management Center at the University of Michigan, conducted a study, published in Obesity Surgery, to find out how readily primary care physicians and pediatricians - those in the front lines of obesity treatment - would refer patients for bariatric surgery.

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