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.
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.
Nearly half, or 48 per cent of the 381 physicians surveyed, said they would never refer an adolescent for any type of bariatric surgery.
SURGEONS WITH A HISTORY
The controversies swirling around NYU's influential bariatric surgery center - as well as its two top surgeons - have done little to ease concerns.
An investigation by the New York State Department of Health in 2006 found that Dr. Fielding falsified data on Vincent Esposito, a 14-year-old boy who was part of the FDA-authorized study that was looking at the use of the device in obese teens.
A week after Vincent's Lap-Band surgery, he developed an infection with an abscess - a common complication with gastric banding - and returned to the NYU facility, where Dr. Fielding performed an appendectomy.
The investigation by New York health authorities determined there was no evidence of appendicitis, according to the report.
"They told me I was a ticking bomb," Vincent had told the Daily Times in Salisbury, Maryland in 2007, referring to his obesity.
Reached by telephone, his father said his son was "fine" and that they are being represented by an attorney and declined to comment.
NYU also declined to comment. In its response to the NYDH report, the university maintained no wrongdoing, saying "the surgeon probably misinterpreted his operative findings." In a statement at the time, the school added, "...we are persuaded that he assumed that the infection did not begin in the gastric band device."
The response and NYU's plan to correct the issues were accepted by state regulators.
In the NYSHD report, Dr. Fielding was also cited for failing to address a post-operative patient's persistent lack of urine output. The patient went into cardiac arrest and died 36 hours later. This was the death that alarmed Dr. Pal and led her to warn patients.
The same report said the program director, Dr. Ren, had permitted two surgeons to practice without the appropriate licenses, in violation of the law.
For four months, the unlicensed physicians "performed multiple surgical procedures, made pre- and post-op assessments, and wrote orders to be carried out by nursing staff," the report said.
After Dr. Ren learned she was being investigated by an internal committee, she went back and removed the name of the unlicensed surgeon from the operative report, according to court testimony. She was found to have committed professional misconduct and received a letter of reprimand that was put in her file for a year.
Dr. Fielding, who got a gastric band himself in 1999, is from Australia, where he left behind multiple personal injury lawsuits, most of which have been settled.
Dr. Robert "Skip" Nelson, a pediatric ethicist at FDA, said he had no specific knowledge about the incident at NYU Medical Center. If the agency did learn that an investigator has entered false data, he said, there would be an investigation.
He added that if the FDA doubted the integrity of the data, they would not be considered in the decision-making process. An investigator, as doctors who run clinical trials are called, could also be disqualified as a result.
FEW GOOD SOLUTIONS
Even critics of gastric band surgery acknowledge that there are few good solutions to adolescent obesity. It is a mounting problem, affecting nearly one in five American teens, and many doctors believe that it should be addressed sooner rather than later when other health problems can develop.
Some experts are wary but believe the benefits may outweigh the potential harm.
"My conclusion is that it makes sense to intervene sooner because surgery can head off other related problems. Kids are better surgical risks, but the downside is that I suspect most teenagers are doing it less for health and more for social and psychological reasons," said Dr. Jeffrey Zitsman, who is leading an independently funded teen study at Columbia University.
Those who do it out of vanity, he cautioned, may have a harder time. "When health reasons don't motivate them," he said, "sometimes there are compliance issues."
Yet, Dr. Robert Murray, director of Nationwide Children's Hospital Center for Healthy Weight and Nutrition, argues that the heavy psychological problems obese teens carry should not be ignored.
"They've been teased out of school, they have social issues, many are depressed, and their quality of life is equal to that of a kid with cancer," he said. "If you get them at 14 and reverse weight and health problems, they've got a shot at a normal life."
To critics, at least, the question is at how big a price.