CHICAGO (Reuters) - 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.
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. 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, 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 Pal.
Known as pioneers in the field, Fielding and 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.
To critics, 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.
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 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, Ren and 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.
A gastric band is just what it sounds like: an inflatable silicone band placed around the top portion of the stomach to create a pouch that restricts food intake. It has become increasingly popular in the United States in recent years, and results in reasonable weight loss. The procedure is considered less invasive and risky than gastric bypass.
Banding could also be an especially attractive option for teens, say proponents, because it is reversible, whereas bypass is not. The 30- to 60-minute procedure, typically performed with a laparoscope, might require one night in the hospital but can also be done on an outpatient basis.
But certain data show gastric bands are less effective and more problematic for teens than adults, said Dr. Thomas Inge, chair of a government study to assess bariatric surgery in adolescents called Teen Longitudinal Assessment of Bariatric Surgery, or Teen-LABS for short.
The Teen-LABS study aims to determine if adolescence is the best time to intervene with surgery. It was launched in 2007 and is expected to report results in about five years.
In more than one in five teens in another study, Inge noted a high rate of “symmetric pouch dilation” -- a complication in which the small pouch created at the top of the stomach by the band gets bigger, allowing patients to consume more food.
This issue was reported in the journal Obesity Surgery, and later in the Journal of the American Medical Association. “We await the U.S. trial data, PMS (post-marketing surveillance) data, and confirmation from non-industry-run trials to make final recommendations,” said Inge, who is the surgical director of the weight loss program for teens at Cincinnati Children’s Hospital.
As Inge and others are quick to point out, trials that studied how teens fared with a gastric band over the short term have been few, and those that were conducted show the device generally is safe and effective, with a relatively low risk for complications or death.
But there is a dearth of long-term data on the outcomes from gastric band surgery. And that worries Dr. Mary Brandt, an investigator in the Teen-LABS study, among other experts.
“I think there’s a fundamental problem with putting a rigid plastic object around a moving organ. You’re asking it to stay in place and not erode over a long period of time,” said Brandt, who is also director of the pediatric surgical program at Texas Children’s Hospital in Houston. “I’ll be happy to reverse my position as soon as I see 10 or 20 year data. Unfortunately, that’s not something that industry is excited about funding.”
She acknowledged a bias against gastric bands, citing a Swiss long-term follow-up study of 167 adults that showed the band failed almost a third of the time after 10 years. About a fifth of the patients required another operation.
And while fewer than 8 percent reported complications in the 30 days following surgery, more than 40 percent had problems after a decade.
Long-term complications included the erosion and slippage of the band, both of which might require another operation, and a dilation of the esophagus, which could result in difficulty swallowing. Infections around the port that sits below the skin and allows the doctor to add or remove saline with a syringe to tighten or loosen the band, as well as leaks, were also common.
“Bands are definitely safe in the short term and definitely work in the short term. What we don’t know is about the long term,” Brandt said. “I‘m not saying it should never be used. We just have to be more careful about how we’re using it.”
The Swiss study of adults who had gastric banding, published in Obesity Surgery, came to the same conclusion. Because of complications, the need for another operation, and long-term failure rates, gastric banding should be performed in “selected cases only” until more data are available, it said.
Another group of 276 adults who underwent gastric band surgery had similarly disappointing results in a long-term Austrian study published in the same journal. Only a little under 54 percent of the patients still had their original band after nine years, with nearly 18 percent having the original replaced with a new one and nearly 29 percent having it removed. Of those who no longer had any band, more than half had a second bariatric operation.
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 percent of the 381 physicians surveyed, said they would never refer an adolescent for any type of bariatric surgery.
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 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 Esposito’s Lap-Band surgery, he developed an infection with an abscess -- a common complication with gastric banding -- and returned to the NYU facility, where 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,” Esposito 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, 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 Pal and led her to warn patients.
The same report said the program director, 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 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.
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.
Despite the reports of misconduct, the NYU Langone Weight Management Program has retained its status as a “Center of Excellence,” a designation conferred by the Surgical Review Corp, an entity created by the American Society for Bariatric and Metabolic Surgery.
Surgical Review Corp CEO Gary Pratt said that he was unaware of the incidents and the NYSHD report. He said the corporation’s reviews maintain the highest standards with the goal of advancing the safety and efficacy of bariatric surgery.
The company intends to put out a new list of approved bariatric clinics that treat teens later this year -- which may coincide with the FDA granting approval, or not.
If the FDA does greenlight it, insurers would be more likely to pay for the procedure, which costs the insured patient $2,000 to $4,000. The uninsured, making up about a third of patients who have the surgery in the United States, pay about $15,000 for the surgery.
Some health professionals worry that band manufacturers will target teens with direct-to-consumer (DTC) ads on television and radio or in subway stations that have proven effective at luring people to doctors’ offices. The FDA said there is no guidance or regulation on DTC ads to young users.
For Allergan, based in Irvine, California, the implications are significant. And the company is acting accordingly. It recently launched a campaign with bariatric surgeons to invite their patients to enter an essay contest and win a chance to go to Washington, D.C. to “share their personal stories with legislators and media.”
Allergan has seen its stock underperform the S&P 500 year to date. Botox remains its key product and has weathered increased competition amid the recession, while obesity intervention was hit hardest by the economy.
At the same time, Lap-Band has also been slowly losing market share to Johnson & Johnson’s competing device called Realize. In 2009, Allergan’s obesity products generated revenue of $258 million, down 13 percent from 2008.
Management is betting that continued investment in direct-to-consumer advertising will stimulate growth in the obesity segment, said Gleacher & Co analyst Amit Hazan. He estimates there will be 83,500 gastric band procedures in the United States in 2010, up 6 percent from 2009.
Sanford Bernstein analyst Aaron Gal said FDA approval of the Lap-Band for teens could increase sales by as much as $20 million for Allergan.
Even critics of gastric band surgery acknowledge that there are few good solutions to adolescent obesity. It is a mounting problem, affecting nearly 1 in 5 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.
Additional reporting by Ellen Freilich, editing by Jim Impoco and Claudia Parsons