Teen Bands - potential problems ?

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Targeting teens for gastric bands: Special report

By Debra Sherman, Reuters October 26, 2010 Comments (4)

Dr. Neelu Pal was fired weeks after authorities at New York University Langone

Medical Center Surgical Weight Loss Program learned she had contacted patients

about the dangers of Lap-Band surgery in January 2006.Photograph by:

Stapleton, ReutersAfter 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. Ren and Dr.

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, & 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.

BAND OF GOLD?

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. 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. 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.

COMPLIANT TEENS

Gastric banding demands that teens do something they often aren't very good at

-- sticking to a rigorous follow-up routine.

Dr. a 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. 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.

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

Fielding falsified data on 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, land 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. " Skip " , 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.

MEASURING EXCELLENCE

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 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 &

'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 Gal said FDA approval of the Lap-Band for teens

could increase sales by as much as $20 million for Allergan.

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 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. 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. 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.