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One Alternative: A Ring That Squeezes the Stomach
By BARNABY J. FEDER (NYT)
Other Perils of Overweight; Insurers Balk at Bariatric Operations,
By MILT FREUDENHEIM
Ben Zuckerman, a 57-year-old bottling executive from King of Prussia, Pa.,
was not surprised last year to find himself carrying more than 290 pounds
on his 6-foot-1 frame. Mr. Zuckerman said he could look back on decades of
binge eating and failed diets.
But he was worried about the onset of health problems often linked to
obesity, like the potentially lethal nighttime interruptions in breathing
known as sleep apnea. ''I told myself it was crazy and I was killing
myself,'' Mr. Zuckerman said.
Still, he could not bring himself to face the risks, pain and slow
recuperation that come with what is generally regarded as the most
effective obesity treatment doctors have to offer -- bariatric surgery to
shrink the stomach's capacity and bypass the upper intestine. Instead, he
opted last month to travel to Lenox Hill Hospital in New York for a
simpler surgery that implanted an inflatable silicone ring around his
stomach.
The Lap-Band, as the device is called, squeezes Mr. Zuckerman's stomach
into a bottom-heavy hourglass shape with an upper pouch about the size of
a walnut. Filling the pouch stimulates nerves that create a sensation of
fullness. The small opening to the lower stomach slows digestion to delay
the onset of new hunger pangs.
Bariatric surgery patients lose more weight on average but research has
shown that many Lap-Band patients manage gradually to shed 50 percent of
their excess weight. Lap-Band patients can suffer a variety of side
effects, including hoarseness, vomiting, acid reflux and nausea. One study
published last year concluded that around 6 percent of patients lose no
weight or have complications forcing them to have the device removed.
Those who fail often undermine themselves by consuming high-calorie drinks
that slip rapidly through the upper pouch.
''Once I made up my mind to do it, I would have gone ahead even if the
insurance hadn't been approved,'' Mr. Zuckerman said.
Since Lap-Band procedures are being billed at anywhere from $15,000 to
$40,000 by hospitals in various parts of the country -- Mr. Zuckerman's
was $31,500 -- that kind of talk makes a strong impression on device
makers.
In the last few years, medical device companies from start-ups to giants
like Medtronic and Johnson & Johnson have concluded that the obesity
market is too inviting to leave to drug makers, diet mavens and
traditional surgeons.
The Lap-Band is currently the only medical device approved by the Food and
Drug Administration to treat obesity, but similar internal cinches already
compete with it overseas. And a variety of other devices are in the
pipeline, including variations on heart pacemakers that use electrical
signals to modify the digestive system.
''Obesity is a multi-hundred-billion-dollar market ready and waiting for
device developers to catch up with an enormous unmet need,'' said Mary
Stuart, author of a 2003 research report in Start-Up, a review of emerging
markets published by Windhover Information.
It is hard to put much faith, though, in such market projections for
obesity devices. Device companies have built large businesses by focusing
on organs like the heart and on major joints, where research and
widespread use of surgery have led to a deep knowledge of the medical
issues.
''The basic science of digestion and the fat cycle is not as well
understood,'' said Dr. Thomas J. Fogarty, a professor at the Stanford
University School of Medicine. That limited knowledge is a major barrier
for anyone trying to design a pacemaker for the stomach or the major
nerves that connect it to the brain.
''The right wiring is in place to communicate with the brain, but we
really don't know the language yet,'' said Dr. Mitchell Roslin, the Lenox
Hill stomach specialist who inserted Mr. Zuckerman's Lap-Band and has also
experimented with pacemakers.
That leaves stomach-banding products as the device industry's best
near-term bet. Lap-Band sales are surging despite the still limited number
of doctors trained to implant it and the refusal of most insurers to pay
for it. Its maker, Inamed, based in Santa Barbara, Calif., reported that
its worldwide sales of obesity devices -- nearly all Lap-Bands -- grew at
40 percent last year, to more than $88 million.
Lap-Band is made under a license from Johnson & Johnson. But that medical
giant's Ethicon Endo-Surgery division is looking to compete with a
different band made in Sweden. Johnson acquired rights to the Swedish band
when it bought Obtech Medical, the company that sells it overseas, for an
undisclosed sum in 2002.
Lap-Band accounted for 11 percent of anti-obesity operations last year,
according to the American Society of Bariatric Surgeons. The rate is
considerably higher in the New York area, where more than 100 surgeons
have been trained to install it, according to Inamed. One leader in the
field, Dr. George A. Fielding of the New York University Medical Center,
underwent the procedure himself in 1999.
The band's advantages over bypass surgery are that the risk of death or
serious complications is about one-tenth as much and that it is easily
adjustable and reversible. That makes it attractive for women who may want
to become pregnant and increase their food intake at some point.
Less invasive surgery also leads to quicker recoveries in most cases. Mr.
Zuckerman had his surgery on Friday, April 8, returned home the next day
and was fit enough to return to work the following Monday. Now, six weeks
later and 26 pounds lighter, he returned yesterday to Lenox Hill to have
the Lap-Band inflated enough to stimulate further weight loss.
Photos: Dr. Mitchell Roslin, center, prepares to insert a stomach band at
Lenox Hill Hospital in Manhattan.; The inflatable Lap-Band. (Photographs
by Diane Bondareff for The New York Times)
Chart: ''In the Works''
Here are some treatments for obesity that are under development.
TREATMENT: Electrical stimulators implanted in stomach
MAKER: Transneuronix, Mt. Arlington, N.J.; IntraPace, Menlo Park, Calif.
STATUS: Transneuronix device sold in Europe, in clinical trials in the
United States
TREATMENT: Stimulators implanted on main nerve connecting stomach to brain
MAKER: Advanced Neuromodulation Systems, Plano,Tex.; Metacure, Israel;
Cyberonics, Houston; EnteroMedics, St. Paul
STATUS: Metacure has completed human safety trial; Cyberonics and Advanced
Neuromodulation have similar stimulators approved by the Food and Drug
Administration for other applications
TREATMENT: Surgery-avoiding devices enter stomach from throat to make it a
smaller pouch
MAKER: Satiety Inc., Palo Alto, Calif.; C. R. Bard, Murray Hill, N.J.
STATUS: Bard approved by the F.D.A. to treat acid reflux and will start
obesity trial this year
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