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Allergan Pulled Teen Lap-Band Plans

Allergan Inc. won’t seek U.S. clearance to sell its popular Lap-Band stomach shrinking device to an increasing population of obese teenagers.  Not. surprising. 

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The LAP-BAND® Adjustable Gastric Banding System is the first adjustable medical device approved by the U.S. Food and Drug Administration (FDA) in the United States for individualized weight loss for obese patients whose weight is affecting their health. The LAP-BAND® System was originally approved by the FDA in 2001 for use in weight reduction for severely obese adults with a Body Mass Index (BMI) of 40 or more, or for adults with a BMI of at least 35 plus at least one severe obesity-related health condition, such as Type 2 diabetes, hypertension and asthma. In February 2011, the FDA approved the expanded use of LAP-BAND®for adults with obesity who have failed more conservative weight reduction alternatives, such as diet and exercise and pharmacotherapy, and have a Body Mass Index (BMI) of 30-40 and at least one obesity related comorbid condition. In addition, the LAP-BAND® System has been approved internationally since 1993. The LAP-BAND® System is now the first and only FDA-approved device for weight-loss surgery in patients with a BMI of 30-35.

Businessweek -

Allergan Inc. (AGN) won’t seek U.S. clearance to sell its popular Lap-Band stomach shrinking device to an increasing population of obese teenagers.

In the wake of congressional criticism and lawsuits, the Irvine, California-based company has decided to shelve any plans for marketing its Lap-Band device to adolescents, among the fastest-growing group of obese Americans.

Businessweek -

Health advocacy groups have warned about the surgery’s safety and its effect on a young person’s developing body. And a 2011 Archives of Surgery study found that almost half of adult patients who had gastric banding had the device removed following infections and other complications.

“These products are marketed as the surgery that can save your life,” Amy Allina, program director of the National Women’s Health Network, a Washington-based advocacy group, said in an interview. “People are being misled.”

Allergan rose less than 1 percent to $93.31 at the close of New York trading. The stock has risen 17 percent in the past 12 months.

About one-third of 200,000 weight-loss surgeries in the U.S. annually use gastric banding, wrapping the small rubber devices around the upper stomach to limit capacity. It costs less than surgery that alters or staples parts of the stomach, and is adjustable and reversible.

Obesity Rates

Use of the Lap-Band device may grow because obesity rates are predicted to increase. More than one-third of U.S. adults are obese, according to the Centers for Disease Control and Prevention in Atlanta, and medical costs associated with obesity were estimated at $147 billion in 2008 dollars. The adolescent market had been seen as potentially lucrative: the rate of obesity among all U.S. children and adolescents has tripled since 1980 to about 17 percent.

Allergan isn’t elaborating on why it isn’t seeking U.S. permission to market its weight-loss device to a younger patient population. The decision was made at the beginning of the year, Allergan spokeswomen Naziah Lasi-Tejani wrote in an e-mail. The company stands behind the safety and effectiveness of the Lap- Band system it obtained in its 2006 acquisition of Inamed Corp. for about $3.3 billion, Lasi-Tejani said.

“The Lap-Band AP system has an 18-year safety and effectiveness record with more than 650,000 procedures performed to date and adverse events reported in less than two percent of patients,” Lasi-Tejani said in an e-mail.

Devices Removable

Patients who undergo gastric banding with Lap-Band can have the rubber device removed entirely if it’s problematic, or have it adjusted using saline infusions to tighten it. The procedure has been popularized by such high-profile patients as Rex Ryan, the New York Jets professional football coach who told the New York Post he lost almost a third of his weight, dropping to 242 pounds.

At the same time, some clinics, hospitals and doctors that offer gastric banding with Lap-Band devices are facing lawsuits over patient care and, in some instances, the tragic outcomes that have followed surgery.

After having the Lap-Band device implanted in May 2009, Rebecca Quatinetz kept vomiting. Then the 27-year-old lawyer struggled to swallow. Two months later, Quatinetz died in her New York apartment of cardiac arrest caused by long QT syndrome, a condition that causes a racing heart, according to an Aug. 4, 2009, autopsy report.

Higher Risk

A pre-operative exam detected the condition, but Quatinetz’s doctors went ahead with the gastric surgery, her mother, Stephanie Yutkin, 57, of Scarsdale, New York, said in an interview. Yutkin maintains the surgery should never have been done because, she was later informed, Quatinetz was at a higher risk due to her heart condition and should have been treated for that prior to any operation.

“A lot of doctors feel Lap-Band is a simple, little procedure,” Yutkin said. “She was a beautiful girl, a writer, an artist. She believed the doctors were telling her the truth.”

Yutkin filed an April 5, 2010, lawsuit in New York Supreme Court against New York University Langone Medical Center, her daughter’s doctors and others.

“Because the litigation is ongoing, it would be inappropriate to comment on issues specific to this case,” according to an e-mail from NYU Langone Medical Center.

Lawsuits Filed

The Quatinetz litigation is similar to other lawsuits that claim doctors are operating on unsuitable patients, engaging in misleading advertising and neglecting to provide follow-up care. Some lawsuits claim doctors have lied about patient heights to get insurance coverage, that patients have been seen by doctors who were under medical board investigations, and that patients didn’t receive proper follow-up tests after surgery that may have detected concerns that led to long-term health problems.

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