Allergan, headquartered in Irvine, pulled plans to offer its Lap-band… (Mark Boster/Los Angeles…)
Allergan Inc. 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.
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."
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.
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.