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.”
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.
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.
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.
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.
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.
Some Democrats in Congress in January called for hearings on whether the U.S. Food and Drug Administration failed to protect the public from Lap-Band devices. Democrats on the House Energy and Commerce Committee said at the time that Allergan was pursuing the expanded use in children as young as 14 despite concerns by some doctors the procedure is too drastic for a young person’s developing body, according to a Jan. 20 letter to Republican leaders. The adverse public health consequences associated with the device are exacerbated by aggressive marketing, the lawmakers said.
About half of patients who had gastric banding needed to have the device removed, according to a March 21, 2011, study in the Archives of Surgery that found the treatment caused more complications, such as hernias, infection and band slippage, than weight loss. About 1 of 3 had band erosion, which occurs when the band grows into the stomach.
The data is no longer relevant as clinical practices around implantation techniques and follow-up care have significantly improved involving Lap-Band, said Lasi-Tejani of Allergan. Data from about 60,000 patients have shown laproscopic adjustable gastric banding has complication rates that are four times lower than gastric bypass surgery, she said.
Problems have dogged some surgery clinics that provide or market the Lap-Band, including those affiliated with a 1-800-GET-THIN LLC marketing campaign. The use of Lap-Bands by surgical centers associated with 1-800-GET-THIN have been associated with five deaths since 2009, according to the January letter from House Democrats, citing Los Angeles Times stories on fatalities.
Laura Faitro underwent gastric banding with a Lap-Band device on July 21, 2010, and her liver was lacerated during surgery, according to a class action lawsuit filed in 2011 in Superior Court of California in Los Angeles against 1-800-GET-THIN LLC, a marketing campaign in Beverly Hills, California, and other parties.
Faitro was discharged despite severe abdominal pain, and died July 26, 2010, at Simi Valley Hospital in California, according to the lawsuit. Her autopsy revealed three liver lacerations and more than three liters of bloody fluid in her abdominal cavity, the lawsuit states.
Konrad Trope, a lawyer in Beverly Hills, California, who represents 1-800-GET-THIN, said in an interview and e-mail that all patients receive and review a booklet that contains FDA-mandated warnings and information on the surgery, safety and statistics.
“Nobody condones or views any patient death as ‘acceptable,’” Trope said in an e-mail. “Our surgery centers do their utmost to promote and implement patient safety.”
The FDA sent a Dec. 12 letter to 1-800-GET-THIN stating their advertising was misleading and failed to reveal the risks of surgery.
1-800-GET-THIN is committed to patient safety and advocacy, and all callers are referred to licensed doctors and accredited facilities that provide disclosure on risks and benefits, according to a press release on their website.
In July, the FDA also told Los Angeles-based Lap-Band VIP in a letter to immediately stop running television ads that leave out information about the procedure’s risks.
Obesity is a measurement of a person’s body mass index, which is calculated using height and weight. A person with a BMI of 30 or more, such as a 6-foot man weighing more than 220 pounds (100 kilograms) is considered obese, according to the National Institutes of Health.
The FDA in February 2011 expanded the use of Allergan’s Lap-Band to include obese individuals with a BMI of 30 to 34 who have an existing medical condition related to their weight. The procedure was approved in 2001 for severely obese patients with a BMI of at least 40; a index of at least 35 and an existing, related condition such as diabetes, or those who are at least 100 pounds (45 kilograms) overweight.
Allergan in 2011 reported about $203 million in net sales worldwide of its obesity intervention products.
“It’s the safest procedure we have,” Jaime Ponce, president of the American Society for Metabolic & Bariatric Surgery, said in an interview. “The procedure itself can have problems, but they get more pronounced if they don’t have the proper follow up.”
Some patient advocacy groups such as the National Women’s Health Network remain skeptical of such assurances, saying deaths and complications raise questions about how well informed patients are before undergoing gastric banding with the Lap-Band. Yutkin, Rebecca Quatinetz’s mother, said more oversight is needed of doctors and the product.
“Words cannot describe how I feel that she was taken away from our family at such a young age,” she said in an e-mail. “Rebecca’s whole life was in front of her.”