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.
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.
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.
After five patient deaths in recent years via outpatient weight loss surgery clinics affiliated with 1-800-Get-Thin, a new law has been established to maintain control over the facilities.
The Lap-Band, is manufactured by Allergan Inc.
The patients' deaths and injuries have led to a series of wrongful death and personal injury lawsuits against 1-800-GET-THIN, its affiliated surgery centers and doctors who performed the procedures, says the LA Times. Allergan is not affiliated with 1-800-GET-THIN.
Outpatient surgery centers in California that perform Lap-Band operations and other procedures will face new scrutiny under a law signed by Gov. Jerry Brown.
The legislation requires private accrediting firms to inspect outpatient centers at least once every three years and allows for surprise inspections to ensure the centers meet safety standards for such things as cleanliness and proper use of medication.
It also requires accrediting firms to demand improvements or revoke certification if a surgery center does not meet the standards.
The author of the law, state Sen. Curren Price Jr. (D-Los Angeles), said he became interested in the safety of outpatient centers after singer Kanye West's mother died in 2007 after liposuction and breast augmentation surgery at a Westside clinic.
"It brings oversight that's long overdue over these clinics," Price said Sunday after the governor signed the law. "It's going to protect the public's health and safety."
Double-take, or three. I didn't catch it at first. This looks just like some of those California band billboards. (I photographed some when I was out there.)
"I had a bad dream the other night. In the dream world, it was forbidden to publicly oppose stomach binding (aka lap band surgery). I was under house arrest, waiting for my punishment: mandatory leg removal. I had failed to use my legs for the approved activity of running on treadmills to lose weight and had instead enjoyed walking, dancing, swimming, bicycling, doing yoga, gardening, having sex, and sitting cross-legged — none of which made me thin. So I didn't deserve my lower extremities.
I don't think my dream was all that different from our current reality, where people of lesser and lesser weights (mostly women) are encouraged to sign up for surgeries to correct such problems as normal absorption of nutrients and failure to routinely regurgitate. It's the Victorian era all over again — "Lie back and think of England (with every bite)."
In February, the U.S. Food and Drug Administration approved lap band surgery for average-height women who weigh as little as 174 pounds (206 pounds for average-height men), prompting get-thin-now billboards to spread across Bay Area scenery. Compare that with the average weight of American women (164 pounds) and men (191 pounds) according to a study from the U.S. Department of Health and Human Services."
This is part one of a two part series "Life After Lap-Band Surgery: It's Complicated." I know many banders who'd agree with her, and countless who will want to rip her head off. I sit here with my gastric bypass, in a body that's nearly big enough for a gastric band and laugh that I almost qualify for ANOTHER WEIGHT LOSS SURGERY at a normal body weight, after losing 160+ pounds.
As opposed to the idiot I posted yesterday — this woman has brains and is replying to her commenters at the newspapers' website.
I stutter at posting articles like this, because I write about this industry, and Allergan is huge and has a huge impact. Allergan is seeking to get approval to band teens.
I am ALSO reading this article as a consumer, not just a blogger who writes about weight loss surgery. I am a potential consumer of THIS PRODUCT. (What? You never know.)
I am also a parent of overweight children.
A parent, of one child, who is nearly old enough, according to this article: to have a Lap-Band put in her body. She's within the BMI guidelines, and I KNOW that if given the chance — SHE would jump on the opportunity to lose weight "forever."
Taking any of MY (or yours) personal feelings of my own out of it, I know she would consider it.
I see how she reacts to other kids, I see the size 0 peers on Facebook with shorts cut-up-to-here. She shows me. I know she would probably want to "do it" — and push through the pre-operative counseling and testing just to get it done (like many of US DID, do you remember that feeling?) because the PROMISE of losing ___ pounds FEELS SO GOOD.
I'm trying to think back to being 13-15 years old, wondering if someone approached me with this idea, that they could install a device, that would help me lose 50-75-100 pounds, would I have done it? I was ranged 175-220 pounds and definitely in the top 1/3 of my class in size.
Would I have done it, back in 1993, 1994?
Um. Yes. Twice. Again?
Now, think about it. Overweight teenagers full of ANGST.
"But, mooooom! I have to have a Lap-Band! It's the only way I'll ever be skinny. You won't let me have a band because you HATE me."
It will happen. (I'm psychic, we know this.)
With sales of its Lap-Band weight-loss device declining, Allergan Inc. has its eyes on a new set of potential customers — overweight teenagers.
The Irvine company has asked the Food and Drug Administration to approve Lap-Band surgeries for adolescents as young as 14, and is conducting clinical trials on teenage patients, said Cathy Taylor, a company spokeswoman.
Allergan says the device — a silicon ring fitted around the stomach to reduce food intake — has proved a safe and effective way for obese adults to shed pounds. With an estimated one-third of U.S. children now overweight, the benefits should be extended to teenagers, Taylor said.
"We identified a significant need with this patient population in terms of the increasing rate of obesity in younger populations," Taylor said. "Obesity, if left untreated, correlates to life-threatening diseases."
But many doctors and health experts are concerned that there are not enough data about the Lap-Band's long-term safety and effectiveness, something that would be particularly relevant when considering the device for children.
"It's hard to imagine taking a device … and putting it around the stomach and giving it a warranty for 50 or 60 years," said Mary Brandt, head of adolescent bariatric surgery at Texas Children's Hospital in Houston.
Brandt said she believes gastric bypass, surgically shrinking the stomach, is a better option because it does not require installing a foreign object in the body.
A recent European study found that many adult Lap-Band patients had "relatively poor long-term outcomes" and required additional surgeries to have the devices removed or replaced. Allergan took issue with that study, saying it was based on too small a pool of patients and that the device has been improved in recent years.
The procedure is performed under general anesthesia, and complications can occur. In the last two years, four Southern California adults have died within days of undergoing Lap-Band surgery.
Health experts said Lap-Band surgery should be a last resort for the morbidly obese, only after less radical methods, such as diet and exercise, have been exhausted.
"I'm concerned that FDA approval would send the wrong message, that this is a safe way to lose weight," said Diana Zuckerman, president of the National Research Center for Women and Families. "There are risks to this."
Doctors can already perform Lap-Band surgery on minors whose parents give their consent. FDA approval would allow Allergan for the first time to market the product for use on adolescents, said Jeffrey Gibbs, a former FDA attorney now in private practice in Washington specializing in medical device law. And it could make it more likely that insurers would pay for it, Gibbs said.
Taylor Blackburn of Palmdale had the Lap-Band installed in 2008, at age 14. Two years later, the Palmdale teenager had it removed after experiencing stabbing abdominal pains and diarrhea, her mother, Susan Blackburn, said.
"She got zero results. She was gaining weight," Blackburn said. "It was very discouraging for her."
Taylor Blackburn underwent gastric bypass surgery last year. She has lost 70 pounds, her mother said.
Allergan spokeswoman Cathy Taylor declined to comment, saying it "wouldn't be appropriate for us to comment on a patient when we are not privy to all the details."
More generally, Allergan executives have said the Lap-Band has proved effective at helping patients lose weight safely and has advantages over some other bariatric surgeries. Unlike bypass surgery, Lap-Band surgery is relatively easy to reverse and has a lower mortality rate, said Allergan Chief Executive David E.I. Pyott.
Jacy Johns, a Jacksonville, Fla., student, got the Lap-Band at her mother's urging when she was 15. She said it has transformed her life for the better.
Johns had tried Slim-Fast and Atkins diets without success. Before her June 2008 surgery, she weighed 225 pounds at 5 feet, 5 inches and looked to be developing diabetes. Afterward, she lost 95 pounds and joined her high school cross-country team. She recently attended prom.
"When I came back to school, everyone was blown away. Everyone was shocked," said Johns, now 18. "They told me I looked great. They wanted to know what I was doing."
Allergan has become a darling of Wall Street by catering to Americans' vanity with products including wrinkle-erasing Botox, Natrelle breast implants and Latisse eyelash lengthener. Lap-Band accounted for less than 5% of the company's $4.9 billion in revenue last year. But the company is moving aggressively to expand that business.
Allergan's focus on teens marks its latest effort to expand the customer base for the weight-loss device. In February, the FDA approved the company's request to reduce the weight requirements for adults to be eligible for the Lap-Band, adding millions of Americans to its approved pool of potential customers.
The change meant that a 5-foot-10-inch man with one obesity-related illness now needs to weigh at least 209 pounds to qualify for the surgery, down from 243 pounds, according to a body mass index table available on the U.S. Department of Health and Human Services website.
More than 600,000 people worldwide have had Lap-Band surgeries since 1993. It was approved for use in the U.S. in 2001. But U.S. sales have slumped during the economic downturn. The procedure can cost as much as $20,000, and some insurers won't cover it or require expensive co-payments. First-quarter sales of Allergan's obesity intervention products, primarily Lap-Band, were down 15% from a year earlier.
Allergan's Taylor declined to say how many U.S. children would be eligible for the surgery if the FDA lowers the age limit. About 12% of U.S. high school students are obese, according to a 2009 federal survey. Census data put the number of U.S. residents ages 14 to 17 at more than 16 million.
Teenagers would qualify only if they met specific weight requirements and had at least one obesity-related health condition such as heart disease or diabetes, Taylor said. They would need to be heavier than adults of the same height.
A girl who was 5 feet 6 inches would need to weigh 216 pounds — 30 pounds more than an adult of that height — and have one of the health conditions to qualify, according to the body mass index table. And youngsters would have to prove they have tried other weight-loss methods, Allergan's Taylor said.
"We're not talking about someone who's 20 pounds overweight who's looking to fit in a prom dress," she said. "You're looking at an adolescent who's morbidly obese, 100 pounds or more overweight, who has significant health problems because of their obesity."
Neither the FDA nor Allergan executives would say when they expect a decision regarding approval of the Lap-Band for teens. The company submitted its FDA application nearly two years ago, but it does not expect to conclude clinical trials until 2013. The approval process can take years, so the length of the process "is not unusual at all," said Stephen D. Terman, a medical device attorney in Washington.
Robert Cywes of Jacksonville, Fla., is one of the surgeons participating in Allergan's clinical trial of young patients. He said he has performed more than 500 of the procedures on adolescents, including Johns. Cywes said many children can't lose weight and keep it off because they're addicted to high-carbohydrate foods.
"Our adolescents are getting fatter, and there's really not anything outside of surgery that is reducing that in a significant way," he said.
The trend is discouraging to Russell Pate, a professor of exercise science at the University of South Carolina. He said the nation should be pushing diet and physical activity instead of making it easier for children to get weight-loss surgery.
"What we're saying is it's perfectly fine for us to become overweight because we're just going to apply treatment whenever that happens, and everyone will be good to go," Pate said. Obesity is "a preventable problem, and we really ought to be working to prevent it."
In a recent study, bypassed diabetics lost 64% of excess weight in a year, banded diabetics lost 36% excess weight in a year. Complication rates were nearly the same.
PS. I searched "Lap Band" for an image to share in this post, but I found my own images in used in posts about the "lap band." That's ironic. I don't have a band, but my fat-pants pictures are selling bands! Woo! Look! That's my ass!)
What would you choose? Me? Neither. Today. Ask me again in a few weeks.
What's terrifying is that your ever so friendly blogger qualified today on the Bariatric Surgeon's SCALE. I can have a LAP BAND! "Happy day!"
People no longer need to be quite as obese as before to qualify for weight loss surgery.
Allergan estimated that more than 26 million Americans would be newly eligible for the surgery, more than doubling the 15 million to 18 million eligible under the old standard.
Still, Allergan did not get all it asked for. The F.D.A. lowered the weight requirement only for people who have a health problem related to obesity, like hypertension or diabetes, not for people who are heavy but otherwise healthy.
“In order to target this therapy to patients who will benefit the most, the approved indication is limited to patients at the highest risk of obesity-related complications,” said Karen Riley, a spokeswoman for the agency.
Allergan said it was pleased nonetheless.
Until now the Lap-Band has been approved for people with a body mass index, or B.M.I., of at least 40 if they have no obesity-related health problems and at least 35 if they have such a problem.
Allergan applied to lower the threshold to 35 for people without complications and to 30 for those with a related health condition.
The F.D.A. agreed to lower the requirement for those with an associated health condition to 30. But it left the requirement for otherwise healthy people at 40. An index of 30 is considered the lower boundary of obesity.
Under the previous rules, a person who is five-foot-six and has diabetes would have had to weigh 216 pounds to qualify. Now that person would have to weigh only 186 pounds.
An advisory committee to the F.D.A. voted 8 to 2 in December to endorse the wider use of the Lap-Band, concluding that the benefits of the device exceed the risks for the patients in the lower range of obesity.
Some experts say the expanded approval for the Lap-Band, combined with a dearth of weight-loss drugs, will drive more moderately obese people to consider surgery. In recent months the F.D.A. declined to approve three new diet pills and forced the withdrawal from the market of an older drug, Meridia.
The Lap-Band is approved for use only in people who have failed to lose weight by diet, exercise or drugs.
The Lap-Band is an inflatable silicone ring that is placed around the upper part of the stomach. It restricts how much a person can eat and makes one feel full more quickly.
In the study Allergan submitted to win the expanded approval, patients lost an average of 18 percent of their weight after a year. Allergan has agreed to follow patients in that study for another five years.
The company, based in Irvine, Calif., is hoping to increase sales of the Lap-Band, which it says have been soft because of the poor economy. Still, it expects obesity product sales of $220 million to $240 million this year. That is a small part of its business; Allergan is best known for the Botox wrinkle treatment.
The photos from the LA Times make me wish I took more photos of the advertising campaigns in California while I was there several times, because it really IS, un-real.
The chief executive of Lap-Band maker Allergan Inc. said he doesn't support an independently run Southern California billboard marketing campaign that promotes the weight-loss surgery with slogans such as: "Diets fail! The Lap-Band works!"
"That isn't the wording I would use. We put patients' welfare and safety at the top, so I wouldn't support it," David E.I. Pyott said in an interview Wednesday.
The Irvine company does not fund the 1-800-GET-THIN ads that were created by a marketing company that directs prospective patients to clinics that perform the weight-loss procedure using Allergan's device. The Lap-Band is a silicone ring that's surgically fitted over part of the stomach to discourage overeating.
Pyott's statements mark the first time the chief executive has publicly questioned the high-profile advertising campaign. His remarks came as the Food and Drug Administration considers Allergan's request to allow the surgery on less-obese patients, a decision that would add millions more Americans to the pool of potential customers.
Pyott said Allergan is in the process of producing guidelines to be distributed to surgeons advising them that any advertising should include clear statements about the risk associated with the stomach-banding surgery.
Although the guidelines would not be binding, Pyott said he hoped to prevent the billboard marketing campaign from spreading to other regions of the United States. He did not say when the company would distribute its advertising recommendations.
The weight-loss surgery advertising campaign is conducted by a marketing company called 1-800-GET-THIN. People who call the toll-free number are screened and some eligible patients are referred to facilities that perform the Lap-Band procedure, said Robert Silverman, an attorney who said he represents the marketing company.
"Like Allergan, 1-800-GET-THIN is fully committed to patient safety and full compliance with all legal requirements associated with the marketing of the Lap-Band medical device," Silverman said in an e-mail statement. "All new television, radio and billboard ads already contain specific disclosures that address the risks associated with the Lap-Band procedure.
"1-800-GET-THIN looks forward to receipt of the guidelines being created by Allergan and anticipates that the current risks disclosures will meet or exceed the guideline recommendations of Allergan. 1-800-GET-THIN has never received any complaint from Allergan regarding any advertisement campaign."
Three Southern California patients have died after Lap-Band procedures, according to family members and autopsy reports in Los Angeles and Riverside counties. The most recent was Lawndale resident Tamara Walter, who died in December after Lap-Band surgery at a clinic in Beverly Hills.