Allergan Inc. (AGN), the maker of the wrinkle treatment Botox, received a U.S. government subpoena over its gastric banding device for obesity.

Allergan received the subpoena from the Department of Health and Human Services’s Inspector General this month, the company reported today in a filing. Bonnie Jacobs, a spokeswoman for Irvine, California-based Allergan, acknowledged the subpoena but declined to comment further.

Allergan generated $203.1 million of its $5.42 billionrevenue (AGN) last year from devices for obesity. The company acquired the product, called Lap-Band, in 2006 with its purchase of Inamed Corp. The adjustable silicon band helps people lose weight by reducing the amount of food their stomachs can hold.

In January, House Democratic lawmakers called for hearings on medical devices including Lap-Band, following a study in the medical journal Archives of Surgery, that found almost half of patients with a gastric band had no weight loss or needed the device removed after six years. More than 40 percent had long- term complications.

Where does this 40 %come from?

The Food and Drug Administration approved the device in 2001 for patients who were at least 100 pounds (45 kilograms) overweight, had a body mass index of at least 40, or an index of 35 with obesity-related conditions such as heart problems. Allergan gained clearance in February 2011 to expand marketing of the device to people with lower body mass indexes and at least one obesity-related condition.

http://www.businessw...ght-loss-device

Because that is not taking into consideration PATIENT CAUSED FAILURES. We live in a society of blame. We love to blame everyone and everything else for our failures. This is another perfect example of this victim mentality.

There is a huge difference between people who are compliant with their doctors and band rules and those who screw up and have only themselves to blame for their failures.

For actual facts, here is a recent and long term study proving only 5% of band patients fail by no fault of their own:

Weight stays off long after lap band surgery

MONASH U. (AUS) — Gastric banding is safe and effective for managing obesity long-term, according to a study of patients 10 to 15 years after their surgeries.

The study, the longest and most comprehensive yet reported, appears in the Annals of Surgery, and finds a significant number of laparoscopic adjustable gastric banding (lap banding) patients maintained an average weight loss of 26 kilograms for more than a decade after their procedure.

Researchers analyzed the results in 3,227 patients who had gastric banding surgery in Australia between 1994, when the procedure was first introduced, and 2011. The patients in the study were averaged at 47 years-of-age and 78 percent were women.

Of those patients, 714 had surgery at least 10 years ago and, on average, had maintained a weight loss of 26 kilograms, or almost half of their excess weight.

The weight loss results were similar for the 54 patients in the study who had undergone treatment at least 15 years ago.

“These results show that when you have a significant problem with obesity, a long-term solution is available,” says Professor Paul O’Brien of the Centre for Obesity Research and Education at Monash University in Melbourne.

“This surgery is safe and effective, and it has lasting benefits. Substantial weight loss can change the lives of people who are obese—they can be healthier and live longer.”

O’Brien says there are also important ramifications for the control of type 2 diabetes, which was strongly associated with being overweight.

“In obese patients with type 2 diabetes, weight loss after gastric banding can lead to effective control of blood sugar levels without the need for medication in about three-quarters of cases,” O’Brien says.

The patients included in the study had followed the rules of their treating team regarding eating, exercise, and activity and committed to returning permanently to the aftercare program.

All the surgery was performed by O’Brien, an international pioneer of the technique, and Associate Professor Wendy Brown, President of the Obesity Surgery Society of Australia and New Zealand.

There were no deaths associated with the surgery or with any later operations that were needed in about half of the patients. About one in 20 patients had the band removed during the study period.

“In treating a chronic disease such as obesity over a lifetime, it is likely that something will need to be corrected at some time in some patients,” says O’Brien.

“The study shows a marked reduction of revisional procedures with the introduction of the new version of the Lap-Band 6 years ago. Importantly, those who had revisional surgery lost as much weight in the long term as those who did not need it.”

The report also included a comparison of gastric banding—which can be done as a day-surgery procedure—and more invasive types of weight-loss surgery such as gastric bypass that are high risk and require longer hospital stay. The weight loss with gastric banding, and the need for future revisional surgery, was similar to that with gastric bypass.

“Access to weight-loss surgery in Australia remains severely limited for many obese patients as relatively few cases are treated within the public health system. We are working hard to improve access,” says O’Brien.

“We have ample evidence that weight-loss surgery is effective, and it is unfair that half of eligible patients cannot be treated, particularly as it has been shown that gastric banding is a highly cost-effective health care measure. The stigma of obesity, and the assumption that it is the person’s fault, entrenches discrimination against people who could benefit.”

http://www.futurity....p-band-surgery/

BTW, if you notice, the statistics improved considerably after the NEW bands were used instead of the older 4cc bands.

....and are you bored today? You seem to be trolling for conflict far more than usual. If you hate the band so much, why not just get rid of yours and be on your merry way? Just say'n.

Where does the 40% come from? Haven't got a clue...but I do know one thing, just because some congressman says it, sure as hell doesn't mean it is true. How many congressmen where "birthers" who tried to prove that President Obama was a secret Muslim, born in Kenya.

But I find it amazing that my Surgeon (who has the center of excellence certification) and has installed 900+ LB operations over 10 years has had only has a 4% removal rate, when I see people claiming "everyone they know has had theirs removed". He must be one hell of a surgeon

Because that is not taking into consideration PATIENT CAUSED FAILURES. We live in a society of blame. We love to blame everyone and everything else for our failures. This is another perfect example of this victim mentality.

There is a huge difference between people who are compliant with their doctors and band rules and those who screw up and have only themselves to blame for their failures.

For actual facts, here is a recent and long term study proving only 5% of band patients fail by no fault of their own:

YEA!!! Missy is back and in her usual fine form!

The best thing I ever did was the BAND!! I am zero regrets. You treat it right and it will treat you right. Like everything else in this world when you are advised not to do something and then do it, whose fault? Speeding in a car and texting while driving, same thing, you are advised not to but people do it and end up hurt or dead. Follow your doctor's advise and you should have no problems

I don't look for the bad, I only want to hear about the good. Yes I wear blinders. People who have by pass or the sleeve, eat too much and they stretch it out and have problems too.

This is a prime example of how the quality of science reporting has continued to devolve despite the increasing need for comprehensive coverage of emergent technologies.

The statement doesn't even make sense...

"almost half of patients with a gastric band had no weight loss or needed the device removed after six years. More than 40 percent had long- term complications."

If half the patients had the band removed that would mean 80% of the people who had it removed had long term complications which seems hard to judge based on a 6 yr time frame. If on the other hand they're saying 40% of all patients had long term complications that would mean only 10% or people had no complications which if that was the case the FDA wouldn't have approved it for anyone and more importantly no insurance company would ever agree to pay for it.

If this is an actual quote the original reporter obviously doesn't know how to read medical statistics.

WLS isn't for everyone and the less weight you "need" to lose the less likely it's the right solution for you. Unfortunately as WLS becomes an options for larger sections of the population that also means the statistics get harder to interpret in terms of success not to mention harder to simply comprehend in terms of success.

It's easy to see that a person who is diagnosed as morbidly obese; hyper tensive; and diabetic has show improvement when they don't need medication and are now classified as simply obese or even overweight. It's much harder to judge success if the person just wanted to lose a persistent 50lbs and only lost 5 or 10 lbs.

This is a prime example of how the quality of science reporting has continued to devolve despite the increasing need for comprehensive coverage of emergent technologies.

The statement doesn't even make sense...

"almost half of patients with a gastric band had no weight loss or needed the device removed after six years. More than 40 percent had long- term complications."

If half the patients had the band removed that would mean 80% of the people who had it removed had long term complications which seems hard to judge based on a 6 yr time frame. If on the other hand they're saying 40% of all patients had long term complications that would mean only 10% or people had no complications which if that was the case the FDA wouldn't have approved it for anyone and more importantly no insurance company would ever agree to pay for it.

If this is an actual quote the original reporter obviously doesn't know how to read medical statistics.

OMG, you are trying to use logic and that simply won't do, when you mix logic and facts with FUD, people's heads will explode!

I wondered how long it might take for you to attack me personally Missy.

It's okay, I have Broad shoulders I don't need to attack personally to feel better about myself. No, I'm not bored actually I like to post, unlike some here i like to help people. Since the Forum promotes Support it's the only reason I post. NOT everyone is thrilled with the band, unfortunately some are looking for HELP. You keep quoting a study Funded By Allergan so that's why I have a problem with you telling everyone it's THERE FAULT. Does anyone really think a study funded by the manufacturer is going to be unbiased? no matter, believe what you will .. and thank you for the compliment as anyone living in Michigan and under the bridge is considered a troll, I guess that makes you a troll as well

looking forward to your next reply since you seem to like stalking my posts.

Wondering if you've ever looked in a mirror?

Yes, there will be a risk for complications. There is a risk associated with all medical procedures. We all are also aware of the medical complications associated with being obese or morbidly obese.

There is no way to predict who amongst the population who opt for band WLS will develop the complications. I made a calculated risk to have my band placed, I did my research, and knew ahead of time the risks, which I discussed with my internal medicine PCP.

At this point, I believe that you have gotten your point across. Many times over.

Perhaps it is time to accept that this topic is like the proverbial "dead horse". There is no sense in continuing to beat the dead horse.

Time for you to get down off your "soap box". We get your position. Perhaps you should begin to listen to the feedback you receive here on this topic..j/s.

Allergan Inc. (AGN), the maker of the wrinkle treatment Botox, received a U.S. government subpoena over its gastric banding device for obesity.

Allergan received the subpoena from the Department of Health and Human Services’s Inspector General this month, the company reported today in a filing. Bonnie Jacobs, a spokeswoman for Irvine, California-based Allergan, acknowledged the subpoena but declined to comment further.

Allergan generated $203.1 million of its $5.42 billionrevenue (AGN) last year from devices for obesity. The company acquired the product, called Lap-Band, in 2006 with its purchase of Inamed Corp. The adjustable silicon band helps people lose weight by reducing the amount of food their stomachs can hold.

In January, House Democratic lawmakers called for hearings on medical devices including Lap-Band, following a study in the medical journal Archives of Surgery, that found almost half of patients with a gastric band had no weight loss or needed the device removed after six years. More than 40 percent had long- term complications.

Where does this 40 %come from?

The Food and Drug Administration approved the device in 2001 for patients who were at least 100 pounds (45 kilograms) overweight, had a body mass index of at least 40, or an index of 35 with obesity-related conditions such as heart problems. Allergan gained clearance in February 2011 to expand marketing of the device to people with lower body mass indexes and at least one obesity-related condition.

http://www.businessw...ght-loss-device

why are you posting things like this?

let mature people decide to have wls and deal with what happens

this sounds very familiar to a former ms maui person who posted BS like this just to start trouble...and this is exactly what you are doing..

OMG, you are trying to use logic and that simply won't do, when you mix logic and facts with FUD, people's heads will explode!

What can I say I really enjoyed watching "Scanners" as a kid.

No actually, I was just asking a legitimate question of where did the 40% come from, because the monash reports only 5. But if it's unknown, no problem, Go back about your business the Troll has left the Forum :lol:

I wondered how long it might take for you to attack me personally Missy.

It's okay, I have Broad shoulders I don't need to attack personally to feel better about myself. No, I'm not bored actually I like to post, unlike some here i like to help people. Since the Forum promotes Support it's the only reason I post. NOT everyone is thrilled with the band, unfortunately some are looking for HELP. You keep quoting a study Funded By Allergan so that's why I have a problem with you telling everyone it's THERE FAULT. Does anyone really think a study funded by the manufacturer is going to be unbiased? no matter, believe what you will .. and thank you for the compliment as anyone living in Michigan and under the bridge is considered a troll, I guess that makes you a troll as well

looking forward to your next reply since you seem to like stalking my posts.

Wondering if you've ever looked in a mirror?

I never once attacked you personally. I'm way too old for such childish antics. I'm asking a sincere question based on the fact you seem to bash the band at every chance. If you hate it so much, why not get rid of it and go on with your life? I don't see the sense in repeatedly posting false and misleading information to scare others into sharing your opinion. If you're so unhappy, why not do what you need to do be happy instead of trying to drag others down with you?

I never once attacked you personally. I'm way too old for such childish antics. I'm asking a sincere question based on the fact you seem to bash the band at every chance. If you hate it so much, why not get rid of it and go on with your life? I don't see the sense in repeatedly posting false and misleading information to scare others into sharing your opinion. If you're so unhappy, why not do what you need to do be happy instead of trying to drag others down with you?

missy you have never attacked anyone

you just cleared up the facts...alot of people thank you for always doing that

including me.

Today at kaiser the chief of bariatric surgery said that within 5 years they have over a 50% of patients come back to get the band removed.

Yo! This news story is over a year old... so, did the FDA ban lap-band surgery? What was the outcome? Did that 40% removal rate include the early 4 cc bands?