FDAs 3 yr study in lap band

[rene2005 0]

New Device Approval

Address:http://www.fda.gov/cdrh/mda/docs/p000008.html Changed:4:12 AM on Friday, March 4, 2005

This states the average loss after three yrs is 35% so 100 pds overweight would be 35 pounds after three yrs. Have the numbers changed?? Where is there new stats on average loss?

Rene

[Chickie 15]

Well, no wonder people go straight to RNY if they are the numbers given to them! I would think that the % lost after 3 years would have to be higher than that, wouldnt it?

[Alexandra 55]

This study is WAY outdated. By its very nature, FDA trials involve doctors who are new to the device and may not have managed their patients as well as they do now. I've even heard that fills were done on a schedule for this trial, as opposed to the personalized approach that is so important.

Inamed might have newer statistics. Have you tried contacting them?

[piercedqt78 658]

I didn't see Friday March 4th 2005 anywhere. I saw a date of "Approval Date: June 5, 2001" And the letter of approval is dated the same. Where are you seeing such a current date on that page? ~Mandy

["Nita 0]

According to my doctor, these statistics are far from acurate. They include the good band docs as well as the quacks, the patients who follow the rules as well as those who don't the patients who know the rules as well as those who don't.

What he said, and I truly believe from the research I have done, is that if you choose a good doctor, inform yourself about the procedure, the rules, and then follow them, your success rate will be much higher. Many studies are starting to suggest that at the five year point the band has a higher % of loss than the bypass because at that point the bypass has started gaining back. I would be making up numbers if I tried to quote any as I really don't remember the exact % my doctor used, but they were much higher than that!!!! I agree with other replys that those numbers are outdated.

The shame is that they can't do a study of long term statistics for those who go to good doctors and comply with the band rules and a seperate study for those who don't. But just like in school, there are always the kids who throw off the grading curve one way or another.

[Charlie 0]

Hey guys - you get out of this what you put in.....having a band doesn't mean you can still eat anything you want. It's a tool - and only allows a small amount of food to enter. It's what you eat that counts. BIG difference between candy and veggies - ice cream (which goes down so easy) and fruit. As with any weight loss program - you still have to watch what you eat. The band just makes it easier = but you still have to make the CHOICE. Even RNY patients have to make choices. This is much less invasive and easier on the body. It's taking personal responsibility.......that's all.

[nygrl 0]

New Device Approval

Address:http://www.fda.gov/cdrh/mda/docs/p000008.html Changed:4:12 AM on Friday, March 4, 2005

This states the average loss after three yrs is 35% so 100 pds overweight would be 35 pounds after three yrs. Have the numbers changed?? Where is there new stats on average loss?

Rene

how can that be right?? just from looking on here you can get a much better average... most people lose that in the first few months not years!!

[rene2005 0]

Well I'm just gonna wait for medicares study. Medicare said that it would take 5 months ( its been like 7) to see if it would cover the band. Medicare stated this when they took out the wording the obesity is NOT a disease.

Something must have been up with the FDA study as I don't think it should have been approved- meaning that they figured the US doctors will get better at the band thus more weight loss.

[La_madam 20]

If we all worried about statistics, in everything out there in the world we would all be dead by now. I do not base what I do on any statistics

I will love to come back to this post in a year and a half to prove the 35% wrong though. it has been 15 months and I have lost 93 lbs

[rene2005 0]

¸Entrez PubMed

Address:http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15621991&query_hl=1

This sounds more like it. Current and from the NIH. I wish the results were better but this is better results then the fds and newer too.

[Persimmon 0]

Folks basically need to ignore the FDA trials study...very flawed with inherent problems, primarily due to all the surgeons participating being very inexperienced. Inexperienced surgeons (and that means aftercare as well as initial placement), generally have poor results...less weight loss, more complications, etc.

Nancy

394/270/180

[GERBEAR1969 0]

I Had My Lap Band On March 7 , 2006 And I Have Lost 40lbs.

[NewSho 20]

As I've posted before, I was in the original FDA LapBand study before approval. I also had my extensive 36-month-mark band testing included in the 3-year followup results published recently. I recommend extensive testing for all Bandsters at the 24-to-36 mark even if you are at goal (rare, but does happen) and even if you suspect no problems or issues with your band. Keep your tool maintained, folks! :paranoid

According to my doctor, these statistics are far from acurate.

No, the statistics are considered accurate. I am assuming your doctor did NOT participate in the original study, but I bet he wasn't questioning the statistical results - he was merely expressing that he is now seeing better results. That's very different. Those surgeons who did participate were given current and pending stats during and after the process. Your doctor may have been trying to communicate to you that the results have changed and improved at this stage and time - but I'm sure he wasn't questioning the accuracy of the study's original results.

They include the good band docs as well as the quacks

My original surgeon was definitely not a quack (nor have I heard any allegation that were quacks involved in the original study) and the processof getting involved was quite elaborate. In fact, he had been doing LapBanding abroad and his record was examined closely before he was allowed to participate in the FDA study here in the 'States.

...the patients who follow the rules as well as those who don't the patients who know the rules as well as those who don't.

Which is true for all studies, I'm sure. The participants were also closely vetted to make sure they were clear on the requirements involved in the study. Naturally as with any group, there was some attrition or 'drop out' but I don't think the results reflect a lack of knowledge about the process - there wasn't any knowledge about banding in the USA in 2000 and 2001, and I was lucky to have had a surgeon who had done many outside of the USA. I've had 5 years of banding and am pretty well-versed in what it's like to be banded this long - so I'd think I'm more typical of the study participants.

What he said, and I truly believe from the research I have done, is that if you choose a good doctor, inform yourself about the procedure, the rules, and then follow them, your success rate will be much higher.

Makes sense but I think there are often other factors at work when there is not-so-stellar loss with the LapBand. And those aren't all related to being a good Band citizen, as I call it.

Many studies are starting to suggest that at the five year point the band has a higher % of loss than the bypass because at that point the bypass has started gaining back.

I do think that 5-year RnY and other bypass surgeries' patients results are probably still going to be more successful than those of the original 5-yr LapBand results. But things are getting much better. Yes, there is definitely 'bounce back' weight involved with bypass/malabsorption types of surgeries, but their initial success in pounds and excess weight lost still tends to lean in their favour for overall 5-year results. We'll see.

I say that because, to my knowledge (and my surgeon's) there aren't any official publicly-released 5-year USA studies published yet - they are still compiling the results from the 5-year participants here. If you know otherwise, please provide web links or references.

I would be making up numbers if I tried to quote any as I really don't remember the exact % my doctor used, but they were much higher than that!!!! I agree with other replys that those numbers are outdated.

This study is WAY outdated. By its very nature, FDA trials involve doctors who are new to the device and may not have managed their patients as well as they do now. I've even heard that fills were done on a schedule for this trial, as opposed to the personalized approach that is so important.

I agree they are outdated, but it doesn't make the numbers inaccurate. Many of the doctors were those who had trained in Europe and Mexico and those were experienced Band surgeons. But there was very little success seen initially - just as we still see lower success rates with the LapBand even now, compared to other countries' results even after their early intial surgical periods of Banding. But as for this study, it reflected the success (of lack thereof) at that time.

We all agree the Banding process has gotten more refined and hopefully we will see further long term success now. So let's not throw out the baby with the bath Water - for those of us with bands, it should be important to realize what might possibly lie ahead at the 5-year point. If I'm still banded and the FDA asks for longer term results from me and other patients, then I'm willing to be followed at the 7-and-10 year points if necessary. How else will any of us know how our devices might perform long term?

The shame is that they can't do a study of long term statistics for those who go to good doctors and comply with the band rules and a seperate study for those who don't. But just like in school, there are always the kids who throw off the grading curve one way or another.

I guess I do bristle a bit at the assumption that the FDA original patients were all gathering nationwide for late night shakes and ice cream parties to throw off the results. The results are, what they are.

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The early FDA patients (including myself) were subject to all sorts of very severe (and unsuccessful) protocol that in my opinion (and the opinions of many of the participating surgeons) made it exceedingly difficult to suceed at that time. Also there have been major changes in the actual technology and surgical protocol of the band. I still have the Old-School surgical placement of the band - but this placement has later been termined to be involved in more frequent occurences of slippage (and some surgeons think, possibly in erosion.) So I have to be vigilant in having my band checked regularly for any irregularities. I have already had a replacement to the newer, lower-profile port. Like many devices it is smaller and more efficient (we hope).

Something must have been up with the FDA study as I don't think it should have been approved- meaning that they figured the US doctors will get better at the band thus more weight loss.

Cars that were manufactored five years ago may have not had the technical expertise of cars manufactored now - there are lots of advances in technology, and LapBanding is no different. Be happy that you have better information and better technology at your disposals and hopefully you can be confident in your decisions to get banded.

Folks basically need to ignore the FDA trials study...very flawed with inherent problems, primarily due to all the surgeons participating being very inexperienced. Inexperienced surgeons (and that means aftercare as well as initial placement), generally have poor results...less weight loss, more complications, etc.

No I disagree about "ignoring" it. Every patient and surgeon should be aware that this is, to date, the only American series of results published from this device. And we live in a different culture and environment than our overseas counterparts who are banded. Rest assured this DOES affect the results for American band patients in my opinion. But there is a value in having those original unsuccessful results 'out there.' It provides a benchmark of what kind of results were done in the early pioneer days of US LapBanding. But don't be so hard on the original participants and original doctors: there are a lot more factors involved other than just some 'slow losers' skewering the results.

Happy Band Journeys To All...

[waterlily1072 5]

Well my surgeon considers 60% at 2yrs a clinical success. Their success rate at that clinic is very very high. They also say that many of their patients go well beyond that mark to lose anywhere from 61% to 100% of excess weight depending on the individual.