LAPBAND COMPLICATIONS SUMMARY

Hi all, The complications data in the Inamed patient booklet are reported in order of frequency. I find it hard to make sense of them that way, because I tend to think chronologically. Here is my attempt to organize the information into operative and postoperative phases. I apologize if you have trouble comparing the percentages. I originally set this up as a table, but none of that format transferred to this post. The most amazing information is that 88% OF PATIENTS HAVE COMPLICATIONS. Does this mean we shouldn't have weight loss surgery? Well, no. You have to remember to compare information on complications to the known risks of continuing morbid obesity. Does this mean we shouldn't have Lap-Band surgery? That one's trickier to answer. You need to compare effectiveness, complications, cost etc. of the various surgeries to find the answer that's right for you. If you're considering Lap-Band surgery, it's important to be aware of the overall complication rate, as well as those of the types of complications. You may well decide to get the Lap-Band (I have), but you'll be better prepared for complications, knowing that you may well encounter them during your recovery. NancyRN ____________________________________________________________________ From US clinical study of 239 patients 3 years after surgery (Citation? Date?) As reported in, "A Surgical Aid in the Treatment of Morbid Obesity: Lap-Band System Information for Patients" (Inamed booklet) (Note: the following complications are not mutually exclusive, that is, patients could have more than one) Problem/ Percentage Overall Complication Rate: 88% During surgery: Death 0% Gastric perforation 1% After surgery: Major complications: Band slippage or pouch dilatation 24% Stoma obstruction 14% Poor esophageal function 11% Erosion 1.3% Side effects: Nausea & vomiting 51% Gastroesophageal reflux 34% Constipation, diarrhea, difficulty swallowing 9% Other 1 % Second surgery: 18% Band problems 9% Stoma problems 9% Band removal: 25% By choice 9% Due to adverse event(s) 16% By laparoscopy 60% By open procedure 40%

1. These are the stats from the FDA trials where many of the surgeons were in the learning curve which adversely affects complication rates. It certainly still applies to new surgeons now and in the future...however, more experienced surgeons experience significantly lower complication rates as well as greater weight loss. Both placement experience and aftercare experience factor into these problems. 2. If 88% of the folks in this study experienced complications, these numbers don't add up. It means they're factoring in side effects such as vomiting and constipation, etc. It's very good to be aware of what can possibly go wrong, but the FDA study is outdated...it's just really important for people to thoroughly check out surgeons and not just go with whoever gives them an appointment regardless of actual experience. I know surgeons need to learn on someone, but heck, it wasn't going to be me. I feel we have the right to be selfish about that sort of thing LOL One of the problems I've observed in over 5 years on numerous boards as to why the American surgeons and patients in general haven't met the averages (higher average weight loss and even lower average complication rate) of surgeons and patients elsewhere is the general culture of impatience we seem to cultivate here. I see so many surgeons trying to find shortcuts and it backfires at the expense of the patient. They then see the band as "bad" instead of seeing that their surgeon was bad...or that their research prior to picking a surgeon and what banding is supposed to be about was "bad". It's easier to blame the device...We need to stop being in such a hurry... Nancy -156

I'm quoting the study that was posted...they list those as side effects, not complications. Now, RNY patients won't acknowledge dumping as a complication, which in fact it is...heck, it's hard to get them to acknowledge it's even a side effect... Nancy

Nancy, Thanks so much for your comments. I am SO relieved to hear these complications do NOT apply to experienced surgeons. I wonder why Inamed is quoting them now, though? I printed their booklet off the Internet only a week ago. At first, I thought I shouldn't count the vomiting, either, but it seems to me it really IS a complication. Even taking that out of the statistics, though, the complication rate still is 38%! That's appalling. I would never in a million years have surgery with such a high complication rate if I weren't desperate to lose the weight threatening my health. Do you know the citation for the original study? I'd like to find out how old this data is. How amazing to hear that surgeons in other countries have better results! I'd assumed people went to other countries because of the cost savings. I hadn't been aware they might go to get more experienced surgeons! Do you have any more recent references on complication rates? Thanks, NancyRN

The FDA study concluded in late 2000/early 2001 with FDA approval occurring in June 2001. So the data's a good 5+ years old. The actual slippage and erosion rates are in the 1-3% range. Slippage went way down as surgeons became more familiar with the pars flaccida method of installing/securing the band where they pull a small piece of outer stomach tissue down around the band and suture it, thus anchoring one side of the band into place. As this technique became more the standard of care, slippage rates decreased dramatically. The US is one of the newer countries to adjustable gastric banding. In the arena of bariatrics, the US is a good 10+ years behind other countries in most areas. Europe, Australia and Mexico have been banding quite a bit longer. Although Inamed (then Bioenterics) is an American company, the Lap-Band was first introduced (a few years after the Swedish AGB) in Europe...I think it was 1993 for the first actual Lap-Band, and that was several years after the SAGB had been in use. While out of country can be scary in terms of quality of care if you're not careful, some of the most experienced and good banding surgeons in the world are in Mexico and are the surgeons who handled quite a bit of the initial training of US surgeons in banding installation techniques. One of my theories as to why other countries generally see overall better results with the band than the US is that we Americans suffer from cultural Veruca Salt-ism. We want instant gratification. We have no patience. We're willing to take shortcuts to get that instant gratification. If some is good, more must be better...if losing 1-2 lbs a week is good, losing 5-6 must be better...as a culture, we don't have the patience for what the AGB actually is supposed to do...and some surgeons attempt to cater to this demand for instant gratification by inventing shortcuts and participating in "extreme banding" which more often than not, backfires. The band wasn't designed for rapid loss so when surgeons attempt to turn it into the RNY, it doesn't go well. Unfortunately, far too many patients don't do their homework and just jump right in and nod their heads at what any old surgeon who's willing to see them tells them... Nancy

The FDA study data is 5+ years old? Wow, that is old. I'm looking forward to the article Dr. C's planning to post on more recent data. You're very knowledgeable about banding. Is that from your own research or do you work in the field? Nancy Holloway

Research combined with slight OCD tendencies LOL I've been on numerous huge boards since early 2001... Nancy

Your answer cracked me up. I too have OCD tnedencies that really come out when I'm researching. I've been known to spend days researching something complex! Glad to hear you've been on huge boards for several years...makes you a great resource to other newbies like me. Would you be able to help me with some questions? 1. Do you know of any current stats (and sources if you have them) about what % of banders lose what % of weight? Inamed has stats, but they're from the same 2000 survey. 2. Can banders feel the port? The band itself? NancyRN

Nancy, I haven't got time right now to check back but within the last 2 or 3 days, someone posted a link on the lapband message board which quoted a very recent study. If my memory is correct, the bit that the link led to only quoted a few stats and I can't remember them! But if you follow the link, identify the study, then you could chase it up. The post heading actually said something about a recent or new study in the title. Good luck. I am a relatively recent bandster and VERY happy with my band. It is seen as the main way forward now in much of Europe. Kate

For what it's worth, my surgeon told me that the rate of complications for the band is pretty much the same rate of any WLS. However that the severity of complications from the band is much lower.