Questions and Concerns

[Guest Bird Lady]

Hello. This is my first time here.

I attended a seminar about banding it sounds interesting.

Aetna, our insurance carrier, would rather I get Roux-En-Y, but will pay for banding if I have liver or respiritory problems, or abdominal adhesions. I have adhesions, but can't prove it.

Here is Aetna's reasons for wanting GB, over LB. Please share your thoughts.

Laparoscopic Adjustable Silicone Gastric Banding (LASGB or LAP-BAND):

Recent advances in laparoscopy have renewed the interest in gastric banding techniques for the control of severe obesity. Laparoscopic adjustable silicone gastric banding (LASGB) using the adjustable LAP- BAND, has become an attractive method because it is minimally invasive and allows modulation of weight loss. The claimed advantage of LASGB is the adjustability of the band, which can be inflated or deflated percutaneously according to weight loss without altering the anatomy of the stomach. This method entails encircling the upper part of the stomach using bands made of synthetic materials, creating a small upper pouch that empties into the lower stomach through a narrow, non-stretchable stoma. The reduced capacity of the pouch and the restriction caused by the band diminish caloric intake, depending on important technical details, thus producing weight loss comparable to vertical gastroplasties, without the possibility of staple-line disruption and lesser incidence of infectious complications. However, distension of the pouch, slippage of the band and entrapment of the foreign material by the stomach have been described and are worrisome.

The published results of LASGB have been highly variable, perhaps reflecting surgeons' relative lack of experience with this new bariatric surgical procedure. Several studies have reported high rates of complications associated with gastric banding include those associated with the operative procedure, such as splenic injury, esophageal injury and wound infection, and those occurring later, such as band slippage, reservoir deflation/leak, persistent vomiting, failure to lose weight and acid reflux (see e.g., Gustaavson, et al. 2002; Victorzon and Tolonen, 2001; Holeczy, et al., 2001). In studies reported to the FDA, 89% of patients experienced at least one side effect. These included nausea and vomiting (51%), heartburn (34%), abdominal pain (27%), and band slippage or pouch enlargement (24%). Nine percent of patients needed to have another operation to correct a problem with the device. Twenty-five percent had their entire Lap-Band Systems removed, mostly because of adverse side effects. In about one-third of those patients, insufficient weight loss was also reported as a contributing factor to the decision to have the Lap-Band removed.

One of the claimed advantages of the LASGB procedure is its reversibility. Kellum (2003) noted, however, that “[t]he fact that two deaths in the FDA study occurred immediately following bend removal (one each from 'mixed drug intoxication' and multiple pulmonary embolism) suggest that secondary operations always carry significant risks.”

In addition, the long-term safety of LASGB is undetermined. Kellum (2003) notes that one of the reasons that surgeons may want to proceed cautiously before adopting LASGB is the concern about the long-term problems related to apposition of a foreign body with the gastrointestinal tract. “Older surgeons will recall the many reports of migration and erosion associated with the Angelchick prosthesis for the treatment of esophageal reflux.” Several recent reports have detailed problems with LASGB slippage and erosion (Holeczy, et al., 2001; Silecchia, et al., 2001). Gustavsson & Westling. (2002) provided one of the few reports on the long-term outcomes with LASGB, and concluded that this procedure “will not stand the test of time.” The investigators reported that, after a median follow-up of 7 years, 58% of the patients who had undergone LASGB had been reoperated on, almost always with excision of the banding system and conversion to Roux-en-Y gastric bypass (RYGBP). The reasons for reoperation were esophagitis, band erosion, pouch dilatation, leakage from the balloon, and esophageal dilatation. A lower incidence of band erosion has been reported with the so-called Swedish adjustable gastric band due to the relatively lower pressure exerted on the stomach (Ceelen, et al., 2003). The Swedish adjustable gastric band has not been approved by the U.S. food and Drug Administration, and is currently under investigation. Although the Swedish adjustable gastric band offers the possibility of significant technical improvements over LASGB, it still represents a purely restrictive operation like the vertical banded gastroplasty, which most U.S. surgeons have abandoned in recent years.

Because of the lack of direct comparative studies, the comparative efficacy of LASGB with established methods of obesity surgery is undetermined. In studies of laparoscopic adjustable silicone gastric banding reported to the FDA, the mean excess weight loss was 36.2% at 3 years. This figure contrasts with a 40-60% excess weight loss reported in other series of VBG and 50% for RYGB. (Maclean, et al., 1990; Willbanks, 1987; Melissas, et al., 1998) and 50% for gastric bypass (Griffen, et al., 1987; Pories, et al., 1995). Kellum (2003) notes that multiple reports have demonstrated the superiority of RYGB over VBG. Since LASGB, like VBG, is a purely restrictive operation, “one would expect that laparoscopic Roux-en-Y gastric bypass would yield superior long-term weight loss results when compared to laparoscopic Lap-Band placement.” Kellum (2003) cited the report of Belachew and Monami (1996) that concluded that LASGB had an identical weight loss curve to the open VBG performed by the same surgeons. Kellum (2003) concluded that “t is obvious that only a prospective, randomized series would definitively establish which operation is best in terms of safety and efficacy.”

Investigators from the Medical College of Virginia, one of the eight original U.S. centers performing LASGB, published their results. (Demaria, et al., 2001). The investigators “did not find LASGB to be an effective procedure for the surgical treatment of morbid obesity.” At the time of the report, LASGB devices had been removed in 41% patients, either because of inadequate weight loss or intolerable side effects. In 71% of patients with bands in place who underwent long-term evaluation, a significantly increased esophageal diameter developed; of these, 72% had prominent dysphagia, vomiting, or reflux symptoms. Of the patients who still had bands in place, more than one-third were reported to currently desire removal and conversion to RYGB for inadequate weight loss. About a third of the remaining patients have persistent severe obesity at least 2 years after surgery but refuse to undergo further surgery or claim to be satisfied with the results. Overall, only about 10% patients who underwent LASGB achieved a body-mass index of less than 35 and/or at least a 50% reduction in excess weight. The authors predicted that the overall need for band removal and conversion to RYGB in their series will ultimately exceed 50%. The researchers concluded that more study is required to determine the long-term efficacy of LASGB.

Reporting on the results of a systematic review of the published medical literature on obesity surgery, Gentileschi, et al. (2002) concluded that “the efficacy of [LASGB] cannot be determined because of poor evidence.” An assessment of the literature on obesity surgery conducted for the National Institute for Clinical Excellence concluded that LASGB is both more costly and less effective than RYGB for severe obesity (Clegg, et al., 2001). An assessment of LASGB by the Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S) concluded that the “[l]ong-term efficacy of laparoscopic gastric banding remains unproven and further evaluation by randomised controlled trials is recommended to define its merits relative to the comparator procedures” (Chapman, et al., 2002). The French National Agency for Accreditation and Evaluation in Health (ANAES, 2001) concluded that “n view of the inadequate long-term evaluation of either efficacy or inherent risk of gastroplasty rings (notably risks relating to how the prosthetic material is tolerated, and risk of migration of the ring into the stomach), the working group was concerned about the extensive and unevaluated diffusion of this technique which is currently taking place.” An assessment conducted by the BlueCross BlueShield Association Technology Evaluation Center (2003) stated that there is insufficient evidence to conclude that LASGB either improves net health outcomes or whether it is as beneficial as current established surgery, RYGB. “For laparoscopic gastric banding, the available evidence suggests that weight loss at one year is less than that achieved with gastric bypass. More limited evidence on three-year weight loss suggests that this difference in weight loss may lessen over time. Early adverse event rates are low following laparoscopic gastric banding, and are probably lower than gastric bypass. There is a higher rate of long-term adverse events, and there are a number of potentially serious long-term adverse events such as band slippage or erosion. The incidence of slippage of the device from its intended location, or erosion through the gastric wall increases over time, and can result in visceral organ damage, abdominal pain, and intestinal obstruction. The available data are not sufficient to determine the rates of these longer-term adverse events with confidence.” An assessment conducted by the Australian Medical Services Advisory Committee (2003) concluded that LASGB is as effective as VBG but less effective than RYGB in terms of weight loss. The Canadian Coordinating Office of Health Technology Assessment (CCOHTA, 2003) concluded that “[l]ong-term outcomes data on the effectiveness and safety of the laparoscopic adjustable gastric banding procedure is needed.” In a systematic review of the literature on LASGB, Chapman, et al. (2004) concluded “the long term efficacy of LB remains unproved, and evaluation by randomized controlled trials is recommended to define its merits relative to the comparator procedures.”

An assessment of LASGB prepared for the California Technology Assessment Forum (Tice, 2004) concluded that this technology did not meet CTAF criteria. Regarding comparisons of LASGB with other established bariatric surgical procedures, the assessment found:

Thus, the mean excess weight loss following open or laparoscopic ASGB appears to be roughly equivalent to vertical banded gastroplasty, but significantly less than Roux-en-Y gastric bypass. None of the comparative trials reported on reductions in co-morbidities. Additionally, in spite of lower peri-operative complications, there seem to be more, and more serious, late complications following ASGB. The lack of well controlled, randomized studies precludes any meaningful assessment of the strengths and weaknesses of LapBand compared with Roux-en-Y gastric bypass. Therefore, it cannot be concluded that LB improves net health outcomes as much as or more than established alternatives of roux-en-Y gastric bypass or vertically banded gastroplasty.

An evidence review completed by the Ontario Ministry of Health and Long-Term Care (2005) concluded that, “[r]egarding specific procedures, there is evidence that malabsorptive techniques are better than other banding techniques for weight loss and resolution of comorbid illnesses.”

[the best me 6]

wow, that's a mouthful. Thank God for copy/paste, right? whew!

that was very informative. It's hard to argue, but where are they getting their data? Canada and Austrailia? how come noone comes here asking? we have very successful Canandian and Austrailian bandsters here.

I also "heard" that the clinical trials in the US were not very successful because they basically banded people and let them be. I know Coffeewench here was part of the US clinical trials and she's done great.

My conclusion: if you prefer to be banded, your insurance has enough of what they call proof to deny coverage. However, if there is a smidgen of hope (and it sounds as if there is) it may take some fighting and appealing but you should be able to get coverage.

Do your homework, make sure the Band is for you and you are prepared to fight for it. Know what life after banding will be like. Be prepared to be your own advocate and make SURE your doc is equally as supportive. I think over time the data will prove the Band's effectiveness for well-informed, well-supported, and motivated patients. Unlike any of the bypass procedures, you can't just sit back and drop the pounds. And I KNOW it takes effort with the RNY, and support, and motivation, so don't get me wrong, but the Band isn't malabsorptive. So the effort is different.

[Alexandra 55]

Hi Bird lady,

I read all that Aetna claptrap too, with a magnifying glass. When I started in 2002 Aetna excluded the band altogether based on its being "experimental." Phooey.

The band is LESS INVASIVE than RNY, so any complications that occur are going to be less dangerous, difficult, and damaging. Excess weight lost is a function of US and our behavior; I refuse to be defined by statistics. It doesn't surprise me one whit that it has records of less "success" than RNY--people have to work with the band more than with the RNY and of course there will be more failures due to noncompliance. I do not see that as a bad thing, just a fact.

The RNY changes your anatomy and permanently creates malnutrition. Of COURSE you're going to lose weight. But I for one had absolutely no desire to relinquish control of my health to a one-size-fits-all rearrangement of my intestines. Malabsorption is NOT something I wanted to face the rest of my life with.

Aetna has a vested interest in not adopting a new procedure that will attract thousands more patients who might otherwise not have surgery. Of course it's going to pick and choose the studies that support its position. If you think that having help controlling your caloric intake is going to help you lose weight and maintain that loss, then banding is for you. That's all there is to it.

[keri 0]

Hi Birdlady-

I have Aetna too! I recieved the very same letter- but my surgeon appealed and they are covering it now! The surgery is considered out of network- but they are still covering a huge portion. Did you appeal? My surgery is 6/15!

[Alexandra 55]

Keri, that's fantastic news that you won an appeal over Aetna!! Can you share what the reasons were that your doctor used to appeal? How many times did you have to appeal? Did you actually get Aetna to reverse its own position? That would be awesome!!

[KarenB 0]

What a bunch of claptrap. I notice that they don't mention that there is a built in morbity rate just from the bypass surgery alone. Help me out here, guys, is it 1:200, 1:400, something like that.

[Blonde.Moment 0]

I know people that have had the gastric bypass, and they are always sick, and anemic and God only knows whatelse that we don't hear about. And you certainly are not hearing about the people that are dying from it. I have a neighbor that had gastric bypass 11 months later she was ill, and went to the hospital she didn't make it, her stomach was leaking toxins into her body and it pretty much ruptured. So banding was a no brainer for me.

[Madeline's mom 0]

Very intresting reading but where did these guys get their data?? Hhhhmmmmm!

[keri 0]

Alex-

I'm not sure what my surgeon sent in- the letter I received back from Aetna indicated that they had a gastric surgeon review the orignal submission and he said he would reverse the original denial! I also had a letter with weight history from my reg. doctor- I don't know what did it---I was just thrilled. I will be banded on 6/15 and started my Clear Liquids today--thank God for sugar free popcicles and Crystal light!

[Guest Bird Lady]

Thank you all for your replies. I had my first visit and decided against surgery, for my own physical reasons. And because I am just not up to fighting Aetna all the way.

But mainly because a problem with my esophogas, I am not a good candidate.

The DEATH rate for GB is 1:100. Banding is 1:400 or less.

Yes, Aetna chose results to make banding look bad, so they don't have to pay for it.

The studies they used have doctors who were not experienced with laproscopic surgery doing a new procedure.

[porclndoll 0]

BLAH BLAH BLAH! 'The investigators “did not find LASGB to be an effective procedure for the surgical treatment of morbid obesity.” ' ... They obviously didn't come here and see our results! My surgeons office warned me about proceeding with Aetna, they said it would be very difficult to get it approved by them...guess they were right. My insurance changed as of March 1st to GHI and they approved me in two days! I worked for an insurance company...seems that this letter you got is their way to discourage you...dont give in GO FOR IT! Appeal as many times as your allowed! They need to hear that this surgery has been approved by the FDA some years ago (1996 if Im right) and it has been proven EFFECTIVE.....Good luck in your battle, please let us know if theres anything we can do to help...we have awesome brain storming powers!!!

TTYL

[vinesqueen 2]

Welcome Lady Bird. I don't think you will find anyone here on LBT that would advocate the types of WLS. We have all chosen the band, and are invested in the band. Pretty typical of people who make life chaning investments. However, one thing different about this board--we will be supportive of what ever you choose.

I've visited other boards and one of the things I noticed right away was the name calling. "you're stupid if you choose X type of WLS. The only effective type of WLS is Z procedure." You won't find any of that smack talk here.