Tuesday, October 21, 2008

The new non surgical WLS which isn't - non surgical!

You have probably seen by now, the media hype. "New WLS - no cutting needed".

Transoral Gastroplasty the so called TOGA procedure, has already been hawked in the media as the latest and greatest.

What the TOGA is, is that they stick a bunch of flexible staplers down your esophagus and pleat part of the inside of your stomach (with staples) into a small pouch:

The TOGA System (Satiety, Inc), a set of transoral endoscopically guided staplers, was used to create a stapled restrictive pouch (similar to other restrictive pouches) along the lesser curve of the stomach.
The news media lost no time in hawking this as the latest and greatest WLS with no cutting:

Unlike other bariatric procedures, the TOGA does not require any incisions. That translates into quicker recover times, shortened hospital stays, and a decreased risk of complications.

Decreased risk of complications? Well, partially true. That is, decreased risk of complications from incisions like hernia and wound healing. We won't talk about complications which may arise from stapling the interior soft tissue of the stomach and of course, other complications which generally arise from WLS.

Other sites have called this procedure 'non surgical'. Again the term may be misleading - that just means there is no incision. But it certainly IS surgery. For example, if a surgeon does a vaginal hysterectomy would that be "non surgery" just because there was no incision?

Below is the best description I could find of it - Medscape news (requires free membership in Medscape to read this)
There were no complications; all but 2 instances of procedure-related adverse effects (nausea, vomiting, pain, dysphagia, pharyngitis) resolved within 5 days and none were serious. The most recent follow-up visits (endoscopy at 3 or 6 months) showed persistent full or partial stapled sleeves in all patients. Weight loss averaged 17.5 lb at 1 month and 24.7 lb at 3 months after treatment (excessive weight loss [EWL], 14.9% and 20.5% at the respective time points). At 6 months, average weight loss was 31.1 lb and EWL was 24.9% for 6 patients followed up so far.

According to Dr. Scott, "Gaps between staple lines [negatively] affected weight loss. The gaps were dependent on stomach anatomy. As we gained more experience with the instruments and the procedure, we made adjustments, and weight loss increased."

... Dr. Scott reports a financial relationship with Satiety, Inc. Dr. Zundel reports financial relationships with Ethicon and Inamed.
One is left with many questions about this procedure. First of that, that's soft tissue inside the stomach and also has a lot of important digestive cells, much softer than rather than the outside of the stomach which is stapled. Secondly the Rose and Stomaphyx procedures which are used to revise gastric bypass patients who have experienced regain, apparently have a problem with the tacks (Stomaphyx) or sutures (Rose) coming out. The Stomaphyx has been all but dropped because the tacks came out pretty soon. (The two patients I know personally who had it say not only was it ineffective in helping them to lose weight again but had a painful aftermath). In doing the Rose procedure, surgeons tell patients the sutures are only guaranteed for a year after surgery.

And a major issue ... the Vertical Banded Gastroplasty which is more permanent than the TOGA but similar in concept, was EXTREMELY ineffective for keeping weight off.

I have known one patient who kept off her weight for 9 years but after that, it started piling on as she became increasingly ill with autoimmune disorder and a host of other things (which many of her medical team DID attribute to repercussions of her WLS). At the 22 year point when this patient had to have her pouch amputated because her stoma stayed shut and she could not even swallow saliva, she was 15 lbs heavier than she had been on the day of her WLS, 22 years ago.

Typical of these patients are things like losing all their teeth, gastroparesis and atrophic gastritis and more.

It's true that the VBG was safer than the gastric bypass (which is why Mason invented it- he wrote) and many of those patients are still around at the 25 year point but I have not met one long termer VBG who is a happy camper. On the contrary.... and every one of them has regained all the weight.

Of course, this TOGA procedure has no silastic band and no stoma. But even after a few months they found (by their own admission): "partially stapled sleeves". In other words, the staples seem to last less time than the sutures....

What damage does this do to the patient's stomach, I wonder....

Studying history is helpful here. The vertical banded gastroplasty which seemed much more permanent was neither effective in the long run nor complication free. For instance here is a patient case history with endoscopic photos:

And even the horizontal gastroplasty which was extremely ineffective as far as weight loss, had its own set of long term complications which interestingly enough resemble the VBG long term. Here is a case history of a 30 year post op horizontal gastroplasty patient. NOTE: although she is very ill, she has been told that any type of take down or reversal will destroy her stomach and put her under risks of dying on the table:

NOTE: both these courageous patients have requested of me that I include their real names AND their photos because they very much wish to warn those considering similar surgery....

The weight loss seems typical of what we have seen with other gastroplasties. Even in the medscape article, the average loss per week by the 6th month was 5 lbs per month or approx 1 lb a week. (this was omitted from the media hype about the procedure - how surprising!) :)

So I would wonder why do they even run a trial of this because it seems doom to fail, even at keeping off the weight any length of time.

The answer may be in the funding they are getting from the manufacturers...
Dr. Scott reports a financial relationship with Satiety, Inc. Dr. Zundel reports financial relationships with Ethicon and Inamed.
And of course, as Roy Spenser remarks in "CLIMATE CONFUSION" (he was senior scientist and climatologist for NASA), any newspaper reporter will jump at "big news" (like "NEW WLS") in hopes of the typically elusive Pulitzer Prize. "Scientists are human" writes Roy continuing that proclamation of "truths" is likely to get scientists, more and better funding. But writes Roy, dourly:

"If you want possible explanations of nature, go to science. If you want truth, go to church!" (Spencer, Roy, PhD: CLIMATE CONFUSION, NY, 2008)