04/01/05

The Lap-Band® (short for Laparoscopically placed stomach Band) is a promising technology that is new to the United States (approved by the FDA in June 2001).  This procedure recalls the principle of doing the smallest (least invasive) procedure possible to achieve the desired result.  The operation is accomplished by placing the Band, which is a belt-like section of silastic elastomer, around the upper stomach to create a tiny stomach pouch.  The concept here is to create anatomy that provides a sensation of fullness (called "satiety") after a very small meal.

 

This plan is reminiscent of the older, Vertical Gastric Bypass in terms of its focus on restricting the volume of food that a patient will eat.  However, in contrast to the older VBG, the Band that is placed around the stomach in this case is adjustable.  Adjustment is accomplished by means of a balloon that lines the inside of the Band.  When the Band is placed the balloon is empty, providing slight restriction to eating.  Over the months following surgery the balloon within the Band is gradually filled (outlet is tightened) to provide progressively increasing restriction matched to each patient.  Later, the balloon is either filled (squeezing the stomach more tightly) to create earlier fullness, or emptied (relaxing the squeeze on the stomach) if the patient experiences undue difficulty eating.  The balloon adjustment is accomplished using the access port (which is buried under the skin) to increase or decrease the amount of saline fluid contained in the balloon.  The Band is pictured in its normal position on the upper stomach below:
 

Key features

There are several key features that make the Lap-Band appear to be an attractive surgical technique for weight loss:
 

The first two of the features above appear to reduce the risk of surgery, which is especially important when operating on patients who suffer from morbid obesity.  The fact that there is no cutting or repositioning of any intestine brings the risk of leak or obstruction to very low levels (not impossible, as outlined in the risks section below).  The fact that the procedure is almost always done laparoscopically may allow decreased risk on the vital organs (heart, lungs, etc.) and may allow quicker recovery in comparison to open procedures
 

"Removable" in the list of key features refers to the fact that all surgeons experienced with the Lap-Band report that it can be removed from the patient with little residual impact on the stomach.  These surgeons report that this is even true when the band has eroded into the stomach, or become infected, or slipped out of position.  This is possible because the silastic substance from which the band is made creates essentially no tissue reaction, so that the Band is not stuck in place over time.  This feature also means that the Lap-Band procedure is "reversible" in a certain sense.  The Band could be removed because of medical necessity, and that if it were not replaced by some other weight loss procedure that the patient would be guaranteed to experience significant weight regain.
 

The feature of the Band that deserves the most attention is that it is adjustable.  This is the feature that makes the Band (in many published reports) successful in helping patients achieve significant sustained weight loss.  After all, if the Lap-Band were not successful, then the decrease in operative risk would not mean much.  The fact that the Band can be adjusted to help the patient modify their eating pattern in a way that is specific to that patient is the feature that makes it different from the failed VBG, which created a fixed/hard restriction on eating that frequently led to problems over the long haul.
 

There are several other potential advantages claimed by advocates of the Lap-Band, which deserve mention.
 

Slower weight loss - the Lap-Band aims to create slower and steadier weight loss than the results seen after most other surgical procedures.  Most weight loss operations create very rapid weight loss in the first few months, which then slows and stabilizes at 10-18 months after surgery.  On the other hand, Lap-Band patients begin with a relatively loose Band that allows ongoing intake of nutrition, and the Band is gradually "tightened" according to the patient's weight progress and satiety symptoms.  This approach aims to achieve a weight loss of 1-2 pounds per week, that continues up to or beyond 24 months after surgery.  Lap-Band advocates promote this difference as "gentler" or "safer" or "more physiologic," but we have frankly seen very few nutritional problems in our many gastric bypass patients related to rapid weight loss.
 

Iron, calcium, B12 -  operations that involve rearrangement of the small intestine such as the gastric bypass or the BPD-DS create a deficiency of absorption of these nutrients.  Purely restrictive procedures such as the Lap-Band should theoretically not cause such problems because no intestine is bypassed.  Caution is needed, however; almost all VBG patients we see  for surgical repair are deficient in Iron and B12.   It may well turn out that the reduction in overall intake is more important than the specific bowel anatomy.  In our practice for the time being, we are recommending exactly the same supplements after either the gastric bypass or the Lap-Band.
 

Open questions The Lap-Band system has only been in use since the early/mid-1990's, so there is no long-term data on outcomes.  Unbiased observers have raised several questions about the Lap-Band as outlined below:
 

Weight loss results & maintenance - early studies from Europe reported weight loss results that were less substantial than the Gastric Bypass.  However, more recent studies from Australia (especially from Dr. Paul O'Brien and Dr. George Fielding) have put out reliable-appearing results in which weight loss after Lap-Band is essentially equivalent to GBP.  The course of weight over many years after Lap-Band points in the direction of long term maintenance of weight, but the actual long term results do not yet exist.
 

Band erosion - all surgeons who perform the Lap-Band have found erosion of the Band into the patient's stomach in a small percentage of cases.  It appears that this event (which requires removal of the Band) occurs mainly in the first year or so after surgery.  However the truly long-term incidence of Band erosion remains to be seen.
 

Esophageal function - some patients have experienced failure of normal esophageal peristalsis (swallowing function) after Lap-Band.  If this occurs, it causes painful swallowing, reflux, or regurgitation.  Band deflation or removal is required.  More recent studies suggest that the occurrence of esophageal failure arises from tightening the Band too aggressively, and that this complication can be almost completely avoided.
 

Silastic reaction - it is possible that the material of the Band could create some type of body immune reaction that stimulates a separate disease process such as arthritis or Systemic Lupus Erythematosis (SLE).  However the Band is made of a silicone elastomer which is completely non-reactive to the body tissues, as far as it has been possible to determine.  The same type of material has been in use in a number of implanted medical devices over time, and no problems with tissue reaction have been demonstrated.  Here again, the early data is reassuring but no true long-term information exists.
 

Risks specific to Lap Band
 

Band erosion - the Band can erode through the wall of the stomach.  This results in loss of restriction to eating, or Band infection caused by leakage of stomach juices onto the Band.  It is reported that such erosion rarely results in a sudden life-threatening situation for the patient.  Erosion of the Band almost always requires removal of the Band, with plans for a later conversion to a different weight loss procedure.
 

Band slippage or shifting - the Band must remain in the correct position on the upper stomach in order to function properly.  If it slips out of place or twists, it is likely to cause obstruction of the stomach, requiring fairly urgent re-operation to reposition the Band.
 

Swallowing problems - as mentioned above, the function of the Band as a partial blockage against outflow from the stomach pouch may cause the esophagus (which normally pushes food down in a very coordinated way) to become fatigued or damaged and to fail its normal swallowing function.  The rate of occurrence of this problem varies widely among published reports, with the more recent studies being more reassuring.
 

Hardware breakage - the Band, the port, and the connection tubing are designed to last for life.  In fact, the Band itself is almost never reported to break or leak.  However, the tubing and the port definitely can become twisted, kinked, or broken.  Such events require re-operations (usually minor) for repair or repositioning of the problem spot.
 

Injury to stomach or other nearby organs during surgery - even in capable hands, the maneuvers involved in placing the Band may sometimes create injury to the stomach, esophagus, spleen, liver, or to the tissues involved in placement of the trochars.  Sometimes such injuries can be addressed at the time of surgery and the Band can still be placed.  Sometimes the nature of the injury means it is most reasonable to abandon the operation.