Clinically severe obesity is a result of persistent and uncontrollable weight gain that constitutes a present or potential threat to life. There are a variety of surgical procedures intended for the treatment of clinically severe obesity. This document addresses those procedures.

Medically Necessary:

Gastric bypass and gastric restrictive procedures with a Roux-en-Y procedure up to 150 cm, laparoscopic adjustable gastric banding (for example, the Lap-Band^® System or the REALIZE^™ Adjustable Gastric Band), vertical banded gastroplasty, biliopancreatic bypass with duodenal switch, and sleeve gastrectomy (open or laparoscopic) are considered medically necessary for the treatment of clinically severe obesity for selected adults (18 years and older) who meet ALL the following criteria:

1. BMI of 40 or greater, or BMI of 35 or greater with an obesity-related co-morbid condition including, but not limited to:
   • diabetes mellitus; or
   • cardiovascular disease; or
   • hypertension; or
   • life threatening cardio-pulmonary problems, (for example, severe obstructive sleep apnea, Pickwickian syndrome, obesity related cardiomyopathy); AND
2. The individual must have actively participated in non-surgical methods of weight reduction; these efforts must be fully appraised by the physician requesting authorization for surgery; AND
3. The physician requesting authorization for the surgery must confirm the following:
   • The individual's psychiatric profile is such that the candidate is able to understand, tolerate and comply with all phases of care and is committed to long-term follow-up requirements; and
   • The candidate's post-operative expectations have been addressed; and
   • The individual has undergone a preoperative medical consultation and is felt to be an acceptable surgical candidate; and
   • The individual has undergone a preoperative mental health assessment and is felt to be an acceptable candidate; and
   • The individual has received a thorough explanation of the risks, benefits, and uncertainties of the procedure; and
   • The candidate's treatment plan includes pre- and post-operative dietary evaluations and nutritional counseling; and
   • The candidate's treatment plan includes counseling regarding exercise, psychological issues and the availability of supportive resources when needed.

Surgical repair following gastric bypass and gastric restrictive procedures is considered medically necessary when there is documentation of a surgical complication related to the original surgery, such as a fistula, obstruction, erosion, disruption/leakage of a suture/staple line, band herniation, or pouch enlargement due to vomiting. 

Repeat surgical procedures for revision or conversion to another surgical procedure (that is also considered medically necessary within this document) for inadequate weight loss, (that is, unrelated to a surgical complication of a prior procedure) are considered medically necessary when all the following criteria are met:

• The individual continues to meet all the medical necessity criteria for bariatric surgery (see page 1);  and
• There is documentation of compliance with the previously prescribed postoperative dietary and exercise program;  and
• 2 years following the original surgery, weight loss is less than 50% of pre-operative excess body weight and weight remains at least 30% over ideal body weight (taken from standard tables for adult weight ranges based on height, body frame, gender and age, an example is available from the National Heart Lung and Blood Institute [NHLBI] at: http://www.nhlbi.nih.gov/guidelines/obesity/bmi_tbl.htm.).

Not Medically Necessary:

Stretching of a stomach pouch formed by a previous gastric bypass/restrictive surgery, due to overeating, does not constitute a surgical complication and the revision of this condition is considered not medically necessary.

Investigational and Not Medically Necessary:

Gastric bypass, using a Billroth II type of anastomosis (also known as a "mini gastric bypass") is considered investigational and not medically necessary as a treatment of clinically severe obesity.

Bariatric surgical procedures including, but not limited to, laparoscopic adjustable gastric banding are considered investigational and not medically necessary for individuals with a BMI of 30-34.9 kg/m.²

Malabsorptive procedures including, but not limited to, jejunoileal bypass, biliopancreatic bypass without duodenal switch, or very long limb (greater than 150 cm) gastric bypass (other than the biliopancreatic bypass with duodenal switch) are considered investigational and not medically necessary as a treatment of clinically severe obesity.

Repeat procedures for repair, revision, or conversion to another surgical procedure following a gastric bypass or gastric restrictive procedure are considered investigational and not medically necessary when the criteria listed above are not met.

All other surgical gastric bypass/restrictive procedures not listed above as medically necessary are considered investigational and not medically necessary including, but not limited to, minimally invasive endoluminal gastric restrictive surgical techniques, such as use of the EndoGastric StomaphyX^™ endoluminal fastener and delivery system, and laparoscopic gastric plication (laparoscopic greater curvature plication [LGCP]) with or without gastric banding.

Further Consideration:

A bariatric surgeon with experience in the pediatric population may request further consideration of a case of an individual under 18 years old with severe morbid obesity and unique circumstances by contacting a Medical Director.

At this time, there is sufficient evidence in the peer-reviewed medical literature to support the use of gastric bypass with a Roux-en-Y procedure (RYGB) up to 150 cm and/or vertical banded gastroplasty (VBG) for the indication of clinically severe obesity. The evidence suggests that these procedures are beneficial for this indication in a selected group of individuals. The most compelling evidence for an improvement in comorbid conditions comes from the Swedish Obese Subjects (SOS) intervention trial that reported a large reduction in diabetes over a 5.5 year mean follow-up for the surgery group. While there is substantial evidence that these procedures can facilitate significant weight loss and improve co-morbidities in clinically severe obese individuals, perioperative mortality may occur in such individuals as well, occurring at a rate of approximately 1 in 200 procedures. In order to minimize potential morbidity and mortality, individuals who undergo such treatment should meet specific criteria prior to undergoing the procedure. The evidence supporting this conclusion includes properly randomized controlled trials.

Results of a prospective, nonrandomized, comparative trial reported long term outcomes of 563 VBG and 554 adjustable gastric banding (AGB) procedures performed by two surgeons. The mean BMI was 46.9 +/- 09.9 kg/m⁽²⁾ for those undergoing VBG and 46.7 +/- 07.8 kg/m⁽²⁾ for those in the AGB group. VBG was performed by laparotomy and AGB using laparoscopy. The Bariatric Analysis and Reporting Outcome System (BAROS) was used to evaluate postoperative health status and quality of life. The mean duration of follow-up was 92 months (range 60-134), with a minimum of 5 years. The overall follow-up rate was 92%. The 30-day mortality rate was 0.4% for VBG and 0.2% for AGB. The overall re-intervention rate in the long term was 49.7% for VBG and 8.6% for AGB (p < 0.0001). The reoperation rate was 39.9% for VBG and 7.5% for AGB (p < 0.0001). The excess weight loss (EWL) was significantly greater in the VBG group (58%) than the AGB group (42%) after 12 months (p < 0.05). At 92-month follow-up, no significant difference in weight loss was found between the two study groups (59% for VBG and 62% for AGB, p = 0.923). The BAROS score was significantly in favor of the AGB group (p < 0.0001). The overall resolution rate of co-morbidities was 80% in both groups (Miller, 2007).

A retrospective cohort study of different procedures for morbid obesity was reported for: open VBG (n = 125), open Scopinaro biliopancreatic diversion (BPD; n = 150), open modified BPD (i.e., common limb 75 cm; alimentary limb 225 cm; n = 100), and laparoscopic RYGB (LRYGB; n = 115). Mean follow-up was 12 years for VBG, 7 years for BPD, and 4 years for LRYGB. An excellent initial weight loss was observed at the end of the second year of follow-up in all techniques, followed by regain of weight observed in the VBG and LRYGB groups. Participants in the BPD groups maintained weight loss results. Mortality was: VBG 1.6%, BPD 1.2%, and LRYGB 0%. Early postoperative complications were: VBG 25%, BPD 20.4%, and LRYGB 20%. Late postoperative morbidity was: protein malnutrition 11% in Scopinaro BPD, 3% in modified BPD group, and no cases reported either in the VBG group or the LRYGB group; iron deficiency was 20% for VBG, 62% for the Scopinaro BPD, 40% for the modified BPD, and 30.5% for the LRYGB group. Conversion to gastric bypass or to BPD was needed for 14.5% of the VBG group, due to 100% weight regain or vomiting. For those in the Scopinaro BPD group, revision surgery was needed to lengthen the common limb to 100 cm in 3.2% of cases, due to severe protein malnutrition. Revision surgery also was required for 0.8% of the LRYGB subjects, due to 100% weight regain. It was noted that the more complex bariatric procedures increase effectiveness but also increase morbidity and mortality. The authors concluded, "LRYGB is safe and effective for the treatment of morbid obesity. Modified BPD (75-225 cm) can be considered for the treatment of superobesity (BMI greater than 50 kg/m^2_), and restrictive procedures, such as VBG should only be performed in well-selected patients, due to high rates of failure in long-term follow-up" (Gracia, 2009).

Reoperation rates have been reported to be higher for VBG, although the evidence reflects that substantial weight loss can be achieved.  According to information from the Centers for Medicare and Medicaid Services (CMS), VBG has been largely replaced by AGB and is now rarely performed (CMS, 2006). 

A Swedish study describes the high revision rates noted following laparoscopic VBG in a study of 486 subjects consecutively attempted, 64 of which were converted to an open procedure, with ten year follow-up data reported.  The mean BMI at time of surgery was 42.4 kg/m^2_.  The median follow-up was three years (with a range of 0-11 years).  All participants lost weight with a total of 104 subjects (21%) requiring revisional surgery 114 times during the follow-up period.  Food intolerance/vomiting and inadequate weight loss were the most common reasons for surgical revisions.  Of the 104 who underwent revisional surgery, 31 underwent repeat VBG, ten of whom needed a second revisional surgery, and 49 required conversion to gastric bypass.  None of those 49 have required any further revisional procedures.  The authors concluded that laparoscopic VBG is associated with high revision rates; in the case of failed VBG, repeat VBG seems to be a poor option with conversion to gastric bypass yielding better results (Marsk, 2009).

There is sufficient evidence to support the use of the biliopancreatic bypass with duodenal switch (BPD/DS) for individuals who have clinically severe obesity. Mortality is similar to the RYGB procedure, and the evidence suggests that up to 70% EWL can be maintained over long-term follow-up (up to 6 years post-surgery). The evidence supporting this conclusion includes multiple large case series. 

There is now sufficient U.S. data available supporting the safety and efficacy of laparoscopic adjustable gastric banding (LAGB), using FDA-approved devices, such as the Lap-Band^® system or the REALIZE^™ Adjustable Gastric Band, for the treatment of clinically severe obesity. While EWL with a LAGB procedure is more gradual than with other bariatric surgical procedures, studies with up to three years follow-up have shown that an EWL of 40% to 60% can be achieved. This is accompanied by improvements in quality of life scores. Recent improvements in the band design and use of the "pars flaccida" surgical approach have resulted in a lower complication rate. Both international and U.S. case studies have reported mortality rates for the LAGB procedure that are lower than the mortality rates found for most other bariatric procedures, including the standard RYGB. The evidence supporting this conclusion includes large case studies, including a single-surgeon, single-institution non-randomized case series (Jan, 2005) that studied 219 subjects undergoing laparoscopic gastric bypass and 154 subjects undergoing LAGB. On average, participants in the former group were observed to require 58 additional minutes of operating time, lost 15 cc more blood, and stayed 1.3 more days in the hospital, but after 12 months lost 64% vs. 36% of their excess weight, as compared with the LAGB group. By 36 months, EWL was 60% vs. 57%, respectively, but by this time 20% of LAGB recipients required reoperation vs. 10% in the gastric bypass group. In this study, degree of obesity did not seem to matter as much in those receiving LAGB, but in those receiving laparoscopic bypass, EWL during the first two years was less in those with higher BMI. The significant majority of individuals in this case series had a BMI of less than 50.

Conversely, in another single-institution case series (Myers, 2006) reporting on 352 individuals, a retrospective review of 53 subjects with initial BMI greater than or equal to 60 who underwent LAGB revealed that 28% of excess weight was lost by 12 months, and 35% by 18 months. Within this group, four subjects had extended hospital stays, due to transient post-operative obstruction from edema. Other postoperative complications included one band removal for chronic obstruction, one band revision for slippage, and one nonfatal pulmonary embolism. The remaining group, with BMI less than 60, demonstrated more rapid EWL, averaging 36% at 12 months and 45% by 18 months. There was no statistically significant difference in postoperative complication rates in those with preoperative BMI greater than 60 and those with preoperative BMI less than 60. There is no prospective, randomized controlled data available with regard to studies directly comparing the Lap-Band^® system vs. RYGB for individuals with BMI greater than 50. In summary, there is conflicting information, coming purely from case series data, as to the effectiveness of the Lap-Band^® system in persons with BMI greater than 50. However, based on national physician specialty society recommendations, and the views of a wide array of medical practitioners practicing in this clinical area, the use of the Lap-Band^® system for those with initial BMI greater than 50 was felt to be in accordance with generally accepted standards of medical practice at this time.

The FDA based its new expansion decision (February 16, 2011) on use of the Lap-Band device for "Weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m² or a BM1 of at least 30 kg/m² with one or more obesity related comorbid conditions" on the results of an ongoing prospective, single-arm, non-randomized, five year study sponsored by the manufacturer, Allergan, Inc.  The study entitled the "Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m² and < 40 kg/m^2_," is intended to determine whether the Lap-Band system is safe and effective in subjects with BMI >/= 30 kg/m² and < 40 kg/m^2_.  The primary outcome measure was to determine the percent of subjects who attained clinically successful weight loss of ≥ 30% EWL at one year post Lap-Band implantation.  According to the FDA Executive Summary Memorandum, a total of 151 subjects were enrolled in the study, and 149 subjects underwent Lap-Band placement.  A total of 145 participants (97.3%) completed the 12-month follow-up.  Over the first 12 months after device placement, the subjects underwent a mean of 6.1 band adjustments (range of 0 to 14 adjustments).   The study device was determined to be clinically effective if at least 40% of subjects achieved an EWL of 30% or greater at one year.  The one year study results showed that this goal was reached by 80.5% of all implanted subjects with 65.8% of evaluable subjects (n = 143) having lost at least 50% of their excess weight.  The mean BMI decreased from 35.4 kg/m² at baseline to 28.8 kg/m² at month 12 with a mean decrease from baseline of 6.5 points (p < 0.0001).  The proportion of subjects who were obese (≥ 30 kg/m^2₎ decreased from 99.3% at baseline to 36.9% at 12 months.  A total of 105 subjects (70.5% of the total enrolled subjects) experienced a device-related adverse event.  The majority of device-related adverse events were mild in severity (n=118, 54.9%) and only 2.3% were severe (5 events in 3 subjects) with the most common device-related adverse events reported as vomiting (n = 43, 20.0%), dysphagia (n = 33, 15.3%), post-procedural pain (n = 28, 13.0%), and gastroesophageal reflux disease (n = 22, 10.2%).  There was one occurrence of band erosion and two reports of esophageal dilatation in the first 12 months.  Surgical revision was performed for ten device related events in seven subjects.  This study is to continue for collection of up to five years of data on the study participants, subject to FDA concerns related to multiple issues, including potential selection bias possibly impairing the generalizability of outcomes data, the unclear clinical basis for the five-year primary endpoint (defined as at least 40% of subjects with EWL% greater than or equal to 30%), and inadequate details about safety evaluations (FDA, 2011).  To date, no articles have been published regarding this study which has an estimated completion date of November 2013.  No additional studies were identified that are sufficiently powered to support these findings and, for this reason, use of the Lap-Band for BMI of 30-34.9 kg/m² is considered investigational and not medically necessary, at this time.

The Agency for Healthcare Research and Quality (AHRQ) is conducting an evidence-based practice center systematic review protocol entitled: "Comparative Effectiveness of Bariatric Surgery and Non-Surgical Therapy in Adults with Metabolic Conditions and Body Mass Index of 30 to 34.9," which will examine the evidence regarding the comparative effectiveness of bariatric surgery versus conventional non-surgical therapies for treating adults with a BMI of 30 to 34.9 kg/m²  and metabolic conditions, including diabetes.  This assessment will attempt to determine if certain surgical procedures are more effective than others (laparoscopic adjustable gastric banding, gastric bypass, or sleeve gastrectomy) and will also investigate other individual factors (social support, counseling, pre-operative weight loss, compliance), in terms of how they are related to successful outcomes.  This research will also review the evidence regarding adverse effects, complication rates and long-term benefits/harms of bariatric surgery for adults with a BMI of 30 to 34.9 kg/m²  who have metabolic conditions and will compare these findings to short-term outcomes (within 1 year from surgery).  The timing for this evaluation of short-term outcomes is one year and five years for long-term outcomes or best available post surgery intervention (AHRQ, 2010).

In October 2011, the American Society for Metabolic and Bariatric Surgery (ASMBS) updated its position statement on sleeve gastrectomy (SG) to state that it now,

 "Recognizes SG as an acceptable option as a primary bariatric procedure and as a first stage procedure in high risk patients as part of a planned staged approach.  Substantial comparative and long-term data are now published in the peer-reviewed literature demonstrating durable weight loss, improved medical comorbidities, long-term patient satisfaction, and improved quality of life after SG.  Based on the current published literature, SG has a risk/benefit profile that lies between the LAGB and the laparoscopic RYGB"  (ASMBS, 2011).

In 2010, Himpens published long term (six year) results of laparoscopic sleeve gastrectomy (LSG) for 53 consecutive persons considered to be "morbidly obese" who electively underwent LSG at a single institution in Belgium between November 2001 and October 2002.  Full postoperative evaluation was possible for 41 of these subjects.  Median age at the time of surgery was 44 years and median preoperative BMI was 39.0 kg/m² (range 31-57; standard deviation [SD] 5.4).  Seven of the 41 trial participants admitted having preoperative conditions (5 were hypertensive, one had type II Diabetes, and 1 suffered from symptoms of gastroesophageal reflux [GERD]).  At three years postop, overall EWL was recorded as 72.8%.  After the sixth year, weight regain was observed in 31 cases (75.6%), which resulted in a residual mean overall EWL of 57.3%.  These results included 11 (of the 41 evaluated in follow-up) who underwent an additional malabsorptive procedure (duodenal switch) as a second stage procedure due to weight regain and 2 underwent a resleeve procedure between the third and sixth postop years, due to weight regain and pouch dilation.  Major complications (leakage, stenosis, bleeding, hernia) occurred in 12.2% of study subjects and symptoms associated with GERD were reported in 18% in the LSG stand-alone group and 21% in the overall group of surgical subjects.  One diabetic subject reported resolution of symptoms and 2 of the 5 hypertensive subjects reported being normotensive at six years postop.  Quality of life scores were reported as a mean of 5 BAROS score at six years.  Despite the limitations of this small study, safety and efficacy results for the stand alone LSG-treated group appear to be relatively equivalent to those obtained from other restrictive surgical techniques.  These findings are consistent with results of other small studies of LSG as a stand-alone procedure, although symptoms associated with GERD seem to be a persistent complaint at follow-up of 1-5 years (Bohdjalian, 2010; Gandsas, 2010).

Recently, bariatric surgery has been investigated as a treatment for type 2 diabetes mellitus (T2DM).  To date, studies reporting the results of bariatric surgery on T2DM have primarily included individuals with morbid obesity (that is, with a BMI greater than or equal to 40 or 35–39.9 kg/m² with a clinically significant obesity-related comorbidity).  There have been very few studies that investigated the safety and efficacy of bariatric surgery, also referred to as metabolic surgery, in individuals with a BMI less than 35.  In 2012, Mingrone published results of a single-center, nonblinded, randomized, controlled trial of sixty subjects between the ages of 30 and 60 years with a BMI of 35 or more and a history of at least 5 years of diabetes.  Study participants were randomly assigned to receive conventional medical therapy or bariatric surgery (either GB or BPD).  The primary end point was the rate of diabetes remission at 2 years (defined as a fasting glucose level of < 100 mg per deciliter [5.6 mmol per liter] and a glycated hemoglobin level of < 6.5% in the absence of pharmacologic therapy).  At 2 years, diabetes remission had occurred in no subjects in the medical-therapy group versus 75% in the GB group and 95% in the BPD group (P < 0.001 for both comparisons). Age, sex, baseline BMI, duration of diabetes, and weight changes were not significant predictors of diabetes remission at 2 years or of improvement in glycemia at 1 and 3 months. At 2 years, the average baseline glycated hemoglobin level (8.65 ± 1.45%) had decreased in all groups, but subjects in the two surgical groups had the greatest degree of improvement (average glycated hemoglobin levels, 7.69 ± 0.57% in the medical-therapy group, 6.35 ± 1.42% in the GB group, and 4.95 ± 0.49% in the BPD group.  The authors concluded that, in severely obese subjects with T2DM, bariatric surgery resulted in better glucose control than did medical therapy and that preoperative BMI and weight loss did not predict the improvement in hyperglycemia seen after surgery (Mingrone, 2012).

Another recent randomized, nonblinded, single-center study evaluated the efficacy of intensive medical therapy alone versus medical therapy plus RYGB or SG in 150 obese subjects with uncontrolled T2DM.  The average pre-treatment glycated hemoglobin level was 9.2 ± 1.5%, and the primary end point was the proportion of subjects with a glycated hemoglobin level of 6.0% or less at 12 months post treatment.  Results showed that of the 150 subjects, 93% completed 12 months of follow-up.  The proportion of subjects meeting the primary end point at 12 months was 12% (5 of 41) in the medical therapy alone group versus 42% (21 of 50) in the RYGB group (P = 0.002) and 37% (18 of 49) in the SG group (P = 0.008).  Glycemic control improved in all three groups, with a mean glycated hemoglobin level of 7.5 ± 1.8% in the medical-therapy group, 6.4 ± 0.9% in the RYGB group (P < 0.001), and 6.6 ± 1.0% in the SG group (P = 0.003). Weight loss was greater in the RYGB group and the SG group (−29.4 ± 9.0 kg and −25.1 ± 8.5 kg, respectively) than in the medical-therapy group (−5.4 ± 8.0 kg; P < 0.001) for both comparisons.  It is noteworthy that during the study, use of anti-diabetic medications increased in the medical therapy group and decreased in both surgical groups.  All subjects in the RYGB group who achieved the primary endpoint did so without medications, while 28% of those in the SG group who reached the primary endpoint required continued medication use.  The authors concluded that in obese individuals with uncontrolled T2DM, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more subjects than in those treated with medical therapy alone (Schauer, 2012).  However, both studies were small and limited by confounders, such as wide BMI ranges, short-term outcomes data and single center study design.  Additional larger, well designed studies are needed to more fully assess the safety, efficacy and durability of therapeutic effect of any bariatric surgical procedure on T2DM. 

There are relatively few randomized comparative studies evaluating the relative risk and benefit of each of the surgical options. Furthermore, long-term results (greater than 6 years) are not abundant for any of the bariatric procedures. Thus, the quality of evidence to guide operative choice is fair at best, based primarily on single-institution case series. At this time, there is insufficient convincing evidence in the peer-reviewed medical literature, in terms of safety, to support the use of "mini gastric bypass" and malabsorptive procedures, other than the BPD with duodenal switch, in individuals with clinically severe obesity. Therefore, these procedures cannot be recommended for such individuals. The investigational status of these procedures is based on the judgment that there is insufficient evidence to demonstrate that the increased risks of these procedures, compared specifically to the gastric bypass with the Roux-en-Y procedure, are outweighed by a significantly greater reduction in obesity-related morbidities and EWL. A new minimally invasive surgical technique is done endoscopically and is referred to as endoluminal gastric restrictive surgery or "natural orifice" transluminal endoscopic surgery (NOTES). This technique utilizes flexible endoscopy with a specialized device, the EndoGastric StomaphyX^™ device (EndoGastric Solutions^™ Inc., Redmond, WA). The StomaphyX device received U.S. Food and Drug Administration (FDA) clearance through the 510(k) approval process on March 9, 2007. This endoluminal fastener and delivery system is indicated for use in endoluminal trans-oral tissue approximation and ligation in the GI tract (FDA, 2007). Published evidence is currently insufficient to demonstrate the safety and efficacy of this surgical technique, as compared to conventional surgical treatment options (Swanstrom, 2005).

In January 2009, the ASMBS Emerging Technologies and Clinical Issues Committee issued a position statement on Emerging Endosurgical Interventions for Treatment of Obesity. The committee stated that:

There are currently a number of endoluminal innovations and novel devices and technologies in various stages of development or application to the elective treatment of obesity, including revisional interventions. Theoretical goals of these therapies include decreasing the invasiveness, risk, and barriers to acceptance of effective treatment for obesity, but these outcomes cannot be assumed and must be proven.  Therefore, use of novel technologies should be limited to clinical trials done in accordance with the ethical guidelines of the ASMBS and designed to evaluate the risk and efficacy of the intervention (ASMBS, 2009b).

On October 6, 2011 the ASMBS issued a policy statement on laparoscopic gastric plication, also known as laparoscopic greater curvature plication (LGCP), which is a relatively new bariatric procedure being proposed as a surgical option for the treatment of obesity.  Gastric plication involves mobilizing the greater curvature of the stomach similar to the dissection for a SG and infolding (or imbricating) the stomach to achieve gastric restriction utilizing specialized surgical tools and sutures manufactured by Ethicon Endo-Surgery, Inc. (Cincinnati, OH).  According to the ASMBS statement, "The rationale for this procedure addresses issues that may limit the acceptance of other bariatric procedures, specifically, gastric plication does not involve gastric resection, intestinal bypass or placement of a foreign body, and could potentially provide a lower risk alternative for patients and referring physicians."  A combination of gastric banding with LGCP has also been proposed which involves placement of an adjustable gastric band, at the time of LGCP. This combined technique has been suggested to augment the early weight loss seen after gastric banding with possible decrease in the need for band adjustments. However, based on the current lack of published data to support any definitive conclusions regarding the safety and efficacy of gastric plication procedures, the ASMBS provided the following recommendations regarding gastric plication, performed alone or in combination with adjustable gastric band placement, for the treatment of obesity: 

Gastric plication procedures, performed alone or in combination with adjustable gastric banding, should be considered investigational at this time. This procedure should be performed under a study protocol with third party oversight (local or regional ethics committee, Institutional Review Board, Data Monitoring and Safety Board, or equivalent authority) to ensure continuous evaluation of patient safety and to review adverse events and outcomes.  Reporting of short- and long-term safety and efficacy outcomes in the medical literature and scientific meetings is strongly encouraged.  Data for these procedures should also be reported to a program's center of excellence database.  Any marketing or advertisement for this procedure should include a statement to the effect that this is an investigational procedure (ASMBS, 2011).

A study conducted by the Agency for Healthcare Research and Quality (AHRQ) is purported to be the most extensive, to date, on postsurgical complications from obesity operations.  The AHRQ researchers found that the complication rate among privately insured, nonelderly subjects receiving obesity surgery increased from 21.9%, while they were still hospitalized, to 39.6% by the end of the 180-day study period.  Most studies of complications from obesity surgery have been limited to those that occur before hospital discharge or, at the most, up to 30 days post-discharge.  This study extends the observation period up to 180 days, (i.e., six months) after hospital discharge.  The five most common complications were dumping syndrome, which includes vomiting, reflux, and diarrhea (nearly 20%); anastomosis complications (i.e., complications resulting from the surgical joining of the intestine and stomach), such as leaks or strictures (12%); abdominal hernias (7%); infections (6%); and pneumonia (4%).  The overall death rate for the entire 180-day postoperative period studied was low (0.2%).  These findings were based on claims for hospital care and outpatient care for 5.6 million enrollees under age 65 in employer-sponsored health plans for 45 large employers in 49 states for the time period of 2001 and 2002.  The claims data included information on 2,522 bariatric procedures (AHRQ, 2009). 

Of note, further information published in May 2009 reported an improvement in complication rates following bariatric surgical procedures.  According to this article entitled, "Recent Improvements in Bariatric Surgery Outcomes" the AHRQ study reported that the average rate of post-surgical and other complications in those who have had obesity surgery declined 21% between 2002 and 2006.  They also found that the complication rate among those initially hospitalized for bariatric surgery dropped from approximately 24% to roughly 15%, much of this driven by a reduction in the post-surgical infection rate, which plummeted 58%.  Other factors believed to contribute to the improved bariatric outcomes included a mix of within-hospital volume increases, a move to laparoscopic techniques, and an increase in banding without bypass (Encinosa, 2009).  

In addition to surgical complications following bariatric procedures, (e.g., stricture, erosion, leakage, band slippage, etc.), it has been noted that some individuals do not achieve, or maintain, adequate weight loss post-operatively, despite documented compliance with postoperative nutritional and exercise regimens.  In general, it may take up to two years to reach maximum weight loss following bariatric surgery.  Follow-up bariatric surgery, such as conversion to RYGB, may be proposed when adequate weight loss has not occurred after one to two years following the initial surgery.  There is agreement amongst some experts in the field that adequate weight loss has been achieved when at least 50% of EWL has been achieved, or when the body weight has reached within 30% of ideal weight ranges (by age, gender, height, etc.).  Inadequate weight loss due to noncompliance with the recommended postoperative regimens is not considered to be a failure of the original surgery.

There is, at present, insufficient evidence to support the use of bariatric surgery for the pediatric and adolescent population. Several small case series have shown some promising results. However, in one case series of 33 subjects, five individuals (15%) regained most or all of their weight five to ten years post-surgery. Concerns about possible nutritional deficiency in growing children and adolescents also exist, and selection criteria for which surgical procedure is best and for appropriate surgical candidates are unclear. Further results are required before it is clearly known whether the benefits of surgery outweigh the risks in this population. However, in a small subset of adolescents with severe morbid obesity, the risks from comorbidities and complications are sufficiently high that bariatric surgery may be indicated. Consequently, special consideration for such surgery may be given for an adolescent with severe morbid obesity presenting with unique circumstances (O'Brien, 2010; Pratt, 2009; Treadwell, 2008).

Gastric wrapping and the Garren Gastric Bubble represent obsolete techniques. The jejunoileal bypass has also been abandoned due to severe metabolic complications.

Surgery for clinically severe obesity (bariatric surgery) falls into two categories: gastric restrictive procedures and malabsorptive procedures. The first category, gastric restrictive procedures, includes procedures in which a small pouch is created in the stomach. Weight loss occurs as the individual feels full sooner, having eaten much less than usual. The second category, malabsorptive procedures, includes procedures that rearrange the connections between the stomach and intestines, causing the food to be poorly digested and incompletely absorbed. Weight loss is due to malabsorption without necessarily requiring dietary modification.

Surgery for the treatment of clinically severe obesity may be appropriate in a select group of individuals. According to the National Institutes of Health (NIH), weight loss surgery should be reserved for individuals suffering from the complications of extreme obesity, for whom conservative medical therapy has failed. Possible surgical candidates are those with severe obesity, defined as a body mass index (BMI*) of 40 or greater, or 35 or greater with other medical complications. Such complications include, but are not limited, to the following:

• Diabetes mellitus;
• Hypertension;
• Coronary artery disease;
• Obstructive sleep apnea;
• Pulmonary hypertension of obesity.

*BMI is calculated by dividing an individual's weight (in kilograms) by height (in meters) squared. To convert pounds to kilograms, multiply pounds by 0.45; to convert inches to meters, multiply inches by 0.0254.

According to the National Institutes of Health (NIH), an increase of 20 percent or more above an individual's ideal body weight is the point at which excess weight becomes a health risk. Today, nearly two-thirds of Americans are overweight or obese. Nearly 15 million of those are considered to have clinically severe obesity, in which there is higher risk of one or more obesity-related health conditions that result either in significant physical disability or even death. While medical complications of obesity may occur in moderately obese people, the frequency increases dramatically as weight increases.

The first line treatment of clinically severe obesity is dietary and lifestyle changes, including regular exercise. In order to lose weight, an individual must have a caloric deficit, i.e., calories out must be greater than calories in. This can be accomplished by decreasing the calories ingested with some form of dietary restriction and by increasing the calories expended through exercise. All available therapies (dietary, behavioral, pharmacologic, and surgical) help with weight loss by changing the calories ingested, absorbed, or expended.

Surgery for clinically severe obesity is performed in a hospital setting. The number of days the individual is hospitalized is dependent on the type of surgery performed. When surgery is required for clinically severe obesity, the following are some of the more common procedures:

Gastric Restrictive Procedures 

1.   Vertical Banded Gastroplasty (VBG)

VBG is a purely restrictive procedure. The stomach is divided vertically, and a band is stapled around the top portion of the stomach to decrease its size. Because the normal flow of food is preserved, metabolic complications are rare. Complications of this procedure include esophageal reflux, as well as either widening or blockage of the narrow portion of the stomach, which may require re-operation. VBG may be performed using an open or laparoscopic approach. Many surgeons have abandoned this approach because of unsatisfactory long-term maintenance of weight loss.

2.   Adjustable Gastric Banding (AGB)

AGB is also a purely restrictive procedure. It involves surgically placing a gastric band around the exterior of the stomach.  Because the stomach is never entered, the surgery is proposed to be safer than conventional surgical treatments. Additional proposed advantages include reversibility of the procedure and maintenance of gastrointestinal anatomic integrity. However, serious complications may include slippage of the external band or band erosion through the stomach wall. Furthermore, incorrect positioning of the band may result in vomiting, as well as ineffective weight loss. Recent improvements in surgical technique have decreased the incidence of such complications in some series, based on preliminary results, with erosions becoming rare and slippage (necessitating re-operation) occurring in about 2–5% of surgeries. Mortality is also generally less than with other bariatric surgery procedures, amounting to about 1 in 1,000 to 1 in 2,000 procedures. The first device cleared by the FDA, (in June, 2001) for marketing in the United States, was the Lap-Band^® System (Allergan, Inc., Irvine, CA [formerly owned by Inamed Health]).  On February 16, 2011 FDA clearance was obtained for expanded use of the Lap-Band device for "Weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m² or a BM1 of at least 30 kg/m² with one or more obesity related comorbid conditions.  It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs.  Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives." (FDA, 2011)  This expanded FDA clearance is contingent upon the submission of annual post-approval reports regarding safety and effectiveness, in addition to two post-approval studies intended to evaluate the long-term effectiveness and incidence of adverse events. 

On September 28, 2007 the REALIZE^™ Adjustable Gastric Band modified Model 2200-X with Velocity Injection Port (Ethicon Endo-Surgery, Inc., Cincinnati, OH) received 510(k) FDA clearance through the premarket approval process for the following indications:

For use in weight reduction for morbidly obese patients and is indicated for individuals with a Body Mass Index (BMI) of at least 40 kg/m^2_, or a BMI of at least 35 kg/m² with one or more co-morbid conditions. The Band is indicated for use only in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs  (FDA, 2007).

This FDA approval for the REALIZE device was based on a prospective, multi-center, single-arm trial conducted in the U.S., in which each subject served as his or her own control. Subjects were followed for three years post-implantation. A total of 405 subjects were screened for the study, and 276 were implanted with the device. Complete, 36-month follow-up data are available for 228 subjects. The remaining participants are categorized as discontinued. The mean percentage of EWL at three years post-implantation was 42.8% (one-sided t-test; p-value < 0.001). The %EWL increased between 4-6 weeks and 28 months and remained relatively stable between 28 months and 36 months. Starting at 8 months post-surgery, the %EWL target of 32.6% was already achieved, and this was maintained throughout the remainder of the study. Subjects who reached 36 months of follow-up lost, on average, 42.8% of their excess body weight. The results of the U.S. clinical study demonstrated that:

The REALIZE^™ Band is effective in reducing excess weight in morbidly obese subjects.  At three years post implantation, the %EWL in the 228 subjects who completed the study was 42.8% with 77% of subjects having a %EWL of at least 25%...During the study, 266 (96.4%) of the subjects reported one or more adverse events. Specific adverse events associated with gastric banding reported during the course of the study included: 1 band erosion (0.4%), 7 port displacements (2.5%), 9 band slippages (3.3%), 10 pouch dilatations (3.6%), 9 esophageal dilatations (3.3%), 1 esophageal dysmotility (0.4%), 18 injection port site pain (6%), 1 band leak (0.4%), 12 port disconnections (4.3%), and 3 kinking of catheter (1.1%). Forty-three subjects (15.6%) required re-operations involving the Band including, 2 band replacements, 10 band revisions, 4 band explantations, 5 port replacements, and 22 port revisions. There was one death in the study. Causality was probably related to port replacement surgery.

Notably, FDA approval is contingent upon the results of a post-approval study to be conducted in the U.S. at up to twelve centers to evaluate the long-term safety and effectiveness of the REALIZE device. This device has been registered and marketed under the name Swedish Adjustable Gastric Band (SAGB) outside the U.S. since 1996.

3.   Gastric Bypass (RYGB)

The most commonly performed restrictive approach is the RYGB, which combines gastric restrictive and malabsorptive features. It involves a horizontal or vertical partitioning of the stomach, which results in a 90% restriction. It is followed by a Roux-en-Y procedure, in which the small intestine is reconfigured into a Y consisting of two limbs and a common channel. The proximal small bowel remains attached to the stomach and duodenum below the gastric division or partition. This limb is called the pancreatico-biliary conduit (or limb) and it drains bile, digestive enzymes, and gastric secretions. The other limb, sometimes called the Roux limb, is attached to and drains the small proximal gastric pouch, and so carries only food. The Y is created at the point where the pancreatico-biliary conduit and the Roux limb are connected. At this point, the digestive juices and food mix and go on together, passing through the remaining arm of the Y, known as the common channel. Gastric bypass not only prevents the ability to ingest larger volumes at any one meal, but also induces a "dumping syndrome" if the individual ingests too much food or a high-sugar liquid meal. This unpleasant "dumping syndrome" occurs when a large amount of partially digested food is delivered directly to part of the small intestine from the stomach and can cause nausea, weakness, sweating, faintness, abdominal pain and vomiting. The dumping syndrome may further reduce intake particularly among "sweet eaters." Surgical complications include leakage and stomal stricture. Since a major portion of digestion occurs in the stomach – specifically the process of breaking down food into nutrients – the amount of nutrients available for absorption is also reduced. As a result, this procedure requires that individuals take vitamin and mineral supplements. Gastric bypass may be performed using an open or laparoscopic approach.

4.   Mini Gastric Bypass

Recently a variant of the gastric bypass, called the "mini gastric bypass" has been popularized. Using a laparoscopic (periscope-type) approach, the stomach is divided, similar to a traditional gastric bypass, but instead of creating a Roux-en-Y connection, the jejunum is anastomosed directly to the stomach, similar to a Billroth II procedure to the stomach. The unique aspect of this procedure is not based on its laparoscopic approach, but rather the type of anastomosis used. While this surgical approach may result in shorter operating time, it creates the risk of biliary reflux gastritis, in which bile flows back into the stomach and causes irritation. That is one of the reasons that this procedure has been abandoned in favor of the RYGB.

5.   Sleeve Gastrectomy (SG)

This alternative surgical approach to gastrectomy involves resection of the greater curvature of the stomach resulting in a stomach remnant shaped like a tube or "sleeve."  It can be performed by open or laparoscopic technique and can be done as a stand-alone procedure or as the first in a two-stage procedure subsequently followed by a malabsorptive procedure, such as biliopancreatic diversion with duodenal switch (BPD/DS).  It has been proposed by some surgeons for very high risk individuals where weight loss following SG may improve the overall medical status and reduce risk for subsequent more extensive malabsorptive procedures.

Malabsorptive Procedures 

1.   Biliopancreatic Bypass Procedure (also known as the Scopinaro procedure) BPB

The BPB procedure, developed and used extensively in Italy, was designed to address some of the drawbacks of the original intestinal bypass procedures that have been abandoned, due to unacceptable metabolic complications. Many of the complications were thought to be related to bacterial overgrowth and toxin production in the bypassed segment of the intestine. In contrast, BPB consists of a subtotal gastrectomy and diversion of the biliopancreatic juices into the small intestine by a long Roux-en-Y procedure. This results in a 200 cm long alimentary tract and a 300 to 400 cm biliary tract. After these two tracts are joined at the distal anastomosis, there is only a 50 cm common absorptive alimentary tract. Because of the high incidence of gallstones associated with the procedure, subjects typically have their gallbladders removed at the same time as the surgery. There are many potential complications related to BPB, including iron deficiency anemia, protein malnutrition, hypocalcemia, and bone demineralization. Protein malnutrition may require treatment with total parental nutrition. In addition, there have been several case reports of liver failure resulting in death or requiring liver transplant.

2.   Biliopancreatic Bypass with Duodenal Switch (BPD/DS)

The duodenal switch procedure is essentially a variant of the biliopancreatic bypass described above. However, instead of performing a distal gastrectomy, a "sleeve" gastrectomy (SG) is performed along the vertical axis of the stomach, preserving the pylorus and initial segment of the duodenum, which is then anastomosed to a segment of the ileum to create the alimentary limb. Preservation of the pyloric sphincter is designed to be more physiologic. The SG decreases the volume of the stomach and also decreases the parietal cell mass, with the intent of decreasing the incidence of ulcers at the duodenoileal anastomosis. The basic principle of this procedure is similar to that of the BPB, which promotes weight loss by producing selective malabsorption by limiting the food digestion and absorption to a short common ileal segment. The potential for metabolic complications still exist with this procedure; however, this potential is not as great as with BPB. Individuals undergoing the duodenal switch procedure require long-term medical follow-up and regular monitoring of fat soluble vitamins, vitamin B-12, iron and calcium. There is some disagreement among surgeons about how long to make the alimentary and common channels. In some series, the common channel was created to be 100 cm for all subjects. In another series that obtained good results, the small bowel segments varied according to the original length of the bowel. In that series, the alimentary limb segment (excluding the common channel) is about 40% of the total length of the small bowel, with the common limb being about 10% of the length of the total original small bowel length in increments of 25 cm. The common limb, therefore, is usually 50 cm, 75 cm, or 100 cm long depending on the individual. The important consideration is to make the channels long enough to prevent malnutrition and short enough to result in effective EWL.

3.   Long Limb Gastric Bypass (i.e., greater than150 cm)

Recent variations of gastric bypass procedures have been described, primarily consisting of long limb Roux-en-Y procedures.  The stomach may be bypassed in a variety of ways, i.e. either by resection or stapling along the horizontal or vertical axis.  Unlike the traditional gastric bypass, which is essentially a gastric restrictive procedure, these very long limb RYGB procedures function essentially as a malabsorptive procedure, more similar in concept to the BPB.  In the BPB, the ileum is used as the alimentary limb, while in long limb gastric bypass, the jejunum functions as the alimentary limb.  The long limb gastric bypass is designed to reduce the incidence of metabolic complications, but the potential complications are similar to those of the BPB.

Operator Dependence in the Safety and Efficacy of Bariatric Procedures

Furthermore, strong evidence from a number of reports and case series exists for "operator dependence" in determining the risks and benefits of any bariatric procedure. It is important that the surgeon be extensively trained in the respective procedure and that the initial surgeries are supervised by an experienced bariatric surgeon until the "learning curve" is passed.  It is also important that these surgeries be performed in facilities that are appropriately qualified to support peri-operative and post-op services by an appropriately trained, multi-disciplinary team to ensure maximal success. 

Body mass index (BMI):  The key index for relating body weight to height.  The BMI is a person's weight in kilograms (kg) divided by their height in meters (m) squared.  (See the definition below for obesity for further information.)

Excess body weight:  This term refers to the difference between an individual's actual (measured) and ideal body weight.  Ideal body weight ranges are established based on height, body frame, gender and age; an example is available from the National Heart Lung and Blood Institute [NHLBI] at: http://www.nhlbi.nih.gov/guidelines/obesity/bmi_tbl.htm.)

Gastric balloon (Gastric bubble): This device is inserted into the stomach to reduce the stomach's capacity and produce early satiety.  It is now generally considered obsolete and was originally intended for temporary use as an adjunct to diet and behavior modification to assist with weight loss.

Gastric banding:  This surgical procedure is intended to help a person lose weight.  A band is placed around the upper part of the stomach, creating a small pouch that can hold only a small amount of food.  The narrowed opening between the stomach pouch and the rest of the stomach controls how quickly food passes from the pouch to the lower part of the stomach.  This system helps the person to eat less by limiting the amount of food that can be eaten at one time and increasing the time it takes for food to be digested.

Gastric bypass:  This surgical procedure reduces the stomach capacity and diverts partially digested food from the duodenum to the jejunum (section of the small intestine extending from the duodenum).

Gastroplasty:  A surgical procedure that decreases the size of the stomach.

Laparoscopic gastric plication (laparoscopic greater curvature plication [LGCP]):  This is a gastric restrictive bariatric procedure, which is performed alone or in combination with adjustable gastric banding, where the stomach's volume is reduced by dissecting the greater omentum and short gastric vessels, and the greater curvature is invaginated using multiple rows of non-absorbable sutures performed over a bougie or endoscope to ensure a patent lumen.  This investigational procedure is proposed as a minimally invasive surgical alternative to conventional bariatric surgical procedures.

Obesity:  The state of being well above one's normal weight which is measured and determined by the Body Mass Index (BMI).  Severe obesity is defined by the National Institutes of Health (NIH) as a BMI of 40 kg/m² or greater, or a BMI of 35 kg/m² or greater along with other medical complications.  The NIH defines obesity as a BMI of greater than or equal to 30 kg/m² and considers a person overweight with a BMI of 25 to 29.9 kg/m^2_. 

Repair:  Refers to a subsequent surgical procedure performed to correct an anatomic complication, and in this document is used to refer to a complication, resulting from a prior gastric bypass or gastric restrictive procedure.

Revision:  Refers to a surgical procedure performed either to anatomically reverse a prior bypass/restrictive procedure or to anatomically convert the organs from a prior bypass/restrictive procedure to another procedure, (e.g., from a prior vertical banded gastroplasty to a conventional Roux-en-Y bypass procedure).

Sleep apnea:  The temporary stoppage of breathing during sleep, often resulting in daytime sleepiness.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  A draft of future ICD-10 Coding (effective 10/01/2014) related to this document, as it might look today, is included below for your reference.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services may also be Medically Necessary when criteria are met:

When services are Not Medically Necessary or Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met, for the following diagnoses, or when the code describes a procedure indicated in the Position Statement section as not medically necessary or investigational and not medically necessary.

When services are Investigational and Not Medically Necessary:

When services are also Investigational and Not Medically Necessary:

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Government Agency, Medical Society, and Other Authoritative Publications:

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41. U.S. Food and Drug Administration 510(k) Premarket Notification Database.  LapBand^® Adjustable Gastric Banding (LAGB^®₎ System. Summary of Safety and Effectiveness. No. P000008. Rockville, MD:FDA. June 5, 2001.  Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm088965.htm.  Accessed on September 28, 2012.
42. U.S. Food and Drug Administration 510(k) Premarket Notification Database.  LapBand^® Adjustable Gastric Banding (LAGB) System.  Summary of Safety and Effectiveness and labeling information.  No. P000008/S017.  Rockville, MD:FDA.  February 16, 2011.  Available at:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p000008s017.  Accessed on September 28, 2012.
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1. American College of Surgeons. Available at:  http://www.facs.org/public_info/ppserv.html.  Accessed on September 28, 2012.
2. American Society for Bariatric Surgery. Guidelines on Bariatric Surgery.  Available at: http://www.lapsurgery.com/BARIATRIC%20SURGERY/ASBS.htm.  Accessed on September.
3. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH).  Longitudinal Assessment of Bariatric Surgery (LABS).  Available at:  www.niddklabs.org.  Accessed on September 28, 2012.
4. The Obesity Society.  Available at:  http://www.obesity.org/.  Accessed on September 28, 2012.

Adjustable Gastric Banding
Adjustable Silicone Gastric Banding
Bariatric Surgery
Biliopancreatic Bypass, with Duodenal Switch
Clinically Severe Obesity
Duodenal Switch Procedure
Gastric Banding
Gastric Bypass
Gastric Restrictive Procedures
Gastric Stapling
Jejunoileal Bypass
Lap-Band^®
Laparoscopic gastric plication
Laparoscopic greater curvature plication [LGCP]
Long Limb Gastric Bypass
Malabsorptive Procedures
Mini-Gastric Bypass
Morbid Obesity, Surgical Treatment of
REALIZE^™ Adjustable Gastric Band
Scopinaro Procedure
Sleeve Gastrectomy
Stomach Stapling
StomaphyX^™
Swedish Adjustable Gastric Band
Vertical Banded Gastroplasty

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.