The LAP-BAND AP® Adjustable Gastric Banding System is designed to induce weight loss in severely obese patients by limiting food consumption. The band’s slip-through buckle design makes laparoscopic placement around the stomach easier, allowing the formation of a small gastric pouch and stoma. No cutting or stapling of the stomach is required, and there is no bypassing of portions of the stomach or intestines.
The LAP-BAND AP® Adjustable Gastric Banding System with OMNIFORM™ Design is the latest advance in laparoscopic adjustable gastric banding for the treatment of morbid obesity. The initial pouch and stoma sizes are established through the use of the calibration tube. The inner surface of the band is inflatable and connected by kink-resistant tubing to the Access Port, which is included in the LAP-BAND AP® System. This permits post-operative percutaneous, stoma size adjustment. Dietary and behavior modification counseling and frequent, long-term follow-up are required for all patients after weight- loss surgery.
Surgeons planning laparoscopic placement must have extensive advanced laparoscopic experience, i.e., fundoplications as well as previous experience in treating obese patients, and have the staff and commitment to comply with the long-term follow-up requirements of obesity procedures. They should comply with the American Society for Metabolic & Bariatric Surgeons (ASMBS) and the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) joint “Guidelines for Surgical Treatment of Morbid Obesity” and the SAGES “Guidelines for Framework for Post-Residency Surgical Education and Training”. Surgeon participation in a training program authorized by ReShape Lifesciences, Inc. or by an authorized ReShape Lifesciences, Inc. distributor is required prior to use of the LAP-BAND AP® System. Please see the last page for directions on obtaining additional information.
During the surgical procedure, the inflatable band is flushed with sterile saline. The band is placed around the stomach and inflated with sterile saline to create the proper stoma diameter and pouch size using the calibration tube. The tubing is connected to the Access Port placed on the rectus muscle or fixed in an accessible subcutaneous space. Arrows pointing in the direction of the Access Port are printed on the tubing. These arrows assist the surgeon in identifying the correct tubing orientation. The tubing may be shortened to tailor the position of the port to the patient. The two components (tubing and Access Port) are joined with the stainless steel tubing connector. Ligatures may be placed on both tubing ends over the connector. The Access Port may then be secured in place utilizing the suture holes in the port base, stainless steel anchors using the RapidPort® EZ Applier Tool, or other fixation methods. Postoperatively, the surgeon may adjust the stoma size percutaneously by injecting or aspirating saline with the Access Port needle.
Please refer to the Surgical Procedure section for more information.
The LAP-BAND® System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI 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.
The LAP-BAND AP® System is contraindicated in:
It is important to discuss all possible complications and adverse events with your patient. Complications which may result from the use of this product include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the patient’s degree of intolerance to any foreign object implanted in the body.
Perforation of the stomach can occur. Death can also occur. Specific complications of laparoscopic surgery can include spleen damage (sometimes requiring splenectomy) or liver damage, bleeding from major blood vessels, lung problems, thrombosis, and rupture of the wound.
Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.
Band slippage and/or pouch dilatation can occur. Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be successfully resolved by band deflation in some cases. More serious slippages may require surgery to reposition and/or remove the band. Immediate reoperation to remove the band is indicated if there is total stoma outlet obstruction that does not respond to band deflation or if there is abdominal pain.
Gastric banding done as a revision procedure has a greater risk of complications. Prior abdominal surgery is commonly associated with adhesions involving the stomach. In the US pivotal study of severely obese adults, 42% of the subjects undergoing revision surgery were reported to have adhesions involving the stomach. Care and time must be taken to adequately release the adhesions to provide access, exposure and mobilization of the stomach for a revision procedure.
There is a risk of band erosion into stomach tissue. Erosion of the band into stomach tissue has been associated with revision surgery after the use of gastric-irritating medications, after stomach damage and after extensive dissection or use of electrocautery, and during early experience. Symptoms of band erosion may include reduced weight loss, weight gain, Access Port infection, or abdominal pain. Reoperation to remove the device is required.
Reoperation for band erosions may result in a gastrectomy of the affected area. Eroded bands have been removed gastroscopically in a very few cases. Consultation with other experienced LAP-BAND® System surgeons is strongly advised in these cases.
Esophageal distension or dilatation has been infrequently reported. This is most likely a consequence of incorrect band placement, over-restriction or stoma obstruction. It can also be due to excessive vomiting or patient noncompliance, and may be more likely in cases of pre-existing esophageal dysmotility. Deflation of the band is recommended if esophageal dilatation develops. A revision procedure may be necessary to reposition or remove the band if deflation does not resolve the dilatation.
Obstruction of stomas has been reported as both an early and a late complication of this procedure. This can be caused by edema, food, improper initial calibration, band slippage, pouch torsion, or patient non-compliance regarding choice and chewing of food.
Infection can occur in the immediate post-operative period or years after insertion of the device. In the presence of infection or contamination, removal of the device is indicated.
Unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.
Nausea and vomiting may occur, particularly in the first few days after surgery and when the patient eats more than recommended. Nausea and vomiting may also be symptoms of stoma obstruction or a band/stomach slippage. Frequent, severe vomiting can result in pouch dilatation, stomach slippage or esophageal dilatation. Deflation of the band is immediately indicated in all of these situations. Deflation of the band may alleviate excessively rapid weight loss and nausea and vomiting. Reoperation to reposition or remove the device may be required.
Rapid weight loss may result in symptoms of malnutrition, anemia and related complications (i.e., polyneuropathies). Deflation of the band may alleviate excessively rapid weight loss.
Rapid weight loss may result in development of cholelithiasis which may require cholecystectomy.
Table 1 summarizes serious adverse events (SAEs) that were reported to have occurred during the 3-year US pivotal clinical trial in severely obese adults, initiated in 1995. A total of 299 subjects were studied with a total of 633 subject years.
|TABLE 1: SERIOUS ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND® SYSTEM FOR THE US PIVOTAL STUDY IN SEVERELY OBESE ADULTS|
|Adverse Event||% of 299 subjects|
|Band Slippage, Pouch Dilation||11|
|Nausea and/or Vomiting||2|
|Delayed Esophageal Emptying||1|
|Improper Band Placement||1|
There were additional occurrences of these events that were considered to be non-serious.
Table 2 shows occurrences of all adverse events reported at a rate of 5% or more.
|TABLE 2: ALL ADVERSE EVENTS THAT OCCURRED AT A RATE OF 5% OR MORE FOR THE US PI VOTAL STUDY IN SEVERELY OBESE ADULTS|
|ADVERSE EVENT||# of subjects||% of 299 subjects|
|Nausea and/or Vomiting||152||51|
|BODY AS A WHOLE|
|Band Slippage/ Pouch Dilation||72||24|
|METABOLIC AND NUTRITIONAL|
|Port Site Pain||26||9|
|SKIN AND APPENDAGES|
Other adverse events considered related to the LAP-BAND® System that occurred in fewer than 1% of subjects included: esophagitis, gastritis, hiatal hernia, pancreatitis, abdominal pain, hernia, incisional infection, infection, redundant skin, dehydration, GI perforation, diarrhea, abnormal stools, constipation, flatulence, dyspepsia, eructation, cardiospasm, hematemesis, asthenia, fever, chest pain, incision pain, contact dermatitis, abnormal healing, edema, paresthesia, dysmenorrhea, hypochromic anemia, band leak, cholecystitis, esophageal dysmotility, esophageal ulcer, esophagitis, port displacement, port site pain, spleen injury, and wound infection.
Twenty-six subjects (9%, 26/299) had a total of 27 reoperations. Thirteen of these 27 (48%) revision procedures were completed laparoscopically. In 9 of the 27 procedures (33%), the band was removed and replaced with a new band in the same procedure. These were due to: 3 initially incorrect placements, 5 stoma obstructions or band slippage/pouch dilatation, and 1 band system leakage. Two subjects had new band replacements at separate interventions. Sixteen of 27 revision procedures (59%) did not require removal of bands. All of these revisions were performed to correct band slippage/pouch dilatation. Six of these (37.5%) were completed laparoscopically. There were no deaths associated with LAP-BAND® System revisions.
Seventy-five subjects had their entire LAP-BAND® Systems explanted. Fifty-one of the 75 explants (68%, 51/75) were counter measures to adverse events. Band slippage/pouch dilatation and/or stoma obstruction was the most common adverse event associated with these explants (32%, 24/75). Other events associated with these explants were erosion (5%, 4/75), infection (4%, 3/75), GI disorders such as gastroesophageal reflux and/or dysphagia (11%, 8/75),
LAP-BAND® System leak (4%, 3/75); one needle damage to shell and 2 access port tubing leaks, esophageal disorders, such as dilatation and delayed emptying (7%, 5/75); gastric perforation (3%. 2/75); one abdominal pain; and one respiratory disorder. Insufficient weight loss was also reported as a contributor to the decision to explant in 24 of the 75 explants (32%, 24/75). Data from a post-approval study showed an estimated explant rate of 6.5% per year over the first five years following implantation.
One-year data are available for 149 obese subjects with BMI ≥30 and <40 who underwent LAP-BAND® System placement surgery in a Lower BMI study, initiated in 2007. This study will continue to follow subjects for an additional 4 years (5 years in total). The following table summarizes the SAEs that were reported to have occurred in the US Lower BMI clinical trial.
|TABLE 3: SERIOUS ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND® SYSTEM FOR THE US LOWER BMI STUDY|
|ADVERSE EVENT||# of subjects||% of 149 subjects|
|Medical Device Complication (Band Erosion)||1||0.7|
|Gastric Outlet Obstruction||1||0.7|
These seven device-related SAEs occurred in three subjects (2%, 3/149). They were hospitalized for 7 days or less and discharged following band removal. There were no deaths in the Lower BMI Study.
|TABLE 4. DEVICE-RELATED ADVERSE EVENTS THAT OCCURRED IN ≥2% OF SUBJECTS IN THE US LOWER BMI STUDY|
|N||(%)a||N||(%)b||n (%)||n (%)||n (%)|
|Vomiting||43||(28.9%)||43||(20.0%)||29 (67.4%)||13 (30.2%)||1 (2.3%)|
|Dysphagia||33||(22.1%)||33||(15.3%)||20 (60.6%)||12 (36.4%)||1 (3.0%)|
|Post procedural pain||28||(18.8%)||28||(13.0%)||1 (3.6%)||27 (96.4%)||0 (0.0%)|
|Gastroesophageal reflux disease||22||(14.8%)||22||(10.2%)||15 (68.2%)||7 (31.8%)||0 (0.0%)|
|Abdominal pain||8||(5.4%)||8||(3.7%)||2 (25.0%)||6 (75.0%)||0 (0.0%)|
|Nausea||8||(5.4%)||8||(3.7%)||5 (62.5%)||3 (37.5%)||0 (0.0%)|
|Dyspepsia||7||(4.7%)||7||(3.3%)||4 (57.1%)||3 (42.9%)||0 (0.0%)|
|Implant Site Pain||7||(4.7%)||7||(3.3%)||6 (85.7%)||1 (14.3%)||0 (0.0%)|
|Abdominal pain upper||4||(2.7%)||4||(1.9%)||3 (75.0%)||1 (25.0%)||0 (0.0%)|
|Constipation||4||(2.7%)||4||(1.9%)||3 (75.0%)||1 (25.0%)||0 (0.0%)|
|Medical device complicationc||4||(2.7%)||4||(1.9%)||2 (50.0%)||1 (25.0%)||1 (25.0%)|
|Dehydration||3||(2.0%)||3||(1.4%)||1 (33.3%)||2 (66.7%)||0 (0.0%)|
|Device malfunctioned||3||(2.0%)||3||(1.4%)||0 (0.0%)||2 (66.7%)||1 (33.3%)|
|Shoulder pain||3||(2.0%)||3||(1.4%)||1 (33.3%)||2 (66.7%)||0 (0.0%)|
a Percentage is based on 149 subjects
b Percentage is based on 215 device-related adverse events
c Complications included band erosion, tubing palpated in umbilical hernia, and band slippage
d Malfunctions included partial slip, flipped port, and band slippage.
Other adverse events considered related to the LAP-BAND® System that occurred in fewer than 2% of study patients included: diarrhea (n=2), gastric pouch dilatation (n=2), gastritis (n=2), esophageal dilatation (n=2), syncope (n=2), seroma (n=2). Other events reported to occur in only one patient per event included; abdominal discomfort, alopecia, anemia, arthralgia, decrease blood folate, flatulence, gastrointestinal motility disorder, bronchitis, chills, implant site infection, implant site irritation, implant site hemorrhage, night sweats, hypotrichosis, headache, nail infection, pyrexia, skin irritation, esophageal obstruction, esophageal spasm, postoperative infection, urinary tract infection, muscle spasms, depression, back pain, and hypertension.
Seven subjects (4.6%, 7/149) each required one reoperation, and there were no intraoperative complications. Four of these (57.1%, 4/7) were LAP-BAND® System explantations due to dysphagia (in 2 subjects), erosion of the band, or abdominal pain. Two reoperations were access port revisions due to port flip or port site pain; the original ports were retained. One reoperation was for repositioning of the original band to correct for band slippage.
Global product experience obtained through complaint and adverse event reporting during the course of real-world clinical use provides valuable insight into the safety profile of the LAP-BAND device. As of July 31, 2017 more than 1,048,000 devices have been distributed to countries with LAP-BAND approval. No regulatory approvals have been revoked or withdrawn. The ReShape Lifesciences, Inc. complaint database houses vigilance reports for adverse events submitted to various competent authorities by mandatory reporters (manufacturers, importers, and device user facilities) and voluntary reporters such as healthcare professionals and patients. Device- and procedure-related adverse events or complaints reported through clinical product surveillance and literature reviews are contained within this data. A total of 10,970 complaints spanning a period from January 1, 2008 to July 31, 2017 are presented in Table 5; however, this data has not been scientifically validated and may include duplication of some events due to multiple sources of data collection. Some events have not been directly attributed to LAP-BAND®.
|Table 5. LAP-BAND® device- and procedure- related adverse events and complaints reported through clinical product surveillance1 between January 1, 2008 and July 31, 2017.|
|Aneurism (Band Aneurism)||37||0.004%|
|Band Restriction Issue||54||0.005%|
|Broken / Damaged / Defective Component||3||0.000%|
|Buckle Disengagement / Band Disengagement||43||0.004%|
|Connective Tissue / Autoimmune Disorders||7||0.001%|
|Damaged Port Tubing||1||0.000%|
|Device Appearance – Post Operative||3||0.000%|
|Difficulty Adding/Removing Saline||95||0.009%|
|Displacement / Port Displacement||249||0.024%|
|End User Error||2||0.000%|
|Fold In Tubing||23||0.002%|
|Leak(s) or Leakage – Band, Port, Port Base, Port Tubing, Port Septum and Access Port Leakages4||3,887||0.371%|
|Port Tubing Disconnection / Disengagement||10||0.001%|
|Product Material Anxiety||1||0.000%|
|Stomach Perforation / Erosion||59||0.006%|
|Surgery Related Observation / Complication||140||0.013%|
|Symptoms of Autoimmune / Connective Tissue Disorders||3||0.000%|
|Unsatisfactory Weight Loss||320||0.031%|
|Vessel Damage / Bleeding||4||0.000%|
The LAP-BAND® System is indicated for use only in 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.
The effects of the LAP-BAND® System have been studied in severely obese subjects (BMI ≥ 40 or those who are 100 lbs. or more over their estimated ideal weight) as well as in mild to moderately obese subjects (BMI ≥30 and <40) in the US, in the pivotal study and Lower BMI study, respectively.
This study evaluated the safety and effectiveness of the device for use in weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 40, or those who are 100 lbs. or more over their estimated ideal weight, as determined using the 1983 Metropolitan Life Insurance Height and Weight Table (using the midpoint for medium frame).
A 3-year, single-arm, multi-center study was initiated in June 1995 with 299 subjects enrolled at 8 centers under the care of 12 surgeons. All procedures were completed utilizing aperigastric dissection technique with pouches of 25 ml or (later in the study) 15 ml, using the 9.75cm (B-2210) and 10.0cm (B-2220) LAP-BAND® Systems. Of the procedures, 259 were completed laparoscopically and 33 via laparotomy, including 13 intraoperative conversions (4.7% conversion rate).
The primary effectiveness measure was the percent Excess Weight Loss (%EWL) at 1, 2, and 3 years following the LAP-BAND® implantation. The secondary effectiveness measures used in the study determined the differences between the weight loss (at years 1, 2 and 3) and the weight loss/gain experienced by the subject in the years(s) prior to the placement of the LAP-BAND® System. In addition, changes in a subject’s quality of life were also determined as part of the secondary effectiveness measure.
The %EWL is defined as weight loss (operative weight minus selected weight) divided by excess weight (operative weight minus ideal weight) multiplied by 100. Study subjects were weighed immediately before surgery, at 3 weeks postoperatively, and then again at regular intervals over the next 3 years (3, 6, 9, 12, 18, 24, 30, and 36 months). The 1983 Metropolitan Life Height and Weight Table was used to determine ideal weight.
The primary safety parameters included incidence and severity of complications. Safety measurements were based on subjects’ reported adverse events before surgery (< 3 weeks) and postoperatively (> 3 weeks), either during scheduled visits or as called to the attention of the study nurse or investigator to report urgent problems. Any noted complications were divided into device-related and non- device-related events.
A total of 299 subjects participated in the U.S. study, with 85% of participants being female and 15% being male. Distribution by race was 81% Caucasian, 15% African-American and 4% Hispanic. The average age at which subjects became obese was 18.4 and the average age at the time of surgery was 38.8 years.
The mean weight at entry into the trial was 293 pounds, with mean excess weight of 156 pounds and mean BMI of 47.4. Thirty percent (30%) of subjects had BMI ≥ 50 and were classified as “superobese.” During the five years prior to surgery, subjects on average gained 54 pounds, with the average BMI increasing from 39 to 47.4. These subjects had significant comorbidities which included: hypertension (42%), gallstone/gallbladder disease (25%), gastrointestinal diseases (24%), asthma (16%), non-insulin dependent diabetes (11%), and insulin dependent diabetes (5%).
|Atresia||The absence, or the closure, of an opening, passage, or cavity.|
|Barrett’s esophagus||A condition in which the cells lining the lower part of the esophagus have changed or been replaced with abnormal cells that could lead to cancer of the esophagus.|
|Cardiopulmonary||Heart and lungs|
|Cirrhosis||A chronic disease of the liver characterized by the replacement of normal tissue with scar tissue and the loss of functional liver cells.|
|Cholecystectomy||Removal of the gallbladder.|
|Contraindicated||A treatment, procedure, or activity should not be done or used in this situation for medical reasons.|
|Crohn’s disease||A chronic inflammatory disease, primarily involving the small and large intestine, but which can affect other parts of the digestive system as well. It can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition.|
|Dysphagia||Difficulty or discomfort in swallowing.|
|Duodenal ulceration||Irritation/injury of the inside wall of the small intestine|
|Dysmotility||Diseases of the muscles of the gastrointestinal tract (esophagus, stomach, small and large intestines) in which the muscles do not work normally.|
|Esophageal Varices||Swollen veins in the lower esophagus.|
|Esophagitis||Inflammation of the upper part of the intestine connecting mouth to stomach|
|Explantation||Taking out of the body|
|Fundoplication||Surgical operation of wrapping part of the fundus of the stomach around the base of the esophagus|
|Gastric ulceration||Irritation/injury of the inside wall of the stomach|
|Gastric varices||Swollen veins in the stomach|
|Gastrointestinal tract||Both stomach and intestine|
|Hernia||A general term used to describe a bulge or protrusion of an organ through the structure or muscle that usually contains it.|
|Hypertension||Abnormally high blood pressure|
|Intestine||A long, continuous tube running from the stomach to the anus. Most absorption of nutrients and water happen in the intestines. The intestines include the small intestine, large intestine, and rectum|
|Laparotomy||Surgical incision of the abdominal wall|
|Lupus erythematosus||Skin inflammation|
|Pancreatitis||Inflammation of the pancreas|
|Percutaneous||Through the skin|
|Polyneuropathies||A condition in which a person’s nerves that run throughout your body are damaged. It affects the nerves in your skin, muscles, and organs. When nerves are damaged, they can’t send regular signals back to your brain.|
|Reflux||Flow back or return. Gastroesophageal reflux is when what’s in your stomach backs up into your esophagus.|
|Revision procedure||Revision weight loss surgery is a surgical procedure that is performed on patients who have already undergone a form of bariatric surgery, and have either had complications from such surgery or have not achieved significant weight loss results from the initial surgery.|
|Splenectomy||Removal of the spleen|
|Stenoses||Narrowing of the diameter of the GI track|
|Sutured||Sewn in with at thread|
|Trocar||A surgical instrument with a three-sided cutting point enclosed in a tube. Trocars are placed through the abdomen during laparoscopic surgery.|