The Lap-Band® System is indicated for use in weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 35 or a BMI of at least 30 with one or more severe comorbid conditions, or those who are 100 pounds or more over their estimated ideal weight according to the 1983 Metropolitan Life Insurance Tables (use the midpoint for medium frame). It is indicated for use only in severely obese patients 14 years and older 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.
Weight loss associated with the Lap-Band® System has been shown to improve or lead to remission of type 2 diabetes in patients with BMI greater than or equal to 35.
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
U.S. 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 surgeon 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 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.
|Abscess||Collection of puss surrounded by inflamed tissue|
|Adhesion||Steady or firm attachment|
|Anemia||Condition in which the blood is deficient in red blood cells|
|Aneurism||Abnormal blood-filled bulge of a blood vessel|
|Asthenia||Loss of strength|
|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|
|Cellulitis||Inflammation of connective tissue|
|Cholecystectomy||Removal of the gallbladder.|
|Cholecystitis||Inflammation of the gallbladder|
|Cirrhosis||A chronic disease of the liver characterized by the replacement of normal tissue with scar tissue and the loss of functional liver cells.|
|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.|
|Eructation||The act of belching (gas expelled suddenly from stomach through the mouth)|
|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|
|Fistula||An abnormal passage that leads from an abscess to the body surface|
|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|
|Hematemesis||Vomiting of blood|
|Hematoma||A mass of usually clotted blood that forms in a tissue, organ, or body space as a result of a broken blood vessel|
|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|
|Hypodermic||Relating to part beneath the skin|
|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|
|Malnutrition||Inadequate intake of nutrients|
|Myocardial Infraction||heart attack|
|Necrosis||Localized death of living tissue|
|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|
|Stoma||Artificial opening made in surgical procedures|
|Sutured||Sewn in with at thread|
|Thrombosis||Presence of a blood cloth within a blood vessel|
|Trocar||A surgical instrument with a three-sided cutting point enclosed in a tube. Trocars are placed through the abdomen during laparoscopic surgery.|