Risks and Complications

What are the potential risks and complications of gastric banding surgery?

The REALIZE^™ Adjustable Gastric Band is for adult patients who have morbid obesity or morbid obesity with serious obesity-related conditions and who have failed more conservative weight loss alternatives. The REALIZE^™ Band is not for patients with certain medical conditions that may put them at increased risk during or after surgery, or for patients who are unwilling to make significant changes in eating and behavior patterns. If you have a hiatal hernia, it may need to be repaired before or during gastric banding surgery.

Risks may be associated with any general abdominal surgery. Serious complications related to the gastric band, the injection port, and the tubing include band erosion, band slippage, port displacement, port disconnection and tubing kinking. After gastric banding surgery, if you have abdominal pain that lasts more than 3 hours, you need to contact your surgeon right away. In some instances, reoperations may be necessary.

Other serious and non-serious complications can occur. Death can occur during or soon after any surgery, even when every precaution has been taken. Please speak to your doctor or surgeon to better understand the risks and benefits associated with the REALIZE^™ Band.

More patient information is available in the REALIZE^™ Patient Guide. You can request a free REALIZE^™ Patient Guide by calling 1-855-2-REALIZE (1-855-273-2549).

What are the potential risks and complications of gastric bypass surgery?

As with any surgical procedure, there are potential risks and complications that can occur with gastric bypass. We’re committed to providing you with the information you need to make a wellinformed decision about your surgery. Although these problems rarely occur, we want you to know the facts. Listed below are gastric bypass risks, bariatric surgery risks, and abdominal surgery risks.

Potential concerns and risks of gastric bypass

• A condition known as dumping syndrome can occur from eating high-fat, high-sugar foods. The results can be unpleasant and may include vomiting, nausea, weakness, sweating, faintness, and diarrhea. Some patients actually view this as a positive mechanism that prevents them from reverting back to unhealthy eating habits.
• Patients must supplement their diet with a daily multivitamin and calcium. Some patients must take vitamin B12 and/or iron.
• The stomach, duodenum, and parts of the small intestine cannot be seen easily using X -ray or endoscopy if there are problems after surgery such as ulcers, bleeding, or malignancy.
• Dehiscence (separation of tissue that was stitched or stapled together)
• Leaks from staple lines
• Ulcers
• Increased gas

Bariatric Surgery Risks

• Abdominal hernia
• Chest pain
• Collapsed lung
• Constipation or diarrhea
• Dehydration
• Enlarged heart
• Gallstones, pain from passing a gallstone, inflammation of the gallbladder, or surgery to remove the gallbladder
• Gastrointestinal inflammation or swelling
• Stoma obstruction
• Stretching of the stomach
• Surgical procedure repeated
• Vomiting and nausea

Note: Your weight, age and medical history play a significant role in determining your specific risks. Your surgeon can inform you about your specific weight loss surgery risks.

Risks Associated with Abdominal Surgery

• Bleeding
• Pain
• Shoulder pain
• Pneumonia
• Complications due to anesthesia and medications
• Deep vein thrombosis
• Injury to stomach, esophagus, or surrounding organs
• Infection
• Pulmonary embolism
• Stroke or heart attack
• Death

Note: Risks are associated with any type of surgery, including abdominal surgery. These risks are greater for individuals who suffer from obesity.

Mortality rates

According to the American Society for Metabolic and Bariatric Surgery 2004 Consensus Statement, the gastric bypass complication rate in the hands of a skilled surgeon is roughly 5%, and the operative mortality (death) rate is roughly 0.5%.²¹

Sleeve Gastrectomy Surgery Risks and Complications

As with any surgical procedure, there are potential risks and complications that can occur with sleeve gastrectomy. We’re committed to providing you with the information you need to make a well-informed decision about your surgery. Although these problems rarely occur, we want you to know the facts.

Potential bariatric surgery complications following the procedure²⁸

One or all of the following conditions and bariatric surgery complications are possible following all types of weight loss surgery procedures, as well as for all types of bariatric procedures.

Potentially serious complications

Surgical:

• Perforation of stomach/intestine or leakage, causing peritonitis or abscess
• Internal bleeding requiring transfusion
• Severe wound infection, opening of the wound, incisional hernia
• Spleen injury requiring removal/other organ injury
• Gastric outlet or bowel obstruction

Pulmonary:

• Pneumonia, atelectasis (collapse of lung tissue), fluid in chest
• Respiratory insufficiency, pulmonary edema (fluid in lungs)
• Blood clots in legs/lungs (embolism)

Cardiovascular:

• Myocardial infarction (heart attack), congestive heart failure
• Arrhythmias (irregular heartbeats)
• Stroke (cerebrovascular accident)

Kidney and liver:

• Acute kidney failure
• Liver failure
• Hepatitis (may progress to cirrhosis)

Psychosocial:

• Anorexia nervosa, bulimia
• Postoperative depression, dysfunctional social problems
• Psychosis
• Death

Other complications (may become serious):

• Minor wound or skin infection/scarring, deformity, loose skin
• Urinary tract infection
• Allergic reactions to drugs or medications
• Vomiting or nausea/inability to eat certain foods/improper eating
• Inflammation of the esophagus (esophagitis), acid reflux (heartburn)
• Low sodium, potassium, or blood sugar; low blood pressure
• Problems with the outlet of the stomach (narrowing or stretching)
• Anemia, metabolic deficiency (iron, vitamins, minerals), temporary hair loss
• Constipation, diarrhea, bloating, cramping, malodorous stool or gas
• Development of gallstones or gallbladder disease
• Stomach or outlet ulcers (peptic ulcer)
• Staple-line disruption, weight gain, failure to lose satisfactory weight
• Intolerance to refined sugars (dumping), with nausea, sweating, weakness