THE LAP –BAND RISK AND COMPLICATIONS.
Risks, complications, and adverse events you need to know about
All surgical procedures have risks. When you decide on a procedure, you should know what the risks are. Talk with your surgeon in detail about all the risks and complications that might arise. Then you will have the information you need to make a decision.
What are the general risks?
Using the LAP-BAND System includes the same risks that come with all major surgeries. There are also added risks in any operation for patients who are seriously overweight. You should know that death is one of the risks. It can occur any time during the operation. It can also occur as a result of the operation. Death can occur despite all the precautions that are taken. There is a risk of gastric perforation (a tear in the stomach wall) during or after the procedure that might lead to the need for another surgery. In the U.S. clinical study this happened in 1% of the patients. There were no deaths during or immediately after surgery in the U.S. study. Your age can increase your risk from surgery. So can excess weight. Certain diseases, whether they were caused by obesity or not, can increase your risk from surgery. There are also risks that come with the medications and the methods used in the surgical procedure. You also have risks that come from how your body responds to any foreign object implanted in it.
Published results from past surgeries, however, do show that LAP-BAND System surgery may have fewer risks than other surgical treatments for obesity.
Patients can experience complications after surgery. Most complications are not serious but some may require hospitalization and/or re-operation.
In the United States clinical study, with 3-year follow-up reported, 88% of the 299 patients had one or more adverse events, ranging from mild, moderate, to severe.
Nausea and vomiting (51%), gastroesophageal reflux (regurgitation) (34%), band slippage/pouch dilatation (24%) and stoma obstruction (stomachband outlet blockage) (14%) were the most common post-operative complications.
In the study, 25% of the patients had their band systems removed, two-thirds of which were following adverse events. Esophageal dilatation or dysmotility (poor esophageal function) occured in 11% of patients, the long-term effects of which are currently unknown. Constipation, diarrhea and dysphagia (difficulty swallowing) occurred in 9% of the patients. In 9% of the patients, a second surgery was needed to fix a problem with the band or initial surgery. In 9% of the patients, there wasan additional procedure to fix a leaking or twisted access port. The access portdesign has been improved. Four out of 299 patients (1.3%) had their bands erode into their stomachs. These bands needed to be removed in a second operation. Surgical techniques have evolved to reduce slippage. Surgeons with more laparoscopic experience and more experience with these procedures report fewer complications. Adverse events that were considered to be non-serious, and which occurred in less than 1% of the patients, included: esophagitis (inflammation of the esophagus), gastritis (inflammation of the stomach), hiatal hernia (some stomach above the diaphragm), pancreatitis (inflammation of the pancreas), abdominal pain, hernia, incisional hernia, infection, redundant skin, dehydration, diarrhea (frequent semi-solid bowel ovements), abnormal stools, constipation, flatulence 7 (gas), dyspepsia (upset stomach), eructation (belching), cardiospasm (an obstruction of passage of food through the bottom of the esophagus), hematemsis (vomiting of blood), asthenia (fatigue), fever, chest pain, incision pain, contact dermatitis (rash), abnormal healing, edema (swelling), paresthesia (abnormal sensation of burning, prickly, or tingling), dysmenorrhea (difficult periods), hypochromic anemia (low oxygen carrying part of blood), band system leak, cholecystitis (gallstones), esophageal ulcer (sore), port displacement, port site pain, spleen injury, and wound infection. Be sure to ask your surgeon about these possible complications and any of these medical terms that you don't understand.
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