Device labeling: precautions: it is the responsibility of the surgeon to advise the patient of the dietary restrictions that follow this procedure and to provide diet and behavior modification support.Failure to adhere to the dietary restrictions may result in obstruction and/or failure to lose weight.Over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.Adverse events: 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.Slippage and/or pouch dilatation of the band can occur.Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be in some cases successfully resolved by band deflation.More serious slippages may require band repositioning and/or removal.If there is total stoma outlet obstruction that does not respond to band deflation, or if there is abdominal pain, then immediate re-operation to remove the band is indicated.Warnings: patients should be advised that the lap-band ap® system is a long-term implant.Explant and replacement surgery may be indicated at any time.Medical management of adverse reactions may include explantation.Revision surgery for explantation and replacement may also be indicated to achieve patient satisfaction.
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Per sus voluntary event report, band slipped in 2013 although, the surgeons states this should have been nearly impossible.Per report, issue caused severe malnutrition and weight loss of approximately 100 pounds in a one year period - patient had to have surgery to unhook band, surgery was not covered by insurance.
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