Medwatch sent to the fda 09/21/2016.This complaint was reported by the patient.Further information regarding the event description, dates of diagnostic testing, patient information, and device information has been requested of the patient's physician.To date, apollo has been unable to confirm the events with the physician or received additional information.Device labeling addresses the events as follows: adverse event: 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.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.Warnings: patients should be advised that the lap-band system is a long-term implant.Explant (removal) 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.The manufacturer of the lap-band ap adjustable gastric banding system has designed, tested and manufactured it to be reasonably fit for its intended use.However, the lap-band ap system is not a lifetime product and it may break or fail, in whole or in part, at any time after implantation and notwithstanding the absence of any defect.Causes of partial or complete failure include, without limitation, expected or unexpected bodily reactions to the presence and position of the implanted device, rare or atypical medical complications, component failure and normal wear and tear.In addition, the lap-band ap system may be easily damaged by improper handling or use.
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Reported as: a patient with the lap-band system was reported to occasionally vomit when eating bread too fast.Patient had a stroke a couple of months ago.Patient "has never had any real complications or problems," however, patient "wants her band to work, and the physician simply said "it has to come out." patient lost about (b)(6) pounds and has regained about (b)(6).The device has been explanted.
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