Unknown taper.Medwatch sent to the fda on 09/oct/2018.The reporter of the event was asked if the product was available for analysis and to provide device information.To date, apollo has not been able to confirm device information from the reporter and the device manufacturer is unknown.Further information has been requested of the reporter regarding: implant date, explant date, date of occurrence, and additional patient information.To date, no additional information has been received by apollo.A review of the labeling notes the following: 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.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 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.
|
Literature review performed: "gastric band tubing-related complication during pregnancy." yuni f.Ongso* and han n.Beh; journal of surgical case reports, 2017; 11, 1-2.Case report: patient was at six weeks gestation and was "admitted with 3 days of severe colicky periumbilical abdominal pain.This was associated with nausea." abdominal examination revealed tender periumbilical area without peritonism.During laparoscopy, it was found that the middle part of the tubing was wrapped around a loop of small bowel, creating an adhesion band around the bowel.The tubing and the band were removed.The patient recovered well from the procedure and was discharged following a normal ultrasound confirming viable pregnancy.Although the manufacturer of the device is unknown, it is apollo's approach to compliance to resolve all doubt in favor of reporting.
|