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LAP-BAND® Adjustable Gastric Banding System with the Access Port II

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LAP-BAND® Adjustable Gastric Banding System with the Access Port II LAP-BAND® Adjustable Gastric Banding System with the Access Port II Directions For Use (DFU) A detailed booklet called “A surgical Aid in the treatment of Morbid obesity” is available from Allergan. this booklet should be provided to all patients considering LAP-BAnD® system surgery. the booklet includes a patient acknowledgment/consent form which should be completed prior to surgery. Description .................................................................................................. 1 intended Use / indications ........................................................................ 1 contraindications ...................................................................................... 1 Warnings ..................................................................................................... 1 Precautions ................................................................................................. 2 Adverse events .......................................................................................... 3 clinical experience .................................................................................... 5 individualization of treatment ................................................................. 7 Patient counseling information ............................................................... 7 operator’s Manual ..................................................................................... 9 LAP-BAnD® system 9.75/10.0 Preparation ............................................. 9 LAP-BAnD® VG system Preparation ..................................................... 10 LAP-BAnD® system surgical Procedure .............................................. 10 instructions for Use: Band Adjustment ................................................. 12 How supplied ........................................................................................... 14 Authorized training Program and Product ordering information ........................................................ 14 DESCRIPTION weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs. Cat. No. B-2215 Patients who elect to have this surgery must make LAP-BAND® System 9.75 with Access Port II the commitment to accept significant changes in their eating habits for the rest of their lives. Cat. No. B-2225 LAP-BAND® System 10.0 with Access Port II CONTRAINDICATIONS the LAP-BAnD® system is contraindicated in: Cat. No. B-2255 LAP-BAND® VG System with Access Port II 1. Patients with inflammatory diseases of the gastrointestinal tract, including severe intractable the LAP-BAnD® Adjustable Gastric Banding system esophagitis, gastric ulceration, duodenal is designed to induce weight loss in severely obese ulceration, or specific inflammation such as patients by limiting food consumption. the band’s crohn’s disease slip-through buckle design eases laparoscopic placement around the stomach, allowing the 2. Patients with severe cardiopulmonary diseases or formation of a small gastric pouch and stoma. no other serious organic disease which may make cutting or stapling of the stomach is required, and them poor surgical candidates there is no bypassing of portions of the stomach 3. Patients with potential upper gastro-intestinal or intestines. bleeding conditions such as esophageal or the LAP-BAnD® VG system is constructed with gastric varices or congenital or acquired intestinal OmniForM® technology, which employs soft, pre- telangiectases curved sections in the inflation area. the initial 4. Patients with portal hypertension pouch and stoma sizes are established through the use of the calibration tube. the inner surface of the 5. Patients with congenital or acquired anomalies of band is inflatable and connected by kink-resistant the Gi tract such as atresias or stenoses tubing to the Access Port, which is included in the 6. Patients who have/experience an intra-operative ® LAP-BAnD system. this enables post-operative gastric injury during the implantation procedure, percutaneous stoma size adjustment. Dietary and such as a gastric perforation at or near the behavior modification counseling and frequent and location of the intended band placement long-term follow-up are required for all patients after weight-loss surgery. 7. Patients with cirrhosis surgeons planning laparoscopic placement must 8. Patients with chronic pancreatitis have extensive advanced laparoscopic experience, 9. Patients who are addicted to alcohol and/or drugs i.e., fundoplications as well as previous experience in treating obese patients, and have the staff and 10. Non-adult patients (patients under 18 years commitment to comply with the long-term follow-up of age) requirements of obesity procedures. they should 11. Patients who have an infection anywhere in their comply with the American society of Bariatric body or where the possibility of contamination surgeons (AsBs) and the society of American prior to or during the surgery exists Gastrointestinal endoscopic surgeons (sAGes) joint “Guidelines for surgical treatment of Morbid 12. Patients on chronic, long-term steroid treatment obesity” and the sAGes “Guidelines for Framework 13. Patients who are unable or unwilling to comply for Post-residency surgical education and training”. with dietary restrictions, which are required by this procedure Brief Description of Procedure 14. Patients who are known to have, or suspected to During the surgical procedure, the inflatable band have, an allergic reaction to materials contained is flushed with sterile saline. Using the calibration in the system or who have exhibited pain tube, the band is placed around the stomach and intolerance to implanted devices inflated with sterile saline to create the proper stoma diameter and pouch size using the calibration tube. 15. Patients or family members with a known the tubing is connected to the Access Port placed diagnosis or pre-existing symptoms of on or in the rectus muscle or fixed in an accessible autoimmune connective tissue disease such as subcutaneous space. the tubing may be shortened to systemic lupus erythematosus or scleroderma tailor the position of the port to the patient. the two 16. Pregnancy: Placement of the LAP-BAnD® system components are joined with the stainless steel tubing is contraindicated for patients who currently connector. Ligatures may be placed on both tubing are or may be pregnant. Patients who become ends over the connector. the Access Port is then pregnant after band placement may require sutured in place utilizing the suture holes in the port deflation of their bands base. Postoperatively, the surgeon may adjust the stoma size percutaneously by injecting or aspirating saline with the Access Port needle. Please refer to the WARNINGS LAP-BAnD® system surgical Procedure section for CAUTION: Laparoscopic or laparotomic placement of more information. the LAP-BAnD® system is major surgery and death can occur. INTENDED USE / INDICATIONS CAUTION: Failure to secure the band properly the LAP-BAnD® system is indicated for use in weight may result in its subsequent displacement and reduction for severely obese patients with a Body necessitate reoperation. Mass index (BMi) of at least 40 or a BMi of at least CAUTION: A large hiatal hernia may prevent accurate 35 with one or more severe comorbid conditions, or positioning of the device. Placement of the band those who are 100 lbs. or more over their estimated should be considered on a case-by-case basis ideal weight according to the 1983 Metropolitan depending on the severity of the hernia. Life insurance tables (use the midpoint for medium frame). it is indicated for use only in severely obese adult patients who have failed more conservative 1 CAUTION: the band should not be sutured to the during implantation of the device to avoid damage to stomach. suturing the band directly to the stomach may the gastrointestinal tract. Any damage to the stomach result in erosion. during the procedure may result in erosion of the device into the Gi tract. CAUTION: Patients’ emotional and psychological stability should be evaluated prior to surgery. Gastric CAUTION: During insertion of the calibration tube, banding may be determined to be inappropriate, in care must be taken to prevent perforation of the the opinion of the surgeon, for select patients. esophagus or stomach. CAUTION: Patients should be advised that the CAUTION: in revision procedures the existing staple LAP-BAnD® system is a long-term implant. explant line may need to be partially disrupted to avoid and replacement surgery may be indicated at any having a second point of obstruction below the time. Medical management of adverse reactions band. As with any revision procedure, the possibility may include explantation. revision surgery for of complications such as erosion and infection is explantation and replacement may also be indicated increased. Any damage to the stomach during the to achieve patient satisfaction. procedure may result in peritonitis and death, or in late erosion of the device into the Gi tract. CAUTION: esophageal distension or dilatation has been reported to result from stoma obstruction due CAUTION: care must be taken to place the Access to over-restriction due to excessive band inflation. Port in a stable position away from areas that may Patients should not expect to lose weight as fast as be affected by significant weight loss, physical gastric bypass patients, and band inflation should activity, or subsequent surgery. Failure to do so proceed in small increments.
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