LAP-BAND Adjustable Gastric Banding System DFU

damaged, the product may not be sterile and maycause an infection. Do not attempt to clean,re-sterilize or re-use any part of the LAP-BAND Adjustable Gastric Banding System. The product maybe damaged or distorted if re-sterilized.days post-adjustment to deflate the band in case ofan obstruction.CAUTION: It is the responsibility of the surgeon toadvise the patient of the dietary restrictions whichfollow this procedure and to provide diet andbehavior modification support. Failure to adhere tothe dietary restrictions may result in obstruction and/or failure to lose weight.CAUTION: It is important that special care be usedwhen handling the device because contaminants suchas lint, fingerprints and talc may lead to a foreignbody reaction.CAUTION: Patients must be carefully counseled onthe need for proper dietary habits. They should beevaluated for nutritional (including caloric) needs andadvised on the proper diet selection. If necessary toavoid any nutritional deficiencies, the physician maychoose to prescribe appropriate dietary supplements.The appropriate physical monitoring and dietarycounseling should take place regularly.CAUTION: Care must be taken to avoid damaging theband, its inflatable section or tubing, the Access Portor the Calibration Tube. Use only rubber-shod clampsto clamp tubing.CAUTION: The band, Access Port and CalibrationTube may be damaged by sharp objects andmanipulation with instruments. A damaged devicemust not be implanted. For this reason, a stand-bydevice should be available at the time of surgery.CAUTION: Patients must be cautioned to chew theirfood thoroughly. Patients with dentures must becautioned to be particularly careful to cut their foodinto small pieces. Failure to follow these precautionsmay result in vomiting, stomal irritation and edema,possibly even obstruction.CAUTION: Failure to use the tubing end plug duringplacement of the band may result in damage to theband tubing during band placement.CAUTION: Do not push the tip of any instrumentagainst the stomach wall or use excessiveelectrocautery. Stomach perforation or damage mayresult. Stomach perforation may result in peritonitisand death.CAUTION: Patients must be seen regularly duringperiods of rapid weight loss for signs of malnutrition,anemia or other related complications.CAUTION: Anti-inflammatory agents, which mayirritate the stomach, such as aspirin and non-steroidalantiinflammatory drugs, should be used with caution.The use of such medications may be associated with anincreased risk of erosion.CAUTION: Over-dissection of the stomach duringplacement may result in slippage or erosion of theband and require reoperation.CAUTION: Failure to use an appropriate atraumaticinstrument to lock the band may result in damage tothe band or injury to surrounding tissues.CAUTION: Patients who become pregnant or severelyill, or who require more extensive nutrition, mayrequire deflation of their bands.CAUTION: The band is not intended to be openedlaparoscopically with surgical instruments.Unrecognized damage to the band may result insubsequent breakage or failure of the device.CAUTION: All patients should have their reproductiveareas shielded during radiography.CAUTION: Insufficient weight loss may be causedby pouch enlargement or more infrequently banderosion, in which case further inflation of the bandwould not be appropriate.CAUTION: When adjusting band volume take care toensure that the radiographic screen is perpendicularto the needle shaft (the needle will appear as a dot onthe screen). This will facilitate adjustment of needleposition as needed while moving through the tissueto the port.CAUTION: Elevated homocysteine levels have beenfound in patients actively losing weight after obesitysurgery. Supplemental folate and vitamin B12 maybe necessary to maintain normal homocysteinelevels. Elevated homocysteine levels mayincrease cardiovascular risk and the risk of neuraltube abnormalities.CAUTION: When adjusting band volume use of aninappropriate needle may cause Access Port leakageand require re-operation to replace the port. Useonly LAP-BAND System Access Port Needles. Donot use standard hypodermic needles, as these maycause leaks.CAUTION: Although there have been no reportsof autoimmune disease with the use of the LAPBAND System, autoimmune diseases/connectivetissue disorders (i.e., systemic lupus erythematosus,sclero-derma) have been reported following longterm implantation of other silicone devices. Theseconditions have primarily been hypothesized tobe associated with silicone breast implants. Thereis currently no conclusive clinical evidence tosubstantiate a relationship between connectivetissue disorders and silicone implants. Definitivelong-term epidemiological studies to furtherevaluate this possible association are currentlyunderway. However, the surgeon should be awarethat if autoimmune symptoms develop followingimplantation, definitive treatment and/or bandremoval may be indicated. Likewise, patients whoexhibit pre-existing autoimmune symptoms shouldbe carefully evaluated prior to implantation of theLAP-BAND System and may not be appropriatecandidates (see Contraindications).CAUTION: When adjusting band volume, the needlemust be inserted perpendicular to the Access Portseptum. Failure to do so may cause damage to theport and result in leaks.CAUTION: When adjusting band volume never enterthe Access Port with a “syringeless” needle. The fluidin the device is under pressure and will be releasedthrough the needle.CAUTION: When adjusting band volume once theseptum is punctured, do not tilt or rock the needle,as this may cause fluid leakage or damage tothe septum.CAUTION: When adjusting band volume if fluid hasbeen added to decrease the stoma size, it is importantto establish, before discharge, that the stoma isnot too small. Care must be taken during bandadjustments not to add too much saline, therebyclosing the gastric stoma. Check the adjustmentby having the patient drink water. If the patient isunable to swallow, remove some fluid from theport, then re-check. A physician familiar with theadjustment procedure must be available for severalADVERSE EVENTSIt is important to discuss all possible complicationsand adverse events with your patient. Complications3

which may result from the use of this productinclude the risks associated with the medications andmethods utilized in the surgical procedure, the risksassociated with any surgical procedure and thedays after surgery and when the patient eats morethan recommended.Nausea and vomiting may also be symptoms ofstoma obstruction or a band/stomach slippage.Frequent, severe vomiting can result in pouchdilatation, stomach slippage or esophageal dilatation.Deflation of the band is immediately indicated in all ofthese situations. Deflation of the band may alleviateexcessively rapid weight loss and nausea andvomiting, or re-operation to reposition or remove thedevice may be required.patient’s degree of intolerance to any foreign objectimplanted in the body.Perforation of the stomach can occur. Death can alsooccur. Specific complications of laparoscopic surgerycan include spleen damage (sometimes requiringsplenectomy) or liver damage, bleeding from majorblood vessels, lung problems, thrombosis, andrupture of the wound.Rapid weight loss may result in symptoms ofmalnutrition, anemia and related complications (i.e.,polyneuropathies). Deflation of the band may alleviateexcessively rapid weight loss. Rapid weight loss mayresult in development of cholelithiasis which mayresult in the need for a cholecystectomy.Ulceration, gastritis, gastroesophageal reflux,heartburn, gas bloat, dysphagia, dehydration,constipation, and weight regain have been reportedafter gastric restriction procedures.Slippage of the band can occur. Gastro-esophagealreflux, nausea and/or vomiting with early or minorslippage may be in some cases successfully resolvedby band deflation. More serious slippages may requireband repositioning and/or removal. If there is totalstoma outlet obstruction that does not respond to banddeflation, or if there is abdominal pain, then immediatere-operation to remove the band is indicated.The following table summarizes serious adverseevents that were reported to have occurred duringthe U.S. clinical trial. Two hundred and ninety-ninepatients were studied with a total of 633 patient years.Serious Adverse Events Considered Relatedto the LAP-BAND System for the US Study(Recorded as of December 2000, 299 Patients)Gastric banding done as a revision procedure hasa greater risk of complications. Prior abdominalsurgery is commonly associated with adhesionsinvolving the stomach. In the U.S. study, 42% of theU.S. patients undergoing revisions were reported tohave developed adhesions involving the stomach.Care and time must be taken to adequately releasethe adhesions to provide access, exposure andmobilization of the stomach for a revision procedure.Adverse EventBand Slippage, Pouch DilationStoma ObstructionGastroesophageal RefluxThere is a risk of band erosion into stomach tissue.Erosion of the band into stomach tissue has beenassociated with revision surgery, after the use ofgastric-irritating medications, after stomach damageand after extensive dissection or use of electrocautery,and during early experience. Symptoms of banderosion may include reduced weight loss, weight gain,Access Port infection, or abdominal pain.Esophageal distension or dilatation has been reportedinfrequently. This is most likely a consequence ofincorrect band placement, over-restriction, stomaobstruction, and can also be due to excessivevomiting, or patient noncompliance, and may bemore likely in cases of pre-existing esophagealdysmotility. Deflation of the band is recommended ifesophageal dilatation develops. A revision proceduremay be necessary to re-position or remove the bandif deflation does not resolve the dilatation.322Incisional Infection2Abdominal Pain2Gastroenteritis22Port Leak2Delayed Esophageal Emptying1GI Perforation1Hernia1Band Erosion1Chest dache1Abnormal Healing1Hiatal Hernia1Improper Band Placement1Respiratory Disorder1Thrombosis1Thyroid Disorder1DeathInfection can occur in the immediate post-operativeperiod or years after insertion of the device. In thepresence of infection or contamination, removal of thedevice is indicated.8CholelithiasisInfectionObstruction of stomas has been reported as bothan early and a late complication of this procedure.This can be caused by edema, food, improper initialcalibration, band slippage, pouch torsion, or patientnon-compliance regarding choice and chewingof food.11Esophageal DilatationNausea and/or VomitingRe-operation to remove the device is required.Re-operation for band erosions may result in agastrectomy of the affected area. Eroded bands havebeen removed gastroscopically in a very few cases,depending on the degree of erosion. Consultationwith other experienced LAP-BAND System surgeonsis strongly advised in these cases.% ofpatients0There were additional occurrences of these eventsthat were considered to be non-serious. Otheradverse events considered related to the LAPBAND System that occurred in fewer than 1% ofsubjects included: esophagitis, gastritis, hiatal hernia,pancreatitis, abdominal pain, hernia, incisionalDeflation of the band may occur due to leakage fromthe band, the port or the connecting tubing. Nauseaand vomiting may occur, particularly in the first few4

these explants (32% - 24/75). Other events associatedwith these explants were erosion (5% - 4/75), infection(4% - 3/75), GI disorders such as gastroesophagealreflux and/or dysphagia (11% - 8/75), LAP-BAND System leak (4% - 3/75); one needle damage to shelland 2 Access Port tubing leaks, esophageal disorders,such as dilatation and delayed emptying (7% - 5/75),gastric perforation (3% - 2/75), one abdominal pain,and one respiratory disorder. Insufficient weightloss was also reported as a contributor to the decisionto explant in 24 of the 75 explants (32%). Data froma post-approval study showed an estimated explantrate of 6.5% per year over the first 5 yearsfollowing implantation.infection, infection, redundant skin, dehydration, GIperforation, diarrhea, abnormal stools, constipation,flatulence, dyspepsia, eructation, cardiospasm,hematemesis, asthenia, fever, chest pain, incisionpain, contact dermatitis, abnormal healing, edema,paresthesia, dysmenorrhea, hypochromic anemia,band leak, cholecystitis, esophageal dysmotility,esophageal ulcer, esophagitis, port displacement,port site pain, spleen injury, and wound infection.Twenty-seven revision procedures, involving 26subjects (9%, 26/299) occurred. Thirteen of these27 (48%) revision procedures were completedlaparoscopically. In 9 of the 27 procedures (33%), theband was removed and replaced with a new bandin the same procedure. These were due to 3 initiallyincorrect placements, 5 stoma obstructions orband slippage/pouch dilatation, and 1 band systemleakage. Two subjects were revised with a new bandat separate interventions. Sixteen of 27 revisionprocedures (59%) did not require removal of theband. All of these were performed to correct bandslippage/pouch dilatation. Six of these (37.5%) werecompleted laparoscopically. There were no deathsassociated with LAP-BAND System revisions.CLINICAL EXPERIENCEPurpose of the TrialThe purpose of the study was to support the safetyand effectiveness of the device for use in weightreduction for severely obese patients with a BodyMass Index (BMI) of at least 40 or those who are100 lbs. or more over their estimated ideal weightaccording to the 1983 Metropolitan Life InsuranceTables (use of the mid-point for medium frame).The product is indicated for use only in patientswho have failed more conservative weight-reductionalternatives, such as supervised diet, exercise andbehavior modification programs. Patients who electto have this surgery must make the commitment toaccept significant changes in their eating habits forthe rest of their lives.Seventy-five subjects had their entire LAP-BAND Systems explanted. Fifty-one of the 75 explants (68%)were countermeasures to adverse events. Bandslippage/pouch dilatation and/or stoma obstructionwas the most common adverse event associated withAll Adverse Events (Mild, Moderate, Severe)that Occurred at a Rate of 5% or MoreStudy Design(Recorded as of December 2000, 299 Patients)In June of 1995, a nonrandomized, single-arm(non-comparative) study was initiated. The studyconsisted of a multi-center clinical evaluation witheight (8) participating sites and an enrollment of299 subjects. The study was approved with patientfollow-up at 3 weeks, 3 months, 6 months, 9 months,12 months, 18 months, 24 months, 30 months, and36 months. The 9.75cm (B-2210) and 10.0cm (B-2220)LAP-BAND Systems were used in the study. Theprimary efficacy measures included the percentexcess weight loss (%EWL) at one, two, and threeyears following the procedure. The differencesbetween these weight losses and the weight loss/gainexperienced by the subjects in the years(s) prior toplacement of the LAP-BAND System were consideredas secondary efficacy measures. In addition, secondaryefficacy measures also included changes in quality oflife. The primary safety parameters included incidenceand severity of complications. These complicationswere divided into device-related and non-devicerelated events.# of% ofpatients patientsDigestiveNausea and/or VomitingGastroesophageal RefluxStoma 69Diarrhea227Abnormal Stools186Abdominal Pain8027Asthenia258Body as a WholeIncisional Infection217Infection207Fever186Patients StudiedHernia165Pain165There were 299 patients in the U.S. study. The patientgender breakdown was 85% female and 15% male,which is consistent with gender distribution amongpatients seeking surgical treatment for severe obesity.Patient race categories were 81% Caucasian, 15%African-American and 4% Hispanic. The average agethat patients became obese was 18.4 years and theaverage age at the time of surgery was 38.8 years.Chest PainPain Incision1551457224238Band-SpecificBand Slippage/Pouch DilationMetabolic and NutritionalPort Site Pain269Port Displacement186The mean weight at entry was 293 pounds, and themean excess weight was 156 pounds. The mean BMIwas 47.4. Thirty percent had a BMI 50 and thusclassified as “superobese”. During the five yearsprior to surgery, patients had gained an average of54 pounds and the average BMI had increased from39 to 47.4.238In these patients, significant comorbidities included:hypertension (42%), gallstone/gallbladder diseaseHealing AbnormalPort-SpecificSkin and AppendagesAlopecia5

(25%), gastrointestinal diseases (24%), asthma (16%),non-insulin dependent diabetes (11%), and insulindependent diabetes (5%).loss was equal to operative weight minus selectedweight. Study subjects were weighed immediatelybefore surgery and postoperatively at 3 weeks, 3, 6, 9,12, 18, 24, 30, and 36 months. The 1983 MetropolitanLife Height and Weight Table was the scale todetermine ideal weight.Patient inclusion criteria Age 18 to 55 Male or female BMI of 40 or above, or 100 pounds aboveestimated ideal weight Willingness to comply with the substantiallifelong dietary restrictions required bythe procedure History of obesity for at least 5 years History of failu

LAP-BAND System 9.75 with Access Port II Cat. No. B-2225 LAP-BAND System 10.0 with Access Port II Cat. No. B-2255 LAP-BAND VG System with Access Port II the LAP-BAnD Adjustable Gastric Banding system is designed to induce weight loss in severely obese patients by limiting food consumption. the band's