A SURGICAL AID IN THE TREATMENT OF MORBID OBESITY

BioEnterics® LAP-BAND® System Information for Patients

MORBID OBESITY AND THE LAP-BAND SYSTEM

In America, obesity is a leading cause of preventable death. As such, it is a majorpublic health challenge. Millions of adults are overweight or obese. Because they are,they have a greater risk for health problems, such as:

° high blood pressure

° heart disease

° type 2 diabetes

° sleep apnea

° respiratory problems

The BioEnterics LAP-BAND System can help you achieve your goal of sustainedweight loss. Combined with diet and a behavior modification program, it offers achance to reduce your weight and the health risks associated with obesity.

The LAP-BAND System is not a miracle cure. It is a tool to lose weight. Not everyonewill lose weight or keep it off. To get the long-lasting weight-loss results you want, you will need to work at it.

The purpose of this booklet is to give you the following information about the LAP-BAND System:

° how it works

° what its benefits are

° what its potential risks and complications might be

This booklet also covers topics such as

° obesity

° related health risks

° surgical and non-surgical options to treat obesity

° eating habits

° frequently asked questions about the LAP-BAND System

CONTENTS

Record of booklet receipt

Introduction ..................................1

The concept of obesity ................1

Obesity causes.............................1

The risks of severe obesity ..........2

Treatments for severe obesity .....2

The LAP-BAND® System ..............4

Indications ....................................6

Contraindications..........................6

Risks, complications and adverse events .............................7

The LAP-BAND operation.............9

After LAP-BAND surgery ............10

LAP-BAND adjustments .............10

Your new nutrition plan...............11

Frequently asked questions........13

BMI charts ..................................15

Patient consent

RECORD OF RECEIPT(TO BE SIGNED BY PATIENT UPON RECEIPT OF THIS BOOKLET AND STORED IN THE PATIENT FILE)

Patient Signature Date

Patient Name Printed

Surgeon Signature Date

Surgeon Name Printed

My surgeon has provided me with the brochure “A Surgical Aid in the Treatment of Morbid Obesity, BioEnterics®

LAP-BAND® System Information for Patients” for my use prior to surgery.

INTRODUCTIONAlmost every day, you see reports in themedia about an amazing new diet orsome new pill for weight loss. Even so,the number of people with a seriousweight problem keeps going up. If youare one of those people, you probablyalready know that weighing more thanyou should is bad for your health.

If you are severely obese, you have ahigher risk for problems such as heartdisease and diabetes. Plus, weighingmore than you should can affect the wayyou feel about yourself. It can give you anegative self-image. It also can cause youto become socially isolated.

The best remedy for being overweight isto exercise more while you eat less andeat sensibly. With this approach, you canuse up more energy than you take in andlose weight. A diet can help people loseweight, and some people can havesuccess with drugs that make them feelless hungry. But over the long term,these methods don’t work for everyone.Some people quickly regain the weightthey lose on a diet. Some even end upweighing more. Drugs that make you feelless hungry do not usually produceweight loss that lasts.

If you’ve tried these methods and stillhave a problem with excess weight, youmay want to consider surgery. Surgerycan help some people lose weight andkeep it off. This booklet gives youimportant information about one type ofsurgery used to treat severe obesity withthe aid of the BioEnterics® LAP-BAND®

System (also referred to as the LAP-BAND Adjustable Gastric BandingSystem or the LAP-BAND System).

The LAP-BAND System overview

The LAP-BAND System is an adjustablesilicone elastomer band that is surgicallyplaced around the stomach. (This will beexplained in more detail later in thisbooklet.) The band is designed to limitfood intake. When you eat less food yourbody draws on its own fat reserves toget the energy it needs. The result is youlose weight.

Besides telling you about the LAP-BANDAdjustable Gastric Banding System, thisbooklet looks at obesity and the healthrisks it brings. It explains some treatmentoptions, and gives you information youneed to decide what is best for you. Butplease be sure you talk to your doctorabout all your options. The LAP-BANDSystem is an aid to weight loss. It is not amiracle cure. Not everyone will lose weightor keep it off. You will still need to work tohave long-lasting weight-loss results.

THE CONCEPT OF OBESITYNot everyone who has a weight problemshould consider surgery. It depends onwhether or not you are overweight,obese, or morbidly obese. One way totell is by your Body Mass Index (BMI).

Your BMI depends on both your weightand your height. There is a chart on page15 to help you find your own BMI.

Surgical candidates

An ideal BMI is 19 to 25.1 If your BMI isbetween 25 and 30, you are thought to beoverweight. If it is higher than 30, you areobese. That means you are at risk forhealth problems. If your BMI is 40 ormore, you are said to have “morbid”obesity. A BMI higher than 40 suggestssurgery might be a proper approach. Forsome people with a BMI between 35 and40 (“severe” obesity), surgery might alsobe a good choice. These are people whohave other conditions. For instance, if yourBMI is 37 and you have severe sleepapnea, diabetes mellitus, or heartproblems, your doctor might suggestsurgery to help you lose weight.2,3

In the following pages, you will find outmore about the causes of obesity andmorbid obesity. You will also find out aboutproblems connected with excess weightand learn about methods for treating it.

OBESITY CAUSESMany things can lead to obesity andmorbid obesity. The five main causes arediscussed below:

Energy balance

To work right, your body needs theenergy that comes from food. When youeat the same amount of food your bodyneeds, your weight stays the same. Ifyou get more energy from your food thanyou need, some is left over. Your bodystores that extra energy as fatty tissue. Ifyour body never uses the extra fat, youwill gain weight. How much food youneed depends on how fast your body

GASTRIC BAND

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THE BIOENTERICS LAP-BAND SYSTEM

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uses energy. Some people with highermetabolism use energy faster thanothers. Some need more energy becausethey are more active.

Heredity

If others in your family are obese, thenyou have a higher risk for obesity. A studyin Canada looked at 12 sets of identicaltwins. Each twin consumed 1000 extracalories a day for three weeks. All of thesubjects in the study gained weight. Butnot all subjects gained the same amountof weight. The interesting thing, though,was that in each set of twins, one twingained the same amount as the other.4

In 1994, scientists found a gene in micethat was linked to obesity. This geneproduces the protein leptin, whichcontributes to feeling full. Mice with adefective gene eat large amounts of food.But when humans were studied, theresults were not the same. So it seemsunlikely that a single gene can explainsevere obesity.

Genetic research does show that anumber of processes don’t work as well inobese people as they do in others. Theseinclude how fat is burned, metabolism,and feelings of hunger and fullness.

Metabolic disorders

Metabolism refers to how your body getsenergy from food. Lots of things can affectmetabolism. For instance, trouble with yourthyroid gland can change your metabolismand lead to obesity or morbid obesity.

Eating and social habits

Your eating habits can affect your weight.Things like not eating a balanced diet oreating fast-food and fatty snacks betweenmeals can all cause obesity. Another habit

that can cause obesity is eating portionsthat are too large or too rich. Drinking toomany high-calorie soft drinks can alsocause it. Not getting enough exercise canmake the effect of these habits worse.

Psychological factors

Most people’s eating habits are affected bytheir surroundings. For some people, smelland color will cause them to eat more.Some will eat to be social. For instance,someone might say to you, “Don’t be sucha snob. Have a piece of cake.”

Some people eat for comfort. They mayeat in times of grief or stress. The “blow-out” is a common response after a dietfails. Then a person might say, “It neverworks.” Thinking that way can lead to avicious cycle of eating and dieting that willonly make the person gain more weight.

THE RISKS OF SEVERE OBESITYIf you are morbidly obese, you have majorrisks to your

° health

° psychological and social well-being

° day-to-day living

Health risks

Obese people have more risk for

° diabetes

° joint problems

° high blood pressure

° high cholesterol

° cancer

° gallbladder problems

° breathing difficulties

° coronary artery disease

If you already have some diseases, suchas diabetes or heart disease, they can getworse. Plus, the more weight you gain,the more risk you have. As a result, yourlife expectancy is shorter. You also maybe less able to do things to help yourhealth improve. Exercise is important togood health. But severe obesity makesyou less mobile. It is hard to exercise ortake part in sports. Severe obesity canalso affect fertility. That means you areless likely to become pregnant. On theother hand, if you do become pregnant,you have more risk of problems duringpregnancy and childbirth.

Psychological and social well-being risks

People with a weight problem oftenhave a negative self-image. Theirenvironment can make this worse.Obese children, for instance, may beteased at school and have few friends.You may find it hard to buy clothes thatlook good. Bus or train seats, telephonebooths and cars may be too small. Youare also likely to be left out of socialfunctions that require exercise. Peoplewith severe obesity often findthemselves socially isolated.

Day-to-day living risks

Even normal tasks become harder whenyou are severely obese. You tend to tiremore quickly. You may also have breathingproblems. Not being able to move as wellmakes it hard for some people tomaintain personal hygiene.

TREATMENTS FOR SEVEREOBESITYThere are several options for treatingsevere obesity. Some treatments do notinvolve surgery and some do.

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Non-surgical treatments

The most common approach for losingweight is to eat less, eat more sensibly,and exercise more. But if you are severelyobese, this approach may not be enough.Sticking to a diet and exercise plan is hardand sometimes painful. Many who loseweight quickly gain it back when the dietends. That leads to more diets, or takingspecial drinks that replace a meal, or usinga so-called “wonder pill.” The cycle oflosing weight and gaining it back is calledthe yo-yo effect. While temporary weightloss can help, the yo-yo effect can alsomake it harder to lose weight in the future.

Asking professionals can help. A physicianor a dietitian can help you change yourlifestyle. A program of improved eatinghabits and exercise will be important overtime. A doctor may even prescribe drugs toreduce your appetite for a while. Butstudies show that diets and weight-lossaids rarely work in helping severely obesepeople reach the goal of long-lasting weightloss. Nor do other options that don’t usesurgery. Those options include jaw wiring,hypnosis, or counseling, for example.

Surgical options

If non-surgical methods have not helpedyou lose weight and keep it off, you stillhave another option. Surgery to reducehow much your stomach holds may workfor you. But keep in mind that a positiveattitude is key to the success of thesurgery. Surgery can help you achieveyour long-term goal only if you are readyfor and committed to losing weight andkeeping it off.

There are two types of surgery forobesity. One is called malabsorptive.This surgery shortens the digestivetract. The other kind is called restrictive.This surgery reduces how much food

the stomach can hold. Some surgeriesare combinations of the two types. Thetwo most common obesity surgeries inthe United States are the Gastric Bypassand the Vertical Banded Gastroplasty.

The Gastric Bypass

The Gastric Bypass is both a restrictiveand a malabsorptive procedure. With thissurgery, most of the stomach and part ofthe intestines are bypassed. With theGastric Bypass, the stomach is stapledto make a smaller pouch. Then a part ofthe intestines is attached (usuallystapled) to the small stomach pouch. Theresult is that you cannot eat as much andyou absorb fewer nutrients and caloriesfrom your food.

Vertical Banded Gastroplasty (VBG)

The VBG is a restrictive surgery. Thesurgeon uses staples to make a smallstomach pouch. This reduces how muchfood your stomach can hold. When theamount of food the stomach can hold isreduced, you feel full sooner. But at thesame time, the stomach digests nutrientsand calories in a normal way.

There is more than one way to reduce how much food the stomach can hold. VBG is one. Another is to usethe LAP-BAND Adjustable Gastric Banding System.

LAP-BAND Adjustable Gastric

Banding System

This option restricts how much thestomach can hold by placing an adjustableband around the upper part of the stomach.There is no cutting or stapling needed todivide the upper stomach pouch from thelower stomach. The result is you take inless food. But unlike stomach stapling, theLAP-BAND can be adjusted to suit yoursituation, and can be removed if necessary.

GASTRIC BYPASS

STOMACH STAPLING/VGB

THE LAP-BAND SYSTEM

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The LAP-BAND System uses new surgicaltechnology to help you lose weight byreducing how much your stomach canhold and lengthening the feeling of beingfull. The success of this process, however,also depends on how motivated you areand how committed you are to your goalof long-lasting weight loss.

THE LAP-BAND SYSTEMThe LAP-BAND System was designed tohelp you lose excess body weight. It usesa process called laparoscopic banding.This process is the least invasive way touse surgery to reduce the amount of foodyour stomach can hold. The name “LAP-BAND” comes from the surgicaltechnique used (laparoscopic) and thename of the product used (gastric band).

One big advantage of the LAP-BANDSystem is that the band’s size can bechanged to meet your needs. This is notpossible with other techniques.

How does the LAP-BAND

System work?

Your body gets energy from food while itpasses through the alimentary canal. Thisconsists of the mouth, the esophagus,the stomach, and the small and largeintestines. Digestion starts in the mouthwith chewing and the addition of saliva.After the food passes through theesophagus, this process continues in thestomach. The stomach then providestemporary storage for food. Gastric juices,which contain enzymes, break down thefood. This way, energy can be carriedthrough the body by the blood.

The LAP-BAND System’s adjustable bandis a silicone elastomer hollow ring filledwith saline and placed around the upperpart of the stomach. This creates a new

small stomach pouch, with the larger partof the stomach below the band. This way,the food storage area in the stomach isreduced. The pouch above the band canhold only a small amount of food. Theband also controls the stoma (stomachoutlet) between the two parts of thestomach. The size of the openingbetween the two parts of the stomachcontrols the flow rate of the food fromthe upper to the lower part of thestomach. This lets you feel full sooner. The feeling also lasts longer.

To change the size of the stoma, the innersurface of the band can be adjusted byadding or removing saline. This process iscalled inflating or deflating. Saline is a saltysolution like other fluids in your body.

The band is connected by a tube to anaccess port placed beneath the skinduring surgery. Later, the surgeon cancontrol the amount of saline in the bandby piercing the access port through theskin with a fine needle. If the band is tooloose and weight loss too small, addingmore saline can reduce the size of thestoma. If the band is too tight, thesurgeon will remove some saline. This toocan be done without more surgery. Beingable to adjust the band is a unique featureof the LAP-BAND System and is a normalpart of the follow-up. If adjusting the banddoes not help you lose weight the wayyou and your doctor want it to, or if theband is still too tight, another surgery maybe needed. The band position on thestomach can be changed or the size ofthe upper stomach pouch can be reduced.

How is the LAP-BAND System placed

around the stomach?

The LAP-BAND System is usually placedlaparoscopically. Laparoscopic surgeryrequires general anesthesia. First thesurgeon makes a few small incisions inthe abdominal wall and inserts narrow,hollow tubes. Thin surgical instrumentsare then passed through the tubes. Thesurgeon can see inside the abdomen byusing a small camera that also goesthrough the tubes. The picture the cameratakes is shown on a monitor that is like aTV screen. This technique is called“laparoscopy” and is considered“minimally invasive.” A small tunnel ismade behind the top of the stomach.Then the band is pulled around thestomach to form a ring. The band has alocking part which securely holds theband in a circle around the stomach.

There are clear advantages to this kind ofsurgery. In an “open” surgery, a largerincision is made. After a laparoscopicsurgery, most people feel much less pain.

LAP-BAND SYSTEMDEFLATED

LAP-BAND SYSTEM INFLATED

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ESOPHAGUS

LIVER

STOMACH

GALLBLADDER

PANCREAS

SMALLINTESTINE

LARGEINTESTINE

There are fewer wound complications.Patients also recover faster and are ableto resume normal activities sooner.

Sometimes, for a variety of reasons, the surgeon may need to make a largerincision to place the LAP-BAND System.The surgeon may need to decide thisduring the operation. Both techniques arediscussed in this booklet. You and yoursurgeon should decide together what planis best for you.

How is the LAP-BAND System used?

The LAP-BAND System is an aid to helpyou achieve longer-lasting weight loss. Itdoes this by limiting how much you caneat, reducing your appetite, and slowingdigestion. You should still remember,though, that the LAP-BAND System byitself will not solve your problem ofsevere obesity. Nor will it ensure that youreach your goal weight or even loseweight. The amount of weight you losedepends both on the band and on yourmotivation and commitment to a newlifestyle and eating habits.

How much weight will you lose with

the LAP-BAND System?

The average weight loss in the UnitedStates clinical study was approximately36-38% of excess weight, 2 and 3 yearsafter surgery. A few people lost up to100% of their excess weight, some didnot lose any weight, and a few gotheavier. The table at the bottom of thispage includes information about howmuch weight patients lost in the U.S.study. Weight loss is described in termsof the percent of the excess weight aperson lost (EWL = Weight Loss/ExcessWeight X 100).

Assume that you weigh 330 pounds.Also assume that for your height yourideal weight is 155 pounds. That meansyou weigh 175 pounds more than yourideal weight. 38% of 175 pounds is66.5 pounds.

Some people lose more than others. Youmay never reach your ideal weight. Atthe same time, chances are good thatyour health will improve, along with yourself-image.

What if the LAP-BAND System needs

to be removed?

If there is a problem with the band, or ifyou can’t lose enough weight or adjust tothe new eating habits, your surgeon maydecide to remove the band. That decisionwill come after your surgeon consultswith you. Removing the LAP-BANDSystem will most likely restore yourstomach to its original form. Also, thedigestive tract will again functionnormally. Please keep in mind, though,that when the band is removed, yourweight will likely increase.

The LAP-BAND System advantages

The LAP-BAND System has the followingadvantages:

° It is less invasive than other surgicaltechniques.

° The band can be adjusted.

° The process can be reversed.

° It may require less hospital time thanother surgical techniques.

° Recovery may be quicker.

EXCESS WEIGHT LOSS AT 3 YRS

Gained over 5% EWL

No Change ± 5% EWL

Lost at least 25% EWL

Lost at least 33% EWL

Lost at least 50% EWL

Lost at least 75% EWL

Total # of patients

ALL PATIENTS

% #OF PATIENTS

2% 4

5% 9

62% 110

52% 93

22% 39

10% 18

178

DIABETIC PATIENTS

% #OF PATIENTS

4% 1

0% 0

50% 12

46% 11

13% 3

8% 2

24

SUPER OBESE PATIENTS (BMI OF AT LEAST 50)

% #OF PATIENTS

0% 0

9% 5

58% 32

53% 29

15% 8

4% 2

55

STOMACH

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The process is less invasive

Of the surgeries used to treat obesity, theone used to place the LAP-BAND Systemcauses the least trauma. There is no needfor cutting or stapling the stomach. Also,the LAP-BAND System can usually beplaced laparoscopically. The main benefitsof that kind of surgery are:

° fewer operative complications

° less pain

° faster recovery

With this surgery, it’s possible to avoidlarge incisions and scars.

The band is adjustable

Normally, you don’t need more surgery toadjust the size of the stoma. Bandadjustment is a regular part of follow-upfor this procedure. It’s also a feature thatmay become more important as you loseweight. There are reasons you might needto change how much food you can eat.These can include your weight-lossprogress, pregnancy, and illness. With theLAP-BAND System, the amount of foodyou can eat at one time can often bechanged without more surgery. This canbe done simply by inflating or deflatingthe band.

Changes can be reversed

If it needs to be, the LAP-BAND Systemcan be removed. When it is, the stomachgenerally returns to its original form. Ingeneral, it’s easier to remove the LAP-BAND System than it is to reverse otherprocedures. Reversing other procedurestypically leaves staples and moretraumatized tissue.

You need less hospital time

Patients normally leave the hospital oneto three days after laparoscopic surgery. Ifa large incision is required or if there are

complications, more days in the hospitalmay be needed.

You may recover more quickly

After the procedure, patients usually getback to their normal activities in a week ortwo. It may take four weeks or more ifthe procedure is not done laparoscopicallyor if there are complications.

THE LAP-BAND SYSTEMINDICATIONS5

The LAP-BAND System is not right foreveryone. You and your surgeon shouldwork together to decide if this is the righttreatment for you. Here are some of thethings your surgeon will consider.

The LAP-BAND System may be right foryou if:

° You are an adult (at least 18 years old).

° Your BMI is 40 or higher or you weighat least twice your ideal weight or youweigh at least 100 pounds (45 kilos)more than your ideal weight.

° You have been overweight for morethan 5 years.

° Your serious attempts to lose weighthave had only short-term success.

° You do not have any other disease that may have caused you to beoverweight.

° You are prepared to make majorchanges in your eating habits andlifestyle.

° You are willing to continue workingwith the specialist who is treating you.

° You do not drink alcohol in excess.

If your BMI is less than 40, the LAP-BANDSystem may not be right for you. On the

other hand, your surgeon may consider itif you have health problems that arerelated to obesity. Your surgeon may alsohave other criteria he or she uses. Askhim or her to discuss the criteria with you.

CONTRAINDICATIONSThe LAP-BAND System is not right for you if:

° You have an inflammatory disease orcondition of the gastrointestinal tract,such as ulcers, severe esophagitis, orCrohn’s disease.

° You have severe heart or lung diseasethat makes you a poor candidate forsurgery.

° You have some other disease thatmakes you a poor candidate for surgery.

° You have a problem that could causebleeding in the esophagus or stomach.That might include esophageal orgastric varices (a dilated vein). It mightalso be something such as congenitalor acquired intestinal telangiectasia(dilation of a small blood vessel).

° You have portal hypertension.

° Your esophagus, stomach, or intestineis not normal (congenital or acquired).For instance you might have anarrowed opening.

° You have or have experienced an intra-operative gastric injury, such as a gastric perforation at or near thelocation of the intended bandplacement.

° You have cirrhosis.

° You have chronic pancreatitis.

° You are pregnant. (If you becomepregnant after the LAP-BAND Systemhas been placed, the band may needto be deflated. The same is true if youneed more nutrition for any otherreason, such as becoming seriously ill.

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In rare cases, removal may be needed.)

° You are addicted to alcohol or drugs.

° You are under 18 years of age.

° You have an infection anywhere in yourbody or one that could contaminate thesurgical area.

° You are on chronic, long-term steroidtreatment.

° You cannot or do not want to followthe dietary rules that come with thisprocedure.

° You might be allergic to materials inthe device.

° You cannot tolerate pain from animplanted device.

° You or someone in your family has anautoimmune connective tissuedisease. That might be a disease suchas systemic lupus erythematosus orscleroderma. The same is true if youhave symptoms of one of thesediseases.

Some surgeons say patients with a“sweet tooth” will not do well with theLAP-BAND System. If you eat a lot ofsweet foods, your surgeon may decidenot to do the procedure. The same is trueif you often drink milkshakes or otherhigh-calorie liquids.

Your motivation is key

Your surgeon will not do the operationunless he or she knows you understandthe problems your excess weight iscausing. Also, your surgeon will makesure you know you have responsibilities.These include new eating patterns and anew lifestyle. If you are ready to take anactive part in reducing your weight, yoursurgeon will consider the treatment. First,though, your surgeon will want to makesure you know about the advantages,disadvantages, and risks involved.

RISKS, COMPLICATIONS, ANDADVERSE EVENTS YOU NEEDTO KNOW ABOUTAll surgical procedures have risks. Whenyou decide on a procedure, you shouldknow what the risks are. Talk with yoursurgeon in detail about all the risks andcomplications that might arise. Then youwill have the information you need tomake a decision.

What are the general risks?

Using the LAP-BAND System includes thesame risks that come with all majorsurgeries. There are also added risks in anyoperation for patients who are seriouslyoverweight. You should know that death isone of the risks. It can occur any timeduring the operation. It can also occur as aresult of the operation. Death can occurdespite all the precautions that are taken.There is a risk of gastric perforation (a tearin the stomach wall) during or after theprocedure that might lead to the need foranother surgery. In the U.S. clinical studythis happened in 1% of the patients. Therewere no deaths during or immediately aftersurgery in the U.S. study. Your age canincrease your risk from surgery. So canexcess weight. Certain diseases, whetherthey were caused by obesity or not, canincrease your risk from surgery. There arealso risks that come with the medicationsand the methods used in the surgicalprocedure. You also have risks that comefrom how your body responds to anyforeign object implanted in it. Publishedresults from past surgeries, however, doshow that LAP-BAND System surgery mayhave fewer risks than other surgicaltreatments for obesity.

Patients can experience complications aftersurgery. Most complications are notserious but some may require

hospitalization and/or re-operation. In theUnited States clinical study, with 3-yearfollow-up reported, 88% of the 299patients had one or more adverse events,ranging from mild, moderate, to severe.Nausea and vomiting (51%),gastroesophageal reflux (regurgitation)(34%), band slippage/pouch dilatation(24%) and stoma obstruction (stomach-band outlet blockage) (14%) were the mostcommon post-operative complications. Inthe study, 25% of the patients had theirband systems removed, two-thirds ofwhich were following adverse events.Esophageal dilatation or dysmotility (pooresophageal function) occured in 11% ofpatients, the long-term effects of which arecurrently unknown. Constipation, diarrheaand dysphagia (difficulty swallowing)occurred in 9% of the patients. In 9% ofthe patients, a second surgery was neededto fix a problem with the band or initialsurgery. In 9% of the patients, there wasan additional procedure to fix a leaking ortwisted access port. The access portdesign has been improved. Four out of 299patients (1.3%) had their bands erode intotheir stomachs. These bands needed to beremoved in a second operation. Surgicaltechniques have evolved to reduceslippage. Surgeons with more laparoscopicexperience and more experience withthese procedures report fewercomplications.

Adverse events that were considered to benon-serious, and which occurred in lessthan 1% of the patients, included:esophagitis (inflammation of theesophagus), gastritis (inflammation of thestomach), hiatal hernia (some stomachabove the diaphragm), pancreatitis(inflammation of the pancreas), abdominalpain, hernia, incisional hernia, infection,redundant skin, dehydration, diarrhea(frequent semi-solid bowel movements),abnormal stools, constipation, flatulence

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(gas), dyspepsia (upset stomach), eructation(belching), cardiospasm (an obstruction ofpassage of food through the bottom of theesophagus), hematemsis (vomiting ofblood), asthenia (fatigue), fever, chest pain,incision pain, contact dermatitis (rash),abnormal healing, edema (swelling),paresthesia (abnormal sensation of burning,prickly, or tingling), dysmenorrhea (difficultperiods), hypochromic anemia (low oxygencarrying part of blood), band system leak,cholecystitis (gallstones), esophageal ulcer(sore), port displacement, port site pain,spleen injury, and wound infection. Be sureto ask your surgeon about these possiblecomplications and any of these medicalterms that you don’t understand.

Is there a chance the device will need

to be removed?

The LAP-BAND System is a long-termimplant, but it may have to be removed orreplaced at any time. For instance, thedevice may need to be removed tomanage any adverse reactions you mighthave. The device may also need to beremoved, repositioned or replaced if youaren’t losing as much weight as you andyour doctor feel you should be losing.

What are the specific risks and

possible complications?

Talk to your doctor about all of thefollowing risks and complications:

° ulceration

° gastritis (irritated stomach tissue)

° gastroesophageal reflux (regurgitation)

° heartburn

° gas bloat

° dysphagia (difficulty swallowing)

° dehydration

° constipation

° weight regain

° death

Laparoscopic surgery has its own set ofpossible problems. They include:

° spleen or liver damage (sometimesrequiring spleen removal)

° damage to major blood vessels

° lung problems

° thrombosis (blood clots)

° rupture of the wound

° perforation of the stomach oresophagus during surgery

Laparoscopic surgery is not always possible.The surgeon may need to switch to an“open” method due to some of the reasonsmentioned here. This happened in about 5%of the cases in the U.S. Clinical Study.

There are also problems that can occurthat are directly related to the LAP-BANDSystem. They include:

° The band can spontaneously deflatebecause of leakage. That leakage cancome from the band, the access port,or the tubing that connects them.

° The band can slip.

° There can be stomach slippage.

° The stomach pouch can enlarge.

° The stoma (stomach outlet) can beblocked.

° The band can erode into the stomach.

Obstruction of the stoma can be caused by

° food

° swelling

° improper placement of the band

° the band being over-inflated

° band or stomach slippage

° stomach pouch twisting

° stomach pouch enlargement

There have been some reports that theesophagus has stretched or dilated insome patients. This could be caused by

° improper placement of the band

° the band being tightened too much

° stoma obstruction

° binge eating

° excessive vomiting

Patients who have a weaker esophagusmay be more likely to have this problem.A weaker esophagus is one that is notgood at pushing food through. Tell yoursurgeon if you have difficulty swallowing.Then your surgeon can evaluate this.

Weight loss with the LAP-BAND Systemis typically slower and more gradual thanwith some other weight-loss surgeries.Tightening the band too fast or too muchto try to speed up weight loss should beavoided. The stomach pouch and/oresophagus can become enlarged as aresult. You need to learn how to use yourband as a tool that can help you reducethe amount you eat.

Infection is possible. Also, the band canerode into the stomach. This can happenright after surgery or years later, althoughthis rarely happens.

Complications can cause reduced weightloss. They can also cause weight gain.Other complications can result thatrequire more surgery to remove,reposition, or replace the band.

Some patients have more nausea andvomiting than others. You should see yourphysician at once if vomiting persists.Rapid weight loss may lead to symptoms of:

° malnutrition

° anemia

° related complications

It is possible you may not lose muchweight or any weight at all. You could alsohave complications related to obesity.

8

If any complications occur, you may needto stay in the hospital longer. You mayalso need to return to the hospital later.A number of less serious complicationscan also occur. These may have littleeffect on how long it takes you torecover from surgery.

If you have existing problems, such asdiabetes, a large hiatal hernia (part of thestomach in the chest cavity), Barrett’sesophagus (severe, chronic inflammationof the lower esophagus), or emotional orpsychological problems, you may havemore complications. Your surgeon willconsider how bad your symptoms are,and if you are a good candidate for theLAP-BAND System surgery. You also havemore risk of complications if you’ve hadsurgery before in the same area. If theprocedure is not done laparoscopically byan experienced surgeon, you may havemore risk of complications.

Anti-inflammatory drugs that may irritatethe stomach, such as aspirin and NSAIDs,should be used with caution.

Some people need folate and vitamin B12supplements to maintain normal homo-cysteine levels. Elevated homocysteinelevels can increase risks to your heart andthe risk of spinal birth defects.

You can develop gallstones after a rapidweight loss. This can make it necessary to remove your gallbladder.

There have been no reports ofautoimmune disease with the use of theLAP-BAND System. Autoimmune diseasesand connective tissue disorders, though,have been reported after long-termimplantation of other silicone devices.These problems can include systemiclupus erythematosus and scleroderma. At this time, there is no conclusive clinicalevidence that supports a relationship

between connective-tissue disorders andsilicone implants. Long-term studies tofurther evaluate this possibility are stillbeing done. You should know, though, thatif autoimmune symptoms develop after theband is in place, you may need treatment.The band may also need to be removed.Talk with your surgeon about thispossibility. Also, if you have symptoms ofautoimmune disease now, the LAP-BANDSystem may not be right for you.

Removing the band

If the LAP-BAND System has been placed laparoscopically, it may be possible to remove it the same way. This is an advantage of the LAP-BANDSystem. However, an “open” proceduremay be necessary to remove a band. In the U.S. Clinical Study, 60% of thebands that were removed were donelaparoscopically. Surgeons report thatafter the band is removed, the stomachreturns to essentially a normal state.

At this time, there are no known reasons tosuggest that the band should be replacedor removed at some point unless acomplication occurs or you do not loseweight. It is difficult, though, to saywhether the band will stay in place for therest of your life. It may need to be removedor replaced at some point. Removing thedevice requires a surgical procedure. Thatprocedure will have all the related risks andpossible complications that come withsurgery. The risk of some complications,such as erosions and infection, increasewith any added procedure.

THE LAP-BAND OPERATIONThe more you know about the LAP-BANDSystem procedure, the easier the processshould be for you.

Getting ready for surgery

Before your surgery, you should talkabout the procedure in detail with yoursurgeon. Your doctor may also want youto meet with other experts. They can helpyou understand what will happen duringand after the operation. These expertsmight include

° a dietitian

° a physiotherapist

° a psychologist

° other specialists

You will also need to have a number oftests before your surgery. These are toevaluate your health. When it is time forthe surgery, you will be admitted to thehospital either the day before or on themorning of your surgery.

The surgery

When it is time for the operation, you willreceive a general anesthesia. If your caseis typical, the operation will be donelaparoscopically. During the operation, theband part of the LAP-BAND System willbe fastened around the upper part of yourstomach. This will create a small stomachpouch. Part of the lower stomach will thenbe sutured over the band. The rest of thelower stomach will stay in its normalposition. The access port for adjusting theband will be placed under your skin. To dothis, the surgeon will slightly enlarge oneof the incisions that he or she made forthe laparoscopic tubes.

Open operation

Sometimes laparoscopic surgery can’t bedone. Or sometimes, even after thelaparoscopic surgery has started, thesurgeon may switch to the “open” method.There could be a number of reasons forthis. For instance, bleeding or problemsplacing the band could make the open

9

method with the larger incision necessary.If this is the case, you will not be aware ofit while you are under the anesthesia. Thesurgeon will make a larger incision in theabdomen to perform the operation. Afterthis “open” surgery, you will most likelyneed to stay in the hospital longer. That’sbecause there could be more complications.It also may take more time for you to getback to your normal routine. In the U.S.study, about 5% of the patients wereconverted to open procedures.

AFTER LAP-BAND SURGERYOnce the anesthesia has worn off, youmay feel some pain. This pain can usuallybe relieved with ordinary painkillers. Thehospital staff will help you get out of bedand start moving as soon as possible. Thiswill help prevent blood clots, respiratoryproblems, and bedsores.

On the day after the surgery, you willlikely be given an X-ray. This is so yourhealth team can see that the LAP-BANDSystem is in the right place. It is also tosee that the new stomach outlet is open.You may be asked to swallow a liquid thatcan be seen on X-ray.

After a laparoscopic surgery, you willnormally stay in the hospital for 1 to 3days. The hospital stay may be longerafter the open procedure or if there are complications. If there are nocomplications, you should be able toresume normal activities within a week or two after the surgery.

Eating and drinking after the operation

After your surgery, you will need a newdiet. You should discuss this in detail withyour surgeon and/or dietitian. They canhelp you learn and get used to thechanges in lifestyle and eating habits you need to make.

Note: The following information is meantto be an overview. Your surgeon may giveyou specific instructions just for you. Besure you know the instructions yourdoctor wants you to follow.

It is very important to follow the eatingand drinking instructions right from thestart after the operation. That’s becauseyou must allow the new stomachstructure to heal completely and in theright position. It may take a month ormore for this to happen. It is important,especially in the early weeks, not tostretch the small stomach pouch abovethe band. Vomiting can do this, so it isimportant not to vomit. Vomiting canincrease the chance of stomach tissueslipping up through the band.

The first few days after the operation

Right after the operation, you can have anoccasional sip of water or suck on an icecube. You shouldn’t drink more than this. Theday after the operation, you can take a littlemore fluid. But you should take only a smallamount at a time. Besides water, you shouldalso choose liquids that have an adequatenumber of calories. To prevent nausea andvomiting, do not drink too much.

The first one to four weeks

These liquid and very soft foods arerecommended for the first four weeksafter the operation:

° clear broth or soup (with novegetables or meat and not creamy)

° low-fat yogurt

° milk (preferably skim)

° jello

° fruit juice or pureed soft fruit

As time goes on, you will slowly move tosolid food based on your surgeon’s and/ordietitian’s advice.

In the first few weeks, you may be able toeat foods that may not be allowed in yourdiet later because these foods maycontain too many calories. It is moreimportant in the first few weeks to letyour stomach adjust to the LAP-BANDSystem than it is to lose weight. Ingeneral, you should follow the advice ofyour dietitian about these foods.

Four to six weeks

At this time, you may start havingslightly thicker, creamier soups. This willhelp you switch gradually to more solidfoods later. Some products like bread,red meat, and rice may still cause youproblems. So it is better to eat softerfoods that are easier to digest. Thesemight include foods such as moist whitemeat (chicken, pork) and fish.

Chew all your food well. If you havedentures be sure to cut your food intosmall pieces and to chew it thoroughly. Ifyou don’t follow these precautions, youmay have vomiting, stomach irritation,and swelling. You could also havestomach obstruction.

If you have problems with solid foods andsuffer from nausea or vomiting, go back tothe liquid diet you had earlier. Then slowlyadd soft foods to help you transition tosolid foods later. Always ask for advicethat is specific to your situation from yourdoctor or dietitian. Vomiting may increasethe incidence of band slippage, stomachslippage, or stretching of the smallstomach pouch above the band.

LAP-BAND ADJUSTMENTSWith the LAP-BAND System, the band canbe adjusted to meet your specific needs.That is one of its more attractive aspects.This feature allows you and your surgeon tofind the right level of restriction just for you!

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When first placing it, your surgeon usuallyleaves the band empty or only partiallyinflated. This lets you get acquainted withyour band during the first few weeks aftersurgery. It also lets healing occur aroundthe new band site.

These first few weeks are a critical time.You need to avoid vomiting. You also needto avoid putting pressure on your newsmall stomach above the band. The firsttime the band is adjusted is usually 4 to 6weeks after your surgery. The exact timewill vary. You and your surgeon will decidewhen the right time is for your bandadjustment. To determine how ready youare for a band adjustment, your surgeonwill consider:

° your weight loss

° the amount of food you cancomfortably eat

° your exercise routine

° how much fluid is already in your band

Being able to adjust the LAP-BAND Systemgives you and your surgeon control. If theband is too tight, your surgeon can“loosen” it by taking out some of the fluid.If the band is too loose, your surgeon cantighten it. Your surgeon does this byinjecting fluid. Only a clinician trained andauthorized by INAMED Health can adjustyour band. Never let an untrained cliniciando it. Never let a non-medical person do it.And never try to adjust your own band. Youcould cause yourself adverse reactions. Youcould also damage your band.

To adjust your band, the clinician injectssaline into the self-sealing access port.This port is located just under your skin.The band can also be adjusted byremoving saline from the port. This is donewith a special fine needle. You may feel apricking sensation when this is done. Thefeeling is similar to when you give blood.

Adjustments are done either in thehospital or in a doctor’s office that has X-ray equipment (fluoroscopy). The clinicianmay use fluoroscopy to assist in locatingthe access port. The surgeon may also useit to guide the needle into the port and toview inserting the needle. It is also usedafter the band has been adjusted toevaluate your pouch size and stoma size.

To get the best results, you may need morethan one adjustment. Each one will rangefrom 0.5 cc to 2 cc of fluid. The most theband can hold is 4 cc. The exact amount offluid required to make the stoma the rightsize is unique for each person. An ideal“fill” should be just tight enough to let yougradually lose weight. That means youshould still be able to eat enough to get thenutrients that you need while still reducingthe overall amount you can eat.

The LAP-BAND System is meant to offeryou a way to obtain steady and safeweight loss. Don’t be in a hurry to have anadjustment before you’re ready. To work,the band needs your participation. Yoursuccess will depend on you and on thepartnership between you and yourclinicians.

YOUR NEW NUTRITION PLANWhen you can eat solid foods withoutproblems, you will need to pay closeattention to your diet. Liquids will passthrough the reduced stomach pouchquickly and will not make you feel full. Youshould avoid high-calorie drinks from thispoint on. Drink water, broth, tea, andcoffee (without sugar).

Too much food or big chunks of food canblock the stomach pouch outlet. You canavoid this problem by chewing food welland eating small bits at a time. Eat only

three small meals a day. Make sure thatthese meals contain adequate nutrients. A healthy meal has vegetables, fruit,meat, bread, and/or dairy products.

A general guide on page 13 of thisbooklet can help you create good andhealthy meals that contain adequatenutrients but little sugar and fat. Also, askyour surgeon and/or dietitian about yourfood choices.

10 important rules

Here are ten rules for eating, drinking, andexercise that will help you get the bestresults you can with the LAP-BANDSystem. How willing you are to follow anew way of eating is key to making theoperation a success.

1. Eat only three small meals a day.2. Eat slowly and chew thoroughly

(approximately 15 to 20 times a bite).3. Stop eating as soon as you feel full.4. Do not drink while you are eating.5. Do not eat between meals.6. Eat only good quality foods.7. Avoid fibrous food.8. Drink enough fluids during the day.9. Drink only low-calorie liquids.10. Exercise at least 30 minutes a day.

Why the rules are important and how

to make them work

Rule 1: Eat only three small meals a dayThe LAP-BAND System creates a smallstomach pouch that can hold only abouthalf a cup (3 to 4 ounces) of food. If youtry to eat more than this at one time youmay become nauseated. You may alsovomit. If you routinely eat too much, thesmall stomach pouch may stretch. Thatwill cancel the effect of the operation.Frequent vomiting can also cause certain

11

complications, such as stomach slippage.You need to learn how much yourstomach pouch can hold comfortably andthen not exceed this amount.

Rule 2: Eat slowly and chew thoroughlyFood can pass through the new stomaonly if it has been “chopped” into verysmall pieces. Always remember to takemore time for your meals and chewyour food very well.

Rule 3: Stop eating as soon as you feel fullOnce your stomach is full, your bodyreceives a signal that you have eatenenough. It takes time, though, for you tobecome aware of this signal. If youhurry your meal, you may eat morethan you need. This can lead to nauseaand vomiting. Take time over your meal.Try to recognize the feeling of fullness.Then stop eating at once.

Rule 4: Do not drink while you are eatingThis operation can work only if you eatsolid food. If you drink at mealtimes, thefood you have eaten becomes liquid. Thenthe effectiveness of the LAP-BANDSystem is greatly reduced. You shouldnot drink anything for one to two hoursafter a meal. That way you can keep thefeeling of fullness as long as possible.

Rule 5: Do not eat between mealsAfter a meal, do not eat anything elseuntil the next meal. Eating snacksbetween meals is one of the majorreasons for weight-loss failure. It is veryimportant to break this habit.

Rule 6: Eat only good quality foodsWith the LAP-BAND System in place, you should be able to eat only a smallamount. So the food you eat should be as

healthy as possible. Do not fill yoursmall stomach pouch with “junk” foodthat lacks vitamins and other importantnutrients. Your meals should be high inprotein and vitamins. Fresh vegetables,fruit, meat, and cereals are good foods tochoose. Foods high in fat and sugar arenot. You may eat apples and oranges, buttry to avoid orange juice and apple juice.Ask your doctor or dietitian before youtake any vitamin supplements.

Note: Solid food is more important thanliquid food. The LAP-BAND System willhave little or no effect if you eat onlyliquid food. Liquid food passes throughthe stomach outlet very quickly and doesnot make you feel full.

Rule 7: Avoid fibrous foodFood such as asparagus that containsmany fibers can block the stoma. That’sbecause you can’t chew this food wellenough to break it up into small pieces andyour saliva can’t break it down. Fibrousfood should be avoided. If you would liketo eat asparagus or other fibrous foodsonce in a while, then you must be sure tocook them well, cut them into very smallpieces first and then chew thoroughly.

Rule 8: Drink enough fluids during the dayIf you lose weight, your fat content willdrop. This results in waste products. Youwill need to drink large amounts of liquidevery day in order to urinate more andexcrete these waste products from yourbody. Individual needs will vary, but youshould drink at least 6-8 glasses of water aday. Remember: you should only drinkwater, tea, or coffee (without milk orcream and sugar). Also, keep your foodand drinks completely separate duringthe day.

Rule 9: Drink only low-calorie liquidsDrinks, including those containing calories,simply run through the narrow outletcreated by the band. If you drink liquidshigh in calories, you will lose little weight,even if you otherwise follow your diet.

Rule 10: Exercise at least 30 minutes a dayThis rule is just as important as the othernine rules. Since physical exerciseconsumes energy and burns calories, it isvery important to successful weight loss.

Exercise can help improve your generalhealth. Your size may make it hard for youto exercise as much as you should. Butget started, even if it is a little at first. The more weight you lose, the easier itshould get. Start with simple exercises,such as walking and swimming.Gradually expand your program toinclude more vigorous forms of exercisesuch as cycling, jogging, and aerobics.Increase your activity level in the courseof daily living. For example, stand ratherthan sit, walk rather than stand, beoutside rather than inside, walk ratherthan drive, climb the stairs rather thanuse the elevator, etc.

Important: Always check with your doctorabout the amount and type of exercisethat is best for you.

Note: Although these rules restrict yourfood intake and the types of food you areable to eat, make sure to keep your dietas varied and balanced as possible.

The rules described above are based onrecommendations from Prof. P. O’Brien,Melbourne, Australia; Dr. R. Weiner,Frankfurt, Germany; and J. GabrielleRabner, MS RD, New York, United States.

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Good food choices

Use this section to help you plan what youeat. You may choose what you would likefrom each of these food groups each day:

Fruit and vegetables

° 1 to 2 servings of fresh fruit daily

° 2 to 3 servings of fresh vegetables daily

Bread and cereals

° 1 small portion of corn flakes for breakfast

° 1 to 2 slices of whole wheat or ryebread each day (If you want, you canspread just a little margarine or butteron the bread)

Meat, fish, poultry, eggs

° 1 oz. to 2 oz. of meat, fish, or poultryor one egg each day(Remove all visible fat from the meat.Remove the skin from poultry. Preparethe meat in ways that need very littlefat. Grilling, steaming, microwaving, orboiling are all good ways to do that.)

Dairy productsMilk and yogurt are calories in liquid form.In theory, then, they should be avoided.But these types of food have calcium.That makes them an important part of ahealthy daily diet. Choose a maximum of2 cups of skimmed milk or low-fat yogurtand 1 oz. of cheese a day.

FatsRestrict the use of fat to 3 to 4 teaspoonsof margarine, butter, or oil per day. Youcan have low-fat salad dressings andmayonnaise in moderation.

DrinksDrink as many calorie-free liquids per dayas you wish. Suitable drinks are:

° tea or coffee (black) with low-calorie sweetener

° water

° non-carbonated beverages containingfew or no calories

° clear soup

Some doctors have reported thatcarbonated beverages may contribute toenlargement of the small pouch andshould be avoided.

Foods to avoidSome foods have a concentrated supplyof calories with little nutritional value andshould be avoided as much as possible. They include:

Sugar and foods containing largequantities of sugar, such as

° high-calorie soft drinks

° syrups

° cakes

° biscuits

° sweets

° jam

° marmalade

° honey

High-fat foods including

° chocolate

° chips

° pies

° pastries

Alcoholic drinks should be consumed inmoderation, such as a glass of wine or less per day.

FREQUENTLY ASKEDQUESTIONSQ: Will I be sick a lot after theoperation?A: The LAP-BAND System limits foodintake. If you feel nauseated or sick on aregular basis, it may mean you are notchewing your food well. It could alsomean you are not following the diet rulesproperly. Another reason you would feelsick may be that there is a problem withthe placement of the band. So you shouldcontact your doctor. Vomiting should beavoided as much as possible. It can causethe small stomach pouch to stretch. It can also lead to slippage of part of thestomach through the band. That wouldreduce the success of the operation. In some cases, it would also requireanother operation.

Q: Will I suffer from constipation?A: There may be some reduction in thevolume of your stools. That’s normal aftera decrease in food intake, because youeat less fiber. This should not causesevere problems. If difficulties do arise,check with your doctor. He or she maysuggest you take a mild laxative and drinkplenty of water for a while. Drinkingplenty of water is a good idea, anyway.Your needs will vary, but you should drinkat least 6-8 glasses of water a day.

13

Q: Will I need to take vitaminsupplements?A: You may. It’s possible you may not getenough vitamins from three small meals a day. At your regular check-ups, yourspecialist will evaluate whether you aregetting enough vitamin B12, folic acid,and iron. Your surgeon may advise you to take supplements.

Q: What about other medication?A: You should be able to take prescribedmedication. You may need to use capsulesor break big tablets in half or dissolve themin water so they do not get stuck in thestoma and make you sick. You shouldalways ask the doctor who prescribes thedrugs about this. Your surgeon may tell youto avoid taking aspirin or other non-steroidalanti-inflammatory pain relievers. That’sbecause they may irritate the stomach. Theproblems these drugs may cause couldmean the band would need to be removed.

Q: What about pregnancy?A: Becoming pregnant can be easier asyou lose weight. Your menstrual cycle maybecome more regular. If you need to eatmore while you are pregnant, the bandcan be loosened. After the pregnancy, theband may be made tighter again. Thenyou can go back to losing weight.

Q: Can the band be removed?A: Although the LAP-BAND System is notmeant to be removed, it can be. In somecases this can be done laparoscopically.Surgeons report that the stomachgenerally returns to its original shapeonce the band is removed. After theremoval, though, you may soon go backup to your original weight. You may alsogain more.

Q: What if I go out to eat?A: Order only a small amount of food,such as an appetizer. Eat slowly. Finish atthe same time as your table companions.You might want to let your host orhostess know in advance that you cannoteat very much.

Q: What about alcohol?A: Alcohol has a high number of calories.It also breaks down vitamins. Anoccasional glass of wine or other alcoholicbeverage, though, is not consideredharmful to weight loss.

Q: Will I need plastic surgery for thesurplus skin when I have lost a lot of weight?A: That is not always the case. As a rule,plastic surgery will not be considered forat least a year or two after the operation.Sometimes the skin will mold itselfaround the new body tissue. You shouldgive the skin the time it needs to adjustbefore you decide to have more surgery.

Q: What will happen if I become ill?A: One of the major advantages of theLAP-BAND System is that it can beadjusted. If your illness requires you toeat more, the band can be loosened. Thiscan be done by removing saline from it.When you have recovered from yourillness and want to lose weight again, theband can be tightened. This can be doneby increasing the amount of saline. If theband cannot be loosened enough, it mayhave to be removed.

Q: How is the band adjusted?A: Adjustments are often carried out inthe X-ray department. They are done thereso the access port can be clearly seen.When X-rays are used, your reproductive

organs should be shielded. Sometimesadjustments can be done in an outpatientclinic or office. Local anesthesia may ormay not be needed. A fine needle ispassed through the skin into the accessport to add or subtract saline. Thisprocess most often takes only a fewminutes. Most patients say it is nearly painless.

Q: How much weight will I lose?A: The amount of weight you may losedepends on several things. The band needsto be in the right position. And you need tobe committed to your new lifestyle andeating habits. In the U.S. clinical trial, 2% ofpatients gained some weight; 5% neithergained, nor lost weight (±5%); 61% of thepatients lost at least 25% of their excessweight; 52% of the patients lost at least33% of their excess weight; 22% lost atleast 50% of their excess weight; and 10%lost at least 75% of their excess weight.

You should lose weight gradually. Losingweight too fast creates a health risk andcan lead to a number of problems.Nausea and vomiting are only the mostminor examples. A weight loss of 2 to 3pounds a week in the first year after theoperation is possible, but one pound aweek is more likely. Twelve to 18 monthsafter the operation, weekly weight loss isusually less. Remember that your maingoal is to have a weight loss thatprevents, improves, or resolves healthproblems connected with severe obesity.

One final point:

It is important that you ask your surgeon allthe questions you may have about obesitysurgery and the LAP-BAND AdjustableGastric Banding System. It is also essentialthat you follow his or her advice.

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15

HEIGHT (FT)

4’9” 4’11” 5’1” 5’3” 5’5” 5’7” 5’9” 5’11” 6’1” 6’3”

154 33 31 29 27 26 24 23 22 20 19

165 36 33 31 29 28 26 24 23 22 21176 38 36 33 31 29 28 26 25 23 22187 40 38 35 33 31 29 28 26 25 24198 43 40 37 35 33 31 29 28 26 25209 45 42 40 37 35 33 31 29 28 26220 48 44 42 39 37 35 33 31 29 28

231 50 47 44 41 39 36 34 32 31 29243 52 49 46 43 40 38 36 34 32 30254 55 51 48 45 42 40 38 35 34 32265 57 53 50 47 44 42 39 37 35 33276 59 56 52 49 46 43 41 39 37 35287 62 58 54 51 48 45 42 40 38 36298 64 60 56 53 50 47 44 42 39 37309 67 62 58 55 51 48 46 43 41 39320 69 64 60 57 53 50 47 45 42 40331 71 67 62 59 55 52 49 46 44 42

342 74 69 65 61 57 54 51 48 45 43353 76 71 67 63 59 55 52 49 47 44364 78 73 69 64 61 57 54 51 48 46375 81 76 71 66 62 59 56 52 50 47386 83 78 73 68 64 61 57 54 51 48397 86 80 75 70 66 62 59 56 53 50408 88 82 77 72 68 64 60 57 54 51419 90 84 79 74 70 66 62 59 56 53430 93 87 81 76 72 67 64 60 57 54441 95 89 83 78 73 69 65 62 58 55

452 98 91 85 80 75 71 67 63 60 57463 100 93 87 82 77 73 69 65 61 58

HEIGHT (M)

1.45 1.5 1.55 1.6 1.65 1.7 1.75 1.8 1.85 1.9

70 33 31 29 27 26 24 23 22 20 19

75 36 33 31 29 28 26 24 23 22 2180 38 36 33 31 29 28 26 25 23 2285 40 38 35 33 31 29 28 26 25 2490 43 40 37 35 33 31 29 28 26 2595 45 42 40 37 35 33 31 29 28 26100 48 44 42 39 37 35 33 31 29 28

105 50 47 44 41 39 36 34 32 31 29110 52 49 46 43 40 38 36 34 32 30115 55 51 48 45 42 40 38 35 34 32120 57 53 50 47 44 42 39 37 35 33125 59 56 52 49 46 43 41 39 37 35130 62 58 54 51 48 45 42 40 38 36135 64 60 56 53 50 47 44 42 39 37140 67 62 58 55 51 48 46 43 41 39145 69 64 60 57 53 50 47 45 42 40150 71 67 62 59 55 52 49 46 44 42

155 74 69 65 61 57 54 51 48 45 43160 76 71 67 63 59 55 52 49 47 44165 78 73 69 64 61 57 54 51 48 46170 81 76 71 66 62 59 56 52 50 47175 83 78 73 68 64 61 57 54 51 48180 86 80 75 70 66 62 59 56 53 50185 88 82 77 72 68 64 60 57 54 51190 90 84 79 74 70 66 62 59 56 53195 93 87 81 76 72 67 64 60 57 54200 95 89 83 78 73 69 65 62 58 55

205 98 91 85 80 75 71 67 63 60 57210 100 93 87 82 77 73 69 65 61 58

BMI CHART (LBS/IN)BMI = lbs./inches2 x 704.5

BMI CHART (KG/M)BMI = kg/m2

WEI

GH

T (L

BS

)

WEI

GH

T (K

G)

PLEASE NOTE THAT THE BMI DOES NOT DISTINGUISH BETWEEN FAT AND MUSCLE. IT IS POSSIBLE FOR A HEAVILY MUSCLED INDIVIDUAL TO HAVE A BMI IN EXCESS OF 25 WITHOUT INCREASED HEALTH RISKS.

Body Mass Index Classification

Underweight Ideal BMI Overweight Obesity Severe Obesity Morbid Obesity Super Obesity<19 19-25 25-30 >30 >35 >40 >50

REFERENCES

1 Ideal body weight is associated with the lowest death rate in insured populations and is taken from the 1983 Metropolitan Life Insurance Company tables.

2 National Heart, Lung and Blood Institute, National Institutes of Health, Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweightand Obesity in Adults, 1998, p. XX.

3 American Society for Bariatric Surgery, Web site 10/99.

4 Bouchard, C., et al., The Response to Long-Term Feeding in Identical Twins. New England Journal of Medicine, 1990, 322 (21): 1477-82.

5 American Society for Bariatric Surgery, National Institutes of Health, and the International Federation for the Surgery of Obesity Guidelines.

ACKNOWLEDGEMENTS

This booklet was developed with the help of the patients treated with the BioEnterics LAP-BAND System and the patients receiving treatment for severe obesity.

The content is based partly on the patient booklet produced by Professor Paul O’Brien of Melbourne, Australia. Contributions were also made by Dr. W. Tuinebreijerof Beverwijk, the Netherlands; R. Hörchner of Beverwijk, the Netherlands; Dr. W.L.E.M. Hesp of Dordrecht, the Netherlands; Dr. R. Weiner of Frankfurt, Germany;Gabrielle Rabner of New York, United States; and several dietitians and psychotherapists.

We would like to thank all those involved for their cooperation in the development of this booklet.

Informed Consent: Information for

Patients Considering BioEnterics®

LAP-BAND® System Surgery

Before your surgery, you should know therisks connected with the BioEntericsLAP-BAND System. You should also knowwhat the possible complications are. Tolearn about these, talk with your surgeon.When you do, ask about all the risks. Askabout all possible complications. Also askabout symptoms and conditions thatmight suggest this surgery is not right foryou. To help with that talk, INAMEDHealth has prepared this booklet: “ASurgical Aid in the Treatment of MorbidObesity, BioEnterics® LAP-BAND® SystemInformation for Patients.” Read it. Discusswhat it says with your surgeon. Be sureyou ask about terms you do not

understand. You have to decide howwilling you are to accept the risks andpossible complications.

Additional Information

You should also have other information.Talk with your surgeon about:

° alternatives to the LAP-BAND System surgery

° the information in the package inserts

° risks and benefits this procedureposes for you

Special Notice

The manufacturer of the LAP-BANDSystem has designed, tested andmanufactured it to be reasonably fit for its intended use. However, the

LAP-BAND System is not a lifetimeproduct and it may break or fail, in wholeor in part, at any time, after implantationand notwithstanding the absence of anydefect. Causes of partial or completefailure include, without limitation,expected or unexpected bodily reactionsto the presense and position of theimplanted device, rare or atypical medicalcomplications, component failure andnormal wear and tear. In addition, theLAP-BAND System may be easilydamaged by improper handling or use.Please refer to the Risks, Complicationsand Adverse Events section in thisdocument for a presentation of thegeneral and specific risks and possiblecomplications associated with the use ofthe LAP-BAND System.

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PATIENT CONSENT(TO BE SIGNED BY PATIENT AFTER HE OR SHE HAS READ THIS BOOKLET AND STORED IN THE PATIENT FILE)

I have read the booklet, “A Surgical Aid in the Treatment of Morbid Obesity, BioEnterics® LAP-BAND® System Informationfor Patients” and understand the risks it describes. I understand the potential complications described, as well as thesymptoms and conditions which may not make this procedure right for me. I have discussed the risks with my surgeonand know that not all risks connected with this product can be predicted. I acknowledge that there can be serious riskseven with the best medical manufacturing, technology and surgical care. I fully accept the risks and possible complicationsassociated with the BioEnterics LAP-BAND System procedure and believe that the benefits of the device and procedureoutweigh the risks. I take full responsibility for my choice and choose to proceed with LAP-BAND System surgery.

Patient Signature Date

Patient Name Printed

Surgeon Signature Date

Surgeon Name Printed

5540 EKWILL STREET, SANTA BARBARA, CA 93111TEL: 805-683-6761 FAX: 805-681-5765

WWW.INAMEDHEALTH.COM

CAUTION:THIS DEVICE IS RESTRICTED TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

THE BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM CONTAINS NO LATEX OR NATURAL RUBBER MATERIALS.

BIOENTERICS AND LAP-BAND ARE REGISTERED U.S. TRADEMARKS OF BIOENTERICS CORPORATION. ©2003 INAMED CORPORATION. ALL RIGHTS RESERVED.

HM0011 P/N 94829 REV 08 10/03

For more information about the BioEnterics® LAP-BAND® System,

please call 1-877-LAP-BAND or visit www.inamedhealth.com