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LAP-BAND® and obesity surgery Frequently Asked Questions

  1. What are the general risks?
  2. Is there a chance the device will need to be removed?
  3. What are the specific risks and possible complications?
  4. Will I be sick a lot after the operation?
  5. How long will it take to recover after surgery?
  6. How much weight will I lose?
  7. How do the weight-loss results with the LAP-BAND compare to those with the gastric bypass?
  8. Does the LAP-BAND require frequent visits to my doctor after surgery?
  9. Does the LAP-BAND limit any physical activity?
  10. How is the band adjusted?
  11. Do I have to be careful with the access port just underneath my skin?
  12. Can the band be removed?
  13. Will I need plastic surgery for the surplus skin when I have lost a lot of weight?
  14. Is it true that the LAP-BAND seems "tighter" in the morning?
  15. Will I feel hungry or deprived with the LAP-BAND?
  16. What will happen if I become ill?
  17. What about pregnancy?
  18. Will I need to take vitamin supplements?
  19. What about other medication?
  20. What if I go out to eat?
  21. What about alcohol?
  22. Can I eat anything in moderation?
  23. Will I suffer from constipation?

1. What are the general risks?

Using the LAP-BAND System includes the same risks that come with all major surgeries. There are also added risks in any operation for patients who are seriously overweight. You should know that death is one of the risks. It can occur any time during the operation. It can also occur as a result of the operation. Death can occur despite all the precautions that are taken. There is a risk of gastric perforation (a tear in the stomach wall) during or after the procedure that might lead to the need for another surgery. In the U.S. clinical study this happened in 1% of the patients. There were no deaths during or immediately after surgery in the U.S. study. Your age can increase your risk from surgery. So can excess weight. Certain diseases, whether they were caused by obesity or not, can increase your risk from surgery. There are also risks that come with the medications and the methods used in the surgical procedure. You also have risks that come from how your body responds to any foreign object implanted in it. Published results from past surgeries, however, do show that LAP-BAND System surgery may have fewer risks than other surgical treatments for obesity.

Patients can experience complications after surgery. Most complications are not serious but some may require hospitalization and/or re-operation. In the United States clinical study, with 3-year follow-up reported, 88% of the 299 patients 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 most common post-operative complications. In the study, 25% of the patients had their band systems removed, two-thirds of which were following adverse events. Esophageal dilatation or dysmotility (poor esophageal function) occurred in 11% of patients, the long-term effects of which are currently unknown. Constipation, diarrhea and dysphagia (difficulty swallowing) occurred in 9% of the patients. In 9% of the patients, a second surgery was needed to fix a problem with the band or initial surgery. In 9% of the patients, there was an additional procedure to fix a leaking or twisted access port. The access port design has been improved. Four out of 299 patients (1.3%) had their bands erode into their stomachs. These bands needed to be removed in a second operation. Surgical techniques have evolved to reduce slippage. Surgeons with more laparoscopic experience and more experience with these procedures report fewer complications.

Adverse events that were considered to be non-serious, and which occurred in less than 1% of the patients, included: esophagitis (inflammation of the esophagus), gastritis (inflammation of the stomach), hiatal hernia (some stomach above the diaphragm), pancreatitis (inflammation of the pancreas), abdominal pain, hernia, incisional hernia, infection, redundant skin, dehydration, diarrhea (frequent semi-solid bowel movements), abnormal stools, constipation, flatulence (gas), dyspepsia (upset stomach), eructation (belching), cardiospasm (an obstruction of passage of food through the bottom of the esophagus), hematemsis (vomiting of blood), asthenia (fatigue), fever, chest pain, incision pain, contact dermatitis (rash), abnormal healing, edema (swelling), paresthesia (abnormal sensation of burning, prickly, or tingling), dysmenorrhea (difficult periods), hypochromic anemia (low oxygen carrying part of blood), band system leak, cholecystitis (gall stones), esophageal ulcer (sore), port displacement, port site pain, spleen injury, and wound infection. Be sure to ask your surgeon about these possible complications and any of these medical terms that you don't understand.

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2. Is there a chance the device will need to be removed?

The LAP-BAND System is a long-term implant, but it may have to be removed or replaced at any time. For instance, the device may need to be removed to manage any adverse reactions you might have. The device may also need to be removed, repositioned or replaced if you aren't losing as much weight as you and your doctor feel you should be losing.

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3. What are the specific risks and possible complications?

Talk to your doctor about all of the following 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 of possible problems. They include:

    * spleen or liver damage (sometimes requiring spleen removal)
    * damage to major blood vessels
    * lung problems
    * thrombosis (blood clots)
    * rupture of the wound
    * perforation of the stomach or esophagus during surgery

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

There are also problems that can occur that are directly related to the LAP-BAND System:

    * The band can spontaneously deflate because of leakage. That leakage can come from the band, the reservoir, 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 be blocked.
    * 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 the esophagus has stretched or dilated in some patients. This could be caused by:
          o improper placement of the band
          o the band being tightened too much
          o stoma obstruction
          o binge eating
          o excessive vomiting

      Patients who have a weaker esophagus may be more likely to have this problem. A weaker esophagus is one that is not good at pushing food through. Tell your surgeon if you have difficulty swallowing. Then your surgeon can evaluate this.

      Weight loss with the LAP-BAND System is typically slower and more gradual than with some other weight-loss surgeries. Tightening the band too fast or too much to try to speed up weight loss should be avoided. The stomach pouch and/or esophagus can become enlarged as a result. You need to learn how to use your band as a tool that can help you reduce the amount you eat.

      Infection is possible. Also, the band can erode into the stomach. This can happen right after surgery or years later, although this rarely happens.

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

      Some patients have more nausea and vomiting than others. You should see your physician at once if vomiting persists. Rapid weight loss may lead to symptoms of:
          o malnutrition
          o anemia
          o related complications

      It is possible you may not lose much weight or any weight at all. You could also have complications related to obesity.

      If any complications occur, you may need to stay in the hospital longer. You may also need to return to the hospital later. A number of less serious complications can also occur. These may have little effect on how long it takes you to recover from surgery.

      If you have existing problems, such as diabetes, a large hiatal hernia (part of the stomach in the chest cavity), Barrett's esophagus (severe, chronic inflammation of the lower esophagus), or emotional or psychological problems, you may have more complications. Your surgeon will consider how bad your symptoms are, and if you are a good candidate for the LAP-BAND System surgery. You also have more risk of complications if you've had a surgery before in the same area. If the procedure is not done laparoscopically by an experienced surgeon, you may have more risk of complications.

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

      Some people need folate and vitamin B12 supplements to maintain normal homocycteine levels. Elevated homocycteine levels can increase risks to your heart and the risk of spinal birth defects.

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

      There have been no reports of autoimmune disease with the use of the LAP-BAND System. Autoimmune diseases and connective tissue disorders, though, have been reported after long-term implantation of other silicone devices. These problems can include systemic lupus erythematosus and scleroderma. At this time, there is no conclusive clinical evidence that supports a relationship between connective-tissue disorders and silicone implants. Long-term studies to further evaluate this possibility are still being done. You should know, though, that if autoimmune symptoms develop after the band is in place, you may need treatment. The band may also need to be removed. Talk with your surgeon about this possibility. Also, if you have symptoms of autoimmune disease now, the LAP-BAND System may not be right for you.

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4. Will I be sick a lot after the operation?

The LAP-BAND System limits food intake. If you feel nauseated or sick on a regular basis, it may mean that you are not chewing your food well enough or that you are not following the diet rules properly. However, it could also mean that there is a problem with the placement of the band, so contact your doctor if this problem persists. Vomiting should be avoided as much as possible as it can cause the small stomach pouch to stretch. It can also lead to slippage of part of the stomach through the band and reduce the success of the operation. In some cases, it can require another operation.

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5. How long will it take to recover after surgery?

If LAP-BAND surgery is performed laparoscopically, patients typically spend less than 24 hours in the hospital. It takes most patients about a week to return to work and a month to six weeks to resume exercising. In the case of open surgery or if there are complications, recovery may take longer.

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6. How much weight will I lose?

Weight-loss results vary from patient to patient, and the amount of weight you lose depends on several things. The band needs to be in the right position, and you need to be committed to your new lifestyle and eating habits. Obesity surgery is not a miracle cure, and the pounds won't come off by themselves.

It is very important to set achievable weight-loss goals from the beginning. A weight loss of 2 to 3 pounds a week in the first year after the operation is possible, but one pound a week is more likely. Twelve to eighteen months after the operation, weekly weight loss is usually less. Remember that you should lose weight gradually. Losing weight too quickly creates a health risk and can lead to a number of problems. The main goal is to have weight loss that prevents, improves, or resolves health problems connected with severe obesity.

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7. How do the weight-loss results with the LAP-BAND compare to those with the gastric bypass?

Surgeons have reported that gastric bypass patients lose weight faster in the first year. At five years, however, many LAP-BAND patients have achieved weight loss comparable to that of gastric bypass patients1,2. Focus on long-term weight loss and remember that it is important to lose weight gradually while reducing obesity-related risks and improving your health.

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8. Does the LAP-BAND require frequent visits to my doctor after surgery?

Check-ups with your doctor are a normal and very important part of the LAP-BAND System follow-up. Many surgeons see their patients weekly or biweekly during the first month and every four to twelve weeks for the first year. Adjustments are performed during some of these visits. It is typical for follow-up visits to be scheduled every three to six months during the second and third year, depending on the individual case.

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9. Does the LAP-BAND limit any physical activity?

The LAP-BAND does not hamper physical activity including aerobics, stretching and strenuous exercise.

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10. How is the band adjusted?

Adjustments are often carried out in the X-ray department. They are done there so the access port can be clearly seen. When X-rays are used, your reproductive organs should be shielded. Sometimes adjustments can be done in an outpatient clinic or office, and local anesthesia may or may not be needed. A fine needle is passed through the skin into the access port to add or subtract saline. This process most often takes only a few minutes and most patients say it is nearly painless.

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11. Do I have to be careful with the access port just underneath my skin?

There are no restrictions based on the access port. It is placed under the skin in the abdominal wall, and once the incisions have healed it should not cause discomfort or limit any physical exercise. The only sensation you may experience from the port occurs when you go in for adjustments. If you feel persistent discomfort in the port area, talk to your doctor.

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12. Can the band be removed?

Although the LAP-BAND System is not meant to be removed, it can be, in some cases laparoscopically. Surgeons report that the stomach generally returns to its original shape once the band is removed. After the removal, though, you may soon go back up to your original weight. You may also gain more.

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13. Will I need plastic surgery for the surplus skin when I have lost a lot of weight?

That is not always the case. As a rule, plastic surgery will not be considered for at least a year or two after the operation as, sometimes the skin will mold itself around the new body tissue. Give the skin the time it needs to adjust before you decide to have more surgery.

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14. Is it true that the LAP-BAND seems "tighter" in the morning?

This is a fairly common feeling, especially for people with bands that are tight or just after an adjustment. During the day the water content in the body changes and this may cause the band to feel "tighter" some of the time. Some women have also noticed that the LAP-BAND feels tighter during menstruation.

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15. Will I feel hungry or deprived with the LAP-BAND?

The LAP-BAND makes you eat less and feel full in two ways - first by reducing the capacity of your stomach and second by increasing the time it takes food to get through the digestive system. After a small meal, the amount of which varies from person to person, you should feel full. If you follow the nutrition guidelines when you choose your food and then chew it well, you should not feel hungry or deprived. Remember that the LAP-BAND is a tool to help you change your eating habits.

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16. What will happen if I become ill?

One of the major advantages of the LAP-BAND System is that it can be adjusted. If your illness requires you to eat more, the band can be loosened by removing saline from it. When you have recovered from your illness and want to lose weight again, the band can be tightened by increasing the amount of saline. If the band cannot be loosened enough, it may have to be removed.

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17. What about pregnancy?

Becoming pregnant can be easier as you lose weight. Your menstrual cycle may become more regular. If you need to eat more while you are pregnant, the band can be loosened. After pregnancy, the band may be made tighter again and you can resume losing weight.

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18. Will I need to take vitamin supplements?

You may. It's possible to not get enough vitamins from three small meals a day. At your regular check-ups, your specialist will evaluate whether you are getting enough vitamin B12, folic acid, and iron. Your surgeon may advise you to take supplements.

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19. What about other medication?

You should be able to take prescribed medication, though you may need to use capsules, break big tablets in half or dissolve them in water so they do not get stuck in the stoma and make you sick. Always ask the doctor who prescribes the drugs about this. Your surgeon may tell you to avoid taking aspirin and other nonsteroidal anti-inflammatory pain relievers because they may irritate the stomach. The problems these drugs may cause could result in band removal.

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20. What if I go out to eat?

Order only a small amount of food, such as an appetizer. Eat slowly. Finish at the same time as your table companions. You might want to let your host or hostess know in advance that you cannot eat very much.

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21. What about alcohol?

Alcohol has a high number of calories and breaks down vitamins. An occasional glass of wine or other alcoholic beverage, though, is not considered harmful to weight loss3.

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22. Can I eat anything in moderation?

After your stomach has healed, you may eat most foods that don't cause you discomfort. However, because you can only eat a little it is important to include foods full of important vitamins and nutrients as advised by your surgeon and/or dietitian. If you eat foods that contain lots of sugar and fat or drink liquids full of "empty" calories, such as milkshakes, the effect of the LAP-BAND may be greatly reduced or even cancelled.

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23. Will I suffer from constipation?

There may be some reduction in the volume of your stools, which is normal after a decrease in food intake because you eat less fiber. This should not cause you severe problems. If difficulties do arise, check with your doctor. He or she may suggest you take a mild laxative and drink plenty of water for a while. Your needs will vary, but you should drink at least 6-8 glasses of water a day.

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