While the LAP-BAND® System is an effective treatment
for morbid obesity, the pounds do not come off by themselves. The
LAP-BAND® System is an aid to support you in achieving lasting results
by limiting food intake, reducing appetite and slowing digestion.
However, your motivation and commitment to adopt a new lifestyle are
extremely important for long-term weight loss. New eating habits must be
adhered to for the rest of your life. Exercise is an equally important
component of a changed lifestyle.
Risks of Lap-Band Surgery
A brief description of relevant contraindications,
warnings and adverse events of the LAP-BAND® System
Indications: The LAP-BAND® System is indicated
for use in weight reduction for severely obese patients with a Body Mass
Index (BMI) of at least 40 or a BMI of at least 35 with one or more
severe co-morbid conditions, or those who are 100 lbs. or more over
their estimated ideal weight.
Contraindications: The LAP-BAND® System is not
recommended for non-adult patients, patients with conditions that may
make them poor surgical candidates or increase the risk of poor results,
who are unwilling or unable to comply with the required dietary
restrictions, or who currently are or may be pregnant.
Warnings: The LAP-BAND® System is a long-term
implant. Explant and replacement surgery may be required at some time.
Patients who become pregnant or severely ill, or who require more
extensive nutrition may require deflation of their bands. Patients
should not expect to lose weight as fast as gastric bypass patients, and
band inflation should proceed in small increments. Anti-inflammatory
agents, such as aspirin, should be used with caution and may contribute
to an increased risk of band erosion.
Adverse Events: Placement of the LAP-BAND®
System is major surgery and, like any surgery, death can occur. Possible
complications include the risks associated with the medications and
methods used during surgery, the risks associated with any surgical
procedure, and the patient’s ability to tolerate a foreign object
implanted in the body.
Band slippage, erosion and deflation, obstruction of
the stomach, dilation of the esophagus, infection, or nausea and
vomiting may occur. Reoperation may be required.
Rapid weight loss may result in complications that
can require additional surgery. Deflation of the band may alleviate
excessively rapid weight loss or esophageal dilation.
Please Note: Not all contraindications,
warnings or adverse events are included in this brief description. More
detailed risk information is available at
www.lap-band.com or 1-877-LAP-BAND.
Risks from lapband.com
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, indicate 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 thediaphragm), 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
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 arent losing as
much weight as you and your doctor feel you should be losing.
What are the specific risks and
Talk to your doctor about all of the following risks and complications:
- Gastritis (irritated stomach tissue)
- Gastroesophageal reflux (regurgitation)
- Gas bloat
- Dysphagia (difficulty swallowing)
- Weight regain
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
- 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 stomach can be caused by:
- 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:
- Improper placement of the band
- The band being tightened too much
- Stoma obstruction
- Binge eating
- Excessive vomiting
Patients with a weaker esophagus may be more likely to
have this problem. A weaker esophagus is one that is not good at pushing
food through to your stomach. 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
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:
- 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), Barretts 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 youve 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.
Removing the LAP-BAND System
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-BAND
System. However, an "open" procedure may be necessary to remove a band.
In the U.S. Clinical Study, 60% of the bands that were removed were done
laparoscopically. Surgeons report that after the band is removed, the
stomach returns to essentially a normal state.
At this time, there are no known reasons to suggest that the band should
be replaced or removed at some point unless a complication occurs or you
do not lose weight. It is difficult, though, to say whether the band
will stay in place for the rest of your life. It may need to be removed
or replaced at some point. Removing the device requires a surgical
procedure. That procedure will have all the related risks and possible
complications that come with surgery. The risk of some complications,
such as erosions and infection, increase with any added procedure.
Lap band risk information source