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Informed consent laparoscopic possible open roux-en-y divided gastric bypass
Informed Consent Laparoscopic Possible Open LapBand
G. Derek Weiss, M.D., F.A.C.S.
John S. Oldham, Jr., M.D.
You have decided to undergo laparoscopic, possible open, LapBand placement. During the last several
weeks/months, as we have prepared you for your surgery, we have provided you with complete and detailed
information about the operation, as well as the other options and procedures, which you have, for control of
your weight. You have learned about the potential benefits and risks to you in having the operation. The
purpose of this consent is to confirm your decision, based upon complete knowledge and understanding of the
operation. You may always change your mind about proceeding with the operation.
This consent form should convey 1) the nature of your condition, 2) the general nature of the procedure/surgery,
3) the risks of the proposed treatment/procedure, and 4) reasonable therapeutic alternatives and risks associated
with such alternatives. You have the right, as the patient, to be informed about your condition and the
recommended surgical procedure, so that you may make the decision whether or not to undergo this elective
procedure after knowing the risks and hazards involved.
Please read this information carefully and ask about anything you may not understand.
Morbid obesity is a disease that often has multiple associated medical illnesses and is associated with a
significant decrease in life expectancy. Many of these can be reversed with significant durable weight loss. The
National Institutes of Health panel of physician experts concluded that for the great majority of the morbidly
obese, diet/exercise/medications including M.D. supervised medications/diets have a high failure rate and that
bariatric surgery is the most effective tool to achieve long term weight loss in these patients. The risk of a non-
surgical approach to your morbid obesity, therefore, is a very high failure rate in significant, long-term weight
loss resulting in increased risk for obesity-related medical illnesses and decreased life expectancy.
The LapBand is designed to create a small reservoir at the upper end of the stomach by placing a silicone
adjustable band. This is usually placed laparoscopically although the open method may be used in some rare
instances (“Open” bariatric surgery carries a higher complication rate than a minimally invasive/laparoscopic
approach in appropriately trained and experienced surgeons). The procedure involves making several small
incisions through which the surgeon(s) insert laparoscopic instruments to make the necessary changes and apply
and secure the LapBand device to the upper portion of the stomach. There is also a port attached to the LapBand
device that is secured to underlying muscle on the abdomen. The port can be accessed in the post-operative
period by the surgical team, using a special needle, to make necessary adjustments of the inside lumen. This
procedure functionally restricts the size of the stomach to about 2-oz and is considered a strictly gastric
restrictive procedure although some suggest, when appropriately adjusted, it does decrease appetite as well. The
difference between this and other restrictive bariatric procedures is that the restrictive effect can be adjusted,
and this currently is the only bariatric procedure that can be adjusted without surgery in the post-operative
period. Weight loss occurs by restricted intake – the purpose of the smaller stomach pouch is to create the
sensation of fullness earlier (satiety), thereby decreasing the desire for food and limiting the volume of food one
is capable of consuming at one time. There is no division or bypass of the stomach. Of note, with this limited
intake, if you eat too much at one meal, you may feel discomfort and may even vomit until you learn the
capacity of your “new” stomach. It generally carries the least complications of the current bariatric procedures.
Weight loss is more gradual than other bariatric procedures and eating high calorie liquid or soft foods can
circumvent the procedure. There is no malabsorption of nutrients, no “leaks”, and no “dumping” (see below).
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The usual hospital stay is less than 23 hours (outpatient or same day surgery). Weight loss with the LapBand is
reported at 35-68% of excess body weight. Health problems associated with excess weight are also usually
benefited. Lastly, the LapBand is easily reversible/removed and can be laparoscopically converted to a Roux-
en-Y gastric bypass if needed/desired.
Other bariatric procedures are available including laparoscopic and open Roux-en-Y gastric bypass, vertical
banded gastroplasty (VBG), and duodenal switch/biliopancreatic diversion. Experimental procedures such as
gastric pacing are not available outside the research setting at this time.
The Roux-en-Y divided gastric bypass is the most widely accepted and common procedure performed by
bariatric surgeons in the United States. Weight loss with the Roux-en-Y divided gastric bypass usually exceeds
50% of excess body weight, and many patients lose 75% or more of excess weight. Health problems associated
with excess weight are also usually benefited. Roux-en-Y divided gastric bypass is designed to make a small
reservoir (“pouch”) for food at the upper end of your stomach with a capacity of about 2-oz. This pouch is
connected to the upper small intestine by a new small anastomosis (outlet) of about ½ inch (1.2 cm) in diameter.
The ingested food thereby bypasses the majority of your stomach, which remains alive and undisturbed, but
functional otherwise. In other words, the majority of your stomach does not have food passing through. It often
is associated with a permanent decrease in appetite. The nature and purpose of this operation is to functionally
limit the amount of food or liquid intake at any given time. There also may be a small component of
malabsorption, at least initially. There are side effects such as “dumping” which can occur after eating sweets or
fatty foods and although unpleasant, is an after effect that some find useful in reinforcing good dietary choices.
The risk of gastric bypass is low, but complications such as a “leak” at the suture/staple line can be serious.
Strictures, internal hernias, and outlet ulcers are also a possibility not seen with the LapBand.
The VBG aims to functionally restrict the size of the stomach. It is not adjustable and is associated with a high
failure rate and reflux. For these reasons, is out of favor with the majority of bariatric surgeons.
The duodenal switch/biliopancreatic diversion procedures are malabsorptive procedures and generally carry the
highest complication rate among bariatric procedures. Weight loss occurs by lack of absorption of nutrients
rather than by loss of appetite and restricted intake. These procedures can cause foul smelling diarrhea and can
be complicated by anemia, protein malnutrition, liver failure, vitamin (especially fat-soluble) and mineral
Regardless, all available procedures are TOOLS, which when used appropriately, will allow you to lose a
significant amount of weight and keep it off and have proven benefit over non-surgical weight loss.
For most, weight loss is more gradual with the LapBand than the gastric bypass however the weight loss for the
two groups is about the same after three years in compliant patients. More than any other bariatric procedure,
your chance of achieving your weight loss goals is greatest if you continue regular follow-up with our bariatric
program after your surgery to monitor your progress and perform adjustments as necessary. Like any other
bariatric procedure, there are ways to defeat the purpose of surgery and gain weight. It is also possible to defeat
the purpose of surgery by continuous drinking of high calorie soft foods or liquids and/or snacking throughout
the day. In general, if you choose a balanced menu high in protein content, eat at normal times, and incorporate
exercise into your daily routine, this tool will allow you to lose weight and weight and keep it off for the long
Understandably, you should not be pregnant at the time of surgery or it will be canceled and rescheduled in that
event. If you are a woman, you should avoid pregnancy for the first year post-operatively. Periods of rapid
Lap Band Page 3
weight loss are not the right time to be carrying and nourishing a baby and may lead to complications of the
pregnancy or with the baby. Although you may think you are infertile (unable to bear children), this is often
related to the obesity and once you lose the weight, you may be more likely to get pregnant. So please use
caution in the first year after surgery.
Alcohol consumption is discouraged, as it is a high calorie liquid, which can defeat the purpose of the surgery.
You may also experience increased intoxication with less volume intake than prior to surgery for unclear
General risks which apply to all abdominal surgery include but are not limited to anesthesia (greater in the
morbidly obese), deep venous thrombosis (DVT), pulmonary embolism, death, brain damage, infection,
bleeding, pneumonia, cardiac events (heart attack), stroke, bowel obstruction, intra-abdominal abscess, damage
to other intra-abdominal structures (bowel, solid organs, blood vessels) adhesions (less with laparoscopic than
open procedures), wound infections (less with the laparoscopic approach), incisional hernias (much less with
the laparoscopic approaches’ small incisions), internal hernias, disfiguring scars, the loss of function of body
organs, chronic pain, among others. To this end, in addition to meticulous surgical technique, we try and
prevent these complications in several ways.
You will need medical and possibly cardiac clearance prior to surgery. You may also be required to meet the
anesthesiologist pre-operatively. This is all done to make sure as best as possible that you are at a low or
acceptable risk for anesthesia. If your doctors recommend further testing (such as a stress test, echocardiogram,
etc.), it must be performed and deemed acceptable prior to scheduling surgery. In addition, most patients will
have a medical doctor follow them during their hospitalization.
Blood clots in the veins in the legs or pelvis (DVT’s) can migrate to the lungs (pulmonary embolism) which can
be fatal. Fortunately the risk of this is less than one percent. To avoid this serious complication which can occur
after any type of surgery, we take several important measures. You will be asked to ambulate early, usually in
the first six hours after surgery. We also want you to walk as much as possible prior to surgery to increase blood
flow in the legs. We will have compression stockings on your legs during the surgery and until you are walking
well. We will give you blood thinner subcutaneously during your hospital stay. We will use Toradol, an anti-
inflammatory with some blood thinning properties (anti-platelet), during the first 48 hours. We will give you a
folate vitamin (Foltx) pre-operatively and for one month post-operatively. Folate has been shown to help lower
your homocysteine levels, high levels of which have been reported to be associated with increased blood
clotting. We generally have quick operative times as the risk of DVT goes up with increased length of surgery.
Smoking carries with it an increased risk of clotting and we ask that you stop smoking one month prior to and
after surgery. Hormones (birth control pills, menopause hormones) have been shown to increase the clotting
rate and therefore we require that you avoid hormones for one month before and after your surgery.
Pulmonary complications such as pneumonia and atelectasis (partial collapse of the lungs) can occur after any
type of surgery under general anesthetic. Once again, there are several things you can do to decrease your risk
of these complications including stopping smoking, early walking after surgery, and using your incentive
spirometer. The incentive spirometer is a device to help you expand your lungs in the post-operative period and
you will be given one to take home and practice with prior to your surgery. If you are a smoker, you are at
increased risk of pulmonary complications. Only very rarely do pulmonary complications require prolonged
need for a ventilator (breathing machine).
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Stay well hydrated the day prior to surgery and then nothing to eat after midnight for surgery the next day. The
anesthesiologist will tell you which of your medications you can take the morning of surgery with a sip of
It is unusual that you will need a blood transfusion, as the risk of significant bleeding is less than 1%. If you
require blood, you will be transfused American Red Cross Blood. The most common risks of transfusion are:
2) transfusion reaction – an exceedingly rare instance in which you would receive the wrong blood type which
can cause serious illness, possibly kidney failure 3) Hepatitis – a viral infection of the liver, which can rarely lead to acute liver failure or more likely, can lead to chronic infection which over time can cause cirrhosis and possibly liver failure. Risk 1:3,000 4) HIV – a viral infection which can lead to AIDS. Risk 1:10,000
Risks which apply in particular to the LapBand include the above as well as the following:
1) Slippage of the band: This risk is about 1-2%. Stomach surrounding the band can slip up causing
obstructive symptoms or reflux. It generally occurs with episodes of severe retching, especially early in the post-operative period before the band has scarred in completely. The band is sutured in place during the initial operation. If a slip occurs, it can be repaired in most instances by re-suturing it in place laparoscopically as an outpatient procedure (same day surgery).
2) Damage to the spleen or other organs: The spleen lies close to the upper portion of the stomach and can
be injured in up to 10% of open upper surgeries on the stomach. Fortunately, it is very rare to injure the
spleen during laparoscopic surgery, and the rate is under 1%. If your spleen is injured, this most likely will
require conversion to an open procedure and removal of the spleen to prevent exsanguination (bleeding to
death). In general, you do not need your spleen. However, if you are under 40 years of age, it does afford
protection against certain types of infection and we try to salvage the spleen whenever possible. Pancreatitis
is a rare but reported complication. Liver injury rarely requires any additional treatment. Unrecognized
injury rarely occurs to the stomach or intestines but can lead to peritonitis requiring more surgery. If
recognized, it can be repaired (usually laparoscopically) but the band placement may need to be postponed
to avoid infection.
3) Infection: The risk of band and/or port infection is less than 1%. The entire band/tubing/port is placed
sterilely and resides completely underneath the skin. It can become infected if accessed un-sterilely, if you
develop an infection in another location (urinary tract, pneumonia, etc.) that “seeds” the port/band, or if you
develop an erosion (see below). Once again, this is very rare. Unfortunately, however, if you develop an
infection, the band/port (a foreign body) must be removed. It can be replaced, usually laparoscopically, at a
future time once all infection has resolved.
4) Erosion: A rare complication reported mostly in the early studies in Europe and Australia. Apparently the
band erodes into the stomach causing a loss of restriction and weight gain. It usually does not cause significant peritonitis (intra-abdominal infection), but does require laparoscopic removal of the band/port. It can be laparoscopically replaced at a later date.
5) Port problems: Leaks where the port connects to the band tubing are now very unusual since the company
re-designed the connection to rest in the abdominal cavity rather than on the muscle.
6) Death: The mortality rate of LapBand is well under 0.5% and parallels the death rate of procedures such as
elective laparoscopic cholecystectomy in similar patients. Although very safe, LapBand placement is still Lap Band Page 5
7) major surgery and you and your family members should realize that complications of this procedure could
8) Psychological factors including post-operative depression (as a result of weight loss, required diet
change, complications of surgery) or possibly a reaction to the stress of surgery are possible: Family
members may also experience these. Studies have shown that most patients have an improvement in
depressive symptoms after surgery, and it is much more likely that you will be very pleased with this life-
changing procedure rather than the opposite.
9) Gallstones: There is an increased risk of developing gallstones after LapBand. The exact mechanism is
unknown, but gallstones do develop more often during periods of rapid weight loss. We do not remove your gall bladder at the same time unless you have known stones, gallbladder disease, or abnormality seen at the time of surgery. Some studies suggest that taking a prescription medication (Actigall) in the post-operative period may decrease the rate of gallstone formation. This may or may not be covered by your insurance company and will be prescribed on patient request only, so let us know if you are interested.
10) Extreme weight loss: Fortunately this is very rare. Most people will stabilize at a weight that is healthy for
11) Failure to lose weight: Although almost everyone will lose weight early on, it is possible to defeat the
purpose of this surgery as discussed above. 12) Gas pains or excessive flatulence can occur and are usually controlled with simethicone, sometimes
Levsin: In general, LapBand should not effect your bowel habits to any significant degree.
13) Large folds of skin: This is always a possibility with significant weight loss. There is no reliable way to
determine before surgery if this will occur after surgery. Plastic surgeries are available to correct this problem if desired. 14) It is also possible to get food stuck at the level of the band if you eat too large a piece of food, don’t
chew well, or advance your diet more rapidly than advised: This may require an endoscopy to clear the
Other complications may possibly occur with less frequency. Not all side effects or hazards of the operation may be known, and the result of surgery cannot be guaranteed. Once again, every effort is made to prevent problems, and you need to understand and accept that they may still occur. Although over 95,000 LapBand procedures have been performed worldwide since 1993, and the LapBand received FDA approval in the United States in June 2001, there may be long term problems not known at this time. Re-operation may be needed, at some future time, to correct problems, which might occur. The LapBand is reversible, usually laparoscopically, although there is seldom any practical reason to consider reversal or laparoscopic conversion to bypass. Certainly advances in medical treatment of obesity may occur in the future that would possibly make reversal an appropriate option. Surgical treatment is a participatory alternative (elective) and should not be considered a cure-all or quick fix. It does not affect the underlying causes of obesity whether genetic, environmental, psychological, or hormonal. However, in most cases, surgery is effective in achieving durable weight loss. Lap Band Page 6
You have the right to a second opinion.
You have attended and educational seminar.
You have been given the opportunity to attend support groups and to discuss the results of this procedure with
Your family and friends are encouraged to participate in the educational process, as their support is important
and beneficial following surgery.
You give the consent to the existing possibility that once the procedure has been begun laparoscopically; it may
be necessary to convert to an open procedure. This will be decided by your surgeon and performed with your
best interest in mind. Any other encountered pathology (abnormalities) seen at the time of surgery will be
addressed as indicated in the surgeon’s best judgment. In the rare event that the LapBand cannot be placed
laparoscopically, and you would rather have the LapBand procedure aborted rather than proceed with open
surgical placement, please notify your surgeon pre-operatively.
Your signature below certifies that:
1) You have read the contents of this form, discussed the above verbally with the surgeon, and
understood the risks, benefits, and alternatives involved and hereby give INFORMED consent to
proceed with LAPAROSCOPIC, POSSIBLE OPEN LAPBAND PLACEMENT.
2) You pledge to cooperate with recommended guidelines for eating and for follow-up.
3) You agree to keep your surgeon informed of your address and phone number, and to participate in
__________________________________________________________________________________________ (Signature __________________________________________________________________________________________ (Signature __________________________________________________________________________________________ __________________________________________________________________________________________
Only the Westlaw citation is currently available. In re ZYPREXA PRODUCTS LIABILITY LITIGATION. This Document Relates to All Actions. MDL No. 1596. ORDER REGARDING DAVID EGILMAN, M.D., M.P.H. *1 Upon consideration of the moving party's request for an Order to Show Cause, the response of David Egilman, M.D., M.P.H., and having heard oral argument, IT IS HEREBY ORDERED that: 1. Dr. Egilm