Pursuant to Act 1356 of the 84th
General Assembly of 2003, all physicians in this state, prior to performing
gastric bypass surgery, also known as open or laparoscopic Roux En Y, will have
the patient sign an informed consent form acknowledging that they have been
told information about various complication that can result from the surgery.
The complications and information the patient must be informed of are as
follows:
A. The potential risks,
complications and benefits of the weight loss surgery.
B. The alternatives to surgery including
non-surgical options.
C. The need
for dietary changes, a development of an exercise plan and the possible need
for counseling.
D. The importance
of proper nutrition, eating a balanced diet and taking vitamin and mineral
supplements for the remainder of their life.
E. There is no guarantee of weight loss or
long -term weight management as a result of getting the surgery.
F. A lifetime of follow up medical care is
required.
G. Lab work will be
required annually or more often than that as directed by the
physician.
H. Potentially serious
complications from the surgery could result in death, further surgery or
prolonged hospital stays for the patient.
I. The following surgical complications may
arise:
1. Bleeding, this may require a
transfusion of blood or blood products.
2. Surgical site infections, either
superficial or deep to include port sites for laparoscopic access. These could
lead to wound breakdowns and hernia formation.
3. Perforations (leaks) of the stomach or
intestine causing peritonitis, subphrenic abscess or enteroenteric or
enterocutaneous fistulas.
4.
Sepsis
5. Systemic Inflammatory
Response Syndrome (SIRS)
6. Adult
Respiratory Distress Syndrome (ARDS)
7. Myocardial infarction (heart
attack)
8. Cardiac rhythm
disturbances
9. Congestive heart
failure
10. Atelectasis
11. Pneumonia
12. Pulmonary edema (fluid in the
lungs)
13. Pleural effusions (fluid
around the lungs)
14. Injury to
adjacent structures, including the spleen, liver, diaphragm, pancreas and
colon.
15. Possible removal of the
spleen
16. Stroke
17. Kidney failure
18. Pressure sores
19. Deep vein thrombosis (blood clots in the
legs or arms)
20. Pulmonary
embolism (blood clots migrating to the heart and lungs)
21. Staple line disruption
22. Ulcer formation (marginal ulcer or in the
distal stomach)
23. Small bowel
obstructions
24. Internal
hernias
25. Incisional hernias,
this includes port sites for laparoscopic access
26. Dehiscence or evisceration
27. Inadequate or excessive weight
loss
28. Kidney stones
29. Gout
30. Encephalopathy
31. Stoma stenosis
32. Urinary tract infections
33. Esophageal, pouch or small bowel motility
disorders
J. Nutritional
complications to include:
1. Protein
malnutrition
2. Vitamin
deficiencies, including B12, Bl, B6, Folate and fat soluble vitamins A, D, E
and K
3. Mineral deficiencies,
including calcium, magnesium, iron, zinc, mpper and other trace
minerals
4. Uncorrected
deficiencies can lead to anemia, neuro-psychiatric disorders and nerve damage,
that is neuropathy
K.
Psychiatric complications include:
1.
Depression
2. Bulimia
3. Anorexia
4. Dysfunctional social problem
L. Other complications to include:
1. Adverse outcomes may be precipitated by
smoking
2. Constipation
3. Diarrhea
4. Bloating
5. Cramping
6. Development of gallstones
7. Intolerance of refined or simple sugars,
dumping with nausea, sweating and weakness
8. Low blood sugar, especially with improper
eating habits
9. Vomiting,
inability to eat certain foods, especially with improper eating habits or poor
dentition
10. Loose skin
11. Intertriginous dermatitis due to loose
skin
12. Malodorous gas, especially
with improper food habits
13. Hair
loss (alopecia)
14.
Anemia
15. Bone disease
16. Stretching of the pouch or the
stoma
17. Low blood
pressure
18. Cold
intolerance
19. Fatty liver disease
or non-alcoholic liver disease (NALF)
20. Progression of preexisting NALF or
cirrhosis
21. Vitamin deficiencies
some of which may already exist before surgery
22. Diminished alcohol tolerance
M. Pregnancy complications should
be explained as follows:
1. Pregnancy should
be deferred for 12-18 months after surgery or until after the weight loss is
stabilized
2. Vitamin
supplementation during the pregnancy should be continued
3. Extra folic acid should be taken if the
pregnancy is planned
4. Obese
mothers have children with a higher incidence of neural tube defects and
congenital heart defects
5.
Pregnancy should be discussed with the obstetrician
6. Special nutritional needs may be indicated
or necessary
7. Secure forms of
birth control should be used in the first year after surgery
8. Fertility may improve with weight loss
Some or all of the complications listed in this regulation may
exist in a patient whether the surgical procedure of gastric bypass is pe
rformed on the patient or not. This regulation is not meant to imply that in
all cases gastric bypass surgery is the only cause of these
complications.
The failure of a physician to inform a patient, prior to gastric
bypass surgery, of the above complications and obtaining the patient's
signature on a form acknowledging the same will be a violation of the Arkansas
Medical Practices Act and may result in disciplinary proceedings before the
Board pursuant to law.
History: Adopted December 4, 2003; Amended February 5,
2004.
