(a)

1. (1) Pursuant to Acts 2003, No. 1356 of the 84th General Assembly, 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 complications that can result from the surgery.

2. (2) The complications and information the patient must be informed of are as follows:

   1. (A) The potential risks, complications, and benefits of the weight loss surgery;
   2. (B) The alternatives to surgery including nonsurgical options;
   3. (C) The need for dietary changes, a development of an exercise plan, and the possible need for counseling;
   4. (D) The importance of proper nutrition, eating a balanced diet, and taking vitamin and mineral supplements for the remainder of their life;
   5. (E) There is no guarantee of weight loss or long-term weight management as a result of getting the surgery;
   6. (F) A lifetime of follow up medical care is required;
   7. (G) Lab work will be required annually or more often than that as directed by the physician;
   8. (H) Potentially serious complications from the surgery could result in death, further surgery, or prolonged hospital stays for the patient;
   9. (I) The following surgical complications may arise:

(b) (b) This may require a transfusion of blood or blood products;

1. (ii)

(b) (b) These could lead to wound breakdowns and hernia formation;

1. (iii) Perforations (leaks) of the stomach or intestine causing peritonitis, subphrenic abscess, or enteroenteric or enterocutaneous fistulas;

   1. (iv) Sepsis;

      1. (v) Systemic Inflammatory Response Syndrome (SIRS);
      2. (vi) Adult Respiratory Distress Syndrome (ARDS);
      3. (vii) Myocardial infarction (heart attack);
      4. (viii) Cardiac rhythm disturbances;
      5. (ix) Congestive heart failure;
      6. (x) Atelectasis;
      7. (xi) Pneumonia;
      8. (xii) Pulmonary edema (fluid in the lungs);
      9. (xiii) Pleural effusions (fluid around the lungs);
      10. (xiv) Injury to adjacent structures, including the spleen, liver, diaphragm, pancreas, and colon;
      11. (xv) Possible removal of the spleen;
      12. (xvi) Stroke;
      13. (xvii) Kidney failure; (xviii) Pressure sores;
      14. (xix) Deep vein thrombosis (blood clots in the legs or arms);
      15. (xx) Pulmonary embolism (blood clots migrating to the heart and lungs);
      16. (xxi) Staple line disruption;
      17. (xxii) Ulcer formation (marginal ulcer or in the distal stomach); (xxiii) Small bowel obstructions;
      18. (xxiv) Internal hernias;
      19. (xxv) Incisional hernias (this includes port sites for laparoscopic access);
      20. (xxvi) Dehiscence or evisceration; (xxvii) Inadequate or excessive weight loss; (xxviii) Kidney stones;
      21. (xxix) Gout;
      22. (xxx) Encephalopathy;
      23. (xxxi) Stoma stenosis; (xxxii) Urinary tract infections; and (xxxiii) Esophageal, pouch, or small bowel motility disorders;

   2. (J) Nutritional complications to include:

      1. (i) Protein malnutrition;
      2. (ii) Vitamin deficiencies, including B12, B1, B6, Folate, and fat-soluble vitamins A, D, E, and K;
      3. (iii) Mineral deficiencies, including calcium, magnesium, iron, zinc, copper, and other trace minerals; and
      4. (iv) Uncorrected deficiencies can lead to anemia, neuro-psychiatric disorders, and nerve damage, that is neuropathy;

   3. (K) Psychiatric complications to include:

      1. (i) Depression;
      2. (ii) Bulimia;
      3. (iii) Anorexia; and
      4. (iv) Dysfunctional social problem;

   4. (L) Other complications to include:

      1. (i) Adverse outcomes may be precipitated by smoking;
      2. (ii) Constipation;
      3. (iii) Diarrhea;
      4. (iv) Bloating;
      5. (v) Cramping;
      6. (vi) Development of gallstones;
      7. (vii) Intolerance of refined or simple sugars, dumping with nausea, sweating, and weakness;
      8. (viii) Low blood sugar, especially with improper eating habits;
      9. (ix) Vomiting and inability to eat certain foods, especially with improper eating habits or poor dentition;
      10. (x) Loose skin;
      11. (xi) Intertriginous dermatitis due to loose skin;
      12. (xii) Malodorous gas, especially with improper food habits;
      13. (xiii) Hair loss (alopecia);
      14. (xiv) Anemia;
      15. (xv) Bone disease;
      16. (xvi) Stretching of the pouch or the stoma;
      17. (xvii) Low blood pressure; (xviii) Cold intolerance;
      18. (xix) Fatty liver disease or nonalcoholic liver disease (NALF);
      19. (xx) Progression of preexisting NALF or cirrhosis;
      20. (xxi) Vitamin deficiencies, some of which may already exist before surgery; and
      21. (xxii) Diminished alcohol tolerance; and

   5. (M) Pregnancy complications should be explained as follows:

      1. (i) Pregnancy should be deferred for twelve to eighteen (12 – 18) months after surgery or until after the weight loss is stabilized;
      2. (ii) Vitamin supplementation during the pregnancy should be continued;
      3. (iii) Extra folic acid should be taken if the pregnancy is planned;
      4. (iv) Obese mothers have children with a higher incidence of neural tube defects and congenital heart defects;
      5. (v) Pregnancy should be discussed with the obstetrician;
      6. (vi) Special nutritional needs may be indicated or necessary;
      7. (vii) Secure forms of birth control should be used in the first year after surgery; and
      8. (viii) Fertility may improve with weight loss.

(b)

1. (1) Some or all of the complications listed in this section may exist in a patient whether the surgical procedure of gastric bypass is performed on the patient or not.

2. (2) This section is not meant to imply that in all cases gastric bypass surgery is the only cause of these complications.

   1. (c) 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, Arkansas Code § 17-95-201 et seq., Arkansas Code § 17-95-301 et seq., and Arkansas Code § 17-95-401 et seq., and may result in disciplinary proceedings before the Arkansas State Medical Board pursuant to law.