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TITLE 25HEALTH SERVICES
PART 7TEXAS MEDICAL DISCLOSURE PANEL
CHAPTER 601INFORMED CONSENT
RULE §601.2Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A

      (iii) Filter migration or fracture (filter could break and/or move from where it was placed).

      (iv) Caval thrombosis (clotting of the main vein in the abdomen and episodes of swelling of legs).

      (v) Risk of recurrent pulmonary embolus (continued risk of blood clots going to blood vessels in the lungs despite filter).

      (vi) Inability to remove filter (for "optional"/retrievable filters).

    (I) Pulmonary angiography.

      (i) All associated risks as listed under paragraph (2)(B) of this subsection.

      (ii) Cardiac arrhythmia (irregular heart rhythm) or cardiac arrest (heart stops beating).

      (iii) Cardiac injury/perforation (heart injury).

      (iv) Death.

    (J) Percutaneous treatment of pseudoaneurysm (percutaneous thrombin injection versus compression).

      (i) Thrombosis (clotting) of supplying vessel or branches in its territory.

      (ii) Allergic reaction to thrombin (agent used for direct injection).

    (K) Vascular access - nontunneled catheters, tunneled catheters, implanted access.

      (i) Pneumothorax (collapsed lung).

      (ii) Injury to blood vessel.

      (iii) Hemothorax/hemomediastinum (bleeding into the chest around the lungs or around the heart).

      (iv) Air embolism (passage of air into blood vessel and possibly to the heart and/or blood vessels entering the lungs).

      (v) Vessel thrombosis (clotting of blood vessel).

    (L) Varicose vein treatment (percutaneous via laser, RFA, chemical or other method) without angiography.

      (i) Burns.

      (ii) Deep vein thrombosis (blood clots in deep veins).

      (iii) Hyperpigmentation (darkening of skin).

      (iv) Skin wound (ulcer).

      (v) Telangiectatic matting (appearance of tiny blood vessels in treated area).

      (vi) Paresthesia and dysesthesia (numbness or tingling in the area or limb treated).

      (vii) Injury to blood vessel requiring additional procedure to treat.

(c) Digestive system treatments and procedures.

  (1) Cholecystectomy with or without common bile duct exploration.

    (A) Pancreatitis.

    (B) Injury to the tube between the liver and the bowel.

    (C) Retained stones in the tube between the liver and the bowel.

    (D) Narrowing or obstruction of the tube between the liver and the bowel.

    (E) Injury to the bowel and/or intestinal obstruction.

  (2) Bariatric surgery.

    (A) Laparoscopic.

      (i) Conversion to open procedure.

      (ii) Injury to organs.

      (iii) Failure of device requiring additional surgical procedure.

      (iv) Obstructive symptoms requiring additional surgical procedure.

      (v) Development of gallstones (Roux-En-Y).

      (vi) Development of metabolic and vitamin disorders (Roux-En-Y).

      (vii) Suture line leak with abscess or fistula formation.

    (B) Open.

      (i) Failure of wound to heal or wound dehiscence (separation of wound).

      (ii) Injury to organs.

      (iii) Failure of device requiring additional surgical procedure.

      (iv) Obstructive symptoms requiring additional surgical procedure.

      (v) Development of gallstones (Roux-En-Y).

      (vi) Development of metabolic and vitamin disorders (Roux-En-Y).

  (3) Pancreatectomy (subtotal or total).

    (A) Pancreatitis (subtotal).

    (B) Diabetes (total).

    (C) Lifelong requirement of enzyme and digestive medication.

    (D) Anastamotic leaks.

  (4) Total colectomy.

    (A) Permanent ileostomy.

    (B) Injury to organs.

    (C) Infection.

  (5) Subtotal colectomy.

    (A) Anastomotic leaks.

    (B) Temporary colostomy.

    (C) Infection.

    (D) Second surgery.

    (E) Injury to organs.

  (6) Hepatobiliary drainage/intervention including percutaneous transhepatic cholangiography, percutaneous biliary drainage, percutaneous cholecystostomy, biliary stent placement (temporary or permanent), biliary stone removal/therapy.

    (A) Leakage of bile at the skin site or into the abdomen with possible peritonitis (inflammation of the abdominal lining and pain or if severe can be life threatening).

    (B) Pancreatitis (inflammation of the pancreas).

    (C) Hemobilia (bleeding into the bile ducts).

    (D) Cholangitis, cholecystitis, sepsis (inflammation/infection of the bile ducts, gallbladder or blood).

    (E) Pneumothorax (collapsed lung) or other pleural complications (complication involving chest cavity).

  (7) Gastrointestinal tract stenting.

    (A) Stent migration (stent moves from location in which it was placed).

    (B) Esophageal/bowel perforation (creation of a hole or tear in the tube from the throat to the stomach or in the intestines).

    (C) Tumor ingrowth or other obstruction of stent.

    (D) For stent placement in the esophagus (tube from the throat to the stomach).

      (i) Tracheal compression (narrowing of windpipe) with resulting or worsening of shortness of breath.

      (ii) Reflux (stomach contents passing up into esophagus or higher).

      (iii) Aspiration pneumonia (pneumonia from fluid getting in lungs) (if stent in lower part of the esophagus).

      (iv) Foreign body sensation (feeling like there is something in throat) (for stent placement in the upper esophagus).

(d) Ear treatments and procedures.

  (1) Stapedectomy.

    (A) Diminished or bad taste.

    (B) Total or partial loss of hearing in the operated ear.

    (C) Brief or long-standing dizziness.

    (D) Eardrum hole requiring more surgery.

    (E) Ringing in the ear.

  (2) Reconstruction of auricle of ear for congenital deformity or trauma.

    (A) Less satisfactory appearance compared to possible alternative artificial ear.

    (B) Exposure of implanted material.

  (3) Tympanoplasty with mastoidectomy.

    (A) Facial nerve paralysis.

    (B) Altered or loss of taste.

    (C) Recurrence of original disease process.

    (D) Total loss of hearing in operated ear.

    (E) Dizziness.

    (F) Ringing in the ear.

(e) Endocrine system treatments and procedures.

  (1) Thyroidectomy.

    (A) Acute airway obstruction requiring temporary tracheostomy.

    (B) Injury to nerves resulting in hoarseness or impairment of speech.

    (C) Injury to parathyroid glands resulting in low blood calcium levels that require extensive medication to avoid serious degenerative conditions, such as cataracts, brittle bones, muscle weakness and muscle irritability.

    (D) Lifelong requirement of thyroid medication.

  (2) Parathyroidectomy.

    (A) Acute airway obstruction requiring temporary tracheostomy.

    (B) Injury to nerves resulting in hoarseness or impairment of speech.

    (C) Low blood calcium levels that require extensive medication to avoid serious degenerative conditions, such as cataracts, brittle bones, muscle weakness, and muscle irritability.

  (3) Adrenalectomy.

    (A) Loss of endocrine functions.

    (B) Lifelong requirement for hormone replacement therapy and steroid medication.

    (C) Damage to kidneys.

  (4) Other procedures.

  (5) See also Pancreatectomy under subsection (c)(3) of this section (relating to digestive system treatments and procedures).

(f) Eye treatments and procedures.

  (1) Eye muscle surgery.

    (A) Additional treatment and/or surgery.

    (B) Double vision.

    (C) Partial or total blindness.

  (2) Surgery for cataract with or without implantation of intraocular lens.

    (A) Complications requiring additional treatment and/or surgery.

    (B) Need for glasses or contact lenses.

    (C) Complications requiring the removal of implanted lens.

    (D) Partial or total blindness.

  (3) Retinal or vitreous surgery.

    (A) Complications requiring additional treatment and/or surgery.

    (B) Recurrence or spread of disease.

    (C) Partial or total blindness.

  (4) Reconstructive and/or plastic surgical procedures of the eye and eye region, such as blepharoplasty, tumor, fracture, lacrimal surgery, foreign body, abscess, or trauma.

    (A) Blindness.

    (B) Nerve damage with loss of use and/or feeling to eye or other areas of face.

    (C) Painful or unattractive scarring.

    (D) Worsening or unsatisfactory appearance.

    (E) Dry eye.

  (5) Photocoagulation and/or cryotherapy.

    (A) Complications requiring additional treatment and/or surgery.

    (B) Pain.

    (C) Partial or total blindness.

  (6) Corneal surgery, such as corneal transplant, refractive surgery and pterygium.

    (A) Complications requiring additional treatment and/or surgery.

    (B) Pain.

    (C) Need for glasses or contact lenses.

    (D) Partial or total blindness.

  (7) Glaucoma surgery by any method.

    (A) Complications requiring additional treatment and/or surgery.

    (B) Worsening of the glaucoma.

    (C) Pain.

    (D) Partial or total blindness.

  (8) Removal of the eye or its contents (enucleation or evisceration).

    (A) Complications requiring additional treatment and/or surgery.

    (B) Worsening or unsatisfactory appearance.

    (C) Recurrence or spread of disease.

  (9) Surgery for penetrating ocular injury, including intraocular foreign body.

    (A) Complications requiring additional treatment and/or surgery.

    (B) Possible removal of eye.

    (C) Pain.

    (D) Partial or total blindness.

(g) Female genital system treatments and procedures.

  (1) Hysterectomy (abdominal and vaginal).

    (A) Uncontrollable leakage of urine.

    (B) Injury to bladder.

    (C) Sterility.

    (D) Injury to the tube (ureter) between the kidney and the bladder.

    (E) Injury to the bowel and/or intestinal obstruction.

    (F) Need to covert to abdominal incision.

    (G) If a power morcellator in laparoscopic surgery is utilized, include the following risks:

      (i) If cancer is present, may increase the risk of the spread of cancer.

      (ii) Increased risk of damage to adjacent structures.

  (2) All fallopian tube and ovarian surgery with or without hysterectomy, including removal and lysis of adhesions.

    (A) Injury to the bowel and/or bladder.

    (B) Sterility.

    (C) Failure to obtain fertility (if applicable).

    (D) Failure to obtain sterility (if applicable).

    (E) Loss of ovarian functions or hormone production from ovary(ies).

    (F) If performed with hysterectomy, all associated risks under paragraph (1) of this subsection.

    (G) For fallopian tube occlusion (for sterilization with or without hysterectomy), see subparagraph (14) of this paragraph.

  (3) Removing fibroids (uterine myomectomy).

    (A) Injury to bladder.

    (B) Sterility.

    (C) Injury to the tube (ureter) between the kidney and the bladder.

    (D) Injury to the bowel and/or intestinal obstruction.

    (E) May need to convert to hysterectomy.

    (F) If a power morcellator in laparoscopic surgery is utilized, include the following risks:

Cont'd...

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