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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

      (vii) Stroke.

      (viii) Contrast nephropathy or other kidney injury (kidney damage due to the contrast agent used during the procedure or procedure itself).

      (ix) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

      (x) Thrombocytopenia (low platelets) or other coagulopathy (blood thinning).

      (xi) Vascular or cardiac perforation (hole in blood vessel or heart).

      (xii) Seizure.

      (xiii) Device migration or malfunction.

      (xiv) Ischemia to limb (lack of blood flow or oxygen to limb that device placed through).

      (xv) Thromboembolism (blood clots in blood vessels or heart and possibly traveling to blood vessels in lungs).

  (2) Vascular.

    (A) Open surgical repair of aortic, subclavian, iliac, or other artery aneurysms or occlusions, arterial or venous bypass or other vascular surgery.

      (i) Hemorrhage (severe bleeding).

      (ii) Paraplegia (unable to move limbs) (for surgery involving the aorta or other blood vessels to the spine).

      (iii) Damage to parts of the body supplied or drained by the vessel with resulting loss of use or amputation (removal of body part).

      (iv) Worsening of the condition for which the procedure is being done.

      (v) Stroke (for surgery involving blood vessels supplying the neck or head).

      (vi) Kidney damage.

      (vii) Myocardial infarction (heart attack).

      (viii) Infection of graft (material used to repair blood vessel).

    (B) Angiography (inclusive of aortography, arteriography, venography) - Injection of contrast material into blood vessels.

      (i) Injury to or occlusion (blocking) of artery which may require immediate surgery or other intervention.

      (ii) Hemorrhage (severe bleeding).

      (iii) Damage to parts of the body supplied by the artery or drained by the vessel with resulting loss of use or amputation (removal of body part).

      (iv) Worsening of the condition for which the procedure is being done.

      (v) Stroke and/or seizure (for procedures involving blood vessels supplying the spine, arms, neck or head).

      (vi) Contrast-related, temporary blindness or memory loss (for studies of the blood vessels of the brain).

      (vii) Paralysis (inability to move) and inflammation of nerves (for procedures involving blood vessels supplying the spine).

      (viii) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).

      (ix) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

    (C) Angioplasty (intravascular dilatation technique).

      (i) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention.

      (ii) Hemorrhage (severe bleeding).

      (iii) Damage to parts of the body supplied by the artery or drained by the vessel with resulting loss of use or amputation (removal of body part).

      (iv) Worsening of the condition for which the procedure is being done.

      (v) Stroke and/or seizure (for procedures involving blood vessels supplying the spine, arms, neck or head).

      (vi) Contrast-related, temporary blindness or memory loss (for studies of the blood vessels of the brain).

      (vii) Paralysis (inability to move) and inflammation of nerves (for procedures involving blood vessels supplying the spine).

      (viii) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).

      (ix) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

      (x) Failure of procedure or injury to blood vessel requiring stent (small, permanent tube placed in blood vessel to keep it open) placement or open surgery.

    (D) Endovascular stenting (placement of permanent tube into blood vessel to open it) of any portion of the aorta, iliac or carotid artery or other (peripheral) arteries or veins.

      (i) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention.

      (ii) Hemorrhage (severe bleeding).

      (iii) Damage to parts of the body supplied by the artery or drained by the vessel with resulting loss of use or amputation (removal of body part).

      (iv) Worsening of the condition for which the procedure is being done.

      (v) Stroke and/or seizure (for procedures involving blood vessels supplying the spine, arms, neck or head).

      (vi) Contrast-related, temporary blindness or memory loss (for studies of the blood vessels of the brain).

      (vii) Paralysis (inability to move) and inflammation of nerves (for procedures involving blood vessels supplying the spine).

      (viii) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).

      (ix) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

      (x) Failure of procedure or injury to blood vessel requiring stent (small, permanent tube placed in blood vessel to keep it open) placement or open surgery.

      (xi) Change in procedure to open surgical procedure.

      (xii) Failure to place stent/endoluminal graft (stent with fabric covering it).

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

      (xiv) Impotence (difficulty with or inability to obtain penile erection) (for abdominal aorta and iliac artery procedures).

    (E) Vascular thrombolysis (removal or dissolving of blood clots) - percutaneous (through the skin) (mechanical or chemical).

      (i) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention.

      (ii) Hemorrhage (severe bleeding).

      (iii) Damage to parts of the body supplied by the artery or drained by the vessel with resulting loss of use or amputation (removal of body part).

      (iv) Worsening of the condition for which the procedure is being done.

      (v) Stroke and/or seizure (for procedures involving blood vessels supplying the spine, arms, neck or head).

      (vi) Contrast-related, temporary blindness or memory loss (for studies of the blood vessels of the brain).

      (vii) Paralysis (inability to move) and inflammation of nerves (for procedures involving blood vessels supplying the spine).

      (viii) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).

      (ix) Kidney injury or failure which may be temporary or permanent (for procedures using certain mechanical thrombectomy devices).

      (x) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere

      (xi) Increased risk of bleeding at or away from site of treatment (when using medications to dissolve clots).

      (xii) For arterial procedures: distal embolus (fragments of blood clot may travel and block other blood vessels with possible injury to the supplied tissue).

      (xiii) For venous procedures: pulmonary embolus (fragments of blood clot may travel to the blood vessels in the lungs and cause breathing problems or if severe could be life threatening).

      (xiv) Need for emergency surgery.

    (F) Angiography with occlusion techniques (including embolization and sclerosis) - therapeutic.

      (i) For all embolizations/sclerosis:

        (I) Injury to or occlusion (blocking) of blood vessel other than the one intended which may require immediate surgery or other intervention.

        (II) Hemorrhage (severe bleeding).

        (III) Damage to parts of the body supplied or drained by the vessel with resulting loss of use or amputation (removal of body part).

        (IV) Worsening of the condition for which the procedure is being done.

        (V) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).

        (VI) Unintended thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

        (VII) Loss or injury to body parts with potential need for surgery, including death of overlying skin for sclerotherapy/treatment of superficial lesions/vessels and nerve injury with associated pain, numbness or tingling or paralysis (inability to move).

        (VIII) Infection in the form of abscess (infected fluid collection) or septicemia (infection of blood stream).

        (IX) Nontarget embolization (blocking of blood vessels other than those intended) which can result in injury to tissues supplied by those vessels.

      (ii) For procedures involving the thoracic aorta and/or vessels supplying the brain, spinal cord, head, neck or arms, these risks in addition to those under clause (i) of this subparagraph:

        (I) Stroke.

        (II) Seizure.

        (III) Paralysis (inability to move).

        (IV) Inflammation or other injury of nerves (for procedures involving blood vessels supplying the spine).

        (V) For studies of the blood vessels of the brain: contrast-related, temporary blindness or memory loss.

      (iii) For female pelvic arterial embolizations including uterine fibroid embolization, these risks in addition to those under clause (i) of this subparagraph:

        (I) Premature menopause with resulting sterility.

        (II) Injury to or infection involving the uterus which might necessitate hysterectomy (removal of the uterus) with resulting sterility.

        (III) After fibroid embolization: prolonged vaginal discharge.

        (IV) After fibroid embolization: expulsion/delayed expulsion of fibroid tissue possibly requiring a procedure to deliver/remove the tissue.

      (iv) For male pelvic arterial embolizations, in addition to the risks under clause (i) of this subparagraph: impotence (difficulty with or inability to obtain penile erection).

      (v) For embolizations of pulmonary arteriovenous fistulae/malformations, these risks in addition to those under clause (i) of this subparagraph:

        (I) New or worsening pulmonary hypertension (high blood pressure in the lung blood vessels).

        (II) Paradoxical embolization (passage of air or an occluding device beyond the fistula/malformation and into the arterial circulation) causing blockage of blood flow to tissues supplied by the receiving artery and damage to tissues served (for example the blood vessels supplying the heart (which could cause chest pain and/or heart attack) or brain (which could cause stroke, paralysis (inability to move) or other neurological injury)).

      (vi) For varicocele embolization, these risks in addition to those under clause (i) of this subparagraph:

        (I) Phlebitis/inflammation of veins draining the testicles leading to decreased size and possibly decreased function of affected testis and sterility (if both sides performed).

        (II) Nerve injury (thigh numbness or tingling).

      (vii) For ovarian vein embolization/pelvic congestion syndrome embolization: general angiography and embolization risks as listed in clause (i) of this subparagraph.

      (viii) For cases utilizing ethanol (alcohol) injection, in addition to the risks under clause (i) of this subparagraph: shock or severe lowering of blood pressure (when more than small volumes are utilized).

      (ix) For varicose vein treatments (with angiography) see subparagraph (L) of this paragraph.

    (G) Mesenteric angiography with infusional therapy (Vasopressin) for gastrointestinal bleeding.

      (i) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention.

      (ii) Hemorrhage (severe bleeding).

      (iii) Damage to parts of the body supplied or drained by the vessel with resulting loss of use or amputation (removal of body part).

      (iv) Worsening of the condition for which the procedure is being done.

      (v) Contrast nephropathy (kidney damage due to the contrast agent used during procedure).

      (vi) Thrombosis (blood clot forming at or blocking the blood vessel) at access site or elsewhere.

      (vii) Ischemia/infarction of supplied or distant vascular beds (reduction in blood flow causing lack of oxygen with injury or death of tissues supplied by the treated vessel or tissues supplied by blood vessels away from the treated site including heart, brain, bowel, extremities).

      (viii) Antidiuretic hormone side effects of vasopressin (reduced urine output with disturbance of fluid balance in the body, rarely leading to swelling of the brain).

    (H) Inferior vena caval filter insertion and removal.

      (i) Injury to or occlusion (blocking) of blood vessel which may require immediate surgery or other intervention.

Cont'd...

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