Current through Reg. 49, No. 38; September 20, 2024
(a)
Splenoportography (needle injection of contrast media into the spleen).
(1) All associated risks as listed under
§
602.2(b)(2) of
this chapter (relating to Cardiovascular System Treatments and
Procedures).
(2) Injury to the
spleen requiring blood transfusion and/or removal of the spleen.
(b) Chemoembolization.
(1) All associated risks as listed under
§
602.2(b)(2) of
this chapter.
(2) Tumor lysis
syndrome (rapid death of tumor cells, releasing their contents which can be
harmful).
(3) Injury to or failure
of liver (or other organ in which tumor is located).
(4) Risks of the chemotherapeutic agent(s)
utilized.
(5) Cholecystitis
(inflammation of the gallbladder) (for liver or other upper GI
embolizations).
(6) Abscess
(infected fluid collection) in the liver or other embolized organ requiring
further intervention.
(7) Biloma
(collection of bile in or near the liver requiring drainage) (for liver
embolizations).
(c)
Radioembolization.
(1) All associated risks
as listed under §
602.2(b)(2) of
this chapter.
(2) Tumor lysis
syndrome (rapid death of tumor cells, releasing their contents which can be
harmful).
(3) Injury to or failure
of liver (or other organ in which tumor is located).
(4) Radiation complications: pneumonitis
(inflammation of lung) which is potentially fatal; inflammation of stomach,
intestines, gallbladder, pancreas; stomach or intestinal ulcer; scarring of
liver.
(d) Thermal and
other ablative techniques for treatment of tumors (for curative intent or
palliation) including radiofrequency ablation, microwave ablation,
cryoablation, and high intensity focused ultrasound (HIFU).
(1) Injury to tumor-containing organ or
adjacent organs/structures.
(2)
Injury to nearby nerves potentially resulting in temporary or chronic
(continuing) pain and/or loss of use and/or feeling.
(3) Failure to completely treat
tumor.
(e) TIPS
(Transjugular Intrahepatic Portosystemic Shunt) and its variants such as DIPS
(Direct Intrahepatic Portocaval Shunt).
(1)
All associated risks as listed under §
602.2(b)(2)-(4)
of this chapter.
(2) Hepatic
encephalopathy (confusion/decreased ability to think).
(3) Liver failure or injury.
(4) Gallbladder injury.
(5) Hemorrhage (severe bleeding).
(6) Recurrent ascites (fluid building up in
abdomen) and/or bleeding.
(7)
Kidney failure.
(8) Heart
failure.
(9) Death.
(f) Myelography.
(1) Chronic (continuing) pain.
(2) Nerve injury with loss of use and/or
feeling.
(3) Transient (temporary)
headache, nausea, and/or vomiting.
(4) Numbness.
(5) Seizure.
(g) Percutaneous abscess/fluid collection
drainage (percutaneous abscess/seroma/lymphocele drainage and/or sclerosis
(inclusive of percutaneous, transgluteal, transrectal and transvaginal
routes)).
(1) Sepsis (infection in the blood
stream), possibly resulting in shock (severe decrease in blood
pressure).
(2) Injury to nearby
organs.
(3) Hemorrhage (severe
bleeding).
(4) Infection of
collection which was not previously infected, or additional infection of
abscess.
(h) Procedures
utilizing prolonged fluoroscopy.
(1) Skin
injury (such as epilation (hair loss), burns, or ulcers).
(2) Cataracts (for procedures in the region
of the head).
