SpaceOARTM Hydrogel Important safety information
Important SpaceOAR and SpaceOAR Vue Hydrogels are intended to reduce the amount of radiation that is delivered to the rectum during radiotherapy for prostate cancer by creating more space between the prostate and the rectum. The products maintain space for approximately 12 weeks and are absorbed and passed naturally by the body in about 6 months, but it may take longer to fully absorb.
SpaceOAR and SpaceOAR Vue Hydrogels contain polyethylene glycol (PEG). SpaceOAR Vue contains iodine. The use of these products in patients who are sensitive or allergic to these materials has not been studied.
With all medical procedures, there are risks associated with the procedure and the use of the device, including long-term implantation. The risks include but are not limited to: Pain associated with injection, pain or discomfort from the hydrogel, site inflammation, infection (including abscess), inability to urinate, urgent need to urinate or pass stool, constipation, rectal muscle spasm, damage to lining of rectum, ulcers, fistula (a hole between rectum and bladder, urethra, or skin below the scrotum), perforation (hole in prostate, bladder, urethra, rectum), necrosis (dead tissue), allergic reaction (local reaction or more severe reaction, such as anaphylaxis), embolism (blood vessel blockage is possible and may happen outside of the pelvis, potentially impacting vital organs or legs), fainting (which may range from briefly losing consciousness to more serious symptoms where CPR might be needed), bleeding. Patients who have undergone previous pelvic radiation therapy may have an increased risk of fistula.
If one or more of these complications occur, you may need medical treatment or surgery. Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the use of the device.