SpaceOAR Hydrogel Risks
SpaceOAR Hydrogel is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR Hydrogel to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR Hydrogel is composed of biodegradable material and maintains space for the entire course of prostate cancer radiotherapy treatment. It is completely absorbed by the patient’s body over time.
Clinical data comparing patients with and without SpaceOAR Hydrogel demonstrated the benefits of SpaceOAR Hydrogel to include reduction of rectal toxicity resulting in improved bowel function, improvements in urinary function, and a higher likelihood to maintain sexual function.
As with any medical treatment, there are some risks involved with the use of SpaceOAR Hydrogel. Please talk to your doctor about the risks and benefits associated with SpaceOAR Hydrogel. Potential complications associated with SpaceOAR Hydrogel include, but are not limited to: pain associated with SpaceOAR Hydrogel injection; pain or discomfort associated with SpaceOAR Hydrogel; needle penetration of the bladder, prostate, rectal wall, rectum or urethra; injection of SpaceOAR Hydrogel into the bladder, prostate, rectal wall, rectum or urethra; local inflammatory reactions; infection; injection of air, fluid or SpaceOAR Hydrogel intravascularly; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; and rectal urgency.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for use only in countries with applicable health authority registrations. This material not intended for use in France. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Please check availability with your local sales representative or customer service.
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URO-750609-AA FEB 2020