To determine if SpaceOAR Hydrogel is right for you, consult your healthcare team. This guide can help facilitate a conversation with your doctor.
1. Mariados N, Sylvester J, Shah D, et al. Hydrogel Spacer Prospective Multicenter Randomized Controlled Pivotal Trial: Dosimetric and Clinical Effects of Perirectal Spacer Application in Men Undergoing Prostate Image Guided Intensity Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys. 2015;92(5):971-977.
2. Data on file with Boston Scientific.
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.
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SpaceOAR 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.
As with any medical treatment, there are some risks involved with the use of 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. Please talk to your doctor about the risks and benefits associated with SpaceOAR Hydrogel.
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