Important Safety Information
BARRIGEL is used to increase the distance between the prostate and the anterior rectal wall, with the intent of decreasing radiation dose delivered to the rectum when treating prostate cancer with radiation. The product should be injected into the anterior perirectal fat. BARRIGEL shall only be administered by qualified and properly trained physicians with experience in ultrasound guidance and injection techniques in the urogenital/pelvic area. Barrigel is contraindicated in prostate cancer patients with clinical stage T4 disease.
As with any medical treatment, there are some risks involved with the use of BARRIGEL. Potential complications associated with the use of BARRIGEL include, but are not limited to: pain associated with BARRIGEL injection; needle penetration of the bladder, prostate, rectal wall, rectum, or urethra; injection of BARRIGEL into the bladder, prostate, rectal wall, rectum, urethra, or intravascularly; local inflammatory reactions; infection; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; constipation; and rectal urgency. More information on Indications, contraindications, warnings and instructions for use can be found in the Instructions For Use at www.barrigel.com.
CAUTION: The law restricts these devices to sale by or on the order of a physician.
For product information, adverse event reports, and product complaint reports, contact:
Palette Life Sciences
Medical Information Department