Barrigel® Hyaluronic Acid Rectal Spacer

Possible bowel complications³ from unwanted radiation exposure to the rectum may include:

SHORT-TERM:

• Needing to have a bowel movement more often than usual (bowel incontinence)
• Diarrhea
• Loose stools
• Hemorrhoids

LONG-TERM:

• Inflammation of the rectum (radiation proctitis)
• Rectal bleeding
• Narrowing of the rectum
• Hemorrhoids
• Chronic diarrhea
• Development of an ulcer in the rectum

BARRIGEL is the first and only spacer that can be sculpted by your doctor, ensuring a custom fit.^1,2 More personalized coverage allows more complete protection.

A PERSONALIZED FIT

Because of its unique sculptable nature, Barrigel remains soft during insertion, allowing your doctor to sculpt the spacer in place to create an optimal fit for your body.^1,2

Barrigel is the only gel spacer that can be viewed clearly on ultrasound, the imaging machine used to guide your doctor’s placement during the procedure. This added visibility during insertion provides your doctor greater control and precision over the placement of the spacer.^1,2

BARRIGEL IS CLINICALLY PROVEN to significantly reduce unwanted radiation exposure^1,2

In an FDA clinical study,

of patients

showed Barrigel to be effective in achieving a significant reduction in radiation to the rectum.^1,2

What is the

of reduced radiation to the rectum?

Through 3 and 6 months, patients with Barrigel experienced fewer short-term and long-term negative side effects than patients who did not receive Barrigel.^1,2

Barrigel reduced the rate of complications including inflammation of the rectum (radiation proctitis), diarrhea, and hemorrhoids.^1,2

Made from Non-Animal Stabilized Hyaluronic Acid (known as NASHA^®), Barrigel is the first commercially available hyaluronic acid rectal spacer.⁴

Hyaluronic acid is a substance naturally present in the human body. Highly compatible and fully absorbable by the body, it is a natural substance used in many common medical procedures.

WHAT TO EXPECT - THE PROCEDURE

• Spacing procedures are performed in hospitals, outpatient clinics or doctors’ offices prior to the start of radiation treatment.
• Barrigel may be implanted at the same time as fiducial markers – small markers placed in your prostate to help your treatment team line up the radiation beams.
• The procedure is typically performed in under an hour, and may be performed under local, regional or general anesthesia.
• Following the procedure, you can expect to be monitored in recovery before being discharged.
• Most patients continue with normal daily activities shortly after the procedure, although your doctor may ask you to refrain from heavy lifting and strenuous physical activity for a few days.

It’s important to adhere to all of your doctor’s pre‑procedure preparation and post-procedure instructions.

REFERENCES: 1. Data from Palette Life Sciences 510(k) K220641. 2. Data on file. Palette Life Sciences. 3. Mayo Clinic. Radiation therapy. www.mayoclinic.org. Accessed: August 1, 2021. https://www.mayoclinic.org/tests-procedures/radiation-therapy/about/pac-20385162. 4. Q-Med. NASHA- the Monograph. Uppsala, Sweden. 5. Restylane® celebrates 25 years of natural-looking results with its signature line of hyaluronic acid fillers. 2021. Available at: www.prnewswire.com/news-releases/restylane-celebrates-25-years-of-natural-looking-results-with-its-signature-line-of-hyaluronic-acid-fillers-301388779.html. Accessed Sept 30, 2021.

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. BARRIGEL is only administered by qualified and properly trained physicians. 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. Discuss these adverse effects with your healthcare provider. For more information about BARRIGEL, please visit barrigel.com.

© 2023 Palette Life Sciences, Inc. Barrigel^® and NASHA^® are registered trademarks. All images and illustrations are property of Palette Life Sciences. All rights reserved. APM545A