Get the facts on the safety of Deflux

Deflux Recovery and Safety Information

Deflux treatment and recovery are preferred over antibiotics and surgery1

In comparison to VUR surgery (ureteral reimplantation), endoscopic treatment with Deflux offers major advantages to patients and parents.1 The procedure takes less than 15 minutes and is performed in an outpatient setting.1 Deflux has greater patient convenience, less pain and reduced cost in comparison to surgery and antibiotics.1 A study showed that both patients and parents saw injection therapy as the least bothersome aspect of VUR treatment followed by antibiotics and VCUG testing.2

Deflux Recovery  vs. Surgery Recovery

  • With Deflux, children are able to return to normal activities the next day3 vs a prolonged hospital stay with surgery3
  • Deflux procedure is considered minimally invasive with minimal post-operative pain and no need for urinary catheter4
  • Surgical reimplant generally requires hospitalization for post-operative pain and temporary urinary catheter drainage4

After the procedure, your doctor will determine what type of follow-up is needed and if additional treatment is required.

Deflux has been used safely and effectively for well over 20 years1

The first question most parents ask about Deflux is, “How safe is it?” Your child’s well-being is your #1 priority, so you will want to take a long, hard look at any potential treatment.

Since 2001, in the U.S., Deflux has been used to treat vesicoureteral reflux (VUR) grades 2-4 in children. Deflux is made from two tissue-friendly polysaccharides (types of sugar molecules – hyaluronic acid (HA) and dextranomer (Dx).

The hyaluronic acid (HA) is naturally broken down (biodegraded) over a short time and replaced by the body’s own material, while the dextranomer remains in place longer. The HA in Deflux is Non-Animal Stabilized Hyaluronic Acid (NASHA®™), a patented HA technology that is made from non-animal bacteria and crosslinked specifically for optimal stabilization. NASHA has been used safely for VUR for over two decades and has been used in more than 40 million procedures worldwide, often as a dermal filler.5

The risk of infection and bleeding with the procedure is low6

The following adverse events have been reported with Deflux (occurring 1%): blockage of the ureters (some cases require temporary placement of a ureteric stent), painful urination, blood in the urine, urgency of urination, frequency of urination, swelling of the kidneys, inflammation of the kidneys, urinary tract infection, foreign body reaction, calcification, and fever.

  • Safety and efficacy of Deflux in children under one year of age have not been established
  • Safety and efficacy of Deflux in duplex kidney systems have not been established
References:
  1. Cerwinka WH, Scherz HC, Kirsch AJ. Endoscopic treatment of vesicoureteral reflux with dextranomer/hyaluronic acid in children. Advances in Urology. 2008; 1-7.
  2. Stenberg A, Lackgren G. Treatment of vesicoureteral reflux in children using stabilized non-animal hyaluronic acid/dextranomer gel (NASHA/Dx): a long-term observational study. J Pediatr Urol. 2007;3(2):80-85.
  3. Ogan K, Pohl HG, Carlson D, et al. Parental preferences in the management of vesicoureteral reflux. J Urol. 2001;166(1):240-243.
  4. Sung J, Skoog S. Surgical management of vesicoureteral reflux in children. Pediatr Nephrol. 2012;27:551-561.
  5. Data on file
  6. Deflux [prescribing information]. Santa Barbara, CA: Palette Life Sciences, Inc.; 2019.