Sun, 09/12/2010 - 12:25 | by admin

Safety

DEFLUX was developed during the 1990s specifically to fulfill the criteria of an ideal profile for an injectable material including:

  • Biocompatibility allowing good tissue tolerance
  • Durability
  • Lack of migration from the injection site
  • Ease of use
  • High response rates

 

Observation

Evidence
Deflux does not cause an allergic reaction
  • There have been no reports of an allergic reaction to Deflux in over 10 years’ use in the clinic or during 7.5 years’ long-term clinical trial follow-up.3
  • l Injection of Deflux into the bladder of pigs did not cause the lymph nodes to enlarge – this indicates lack of an immune response.1
A mild inflammatory reaction following Deflux injection occurs as expected
  • In the early stages (2–6 weeks) after Deflux injection into pigs and rats, cell types indicative of a mild inflammatory response are present (macrophages, lymphocytes and giant cells).1 Giant cells have been observed at the site of the implant both in animal studies and in patients with VUR injected with Deflux.1, 2 These indicate a foreign body type inflammatory reaction. Such an inflammatory response is to be expected and is a natural reaction provoked by injection of any substance into the body.
The tissues surrounding the implant show no evidence of major changes in structure
  • Observation of the tissues surrounding the implant in pigs and humans has revealed signs of limited foreign body reaction.1, 2 In rats undergoing abdominal injection of Deflux, no changes in the organs were observed.1 Fibrosis in the area of the Deflux implant was observed in 13 patients with VUR examined following ureteral reimplantation. However, the incidence of fibrosis was similar to control patients, suggesting that it is a result of the condition and not of the treatment.2

 

 

  1. Stenberg Å, Larsson E, Lindholm A, et al. Injectable dextranomerbased implant: histopathology, volume changes and DNA analysis. Scand J Urol Nephrol 1999; 33: 355-61.
  2. Stenberg A, Larsson E, Läckgren G. Endoscopic treatment with dextranomer-hyaluronic acid for vesicoureteral reflux: histological findings. J Urol 2003; 169: 1109-13.
  3. Läckgren G, Wåhlin N, Sköldenberg E, et al. Long-term follow-up of children treated with dextranomer/hyaluronic acid copolymer for vesicoureteral reflux. J Urol 2001; 166: 1887-92.