Safety Information

​

Silver materials in the concentration ranges of 0.01-1 mg/ml are currently used as active ingredients in several FDA-cleared and marketed skin products due to their antimicrobial activity and skin safety profiles (1, 2). To date, 27 silver-based products including wound dressings, bandages, mesh foams, gels, and creams have been deemed safe and approved for use in human skin (3).  Silver is also found in FDA-approved implantable devices e.g. stents, defibrillators, pacemakers, catheters, IV infusion components, and needles (4). 

Silver materials including silver nanoparticles in skin formulations are widely reported in scientific research and are of the most studied materials for antimicrobial, antiviral and antifungal activities. 

 

In one study, no adverse skin reactions were uncovered after 2 weeks of using silver-containing dressings for catheter infections, nor in the 5-year subject follow up (5). Additionally, no tolerance issues were found in a randomized control trial comparing the biocompatibility of silver- and non-silver-based wound dressings for treating chronic and acute wounds when used over several weeks (5). 

 

Another clinical study evaluated the silver absorption from silver-containing wound dressings for potential systemic effects in subjects.  Despite covering up to 53% of the total body area for up to 19 days and measuring detectable levels of silver in the serum, clinical researchers saw no adverse skin effects, no changes in biochemical activity (including liver and renal function), and no hematological toxicity (including hemoglobin levels, platelet counts, and eosinophil counts) (1, 6). 

​

Silver nanoparticles can be used as antimicrobial preservatives in cosmetics, as data suggests they are effective at inhibiting microorganism growth, are highly stable, non-cytotoxic to human skin cells, and incapable of penetrating human skin (1, 7).   

The literature further reports the safety of silver-coated implantable devices.  Long-term animal models have been used to show that silver-coated catheters are minimally inflammatory and comparable to catheter controls (8). Clinical trials have substantiated these claims as the implantation of silver-coated heart valve prostheses revealed no difference in the rate of complication compared to subjects with uncoated prostheses (9). 

​​

WARNING, inappropriate use or prolonged chronic use of silver can result in argyria, a rare and non-life threatening condition where the skin turns permanently blue. Use as indicated.

​

References

​

1. https://nanocomposix.com/pages/silver-nanoparticle-safety

2. Nowack, B.; Krug, H. F.; Height, M. "120 Years of Nanosilver History: Implications for Policy Makers" Environ. Sci. Technol. 2011 PMID:21218770.

3. accessdata.fda.gov accessed 10/3/2011

4. Hill, M. L.; Baldwin, L; Slaughter, J. C.; Walsh, W. F.; Weitkamp, J. H. "Silver-alginate-coated dressing to reduce peripherally inserted central catheter (PICC) infections in NICU patients: a pilot randomized controlled trial" J. Perinatol 2010, 30, 469-473 PMID:20010613.

5. Trial, C.; Darbas, H.; Lavigne, J. P.; Sotto, A.; Simoneau, G.; Tillet, Y.; Teot, L.; "Assessment of the antimicrobial effectiveness of a new silver alginate wound dressing: a RCT" J. Wound Care 2010, 19, 20-26 PMID:20081570.

6. Vlachou, E.; Chipp, E.; Shale, E.; Wilson, Y. T.; Papini, R.; Moiemen, N. S. "The safety of nanocrystalline silver dressings on burns: a study of systemic silver absorption" Burns 2007, 33, 979-985 PMID:17959313.

7. Kokura, S.; Handa, O.; Takagi, T.; Ishikawa, T.; Naito, Y.; Yoshikawa, T. "Silver nanoparticles as a safe preservative for use in cosmetics" Nanomedicine 2010, 6, 570-574 PMID:20060498.

8. Oloffs, A; Grosse-Siestrup, C.; Bisson, S.; Rinck, M.; Rudolph, R.; Gross, U. "Biocompatibility of silver-coated polyurethane catheters and silver-coated Dacron material" Biomaterials 1994, 15, 753-758 PMID:7986938.

9. Auer, J.; Berent, R.; Ng, C. K.; Punzengruber, C.; Mayr, H.; Lassnig, E.; Schwarz, C.; Puschmann, R.; Hartl, P.; Eber, B. "Early investigation of silver-coated Silzone heart valves prosthesis in 126 patients" J. Heart Valve Dis. 2001, 10, 717-723 PMID:11767176.

 

This product has not been evaluated by the Food and Drug Administration (FDA). The information provided is not intended to diagnose, treat, cure, or prevent any disease. Consult with a healthcare professional before using any product or making changes to your health regimen.