Evaluation of the skin sensitizing potential of biodegradable magnesium alloys.

Corroding metals made of magnesium alloys represent a new class of degradable implants for musculoskeletal surgery. These implants may be associated with skin sensitizing reactions because of the release of metal ions. This study was conducted to compare the sensitizing potential of four different magnesium alloys (AZ31, AZ91, WE43, and LAE442) to current implant materials such as titanium (TiAl6V4) and a degradable polymer (SR-PLA96). Solutions and solid chips of these materials were prepared and tested in 156 guinea pigs according to the Magnusson-Kligman test. A standard allergen (hydroxy-cinnamon-aldehyde) causing allergic erythema was used as positive control and a standard irritant (sodium-lauryl-sulfate) causing local skin irritation for less than 24 h was used as negative control. All erythema were graded immediately and 24 h after patch removal by three independent observers. Histomorphological analyses were performed on skin biopsies taken 24 h after patch removal. We found that initial erythema in animals treated with solid chips diminished within 24 h and were caused by local skin irritation. Local skin irritation was also determined in erythema remaining for 24 h after patch removal in animals treated with dissolved test materials. No allergenic reactions according to the histomorphological criteria were observed in skin biopsies. We conclude that no skin sensitizing potential were detected for standard materials as well as for all tested magnesium alloys by the used methods.

In vitro and in vivo corrosion measurements of magnesium alloys.

The in vivo corrosion of magnesium alloys might provide a new mechanism which would allow degradable metal implants to be applied in musculo-skeletal surgery. This would particularly be true if magnesium alloys with controlled in vivo corrosion rates could be developed. Since the magnesium corrosion process depends on its corrosive environment, the corrosion rates of magnesium alloys under standard in vitro environmental conditions were compared to corrosion rates in an in vivo animal model. Two gravity-cast magnesium alloys (AZ91D, LAE442) were used in these investigations. Standardized immersion and electrochemical tests according to ASTM norms were performed. The in vivo corrosion tests were carried out by intramedullar implantation of sample rods of the magnesium alloys in guinea pig femura. The reduction in implant volume was determined by synchrotron-radiation-based microtomography. We found that in vivo corrosion was about four orders of magnitude lower than in vitro corrosion of the tested alloys. Furthermore, the tendency of the corrosion rates obtained from in vitro corrosion tests were in the opposite direction as those obtained from the in vivo study. The results of this study suggest, that the conclusions drawn from current ASTM standard in vitro corrosion tests cannot be used to predict in vivo corrosion rates of magnesium alloys.

Composition and in vitro biocompatibility of corroding tungsten coils.

The purpose of the article is to evaluate composition and biocompatibility of corroding mechanically detachable spirals (MDS, Balt Extrusion, Montmorency, France). Analysis of the material composition of corroding MDS coils was assessed by inductively coupled plasma atomic emission spectroscopy, inductively coupled plasma mass spectroscopy, and wavelength-dispersive x-ray spectrometry. Toxicity assays were performed with human venous endothelial cells, venous smooth muscle cells and fibroblasts. The analyses of the MDS coils demonstrated a tungsten content of the dissolving MDS spirals of > 99.9 mas%. In vitro, human endothelial, vascular smooth muscle cells and fibroblasts were not adversely affected by markedly elevated tungsten concentrations (60,500 microg/l) after 12 days in the culture medium. The examined cells showed an extensive vital growth on the coil surface. Corrosion of tungsten coils leads to markedly elevated tungsten levels in the culture medium. However, growth and vitality of endothelial cells, fibroblasts, and vascular smooth muscle cells are not adversely affected by elevated tungsten concentrations.

Degradation of tungsten coils implanted into the subclavian artery of New Zealand white rabbits is not associated with local or systemic toxicity.

OBJECTIVE: To assess whether corrosion of tungsten coils is related to residual shunting and to evaluate whether elevated tungsten serum levels are associated with local or systemic toxicity. METHODS: Tungsten coils (SPI, Balt, France) were implanted into the subclavian artery of New Zealand white rabbits leading to a residual high-flow shunt in 5/10 rabbits. Serial serum tungsten levels, complete blood count and clinical chemistry were analysed prior to the implantation as well as 15 min, 2 and 4 months thereafter. After 4 months the rabbits underwent repeat angiography before they were sacrificed and the internal organs were evaluated histopathologically. RESULTS: Mean tungsten levels rose from 0.48 microg/l prior to the implantation to 12.4 microg/l 4 months post-implantation. The rise in serum tungsten levels was neither associated with residual shunting present at the time of implantation nor with residual shunting at the time of explantation. One animal had to be sacrificed because of non-resolving palsy of the upper extremity. The remaining animals had an uneventful clinical course with no signs of toxicity of the elevated tungsten levels. Histological examination revealed no evidence of local or systemic toxicity of the tungsten coils. CONCLUSION: Tungsten coils corrode and lead to a steady increase in serum tungsten levels starting as early as 15 min after implantation. Residual shunting does not seem to influence the kinetics of corrosion of tungsten coils. Despite markedly elevated serum tungsten levels 4 months after implantation degradation of tungsten coils is not associated with local or systemic toxicity.