Platina

Wat zegt de FDA?

FDA Backgrounder on Platinum in Silicone Breast Implants >>

Platinum is a metal used as a catalyst in the manufacture of the shell and gel components of silicone breast implants. Because small amounts of platinum remain in the product following manufacturing, concerns have been raised that platinum may enter the body, either by diffusing through the intact shell or through an implant rupture, and cause adverse effects.


Er is onderzoek gedaan naar Platina in siliconen borstimplantaten, oa. door CANDO (chemically associated neurological disorders)

Platinum Research Project for Women with Breast Implants and their Offspring

A complex platinum salt, hexachloroplatinate, has been used in silicone gel-filled breast implants as a catalyst in both the gel and envelope. Platinum salt exposure has been associated with a range of problems, from positive skin-patch tests (indicating an allergic reaction) and contact dermatitis, to more serious problems such as asthma, immunogenicity, inhibitory effects on brain enzymes (brain damage), neurotoxicity (nerve damage), mutagenicity, carcinogenicity, and allergic anaphylactic reactions.

The average platinum concentration in samples from women exposed to silicone breast implants was found to be the following when compared to samples from individuals with no known platinum exposure:

Hair samples 14 times higher

Nail samples 3 times higher

Breast Milk 100 times higher

Urine 60 - 1700 times higher

Silicone implants -- a possible confounder for urinary platinum background concentrations? 2014 >>

Platina in bloed, urine, haren, nagels, zweet, hersenweefsel, moedermelk gemeten bij vrouwen met borstimplantaten >>

Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue, and Explants from Women Exposed to Silicone and Saline Breast Implants by IC−ICPMS

Ion chromatography-inductively coupled plasma-mass spectrometry was used to determine the total platinum concentration and platinum oxidation states in samples from women exposed to silicone and saline breast implants. Samples included the following: whole blood, urine, hair, nails, sweat, brain tissue, breast milk, and explants. Mean Pt concentration in samples from women exposed to silicone breast implants were as follows: whole blood, 568.1 ± 74.77 pmol/L (n = 9); urine, 1.77 ± 0.847 μg/g of creatinine (n = 10); hair, 2.13 ± 2.984 ng/g (n = 9); nails, 0.88 ± 0.335 ng/g (n = 9); sweat, 1.90 ± 1.691ng/g (n = 9); breast milk, 1.09 ± 0.316 μg/L (n = 6). Pt in explanted silicone breast implant gel (n = 9) occurred mainly in the +2, +4, and +6 oxidation states. Pt in whole blood (n = 7) and breast milk samples (n = 6) from women exposed to silicone breast implants occurred mainly in the +2 and +4 oxidation states. Saline breast implant fluid (n = 2) did not contain detectable levels of Pt. This is the most comprehensive report, to date, to show that women exposed to silicone breast implants have Pt levels that exceed that of the general population, and the first report, to date, to document the various Pt oxidation states present in samples from women exposed to silicone breast implants.

Hogere dosering Platina bij vrouwen met borstimplantaten >> en Uitgebreider artikel

PLATINUM FROM BREAST IMPLANTS (2006)

Women with silicone breast implants are likely to have higher concentrations of harmful forms of platinum in their bodies than women who have never had implants, according to a new study that is being contested by specialists in silicone chemistry { Anal. Chem. , published online April 1, dx.doi.org/10.1021/ ac05140l6). A key finding of the investigation, which probed the levels and oxidation states of the metal, is that platinum species remain in the body long after the implants have been removed.

One of the steps in preparing medical-grade silicone (polydimethylsiloxane) is cross-linking the polymer chains to control the material's stiffness and viscosity. The process calls for a cross-linking catalyst such as hexachloroplatinate, which is implicated in the study as the source of the metal.

The study's authors note that exposure to platinum species with oxidation states other than zero is believed to be harmful to human health. In particular, exposure to platinum salts has been ...

Vrouwen met siliconen hebben 60 tot 1700 meer platina in de urine >>

Comments on Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue, and Explants from Women Exposed toSilicone and Saline Breast Implants by IC−ICPMS

The paper by Lykissa and Maharaj (Lykissa, E. D.; Maharaj, S. V. M Anal. Chem. 2006, 78, 2925−2933) purports to provide evidence that the urine of women with silicone breast implants contain 60 to over 1700 times more platinum in their urine that the urine of people with no known exposure to platinum. Further, they purport to show evidence that the platinum used in the manufacture of breast implants (Pt0) is converted by a unknown process to yield highly oxidized platinum species, stable in biological matrixes, up to and including Pt6+. This correspondence poses three questions associated with the work and directs the reader's attention to the data, which clearly show that the blood and urineplatinum levels in implanted women and their healthy control group were not significantly different from one another.

Platinum concentration in silicone breast implant material and capsular tissue by ICP-MS 2004 >>

Inductively coupled plasma-mass spectrometry (ICP-MS) was used to determine the concentration of platinum (Pt) in silicone breast implant gel (range, 0.26-48.90 microg g(-1) Pt; n=15), elastomer (range, 3.05-28.78 microg g(-1) Pt; n=7), double lumen (range, 5.79-125.27 microg g(-1) Pt; n=7), foam (range, 5.79-8.36 microg g(-1) Pt; n=2), and capsular tissue (range, 0.003-0.272 microg g(-1) Pt; n=15). The results show that very high levels of Pt are present in the encasing elastomer, double lumen, and foam envelope materials. Silicone breast implants can be a source of significant Pt exposure for individuals with these implants.


Petitie van Michael Harbut over platina voor de FDA >>

Petitie Marlene Keeling over platina, voorzitter Chemically Associated Neurological Disorders / CANDO >>

Patent juni 1984 >>

Patent mei 1984 >>

[0025] a catalytic amount, about 5 to 50 parts per million by weight, of a platinum catalyst, used in layer 16, 18, 20 is present.The vulcanization maybe accelerated by exposing the gel to a temperature of 150°C for 2 to 3 hours.

Lijst van grenswaarden >>

FDA: Summary of safety and effectiviness data >>

Urinary platinum excretion from occupationally unexposed population is very low. Up to now, in Germany, dental noble metal alloys and a platinum based chemotherapy have been identified as reason for elevated urine concentrations. As fabrication of silicone involves platinum as catalyst, this study examines the potential release of platinum from silicone breast implants by quantifying urinary platinum concentration.

Platinum release from three different types of silicone implants into saline solution was measured in a laboratory experiment. It showed a strong increase of platinum concentration during the first 30 min and high platinum concentrations even after 60 h. In the following field study urinary platinum concentrations were determined from 30 women with dental gold alloy restorations and 28 women without such dental inlays. Median platinum concentrations were 5.2 ng/l urine (21.2 ng/g creatinine) for the women with dental gold inlays and 6.0 ng/l urine (5.4 ng/g creatinine) for those without. Compared with the urinary platinum concentrations provided by the German Environmental Survey (GerES) for the general female population the urinary platinum levels of women with silicone implants of the presented study were significantly higher, both for the study groups with and without dental gold alloy inlays.

Silicone breast implants must be considered as a new confounder and as a further contributor to elevated urinary platinum concentrations in human platinum background reference values of women.

Platinum blootstelling volgens de gezondheidsraad >>

3 ppm in implantaten blootstelling van werknemers in de industrie 5ng/m3 per 8 uur blootstelling

5ng = 0.000005mg

5 nanogram (ng) = 0.000000005 gram

3000000ng in implantaten

Uitgaande van het ‘niet-nadelig-effect’-niveau van 10 ng platina per m3 en een extrapolatiefactor van 2, stelt de commissie een gezondheidskundige limietwaarde voor van 5 ng platina per m3, gemiddeld over een achturige werkdag. De limietwaarde geldt alleen voor oplosbare chloroplatinaten

European Medicine Agency >>

No regulatory assessments appear to be available for Pt. The American Conference of Governmental Industrial Hygienists (ACGIH®) has adopted a Threshold Limit Value (TLV) of 1 mg/m3 for platinum metal and 0.002 mg/m3 for soluble salts to protect against sensitisation. The later is equivalent to a daily exposure of 40 μg/day (20 m3 air/day, EPA value).

Pt and its compounds have a wide spectrum of toxicity ranging from relatively low toxicity of Pt metal to genotoxic/cytotoxic effects (e.g. cis-platin) and sensitisation reactions associated with some Pt salts and complexes. Consequently, a conservative approach to the assessment of an appropriate PDE has been adopted.

Artikel

Platinum salt exposure has been associated with a range of problems, from positive skin-patch tests (indicating an allergic reaction) and contact dermatitis, to more serious problems such as asthma, immunogenicity, inhibitory effects on brain enzymes, (brain damage), neurotoxicity (nerve damage), mutagenicity, carcinogenicity, and allergic anaphylactic reactions.


Laag moleculaire siliconen en platina lekken door intacte implantaten. >>

Release of Low Molecular Weight Silicones and Platinum from SiliconeBreast Implants

Leakage of silicones was greatest when the surrounding medium was lipid-rich, and up to 10 mg/day LM-silicones was observed to diffuse into a lipid-rich medium per 250 g of implant at 37 °C. This rate of leakage was maintained over a 7-day experimental period. Similarly, platinum was also observed to leak through intact implants into lipid-containing media at rates of approximately 20−25 μg/day/250 g of implant at 37 °C. The rates at which both LM-silicones and platinum have been observed to leak from intact implants could lead to significant accumulation within lipid-rich tissues and should be investigated more fully in vivo.

Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue, and Explants from Women Exposed to Silicone and Saline Breast Implants by IC−ICPMS 2006 >>

Samples included the following: whole blood, urine, hair, nails, sweat, brain tissue, breast milk, and explants. Mean Pt concentration in samples from women exposed to silicone breast implants were as follows: whole blood, 568.1 ± 74.77 pmol/L (n = 9); urine, 1.77 ± 0.847 μg/g of creatinine (n = 10); hair, 2.13 ± 2.984 ng/g (n = 9); nails, 0.88 ± 0.335 ng/g (n = 9); sweat, 1.90 ± 1.691ng/g (n = 9); breast milk, 1.09 ± 0.316 μg/L (n = 6). Pt in explanted silicone breast implant gel (n = 9) occurred mainly in the +2, +4, and +6 oxidation states. Pt in whole blood (n = 7) and breast milk samples (n = 6) from women exposed to silicone breast implants occurred mainly in the +2 and +4 oxidation states.