My question relates to material safety and potential heavy metal exposure in the event of a borosilicate glass tag failure. I’m trying to determine which metals could potentially leach into the body if the glass capsule of any implant were compromised.
I trust the biosafety, quality, and long-term durability of these implants. However, given that some of the earlier ones are over 12 years old, I wouldn’t mind getting some testing done — just to be sure nothing has unexpectedly broken or degraded over time.
I work in a medical laboratory, where we routinely test for heavy metals including Lead, Mercury, Arsenic, and Cobalt. If anyone here has insight into the types of metals used in these implants, whether additional metals like nickel, chromium, copper or rare earth elements should be included, or if a standard heavy metals panel is sufficient, I’d really appreciate your input.
Hey that is fantastic! The x-series is going to have the largest collection of potential metals, but most are considered core minerals hah. The ferrite rod and wiring are going to be the biggest factors. The rod itself contains mostly iron, which isn’t all that much of an issue given the rate it would dissolve… soldiers from WWI and WWII that had iron shrapnel would often be left alone for it to dissolve over decades. Other materials include zinc, manganese, copper, cobalt, and nickel… the last two being the most problematic.
My question is, what is the level of sensitivity your instruments have? Even if it was compromised and leeching, I kinda doubt your gear would be able to test for it since the levels required to be a problem are likely to be much higher than what would be coming out of a compromised implant.
Still, if you’re game for testing I would be curious to provide some clean but compromised implants in 10ml USP saline. Can you test just the saline for contaminates? I also have other implants that have been sitting in saline for extended periods of time… some for years. I’m very interested in getting that saline tested if you’re up for it.
Thank you so much for the incredibly informative and thorough reply. This was exactly the kind of insight I was hoping for. I really appreciate you taking the time to break down the materials involved and providing your perspective. Your response gives me a much better idea of what could potentially be monitored.
Unfortunately, as much as I’d like to assist and contribute to the community, the scope of testing at my lab is limited to clinical blood specimens and the heavy metals need to be collected in trace element-controlled vacutainers. To complicate things further, most of the heavy metal panels especially those beyond the more commonly screened analytes like lead or mercury are not performed in-house and would be sent out to a reference laboratory.
For what it’s worth, the methodology employed is typically inductively coupled plasma mass spectrometry (ICP-MS), which offers high sensitivity and specificity for trace metals. For example, the reportable range for cobalt is approximately 0.5–1,000 µg/L, with values below < 1.8 µg/L to be considered within normal limits. Values ≥1.8 µg/L indicate elevated exposure and potential systemic toxicity.
That said, even if I had unrestricted access to instrumentation, interpreting results from a saline matrix would be quite challenging. Saline solutions lack important biological context that blood provides. As a result, any detected concentrations would likely appear elevated due to the absence of metabolic clearance mechanisms and most significantly, the dilution factor due to the large amount of circulating blood throughout the body/human physiology. Reference intervals like the one above are validated specifically for human blood samples and wouldn’t directly translate to a medium like USP saline. So, while it’s possible to test and get a value for the metal content, assigning clinical relevance or systemic equivalence to those numbers would be challenging and likely misleading.
Has there been any discussion around the use of imaging techniques such as X-ray or ultrasound to assess the structural integrity of implants? I suspect the resolution offered by these techniques may not be good enough to detect microfractures or hairline cracks in the bioglass, and would only be useful for identifying more catastrophic failures which are likely unheard of. I often tell people that in the event of significant trauma, my wrist and arm are more likely to break than the borosilicate glass encasing the chip, and If I ever were to suffer such damage a broken RFID implant would be the least of my problems. What are your thoughts?
Thanks again, and looking forward to whats yet to come from DT!
We were looking to Nelson Labs (they advise the FDA on med ISO testing standards) for this type of testing, though their equipment is geared toward various solvents, not blood. It is definitely the type of testing we want to do, though testing a broken x-series is not what we were wanting to explore it for.
We have relationships with high end electronics assembly houses that offer 6 axis x-ray inspection equipment that can do real time inspection of components at nearly microscopic levels. The thing is amazing to watch… you can literally zoom in on a specific trace or single wirebond connection on an electronic component in real time, in x-ray. Cracks in bioglass is not generally a problem, for transponder implants that contain ferrite rods, we have only one or two reports of breaks at this point;
Unfortunately we do have a number of reports of our xG3 v1 (axial magnet) breaking, specifically the end cap of the glass gets sheered off, likely due to the fact the axially magnetized magnet is pulling objects directly toward the end cap;
We have just released an updated xG3 v1 that uses a new material we’ve been working on for over a year now - biocompatible resin. This is primarily why I’m interested in ICP-MS, because any result of metals in the saline would indicate ion movement through the material. We’ve done a ton of internal lab tests to build a body of evidence that there is no leeching through the material, but an ICP-MS test would have a very big impact on that body of evidence. As I said, I am confident enough in our testing regimen that we’ve begun releasing products using this material, but I will always pursue more testing data if given the opportunity.
Is there any way we could discuss the possibility of running some tests on these samples? Nelson Labs is always an option for us, but they are the insanely expensive option, and my entire R&D budget is still going to other R&D projects.