Are any 3D printed materials biocompatible (safe for implantation in the human body)?
This question is similar:
But appears to be for non-implantation use. This question is for materials intended to be implanted.
Are any typical 3D printed (extrusion based 3D printer) materials, such as ABS or PLA (or slightly more exotic ones, such as kevlar, fibreglass, or carbon fiber), safe for implantation in the human body? Or in medical terms, are they biocompatible (biofunctionality is not topical for this question)? If not, why not? If most of them are safe, then please explain which ones are NOT safe.
Highly relevant, and perhaps even more interesting is: Are there any peer reviewed medical papers that have investigated what materials are safe for implantation in the human body? A paper which answers this unambiguously would be the ideal answer to this question. Another concern is if the process of 3D printing itself adversely influences the properties of the material in the context of implantation applications.
I've tried to determine the answer to this question myself, but I cannot find any papers or studies which answer it. I can easily find that ABS plastic is "non-biodegradable", but I suppose the issue of adverse host responses is more crucial, e.g. causing inflammation or it being a bacterial growth substrate to promote infections seems like plausible concerns. I'm sure there might be other dangerous complications too, which I'm not aware of.
I found a paper dealing with corrosion issues for implantable metals: DOI: 10.1089/end.1997.11.383
I found a paper dealing with silicone-urethane being prone to breakdown: DOI: 10.1021/ma301965y
I found a paper describing the properties and history of ultra-high molecular weight polyethylene (UHMWPE), which appears to be commonly used as implants: DOI: 10.1109/EEIC.2005.1566331
By extension, a 3D printer using UHMWPE might be safe, barring any adverse chemical or mechanical issues as a result of the 3D printing process itself. However, it is not clear to me if any 3D printers can actually reliably print UHMWPE. Furthermore, it is unclear if UHMWPE is a sane choice, as it appears to be useful in applications where strength is required, such as for joints. What about other applications where load bearing properties are not required (e.g. a simple enclosure for implantable electronics)?
I'm aware that titanium appears to be frequently used for implants, and while titanium 3D printers do exist, they are beyond the scope of this question. The valid context is extrusion based 3D printers in the sub $10,000 range (arbitrarily chosen to make the question avoid being tagged as "too broad").
Either the material is FDA-approved or it isn't. Really no other metric matters.
@CarlWitthoft - It is not that simple: FDA approves load of stuff that in Europe is deemed unsafe, for example.
@CarlWitthoft - Paranoia doesn't play a role, but yes - in EU food safety standards are generally considered better. Most of it boils down to science playing a larger role here than commercial interests. You can read more on: http://www.precautionaryprinciple.eu/
None that I know of, but that doesn't mean they don't exist. A real critical part of the question that's missed is implantable for what purpose? UHMWPE is a good choice for some applications but you wouldn't want your femur made of it. Biggest problem with anything being for implantation is sterilizing it and voids. Some medical grade implants have passed sterilization but then managed to cause an immune system reaction despite the cells on the device being dead. Also voids are a pretty bad problem for FDM printers.
Perhaps more than biocompatible, which generally refers to a material that does not illicit a harmful inflammatory response inside the body, you should be looking at bioresorbable materials, which are materials that dissolve inside the body after a certain time period without needing mechanical removal.
As an example, FDA approved poly (lactic acid) is available in pellet form from Corbion (formerly PURAC biomaterials) and can be extruded into 1.75mm filament for use with any desktop 3D printer (https://www.sciencedirect.com/science/article/pii/S2214860416301385). Similarly, researchers have used poly (caprolactone) to 3D print scaffolds with using a stratasys FDM machine (https://onlinelibrary.wiley.com/doi/pdf/10.1002/1097-4636(200105)55:2%3C203::AID-JBM1007%3E3.0.CO;2-7).
Yes. I have worked with people who have printed implants of PCL, loaded with antibiotics, for delivery at the infection site: https://www.google.com/search?q=pcl+medical+approval
Also look at PPSU: https://www.google.com/search?q=ppsu+medical+approval
These are currently used for appliances; I'm not aware of them being used for implants yet.