Hacker Newsnew | past | comments | ask | show | jobs | submitlogin

I think you might be giving PTFE a stronger pass than it merits.


That's always possible, but why do you think so? The list of materials considered biocompatible enough for implants is pretty short, and PTFE is on that list.


> The list of materials considered biocompatible enough for implants is pretty short, and PTFE is on that list.

Not to stray from the main discussion but biocompatible has a pretty narrow scope.

Time effects are not always fully captured, it often boils down to quite literally "we injected this stuff in 50x bunnies' bloodstream or implanted under their derme and none of them died after a month".

With any new substance a cautionary principle should be applied, the main issue is Industry is spitting out new substances faster than we can meaningfully study them.


It would be possible for your comment to be farther from the truth, but it would take significant effort. It is incorrect to a degree that demonstrates malicious disregard for the truth, and since it pertains to health risks, people who were to rely on it would be putting their health at risk. You should not have posted it.

https://www.fda.gov/medical-devices/biocompatibility-assessm...

https://www.fda.gov/medical-devices/science-and-research-med...

https://www.fda.gov/media/158495/download


I am not sure what was so out of line about my comment. The safety profile you link to itself refers to animal studies.

That profile now looks very complete but before we had all those RCTs and clinical surveilance data, someone had to make a decision on wheather or not we can use PTFE in vascular stents _for_humans_. That decision would have relied on initial animal tests (i.e.literally sticking this stuff in bunnies) and some limited trial data.

My point is not that FDA are somehow clueless bureaucrats but that everytime we introduce a new substances we are taking an educated risk based on limited (animal) data.




Guidelines | FAQ | Lists | API | Security | Legal | Apply to YC | Contact

Search: