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 bu

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.