How is the use of glue (cyanoacrylate) as an embolization device monitored by the government?
When a product has pre-market approval, the FDA rules and regulations require its users to provide reports periodically, regarding the success and/or consequences of the product’s use. After the horrific experiments done on humans during World War II by the Germans, it was clear that hospitals should have what are known as “Institutional Review Boards” (IRBs). The use of glue as an embolization device was an experiment on a human being, if it was done before the pre-market approval. And even though this product has obtained pre-market approval, it still arguably remains an experiment. Accordingly, one would hope that the Institutional Review Board at the hospital where the procedure took place would have reports regarding its use there.
