What they don't tell you about stents

Former US president Bill Clinton's recent procedure to implant 2 stents prompted me to rethink this particular issue.

Few people know that stents, small little thingies stuffed into your coronary arteries to keep them open, are poorly regulated medical devices. Currently in Singapore, medical devices such as stents are not regulated at all. In other words, apart from satisfying some generic compliance to manufacturing standards, there is no need for a supplier to show evidence of safety or efficacy. Odd isn't it for something that you want to stick into a patient's coronary arteries?

In fact, as this paper indicates there is an immense problem in trying to decipher what data is objective with regards to establishing whether stenting procedures are really effective. This is a multibillion dollar industry.

Furthermore, doctors are not regulated at all, with regards to their application of stenting procedures to patients, so there is a lot of off-label use of stents. As far as I know, hospitals also do not track the revision rates of stent procedures, i.e. how many such procedures are due to operator/clinic errors rather.

Shouldn't it be time that we start to systematize this whole area of medicine?