If the regulatory process is failing to prevent unsafe medical devices from reaching the market, something needs to be done. The way I see it, investigative journalists will always have their limitations.
But, by exposing the flaws, and warning consumers and patients, pressure builds up through the political process to crack down the regulatory bodies so improve the approval process.
The problem is the understanding of what an unsafe medical devices is. Medical devices regulations do not require 100 % safe medical devices because this is impossible to achieve. They usually require devices whose benefits outweigh their risks. This is a complex issue which require understating of factos such as the types and magnitudes of benefits the device offer, likelihood of patients experiencing one or more benefits, patient perspective on benefit, how alternatives solutions are in relation to the proposed device, including availability, besides factors related to risk (and these are only a few factors I mentioned). And also post-marketing surveillance considerations for all of these.
This means in practice that medical devices will have risks, including side effects. My concern is that most of the discussion (and I cite again the Netflix documentary) seem to focus only on the part of side effect and adverse events, without considering the myriad of other factors that have to be taken into account to decide if a device is safe or not (and most of the time this is because either the people discussing do not understand the regulations, or lack information or all the factors, or both - the latter is usually the case) and thus it's not a real technical discussion.
The current situation related to the Medical Devices Notification Bodies, all stretched for resources and under increased oversight is due, in part, to similar exposés of the abuses made in some eastern european countries and the lack of proper monitoring onto some shady NB’s.
Yes (although it's really a small part, but who do not follow the historical development of the regulations or understand the regulations tend to think that they played a bigger part than they really have), however, this is not the same as the situation I mentioned before. For once, Notified Bodies are not responsable for defining if a device is safe or not. They are responsible for verifying if a conformity assessment process was followed. For most this seems like the same, but it's not the same and is part of the problems mentioned (such as the PIP and eastern european countries).
I'm not saying that investigations and exposés are not necessary (I think they are), but when you make those, the discussion is more complex that it seems.