I recommend watching Netflix’s The Bleeding Edge which is an exposé into the “medical instruments” industry. The documentary clearly shows that the Food and Drug Administration (FDA) is failing the American people by not adequately checking that products (often very expensive products too) are safe for their proscribed purposes. This includes hip replacements which break down and cause neurological symptoms and contraceptive devices which will stop you having children… by virtue of the fact you won’t be able to have sex because of pain and injuries. (The latter device, Essure, is still for sale in the US for the remainder of 2018 – despite being pulled from overseas sale when regulators asked for more data).
The scam and failure seems to be multi-faceted:
- a clause which allows companies to claim a product is “similar” to an existing product, and so it doesn’t need to go through approval. (A product can be similar to a similar to a similar…)
- much less stringent testing is required for devices than drugs. (One would think a device which stays in the body would need more testing than a drug which passes through the body).
- the FDA’s inability to recall or reject approvals based on “similar” items, even if those items are recalled due to adverse outcomes.
- the partisan-nature of FDA management, who seem to have very cosy relationships with the medical device industry – frequently working with them before and after a stint in the FDA. (Not to mention lobbying of politicians).
- doctors are unaware (or some, complicit) and assume if the FDA approves an item it is safe.
- even when compensation is received from a company, it often is a token-amount of their overall profit (and so hardly going to change their behaviour).
Well worth watching, and telling your friends to watch too. I’d love to see the