It will surely have startled most readers of our joint investigation of medical implants to learn that devices such as surgical mesh, pacemakers, replacement hip joints and contraceptive coils are not subjected to the same stringent tests as medicines. It can take pharmaceutical companies more than a decade to get a new drug through the three phases of clinical trials that are standard practice before it is approved for use in humans. By contrast, the regulation of medical items classed as devices, a category that includes some diet pills, has evolved in such a way that some new products undergo no formal testing at all – because they resemble another item already on sale.
Earlier this year we reported that about one in 15 women fitted with vaginal mesh implants in the UK went on to have it removed as a result of complications including chronic pain. This week’s investigation, carried out in partnership with media organisations around the world, reveals that vaginal mesh is far from the only implant to have caused harm as well as good. Examples of what appears to be a global regulatory failure include thousands of serious incidents linked to breast implants, which have also been linked to a rare form of cancer; the voluntary recall of metal-on-metal hips due to high levels of follow-up surgery; and the withdrawal of the permanent contraceptive Essure (used to block fallopian tubes) in the US and Europe.
Continue reading...from The Guardian https://ift.tt/2AnPQ4C
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