This public letter is from Consumer's Union, and addresses the situation many people fear we have slipped into, with new medical devices being rushed to market without adequate testing.
It’s a nightmare scenario. The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you.
This isn’t science fiction. Millions of medical devices including artificial hips, surgical mesh, contact lens solution, heart stents, and pacemakers are being recalled – 700 different products a year.
And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were “similar” to products already on the market.
Tell Congress we don’t want to be guinea pigs anymore!
Every new prescription drug must undergo rigorous testing on humans before it can be sold, even if it is similar to another drug already in use. Not so with medical devices. Because of this loophole in our safety laws, more than 90 percent of medical devices aren’t safety tested before being sold nor are they routinely tracked afterward to identify safety problems.
For example, a metal hip implant marketed by Johnson & Johnson was approved in 2005 without first undergoing clinical safety trials. It was recalled five years later after having a 1 in 8 failure rate, and leaving potentially deadly metal fragments in the body. Countless patients had to undergo a second, painful ‘revision’ surgery.
It’s time safety standards for medical devices are as strong as those for prescription drugs!
The device industry has unleashed an army of lobbyists and they don’t want things to change. It will take a wave of consumers weighing in to make sure medical devices are safe and effective. Please take action, then forward this to friends and family.
Consumers Union, policy and action from Consumer Reports
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Austin, Texas 78701