When the safety of medical devices is compared to toxic waste dumps and financial scandals, it reflects a sea change in awareness for the public and the White House. The President is right: patients are dying and being permanently injured by medical devices that were never tested in clinical trials of human beings before they were sold to doctors and patients. Those doctors and patients erroneously assume that the FDA wouldn’t allow them to be on the market unless they are proven safe. This is not the case. In fact, the standards for medical devices are not nearly as stringent as those for even the most basic prescription drugs.
Here’s what President Obama said:
“We’ve all paid the price for lenders who sold mortgages to people who couldn’t afford them, and buyers who knew they couldn’t afford them. That’s why we need smart regulations to prevent irresponsible behavior. Rules to prevent financial fraud, or toxic dumping, or faulty medical devices, don’t destroy the free market. They make the free market work better.”
To read the State of the Union address in full, please click here.
Here’s what Consumers Union, one of our coalition partners, said:
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.
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.
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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