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What does it mean if a medical device is recalled?

The bionic man came to life on network television back in 1973. That's when "The Six Million Dollar Man" first aired. Astronaut Steve Austin, critically injured in a test flight crash, was rebuilt using various medical devices and implants that made him faster, stronger, better.

That was science fiction. Today, it is a science fact that millions of Americans are the recipients of artificial medical devices. They include pacemakers, surgical mesh, artificial joints and more.

While the Food and Drug Administration has the task of monitoring the development and sale of such products, it doesn't mean they are all safe. Monitoring does not mean testing, so defective devices do get to market and the problems with them are discovered only after they are in service.

The FDA acknowledges it receives hundreds of thousands of reports every year about suspected malfunctions, injuries and deaths associated with defective devices. Device makers and users and those who import devices are obligated by federal law to report adverse events, but sometimes that doesn't happen or the word comes in too late to be much good to suffering victims.

Recalls are a key tool the government has to respond to these issues. Many people don't understand what that entails. But they should.

The FDA can take recall action if a device is known to be defective or if it is merely thought to pose a risk to human health. A recall does not necessarily mean the device in question needs to be removed from the patient. Sometimes it may only call for a device to be checked. An adjustment or repair might then follow.

If a device is working, but has the potential of failing unexpectedly, doctors and patients might be told to discuss the comparative risks and decide for themselves whether to leave it in or take it out.

Damage due to defective medical devices can sometimes take a long time to become evident. If a victim does seek to make a claim, manufacturers and others who may bear responsibility employ all the resources they can to limit compensation paid to victims. To counter that, an experienced attorney should be consulted to understand the legal options available.

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Reich & Binstock - Pharmaceutical Injury & Class Action Lawyers

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