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FDA medical device approval process leaves many questions

When a new drug is being prepared for distribution, the Food and Drug Administration (FDA) puts it through a rigorous testing process. It’s so rigorous, in fact, that patients and doctors alike complain about how long it can take for a drug that’s widely available overseas to hit the market in the United States.

The same is not true, however, for medical devices — including surgical implants like hip replacements and bladder meshes. Many of those products, which are often marketed to both doctors and patients as the latest in high-tech medicine, are largely untested when they get put into people’s bodies.

As a result, horror stories abound. Hip replacements break and leave patients unable to walk. The mesh straps inserted in women’s pelvic areas end up hardening and turning rigid, causing pain and infection. Those issues have already produced numerous lawsuits — and more medical implants and devices get recalled all the time.

Now, the FDA is starting to reconsider its approach to medical devices. Currently, unless a medical device’s failure could be clearly fatal (as in the case of a pacemaker), human testing isn’t a requirement before that device is put on the general market. Instead, manufacturers essentially just have to show that their new device is similar to some other device that’s already been used.

However, the FDA is considering some significant changes. Last November, officials announced that they expect to be more demanding during the application process for new medical devices. They also plan to look harder at how medical devices are working, rather than waiting on reports from patients to trickle in and alert them of a problem with a given product.

Will that be enough to adequately protect consumers? Unfortunately, there’s no way to know that.

If you or your loved one suffered harm due to a defective medical device or implant, addressing the issue through a lawsuit may be the only way to obtain fair compensation. For more specific information that pertains to your situation, talk to an attorney as soon as possible.


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