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Some Popular Medical Devices Escape FDA Scrutiny

Too many new medical devices reach the market without extensive testing or review. Countless patients around the world depend on advanced medical devices to improve their quality of life. As the $110 billion medical device industry cranks out thousands of products every year, eye-opening reports continue to surface detailing faulty devices, repeat surgeries and massive recalls.

The FDA argues patients need access to life-saving devices quickly. However, a speedy approval process means some risky devices are cleared without clinical testing, and once on the market, receive limited oversight. You should know the risks and realities of medical devices before one is put in your body.

Have you or someone you know ever suffered from a knee or hip replacement? Have you needed transvaginal mesh or had defibrillator leads implanted? These are just a few examples of more notable defective medical devices that have caused injury to patients. Read more about these defects in our monthly newsletter, and find out which 7 medical device failures are catching the FDA’s eye.

Protections From Defective Medical Devices

Here are some ways you can protect yourself and your family from defective medical devices. These tips from Consumer Reports can help protect you or loved ones from the risk of defective medical devices:

Barrow_LegalNewsNowConsider the alternatives: If your doctor suggests an implant, simply ask what will happen if you don’t get it. Sometimes patients aren’t adequately informed about the alternatives. For example, women who received Transvaginal mesh for prolapse repair may not have needed surgery. But people ill enough to require an implantable defibrillator for their heart may not have a choice.

Research the device: The Food and Drug Administration’s website,, contains information on device safety warnings, complaints and recalls, which are all accessible by searching the name of the device. Also look for patient forums and other information about the device by searching online.

Write down the details: Ask for the brand name, model and serial number (if applicable) of your device so that if you learn of a warning or safety recall, you’ll know whether yours is one of the problem models.

Don’t panic: If you learn there are problems with your device, don’t assume that it has to be removed. Contact your doctor and learn to recognize possible negative side effects in your case.

Contact Barrow Law Firm: We will help obtain compensation and justice for victims of health care negligence.

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