Medical Devices

In a three year period, the FDA received 163,800 reports of deaths, serious injuries or malfunctions that were directly related to the use of defective medical devices.

Thousands of medical devices are released to the public each year including orthopedic devices (such as knee and hip replacements), cosmetic implants (such as breast implants), surgical tools and cardiology equipment (such as pacemakers).

The Food and Drug Administration's Center for Devices and Radiological Heath (CDRH) is responsible for testing and approving every medical device made available in this country. The CDRH receives adverse reaction reports on thousands of dangerous and defective devices each year, some so unsafe they need to be recalled from the marketplace. In addition to death, defective medical devices can cause pain, suffering and injuries so severe that corrective surgery is required to fix and/or remove the device.

Why are so many dangerous or defective medical devices released into the marketplace? The approvals process for medical devices is supposed to be rigorous and thorough but this process has come under investigation as more devices are found to be defective. The FDA is always being pressured by major manufacturers for faster approvals and a less strict testing process. Also, similar to drugs, not all of the serious adverse reactions caused by medical devices are documented by the time a device is actually marketed. Even devices approved by the FDA can cause severe side effects and injuries that are not found in the testing process.

There is also the classic story of corporations putting profits over people. The medical device industry is a multi-billion dollar business and the competition to bring a new device to market is fierce. Quality control, manufacturing errors and design flaws can all be ignored in the race to be the first to release a new device. Some companies have gone so far as to hide evidence from the FDA in order to a get a device approved.

If you or a loved one have experienced any major side effects as a result of a defective medical device, please call us at 1.800.966.4999 or fill out the form to the right of the page for immediate attention to your case.

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