Prescription and over-the-counter (OTC) medicines are not the only dangerous and defective medical products on the market. Devices and products implanted during surgery, surgical tools and instruments, and medical equipment, can be defective and cause serious or fatal injuries.
Implanted Medical Devices
The very existence of implantable medical devices, and the fact that they save and improve so many lives, is nothing short of miraculous. However, it is also a very profitable and competitive industry. Getting new devices on the market as quickly as possible, and before competitors release a similar product, often involves shortcuts in testing by device makers, or even hiding the known dangers of a new device.
Device makers are willing to put lives on the line if the believe that the profits will exceed the cost of litigation resulting from the injuries and deaths their products cause.
Examples of defective implantable medical devices include:
- DePuy hip replacements
- Zimmer hip implants
- Zimmer knee implants
- Transvaginal mesh
- Medtronic defibrillator
- Guidant defibrillator
- Shoulder pain pump
- Drug-coated heart stent
- Kugel hernia mesh
FDA Fast-Track Clears Devices without Approval Process
One of the reasons we have so many dangerous and defective medical devices is the 510(k) clearance process. Rather than require that all new medical devices go through the standard approval process which involves clinical trials, the U.S. Food and Drug Administration (FDA) clears many devices through a fast-track process.
New devices can get 510(k) clearance based on their similarity to an existing device, referred to as “predicate”. It is bad enough that the new devices do not have to be tested, but the unbelievable part is that it does not matter if the predicate device has been recalled or found to be defective since being approved.
What this means is that new medical devices are cleared for market, by the FDA, based on the fact that they are similar to preexisting dangerous and defective devices. In fact, the agency is required to clear the new devices, even if they have the same known design flaws as the predicate devices.
When the Institute of Medicine (IOM) reviewed the 510(k) process it found that 71% of high-risk device recalls from 2005 through 2009 involved devices which were cleared through 510(k).
Types of Defects
Design flaw is a common defect which makes medical devices defective, but some devices and medical products are plagued by manufacturing errors or contamination.
For example, Triad alcohol wipes were recalled due to contamination with deadly bacteria. The problem was in the plant where the wipes were made. Multiple deaths have been linked to products from that plant since the recall was initiated.
If you have been harmed by a defective medical product, or if someone you love has died from an injury or illness caused by a medical device, please find a local defective products attorney and schedule a consultation right away.
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