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If a Medical Device Is FDA Approved, Is It Safe?

The United States is home to the largest medical device market in the world. Chances are you or a loved one relies on a medical device to some degree in order to maintain quality of life. The natural assumption for most patients is that their device has been thoroughly tested before hitting the market and that FDA approval is a foolproof system. Unfortunately, this is not always the case. Many individuals find that they must turn to a dangerous medical devices lawyer for representation due to a defective device. But how do these products even make it to the market? We explain below.

FDA Medical Device Classification Simplified

When processing applications for new medical devices, the FDA classifies entries into low risk, medium risk, and high risk categories or, Class 1, Class 2, and Class 3 devices, respectively.

For example, the following devices fall into these categories:

  • Class 1: Elastic bandages and hand-held surgical instruments
  • Class 2: Powered wheelchairs and infusion pumps
  • Class 3: Heart valves, metal-on-metal hip joints, and other implants

The different classes are subjected to varying degrees of trial and study before hitting the market. Certain devices, regardless of class, are approved by the FDA through either pre-market approval (PMA) or 510(k) reviews. The PMA process consists of thorough studies on the device before it hits the market. This route is most commonly used for new or very-high risk devices and can be quite costly. The 510(k) route proves much simpler: the medical device manufacturer must present evidence that the device is equivalent to an existing device on the market. This approval process is most commonly used for Class 1 and Class 2 devices.

In short, many devices that are deemed low or medium risk gain FDA approval without extensive testing, and the extensive costs of thorough testing on high-risk devices leads many manufacturers to attempt to circumvent the PMA process. This can be detrimental to the unassuming consumer/patient, and require the legal help of a seasoned dangerous medical devices attorney.

Does the System Work? FDA Medical Device Recall Statistics

In the FDA’s own reports, statistics taken from their 2003 to 2012 fiscal year recalls show that while Class 1 recalls remained minimal and Class 3 recalls declined by 35%, Class 2 recalls doubled from 460 recalls in 2003 to 1,043 recalls in 2012. It should be noted in these numbers that recalls are not equivalent to the device being pulled from the market, and that the overall functioning product numbers have increased proportionally to the recalled items, meaning the average number of products per recall hasn’t significantly increased over the years.

Notable FDA Approved Device Recalls

The exceptions to the positive FDA statistics, no matter the number, can wreak havoc on a patient’s life and cause severe emotional, physical, and financial stress - and in some cases, death. Headline-worthy recalls in the FDA’s past have ranged from a Medtronic defibrillator wire that was not tested in a clinical trial to faulty pelvic mesh devices that severely decreased quality of life for thousands of women. Many cases are made worse by the fact that the devices cannot be removed without serious risk, as seen in the case of pelvic mesh implants and even seemingly simpler devices, such as a metal-on-metal hip implant which leaked metal ions into patients’ blood. Though the FDA quickly took steps to remedy these situations, the damage was irreversible for many.

You’ve Been Injured: What’s Next?

The FDA system is consistent in weeding out a majority of hazardous devices; however, every system is faulty at some point. If you’ve been injured due to the defects of an FDA approved medical device, Arnold & Itkin is passionate about getting you just compensation, and is experienced in handling medical device lawsuits.

Contact our dangerous medical devices attorneys today
to get the justice you deserve.