How Were Dangerous Hip Implants Approved?

Many recipients of metal-on-metal hip implants have suffered severe pain and other complications due to the failure of their devices. Not only have these complications ruined their quality of life, many of these patients have had to undergo painful revision surgeries. How could the U.S. Food and Drug Administration (FDA) have possibly approved these dangerous implants?

The “Fast-Track” Program

Most metal-on-metal hip implants hit the market after going through the FDA’s so-called “fast-track,” or 510(k) program. This is an easier path to approval, used when a manufacturer is able to prove that the product under scrutiny is substantially equivalent to those that have already gone through the FDA’s pre-market approval process and been introduced to the public.

Unfortunately, metal-on-metal implants were viewed as being similar to the ceramic and plastic hip implants that have been used for decades. As a result, they were fast-tracked without the need for clinical trials and other requirements of the FDA pre-market approval process.

Thousands of people have suffered debilitating complications from metal implant failure. One of the most common side effects is a condition known as metallosis. This occurs when tiny particles of metal that have worn off of the implant enter the bloodstream. This can cause pain and swelling in the hip, severe damage to the tissues and bone surrounding the implant, as well as other problems throughout the rest of the body.

Taking Legal Action

Thousands of people received these implants without having any idea that they could be in store for major problems, and many of them don’t know that they may qualify to file a lawsuit against the metal hip manufacturer. They thought they’d finally find relief from years of agonizing pain, only to find out they now had to face a whole new set of issues. Many implant recipients have had to undergo painful and invasive revision surgeries to try and correct the problems caused by the failure of the devices.