A recent Netflix documentary called “The Bleeding Edge” illustrates some of the problems with the way that many medical devices, including metal on metal hip implants, get approved and make their way to the market. Specifically, the documentary calls into question the safety of certain procedures used by the Food and Drug Administration (FDA) in the approval process, including what is known as the 510(K) loophole.
Many medical devices enter the market through this FDA “fast track” process and are later found to be dangerous after causing multiple injuries to patients. Patients who have been injured by these defective devices often have to undergo painful and invasive procedures to remove the implants. Cases such as this continue to be reported across the country as injured victims file defective hip implant lawsuits against manufacturers of these devices.
What is the FDA 510(K) Approval Process?
![Metal on Metal Hip Implant that is also a dangerous medical device](/wp-content/uploads/2011/04/hip-implant.jpg")
The FDA allows a shortcut to approval when a medical device manufacturer can show that a new medical device is “substantially similar” to a device that the agency has already approved. This is known as the 510(K) loophole. Under this exception, makers of the medical devices may obtain FDA approval with little to no clinical data establishing that the device is safe for patients to use.
Many are claiming that this exception is being over utilized by medical device companies in order to get their products on the market quickly to turn a profit. As evidence of this, the new documentary highlights that 98% of FDA medical device approvals were obtained through the 501(K) loophole, while only 2% were approved through a more rigorous Pre-Market Approval process that included actual clinical trials and data.
Why are Metal-on-Metal Hip Implants Dangerous?
Hip implants are made from a blend of several metals including chromium, cobalt, nickel, titanium, and molybdenum. The metal on metal design of these implants is prone to break down at a faster rate than many other hip implants. When these metal parts rub against one another, they release microscopic particles into the bloodstream and surrounding tissues. The toxic metals build up in the body and can lead to what is known as metallosis or metal poisoning. This could cause permanent damage to tissue, bone as well as the nervous system. Many patients who have undergone hip replacement with these devices have suffered serious side effects and filed defective hip implant lawsuits as a result.
Contact an Experienced Metal on Metal Hip Implant Lawyer
If you or a loved one has been injured after receiving a metal on metal hip replacement implant, you may be able to receive compensation for your medical bills, lost income and pain and suffering, among other losses. Our firm is working with experienced metal on metal hip replacement lawyers across the country, who are investigating these cases.
They may be able to file a metal on metal hip implant lawsuit for you, and they charge no fee unless you win an award or settlement. For a free (no obligation) case evaluation, call our toll free number at 1-800-992-6878 or fill out a contact form online.
Source:
Paul d’Oliveira
Attorney Paul d’Oliveira has been practicing personal injury and disability law for over 30 years. He started his personal injury law practice in 1989 with two offices in Fall River, MA and East Providence, RI. Today his firm has 16 offices in RI and Southeastern, MA.
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