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Metal Hip Implant Lawsuits Highlight Poor FDA Approval Process
By Christina Drury
Hip implants are a relatively new device, allowing for medical marvels in being able to replace brittle bones, or to help those who are suffering from pain and discomfort. Like most medical devices, the metal on metal hip implant is subject to approval by the U.S. Food and Drug Administration (FDA) prior to being available for use by hospitals and physicians. Generally, the rate for successful hip replacement surgery is high, meaning that patients experience a better quality of life after the implant procedure, which is usually uneventful. Metal on metal hip implants, however, have come under scrutiny for several design flaws that not only lead to discomfort, but other serious hip implant side effects.
Prior to the metal on metal hip implant, the standard type involved a metal ball that was inserted into a plastic socket. The metal on metal design has the same metal ball, but instead of a plastic socket, it is a metal socket. When the newer all-metal hip implant was originally introduced by DePuy, it was hailed as the next best thing. It was designed to give patients more flexibility and mobility, thus allowing for a more active lifestyle. What it did, however, was hardly what many patients expected, and it set in motion hip implant lawsuits against many manufacturers.
How the FDA Went Wrong
When medical devices are developed, they are sent through to the FDA for approval for use in the market. Apparently, the design of the metal on metal hip implant was never reviewed as a “new” product to the market. Instead, it piggybacked in on the back of standard hip implant devices on the 510K process. In layman’s terms the 510K process allows manufacturers to submit products for approval that are determined to have “substantial equivalence” to products that already exist on the market. Thus, the FDA approved the metal on metal hip implant without requiring manufacturers to inherently prove its safety. The result is thousands of implants that have caused severe hip implant side effects resulting in lawsuits.
Hip Implant Side Effects
The main side effects of metal on metal hip implants that are being reported are:
- Increased amount of metallic ions in blood
- Chromium and/or cobalt poisoning
- Tissue death where hip implant rests
Each of these hip implant side effects contributes to the level of pain and suffering that is experienced by those who have the devices installed. These side effects are caused by the two metal parts of the hip replacement system rubbing against each other when pressure is put on the hip joint. This causes the metal ions to be released into the recipient’s blood stream.
You Can Get Help
If you have been the recipient of a hip implant or you know someone who has and experienced adverse side effects, you may be eligible for compensation. Visit our DePuy, Biomet, Wright Medical Technology & Others, Metal on Metal Hip Implant Class Action Lawsuit Investigation page to get more information on active proceedings and to submit your information to attorneys who are investigating metal hip implant side effect claims.
Updated January 22nd, 2013
All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.
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