
One of the reasons for the recall was the expected failure rate of the DePuy implant, which is a metal-on-metal type implant. The implant was cleared under the Food & Drug Administration's (FDA) 510(k) approval process, which allows medical devices that are substantially similar to already cleared (predicate) medical devices to be approved in a streamlined fashion. The DePuy hip implant was not tested on humans before being sold on the market.
Nearly 100,000 patients received the DePuy hip implants. Johnson & Johnson has estimated that nearly 13 percent of these implants will need to be replaced at some point in the future. However, experts worry that more patients will be affected than is currently estimated.
Metal-on-Metal Hips Can Cause Illness
Hip implants can be made of metal, ceramic, or plastic materials. With all hip implants there is a chance that particles from the implant will enter the blood stream, because the ball and cup portions of the implant slide against each other when the patient walks or runs.
However, the concern with metal-on-metal hip implants is that metal ions or particles can enter the patient's blood stream, posing a risk that the patient will develop cancer or other illnesses.
Of course, different people will react to the metal ions in different ways. Some patients may experience bone or tissue damage surrounding the affected joint. This is known either as an adverse local tissue reaction or an adverse reaction to metal debris. When this happens, the implant may become loose and ultimately require revision surgery in which the worn-down implant is replaced with a new implant.
High levels of metal ions in the bloodstream may lead to adverse effects on the heart, nervous system, and thyroid gland.
High Failure Rates
Metal-on-metal hips are three times more likely to fail than artificial hips made of other materials. Popular metal-on-metal hip implant brands include the DePuy ASR SL Acetabular Head System, DePuy Hip Resurfacing System, and DePuy Pinnacle Artificial Hip Systems. Other manufacturers of metal-on-metal hips include Stryker, Biomet, and Zimmer. The Zimmer Durom Acebabular Component has also been voluntarily recalled by its manufacturer.
What symptoms should I look for if I've had a DePuy hip implant?
Common symptoms associated with an adverse reaction to the hip implant include:
Other symptoms that are less common, but serious include:
What should I do if I have these symptoms?
If you have any of the above-mentioned symptoms, the FDA recommends that you contact the orthopedic surgeon who performed your operation immediately and set up an appointment in which he or she can better determine whether the hip implant is causing your symptoms.
Your orthopedic surgeon may order the following tests:
How do I know if I have one of the recalled hip implants?
If you are unsure whether you received a metal-on-metal or recalled hip implant, contact the orthopedic surgeon who performed your operation.
If my hip implant was recalled, will I have to get it replaced?
Not all of the hip implants will need to be replaced. If you have already received one of these recalled hip implants, and you are not experiencing any of the above-mentioned symptoms, your orthopedic surgeon may just want to periodically monitor your health to ensure the hip implant is not adversely affecting you.
If you are experiencing some of the above-mentioned symptoms, you should contact your orthopedic surgeon as soon as possible so that he or she can determine which course of action will be best for you.
My orthopedic surgeon told me I will have to have a revision surgery. What does this mean?
A revision surgery is a surgery to replace the current implant that is causing you problems. Revision surgeries include risks that are present in all surgeries like an adverse reaction to the anesthesia, infection, bleeding, and blood clots. Some patients may have more difficulty undergoing a revision surgery if the metal from the previous implant has affected their soft tissue or bone quality in the implant area.
Know Your Legal Rights
If you received a DePuy hip implant and suffered an adverse reaction or had to have the implant replaced, you may have a claim against the manufacturer. The experienced defective medical device attorneys at Van Wey Law may be able to help you. Call us today at (214)329-1350 or (800)489-5082.
Don't hesitate to contact Kay Van Wey at (800)489-5082 for a free, no obligation consultation.
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