Should You Get A Hip Implant?

    As one grows older, the body gradually degenerates in form and function. The skeletal system is no exception, of which posture is an indicator of one’s age. The slowing down of bones is not limited to only its form but also its functionality.  This problem is common and even inevitable for each person as one ages. Thankfully, medical solutions have been developed such as therapy, medication and in cases where these do not work, implants and replacements are the answers, even if there are risks and dangers in having these hip replacements inside your body.

    These implants should stay in optimal condition inside your body as if they are truly part of it. For this reason, wearing and malfunction should not be an option for them to stay in your hip for the rest of your life. But lately, there are hip replacement devices made of material that is subject of emitting metal ions as debris, when it begins to wear off inside your internal tissues. This causes pain and swelling, on the one hand, in the surrounding tissues where the implant is located. Other than that, the debris may travel anywhere through the bloodstream, affecting other organs and systems.

    Knowing these risks, it is important for you to prepare yourself and be informed before having these devices implanted in your body. You first have to actively work with your surgeon or physician by knowing what type and material of implant will be used and how they decided to choose that. Is it the best for you? Does it have no risks on you and if there are, would they be tolerable and is there a solution to that? What are the long-term risks related to the procedure? These are things that you cannot overlook.

    But, what if you already have an implant before you were aware of its risks? Is there anything you can do? Of course, it is not too late. For your health, regular check-ups on the status of your implant is necessary while it is inside your body, especially when you are experiencing pain and discomfort around the area. An x-ray and other series of tests may need to be performed to find out if there is a problem that should be treated right away. Other than that, you might find out upon having yourself checked that your implant device is helped by the FDA from being supplied. Information relevant to the case can be found on  the website about Stryker hip device recall.

    

References: 

fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm

arthritisresearchuk.org/arthritis-information/surgery/mom-hip-q-and-a.aspx

Stryker Sent out Field Safety Notice Before Recall

One of the major ortho hip implant manufacturers, Stryker, issued a voluntary FDA recall on two of it’s products on July 6, 2012.  Both the Rejuvenate and the ABG II modular-neck stems were recalled due revisions potentially associated with fretting and/or corrosion at or about the modular neck junction. 

However, before the voluntary recall Stryker issued a field safety notice in April 2012, which is an urgent warning to doctors and distributors, concerning problems identified with the company’s hip device.   Stryker submitted both systems for FDA approval through the 510(k) Pre-Market Notification Process. Through the 510(k) process company’s can forgo FDA mandated clinical trials by proving that their drug or medical device is substantially similar to an existing product which already has FDA approval.  Stryker was able to prove that both hip implants were similar to other hip implants which had FDA approval.

 What the field safety notice that Stryker sent out before the recall warns that these artificial hips, made from varying combinations of metal, ceramic and polyethylene, are capable of improperly releasing potentially dangerous amounts of metal debris or metal ions into the bodies of hip replacement recipients. According to the notice the biggest problem in these particular hip replacement is different from others in where the problem deals with the articulation of a metal ball and cup, the problem with these implants is mainly the fretting and corrosion of the junction found in the neck of the implants. Fretting and corrosion of this part of the implant can degrade its metal components, placing the patient at risk.

Other complications connected with Stryker hip replacements may include but arenot limited to the following: premature hip system failure, and the need for revision surgery, unexplained hip pain, swelling and inflammation of the surrounding tissue, elevated levels of metal in the body and bloodstream, loosening and dislocation of the implant, and soft tissue reactions to metal debris within the body.

Unfortunately for patients who have begun to show these side effects, the only way to fix them is to have corrective or replacement surgery on the hip implant.

URL Reference:

prnewswire.com/news-releases/seven-more-plaintiffs-sue-stryker-over-defective-hip-implant-devices-169304516.html

mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON155656