FDA Reports Metal-on-Metal Hip Implants Cause Soft Tissue Damage

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Main Category: Bones / Orthopedics
Article Date: 18 Jan 2013 - 0:00 PST



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FDA Reports Metal-on-Metal Hip Implants Cause Soft Tissue Damage

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For many years metal-on-metal hip devices have failed at surprisingly high rates and the question being asked remains: "Is there a lack of clinical benefits with metal-on-metal bearings?"

Recent updated information from the FDA (U.S. Food and Drug Administration) claims that metal-on-mental hip implants can cause soft-tissue damage and pain, possibly leading to more surgery to replace the implant.

Metal hip implants were created to be more sturdy than traditional implants, but instead have become a serious cause of worry following many user discomforts and safety problems.

The traditional implants were made of a ceramic or metal ball with a plastic socket.

Unique Risks Associated With Metal-on-Metal Hip Implants

The FDA reported that all-metal implants can lose metal where two components connect, like the point where the ball and the cup slide against each other during running or walking. A release of metal can cause wear and tear of the implant, bone damage, as well as harm soft tissue around the implant.

Soft tissue damage can produce pain, loosening of the implant, device failure, and need for revision surgery. It is possible that some of the metal pieces could travel to other places in the body and cause symptoms or illness.

Currently, the FDA does not have enough data to precisely identify the concentration levels of metal pieces lost in a patient's body or blood to create adverse effects. Additionally, different patients have different reactions to specific metal wear particles.

Recommendations For Surgeons and Patients

The FDA recommends surgeons select a metal-on-metal hip implant for their patient only after deciding that its advantages are greater than those offered by an alternative hip system.

Every patient should be aware that hip implants have benefits and risks. The FDA urges patients to discuss all options with their surgeon.

If you currently have a metal-on-metal hip implant and are experiencing symptoms such as: ...contact your orthopedic surgeon right away.

If you are not having problems or symptoms and your surgeon thinks your implant is working well, it is recommended that you follow-up with the surgeon every one to two years.

In July of 2012, the FDA released a similar report stating that there are few reasons left to use metal-on-metal hip implants. Experts decided they had fewer benefits than risks. The main concern was how they exposed patients to released metal particles.

Written by Kelly Fitzgerald
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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Visitor Opinions (latest shown first)

Support For All Who Are Suffering With MOM Hips

posted by janthemum on 15 May 2013 at 9:58 am

I also have an MOM hip, fitted in 2005 by an excellent surgeon. But it's a Wright Medical Conserve Plus device, and it seems they have almost as bad a record as the infamous, now withdrawn, de Puy hip.
My cobalt levels are around 100 nmols/L but my chromium is nearly 300 nmols/L and this scares me. So I've decided to have a revision. I also have some strange side-effects which I think might be caused by the chromium - strange flashes and patterns in my vision, sleeplessness, and painful spasms in my ankles. Does anyone else recognise these symptoms? The hip is sore, but I couldn't say it's really painful. However I'm worried about the inflammation damaging my hip bone and muscle tissue.
I'm thinking of getting some good legal advice. Has anyone else found a good firm of solicitors in the UK?

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Zimmer Metal on Metal Hip Implant

posted by Daniel Gatti on 3 Mar 2013 at 2:39 pm

I am crumbling in pain and I can't walk across the street, go to the kitchen, or wake without wondering what the intensity of my pain will be for the day. Work, walking, sports are impossible and I'm 67. I was working and now all I do is spend my days looking for a doctor who will diagnose the cause of my pain. I've tried everything and the doctors say I need to live with this and Oxy. This is not how I expected to live my life. I've had to quit working. Is there a dotor out there who will stop reacting with "conservative" remedies and focus on "curative" alternatives. Is there a cure, or is that just another figment of my imagination? Mine was a Zimmer ML Taper Hip Prothesis with Kinectiv Technology. A Versys Hip System Femoral Head 12/14 Taper and a Continum Acetabular System with KK Liners. Portland Dr. Duwillius said I should try a shoe lift and goodbye. The situation is complicated by the fact my right leg is now 2 centimeters longer than my left. Has anyone experienced relief from similiar situations. A positive response would be a blessing. Thank you. DJG

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Other Complications

posted by Carol S on 30 Jan 2013 at 1:28 am

I had a MOM implant in Dec 2006 and I had maybe one yr without pain followed by constant pain - walking; sitting; sleeping - hip surgeon said bursitis and gave me cortisone shots. Double Vision started in May 2011 diagnosed as Graves Disease endin a long career in sales. Had surgery in Oct 2012 to correct double vision and it came back in four weeks.

I'm going thru another bout of sleepless nights and thyroid issues. A physical three weeks ago showed an abnormal EKG that a heart specialist last night said showed a prior heart attack. I have no history of heart disease in family and have been healthy until this hip issue. I have high cobalt levels and am seeing a new hip surgeon today to discuss removing this hip. These postings have helped me to keep my sanity and know I'm not alone imagining this pain.

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Three left hip replacements

posted by Kathleen on 22 Jan 2013 at 5:54 am

Dec. 10, 2012 was my third surgery to this hip. The previous two replacements failed immediately and the stem was sloshing around in the bone. The first was ten yrs ago the second was 5 yrs ago.
The pain has been horrible.

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I had a tumor removed from my groin area recently

posted by Mike Olstowski on 21 Jan 2013 at 1:32 pm

I'm new to this way of communicating but I have two MOM hips which constantly burn my surrounding tissue. I have recently had a tumor removed from my groin area. I'm convinced that my hips are the cause of it but no medical people seem to agree. I have muscle spasms, kidney pain headaches and sore eyes. Does anyone out there recognize these symptoms?

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device owner - metal on metal hip implant

posted by john la berge on 18 Jan 2013 at 5:18 pm

being informed of the possiblity of relationship between a metal to metal implant and pain of walking is signnificant for owners of such devices. be rest assured readers of this adisory it is not unusual to have the agency publicize the findings years after the fact of the procedure's having been done when the public has grown to accept this form of we just found that out press release being aired. what i wish to know is how long it will take for the f.d.a. to advise persons who have had organic transplant matrial supplied from a.b. melsingen to be made aware of the risk the procedure came with as dominique roy's horrible life and death have proven thie product's being contaminated with jakob kruetzfeld prions?
for that matter when will the public become aware of the risks attached to bearing methyl ethyl acrilade implants in upper skull and mandibular areas ?
love to hear from you. john la berge

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metal-on-metal hip implants

posted by carol on 18 Jan 2013 at 1:54 pm

A lot of people might not even realize that they have a metal-on-metal hip implant, and it's not until they experience signs like pain or swelling do they find out that something has gone wrong. People who had hip surgery and experience pain or anything out of the ordinary should go to their doctor and find out whether or not they have this type of implant. You would think that all approved products are known to be safe, but sadly that it not the case for all-metal hip replacements.

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