Metal-on-Metal Hip Replacement Complications Reported by Thousands: Report
Federal health regulators have received a flood of complaints this year about complications with metal-on-metal hip replacement systems.
Since January, the FDA has received more than 5,000 adverse event reports involving metal-on-metal hip problems, according to a New York Times analysis.
Metal-on-metal hip replacement systems are a widely used type of artificial hip, which are designed to last about 15 years. However, complaints suggest that thousands of people are experiencing early failure of the hip implants within a few years of surgery, often leading to additional surgery to replace the hip.
A few years ago, metal-on-metal hip implants accounted for about one-third of the 250,000 hip replacements performed each year in the United States. However, over the past two years, concerns have increased about a risk metal hip replacement complications, resulting in use of the implants dropping to just 5% of the artificial hip market.
Recent research suggests that as the metal hip replacement parts rub against each other, microscopic particles of cobalt and chromium may be shed into the body, which can result in metal poisoning, also known as metallosis. This may result in soft tissue damage, inflammatory reactions, bone loss, genetic damage, asceptic fibrosis, local necrosis or other problems that may lead to the need for a risky hip revision surgery.
In May 2011, the FDA requested artificial hip manufacturers to provide more data on problems with metal poisoning and metal implants.
It is generally believed that only about 1% to 10% of all complications associated with medical devices are ever reported to the FDA. Therefore, it is likely that the reports identified by the New York Times involving problems with metal-on-metal hip replacements only represent a small portion of the actual injuries suffered.
Problems with DePuy’s ASR hip replacement systems accounted for about 75% of the metal-on-metal hip complications reported to the FDA this year.
A DePuy ASR hip recall was issued last August, involving more than 90,000 components sold throughout the world. There have been about 7,500 reports of DePuy ASR hip complications since 2007.
More than 1,000 people have already filed a DePuy ASR hip replacement lawsuit as a result of complications caused by the recalled system. DePuy Orthopaedics also faces a growing number of DePuy Pinnacle hip lawsuits filed as a result of problems associated with their other metal-on-metal artificial hip implant. Although a DePuy Pinnacle hip recall has not been issued, lawsuits allege that the older system features similar design defects that increase the risk of early loosening or failure.
7 comments
How many complaints will it take before the FDA acknowledges there is a problem with metal on metal hips? Why aren’t the other manufacturers who make metal on metal hips named ? For example Smith&Nephew.
The reported number of problems with metal on metal hips, could be controlled by good old Market Share and Financing. Some people could be unaware of any existing hip problems, they very well could think it’s just them.
Try a significant exposer, like put this information in every newspaper, or means of communication for more people to have access to, then watch the number of complaints.
The FDA didn’t listen to warnings concerning metal particles entering the human body and the possible affects they could have. There were warnings years ago about this,e surgeons warned the FDA about the same as in the past. More importantly doctors’s concerns there was insufficient real statistical data as to answering this concern. Yet a good number of these devices were approved 510k plan. So please explain how Market Share and Financing pushed FDA around, and got what they wanted?
Fractured hip through an accident with a horse, had a pin to hold hip together but this failed. Had a total hip replacement an ASR by Deput Johnson&Johnson. It had never been 100% since it was inserted I still had pain in the groin area. Only for Current Affair there was a story on the ASR hip implants. I went that week to have a blood test and I have high levels of chromium and Cobolt in my system due to the metal on metal rubbing. I have to have the hip taken out, more pain and suffering. I had a lot of trouble with low iron levels with my previous hip surgury I had to have ambulance take me back to hospital, I needed 2 bags of blood my levels were so low. It took me a lot longer to recover. I am only in my 50’s and not looking forward to going back to have a third operation on my hip. Extremely disappointed with Johnson &Johnson and the lack of follow up.
I had MoM hip resurfacing done in 2008. I live with extreme pain now with elevated chromium levels. I am waiting on surgery date to have it removed and replaced. How do I get legal help to stop MoM from being used so others do not have to suffer as I have?????
I was only 48 when I had my metal on metal hip replacement. Six years later I have suffered horrific pain since. I was always a fit active person, and now I cant even walk short distances without paying the price. I have’nt had a good night sleep for a long time and I certainly dont want to become addicted to pain pills! I’ve been back to my doctor alot and found out my ion levels in the blood are high. All they want to do thus far is shoot me with cortozone. This pain has ruined my life!!!!! When will the FDA put a stop to this unneccessary TORTURE!
I had a MOM Zimmer hip replacement done in 2006. The surgeon did a fine job and it has worked very well for me. I am however very concerned about the metal ions. My body has ungone many changes since the surgery and I have feared for a long time now that many of the changes are due to the MOM wear. The biggest problems that I have had are a great decline of my memory and a lot of muscle trouble and pain.
l also get fatigued often. I have goin pain, however it has not been great, I do have a high tolorance for pain. The MOM metal ion problem is on my mind daily, I fear for the future.
In my posting on November 28, 2012 I said that I have a Zimmer Hip, that is incorrect, I have a Wright Medical Hip. I really feel that the time will come that I will have to do something about it. I have no health insurance now, so I can only hope the the need to have something done will not come until I’m 65, but that is still 4 and a half years off. Wish I had know more about what the side effects could have been before I had the replace done.
I have had 2hip replacements. 1in 2001 and other 4 years ago they are both metal, and I am in pain all the time.I cannot sleep at night .the bottom of my spine is sore also. When I went to orthopedic surgeon and told him my hips were sore , he shrugged it off and said it was my back . I cannot take strong pain killers, or I will land back in hospital. Also I have metal in my left leg with 13 screws and that is sore also.Ican hardly walk for the pain. Ihave a walker