Metals from hip replacements present toxic risk for millions, investigation warns

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(CBS News) Millions of people with metal on metal hip replacements may have been exposed to dangerously high levels of toxins that seeped into their bloodstreams, warned the researchers behind a British Medical Journal and BBC Newsnight investigation.

The investigation into the implants found that chromium and cobalt ions from this type of artificial hip can seep into the surrounding tissue to destroy muscle and bone and spread to the lymph nodes, spleen, liver and kidneys, potentially causing damage. The researchers were also concerned the ions could affect a person's chromosomes, resulting in genetic changes.

"This is one very large uncontrolled experiment exposing millions of patients to an unknown risk," Michael Carome, deputy director of the patient advocacy organization, Public Citizen's Health Research Group, said in a BMJ written statement. "We will only find out about the safety of these devices after large numbers of people have already been exposed."

The researchers say manufacturers of metal on metal hip implants changed the design of the hips over the past decade to increase movement for the recipient, but those changes may be responsible for the release of high levels of toxins into the body.

The study was published in the Feb. 28 issue of BMJ, and aired Tuesday night on BBC News.

The investigation also uncovered a 2005 internal memo from implant manufacturer DePuy Orthopaedics, a division of Johnson & Johnson, that shows the company knew about the possible toxicity from implants in 2005. 

"In addition to inducing potential changes in immune function," the memo said, "there has been concern for some time that wear debris may be carcinogenic...Also worrying is the possibility of distant effects. One study suggested a threefold risk of lymphoma and leukemia 10 years after joint replacement."

Despite the memo, marketing for the metal on metal hips "continued unabated," according to the investigators.

How? According to the investigators, the FDA approved the design change in 2005, saying it did not "raise any new issues of safety and effectiveness." The U.K.'s regulatory agency, the Medicines and Healthcare Products Regulatory Agency (MHRA), appointed a committee in 2006 that concluded that patients should be told about the risks, but no alert was issued to surgeons or patients until 2010.

What do the regulators say now?

"Clinical evidence shows that patients have a small risk of suffering complications from having metal-on-metal hip implants," Dr Susanne Ludgate, Clinical Director of the MHRA, said in a statement to BBC News. "As a precautionary measure, we have today issued updated patient management and monitoring advice to surgeons and doctors" that they should monitor these implants annually for a patient's lifetime.

The updated British recommendation won't affect U.S. patients, according to the FDA. Erica Jefferson, spokesperson for the FDA, told the New York Times that it was unclear that testing patient blood for metal ions would accurately reflect damage, so it would maintain its existing recommendation.

"We continue to recommend that hip replacement patients undergo regular follow-up with their physicians," she said.

According to Medscape, the FDA cleared the newer metal on metal hip replacement design through a grandfathered process because the design was similar to older implants. Then In May 2011, the FDA ordered metal on metal prosthesis manufacturers to conduct research into whether the implants were making people sick, HealthPop reported. Until recently, about one-third of the 250,000 hip-replacement operations done in the U.S. each year used a metal-on-metal joint implant.

The investigators point the finger at the regulators for letting the issue get this far.

"This isn't the unlucky failure to spot the misdemeanours of one rogue company or the occasional unforeseen breakdown of a small number of devices," BMJ investigations editor Deborah Cohen told BBC News. "It is the inability to prevent a whole class of failing hip implant from being used in hundreds of thousands of people globally."

Nick Freemantle, an epidemiologist and statistician at University College London, who worked as an editorial advisor for BMJ, told CBS News, "In my mind we've got ourselves into a mess."

Freemantle says we're now facing a situation where possibly millions of people in the U.S. have potentially risky hip replacements and the health impact of these metals in bloodstreams are unknown. Compounding the issue, many younger people have the devices since they were designed to last longer. He said regulators should not be in this position of uncertainty.

"It's very worrying for somebody who may have had one of these implants but we don't know whether it's extreme risk or not, and we shouldn't be in that position."

Freemantle thinks the FDA has been too complacent and had not done enough to evaluate the potential risks of these implants.

"I don't think we're in a situation where nothing can be done," he said. "There's no way of pretending there's no problem - we have a problem and it needs dealing with."

[426hemi2]

I have a personal response to many of these Reponses. I had a BHR implanted in 2008 with no issues to this point. My brother convinced me to try this implant as he had two implanted.(not BHR) I will never forget as my brother and our family met with the oncologist to get his prognosis. He developed metastatic liver cancer from these awful implants. His only response during that meeting was I am worried about my brother, because I convinced him to get this type of implant. He was more worried about himself as he stared at death. He died three months later. I plan on having mine removed in light of this new information. I just hope I didn't wait too long. I wish you all who have this implant to be cautious.

[czlc89]

A study published in the Journal of Arthroplasty pinpointed the head taper junction as the source of corrosion. It was also linked to adverse tissue tissue reactions, which is a common reason for revision surgery
http://www.publichealthwatchdog.com/study-suggests-large-heads-and-trunnion-taper-interactions-contribute-to-failure-of-metal-on-metal-hip-implants/

[floridaman86]

Does anyone know the email address of Ryan Jaslow, the author of this article?

[alphaa10000]

AVOIDING ADULT-ONSET (TYPE 2) DIABETES--
http://articles.mercola.com/sites/articles/archive/2011/03/03/media-finally-states-reversing-diabetes-is-possible.aspx

[Puristat_Wellness_Center]

There are so many toxins we're just beginning to become aware of. It's SO imortant to take care of flushing these toxins with a simple liver cleanse diet, periodic colon cleanse, and these other 5 tips.

http://www.puristat.com/environmentaltoxins/toxinsoverview.aspx

Jill

[kirstinosgood]

Wanna bet it's manufactured in China?

[FormerUSMCSergeant]

While some replacements are due to injury, the vast majority are done because gluttons wear their joints out with the massive stress they place on their joints. No different than overloading a truck to the point that the suspension fails....

I pity any who are facing these issues, but I have less for the gluttons than the injured.

[Bigheader]

I just got a hip replcement surgery at BBalboa Navl 3 of 4 people in my room where maries who worn their hips out carrying 90lb packs I guess they derversed it? you must be a very smart marine

[alphaa10000]

GLUTTONY OR IGNORANCE ?

Dismissing the wave of hip replacement surgeries as the toll of "gluttony" is quite a stretch. The nearer and more likely culprit is the so-called American national diet-- a witch's brew laden with high-fructose corn syrup and empty, fat-creating carbohydrates from
milled grain products coming from the Usual Suspects-- ADM, General Mills, etc.

In any major grocery chain, shelves are 90 percent "processed" foods, and less than 10 percent raw fruits and vegetables. The factory foods are not nearly as nutritious as industry makes it out to be, and are harmful to the general health profile. Factory food is filled with salt, the aforementioned HFC, "stabilizers" and preservatives-- all with a rap sheet that industry would rather not discuss.

A lifetime of eating the typical grocery store diet will harm (or even kill) anybody. But it makes an immense amount of profit for the food processing industry, so much money that the FDA, USDA and other regulators meet intense (and well-funded) lobby opposition to any strengthening of the American diet by new, well-established research.

This American diet, warts and all, is what contributes to the toll of old age-- overweight and/or poor glucose metabolism, heart disease, diabetes, cancer, etc.

[vsmit]

One study that there "may" be a problem. Odd how people believe that one source to be gospel and everything else must be a conspiracy.

[alphaa10000]

Wise people pay attention to reports from authoritative research and warnings -- especially when so much rests upon early and proper corrective measures. The problem is not that we are beset by conflicting research, as no research at all.

[guest173]

hopefully the news media and medical experts keep up with these kind of disturbing reports and medical practice will change to resolve these terrible issues. It is very annoying how excruciatingly slow this country addresses problems.

[floridaman86]

My intentions are to tell my story to the media, medical experts, and for others to listen to my thoughts on improving a system that is in dire need of help. In 2007 I had a metal on metal device put into my body, Smith and Nephew's BHR, 6-8 months after the procedure I began limping, back pain increased, groin pain was getting worse, and low grade fevers appeared. I visited my orthopedic surgeon several times, he x-rayed the hip and saw no signs of a problem. My family doctor checked me almost weekly and recommended I me see a back doctor, this examination and x-rays showed no problem. Things got progressively worse. At one point I thought it was just me. I had an active life, I fished, hunted, competed my Labrador retrievers in field trials, and have 4 grandchildren that were very much part of my life. My grandson was like my son, we were together 2-3 times a week. We last were working on him racing ATV's (four wheeler). I played baseball with him, went to the gym 3-4 times a week, helped coach little league, and worked for 31 years as a full time real estate broker in Sarasota, FL.

By 2010 I walked with a cane, lived in constant pain, but tried to maintain my degree of activities as best I could. In the beginning of January 2010 while getting out of bed I dislocated my hip, which resulted in my 1st ambulance trip to the hospital. The hip was put back in place, and I returned home. My orthopedic surgeon took x-rays and the hip looked ok. Within a week I got out of a chair and the hip dislocated again, another ambulance trip, same routine. This time my orthopedic surgeon said if this happened again the device would probably have to be removed. I told him it was time for another opinion and I was referred to an orthopedic doctor that was a top specialist in hip and knee problems. I was in his office 2 days later and the x-rays looked ok so he wanted me to have an MRI taken to get a better look at the hip area. He also said to me if the hip dislocated again the device would probably need to be removed. He thought there may be a pocket of fluid in the hip area that could cause the dislocation. I left his office, went to my office downtown, and 2 hours later I got up from my chair and the hip popped out. I was then heading back to the hospital in the ambulance. The hip was removed by the second surgeon. After the surgery the doctor told my wife he had never seen such a mess, all the muscle and tissue that supported my hip was gone, deteriorated. I returned home after my short stay in the hospital. I was home and in bed for several hours when a substance came out of the hip area and I had a temperature of 105+. This time I was rushed to the hospital where I spent 9+ months and underwent 12+ operations performed by 3 different surgeons. These operations were not just cleaning out the hip area. In a few of these surgeries parts of my femur were cut off to prevent further complications. The bottom right side of my body looks like the railroad tracks at Grand Central Station. Great doctors and nurses, my loving wife, friends, family, my Labrador retriever that regularly came to the hospital, the apple of my life, my now 8 year old grandson Hayden, my spiritual beliefs, and my will to survive kept me alive.

Going through something like this can't totally be understood unless one has actually lived the experience, I don't wish this to happen to you, my grandchildren, my friends, or anyone.

[floridaman86]

I have spent endless hours reading, researching, learning about the medical device world and how it works. I have read much information about the approval process of medical devices. I have a better understanding on how the hip and knee debacle was allowed to happen. My opinion is to help prevent this from happening again. Indirectly, we allowed a system to be created to help us enjoy a better quality of life; for the most part this has taken place. However, I find it difficult to swallow when I read how the medical device used on me was approved by the FDA. In 2004, Smith and Nephew, the manufacturer of the Birmingham Hip Resurfacing System (BHR) tried to get the FDA approval for this hip device. After the product was submitted to the FDA for approval it was denied for the first time by a 3/2 vote. Some of the reasons for the denial were lack of sufficient data, among others. The data used, was based on information provided by the inventor of the device, who worked for Smith and Nephew at the time. The clinical patients were a controlled group of people, controlled by the inventor of the product. The FDA expressed concerns of not having adequate results on what impact metal chromium and cobalt shavings entering the human body and bloodstream could have, now and in the future. In 2006 and using the same basic information, Smith and Nephew used the 510k plan and was approved by the FDA by a 3/2 vote. During this same period of time, 5 of these medical device manufacturers paid a total fine of $311,000,000 to the United States Government to put a stop to an ongoing investigation by the government of kickbacks being paid to doctors, hospitals, distributors, etc to market their products. Several of these companies were fined again for same and similar accusations. You can patch a roof leak so many times and reality sets in, and the roof needs to be replaced. Adding new rules and regulations means more groups to oversee this group or that group, there are so many groups involved in approving or denying a medical device I get dizzy.

Try to imagine a light switch being turned off, and all the enjoyment of your life was taken from you when that switch went off. Hayden, my 8 year old grandson usually stays over one or two nights with me a week. Last week, he said grandpa I want to go home and not stay, my heart sunk. I picked up my head, looked at Hayden, and asked him was this because we couldn't do most of the things we use to do, he looked at me with those big blue eyes and said yes. My response was, Hayden I understand why you want to go home, and if that's what you want to do it's fine with me.

If you know anyone with a problem with the manufacture Smith and Nephew or someone who had or has the BHR hip, please respond to this comment and we can exchange emails and talk further. Also, if anyone has the email address for Ryan Jaslow, the author of this article, I would greatly appreciate receiving it. Thank you

[jtdev1]

Wheres the list of implants that are causing this???

Are we just supposed to guess which ones are toxic????

[floridaman86]

Smith and Nephew's BHR (Birmingham Hip Resurfacing)