My Story
My name is Richard Edelman and this is my story. It is August 2007. It is apparent from my x-rays and my debilitating pain that both my hips have severe osteoarthritis. My only option it seems is to have a bi-lateral hip replacement (double hip replacement). I am only 51 years old. My orthopedic surgeon in New York is Dr. Scott Marwin. He thinks that the best choice for me is the Birmingham Hip. It is made by Smith & Nephew, a company headquartered in London, England. It is a hip designed for younger patients who want to stay active and who have the proper bone density to support these larger implants. They are made out of metal. In fact, they are made with a greater density of metal than any other hip replacement. They were designed that way so they could withstand the demands of physical activity, like running and skiing. More importantly, these hips are made from two metals, Cobalt and Chromium.
My operation is scheduled for September 10th, 2007. Other than my osteoarthritis, I am in perfect health. The pre–surgical testing performed by both my surgeon and my primary doctor confirms this. When a patient needs both hips replaced, it is rare that they are both done at the same time. Only patients in perfect health are considered.
(I want to establish this because every complication that I presently have came AFTER my metal on metal hip replacements). Being that I was in perfect health, the surgeon proceeded to replace both hips during this 7-hour operation.
After 4 days in the hospital, I was sent to an inpatient rehabilitation facility for one week. It was the most challenging, painful, grueling 11 days of my life. I arrived home on day 12 and I slept in a rented hospital bed. For the duration of two weeks, I received physical therapy at home and a week later, I went to an outpatient facility.
It did not take long before I started feeling sick. In fact, I lost 30 pounds in the first month following my operation. Initially, I thought it was the effects of the operation but now I realize it was most likely metal poisoning.
After many months of rehabilitation I was given the "OK" by my surgeon to start resuming some of the same physical activities that I had participated in prior to my operation. (After all, this was the promise that was made to me by my surgeon and why he recommended the Birmingham Hips in the first place). Unfortunately, from the very outset of resuming these activities, I experienced pain, my hips would squeak and I would feel sick for long periods of time. I realize now that the cause of my sickness was most likely due to metal poisoning.
These hips were a complete failure from the very beginning. I never would have gotten them if I knew that they would not deliver as promised. These hips are much larger, have a greater density of metal and are much more difficult to recuperate from than a traditional hip replacement.
On top of the pain, the squeaking of my hips and the feeling of being poisoned, I started experiencing a long list of additional complications. I developed cardiac and neurological complications, severe memory loss, cognitive impairment, tinnitus and a constant outbreak of rashes. I walk with a noticeable limp and I can barely walk five city blocks without experiencing great pain.
The breaking point for me was when I realized that I was having trouble with my hearing. I went to my primary doctor to get a referral for an audiologist. My doctor said that "he had done some research and that people with metal on metal hips were experiencing a lot of problems." He recommended that we should order blood and urine tests to see the levels of cobalt and chromium in my system. The tests came back. Unfortunately, they showed that my metal levels were “off the charts high". I immediately went to the audiologist in order to find out how bad my hearing really was. It was then that I got the bad news: I was completely deaf in my right ear!
I started to research metal poisoning and I found out that cobalt poisoning had been known to cause deafness in other patients that had metal on metal hip implants. I also found out that my other complications were linked to cobalt poisoning as well.
Both my parents lived into their eighties. My mother lived to 83 and my father was one month short of 90. Both of them were in great health, mentally and physically, until cancer struck both of them. Neither one of them had any of the complications that I have described above and neither one of them ever went deaf. I know this because I took care of both of them until the day they died. Deafness does not run in my family. In fact, there is no one in my entire extended family that ever went deaf. Of course, none of them had metal on metal hip replacements.
To help put my case in perspective and to demonstrate to you how high my test results for Cobalt were at the time of my deafness, I will use a comparison using a more well-known test: Cholesterol. Most of us know that the total cholesterol level in our blood should be 200 milligrams or less. How would you feel if your doctor called you and said that he had very bad news. "Your cholesterol is not 200, it is 10,000”! You would not believe it. You would demand a new test. When the second test came back with the same results, how would you feel? How would you feel if your metal levels was 5000% higher than it should be? How would you feel if your doctor told you that he never saw such high levels in a person before and he did not know how to proceed?
Well, that is what happened to me!
It turns out the medical community had realized for some time that patients with metal implants were experiencing many complications. They realized that they had to create blood and urine tests to test the cobalt and chromium levels in patient’s bodies. The most important, and unfortunately the most difficult part of creating these new tests, was the extensive research necessary to determine the healthy and unhealthy ranges for these metals. This was not some willy-nilly process. This was done with the same precision that cholesterol, triglyceride and glucose tests had to go through when they were being created. In fact, every laboratory test that is available today had to go through extensive research to determine the healthy and unhealthy ranges for that test. Eventually, the research for cobalt and chromium were completed and the healthy and unhealthy ranges were determined.
Unfortunately for me, my metal levels are "off the charts high"!
The analogy that I make regarding my situation is the following:
If I added a little antifreeze into my engine oil every time I had an oil change what would happen to my engine? Every mechanic would agree that running tainted oil throughout an engine would not be good. The question is, how long will it take before that engine died?
Well, with my tainted, poisonous blood circulating throughout my "engine" (body) for the last 10 years, "how long will it take before I die"? (I'm already going deaf). The fact is, every year could be my last year.
Because of my host of complications, having revision surgery to replace these hips with a much healthier choice (ceramic and/or plastic hips) is very risky. I consulted with Dr. Su, the leading hip surgeon at the Hospital for Special Surgery in New York City. He told me that “he will have to chisel them out and that there was no guarantee what the outcome would be." He is one of the top orthopedic surgeons in the country at one of the top orthopedic hospitals in the country informing me that this revision surgery would be risky and that my outcome might be disastrous. There is no one I would trust more to do my revision surgery than Dr. Su. I tried and tried to schedule an appointment with him to do the revision surgery. I called his office so many times that I even started recording my conversations with his staff (which I am still in possession of because there was something amiss and I wanted a record of it). No matter how many messages I left, and how many people that I spoke to, they never called me back. I later found out that Dr. Su was one of the surgeons that was involved with the clinical trials of the Smith and Nephew Birmingham Hip. Whatever his reasons were, it was obvious that he did not want me as a patient.
At the same time that all this is happening to me, Johnson & Johnson, one of the largest and most prestigious companies in the United States was also manufacturing metal hips under their subsidiary, DePuy. Their metal hips were creating metal poisoning as well, and since claims against them were mounting, they decided that they would settle with their patients who had received their metal hip replacements for 4 billion dollars. A company like Johnson & Johnson has the best doctors and the best legal team that money can buy. If there was any way that they could deny these claims they would have. The fact is they could not dispute the claims, and so they paid.
One reason that my manufacturer, Smith & Nephew, has not paid any money to patients who are experiencing the same complications that the Johnson & Johnson hips have is because they feel protected against any and all litigation due to a Pre-Market Approval (PMA). A PMA is an FDA application process that the medical device industry lobbied for and received that virtually protects Smith & Nephew from any and all liability. This is ridiculous! The FDA has been wrong many times about drugs and medical devices that they have approved before and they are wrong now! In fact, concerns about metal hips are presently on the FDA website. So, the very agency that approved them is the same agency that has great concerns about them.
Another concern that I have about Smith & Nephew and the FDA is that Smith & Nephew has bribed government officials before. Did that happen in this case? Did they bribe officials in the FDA to get these hips approved? Why should anyone trust them? Just because they were caught once does not mean that they haven’t tried to bribe, before or since. Cobalt poisoning has long been known to be detrimental. How did this device get approval?
In fact, Smith & Nephew has had numerous improprieties:
1. In 2007, Smith & Nephew was part of a 300 million dollar settlement to avoid criminal charges of conspiracy. Paying kickbacks to induce U.S. doctors to use their products, Smith & Nephew settled for $28.9 million.
2. Smith & Nephew agreed to pay 22.2 million dollars in February of 2012 to settle a number of United States Foreign Corrupt Practices Act offenses committed by its U.S. and German subsidies. This means that Smith & Nephew paid 5.4 million dollars in restitution and interest to settle U.S. Security & Exchange Commission Civil charges and a 16.8 million criminal fine including an admission to a decade long bribery scheme involving government employed physicians in Greece.
Smith & Nephew also entered into a deferred prosecution agreement and agreed to retain an 18-month Compliance Monitor. The Compliance Monitor requirement terminated in 2014.
3. Smith & Nephew agreed to pay 11.3 million to settle allegations about devices that they sold to the U.S. Government Department of Veteran Affairs. They claimed it was U.S. made, but the devices actually came from Malaysia.
4. Smith & Nephew settles Race Bias Suit. They agreed to pay up to $3.5 million plus legal costs to settle a lawsuit over allegations of racial discrimination in their hiring, paying and promoting of employees.
WHAT IS MORE UNBELIEVABLE IS THAT SMITH & NEPHEW CONTINUES TO SELL AND MARKET THESE HIPS KNOWING FULL WELL THAT THEY ARE POTENTIAL HEALTH RISKS!
We cannot allow a foreign corporation like Smith & Nephew to come into our country and poison our people!
My job now is to inform the public about the dangers of metal on metal hips.
If you or someone you know is getting a hip replacement, find out what brand of hip they are going to use. "Google" that company's name and find out if there are lawsuits regarding that company.
For those patients who already had their hip replacements, order your medical records and find out if you had a metal on metal hip replacement. Many patients have no idea that the physical and neurological complications that they are experiencing is due to metal poisoning. Many of them are not aware that their loss of hearing and/or deafness can be a result of their metal poisoning. Many of them are not aware that there are blood and urine tests for Cobalt and Chromium. Patients with metal on metal hip replacements should go for the following blood and urine tests immediately:
Cobalt Urine
Cobalt/Creatinine Ratio
Chromium Urine
Chromium/Creatinine Ratio
Chromium WB
Chromium Plasma
Cobalt Plasma
I also encourage patients to fill out the FDA 3500B form that allows each patient to file a list of physical and mental complications that they have experienced since having their metal on metal hip replacement(s).
This is my David and Goliath story. I have nowhere to turn. No one should suffer as I have.
UPDATE: On April 28th, 2016, I had additional hearing tests that have confirmed my greatest fear: I am now rapidly becoming deaf in both ears due to cobalt poisoning. It appears that in a very short time I will be completely deaf. Soon, my life will change forever. We must work together to stop them from implanting these hips into other unsuspecting people. I for one am going to take action!