Last week I wrote about a problem I encountered when trying to get my eyeglasses repaired — the lenses would not fit the identical replacement frames, because these frames are made in China, and each batch is different. This is just one example of the enormous quality issue surrounding Chinese-made goods. But compared to what happened late last week, it was a minor inconvenience to me … a passing gnat. You see, I'm the proud owner of a DePuy (Johnson and Johnson) ASR XL Acetabular System, one of 93,000 units that have been recalled.
The ASR XL isn't a vehicle with a sticky accelerator pedal, but it definitely is something that has enhanced my speed since I acquired it in 2008. It's a hip implant that — up until last week — I thought was a sterling example of bionics at its best. Now I'm worried that the device is in my body, possibly breaking down and releasing metals into my bloodstream.
When I read the news about the recall, I did what many other hip implant patients undoubtedly did — called my orthopedic surgeon's office. It was late on Friday when I left my message with his nurse, and I really didn't expect a call back until after the weekend. I was surprised to receive one that evening. The nurse — the same nurse who's been with my surgeon since I first consulted him in 2003, which I find comforting — said she was returning all calls about the implants, because she was afraid "patients would freak over the weekend." She then began to go over my records.
Here's the scoop: I had one hip replaced in 2004 with a device that has a metal stem and a composite ball. The surgeon chose this implant specifically because at that time there was no suitable device with a large metal ball. Now six years old, this hip continues to function great. I have had zero problems with it. It is not an ASR XL.
In 2008, I had the second hip done. The surgeon was delighted to be able to implant an all metal device with a large ball. I have had no problems with it, other than a continuous slight pressure on the outside of my leg. This implant is an ASR XL.
I trust my orthopedic surgeon with my life, literally. He did an amazing job with both operations. I spent only one night in the hospital each time and had problem-free, speedy recoveries. Although I was not scheduled to see him again until next year, I soon will be sitting in his examining room looking at x-rays and having blood drawn. This process will continue until I die, or until the device has to be replaced, whichever comes first.
As DePuy announced on its Web site, it is voluntarily recalling the ASR™ XL Acetabular System and the DePuy ASR™ Hip Resurfacing System because of the number of patients who required a second hip replacement procedure, called a revision surgery.
New, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales shows a five-year revision rate of approximately 12 percent for the ASR Hip Resurfacing System and approximately 13 percent for the ASR XL Acetabular System. These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter (check) and among female patients (check).
Now, I'm optimistic and believe that I probably will fall in the 87 percentile of patients who will have no problems. Optimistic, but not stupid. I will continue my checkups and trust my surgeon. DePuy recommends yearly monitoring "to ensure the ASR hip replacement is functioning well, even in the absence of symptoms."
Already the lawsuits have begun. Every manufacturer's nightmare. But as ukjawdoc wrote to another Vicki(e) earlier this year on Help4Hips.com, the failure of these implants might not lie solely with the manufacturer.
Check back for an update after I meet with my surgeon, who is waiting for information from DePuy about where to send blood samples and who's paying for what. This could take awhile.
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About the Author: Vicki Bell
I hope that you continue to update this blog, as I am curious to find out how DePuy handles reimbursing patients with a recalled unit implanted in them who require testing, as you do, to ensure their ongoing safety. I’m not sure what kind of health insurance plan you have, but it appears that there are some loopholes in the language that DePuy is using for their reimbursement policy. Based on what I read, it appears that some government health care providers (including Medicare and ERISA) can make patients reimburse them for the cost of medical treatment if they obtain a third-party recovery (such as DePuy is offering).
Sorry, but I don't trust DePuy Orthopedics anymore, and since I know that my doctor's office pops up as No. 1 as a 'DePuy affiliated doctor's office', I have a hard time to trust them either. News and blogs on 'DePuy hip replacements Made in China', 'DePuy illegal kickbacks of $114 million to doctors', and headlines like 'DePuy managed to have the charges lifted, due to signing a Deferred Prosecution Agreement and agreeing to pay civil settlements to the Departments of Justice and Health and Human Services, which totaled $84.7 million' don't support building trust on the matter.
I like to inform you about my failed hip replacement, medical device used: DePuy ACE Tabular (no confirmation whether it is the ASR XL or not). I also like to update you on my medical condition. Calendar of events and current situation is best described as follows:
1. My right hip was replaced using one of the DePuy devices 2 days before Christmas 2008.
2. For the first 3 months after surgery I was unable to lie down straight in bed, only changing certain positions hourly sitting in a recliner allowed me to bear severe and violent pain. Actually, to the day (almost 2 years after surgery), I am not able to sit, stand, or lie down for more than a couple of hours, rather less. Even when I don’t move at all, severe and violent pain kicks in.
3. Once I was ordered to walk on full weight, I was never able to walk more than half a mile without severe pain kicking in. Actually, to the day my hip replaced leg starts hurting badly when I walk only very short distances, much shorter than half a mile and often when I don’t walk also. My surgeon always suggested to be patient as recovery from a severe operation like that could take up to a year, or more.
4. The last time I saw my surgeon was a little over one year post-surgery. Again, I told him how severe my pains still were.
5. During this past spring/summer I tried to see my surgeon again. Mainly because I was suffering more and more. Unfortunately, due to my long tern ‘Leave of Absence’ I had lost my job and all my benefits including health insurance. My surgeon’s front office told me over the phone that I would have to pay a fee of $160 just to see the doctor as an uninsured person. I simply could not afford that at the time, and I tried to get help through my local Senior Citizen Help Center, but they denied me because they had set minimum age to 55 from 50, and I am only 52 years old.
6. After I learned that I have a ACE tabucular cup hip replacement made by Depuy Orthopedics, I went to the Venice Regional hospital in order to request my Medical Records and Implant Report. It was a kind of odd that the clerks at the hospital said that they can provide my Medical Records, but that it seemed strange that they were unable to find the serial number of my DePuy hip replacement. They told me that they would send me a copy when they would find it. After appr. 2 weeks I received a copy of the implanted system, and it stated ‘DePuy aceTabular’ just as described on many blogs on the internet.
7. My medical condition, personal situation and circumstances get worst and worst. Besides the facts that my pain is constant and severe, I have lost my job, lost health insurance and other benefits due to my illness since December of 2008.
Furthermore, and after my employer had me terminated because of extended ‘Leave of Absence due to illness’, I applied for unemployment benefits. Unemployment was denied because the agency was not able to help me because of my illnesses. Since surgery and after I started to sit for extended time, not only severe pain bothered me, also a condition called Edema (excessive swelling of my right food). Both my doctors back then (until January of 2009), Dr. Cuff and Dr. Schulte knew about that additional condition.
Meanwhile I have developed more severe pain in the hip area of my left hip, back, and all the way up the neck. My severe and violent pain is causing me a lot of discomfort, my overall medical condition seems to get worst and worst, ie.
-I cannot get in and outside of a vehicle without terrible pain in my right leg and right hip.
-I cannot get up from sitting or laying down positions without terrible pain in my left and right leg and left and right hip.
-I can only walk very short distances without severe pain starting inside my right leg and right hip.
-I move and walk very slowly, because I am afraid to fall with every single step I do.
-When I turn my neck to the left or to the right a little faster than very slow, I see 'stars'. Also, when I move my neck, another violent pain stretches out all the way down to my lower back.
-Both my hands and arms developed a tingling sensation that stretches all the way from the tip of my pinky fingers to the ellbows.
-I have Diarrhea almost all the time, no matter what I drink or eat. Many times there is also blood in my stool.
8. At the end of August 2010 I applied for Social Security Disability benefits. My initial claim was denied 11/23/2010. I am in the procedure to appeal that decision.
9. I am also in the procedure to seek legal help on the matter of my failing DePuy hip replacement. According to information I have gathered, I have all the symptoms people write about failing DePuy hip replacements.
10. At the present time, I believe that I am in urgent need of medical care. Having lost medical insurance due to the loss of my job, and being denied help from the local Senior Citizen Help Center, I am trying to gain eligibility for the County's Health Department.
Regards,
Juergen Schaberick
Venice, Florida