recalls

[cookie]

I won't make this too wordy. My Daughter-in-law sent me an article titled Warning! The medical "miracle" that may be hazardous to your health. It is a very interesting read and scarey. The only person that gets notified if there is a recall on an implant is the surgeon! If he doesn't get to it right away (if at all) then you are left out in the cold. One implant that concerns me is in March 2001 Guidant Corp recalled a new aortic graft that endangered thousands and killed 12! In June of 2003 the company pleaded guilty to ten felonies!
I am including a link to a form that is in Good HouseKeeping that states that there are 25 million with some kind of implant and millions more who will get them in the future. We need a foolproof system to make sure patients are notified immediately when a medical device may be threatening to their lives. Good Housekeeping will forward all forms to federal leaders for action. The magazine will report on the progress in a future issue of the magazine.
Haven't figured out how to include a link so I will post it and you can cut & paste. Go to Family health and look for artical listed above.
www.goodhousekeeping.com

 

[Ross]

Thanks Cookie, I'll be checking into it.

 

[bethanne]

I have a friend who has had two of her hip-replacements recalled. This means she has undergone three hip-replacement surgeries....

Too bad we can't go to the manafacturer web-site to access info re the "recalled parts". I didn't realize until two years after I purchased my nissan quest that by accessing their website recalled parts were listed. I did discover one recall that pertained to my vehichle and was able to get in and taken care of...

Seems like body parts should have just as high as a priority!

 

[Janie]

Good post Cookie...

Good post Cookie...

And good article. Sad, but how true.

I found out about my silzone valve from a friend here on the very primitive vr.com and that was the very weekend it was recalled -- around Jan 21, 2000. Back in the days Hank had an e-mail list and that's how it all worked.

I worked up the nerve to get my SJM card out of my desk and read the valve number. Then I accessed the SJM website and saw my valve number among the recalled. I was shocked, shaking, in disbelief and and feeling very vulnerable as I'd gotten the valve only three months before.

I immediately called my surgeon's office and the hospital. I wanted to know exactly WHO chose the valve. I wasn't even given a choice. I didn't even know tissue valves existed or I certainly would have certainly requested one of those. I was told Coumadin was just another 'pill' I'd have to take.

Needless to say, the surgeon's office told me the hospital chose the valve and the hospital told me the surgeon chose the valve. I never did find out the facts.

I got a letter from my surgeon dated March 2, 2000 to inform me of the valve....a form letter.

So Cookie, thank you for posting the article. If it comes into being that a central database is kept -- that would be a wonderful thing for every recipient of a faulty implant and just might help make some of the manufacturers of those recalls a little more diligent.

 

[Nancy]

Joe found out about a potential recall of his Bjork-Shiley valve (circa 1977) while listening to "60 Minutes" which ran an expose on the recall. Those with the affected valves just keeled over and dropped dead because there was a catastrophic failure of the welds in some of the struts. In those days, they didn't routinely give out cards with model numbers, etc. We were both in shock and very, very frightened. Not only that but we were unable to track down any information on which valve he had.

He had to spend a couple of days at Lahey Clinic while they did a very thorough xray examination of the valve to determine its integrity and also to determine the model that he had. Thank goodness he didn't have that particular model. The angst was intense and for a long time afterwards, we were continually worried that there might be an undiscovered fault in his particular valve.

Bjork-Shiley, as a requirement of a class action suit, was forced to give everyone who had a Bjork-Shiley valve, a lifetime membership in MedicAlert. Bjork-Shiley no longer makes valves for the US market.

Joe still has this valve 26 years later.

He had another scare when we heard about the St. Jude valves with silzone. Learned that from the newspaper. But we did have the card with the model number on it and I was able to access the St. Jude site. He does not have a silzone valve.

So we strongly agree that there needs to be uniform notification of any recall of any implanted device or body part, mechanical or tissue. Tissue products are not immune, some tissue products have been recalled or found to be defective or even "tainted", as some unfortunate people have found out. It is not just heart products. It is anything that can be implanted in the body.

 

[Mark Wagner]

Information

Information

Around two weeks ago my brother and mother called me about this recall on the phone, as my mother came accross the article. It was very scary, because my St Jude valve was put in at the time these valves were being inserted in patients. Go to the St Jude site, and if you have your model number, you can check and see if yours is one of them. These valves had (Silzone) silver coating, and were implanted in more then 12,000 americans. Thank God mine was not one of them. Their has been 70 serious problems and 20 deaths. Do a web search, about the valve recall to get the FULL information. Outside of the listed model numbers, St Jude gives vague information; as from a company stand point that does not surprise me. St Jude does have a picture with a comparison of the valve with and without the silizone.

Mark

 

[hensylee]

they send us mail about car parts that are recalled. Our gov''t shoud be ashamed about this. VR/others are NOT cars or any other inanimate thing!

 

[Mark Wagner]

I cannot agree more Ann. Unless your doctor contacts you, or you read the article, or found out through this site, or other second hand information etc., a person could be walking around with a time bomb in their chest and not even know about it. It is a damn shame, and I hope all whom have the listed valves in their chest 'sue' the daylights out of St Jude just for there conduct over this. There is no excuse not to notify patients so they can at least be monitored more closely.

 

[Marge]

It doesn't just happen with valves. My mom got a defective lens in a cataract operation and was never properly notified.
This was back when my parents were running their own lives. I was out of state & all I knew at the time was what my father told me, somewhat vaguely: "your mother had to have a second operation on that eye, but she's OK."
Much much later I found out that this lens had been subject to a recall. Apparently, however, my parents' eye doctor didn't tell them about that; he just said "there are some problems" and redid the surgery. Years later I learned about the recall, the class action suit, etc. (Too late for my mother to be included.)
I was very angry at that doctor, but my parents absolutely adored him & never questioned the way he had handled it. My mom was shocked when I suggested she might want to sue HIM.
The original lens had inflicted some permanent damage on that eye which the later surgery couldn't correct. Sadly, that eye, although damaged, ended up being her "good" eye after she developed macular degeneration in the other eye.

 

[Billy]

Here we go again.....

Here we go again.....

I suppose a few of you have been patiently waiting for me to climb up on my soap-box and join this thread.

Some of the newer members will probably not know that the reason I am here on this forum is because my wife Myrtle died in July 1998, ten weeks after having a St Jude silzone valve implanted.

I would never have known of 'silzone' if I hadn't received a copy of her autopsy report over two years after her death. I then found out that in Northern Ireland there were 19 silzone valves implanted and since then four patients have died.

To say that I am upset is the understatement of the century. In fact, rather than me say much more in this post, I am simply going to suggest that if any of you want any further information or statistics you should e-mail me through the VR.com e-mail service. If I started to tell you all that I know about St. Jude and the silzone valve, this would be the longest post in history.

Due to legal reasons I removed Myrtle's personal story from the 'stories' section of VR.com but I would be happy to e-mail it to anybody who has any concerns or who wants to know more about her untimely death.

There are lawsuits in USA, UK, Canada and Europe, all of which are easily found with a search on Google. While you're in Google you might also want to put the name 'Myrtle McCombe' and the word 'silzone' in the search box. You should come up with about sixteen websites and several newspaper articles which are very informative.

Feel free to send me an e-mail or a PM if I can be of help.

Regards,

 

[Sierra Bob]

Prior to my AVR, the surgeon and I had a long conversation that I definitely wanted a tissue valve as I packed in to the High Sierras several times each summer for as long as three weeks with horses and mules, it was too easy to get seriously hurt with animals in the back country, and I certainly did not want to be on warfarin.

After the surgery, I was informed that the surgeon had implanted a St. Jude mechanical valve. The alleged reason was that the hospital did not have a tissue valve in inventory that would fit !!!! It was the "old" VR forum where I found out about having a Silzone valve. I was never notified by St Jude (although they had to know, as they sent me a card with the model number and serial number that was included in their list of Silzone impregnated sewing cuffs). Nor was I notified by the surgeon or my cardiologist. My cardiologist claimed he had no knowledge regarding the recall and thanked me for the stack of paper I gave him which I had obtained from St. Jude via the internet, including their press releases and letter to physicians.

Needless to say, I had to give up the pack trips. I would probably have had to give them up anyway, as five months later I had surgery for Squamous Cell Carcinoma in the neck and the lack of stamina from seven weeks of radiation after the radical neck dissection would not made for a very pleasurable pack trip. Never-the-less, I'm very upset that I was never notified about my having a Silzone valve, and what to watch for if it starts to fail.

I do get an echocardiogram and have a stress test annually at my own insistance. The "echo" does indicate I have leakage, but according to the cardiologist, he can't tell if it is through the valve or around the valve (leaking sewing cuff), because it is so minor.

 

[Mark Wagner]

How would I find out about silizone impregnated sewing cuffs? I am a little nervous, because my valve was put in during this time frame. I do know my valve itself was not on the list with St. Jude.

Thanks ... Mark

 

[Sierra Bob]

Mark--The easiest way is to go to Google, put in Silzone Coating Advisory and click on Google Search. Wishing you the best. Bob

 

[Dee]

FDA recalls website

FDA recalls website

I too had read the article about recalls in Good Housekeeping. Very scary!!! If you go to the FDA website at FDA.GOV and go to Medwatch, you can sign up to be notified by e-mail about any recalls on medical devices. I'm assuming this would include heart vavles. Anyway, check it out and hopefully it's another way we can be notified of a problem since it seems our Dr.'s won't do it! Hope this helps!
Dee

 

[Billy]

Hey Mark....

Hey Mark....

If you want info from St. Jude, best thing is to contact them by phone, or even better, write to Minnesota so that you have a hard-copy reply.

The most direct route to finding out if your valve is silzone would surely be to contact your Surgeon or Hospital or to ask for copies of all your medical records. If you do have a silzone valve, which I sincerely hope you don't, then chances are you will want your medical records in any case.....well, if you don't want them your Attorney probably will.

Don't expect an immediate reply from St. Jude. The quickest they have answered me is about a month. I imagine that every letter that they write is probably checked by a panel of Lawyers.

I have heard that if there is an 'S' in the serial number of your valve, chances are it is silzone, but I do know that the conditions may be different in the UK.

Good luck with your search and the outcome, and if I can help in any way just holler....as y'all say across the pond.

Regards

 

[Sierra Bob]

Billy-- There is no S in my serial number. There is a S in the model number, but I note from St. Jude's list of Silzone coated valves, not all of these contain a S in the model number.

 

[ShezaGirlie]

SJM information on silzone

SJM information on silzone

Contrary to popular belief, it wasn't just the mechanical valves which were recalled. The list includes:

Devices affected:


SJM® Masters Series Mechanical Heart Valve with Silzone® coating
SJM Regent® valve with Silzone coating
SJM Epic? tissue valve with Silzone coating
SJM Tailor? Annuloplasty Ring with Silzone coating
SJM® Séguin Annuloplasty Ring with Silzone coating



http://www.sjm.com/devices/silzonea...lves&location=in&type=18&section=ModelNumbers

 

[Billy]

Mark and Bob....

Mark and Bob....

Speaking purely from memory...I think that at the time I discovered the 'silzone' word, I checked Myrtle's valve serial number on the US website and it wasn't listed. Perhaps they only listed the serial numbers for valves which were distributed in the US, I don't know.

What I do know is that the valve was distributed and used in Europe for many months before the FDA approval was given for it's use in USA. In an internal memo from St. Jude which was requested by the courts in Minnesota, a St Jude employee stated 'Silzone seems like a pretty slick idea.' He went on to say that they were hoping to get silzone valves implanted in 1997 in the 'GUINEA-PIG CONTINENT OF EUROPE'

Nineteen people were implanted with silzone valves in Northern Ireland. Four have since died and the remaining fifteen had no knowledge that they had a silzone valve until 14th October last year. A local Television company decided to do a documentary on the silzone subject and the Royal Victoria Hospital in Belfast heard about it. Two days before the programme was broadcast, the hospital telephoned all fifteen patients and informed them of what type of valve they had. The documentary was subsequently broadcast on 16th October 2003 which ironically would have been Myrtle's 50th birthday.

The sequence of events.....Most folks in N. Ireland had their silzone valves implanted between April and October of 1998. I have a copy of an e-mail from a Surgeon in the Belfast Hospital to the Medical Devices Agency in London stating that they were having problems with this device and that they had informed St Jude. He also said that they hoped that St Jude had listened to their concerns.

He also stated, and this was in October 1998, that the Hospital had returned their shelf stock of silzone valves to St Jude and didn't intend to use any more of them due to the complications that they had encountered. At about the same time, a Surgeon in Wales had seventeen complications out of 51 surgeries and he was crying out for help. The valve was allowed to be implanted worldwide for a further 15 months before the recall in January 2000.

This is a minute section of the tip of the iceberg of information that I have on the subject. I have been fighting for well over three years for statistics and information and have built up a dossier on the subject. Sometimes I discovered nothing for weeks on end and often considered giving up, but every once in a while another fact would emerge and then another. Each one seemed to be more unbelievable than the one before. Eventually the BBC in London decided to do an investigative programme and they found even more bizarre information than I had found.

This silzone subject is sometimes stranger than fiction. It would make a great movie....but I doubt that anybody would ever believe that the story behind the movie was actually true.

I have sent NTSC copies of the Television Documentary to a few members of VR.com who were interested. If either of you would like to view it, send me an e-mail or private message and I'll try to get somebody to send a copy on to you.

Keep in touch,
Cheers,

 

[Billy]

Mike and Bob.....

Mike and Bob.....

.....and all those interested, check out the link below.


http://biz.yahoo.com/prnews/040212/phth015_1.html


Regards,

 

[SHerrin Hutt]

Recalls

Recalls

Hi Billy
How is my favorite Irish man I wasss loooking some of the web ssight to see if my # was on any of theses lists and found two phone # you can call also 1-800-544-1664 or 1-800922-9219 they will tell you if yours are on any of the lists.
Hey! Billy since I don't drink my daughter tasted your Irish Wiskey for 21 birthday. Miss you! Can't wait till Denver to see everyone.Chicago was so much fun. I promise not to be a party pooper this year and go to bed early. Everyone have a great week.



SHerrin Hutt
Valve repair5/99
Valve replacement