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Marty said:
Thank you Linda. By the time I came along they knew the valve was OK!
You're welcome, Marty, but I don't feel that I did anything to be thanked for. At the time, I felt like I might be signing my life away, but after having had one OHS and facing number two, I knew I didn't want to do it a third time if there was any chance that I might not have to. So I guess I was really going with the St. Jude for selfish reasons. My surgeon convinced me that if it was his wife in my position, he would recommend the St. Jude and that was enough for me. Linda
 
Sympathy not deserved

Sympathy not deserved

Hi Marty,

SJM placed silzone coated valves and other appliances on the market in spite of inadequate research and testing of the silver coating.

SJM did not issue the recall voluntarily--they were forced to. Their only concern was the profit they expected to make. SJM has endangered the health of thousands of silzone patients around the world.

SJM does not deserve sympathy--not mine, not anyone's.

Now I'm off my soapbox.

Cheers
 
lance said:
Hi Marty,

SJM placed silzone coated valves and other appliances on the market in spite of inadequate research and testing of the silver coating.

SJM did not issue the recall voluntarily--they were forced to. Their only concern was the profit they expected to make. SJM has endangered the health of thousands of silzone patients around the world.

SJM does not deserve sympathy--not mine, not anyone's.

Now I'm off my soapbox.

Cheers

I'll stay off the soapbox but this, for me, is really the heart of the issue. I really don't think that St. Jude would knowingly produce a defective valve and anybody can make a mistake. But when it's become obvious that you've made a mistake, you need to admit it. Goodwill intangible assets on the balance sheet are not worth more than peoples' lives.
 
Bet it was the lawyers!

Bet it was the lawyers!

lance said:
Hi Marty,

SJM placed silzone coated valves and other appliances on the market in spite of inadequate research and testing of the silver coating.

SJM did not issue the recall voluntarily--they were forced to. Their only concern was the profit they expected to make. SJM has endangered the health of thousands of silzone patients around the world.

SJM does not deserve sympathy--not mine, not anyone's.

Now I'm off my soapbox.

Cheers

Lance, I accept your point. However I would like to know how many silzone valves were implnted and how many patients died or needed repeat surgery. Is there any way to find this out? Look, I am a radiologist, a specialist in women's imaging, which includes the high risk mammography and OB-Gyn sonography tests. I have had suits filed against me but so far have never been convicted of malpractise or had to settle. When the suits were filed I wanted to reach out to the patients, say I was sorry, and try to find out exactly what went wrong. The lawyers always ordered me to not do any of this.
I bet it was St. Jude lawyers who made them play hardball with the patients, and I think that's bad.
 
Silzone Valves

Silzone Valves

C
Eur J Cardiothorac Surg 2004;25:371-375
© 2004 Elsevier Science NL

--------------------------------------------------------------------------------



The Silzone effect: how to reconcile contradictory reports?
Gary L. Grunkemeier*, YingXing Wu
Providence Health System, Portland, OR, USA

Received 11 September 2003; received in revised form 3 December 2003; accepted 15 December 2003.

* Corresponding author. Address: Providence St Vincent Hospital and Medical Center, 9205 SW Barnes Road, Suite 33, Portland, OR 97225, USA. Tel.: +1-503-216-7272; fax: +1-503-216-7274
e-mail: [email protected]


Objective: To attempt to reconcile reports containing contradictory findings with the St. Jude Medical Silzone heart valve. Methods: Major leak and thromboembolism data were extracted from available Silzone valve studies. Linearized rates were used to summarize and compare the events rates among the studies. Results: The Artificial Valve Endocarditis Reduction Trial (AVERT) study reported significant higher rate of major leak and the Cardiff Embolic Risk Factor Study (CERFS) reported significant higher rate of thromboembolism with Silzone compared to non-Silzone valves. But, current updates of these studies show a diminution of these differences. Three other comparative studies reported no difference between Silzone and non-Silzone valves, and three single arm studies reported acceptable results with Silzone valves. Conclusion: The contradictory findings could be partly due to clinical and technical reasons. No new events have been reported since the original AVERT (major leak) and CERFS (mitral thromboembolism) publications.


Key Words: St. Jude Medical heart valve • Silzone heart valve • Paravalvular leak • Thromboembolism




I think this may be good news for those who are living with silzone valves. Looking into this after not thinking about it for years, I am impressed that you can get all the complications attributed to silzone such as thrombosis and paravalvular leak with regular non-silzone valves.




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ANN THORAC SURG ASIAN CARDIOVASC THORAC ANN EUR J CARDIOTHORAC SURG
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Copyright © 2004 Elsevier Science B.V.
 
Siding with Marty

Siding with Marty

In the development of heart valves there have been many things that didn't pan out. You have to remember that before 1960, if your valve could not be repaired- you died on the table. My first valve just lasted a couple of years, but at least I lived to get another one. At the time, many surgeons wanted to give up on valve surgery because they lost so many pts. As I posted before, one person who had a repair by my doctor the years before my surgery, stated that of the 7 children who had heart surgery the week he did, only 1 other went home. It is very hard on the surgeon to see pts. die. One only has to look at the case of the brilliant pediatric surgeon from Arkansas who killed hmself because he felt he had failed some children who died.:( So if you think that St Judes is a heartless company that thinks only about profits, you are misinformed. First of all, the mistake cost them dearly! When Bjork-Shiley made a change to their valve for improved flow, it was manufactured
with strut welds that were defective and it put the company out of business because of the lawsuits. I have read where Dr. Shiley became very depressed about all the pts. that died. I would bet that the researchers at St Judes who were trying to reduce pt. infection rates
with the silver coating idea, were horrified with what happened and I do have sympathy
for them and the company. There other valves that had fatal outcomes. Many of the single disc valves, had disc escape in to the blood stream, resulting in sure death.:eek: Tissue valve- their development did not go without some horrible losses, valves that fell apart in a matter of months!:eek: Then there was that crazy Frenchmen, who want to stick bovine parts in to people hearts:eek: - Wow I bet that went over big when he announced that stupid idea!;) The rest is history.:) You never know what is going to work in the long run.

What is the “Best valve”(trying to get thread back on track)? Is a little like asking what is the best ice cream, car, teacher, color……………etc, etc. When I had my third
Surgery in 1982, my surgeon could have gone with the new kid on the block, St Judes.
He decided against it, because with twice as many moving parts, twice as many things could go wrong and no one had demonstrated it had superior flow characteristics. He could have gone with the new and improved Bjork-Shiley CC(the one with the bad welds), but he was more like Marty, he would let someone else try the new valve- after all he had already tried 2 new ones on me and figured I had paid my dues! So I got the old tried-and-true Bjork-Shiley 60 degree valve. Was it the best valve? It was certainly
better than the CC type, maybe not as good as the St. Judes- but as my team at CCF decided during my last surgery- “any valve that is in place and doing well should be left
there.” For my other valve, they put in a Carbo-Medic. They couldn’t put the St Judes
Regent in that position. Could they have put a ATS or ON-X in? I’m sure if they felt one or the other was clearly a superior valve, they could have called up one of the companies and they would have sent a chartered jet and a team of surgeon to get CCF to try their valve. Like Marty, my previous surgeon Dr. Kay, the team at CCF will take a wait and see approach. That way, you might not get what may prove to be the best valve
of the future, but a sure thing right now- and hopefully not a defective product.

The “best valve”? What are your criteria? The longest lasting valve is the Starr-Edwards; some of them are approaching 40 years. It will be 15 years before any St. Judes will match that! I’m sure the St. Judes will and more. One poster had an old Kay valve that had been in place for 32 years and doing fine- hard to argue that is not the “best valve” for that poster. It will take years to sort out the answer to this question and I’ll be
willing to bet by the time they know which one is clearly superior (if they ever do), it will
replaced by something even better.:(

Get a surgeon you trust, let him make the call based on which valve he feels the most skilled at implanting.:)
 
Good news from Dr. Grunkemeier

Good news from Dr. Grunkemeier

We have some contributors who have silzone valves and they are four years out. Looks like they are good to go!

Marty,

The problems with the Silzone valve seem to have been limited to a very small subset of patients, and seem to have disappeared by about 2-4 years after surgery. Since all Silzone patients are now at least 5 years beyond their surgery, they should have complication risks similar to a non-Silzone St. Jude valve which, as you know, are very low.

Based on new follow-up information, we recently submitted another paper, titled "Time-related Risks of the St. Jude Silzone Heart Valve". Below is the majority of the abstract to that paper, with some of the technical stuff snipped out:

Objective: The St. Jude Medical (SJM) Silzone heart valve was introduced in 1997 with a silver-impregnated sewing ring designed to reduce the incidence of endocarditis. Recruitment to the randomized AVERT study comparing Silzone valves with non-Silzone Control valves was stopped because of an increased risk of reoperation for paravalvular leak, but patient follow-up continues. Determining the time-related risk profile of the Silzone valve is necessary to help physicians and surgeons manage the approximately 28,000 patients currently living with a Silzone valve.

Methods: From 1998 to 2000, 403 Silzone and 404 Control patients were enrolled in AVERT. As of July 2005, there were 1,819 Silzone and 1,842 Control patient-years of follow-up (mean 4.5 years, median 5.1 years in both groups).

<snip>

Conclusions: The additional risks of the Silzone valve, compared to Control, diminish over time and disappear by 4 years after Implant. The minimum time post implant of the patients currently alive with Silzone is now beyond 5 years, so these current patients have a risk profile similar to that of a standard SJM valve.

Hope this helps. Tell Ed Lefrak 'hello' for me.

Gary G.


-----Original Message-----
From: [email protected] [mailto:[email protected]]
Sent: Thu 12/29/2005 5:48 PM
 
RCB said:
In the development of heart valves there have been many things that didn't pan out. You have to remember that before 1960, if your valve could not be repaired- you died on the table. My first valve just lasted a couple of years, but at least I lived to get another one. At the time, many surgeons wanted to give up on valve surgery because they lost so many pts. As I posted before, one person who had a repair by my doctor the years before my surgery, stated that of the 7 children who had heart surgery the week he did, only 1 other went home. It is very hard on the surgeon to see pts. die. One only has to look at the case of the brilliant pediatric surgeon from Arkansas who killed hmself because he felt he had failed some children who died.:( So if you think that St Judes is a heartless company that thinks only about profits, you are misinformed. First of all, the mistake cost them dearly! When Bjork-Shiley made a change to their valve for improved flow, it was manufactured
with strut welds that were defective and it put the company out of business because of the lawsuits. I have read where Dr. Shiley became very depressed about all the pts. that died. I would bet that the researchers at St Judes who were trying to reduce pt. infection rates
with the silver coating idea, were horrified with what happened and I do have sympathy
for them and the company. There other valves that had fatal outcomes. Many of the single disc valves, had disc escape in to the blood stream, resulting in sure death.:eek: Tissue valve- their development did not go without some horrible losses, valves that fell apart in a matter of months!:eek: Then there was that crazy Frenchmen, who want to stick bovine parts in to people hearts:eek: - Wow I bet that went over big when he announced that stupid idea!;) The rest is history.:) You never know what is going to work in the long run.

What is the ?Best valve?(trying to get thread back on track)? Is a little like asking what is the best ice cream, car, teacher, color?????etc, etc. When I had my third
Surgery in 1982, my surgeon could have gone with the new kid on the block, St Judes.
He decided against it, because with twice as many moving parts, twice as many things could go wrong and no one had demonstrated it had superior flow characteristics. He could have gone with the new and improved Bjork-Shiley CC(the one with the bad welds), but he was more like Marty, he would let someone else try the new valve- after all he had already tried 2 new ones on me and figured I had paid my dues! So I got the old tried-and-true Bjork-Shiley 60 degree valve. Was it the best valve? It was certainly
better than the CC type, maybe not as good as the St. Judes- but as my team at CCF decided during my last surgery- ?any valve that is in place and doing well should be left
there.? For my other valve, they put in a Carbo-Medic. They couldn?t put the St Judes
Regent in that position. Could they have put a ATS or ON-X in? I?m sure if they felt one or the other was clearly a superior valve, they could have called up one of the companies and they would have sent a chartered jet and a team of surgeon to get CCF to try their valve. Like Marty, my previous surgeon Dr. Kay, the team at CCF will take a wait and see approach. That way, you might not get what may prove to be the best valve
of the future, but a sure thing right now- and hopefully not a defective product.

The ?best valve?? What are your criteria? The longest lasting valve is the Starr-Edwards; some of them are approaching 40 years. It will be 15 years before any St. Judes will match that! I?m sure the St. Judes will and more. One poster had an old Kay valve that had been in place for 32 years and doing fine- hard to argue that is not the ?best valve? for that poster. It will take years to sort out the answer to this question and I?ll be
willing to bet by the time they know which one is clearly superior (if they ever do), it will
replaced by something even better.:(

Get a surgeon you trust, let him make the call based on which valve he feels the most skilled at implanting.:)

I believe the " old curmudgeon" said it all. This should be required reading for all pre-op valvers.
 
Although the Silzon controversy seems to have died down and Marty's last post is reassuring for those who still have the valves implanted, some additional information might be shared regarding St. Jude's culpability for its introduction of the silzone valve. A documentary produced by Ulster television was made available on DVD to valve replacement members. The documentary appeared to be well researched and factual, and, as I recall, set forth some of the following points:

The patent on the old St Jude valve was due to expire, if a modification was made to the existing valve, a new patent could be obtained.
The company had no research statistics to back up the claim that silzone was effective against endocarditis. They planted the prototypes in five sheep and one of the sheep died. That was a 20% failure rate. They planted the valve in 19 patients in Northern Ireland and four died......that also was close to 20% failure rate.

St Jude applied to the FDA for a 'materials change' licence for the new device instead of the much longer process of having a new device approved.
It is asserted that to avoid potential punitive damage lawsuits, St Jude sent the first valves to Europe for testing. This is common practice and is considered a cheap way of testing new devices and new drugs. In a memo produced in court, a member of the St Jude Medical marketing team referred to Europe as 'The guinea-pig Continent.' Unfortunately, some of the "guinea pigs" died as a result.

It is not widely known but St Jude does not manufacture their own valves. They are manufactured under licence by Sultzer-Carbomedics. Obviously, as Sultzer-Carbomedics had all the equipment to manufacture the old St Jude valve, the expiry of the patent would allow them to use this equipment to manufacture the same device and market it under their Sultzer-Carbomedics name, probably at a much cheaper price and hence greatly reducing St Jude's profits.

Finally the documentary interviews a Valve Replacement member about the death of his wife following her mitral valve replacement with the silzone valve. She was the first to die in Northern Ireland. Following her death the silzone valve was explanted at autopsy. St Jude did not ask to see the explanted valve and to this day, the valve and her entire heart organ remain in the Pathology department in The Royal Victoria Hospital in Belfast.
 
Wow!

Wow!

Wow, Mary. I never did get that DVD but have just asked Hank if he can still get me one. I reviewed some of Billy's old posts and agree St. Jude doesn't look so good. I almost can't believe they didn't want to see Myrtles valve. The only good news is that Dr. G's research suggests that those patients that survived the first few years are now no longer at risk. I wonder why those Irish surgeons were so quick to use the silzone in the first place?
 
Oh heck!

Oh heck!

Until I came to this site it didn't even occur to me that there was a choice of mechanical valves, I thought the choice was just tissue (and the types of) or mechanical. Then I saw that most of you have St Jude in your signatures and until reading more I thought that might be a hospital or something, then I realised it was a make of valve. Now you are telling me there are different models from a manufacturer. Oh heck, I was perfectly happy with my two ATS valves and now I don't know what to think. You are telling me that mine are unproven, that fills me with confidence. :)
 
I'm dying to do this everytime I read the thread title, so I'm doing it.

The best valve is the one that keeps you alive!
 
I remember how scared I was when I found out I had the "recalled" Bjork-Shiley valve ticking away in my chest. My first thought was, "How can you "recall" a valve that has been sewn into a patient"? Then I was angry because the recall came just before my second OHS and my surgeon knew about the recall yet he did not replace the valve. However, I found out later that, in 1982, there weren't many other choices for mechanicals. St. Jude's valve was brand new at the time. I had a fairly small valve and all the BS strut failures (at the time) were in the 27-29mm sizes (mine was 25mm). Therefore the surgeon thought it was better to leave mine in.

I have had many years to think about the problem and have less anger for Shiley than I did. I realized that they were pioneers in the field and I might have died had that valve NOT been available. Shiley was forced out of business because a great lawyer put together a huge class action lawsuit that bankrupted the company. That lawsuit has been useless to many of us who decided to have their valves explanted. I have seen no money for my third OHS because the lawyers keep coming up with excuses as to why my valve "was not in the danger group". This despite my cardio and surgeon stating that my symptoms were in line with strut failure symptoms. Sometimes class action suits work for the "class" but mostly they work for the lawyers. I apologize, in advance, if I have just insulted any lawyers out there. It was not my intention, just speaking from my experience.

Yes, maybe St. Jude was trying the Silzone valve to hold onto their patent. After all, they are in business to make money. We can all think that motivations should be purely for the "good of the world" but, if companies didn't make money, they would not be in business. Simple fact but very true. I agree with the statement that those people who worked on the Silzone valve must have felt terrible when these problems came up. I am sure the same can be said for Shiley as well. I do not, for one moment, believe these companies put out products they know will kill people. Call me naive but that is a belief I will carry to my grave.

I think it is important for us, who benefitted greatly from medical research, to be grateful for companies like St. Jude and Shiley for creating products that have kept us around. Yes, some of our members had tragedies due to errors. However, if we did not have these companies, none of us would be here today.

As RCB stated, many people died in the early stages of valve surgery. I salute those people because they made what we have today possible. I would like to think my participation in research studies when I lived in the NY area helped people too.

I am off my soapbox now. Please don't throw rocks at my head if you disagree. Know this is all simply my opinion.
 
sue943 said:
You are telling me that mine are unproven, that fills me with confidence. :)

Sue,

The ATS valve has been used since 1992 in nearly half a million people, it is FDA approved and has an excellent track record for performance. I would say it has proven itself quite well to be every bit as good as the St. Jude. I would not worry about it in the least.

Randy
 
I just had my OHS in August, so my St. Jude is still "new & fresh"..I didn't get a choice though. They were suppose to replace my aortic valve, but for complicated reasons, they left the valve in it's place and just "attached" a conduit instead. The conduit already has a St. Jude inside of it...does anyone know if there are conduits with other "brands" of mechanical valves:confused:
 
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