Unapproved Valves.......

[Billy]

To all our European and Canadian Members.

Following the discussions on valves manufactured in USA and used in other countries before FDA approval,.........I have been in touch with a friend who is a Member of the U.K. Parliament, regarding this practice.

He has tabled three questions which were heard in the Westminster Parliament on April 16th and to which we are now awaiting answers. The U.K. Secretary of State for Health has been asked to reply to these questions:

(1) To ask the Secretary of State for Health, what tests his department carried out on the St. Jude 'Regent' range of valves prior to their use by the U.K. National Health Service and when were these valves first used by the NHS.

(2) To ask the Secretary of State for Health if it is his policy that heart valve replacements which have been manufactured in the United States of America may be used by the NHS before they have been approved by the Food/Drug Administration in the USA.

(3) To ask the Secretary of State for Health, what tests his department carried out on the St. Jude 'Silzone' coated mitral valve prior to it's use by the U.K. National Health Service and when were these valves first used by the NHS

This is the first step in a very long journey. Obviously I must first investigate matters in UK before embarking on the European Crusade, however the Euro Parliament in Brussels is probably step two.

As Europeans we must stand together to stop St Jude products being exported here and to Canada to be used, before the FDA approves them in USA. This is, in effect, using us as Human guinea pigs, as no punitive damages can be sought in the European Courts. To St. Jude, it is a very cheap method of field trial, however to the recipient it can be very costly and can result in further surgery or death.

I would ask for the support of all Europeans and Canadians on this forum and also for support from all right-thinking Americans who believe that this practice is a disgrace. Your voices are needed and appreciated.

I will keep you updated on my progress and the responses to the Parliamentary questions.

Thank you

Billy McCombe
(Husband of Myrtle McCombe who died 10 weeks after having a St. Jude silzone mitral valve implanted, aged 44 years)

[hensylee]

My sincere good wishes to you, Billy, in your pursuit of justice for others in the St Jude matter, and for your dear Myrtle. If we, in the USA can add a voice, please suggest how we can and we will, at least, I will. I do think it is a horrid thing that Europe lacks the same approval methods used here, thereby putting Europeans in danger, leaving you without any legal way of speaking out and changing things, unless you pursue the matter through government.

[DickV]

Billy, I agree with you regarding Europe being the proving ground. Remember Elisabeth's below posts. According to her, three children in Vienna received a SynerGraft valve and two of the three died. Those are some odds. Best of luck to you and your efforts.

Quote
Hi!
I am Elisabeth from Vienna, Austria. Please forgive me, that my English is not perfect.
My son Arnold was born in 1994 with truncus arteriosus communis. He had his first operation 1994. One year later he got a new heartvalve (homograft). In November 2001 this homograft had to be changed. He got a SynerGraft. On the 8 th day after his operation he died because of a rupture of the new Synergraft!!
I don´t want to fear you, but it seems that there is an enormous risk in that new material.
Has anyone else heard about any complication?

Greatings from Europe

Elisabeth


Hi Steve!

Of course I want to answer your questions, otherwise I wouln´t take part in this forum. It´s a bit difficult for me to do so in English, but I´ll try to do my best.
The doctors told me that the real reason of the rupture is unknown, but it defintitly was not a problem within the surgery. They just found ot that there must have been an inflammation on that part of the Graft.
Arnold felt well that day, he walked around and he ate with great appetite. It happened while he was sleeping. He didn´t have fever and his blood was controlled that day. Everything seemed to be allright.
He was the third child in Vienna, that got such a SynerGraft valve. And one of the others also died. In that case the reason was an enormous stenosis and they couldn´t help him anymore. But first they thought, that it didn´t happen because of the new material but because of some other reasons.
A fourth child got a SynerGraft a few days after Arnold´s surgery. They changed his valve again after that had happened with Arnold, because they didn´t want to risk it again. And now they don´t use it anymore. They didn´t hear anything about complications in other countries.
I hope for you, that it was a singular malproduction and there won´t be any other complications.
If they´ll find out anything new, I´ll tell you
__________________
Elisabeth, Mama of Arnold (2.10.1994 - 5.12.2001)

Unquote

[srwieland]

Very interesting, Billy. When I was researching new types of valves and such before my surgery, I kind of got that impression that some American companies were trying out their products in Europe before getting them approved here. Having lived for 10 years and traveled widely in Europe, I often found physicians, unlike the public, in extreme awe of American technological advancements. Sounds like they should be more cautious.

Thanks for the info and keep us posted. As an American, it always hurts me whenever it's reported that some of my compatriots are misrepresenting us to others abroad and giving us a bad name for what many of us don't support. I provide managerial support for a group of medical researchers and work closely with Internal Review Boards that strictly control protocols and use of human subjects. I am very concerned that companies would go abroad and exploit circumstances elsewhere to circumvent these safeguards. It also seems to me that it would be unfair to any competition who chose to behave more ethically.

So, thanks Billy for alerting us to these things and keep us posted.

[Elisabeth]

Dear Billy,

first of all I want to thank you for having started to fight for many of us and for our children. I promise you that we (that means me and my husband Markus) will support you in any way we can.

Our cases seem to be similar: my son got a porcine Synergraft heart valve made by cryolife. In cryolife´s press release from January you can read:
"Approximately 31 porcine SynerGraft heart valves have been implanted in patients, 23 of which remain implanted. The first of these valves was implanted in August of 2000. The seven valves that have been explanted have shown that the valves re-modeled themselves in vivo. There was one structural failure of a SynerGraft valve. The other explants appear to have been caused by surgical technique issues. SynerGraft heart valves have been implanted in Australia, Austria, Finland, Norway, Denmark, France and the U.K."
In the USA they use Synergraft processed allografts: "Since February 2001, approximately 394 SynerGraft processed pulmonary allograft heart valves have been implanted. Of these 394 valves, only three have been removed, none of which were removed for structural failure..."

I think, everyone who takes a look at these numbers can make his own opinion!

Best wishes

Elisabeth

[srwieland]

Hi Elizabeth,

So nice to hear from you again. I wanted to update you and others on this website on my SynerGraft valve situation, which has been on a bit of a roller coaster ride since you first apprised us of your son's tragedy with his.

Up to January, I was doing fantastic with the SynerGraft valve. When you first alerted us to the problems in Europe was just before I had my routine followup with an echo that revealed my new SynerGraft valve was mildly leaking, which was of course very disconcerting, especially in light of what you had reported. I still had very little symptoms at that time, though, just an occasional flutter.

Then, in February, I went to another cardiologist who confirmed the leak but said it was mild to moderate. He put me on meds, as the other cardiologist had suggested, and then I immediately ended up in the ER with fainting. For the next month, I went downhill, still on meds and feeling woozy all the time, ending up another time in the ER. They then did another echo and my leak was measured as moderate to severe, so it appeared to be really going downhill.

He then did a cardiac cath which was also reviewed by my surgeon and they concluded that the valve would have to be replaced, although not immediately. Meanwhile, he put me on an event monitor. Based on that, he switched me to different meds which reduced the wooziness, although I still am woozy if I exert going up stairs, etc.

After a month on the new meds (Accupril), I am now doing much better and my leakage on the latest echo was measured as mild to moderate and my heart function is doing well, with a EF of 60% and heart chamber size of 56 (mm?). Now my surgeon says it could be a few years before he recommends replacing it.

In any case, I'm still disappointed in my outcome and have outstanding concerns about the SynerGraft and why it's failing to some degree. No where near what you've had to endure but still well short of the 'promise'.

You're still in our prayers.

God bless

[bruizer]

Hey Steve,

I am glad to hear the leakage has stablized. I hope that you can get a lot of mileage out of this valve. I currently in a similar situation having had a Ross Procedure performed in December, 2000. My valve started leaking in the moderate range about 4 months after the surgery but I have had no symptons. I currently run about 3 miles a day. One of my surgeons has recommended the synergraft if and when my valve needs to be replaced.

Thanks for being one of the pioneers with the synergraft.

God Bless.

P.S. I sent you a private message as well.

[srwieland]

Hi bruizer,

Thanks for the sympathy and encouragement!

Do they have any idea why your new valve is leaking? My surgeon says he can't really tell about mine without explanting it. I'm going to get a second opinion, though.

We'll have to keep tabs on each other and see who goes under the knife again next!

I hope that my pioneering with the SynerGraft helps lead to its improvement and widespread success and not its downfall. Despite the leaking, though, I still feel like my body really likes this valve. I guess intuition doesn't have a whole lot of currency in this matter, though!

Take care.

[Mara]

All-

All this synergraft talk is so interesting. Can't wait to see what shows up on my one-year post-op echo! I feel pretty confident so far. No problems (knock wood) and feeling good.


Steve, did you get the pulmonary synergraft in your aortic position? if so, did the docs ever say that was a contributing factor to the leak? I'd be interested to know if this made a difference just because of the high pressure in the aorta. I think this is useful knowledge for us Ross folks, too, since our pulmonics are now our aortics.

We may know more after Jennie and John have check ups from their new aortic synergrafts.

Bruizer-- I had the Ross, too. Which valve is leaking? The aoritic or the pulmonic? So far the flow murmur I have is across my arotic valve and nothing close to the murmur I had on my original aortic valve. I can live with a small flow murmur. I guess I never really expected to be a 100% completely murmur-free person. So far, I am happy with what I got in the Ross. I'm still here and feel great!

Billy,
One day we may see you on "Prime Minister's Question Time" If so, David and I will be there to cheer you on (quietly of course and only if your Labour).

[bruizer]

Hi all,

My surgeon did not know why one of the leaflets on my new aortic valve had started to prolapsed which is preventing the valve from closing all the way. When I got a second opinion from Dr. Reitz from Stanford with regard to the "redo", he said that it might have been due to the fact that my aortic valve was replaced using the free-hand method instead of a full root replacement. He said, it is a judgement call and there is no right or wrong choice. I remember my surgeon saying prior to my surgery that my root looked good. He recommended that if and when I have the valve replaced again, I should have a full root replacement.

Mara - I'm Bruce, the software engineer from Los Angeles, Ca. We talked many times via email prior to your surgery and maybe once or twice after your surgery. I glad everything is working out well for you. Thanks for some of the encouragement you have given me after my valve began to fail.

Steve - here's hoping that we can get a lot of mileage out of these valve.

God Bless.

[Hank]

Hello My Web Family,

I express my opinion which I guess can also be construed as the opinion of ValveReplacement.com since I am its creator.

First of all, Billy, you are my friend and for that I support your efforts. Your cause is a valiant one and Myrtle is surely proud.

I don't particularly care who or what company we are talking about when it comes to the fact that human life is the most precious gift we have been given, and which must be protected.

Any individual or corporation should conduct practices that do not endanger the sanctity and essence of human life.

If procedures and/or products are utilized to prolong or improve life, than those products and/or procedures should have previously been scrutinized to the fullest.

ValveReplacement.com stands for that which is good.

If you stand for the same, then ValveReplacement.com supports you. If you do not, then you are contrary to our beliefs.

Billy my brother, I believe that your cause is just, and for that I and ValveReplacement.com support you.

If anyone reading this position statement believes that it can rightly be any other way, you know where the door is.

With Love and Honor,

[Zipper]

Hank,

I applaud your statement...we all must be advocates for each other and ourselves. Any person seeking information and /or justice is therefore helping all of us.

Sincerely,

Joan

[LUVMyBirman]

Hi all

Anyone know how long a medical device is in 'trails' before the US FDA will approve such a device? It appears this is not the practice abroad. Morally incorrect. Does a medical device have to be 100% FDA approved before it's use. Correct me if I am wrong. It is my understanding that the Coaguchek is not FDA approved? Maybe that's a good thing????

As we know it here in the US.....FDA approval doesn't mean it's safe. There has to be a way this can be controlled!

Billy, may you find justice and above all peace. You are doing a wonderful thing!

[Zipper]

Really, Gina...well ...no wonder my insurance denied coverage.....U-no..the 'rules' whether we like them or not play a BIG part in our lives..I would sure like to know WHY it is NOT FDA approved..

Joan

[Perrster]

Good luck in your valiant efforts, Billy. Like Hank said, I also believe ValveReplacement.com stands for that which is good.

FYI: ALL WHO HAVE ORDERED T-SHIRTS... if you OBJECT to having a St. Jude logo printed on the back of your t-shirts, please let me know. You can get a shirt with NO BACK PRINT.

Out of respect for Billy, I will hold t-shirt production for an additional week for anyone wishing to do so. Please e-mail me: perrster@ameritech.net

[KIRSONRON]

I had a St. Jude mechanical valve implanted 2 1/2 years ago. About 6 weeks post op, there was an article in my local newspaper reporting problems with the St. Jude mechanical valve with Silzone coating - a material that they put on to minimize infection risk. I freaked because the corrective action if you had that valve was to wait until there was a problem - another time bomb. Thank goodness I had received my valve model number from St. Jude and was able to go on their website and confirm that I had not received the Silzone coated valve. About a week later, I saw the cardiac surgeon for my final visit and asked about the Silzone valve. He told me that it was in a testing stage at various hospitals before final FDA approval. He had not opted to participate in the trials because he did not think that the infection rate was high enough to warrant the change from a time proven valve. The point of this story is that the FDA does demand extensive testing of all medical devices and then if they are promising, permits trial usage before final approval. Its the only way they can determine whether the device is effective and safe. I believe that it is the doctors obligation to inform a patient if an experimental procedure or device is going to be used and the alternative to that process. It is then up to the patient to decide whether to be a part of that study or opt out.

[DickV]

Gina, I believe the Coaguchek is just not approved for individual use. I believe it is approved for Dr.'s just not us mere mortals. Marty may be able to shed some light on same.

I am not sure if you are talking about the "S" or the standard model. My Cardiologist now uses the "S".

[Nancy]

Just wanted to mention that St. Jude silzone and Synergraft valves are not the only heart valves which have had problems. Bjork-Shiley had a valve many years ago that had welds that failed, causing instant death to the patient in many cases.

My husband Joe has a Bjork-Shiley valve, and a St. Jude valve, but both of his valves were not in the failed groups, thank God.

Bjork-Shiley is no longer sold in the US, not sure about other countries though.

[Lorraine]

Hi Billy,

I want to commend you on your efforts. You are doing a great thing in your quest for justice! You have my total support.

To Gina, I believe DickV is right. My Cardio's office uses the Coagucheck too, but when I had first inquired about getting one last year they told me it wasn't available to patients period. So possible by that time it wasn't available.

Hank: It gave me a warm and fuzzie feeling :D
to read what you wrote. That's why I like this web family so much. We do support each other! VR.com does stand for that which is good!

[srwieland]

Mara,

Both my surgeon and cardiologist don't think that the fact that my replacement valve was a pulmonary replacing an aortic valve has anything to do with my problem. First of all, they cite the fact that most Ross procedures are successful transfers of pulmonary valves to the aortic position.

Besides, although my valve started as a pulmonary from its donor, as a SynerGraft it should have been remodeled by my own cells, thus strengthening it to the demand placed on it in the aortic position. After all, after the SynerGraft process is applied, it's just supposed to be collagen. Furthermore, it's just one leaflet that has been damaged/weakened, not a general structural failure of the valve.

My surgeon says he cannot tell what has caused the leak unless the valve is explanted.

My cardiologist speculated that one reason might be that, after some time, my body's reaction or some infection may have damaged one of the valve leaflets. This certainly occurs occasionally with regular homografts.

By the way, I also communicated by email with a VP from CryoLife, and, though expressing sympathy, he reassured me that there had been very few other problems with the valve. I believe he was referring to the US experience with homografts and not that from animal tissue valves in other parts of the world, though. He did confirm that the SynerGraft pulmonary valve had mostly been used in Ross procedures and only a few, as mine, had been implanted in the aortic position.

There is one more thing. It is true that I was never told, to the best of my memory, that the SynerGraft valve being used was pulmonary until after my surgery when Peter Easton from this website inquired about it for himself.

In any case, my best friend is an extremely successful 'ambulance chaser', er, personal injury advocate, and I am working with him to get several opinions from expert witness cardiac surgeons to find out if they think that I have any cause for redress in this matter. Personally, I'm still on the fence and haven't yet personally concluded whether this is just the luck of the draw and the result of taking chances as I did or if I've truly been SCREWED.

I'll keep you posted.

Thanks Mara for your interest and also, again, Billy for standing up for what's right. Medical issues are often hard to sort out and requires a lot of investigation to uncover whether everything gets done for good reason or for ulterior motive.

[Marty]

The original Coaguchek has been approved by FDA since '94-95.
Roche even was asked to perform a "post launch" study which cost a lot of money to make sure that none of the self testers got into trouble.Apparently none did. Roche sent reams of data to FDA and to date have not heard from them. The original Coaguchek is used in hundreds of doctors offices and labs here, in Germany, France, etc.( no, they didn't use the poor Europeans as guinea pigs......they were all cleared by their own health systems).
OK, what about the new Coaguchek S? It has been cleared by FDA for use in doctors offices in the USA. At the present time Roche does not feel the market justifies the additional launch and post launch testing expense to get clearance for sale as a PST device. Is the S any better than the original? No, its just smaller and sexier than the old boxy original. So the bottom line is..if you want a Coaguchek in the USA for self testing you will be sold an original ( brand new) unit. I think your doctor still has to write a prescription for it and arrange for training.

[Hank]

I would also like to add one thing particular about St. Jude. As far as I am concerned, their product saved my life. I have a "regular" St. Jude mechanical aortic valve and it has worked perfectly since the day it was implanted.

Statistically speaking, their products are superior and safe.

I do not mean to lessen the impact that failures have on lives, I only wish to convey that for me personally, I owe my life to their product.

IF wrongs were comitted, then let the blame lie where it may.

[Marty]

Hank, I'm like you I owe three wonderful years... a second chance to St. Jude.....the company , and maybe the saint. Medical progress goes in fits and starts. In the early days of valve replacement many patients were brave martyrs. The early valves clotted, broke, malfunctioned.....The heart surgeons would hear of a death and rush to get the valve out of the patient before the body got to the funeral home so they could see what went wrong. The engineers worked like crazy to correct imperfections and to perfect a valve that was both durable, functional, and didn't clot.
They are still at it . No, I don't wish to "punish" St. Jude. I thank the Lord for them.

[Dan O'Brien]

Best wishes to you Billy on your very important cause. Many of us with valves that will one day need to be replaced want to rely on scientific advances, but should not be subjected to unproven options. I applaud your efforts.

[hensylee]

i am sure so many owe much to St Jude, however, the point of fact is that in Europe there are sufferers who have no recourse against untried/untested (properly) valves and they cause death to some, as we have seen in this sited. The thing we need to speak out against is this method in Europe - and who knows how many other countries outside of Europe. Shouldn't St Jude stand behind its products, no matter where it is used.

[DickV]

That brings up an interesting point. In Europe and for that matter in the US, how do these valves end up in people. Do they implant themselves? Nope. It is the medical community that installs them. Without their cooperation, I do not believe there would even be medical new technology issues. Maybe they need to look closer to home and examine who is implanting new technology valves and why.

[Perrster]

I agree with Hank's and MATXR's comments. I guess I'm just another lucky American, but I feel very badly about healthcare systems in other parts of the world.

However, my heart beats with two St. Jude valves that are (knock on wood!!) perfect.

Billy, I wish you the best and hope you won't be offended by the valvereplacement.com t-shirt that I will wear with the St. Jude Medical logo imprinted on the back.

And, I am still offering all who have ordered t-shirts an opportunity to get them with NO BACK PRINT.

[Marty]

Dick as usual you cut to the chase. When I first read about the silzone valve problem I called my surgeon and found silzone valves have never been stocked at Inova Fairfax. Why not? Well silzone was promoted to cut down on post op infections and my surgeon who is the chief decided the infection rate was so low that it didn;t make sense to abandon a tried and true product. Therefore we have no silzone problem in Northern Virginia. Having said this, the last time I checked there have been only 7 silzone explants and none the last year or so. Some like Janie have a very small
leak and hopefully will never need an explant. I would like to know more about Billy's wife. Do we know exactly what happened and what caused her unfortunate demise? My back fence neighbor had a Medtronic aortic mechanical valve implanted last
year. Everthing went well, uneventful postop course. During his second week home he told his wife he had a little irregular heart beat and didn't feel well and went up to bed. He died during the night.Who's fault is this??...Medtronic, the surgeon, etc. Well at the post mortem they found nothing the matter with the valve or the surgery. Diagnosis;cardiac arrest secondary to arrythmia probably ventricular tachycardia that went into vfib.

[Zipper]

Hey Janie and Marty,

I, too, would be interested in the facts/figures/locations of these valves. I remember hearing the news and checking with St. Jude regarding my valve and I was assured mine was not one of those.

Were there any occurances in California???? How many people still have the valve and are doing fine ?? All sorts of questions have come to mind.

My Gosh, Janie, I can see where it is NO small deal for you!!!!!!

Looking foward to more info!!!

Joan

[Marty]

Janie, I got my info from the Avert study and then talked directly to an information person at St. Jude a couple of weeks ago If you wish I will give you her name and phone number

[Nancy]

Here's an article re: the silzone valve: This is also the link: If you go to the link, there is another link for the recall list.

http://www.st-jude-heart-valve.com/pages/ST_jude_heart_valve_recall.html

*************************************************
St. Jude Has Recalled All Silzone Heart Valves

Heart Valves Affected

St. Jude Heart Valve Replacement and Repair Products

On January 24, 2000, St. Jude Medical, Inc. announced that it had initiated a worldwide voluntary recall of all field inventory of heart valve replacement and repair products incorporating its proprietary Silzone® coating on the sewing cuff fabric. St. Jude indicated that while it will no longer distribute products with Silzone, it was not recommending explants of these products unless individual patient monitoring detected complications.

The announcement and actions followed reports in a clinical trial of an unacceptable level of product re-operations to remove and repair silzone valves due to paravalvular leaks. A paravalvular leak is a flow of blood around the artificial valve usually between the valve sewing ring and the heart tissue to which the valve is attached. This trial, sponsored by St. Jude Medical and designed to compare the incidence of endocarditis (a life-threatening, postoperative infection) in valves with and without Silzone coating, also examined all normally reported complications common to heart valve replacement surgery.

According to St. Jude, the clinical trial, known as AVERT (Artificial Valve Endocarditis Reduction Trial), was designed as the largest, most rigorous, prospective clinical trial ever in the prosthetic heart valve industry. St. Jude described the trial as an independent, multi-year, multi-center randomized study intended to follow 4,400 patients to study the efficacy of Silzone coating on the valve sewing cuff fabric in reducing infection following valve replacement surgery. Based on data from the 792 patients enrolled in AVERT as of January 6, 2000, an independent Data and Safety Monitoring Board advised St. Jude Medical on January 21 that further enrollment in the AVERT study was suspended, given an unacceptable level of explants due to paravalvular leakage in the Silzone "arm" of AVERT. Eight explants for paravalvular leak had been reported out of a total of 398 patients enrolled in the Silzone "arm" of AVERT. One explant for paravalvular leak has been reported out of a total of 394 patients in the non-Silzone "arm" of AVERT.

St. Jude stated that Silzone technology was first introduced in 1997 and purportedly had the potential to reduce the incidence of endocarditis in valve procedures. St. Jude Medical estimated there have been approximately 36,000 implants worldwide of St. Jude Medical heart valve replacement and repair products with Silzone coating. St. Jude has claimed that the reported complication does not involve the valve mechanism itself, but appears to be associated with the Silzone-coated sewing cuff fabric.

A lawsuit was recently filed against St. Jude Medical alleging defective heart valves caused injuries to a Massachusetts woman, Linda Baez.

Linda Baez had open heart surgery in April of 1999, she soon experienced leakage around the heart valve stemming from an infection (endocarditis). This condition called paravalvular leakage, makes the heart a less effective pump and can result in heart failure.

In November 1999, the failing Silzone valve was replaced with another St. Jude Silzone valve. The second valve also leaked requiring a third surgery in May 2000.



Submit an inquiry | Recall List | Recall of Silzone Valves | Leaking Heart Valves | Home Page

If you require immediate attention please call 1-800-942-2056

[Billy]

following on from Nancy's post above, Linda Baez died a few weeks after her third surgery.

[Zipper]

Hi Nancy,

You certainly are a wealth of information!!! I had that list at one time, but couldn't locate in my file.My VR was in May/1998, so I was so thankful my number was not on that list. I appreciate the time you took to share this information for us all.

Joan

[Mara]

Billy,
So when are you appearing at the house of commons.

Maybe I really shoudl take that Qualified Lawyers Transfer Test and be able to beomce a solicitor in the UK. Then I could really join your fight.
You know that you have mine and David's support and we will help in anyway we can.


Steve-
Well, I am pleased to read what you said. I am hoping that my pulmonic does not give out.

As far as achieving some kind of re-dress. I'd look at it from a defendant's point of view, and also as a healthcare consumer who "needs" these companies. If you file a suit and win, what's your objective? If you get a big load of cash then the rest of us schmucks will pay that bill, not to mention those bastards at the insurance companies will likely not cover any CryoLife valves. That's my lawyer 2 cents. But, you have the right to do what you think you need to do. Maybe you can get them to use better testing procedures. I don't know. What ever you decide I'll be with you in spirit because what happens impacts us all in the end.


Bruce- Hey pal. Hope you are feeling fine. I did not realize that Bruzier was you. Any ideas when they might do a re-do on you. Geez, what a drag. I'm thinking of you, and really hope you have a great outcome the next time.

I just want to tell everyone that the people on this site a a really fine collection of humans and display all the qualites that make it all worthwhile. Thanks Hank for sharing your dream!

[LUVMyBirman]

The two 'Silzone incidents that we are aware personally were in the 'Mitral' position. That valve is the most difficult to work on as it is the most interior, i.e. hard to get to. If you look at valve replacement surgeries as a whole, any type. It's usually the mitral valves that have the concerns.

At the time of my MVR they were using the Silzone valves around the US, more so than any other valve. As luck of the draw would have it...... I was at a Medtronic research hospital for my surgery Thus, the Medtronic MVR.

Being a mitral valve recipient, I am convinced that if I were anywhere else at the time......would not be writing this post today.

[bruizer]

Hey Mara,

Dr. Reitz, who is the head of Stanford's Cardiothoracic Department and also performed the first successful heart lung transplant, said that if the leak/regurgitation remains the same, I should not have another surgery. He, my surgeon, and my cardio are basically monitoring the size of my left ventricle along with the leak to decide when to do the "redo". Some far, there has been basically no change since April, 2001. I have no symptons. He's hoping (and obviously I'm hoping) I can get to at least the two year post surgery mark which would make the scar tissue less of an issue. When it is time, he recommended the CyroLife synergraft.

If I remember correctly, you'll be hitting your one year anniversary in July (7th). I'm glad you are doing so well.

Take care.

[srwieland]

Very interesting, Bruce. I've received virtually the exact recommendations you have.

Indeed, I think my surgeon would still favor the SynerGraft for my redo, even though in my case it's the type that's leaking. I do hope to get several more years out (it'll be one year on 5/16) and much wiser before having to reconsider my valve choice, though.

My surgeon said they prefer at least a year post-op before a redo and prefereably several for the scar tissue to improve sufficiently. I asked him how many years would be optimal before the redo and he replied "forever". Duh! I realized how stupid my question was after I got that stupid answer!

All the best to you and Mara and the rest of the gang here.

[Billy]

Hi Everyone,

My sincere thanks to all of you who have given your support to my project. To Hensylee, Dick, Steve, Elisabeth, Janie, Hank, Joan, Mara, Gina, Perry, Lorraine and Dan a very big Thank-You.

My decision to explore the European situation is not simply to 'punish' St Jude as some folks fear and Marty appears to assume. It is to put an end to any valves, irrespective of who makes them or where they come from, being used in Europe before these devices are approved 'at home.'

Why should we allow people's lives to be endangered to provide a cheap testing ground for these half-baked prototypes? Perhaps Marty if you were in my position you would see it very differently. People don't just die without a reason, not even your neighbour. Identifying the reason should be of paramount importance to avoid it happening again.

In reply to Marty's question, the cause of death on Myrtle's autopsy report is given as 'thromboembolic occlusion of the St. Jude artificial 'silzone' coated mitral valve.' It also states that there was a build-up of thrombus on the leaflets which appeared to have occurred over a period of time. Her INR at the time of death was given as 2.54. The INR had been monitored on a daily basis from the time of surgery which was carried out 10 weeks and one day before her death.

Thousands of people all over the world have received 'silzone' valves and many don't even know they have one. Apart from those people who take a keen interest, like the members of VR.com, others just go through surgery, take what they get, and continue with their lives in complete ignorance. I feel that it is only reasonable that recipients should be aware of the make and model of their valve and that they should be notified of any complications associated with it. After all, if your motor vehicle has a defect, you are made aware of this and the car is subsequently recalled and the problem rectified.

Furthermore, even after Myrtle's silzone valve was explanted at autopsy, the Manufacturers showed no interest in having it analysed. It remained in the State Pathologist's keeping until I paid to have the analysis carried out myself. Nobody rushed to find out what was wrong, instead St Jude continued to market all silzone products for a further 19 months obviously quite unconcerned. Subsequently, many thousands of these valves were implanted 'blindly' - Does this sound like a Company who cares?

Just think about it - Would any of you have felt comfortable having a silzone valve implanted after Myrtle's death if you had been aware of this? I don't think so.

I have just received a reply from the U.K. Secretary of State for Health to the question of 'his policy on using replacement heart valves made in USA before they are approved by the FDA.' The reply is as follows:

<<Artificial heart valves manufactured in the USA (or elsewhere) may be used by the National Health Service if they bear the 'CE' marking, which indicates that they comply with European 'essential requirements' for safety, quality and performance. Valves which do not bear the 'CE' marking can also be used (on a restricted basis) as part of controlled clinical trials. Approval by the U.S. FDA is not a prerequisite for the use of artificial heart valves by the NHS, regardless of their country of origin.>>

Seems like my next step is to have a 'long talk' with the European Guy who hands out these 'CE' markings. I think he's going to have a lot of questions to answer.

I'll hook up with him some of these days and let y'all know the outcome.

Brace yourselves, European Parliament...........here I come!!

[Zipper]

Hi Billy,

Again, I'm here to cheer you on and admire the time and effort you are putting in to this. If only a 'recall notice' is accomplished for ANY defects it would be a 'plus' for all future recipients of any procedure. Ideally, the patient would be made aware in advance of any 'testing' status. This should be the responsibility of any competent/caring physician, but it is obviously not being disclosed.

As you said, Billy, many people are TOTALLY unaware and NOT active in being their own advocates. As time goes on and health care technology continues to advance, it becomes even more vital that 'we' consumers be informed in all areas of our health care!!! Thank you for your interest in accomplishing that!

Joan

[sylviayasgur]

hi billy!
my hat goes off to you. i think that you are on a mission to protect people from harm, not to prevent them from getting a solution to their problem. i strongly believe that, although st.jude has saved many lives, they owe it to the public to atleast inform them of any such risks that may be involved (no usa fda approval, etc).
it is interesting though, i am aware that the european standards, even for meds, is much more lax than those in the usa (fda/ approval for use).
there are meds i have bought over the counter in european countries that i know for a fact cannot be bought here in the usa without a prescription. others that i have bought abroad over the counter have not even been approv ed here in this country and do not exist here. (this, despite the fact that these meds are very effective and helpful, many doing the job 10 times faster than the american version!!)
maybe the discrepancy comes into play alongside these standards?
either way, i am behind you.
please keep us abreast of any progress you make. i think you probably have quite a challenge ahead of you!
wishing you all the best of luck.
be well,
sylvia

[Marty]

Thank you , Billy for divulging private and very hurtful information about the cause of death of your beloved wife. There is a lot I don't know about this whole silzone business. Now I have been told by St. Jude people that over 32,000 silzone valves have been implanted and that to their knowledge there has been 7,8, or 9 (?) explants. I read that the explants were for "paravalvular leaks". Not specifically clots. They maintain that the the problem was in the silzone impregnated sewing ring. Now all mechanical valves have a finite % of clotting problems. One of the reasons St. Jude is popular at Inova Fairfax is the 20 year old bileaflet is made of pyrolytic carbon and they have reduced but not zero clotting complication. Other companies such as Medtronic, Carbomedics, et. al. also make good mechanical valves but they also have clotting complications , paravalvular leaks, etc. The science is not perfect. The most disturbing thing to me in your well phrased message was the profound lack of interest St Jude showed in checking the clotted valve. This angers me and I intend to speak to some one about it . I don't like corporate "cover ups". Billy I don't think you are on an unreasonable quest. I support you and hope that you prevail.

[Zipper]

Er..Uh..Janie...could you repeat that ?? LOL! Jus kiddin'

Confusion Everywhere sounded right to me..LOLFOF!!! Whew...quite a read..Thanks, Janie !!

Joan

[Billy]

Thank you Joan, Sylvia, Janie and Marty for your responses to my post. I value your continued help and support.

Marty.........I am aware that the main complication with the silzone valve was originally identified as paravalvular leakage. If you check the net thoroughly you will find several instances where thrombus formation was also mentioned as being a problem with this particular device.

I have compared results of several tests and these vary in their findings. Strangely I cannot find any results produced by St Jude - all tests appear to have been done by outsiders who were obviously more concerned than the manufacturers.

I know that you converse with the St Jude Company from time to time and you are welcome to comment to them on what I have told you. Of course what I have told you is only the tip of the iceberg. When one delves below the surface it is all so bizarre that it becomes stranger than fiction. Maybe we'll meet up some day and I'll share the rest with you.

[hensylee]

You are right, Billy. It's the 'below the surface' things we never hear. My brother is dealing with a health problem now that came about because of a medicine he was on for 1 1/2 yrs. He has Parkinson's as a result and other irreversible side effects. There is no way we can know these things up front.

[Scottie]

Billy ..I just like to add my support ...is there any way I can help ..should I write to my local MSP or MP ?....what would you like me to do ?
Take care
Scottie

[Billy]

Stick around with that support Scottie. I think I've got it figured short term but there will come a time when we'll need all the voices we can get our hands on.

I'll keep you updated on the general progress, on this thread and by e-mail, if it is confidential information. Glad to have you on board - rally any other troops you know, who would be interested in adding their support.

[Scottie]

awaiting instructions here Billy ...going to a British Heart Foundation meeting on Monday night so will look for some suppost there ..take care and keep in touch
Scottie