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]

My Personal and ValveReplacement.com's Position

My Personal and ValveReplacement.com's Position

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]

Very WELL said

Very WELL said

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]

FDA approval

FDA approval

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]

Best O' Luck, Billy

Best O' Luck, Billy

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: [email protected]

 

[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
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.