Unapproved Valves.......

[Marty]

Coaguchek and the FDA

Coaguchek and the FDA

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]

a P.S. To my earlier statement

a P.S. To my earlier statement

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]

St. Jude...a second chance

St. Jude...a second chance

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]

No offense

No offense

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]

Who implants valves? What can go wrong?

Who implants valves? What can go wrong?

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]

The Facts and figures..

The Facts and figures..

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]

to Janie re: silzone

to Janie re: silzone

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]

and............

and............

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

 

[Zipper]

Thank You

Thank You

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]

Sincere thanks

Sincere thanks

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