Anyone here have a RECALL on their valve?

Help Support ValveReplacement.org:

Jkm7

Well-known member
Joined
Oct 15, 2005
Messages
4,384
Location
Massachusetts
:eek: Makes me insane to think such a thing could happen, but has it happened to anyone here? If so, how long after you had the valve placed did you get that awful news?
 
G

geebee

Guest
Yep, my first valve was recalled. It was actually recalled just before my second surgery to remove scar tissue from it but my surgeon left it in for whatever stupid reason. I did not find out about the recall until a couple years after my second surgery.

The valve was ulitmately replaced 14 years after implantation when I started having symptoms that had been reported as consistent with the failures but I lived with the concern for many years.
 
G

geebee

Guest
Somebody on this site has a Bjork-Shiley still in his chest. I can't think what his username is. From what I understand, and I'm sure Geebee knows more, the valves that failed came from one or two manufacturing sites out of several. Our member who still has his, I assume got his valve from one of the sites that weren't known for bad manufacturing. It would be a hard dilemma, trying to decide what to do under those circumstances.
Brian (BDMc) still has his BS valve implanted. I am sure you will hear from him.

They did narrow down the source of the majority of the failed valves. However, there were a few exceptions which is why the class action suit allows for anyone to be reimbursed for removal if the criteria is in place. In my case, I did not qualify, despite the symptoms, because my valve was not in the size that normally failed. However, money is not a factor in trying to save one's life, although I would not have turned it down. ;):D
 
K

Karlynn

Guest
I believe Shezagirlie (Janie) has a St. Jude Silzone valve.
 

Nancy

Well-known member
Joined
Jun 10, 2001
Messages
9,896
Location
upstate New York
Joe had a possible recall on his Bjork-Shiley valve. It turned out to be a different model, but he did have to get an evaluation done on his valve just to make sure. He passed away in 2006 with that valve still in his chest and working fine until the last moment, it was implanted in 1977.

He did not die from valve failure.

Then there was a question about his St. Jude valve, but that turned out OK as well.

I am not sure about his pacemaker, there were some recalls of his model, and he was due for a swap out anyway.

So, yes things can happen.

The Bjork-Shiley had faulty struts, St. Jude had Silzone valves which were recalled and various pacemaker manufacturers have had infection issues, and faulty lead problems.

There have been defibrillator recalls recently too.
 

Jkm7

Well-known member
Joined
Oct 15, 2005
Messages
4,384
Location
Massachusetts
Whoa..... that is Heavy Duty!! I can't imagine the feeling of hearing that kind of news. Then again, all of us who have heard we need OHS probably have a fairly good idea what it feels like. :( There aren't words.......
 

ALCapshaw2

Well-known member
Joined
Mar 20, 2003
Messages
6,910
Location
North Alabama
I'm not sure when the Bjork Shiley Valve was introduced but it has to have been over 30 years ago and has long since been discontinued. The most common failure mode was broken struts (on the Cage of the Ball-in-Cage Design).

The St. Jude Silzone Valve (Google "Silzone" for more information) was recalled for reasons having to do with the coating that was applied to it.

I'm not aware of any other recalls in recent history.

'AL Capshaw'
 

Nancy

Well-known member
Joined
Jun 10, 2001
Messages
9,896
Location
upstate New York
We found out about the Bjork-Shiley from the program 60 Minutes. We were both stunned, didn't have a clue until that. But got on the phone the next day to the cardiologist.

Joe got free lifetime MedicAlert membership from the Bjork-Shiley fiasco even though his valve was not a faulty one. That was his "settlement".

After that I made sure I kept up on the medical news of the day.
 
G

geebee

Guest
I'm not sure when the Bjork Shiley Valve was introduced but it has to have been over 30 years ago and has long since been discontinued. The most common failure mode was broken struts (on the Cage of the Ball-in-Cage Design).

The St. Jude Silzone Valve (Google "Silzone" for more information) was recalled for reasons having to do with the coating that was applied to it.

I'm not aware of any other recalls in recent history.

'AL Capshaw'
Al,
The Bjork-Shiley that was recalled was not a ball and cage valve. It was a tilting disk valve. However, the issue was definitely strut failure.
 

dick0236

Eat the elephant one bite at a time
Joined
Feb 10, 2007
Messages
2,873
Location
louisville, KY USA
JKM7

Anything can happen.....Gas might go back down to 29c per gallon, like it was when I was a teenager....but it ain't likely.

Recently I got to thinking about my valve and I did a quick calculation. If my math was correct, my "ball-in-cage" has cycled one billion four hundred million times.....and its been taken out of production.:confused: The new valves MUST REALLY BE GOOD !!!:D:D
 

Jkm7

Well-known member
Joined
Oct 15, 2005
Messages
4,384
Location
Massachusetts
Thanks everyone. Takes my breath away just thinking about such a thing.
I'm getting very attached to my bovine. :)
 

dick0236

Eat the elephant one bite at a time
Joined
Feb 10, 2007
Messages
2,873
Location
louisville, KY USA
Oaktree

There is still an Edwards #1260 that is available in the USA. They THINK mine is a #1200 or earlier. Neither Edwards Lifesciences or UK hospital has a record of my model no. or serial no. I'm wondering if maybe the doc at UK went down to the local plumbing store and bought a "check valve"...same principle.

The valves being used outside the USA are "MIRA" mechanical valves that incorporate leaflets.

I ain't really informed on all this stuff. I'm reading from a marketing brochure that Edwards Lifesciences sent me a couple of days ago. I finally got around to applying for an ID card. It was like pulling teeth to get them to give me an ID card without having a model or serial number. Was able to "prove" that I had a #9 Starr-Edwards implanted at UK Hospital 8/16/67 and they were good enough to get me an ID card even thought nobody is quite sure of what I have in my chest.:confused::eek::rolleyes::cool::D
 
L

Lisa in Katy

Guest
The Silzone valve became FDA approved in March, 1998. I had my surgery on June 30, 1998 and have a St. Jude's Valve. When they discontinued the use of the Silzone valve in 2000, and announced that it was more prone to leaks around the sewing ring, I had about 15 minutes of minor panic while I called St. Jude's and confirmed that my model number was not a Silzone valve.

In the initial study, there were 8 people out of about 400 that had to have their Silzone valves "explanted" due to paravalvular links. In the non-Silzone group, there was 1. Of course, that is just the report of short term complications. It's possible that those who still have this type of valve will need a reop more quickly than they would have otherwise.
 

Bonzo Dog

Beloved Member
Joined
Mar 17, 2008
Messages
638
Location
West Yorkshire, UK
To move slightly off topic, I had a manufacturers recall on my Meditronic pacemaker leads. It was the pacing box and leads replacement because of this, that began the endocarditis, mech valve out, homograft in saga. :(
 

Freddie

Well-known member
Joined
Jul 19, 2007
Messages
5,932
Location
Canada
Interesting how you would post such a question, considering the same thought came to mind when I was checking out the Health Canada web site and came across their heart related recalls. Scary.
 

BDMc

Well-known member
Joined
Oct 28, 2005
Messages
1,472
Location
Newton, MA
Gina is Right as Usual...

Gina is Right as Usual...

My valve was recalled a few months after my surgery. I found out about it on TV, but thought I was OK because the serial number for it with the dacron graft was different from those I saw listed. Sometime later I checked a published list and found mine. I had a lot of anxiety about it for many years. I met a couple of ex Shiley employees some years back. One expressed surprise my valve hadn't failed yet:(, and the other was very reassuring. He said he thought mine would last a long time if I hadn't already had trouble. I have come to terms with it all now. I figure the past 23+ years are all gravy. I wish I'd done a lot more, but am so grateful to have had the time:)Considering the state of my aneurysm before surgery, I think it is only God's grace manifested in the doctors and nurses that saved me. Love to you all, Brian Mc PS: Dick, you are my hero!
 

dick0236

Eat the elephant one bite at a time
Joined
Feb 10, 2007
Messages
2,873
Location
louisville, KY USA
Brian, I believe I remember when your valve was recalled. My son phoned me one evening (would have been in mid '80s) and urged me to turn on the TV news because my heart valve was being recalled. I assured him that it was not my valve. Glad that your valve has continued to function properly and it would appear that your valve did not have the problem that forced the recall
 

ShezaGirlie

VR.org Donator
Joined
Jun 9, 2001
Messages
1,837
Location
Texas Hill Country
St. Jude Silzone valve...

St. Jude Silzone valve...

I believe Shezagirlie (Janie) has a St. Jude Silzone valve.
Absolutely correctomundo Karlynn -- and at almost 280,000,000 beats later I'm still on the right side of the grass.:D...and enjoying every single day..!!

To answer JKM7's questions: My St. Jude Silzone valve was installed on Oct 7, 1999 and I found out in January 2000 only a day or two after the valve was recalled, so I had the valve just over 100 days. I actually found out from a member of the old original listserve that Hank created back in 1999.

As to how I felt..........hmmmm, I had the St. Jude ID card with my valve's serial number and went to http://www.sjm.com/ and found my serial number was amongst the recalled valves. These valves were recalled off the shelf, not for explant from the patient. I felt just numb - weak in the knees at first, but I'm a 'glass half full' type person - so where's the party..!! On occasion Mike will comment to me, "Janie, I don't know how you do it.." I tell him that really I just don't have any choice, so rock on..!

If you really want to get bored here's a little info on the AVERT trial that Lisa mentions above. I will only include the "Conclusion", but if you want to read the article, here's the link: http://www.ncbi.nlm.nih.gov/pubmed/17315381

"CONCLUSION: In this single-center, non-randomized study of 46 patients, the findings of increased paravalvular leak with the Silzone valve, as identified in AVERT study, could not be confirmed. Moreover, the incidence of thromboembolic complications reported was modest."

As in any clinical trial, one needs to consider the physical condition of all the trial participants.

Sad to say our FDA is in a deplorable state of doing their job. The Silzone valve wasn't a new valve...only the silzone coating was new. In that respect St. Jude was able to get a quick modification approval from the FDA because modifications do not require the many phases of approval that a new product does.

I think Bonzo really went through the mill with his pacemaker leads recall..:eek:...and GeeBee what an ordeal -- actually having the valve explanted due to the integrity of it...:eek: And Dick and Brian are definitely my heros...along with RCB...hey, where is that ornery old codger these days!! Really, he's a sweetie..

Like our crazy Cajun DickV who no longer posts, but keeps his great Cajun humor says, "Every day above ground is a good day...":D
 
2

Latest posts

Top