Anyone here have a RECALL on their valve?

[Jkm7]

Oh my goodness....... I so appreciate those who answered this question. Having had my chest cracked twice, I don't know how I would handle hearing a recall was issued on my valve. I salute the strength and positive attitude so abundant around here. What a group!!!

 

[Ross]

It was a Bjork-Shiley CC valve. It now lives in a jar in my refrigerator.

To the left of the ketchup, behind the pickles that are right next to the jelly?

 

[geebee]

Survival is always foremost (at least to me and, I think, to most of us here) so you do what is needed. I just hope they never try to recall the St. Jude I have because I would have to hurt someone.

 

[geebee]

To the left of the ketchup, behind the pickles that are right next to the jelly?

When were you in my fridge?

 

[lance]

Help me understand ......................

Help me understand ......................

Absolutely correctomundo Karlynn -- and at almost 280,000,000 beats later I'm still on the right side of the grass....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.....and GeeBee what an ordeal -- actually having the valve explanted due to the integrity of it... 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..."

Hi Janie,
There is quite a discrepancy between the information quoted above and the following footnote taken from a court document:
"There are almost 400 adverse event reports for the Master Series Valve with Silzone contained in SJM's FER Database as of July 5, 2005. Exh. 1, SJM 0745309.xls: Declaration of Steven Angstreigh. Due to the nature of the file and its sensitive contents (patient medical information), a copy is not being supplied but is available for filing if the Court directs.
FER=Field Experience Report adverse event=stroke, TIA, explant

What to believe--that is the question. If the FER report is correct I'm surprised it saw the light of day let alone a court room.

 

[twinmaker]

No recall on my St. Jude's valve, but had a recall on my Medtronic defibrillator a few years ago. When I was notified, my heart sank (not really but I was a little upset about having to go through with taking it out and putting in a new one. But I must admit, I was happy to get the new one in. I was kinda frightened to think that I may need a jolt and the recalled one wouldn't work. Anyway, not long ago there was a recall of pacer wires and once again I held my breath but thankfully, mine weren't in the recall batch. I'd be much more concerned about a recall of my valve since the surgery is considerably more. But just having to go through the possiblility of infection when you have a pacer or defibrillator replaced is enough for me. I'm planning on keeping my St. Jude FOREVER!! linda

 

[Jkm7]

Did the manufacturer pay all expenses? If you don't mind my asking. I would think insurance might balk at being asked to pay in the case of a recall.

 

[ShezaGirlie]

Hi Janie,
There is quite a discrepancy between the information quoted above and the following footnote taken from a court document:
"There are almost 400 adverse event reports for the Master Series Valve with Silzone contained in SJM's FER Database as of July 5, 2005. Exh. 1, SJM 0745309.xls: Declaration of Steven Angstreigh. Due to the nature of the file and its sensitive contents (patient medical information), a copy is not being supplied but is available for filing if the Court directs.
FER=Field Experience Report adverse event=stroke, TIA, explant

What to believe--that is the question. If the FER report is correct I'm surprised it saw the light of day let alone a court room.

Hi there -- the aborted AVERT trial consisted of a measly 46 patients so I wouldn't put much credence in those early results, but the more recent "conclusion" is interesting in regard to the opinion that paravalvular leaks are not confirmed. More importantly, I think, is the conclusion in regard to thromboembolic complications being reported as "modest".

It would appear that the 400 incidents reported by SJM in the court documents must be amongst the 36,000 silzone valves implanted worldwide, but I sure could be wrong. One should wonder if all valve manufacturers are required to report to the FDA all adverse events? I would certainly hope so.

As a sidenote: St. Jude Medical has neglected to return my telephone calls. Makes one wonder, huh...about their customer service. Maybe it was because I called the special "Silzone" number they listed on their website...

Did the manufacturer pay all expenses? If you don't mind my asking. I would think insurance might balk at being asked to pay in the case of a recall.

GREAT QUESTION...!!

 

[geebee]

Did the manufacturer pay all expenses? If you don't mind my asking. I would think insurance might balk at being asked to pay in the case of a recall.

My replacement surgery was not paid for by the class action suit set up to pay for such operations. Despite having symptoms that were consistent with strut failure, they said my valve "didn't qualify" for replacement surgery. This is, of course, one of those times where the only people that benefit from most class action suits are the attorneys. The big name attorney that brought the suit is living in a mansion and it took me 7 years to pay the medical bills. Since it was so long after the initial implant, the SOL had run out so I was "you know what".

 

[Jkm7]

Gina........

That stinks but I'm sure you don't need me to say so.
We have no choice but to do what we have to do.

 

[twinmaker]

No, Medtronic didn't pay for everything. In fact, they only paid for the new defibrillator and maybe a little towards the surgery. I too would have thought our insurance would have balked with having to pay for the biggest part of the surgery but they didn't. But I must tell you that my husband's company is self-insured. In other words, our health insurance is handled through United Healthcare but United doesn't insure us. We just have the pricing or in-network stuff done through them. Our company pays for all that an insurance company would. Anyway, when the recall occured, I was asked to come in and talk with my cardio and then with a representative from Medtronic. The rep spoke with me alone and based on my doc's feelings, my feelings, and the advice from the rep it was decided that I should get the new defibrillator since I'm 99% pacemaker dependent. DUH! (My pacer is part of my defibrillator.) I mean if the defibrillator failed then not only might I miss a shock but I would definitely not have much to help keep my heart beating with the pacer not working. Even with the rep deciding that I really needed the redo, Medtronic still didn't cover it all. I think it's because the patient has to be the one to make the final decision. That's where they get you. Doesn't seem fair does it? Thank God for our insurance. Because the chance of something actually going wrong with the recalled defibrillators was small, some people decided not to have the redos but to just monitor their devices every month at home with magnets. Even if I wasn't pacer dependent, I think I still would have opted for the redo. I'm just a worrier and didn't want to constantly fret that I might need a shock and not get it. LINDA

 

[dtread]

Referring back to earlier post in this thread that indicated that Edwards 1260 valve might still be available:

I checked with Edwards Lifesciences LLC regarding whether the ball and cage model 1260 or 6120 were still available and they indicated:

Thank you for contacting Edwards Lifesciences LLC regarding your question about our mechanical valve. The Starr-Edwards model 1260 and 6120 are discontinued. These valves are no longer available in the U.S.A. or any other countries.

For Edwards products information, please visit our website at www.edwards.com

Here is a neat video showing two ball and cage valves in action - go to the website then click on "video" and it should come up: http://coolmristuff.wordpress.com/2008/05/25/nejm-starr-edwards-heart-valve/