New developments

[Dwayne Johns]

My son had a Staph infection which led to a valve replacement in Hamilton Ontario in December 98. Like many others he discovered he had one of the St. Jude valves on their "danger" list.Model number 25AS-601.
Naturally he has an on going concern, and is anxious to know if there has been any further information about the Silzone cuffs and potential repair. His doctors have determined there is a leak but have not advised him where he stands on a scale of 1 to 10, as to the seriousness of the leak.
Any new information or comment on the leak will be greatly appreciated. Contact address is ***@****

[Howard]

To check for adverse event reports for medical devices go to the FDA's Maude database where you can do an online search.  The address is http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

Also, the last time I looked at the St. Jude website they were offering to reimburse people for costs related to the recalled valves that were not covered by insurance.

I have one of the valves and only noticed this because I monitor their website and have been pretty aggressive about getting information.  No one informed me of this program.  My cardiologist informed me of the recall.

[Sonya]

In my experience with a TMJ jaw implant, Dow Corning never alerted me to the fact that my implant needed to be extracted or retrieved. My surgeon also never bothered to inform me either. Sadly, we the public are alerted after the fact, when someone has lost their life and the companies are being taken to court. I just happened to see an advertisement on TV informing me of my right to join a class action law suit against Dow Corning. What a way to find out that your mechanical implant is defective. Something is terribly wrong with this picture. Now that I have a pacemaker, I have written letters to my State Senator and Congressman urging them to push for legislation to better track any type of implant device regardless of type. Every patient should be handed a card recording the implantation date; the brand, model and serial number of the device. We are in dire need of a national implant device Data Base and tracking system. Write your Senator with the following address and salutation.
The Honorable John Doe
The United States Senate
Washington, DC 20510
Dear Senator Doe:
Please urge them to lobby for this most worthy cause. So many people now have artificial heart valves, pacemakers, internal defibrillators, joint implants and so on. Our lives depend on being informed when something malfuntions. We shouldn't have to wait for someone to die first! Thanks for letting me vent.

[james]

Like your son I have one of those St.Jude Silizone valves.  I have had it since my surgery in October of 1999.  I'm 24 and it's annoying to know that I have a potential ticking timebomb sitting in my chest.  I don't want to have to go through open heart surgery.  October was my second time.  I had the first when I was just 16 for a condition I was born with.  I like you I'm sure have checked out the St.Jude website and it has not been updated at all.  No new info on the valves and I find that horrible.  I only found out about my valve's recall cause I saw a blurb in my local paper's business section.  My doctor never called me and I didn't receive any notice from St.Jude either.  I tried to contact them back in Early February and I was given the runaround.  They don't want to deal with the possibility that something could go wrong I guess they only want info on someone they know is having severe problems.  I would think that St.Jude would have sent out some kind of notice to let people with these valves know they are potentially at risk for problems because of their product.  I know they know where all of us are.  I have one of the ID cards I carry in my wallet in the event I am ever hurt or etc.  I would like to have more info about the valves.  I have seen everything on the St.Jude website and they weren't a whole lot of help.  And with no updated info I'm just at a loss.  Since my surgery in October I still don't feel any better from the whole thing.  I didn't feel better before I knew about the valve recall and finding out certainly didn't help me.  Well if you would ever like to contact me I'm at ***@****  Thanks.

[Cleveland Clinic, MD]

I'm not aware of any new developments.  I would check on the company web site.  Also make sure his doctors have his address and phone number and they can call him with anything new.  In addition he will need regular follow up.  Best wishes.