William Kaluta Photography
SAME OLD TUNE?
Dear Ones:There are times when I wish I were not such a prolific writter and this is one of them. Read below about a RECALL of Boston Scientific's implantable defibrillators--it's implantable cardioverter defibrillators (ICDs) and it's cardiac resynchronization therapy defibrillators (CRT-Ds)...ALL OF THEM.
As usual, the 'average person' is at the mercy of the manufacturer, their health care providers and Uncle Sam and others. This is an especially daunting scenario when the object under consideration is a potentially life-saving/disaster-preventing device, such as this!
In trying to give you the best advice I can as a biochemist well-versed in the field of biomedicine, but as a non-medical doctor, all I can tell you at this point is that there is no need to panic if you have one of these Boston Scientific implantables (see the list of specific brand names below). From what I can discern, it seems like there is a manufacturing aspect or aspects that the FDA wants further study and clarification on from B.S. (Boston Scientific). In short, there doesn't appear to be a problem with the functioning of these defibrillators, but with some kind of manufacturing paperwork.
Having worked with the FDA literally hovering beside me at the lab bench as I developed testing protocols for the government medical devices and drugs we manufactured for the military, I know how nit-picky the FDA and other agencies can be. Yet, they do perform a valuable service more often than not by 'keeping us on our toes'...or, as in this case, 'keeping Boston Scientific and cardiac electrophysiologists who do the implants' on their toes.
I will stay on top of this and let you know if and when it seems like there is a functional problem to consider. This has, indeed, happened before with this same company's defibrillators, with batteries running down sooner than expected, etc. So any concerns you have are well-founded and bear vigilence.
Obviously, you should seek the immediate advice of your health care provider if you have one of these implantables. And you must be certain to pay attention to your body, as you probably do anyway.
Let us pray with hope that this recall is not over the efficiency and efficacy of the devices themselves and that it really is just much ado about the government and manufacturing paperwork.
With Concern for you in Christ,
Rev Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
www.DearOnesHealingMinistry.blogspot.com
Boston Scientific Implantable Cardioverter Defibrillators: Recall
Audience: Cardiology healthcare professionals, patients
[Posted 03/19/2010] FDA notified healthcare professionals that FDA has been notified by Boston Scientific that it has stopped shipment and started recalling all of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that have not yet been implanted.
FDA is advising practitioners that they should not use these devices unless and until the agency reviews and approves the changes the company has made. FDA is not aware of new safety concerns and, therefore, does not recommend that any of the devices subject to the recall be explanted.
Product families included in this advisory include Boston Scientific’s Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality.
[03/18/2010 - Statement1 - FDA]
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205409.htm
FDA Statement on Boston Scientific Recall of Implantable Cardioverter Defibrillators
The Food and Drug Administration has been notified by Boston Scientific Corporation that it has stopped shipment and started recalling all of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that have not yet been implanted.
The FDA is advising practitioners that they should not use these devices unless and until the agency reviews and approves the changes the company has made. The FDA is not aware of new safety concerns and, therefore, does not recommend that any of the devices subject to the recall be explanted.
Product families included in this advisory include Boston Scientific’s Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality.
Boston Scientific stated it initiated its voluntary recall due to manufacturing changes that were not submitted to the FDA for review as required. Companies are required to submit a notification of any change in manufacturing procedures or methods of manufacturing that affect the safety or effectiveness of the devices. Companies are required to submit notification of these types of changes to the FDA for evaluation prior to marketing and distribution. Boston Scientific has informed the FDA that it will submit a premarket approval supplement to the agency for review.
The FDA is currently investigating the matter.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm205037.htm
REV BARBARA SEXTON RECOMMENDS THE FOLLOWING FOR HEART HEALTH:
L-CARNITINE 1,000 mg-2,000 mg per day with meals. Cost will be a deciding factor for you with this supplement. L-Carnitine is a must-have to maintain heart health and any amount is beneficial to your body. And, it is very 'cardio-protective', in that it protects those receiving chemotherapeutic agents with known cardiotoxicity, (such as doxorubicin, daunorubicin or fluorouracil). Did you know that the gums and heart tissue are related? It's true. In alternative medicine, treat one and you treat the other when you add things like CoQ-10 to your carnitine regimen. Stay tuned for additional heart and gum healthcare tips soon!
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