[HSF] FDA

[Ani Anyanwu]

Yes Hal I find it strange that Bojan insists on using these devices even where concern has been raised. Personally I would not want one of their products in me (and I suspect no one would) until the issue is clear and their safety assured. While I accept the FDA has its biases and politics, such measures as taken against SHELHIGH are very drastic and unlikely to be totally without any basis. I have seen a lot of smoke and a lot of fires but can rarely recall seeing smoke without any fire. This has nothing to do with bias for or against a product, but to do with responsible practice and protecting our patients. If Edwards had been the company raided by FDA, I would stop using all their rings and valves today (90% of valves and rings we use are Edwards).

The lawyers are already advertising for patients treated with SHELHIGH products to come forward and I suspect despite Bojan's good intentions, it will only be a matter of time before even he will not be able to obtain a SHELHIGH product to implant in his patients. Reminds me of a colleague, who incidentally also believes in Mitrofast, who kept swearing on the virtues of the symmetry device right up till the day the company itself withdrew it for safety concerns. At the barest minimum, Bojan and other surgeons who insist on using SHELHIGH products must inform patients that concerns have been raised about the manufacturer in the USA, and although they (surgeons) believe it to be safe, the patient must be given a choice as to whether he wants to take the risk or seek alternative products. For example, despite my bias for aprotinin, we now specifically obtain consent from patients to use this drug and tell them that some question has been raised that this drug could predispose to some complications after surgery.

My Principle is to treat our patients as we would like ourselves or our family to be treated, which brings me back to Mitrofast - I would honestly want to know if there is ANY surgeon, especially those who implant the Mitrofast, who would have a P2 prolapse today that would opt to have a mitrofast as the treatment for his or her condition, rather than seek a good mitral repair? Why then would we treat our patients in one way and then when we are ill, seek a different therapy for ourselves?

Ani
  ----- Original Message -----
  From: Hgrmd at aol.com<mailto:Hgrmd at aol.com> 
  To: OpenHeart-L at lists.hsforum.com<mailto:OpenHeart-L at lists.hsforum.com> 
  Sent: Saturday, April 21, 2007 6:56 AM
  Subject: Re: [HSF] FDA


  Look, Bojan,
    Don't be so sensitive.  Indeed, Shelhigh's products may be  perfectly safe. 
   However, until the smoke clears, I, for one, wouldn't  consider using their 
  products.  At least in America, pursuing such a course  could turn out to be a 
  legal disaster.  It may turn out that Shelhigh  products will be cleared.  
  Until that happens, I'm sure most surgeons would  steer clear for now.
  Hal



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