[HSF] FDA

Ani Anyanwu anianyanwu at hotmail.com
Sat Apr 21 19:50:50 EDT 2007 

Bojan

Thanks for your response. I would not though dismiss the difference between Europe and the USA. Europe does indeed need to be occasionally saved from the scourge of US companies such as Shelhigh. As you are aware, Europe is the testing ground for US companies. Most devices are tested and even CE approved in Europe long before US regulators allow their use as investigational devices in US patients. The bad lessons of devices such as the Heartmate II and Debakey pumps were learnt on Europeans, and corrected before they were implanted in Americans, long before they had been implant in Americans (indeed neither device is FDA approved in the US though both have been approved in Europe for over 5 years). Indeed there are examples of products made by US companies and marketed in Europe but withdrawn without the products ever being on the US market. There is an advantage in that Europeans see technological advances first, and that innovation is not stifled as is the case in the US, but the flip side is that Europeans also suffer the consequences of imperfect, unrefined or ineffective prototypes. When I worked in UK I remember several occasions unapproved devices were brought in by the reps and we just used them on patients with no regulation whatsoever - some of these devices I never ever heard of or saw published again.

The FDA may have its limitations but Europe also needs to protect its citizens from unsafe or unproven technologies and devices.

Regarding endocarditis, the evidence that Shelhigh valves, or indeed any other valve (including the allograft), is best suited to preventing relapse of acute endocarditis is very weak. I would not think that the several hundreds of patients in US who have surgery for endocarditis each year are suffering because they do not have access to a Shelhigh valve. Indeed there is also published evidence that degeneration is accelerated in Shelhigh valves. These studies are all however far too small to make any definitive conclusion.

Unfortunately the Mitrofast concept was bought by Shelhigh so it will suffer with the bad publicity that the present FDA action will attract. I do accept that the current action has nothing to do with the Mitrofast, but I suspect that this could be the beginning of the end of that concept until some other company can pick it up.

Note though that there will not likely be any product recalls,  - the FDA's problem was with the manufacturing conditions and not the products themselves per se. If Shelhigh builds a new plant, sorts out whatever manufacturing deficiencies there were, and complies with antimicrobial and sterility standards, all the products will be back on the market again.

Ani
  ----- Original Message ----- 
  From: bbiocina at kbd.hr<mailto:bbiocina at kbd.hr> 
  To: OpenHeart-L at lists.hsforum.com<mailto:OpenHeart-L at lists.hsforum.com> 
  Sent: Saturday, April 21, 2007 10:09 AM
  Subject: Re: [HSF] FDA


  Hal, Ani ,
  It seems to be  a misunderstanding  because :
  1. I do not insist of usage of Shelhigh products in my patients , in fact
   I do not  have scheduled any of them  that might require  such a
  product for the  next week.
  2. Of course I feel obliged to  inform my patients  about ANY  feature (
  or possible feature ) of the device  , and I will  centainly  do that in
  the  future specifically targeting recent  events  about  Shelhigh
  devices. That  discussion will , of course , include  explanation of all
  potential benefit of those ( or any other ) product. As there is NO
  mandatory recall so far( of course , it might happen tomorrow) ,
  patients will decide , as they often do ( mech or tissue valve
  explanation/consent).
  3. having  known  major published reports  about  anti-endocarditis
  properties  of Shelhigh aortic valves;

  http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16598398&query_hl=1&itool=pubmed_docsum<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16598398&query_hl=1&itool=pubmed_docsum>

  http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=12645697&query_hl=1&itool=pubmed_docsum<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=12645697&query_hl=1&itool=pubmed_docsum>

  we , in Europe ( in US those valves have not been cleared for  general
  use anyway , so you do not have  such a dilemma) can find ourself 
  caught in dilemma  if an endocarditis case appears: to put  the valve in
  ( and expose the patient  to "potential" contamination) or  not to put
  it ( and to expose patient  to a possible  higher  recurrence rate) -
  again , there is NO mandatory recall.Any oppinion on that?

  4. Last , but not  the least : Mitrofast. I got tired  repeating that
  this device id NOT for P2 prolapse only , but for ANY ( even
  non-repairable  by conventional means) PML damage ( again and again ,
  ECHOs available via Pando to anybody who want to see them). However ,
  all  recent discussions on Mitrofast  have  been based on  analysis of 
  it's DESIGN , therefore I  think it is  inapropriate  to use  the
  recent FDA investigation  about possible  sterility issues  to qualify 
  it as a "scourge  to be saved from".

  I agree with Hal that we have to be cautious , and it is just  how I plan
  to behave , but , in the other hand , I also think  that qualifications 
  should be  based on founded evidence.

  Bojan


  On 4/21/2007, "Ani Anyanwu" <anianyanwu at hotmail.com<mailto:anianyanwu at hotmail.com>> wrote:

  >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<mailto:Hgrmd at aol.com<mailto:Hgrmd at aol.com>> 
  >  To: OpenHeart-L at lists.hsforum.com<mailto:OpenHeart-L at lists.hsforum.com<mailto: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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