News
03/12/1992

<TITLE>Sheily Inc of Irvice, CA, to Notify Patients of Heart Valve Defects</TITLE>
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P92-7                                    Food and Drug Administration
FOR IMMEDIATE RELEASE                    Sharon Snider - (301) 443-3285


    The Food and Drug Administration has asked Shiley Inc. of Irvine,         
Calif., the maker of Bjork-Shiley heart valves, to notify patients and        
physicians that risk of fracture for some sizes of these valves may be        
higher than previously thought.
    The fracture rate for the large sizes of the 60-degree Shiley (C-C)       
valve is now thought to be as much as five times higher than previously       
estimated.  Valve fracture is often fatal.
    FDA believes that the risk of fracture of these large valves, over an     
eight-year period, when implanted to substitute for the heart's mitral        
valve, may be high enough for doctors and patients to consider replacing      
currently intact valves in some individuals.
    "When a critical device such as a heart valve is found to have a problem  
that could result in death or serious injury, FDA has an obligation to see    
that doctors and patients are notified so that they can consider the new      
information in deciding on a course of action," said FDA Commissioner David   
A. Kessler, M.D.
    About 23,000 people in the United States and Canada have 60-degree 
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                                            Page 2, P92-7, Shiley Valve
Shiley (C-C) valves.  These valves were removed from the market in 1986.      
FDA has received about 350 reports of 60-degree valve fractures among the     
roughly 82,000 C-C valves implanted worldwide.
    FDA requested Shiley to notify patients with these valves of the          
fracture problems, in a program begun in 1990 after the agency became aware   
of some risk of fracture.  However, replacement of intact valves was not      
recommended at that time because the surgical risk was thought to far         
outweigh the risk of fracture.  (See press release P90-60, Dec. 11, 1990.)
    The risk of fracture depends on the age of the patient, valve size and    
valve position.  The rate may be as high as 0.8 percent per year for people   
under 50.
    Which patients should now have their heart valve replaced is a decision   
that should be made on a case by case basis by physicians, based on the new   
fracture figures and the patient's medical status, lifestyle and wishes.
    Since certain patients may be at higher risk for valve fracture than was  
previously known, it is important for patients with the larger valves,        
especially those in the higher risk group--younger patients with the larger   
valves implanted in the mitral position--to talk to their doctors about what  
the new risk numbers mean to them, Dr. Kessler said.
    FDA asked Shiley to send letters to all patients with C-C heart valves    
informing them of the increased risk of fracture.  Patients in the affected   
groups will be provided with both the new and old fracture risk figures for   
various valve sizes and age groups and will be advised to discuss the new     
information with their doctors.  Patients unaffected by the new figures will  
be reassured that the new data do not apply to them.
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                                            Page 3, P92-7, Shiley Valve
    Shiley was also asked to send a letter to physicians, enclosing a copy    
of the study upon which the higher estimates are based and discussing the     
option of valve replacement.
    "It is important to remember that this new risk information applies only  
to Shiley C-C valves, not to other makes and models," said James S. Benson,   
director of FDA's Center for Devices and Radiological Health.
    "Even with the C-C valves, the increased fracture risk is confined to     
certain size valves.  The risk figures have not appreciably changed for C-C   
valve patients who have the smaller size valves."
    The study on which the new estimates of risk are based was published in   
the Feb. 1 British medical journal The Lancet.
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