NEWS
01/12/1993

<TITLE>Proposed that manufacturers of testicular implants be required to submit scientific data to show that these products are safe and effective.</TITLE>
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P93-4                                         Food and Drug Administration
FOR IMMEDIATE RELEASE                         Sharon Snider - (301) 443-3285

    The Food and Drug Administration today proposed that manufacturers of     
testicular implants be required to submit scientific data to show that these  
products are safe and effective.
    Testicular implants, which are made of silicone, are intended for         
cosmetic purposes.  They are commonly used to correct congenital              
abnormalities in infants and toddlers who are born without one or both        
testicles.  They are also used in men who have had one or both testicles      
removed because of cancer or other diseases or who have lost one or both      
testicles due to injury.  An estimated l,000 are implanted yearly.
    "We need to make sure these devices are safe and effective,"  said FDA    
Commissioner David A. Kessler, M.D.  "Therefore, we are proposing that        
companies submit data, just as we did for breast implants."
    Testicular implants are pouches that are placed in the scrotum.  They     
are made of solid or gel silicone and have a silicone covering.  Some types   
are coated with polyurethane foam.
    These implants were on the market prior to the Medical Device Amendments  
of 1976, which gave FDA regulatory authority over devices.  Like other        
pre-amendment devices, testicular implants were allowed, under the law, to 
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                                       Page 2, P93-4, Testicular Implants
remain on the market with the understanding that FDA would later require      
manufacturers to demonstrate their safety and effectiveness.
    Although some information on the risks and benefits of testicular         
implants is available, there is not enough scientific evidence to determine   
whether the benefits outweigh the risks.
    The agency's safety concerns regarding the implants involve the lack of   
adequate information in these areas:
    * The incidence of leakage, hardening of surrounding tissue and           
rupture.  The silicone gel in these implants may leak into adjacent tissue,   
causing problems similar to those seen with breast implants.
    * The long-term effectiveness of the implants.  Reported problems of      
unknown frequency and origin include infection, pain, discomfort, erosion of  
the device and its migration to other parts of the scrotum and abdomen.  It   
is also not known how often these complications require corrective surgery.
    * The potential for long-term adverse effects, such as cancer,            
immune-related connective tissue disorders and reproductive problems.  This   
type of information is particularly important because many of the implant     
users are young.
    * The immediate and long-term psychological benefits of the implants,     
such as patient satisfaction and improved self-image and psychological        
outlook.
    If today's proposal is made final, manufacturers planning to continue     
marketing testicular implants will be required to submit a Premarket          
Approval Application demonstrating the safety and effectiveness of these      
products as a condition for keeping them on the market.
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                                       Page 3, P93-4, Testicular Implants 
    FDA's call for safety and effectiveness data on testicular implants is    
part of the agency's ongoing review of pre-1976 devices.  In addition to      
requiring safety and effectiveness data on silicone gel breast implants, FDA  
recently proposed calling for safety and effectiveness data on saline breast  
implants and will soon do the same for inflatable penile implants, heart      
bypass blood pumps and cranial electrotherapy stimulators.
    Today's proposal, which is being published in the Jan. 13 Federal         
Register, provides for a 60-day comment period.  Comments may be submitted    
to Dockets Management Branch, HFA-305, Rm 1-23, 12420 Parklawn Dr.,           
Rockville, Md. 20857.
    FDA is one of the eight Public Health Service agencies within the U.S.    
Department of Health and Human Services.
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