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1993.01.12 :  Testicular Implants 
            
Contact: Sharon Snider - (301) 443-3285 (Home) -- (301) 622-0977
January 12, 1993

    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 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.

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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