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. 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. 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.