Coloplast offers the only FDA-approved testicular implant on the US market today. Alternative products do exist, such as prostheses manually cut from block silicone, but these products do not have FDA approval.
Before deciding if testicular implants are right for you, it is important to understand the significance of FDA approval as a measure of a product’s relative quality, safety, and reliability. With products such as testicular implants, the FDA’s primary role is “ensuring that medical devices are reasonably safe and effective.” Devices are reviewed by the FDA’s Center for Devices and Radiologic Health (CDRH), which makes a determination based on the results of clinical studies, quality of materials, marketing, labeling, and classification, among other areas. An “approval order” is issued for each FDA-approved device, which can be viewed by the public on the CDRH’s website.
Click here to download the PDF version of the FDA approval order for Coloplast testicular implants (please note that at the time of approval, our product was filed under “Mentor Saline-Filled Testicular Prosthesis.”
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