How do clinical trials guarantee the safety of a medical device? According to US regulatory policies, every medical device must pass rigourous testing in order to gain FDA approval. Coloplast testicular implants are the only prosthetic testicles on the market to have FDA approval, so it is important to understand what this means. Last year we published a post describing how FDA approval works, but we didn’t provide much detail about clinical trials. After reviewing a few sources, we think this page from the US National Institutes of Health sums up the purpose and structure of clinical studies nicely:
Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.
Click here for detailed information about the clinical trials for Coloplast’s Saline Filled Testicular Prostheses.
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.”
