Appendix A
Coloplast Clinical Study Results
Saline-filled testicular implants are new medical devices. To assess the safety and effectiveness of this device, a multicenter clinical trial (the “Core Study”) was performed. Additionally, a separate study (the “Adjunct Study”) was performed to collect additional safety data while the Core Study was ongoing. One hundred and forty nine (149) subjects were treated in the Core Study, and 209 subjects were treated in the Adjunct Study. Both studies treated children and adult patients.
Safety
The main complications noted in these studies were as follows:
- Pain and/or discomfort occurred in approximately 10% of patients.
- Temporary swelling at the implant site in approximately 3% of patients.
- Extrusion of the implant in approximately 2% of the patients.
- Infection at the implant site in approximately 1% of patients.
- Displacement/migration of the implant in approximately 2% of patients.
Approximately 1 in 30 patients required resurgery within 1 year after device implantation in these studies, usually to remove the implant. The most common reason for implant removal was extrusion of the implant.
Effectiveness
The effectiveness of the implant is based on the following results of the Core Study:
Physician measurements documented that the implanted device adequately mimics the size of the natural testicle.
The cosmetic appearance and firmness of the implanted device was rated as normal by physicians. Using standardized questionnaires, patients recorded high levels of satisfaction with the implant, as well as increased levels of how they viewed their body in sexual activities. Additionally, there was no decline in either self-esteem or body esteem, as assessed using the Rosenberg Self-Esteem Scale and the Body Esteem Scale.
