A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery
This study will identify a patient population who wishes to address a variety of concerns about the size, shape, or appearance of their penis with the placement of a subcutaneous Silicone Block Penile Implant. Because the Silicone Block is placed subcutaneously, the device can provide immediate and permanent improvements to the appearance of a man's penis. The most notable improvements are enhanced penile cosmesis, improved penile girth, and improved exposure of the penile shaft outside the plane of the body.
The plan is to conduct a study to examine the outcomes of this procedure with respect to:
Incidences of adverse events
Changes in flaccid penile length (through physical measurements pre and post-operatively in a consistent manner)
Changes in flaccid penile girth (through physical measurements pre and post-operatively in a consistent manner)
Changes in satisfaction scores with respect to penile size and patient self-confidence/self-esteem (through validated questionnaires)
Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery
This is a retrospective evaluation of all subjects who successfully received implantation of the Silicone Block for correction of soft tissue deformities of the penis. In addition, subjects will be sent a questionnaire to complete that will evaluate the subject's ongoing satisfaction with the implant and any adverse events that may not have been reported to the physician.
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