Out with the old, in with the new? A retrospective comparison of malleable erectile implants in phalloplasty

To compare the long-term outcomes of the two main types of malleable erectile implants after phalloplasty in transgender men: models originally designed for cisgender men (conventional models) or the more recently developed Zephyr Surgical Implants (Geneva, Switzerland) female-to-male 100 implant (ZSI FtM 100) specifically for phalloplasty.

A retrospective cohort study was conducted in patients who had undergone phalloplasty followed by insertion of a malleable implant between 2012 and 2015.

A total of 32 patients were included who underwent a total of 48 implantation procedures, 22 of which were using the ZSI FtM 100, 24 the Coloplast Genesis, and two the Boston Scientific Spectra. There was no significant difference in postoperative complications, including infection or haemorrhage, between the two groups. For rates of late complications occurring after ≥1 month (infection, breakage, malposition, erosion, and chronic pain), conventional models had significantly more occurrences overall (P = 0.05) and these events were more likely to occur sooner (hazard ratio 2.3, 95% confidence interval 1.2-4.8; P = 0.02). At 24 months postoperatively, 74% of the ZSI FtM 100 devices remained complication free compared to 12% of the conventional models (P < 0.001). However, when separately comparing rates of specific complications, only a single significant difference was found, with the ZSI FtM 100 implants showing more incidents of breakage (P = 0.04).

The ZSI FtM 100 appears more prone to mechanical failure than conventional models but is associated with a lower overall incidence of complications. It also demonstrates a better lifespan in phalloplasty, with a longer complication-free survival. These findings must be interpreted with caution given the retrospective design and small sample size of this study.