Outcomes & Safety: The Numbers Behind the Surgery

Volume and experience

Dr. Edward Gheiler, MD, FACS performs approximately 400 inflatable penile implant procedures a year, part of more than 8,000 prosthetic-urology cases over his career. He is a Boston Scientific AMS 700 Center of Excellence and directs an implant surgical training program for other urologists. In implant surgery, higher surgical volume is associated with better safety and results in the published literature.

His practice also draws a high share of difficult cases: roughly one in four of Dr. Gheiler’s implant procedures are revision or removal-and-replacement cases — a reflection of the complex, redo, and referred implants other surgeons send his way.

A low, honestly measured infection rate

Infection is the complication men fear most, and it is the one most tied to technique and discipline. Under Dr. Gheiler’s standard antibiotic-irrigation protocol, the practice-reported baseline infection rate is 0.3% — 2 infections in 628 primary implants before January 2024.* Infection remains a recognized risk of any implant surgery, so rather than one headline figure, here is what has been measured, period by period:

• The 2021–2026 database cut: across 1,253 primary implants that completed 90-day follow-up, nine were reoperated on and adjudicated as infection — 0.72% for that defined 2021–2026 cohort.
• The Irrisept period (9 January 2024 – 1 September 2025): an increase in observed infections was seen during the period in which Irrisept irrigation was used — 7 infections in 488 primary implants (1.4%). Those cases are counted in the 0.72% above — not set aside.
• Since Irrisept was discontinued: under the current antibiotic-irrigation protocol, zero reoperations for infection have been observed to date — 0 of 137 consecutive primary implants as of the 18 July 2026 database cutoff† — though with a run that size the true underlying rate could still be as high as about 2%.

How that number is measured

A number is only as good as how it is counted, so here is the whole method rather than a headline.

• What counts as an event: any reoperation within 90 days of surgery that is adjudicated as infection — one event per patient — against a written definition adapted from CDC/NHSN surgical-site-infection and Musculoskeletal Infection Society prosthetic-infection criteria.
• Who decides: every reoperation flagged by that rule was re-classified by two urologists blinded to the period, the irrigation used, the hospital, and each other’s answers. They agreed with the original classification on all 13 flagged cases.
• The numbers: 9 infections in 1,253 primary implants (2021–2026, database cutoff 18 July 2026). Of 1,289 implants performed, 36 had not yet reached 90 days and are excluded from the denominator rather than counted as successes.
• What it does not cover: these are primary (first-time) implants only. Revision and removal-and-replacement cases — about a quarter of Dr. Gheiler’s implant work — carry different, generally higher risk and are not in this figure.

The blinded re-adjudication is what makes the classification reproducible rather than a matter of memory. It does not make this an audit: case-finding was done within the practice, so an infection managed elsewhere, treated without reoperation, or appearing after 90 days would not be captured.

†The 137-implant consecutive run is part of an analysis currently under peer review; it has not yet been peer-reviewed or published.

*The 0.3% baseline figure is Dr. Gheiler’s practice-reported single-surgeon rate for primary implants under his standard antibiotic-irrigation protocol (2 of 628, before the Irrisept period); the period figures are the blinded-adjudicated reoperation-for-infection counts described above. None is an independently audited or population-level rate, and the underlying analysis is currently under peer review. Individual results vary; infection and complication rates depend on patient-specific factors, and revision cases carry different risks than primary surgery. Not a guarantee of outcome.