N = 95 reported mechanically failed samples had dates available:
Median : 7 years
Mean : 7 years
Maximum : 19 years
Highest concentration : 4–9 years
≤ 1 yr: 8%
2–5 yrs: 34%
6–10 yrs: 40%
11–15 yrs: 15%
16–20 yrs: 3%
- Tubing fracture/break near pump is the single most frequent failure mode, reported across dozens of cases.
- Tubing leak without confirmed fracture accounts for a distinct subset of removals, often with full fluid loss noted.
- Infection is the second most common cause of explant, consistently resulting in downgrade to a Genesis malleable prosthesis.
- Incorrect sizing (oversized, undersized, or asymmetric cylinders) is a recurring surgical indication for revision, sometimes resolved with downsizing or RTE adjustment rather than full explant.
- Pump malfunction as an isolated component failure — including stiffness, hydraulic failure, inability to inflate or deflate, and cracked pump housing — prompted pump-only replacement in multiple cases.
- Pump tubing disconnection at strain relief was identified as a distinct failure point, with tubing separating from the caged connector rather than fracturing mid-span.
- Reservoir displacement or malposition (wrong anatomical space, migration out of retropubic space, or backward placement by the surgeon) required repositioning or replacement without necessarily replacing the entire device.
- Erosion or extrusion — cylinder or tubing eroding through scrotal or penile tissue — led to explant, sometimes combined with concurrent infection.
- Auto-inflation (spontaneous device inflation without pump activation) prompted pump and reservoir replacement in at least two cases, attributed to hydraulic mechanism issues.
- Failure to fully inflate with device remaining in situ and revision pending is documented in several events, indicating a clinically significant lag between symptom onset and surgical correction.
- Cylinder crossover (proximal or distal, unilateral or bilateral) — cylinders migrating across the midline or out of the corpora — required surgical correction.
- Aneurysmal defect in the corpora caused by cylinder oversizing or mechanical stress led to removal; intraoperative findings confirmed thinned corporal tissue and an opening at the aneurysm site.
- Cylinder migration out of corporotomy with visible scrotal or suprapubic bulge and pain; in at least one case, cylinders were reinserted and corporotomies resecured without replacing the device.
- Reservoir encapsulation/fibrosis prevented reservoir refill, requiring relocation to a new anatomical space without device exchange.
- Pump malposition requiring repositioning — either too posterior causing clothing friction, or adhered to scrotal tissue with concern for early infection — managed with pump relocation and device retention.
- Intraoperative surgical complications including corporal perforation, urethral damage, cylinder nicking, and improper connector seating necessitated immediate or early revision.
- Reservoir rupture as an isolated component failure resulted in full system replacement; one reservoir was punctured iatrogenically during ER needle aspiration of a scrotal abscess.
- Dexterity-based device exchange — patients with arthritis or inability to manipulate the Touch pump mechanism requested downgrade to Classic or malleable Genesis without any device malfunction.
- Inadequate rigidity or loss of penile length post-implant, without confirmed mechanical failure, prompted either revision or was reported as an unresolved patient complaint.
- Unspecified or unknown reason for explant comprises a non-trivial proportion of reports, reflecting incomplete clinical documentation at the time of MDR filing.
