Management of Tunica Albuginea Disruption Secondary to Malleable Penile Implant Fracture: Insights into Etiology and Surgical Approach

doi:10.21203/rs.3.rs-6326068/v1

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Case Report

Management of Tunica Albuginea Disruption Secondary to Malleable Penile Implant Fracture: Insights into Etiology and Surgical Approach

https://doi.org/10.21203/rs.3.rs-6326068/v1

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Journal Publication

published 01 Aug, 2025

Read the published version in Basic and Clinical Andrology →

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Background

The tunica albuginea is a key anatomical structure supporting penile implants. Several factors can lead to anatomical penile defects, contributing to penile prosthesis malfunction.The aim is to describe the consequences of malleable penile implant fractures, their contribution to tunica albuginea defects, and management outcomes.

Results

This study included three patients with malleable penile implant malfunction secondary to device fracture. Two patients underwent PC and device replacement. One patient experienced persistent device instability despite device replacement without PC but later underwent corrective PC. The mean age at revision was 71.3 years. All patients achieved device stability and reported satisfaction after PC and device replacement, with a median follow-up of 28 months.

Conclusions

Malleable penile device fractures are extremely rare. They can cause tunica albuginea disruption and tears, compromising penile penetration and device stability. Device replacement combined with PC is an essential component of surgical management.

Erectile Dysfunction

Treatment

Corporoplasty

Tunica Albuginea

Male erectile dysfunction (ED) is a prevalent condition, affecting 52% of men aged 40 to 70 years according to the Massachusetts Male Aging Study. [1] Penile implants are considered the standard of care for patients with ED refractory to medical therapy. [2] During the past four decades, advancements in the synthetic properties of penile implants have aimed to enhance device durability and function. These improvements have reduced the incidence of penile structural deformities resulting from prosthesis damage. [2–4]

Penile structural abnormalities, particularly in the tunica albuginea, have been evaluated in various studies. These evaluations suggest that such structural abnormalities may affect device function and stability. [3–5] However, these penile abnormalities remain incompletely understood. Various reports have described penile structural defects secondary to penile implant surgery, including urethral erosion, penile wobble effect due to proximal corporal deformity, and/or corpora cavernosa erosion. [4–6] Moreover, some reports suggest that the intrinsic histological features of the tunica albuginea may influence these findings. [7, 8] Notably, most penile structural abnormalities described in the literature are associated with inflatable penile prostheses. [4] In this report, we describe the occurrence of device instability secondary to malleable penile implant damage in a series of three patients, necessitating device replacement and corporal reconstruction.

Patient selection

Following institutional review board approval, a retrospective review was conducted using a penile implant database encompassing surgeries performed between May 2019 and March 2024. All patients underwent penile device implantation for erectile dysfunction refractory to medical therapy. The procedures were performed by a single surgeon (ESR) at three medical centers (two public and one private facility). Patient information and data were documented in a standardized database at the time of surgery and during follow-up visits, with a maximum follow-up period of 6 months. Approximately 23% of patients underwent follow-up for > 1 year.

All cases of malleable penile device revisions were recorded during penile prosthesis revision surgeries. Based on the clinical presentation, malleable penile device fractures and tunica albuginea disruptions were assessed perioperatively by identifying device instability and penile angulation with a hinge effect, confirmed intraoperatively by the presence of tunica albuginea disruption. Cases involving tunica albuginea reconstruction for indications other than malleable penile device fractures were excluded.

Covariates

Patient characteristics and variables were recorded, including age, comorbidities, erectile dysfunction etiology (based on clinical assessment), the number and duration of prior penile implants, and the duration of previous implant failure. Intraoperative findings included the types of explanted and implanted devices, affected cylinders and laterality, previous and current implant measurements, and affected corpora. Postoperative outcomes, including successful sexual intercourse and follow-up duration, were also documented.

Surgical management

Malleable penile device replacement with concomitant plication corporoplasty (PC) was performed during revision surgery. Following initial clinical assessment and confirmation of device fracture, a penoscrotal approach was used. The damaged penile cylinders and their rear tip extenders were removed. The site of the device fracture was identified, and the neurovascular bundles were mobilized at the affected side and over the thinned tunica albuginea. Interrupted 3 − 0 polydioxanone sutures (Ethicon, Inc., Bridgewater, NJ, USA) were applied to plicate the tunica albuginea at the affected site. Antimicrobial irrigation was performed before placing the new device. Corporotomies were closed with a continuous 2 − 0 Vicryl suture (Ethicon, Inc.). Patients were advised to resume sexual intercourse 2 months postoperatively.

In the penile implant database, we identified 15 patients who underwent malleable penile device replacement. Of these, three patients presented with a fractured penile device with or without tunica albuginea disruption with a hinge effect, necessitating PC and device replacement (Fig. 1). All three patients with fractured devices reported difficulty with penile penetration at the time of initial presentation, which was secondary to penile angulation during penetration (Fig. 2). The baseline patient characteristics are shown in Table 1. The median age at the time of surgical management for patients with malleable penile fractures was 64 years. The etiology of erectile dysfunction was consistent across all patients, with arterial insufficiency secondary to diabetes, hypertension, and ischemic heart disease.

Table 1

Demographic and clinical characteristics
Patient	Age (years)	Comorbidities	Etiology of ED	Past implant	Implant failure time	Duration of previous penile implant
1	59	DM, DSL	Arterial insufficiency	Once	15 months	6 years
2	81	DM, HTN, IHD	Arterial insufficiency	Twice	24 months	14 years
3	74	DM, HTN, IHD	Arterial insufficiency	Once	6 months	7 years
ED, erectile dysfunction; DM, diabetes mellitus; DSL, dyslipidemia; HTN, hypertension; IHD: ischemic heart disease

Detailed clinical and intraoperative findings revealed that one patient (Patient 2) had undergone a prior penile implant revision that was unsuccessful and required further revision with corporoplasty. Additionally, a magnetic resonance imaging study performed before the final revision showed bilateral thinning of the corporal wall (Fig. 3). The last implanted device was intact; however, PC had not been performed.

The fractures involved both implanted cylinders in all patients at the same level, affecting the metallic core at the site of the penile base. In two of the six cylinders, the metallic core had eroded through the outer covering material (Fig. 4). Detailed operative findings are presented in Table 2.

Table 2

Operative findings
Patient	Explanted damaged MPP (girth)	Silver wire disruption side	Silicone tube disruption side	Previous implant measurements	Current implant measurement	Affected corpora	Reimplanted MPP (girth)	Follow-up
1	Promedon (11 mm)	Bilateral	Left side	20 cm	22 cm	Left side	Tactra™ (13 mm)	30 months
2	Promedon (11 mm)	Bilateral	Bilateral	19 cm	19.5 cm	Bilateral	Genesis^® (13 mm)	26 months
3	Promedon (13 mm)	Bilateral	Intact	17 cm	18 cm	Intact	Zephyr ZSI 100 (13 mm)	6 months
4
MPP, malleable penile prosthesis

The median follow-up time after device replacement and corporoplasty was 26 months. All patients reported satisfactory sexual intercourse with no complications or need for additional surgery.

In this report, we present a case series of three patients who developed dysfunction of malleable penile prostheses secondary to fractured implants, involving both the central silver wire and the covering silicone tube. These fractures compromised the structural integrity of the penis, as evidenced during clinical evaluation through patient history and physical examination, which revealed an angled penile implant and weakening of the tunica albuginea at the fracture site. Imaging studies further aided in identifying the etiological factors contributing to the device dysfunction. Surgical management included device replacement and PC at the defect site. During follow-up, the malleable devices remained functional, with no recurrence of the hinge effect.

This abnormality was observed in patients with gradually progressive dysfunctional penile penetration due to long-standing fractured malleable penile implants, rather than sudden acute fractures occurring during sexual intercourse. Recognizing this condition requires an understanding of its characteristics to ensure timely and appropriate management. It may be justifiable to perform additional imaging workups, such as conventional X-rays and magnetic resonance imaging, as adjuncts before surgical revision to evaluate the need for device replacement and possible PC.

In this series, three patients experienced dysfunctional sexual intercourse, requiring hand assistance for penile penetration. All patients had undergone prior evaluations, during which the etiological factor for their condition was not initially recognized. We postulate that early detection of concomitant corporal defects, combined with timely device replacement and PC, might have prevented the surgical failures observed in one patient in this series.

Late presentation with sexual dysfunction following penile implant surgery has been reported in the literature, with various etiological factors attributed to device abnormalities and/or penile anatomical issues. [5, 9] Abnormalities of inflatable devices include aneurysmal dilation, cylinder breakage, fluid leakage, and pump failure. Notably, mechanical failure of malleable devices due to device breakage is extremely rare and has been documented only in case reports. [10–15] In the current study, we report the first documented observation of concomitant malleable device fractures with tunica disruption in two of three patients, necessitating PC.

Tunica albuginea defects in penile implant surgery have been reported in the literature in association with various anatomical abnormalities. These penile abnormalities may occur primarily due to proximal corporal dilation or secondarily as a result of inflatable penile device abnormalities, which contribute to corporal cavity dilation and wobble penile defects. [5, 16, 17] In the current study, tunica albuginea defects occurred secondary to device angulation at the site of malleable device fractures, which eroded into the corpora cavernosa wall.

This report has certain limitations, including the small number of patients in this case series. However, given the high volume of malleable penile prosthesis insertions in the region, the rarity and unusual nature of these findings are noteworthy. Despite this limitation, future studies could further investigate the predisposing factors for tunica albuginea disruption, including histological analysis and evaluation of device manufacturing properties. Additionally, the use of adjunct tunica albuginea-supporting grafts alongside corporoplasty may improve long-term outcomes following repair and help prevent future device fractures and tunica weakness at the site of corporoplasty repair. However, this approach requires long-term follow-up to validate its efficacy. The current report highlights the importance of recognizing this phenomenon to enable andrologists to identify pathological tunica albuginea weakness, facilitate immediate repair during device replacement, and avoid incomplete surgical management, thereby improving the likelihood of achieving satisfactory sexual intercourse.

The integrity of the tunica albuginea is crucial for achieving optimal sexual function with a malleable penile device. Fracture of a malleable penile device can lead to tunica albuginea disruption, compromising satisfactory sexual intercourse. Device replacement combined with corporoplasty is an essential component of the surgical management for this phenomenon.

Acknowledgment

None.

Author contributions

The author (E.S.R) who did draft, writing, and editing of the

manuscript.

Fundings

No external fundings.

Availability of data and materials

Further data that support the findings of this study are available from the

Corresponding author upon reasonable request.

Ethics approval and consent to participate

Ethical approval was obtained from Beat Medical Center, Madinah, Saudi Arabia.

Conflict of interest statement

The author declares no conflicts of interest.

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No competing interests reported.

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Journal Publication

published 01 Aug, 2025

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Editorial decision: Revision requested
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You are reading this latest preprint version

Management of Tunica Albuginea Disruption Secondary to Malleable Penile Implant Fracture: Insights into Etiology and Surgical Approach

Status:

Journal Publication

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Abstract

Background

Results

Conclusions

Figures

Background

Materials and Methods

Patient selection

Covariates

Surgical management

Results

Discussion

Conclusion

Declarations

References

Additional Declarations

Status:

Journal Publication

Version 1