Complications and management of penile enhancement procedures

Abstract

Demand for penile enhancement—driven by cosmetic and psychological goals—is rising, and complications are increasingly encountered in urologic practice. This review offers practical, procedure-focused guidance on diagnosing and managing adverse events after injectable fillers, self-injection of foreign substances, dermal matrices, autologous fat transfer, and the subcutaneous silicone Penuma implant. Hyaluronic acid (HA) is the most commonly used filler and, when applied with standardized, low-volume protocols, generally has lower complication rates than polylactic acid (PLA), polymethylmethacrylate (PMMA), silicone, or nonmedical self-injected materials. Typical HA-related issues include migration, nodules, Tyndall effect, phimosis, and infection; management emphasizes early massage/modeling, warm compresses, judicious hyaluronidase for confirmed HA, antibiotics with drainage for abscess, and selective surgical excision for refractory nodules. Permanent fillers and self-injected substances are associated with granuloma, necrosis, infection, lymphedema, and disfiguring inflammation; these often require wide excision down to Buck’s fascia with reconstructive strategies such as split-thickness skin grafts or scrotal/dartos flaps. For dermal matrix and fat transfer, complications include edema, hematoma, infection (commonly Staphylococcus aureus or Escherichia coli), necrosis, contour deformity, and rare fat embolism; treatment ranges from compression and local debridement to staged reconstruction. The Penuma implant presents device-specific problems—seroma, infection, distal flaring with impending erosion, capsular contracture, curvature, and shortening—managed with antibiotics, wound care, traction or vacuum therapy, revision, or explantation with postoperative rehabilitation; salvage in frank infection is not described. Across modalities, prevention hinges on patient selection, informed consent with expectation management, sterile technique, and adherence to standardized injection/implant protocols. Timely recognition of early versus late complications and use of clear algorithms can preserve cosmesis and function. This review distills current data and referral-center experience into actionable steps for clinicians who perform or manage complications of penile enhancement procedures.

Introduction

Background

Historically, society has held a persistent interest in modifying penile size. Approximately 12% of the male population perceives their penis to be small (1). Of these, it is estimated that 3.6% of men suffering with a perceived or actual “small penis” may ultimately choose to seek procedures to enhance their penile length and/or girth (2). Over the years, some have advocated for penile girth enhancement via off-label use of injectable filler agents (3-7), autologous fat injection (8) implantation of dermal matrices (9,10), and soft silicone subcutaneous implants (11-14). It is important to note that in the majority of cases, patients undergoing girth enhancement seek out these procedures for cosmetic and/or psychological reasons. While often treated as minor, cosmetic procedures, penile girth enhancement can be associated with devastating complications that urologists will encounter in everyday practice.

Rationale and knowledge gap

In the future, as more data becomes available, some urologists may consider offering penile enhancement procedures to their patients. There is a growing interest in penile enhancement procedures, however management of complications remains individualized and under-published. For example, a study of long-term outcomes in 200 European patients following pubo-cavernous spacer placement for penile lengthening described that 1 in 5 patients were not completely satisfied with their outcome; however, no algorithm or suggestions were provided to help navigate their complications (15). Additionally, there are individuals who, out of desperation, resort to injecting foreign materials into their penises without proper medical guidance. This could be attributed to the limited availability of healthcare providers, particularly those in the fields of sexual medicine and plastic surgery, who are comfortable offering such procedures. This lack of providers willing to perform penile injections and implantable device procedures may stem from the absence of robust scientific data in this area.

Objective

Considering the broad audience of urologists who may encounter complications from penile enhancement procedures in their practice, we will conduct a review of the management of the most prevalent complications associated with injectable and implantable penile enhancement procedures (Table 1).

Table 1. Injectable and implantable penile enhancement procedure management.

Procedure type	Example products or materials	Common complications	Management strategies
Injectable	HA with/without standardized protocol (Ex. Urofill)	Filler migration, subcutaneous nodules, phimosis, infection, “Tyndall” effect	Warm compress, massage/modeling, additional low volume HA treatment, hyaluronidase (low volume, 10–30 units), circumcision, antibiotics (e.g., doxycycline 100 mg PO BID × 7–14 days)
Injectable	PLA	Granuloma, nodule formation, chronic pain	Corticosteroid injection, surgical excision +/− plastic surgery
Injectable	PMMA	Granuloma, chronic inflammation, foreign body reaction	Surgical excision +/− plastic surgery
Injectable	Liquid silicone	Tissue necrosis, migration, granuloma, infection	Surgical excision, debridement +/− plastic surgery
Self-injection of foreign materials	Mineral/paraffin oil, petroleum jelly, mercury	Ulceration, tissue necrosis, infection, scarring	Surgical excision, antibiotics, skin grafting
Implantable (fat transfer)	Autologous fat injection or graft	Edema, hematoma, fat necrosis, fat embolism, asymmetry	Compression, debridement, excision, grafting
Implantable (dermal matrix)	Acellular dermal matrix	Infection, delayed wound healing, necrosis, discomfort	Antibiotics, debridement, reconstructive surgery
Implantable (silicone device)	Penuma implant	Infection, distal flaring, seroma, erosion, device removal, deformity	Device removal, antibiotics, wound care, traction/VED and consider PDEi

HA, hyaluronic acid; PDEi, phosphodiesterase inhibitor; PLA, polylactic acid; PMMA, polymethylmethacrylate microspheres; PO BID, per os bis in die; VED, vacuum erection devices.

Search strategy

Literature from Scopus, PubMed and Web of Science databases was retrieved using the following query: ((Penile enhancement OR Penis augmentation OR Penile enlargement) AND (complication OR Infection OR Rejection OR ALLERGY) (“Management” OR “Treatment” OR “Intervention” OR “Therapy”) AND (“Complication*” OR “Adverse effects” OR “Side effects”)) AND (“2013/01/01”[PDAT]: “2023/12/31”[PDAT]) (Figure 1).

Figure 1.

PRISMA statement for searched/retrieved articles.

Penile girth enhancement procedures

Injectable penile enhancement complications and management

In a practice that mirrors trends in dermatology and plastic surgery, the injection of various substances into the soft tissue of the penis has been historically reported with varying degrees of success. Of these injectable fillers, the most common used for penile shaft augmentation or girth enhancement include off-label Food and Drug Administration (FDA)-approved hyaluronic acid (HA), polylactic acid (PLA), and polymethylmethacrylate (PMMA). The injection of materials such as autologous fat (8), injectable silicone (16), cross-linked dextran gels (17), and other miscellaneous substances used by patients in absence of medical advice (mineral oil, cod oil, paraffin, petroleum jelly, metallic mercury and methamphetamine) have also been documented (18-25). Notably, significant morbidity has been described for each of these modalities. Complications stemming from penile enhancement procedures can be categorized into both early and late stages. Within these categories, they can be further subdivided based on factors such as surgical technique issues, filler properties, and the overall health status of the patients.

HA

HA is the most common injectable filler for cosmetic surgery, representing 78% of all injectable dermal fillings (26). This substance is the major component of the extracellular matrix and is typically non-immunogenic until it is cross-linked to enhance stability. However, it is worth noting that various industrial processes involved in producing medical-grade HA for injection may introduce impurities or immunogenic materials, which can potentially lead to biological reactivity and associated health issues including hypersensitivity reactions (4). In the absence of hypersensitivity from impurities, the complication rate following penile enhancement with HA injection is very low (4-6). The most common, non-hypersensitivity complications of penile augmentation with HA injection are migration of the filler, subcutaneous nodules (2.2%), self-limited subcutaneous bleeding (1.3%), and infection (1%) (26,27).

If HA for girth enhancement is done conservatively and according to a reproducible protocol (Ex. Urofill^® technique), post-procedure pain and swelling is most effectively managed with conservative treatment and warm compresses. However, if HA is used without proper training, in high volumes via large bore cannula, and/or without following systematic protocols, this practice is likely to lead to poor cosmesis, pain/edema and aforementioned complications. Any filler, including HA, may also migrate distally into the prepuce in uncircumcised males, resulting in a redundant and swollen prepuce or phimosis (Figure 2). We recommend avoiding HA prior to circumcision in all patients with pathology to the prepuce and/or other lesions or infections of the penis where another procedure is first indicated. Management of distal migration can include hyaluronidase treatment, or, surgical management via circumcision depending on tissue health, volume of HA to remove and patient preference. Circumcision can be performed after HA injection, but an optimal cosmetic result may be more difficult to attain compared to pre-emptive circumcision for motivated, well selected, patients. Low volume systematic HA injections may still be reasonable to offer patients who otherwise are accepting the risk of filler migration and/or phimosis with a persistent foreskin. Of course, pre-emptive circumcision prior to injecting HA filler does not eliminate the possibility of nodules or asymmetric girth enhancement along the penile shaft (28). The migration of HA filler to focal areas of the penile shaft can result in painless nodules. These most commonly appear after two weeks of treatment. Nodules may also exhibit the Tyndall effect, appearing with a bluish hue, if the filler was placed too superficially rather than in the correct anatomical plane between Bucks and Dartos fascia (27,28). The formation of nodules can be mitigated by employing a small gauge needle (not trocar or cannula), slow injection column technique with a small volume of HA over multiple sessions. Treatment options for nodules include manual massage, warm compress and/or modeling/molding of the area with repeated punctures, which can be effective if started within 1–2 weeks of their appearance. Alternatively, should conservative treatment fail, nodules can be smoothened out with more HA filler if patients desire preserved girth or treated with enzymatic degradation with hyaluronidase if patient no longer desires increased girth. Low doses of hyaluronidase, for example 10–30 units, has been shown to effectively break down nodules of crosslinked HA in penile and dermatologic uses. The effects of treatment may take three or more days to become visible and may require more than one treatment depending on size of nodule. Of note, hyaluronidase is a component of bee venom and patients with bee allergy may need to take prophylactic precautions prior to being administered hyaluronidase. Finally, due to normal tissue containing HA it is paramount to confirm that a patient had HA injections for girth enhancement, rather than another filler, and the absence of infection prior to treatment with hyaluronidase to minimize the potential for iatrogenic (loss of healthy tissue, spread of infection along tissue planes) morbidity. Surgical excision is based on expert opinion, but may be indicated if patients are unwilling to attempt hyaluronidase, failure of conservative treatment, or for nodules larger than 1 cm (27). Of note, surgical excision can be performed via ellipse and enucleation, but this undermines the penile augmentation effort in the first place.

Figure 2.

Paraphimosis (A) and phimosis (B) from HA penile filler. HA, hyaluronic acid.

Infection associated with HA injection may require broad spectrum antibiotics as well as incision and drainage if there is evidence of abscess formation. Prevention of infection through aseptic technique and pre-procedure antibiotics are paramount. Patients are recommended to remain abstinent for a month or longer as intercourse may introduce bacteria beyond the skin or disturb any biofilm that may have formed at the time of injection (5). Systemic risk factors for infection are similar for this procedure as other skin and soft tissue infections and include immunosuppression and uncontrolled type 2 diabetes (28). Though not reported in the urologic literature, rare complications arising from vascular compromise after facial HA injections and may be treated by vigorous massage and prompt hyaluronidase administration (29).

PMMA microspheres, PLA and silicone injection, and patient “self-injection” of foreign materials

PMMA, PLA, and silicone are all associated with greater reactivity potential than HA injection. PMMA is a biocompatible filler whose main application in medicine is as a bone cement (30,31). PLA and injectable silicone are also polymers used for injection, and unlike HA, they are not native to the extracellular matrix (31). Unfortunately, some patients have injected petroleum jelly, various oils, and mercury into the penis for cosmetic purposes (18-20,24,32-34). Complications from these materials include tissue necrosis, granulomas, chronic inflammatory reactions, edema/lymphedema, and infection (Figure 3). The penis is not the only structure potentially altered as these fillers can also migrate to the scrotal soft tissue and surround the testicles. Unlike in the use of HA, enzymatic degradation of these substances is not an option, and inadvertent further loss of tissue. In minor cases, a circumcision can be performed to correct phimosis secondary to filler migration. In some cases, complete excision of the foreign material may be necessary through a sub-coronal circumcising or longitudinal incision along the shaft of the penis, allowing for granuloma removal and debridement of any non-viable tissue (34,35). Often this will be a difficult dissection and require excision of all effected soft tissue including skin and Dartos’ down to the Buck’s fascia. Skin coverage from extensive debridement or necrosis may require using a split thickness skin graft, allograft or scrotal dartos flap (33-36). Correctly identifying the filler agent used may help guide decision making between conservative management and early aggressive intervention, as permanent fillers such as silicone and paraffin are more likely to require surgical excision and can be disfiguring (33-38).

Figure 3.

Ulceration (A) and impending ulceration (B) after subcutaneous penile self-injection of an unknown foreign material.

Surgically implantable penile enhancement complications and management

Dermal matrix and fat transfer

Acellular dermal matrix and fat transfer, either autologous injection of prepared fat from liposuction or a fat graft isolated from lateral thigh or abdominal tissue, are sometimes used for penile augmentation. However, the American Urological Association (AUA) and urology care foundation do not consider subcutaneous fat injection safe or efficacious for increasing penile girth (https://www.auanet.org/about-us/policy-and-position-statements/penile-augmentation-surgery). The advantage of acellular dermal matrix is less donor site morbidity and a shorter operative time (9,10). Complications associated with these methods include edema, hematoma, delayed wound healing, necrosis, infection (most commonly with Staphylococcus aureus or Escherichia coli), and erectile discomfort (9). Fat embolism has been described when doing high volume fat injections and a fatal fat embolism in setting of concomitant penile trauma/lengthening shaft procedure has been documented (37). For any fat transfer technique, hypertrophy, deformation of the penis as well as atrophy, scarring and contraction of fat graft is a concern that can lead to more surgical intervention (Figure 4) (9,39).

Figure 4.

Asymmetric fat hypertrophy and atrophy following fat injection to the penis.

Complications of dermal matrix and fat transfer can be managed similarly. For simple edema occurring between 3–5 days, compressive dressings have been described, however, local debridement is usually required for non-viable tissue and/or cosmetically unappealing regions (9). With subsequent skin and soft tissue loss, authors have described reconstruction of scrotal and penoscrotal defects with bilateral vascularized scrotal pedicle flaps based on the anterior/posterior scrotal artery which can be extended to the penile shaft (9,35). For more distal skin coverage in a large phallus or dorsal coverage, partial penile reconstruction/phalloplasty following fat augmentation and full thickness dorsal penile skin necrosis has been reported (38). Spyriounis et al. describe an anterolateral thigh perforator flap based off of the lateral femoral circumflex artery and require tunneling under the rectus femoris muscle of the quadriceps (38).

Soft silicone subcutaneous penile implant—Penuma (Himplant)

The Penuma implant is the first medical grade silicone device approved by the FDA for the cosmetic correction of soft tissue penile deformities, and it was FDA-cleared for penile girth enhancement (13,14). The Penuma subcutaneous implant is placed via a lateral scrotal or infrapubic approach just along the penile shaft between Bucks and Dartos fascia. It is held in place by non-dissolvable sutures distally and proximally. The proximal end of the implant sits just inferior to the pubic bone above the root of the penis and suspensory ligament. There are two retrospective case-series study examining complications and a published case by our group (11,14,40). In the original study conducted by Elist, involving 400 men, complications beyond penile pain and postoperative swelling were observed. These complications included seroma (4.8%), scar formation (4.5%), and infection (3.3%) (14). In a retrospective series of 49 men with an average follow up time of 6 months, there was 1 case of infection, 2 cases of erosion, and 4 cases of persistent flaring of the Penuma. Persistent flaring is when the distal end of the device does not follow the natural tapered edge of the penile shaft and “flares out” laterally; this can lead to erosion (Figure 5) and patient/partner dissatisfaction (11). Of the cases of flaring described in the aforementioned study, 3 (75%) required revision surgery, all with a good cosmetic outcome (11). Uncertainty continues to exist regarding patient satisfaction, as non-standardized/validated surveys have been employed. Furthermore, Wilson et al. retrospectively contacted and surveyed 234 patients between 6–17 months postoperatively (13).

Figure 5.

Lateral and superior view of Penuma lateral flaring, impending erosion and inflammation following solid silicone subcutaneous implant. (A) Lateral flaring impending erosion. (B) Top-down view of the same lateral flaring.

They had a response rate of just 100 of 234 (42.7%). Of these respondents, just 57% reported “high–very high” satisfaction with their implant, and 10% had implant removed (13).

A search of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database reveals 59 formal reports involving the Penuma implant (41). No fatalities have been reported, however 40 cases ranging from “pain/inflammation/infection” to “disfigurement” have been reported in the past year alone (40,41). A single center reviewed their own series of treating subcutaneous silicone implant complications between 2012–2022 and identified 13 patients who had at least one complication with mean follow up of 21.6 months Distal lateral protrusion of the implant at the coronal margin leading to patient and partner discomfort occurred in 8/13 (62%) patients. They also reported explants for skin erosion, infection, decreased sensation, ventral curvature and penile shortening. Unfortunately, 9 (69%) patients developed disabling dorsal curvature, 8 (62%) had penile shortening, 3 (23%) had postoperative infections, 2 had de novo sensation changes, 2 (15%) had erectile dysfunction and 1 (8%) had right lateral curvature. Six of 9 patients with disabling curvature underwent scar excision for surgical treatment of capsular contraction and all improved and were able to have functional erections (40). Furthermore, our group has described a case of an infected Penuma implant with gross purulence that was managed by device removal through the infrapubic approach (to best access distal tacking sutures), washout, and closure with extensive postoperative penile rehabilitation. We did not replace the device due to gross purulence and no salvage literature exists to date (39). Given the aesthetic nature of this procedure, it should be considered experimental by default, held to the highest possible safety standards, and further prospective studies are encouraged.

Strengths and limitations

Strengths of our review include highlighting the newest techniques in a rather controversial field. We are limited by retrospective, biased data when it comes to safety and reproducibility of techniques. Furthermore, specifically the urologic literature remains limited in experience with management of injectable and implantable penile enhancement procedures. The basis for management of these complications therefore relies on sound surgical principles, an understanding of how the procedures are performed, penile anatomy and pathophysiology of wound healing. Other specialties such as dermatology and plastics surgery have more experience with aesthetic procedures and approaches to some complications may be analogous.

Conclusions

In conclusion, this review has described the management of complications arising from various penile enhancement procedures, including injectable and surgically implantable methods. In the discussion of injectable penile enhancement complications, the review covered a range of filler materials, including HA, PMMA, PLA, and silicone, as well as the concerning trend of “self-injection” of foreign materials by desperate individuals. Furthermore, the review explored surgically implantable penile enhancement complications, including the use of dermal matrices, fat transfer, and the soft silicone subcutaneous implant (Penuma). Complications associated with these procedures were outlined, and case studies were referenced to provide a practical perspective on managing these challenges. Of the options, low volume HA via standardized protocol (Ex. Urofill^®) and hands-on training may be the safest modality for appropriately counseled and selected patients.

In summary, this review contributes valuable insights into the field of penile enhancement procedures and their associated complications. It underscores the importance of evidence-based practices, patient education, and skilled management in ensuring positive outcomes and patient safety as well as managing negative outcomes in this evolving and complex area of urology. As more data become available and procedures continue to evolve, the knowledge presented in this review will serve as a valuable resource for urologists and healthcare providers facing the management of penile enhancement complications in their practice. Finally, the procedures are not covered by insurance and offered by practitioners as aesthetic procedures receiving cash pay only, thus complications are very important to minimize. As more safety data becomes available, urologists may in the future consider offering penile enhancement procedures to their patients.

Supplementary

The article’s supplementary files as

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All clinical procedures described in this study were performed in accordance with the ethical standards of the institutional and/or national research committee(s) and with the Declaration of Helsinki and its subsequent amendments. Written informed consent was obtained from the patients for the publication of this article and accompanying images.