The prevalence of congenital and acquired penile curvature among men has been reported to be as high as 1% - 10% [1] [2] and 0.4% - 9% [3] -[9] , respectively. Congenital penile curvature is due to an asymmetry of corpora cavernosal length [10] , whereas acquired penile curvature results from Peyronie’s disease, iatrogenic manipulation, or trauma [11] [12] . Regardless of the nature of deformity, most affected men suffer from physical complaints including a negative impact on penile aesthetics and length, pain during erection, and sexual intercourse that is difficult or sometimes impossible [10] [13] , as well as psychological distress, depression, and anxiety [14] [15] .

Non-surgical treatment options such as oral, locally applied, or injectable medication are used for the early stages of Peyronie’s disease with moderate success [16] -[19] . Advanced Peyronie’s disease and other forms of congenital and acquired penile curvature warrant surgical repair, usually with satisfactory results, to resolve the curvature [20] [21] .

At the present time, two types of procedures are used for surgical treatment of penile curvature: penile- shortening procedures (Nesbit and plication) and penile-lengthening procedures (tunical lengthening and grafting) [22] . Surgical procedures yield satisfactory correction of curvature, but are usually associated with penile shortening and palpable suture material and nodules (i.e. “dog ears”) under the skin, resulting in patient dissatisfaction [10] [23] -[27] .

We present a novel approach using a patented and U.S. Food and Drug Administration 510 (k) cleared subcutaneous soft silicone implant for surgical treatment of penile soft tissue deformities with curvature, with prevention of surgery-associated penile shortening and subcutaneous “bumps”, and with additional gains in overall penile length and girth.

All three patients recovered very well from surgery, with no complications or lower urinary tract symptoms (Table 2). All patients reported in Table 2 were followed for 2 - 12 months (mean: 6.7 ± 3.6 months). All three patients expressed objective and subjective satisfaction regarding the corrective results of the surgery (Table 3).

Penile length and girth measurements during follow-up showed a mean increase in length of 4.3 cm (±1.4 cm)

0 = absolutely dissatisfied; 1 = dissatisfied; 2 = somewhat satisfied; 3 = satisfied; 4 = very satisfied; 5 = absolutely satisfied.

SSSI = subcutaneous soft silicone implant.

0 = absolutely dissatisfied; 1 = dissatisfied; 2 = somewhat satisfied; 3 = satisfied; 4 = very satisfied; 5 = absolutely satisfied; N/A = currently not sexually active.

and a mean increase in girth of 3.0 cm (±1.0 cm).

Satisfaction questionnaires were obtained from all patients following insertion of the subcutaneous soft silicone implant (Table 3) and consisted of the following questions:

1. How satisfied are you with your post-surgery penile aesthetics?

2. How much do your post-surgery penile aesthetics affect your self-esteem?

3. How much do your post-surgery penile aesthetics affect your sexual relationships?

4. How much does your post-surgery result affect intercourse?

Patients rated their satisfaction on a scale from 0 to 5, with 0 being absolutely dissatisfied and 5 being absolutely satisfied.

The immediate post-surgical results for patient 1 are shown in Figure 2(d). His current measurements after a follow-up period of 2 months are 16 cm in flaccid penile length and 14 cm in penile girth. During follow-up, patient 1 indicated not being currently sexually active, as per our advice, to allow for full recovery. The results for patient 2 are shown in Figure 2(e). His current measurements after a follow-up period of 6 months are 12.5 cm and 14.0 cm in flaccid penile length and girth, respectively. The results for patient 3 are shown in Figure 2(f). His current measurements after a follow-up period of 12 months are 16 cm in flaccid penile length and 15.5 cm in flaccid penile girth.

Corrective surgery often remains the last solution for advanced congenital and acquired penile curvature that negatively affects the patient physically, sexually, and psychologically [10] [13] -[15] [20] [21] . Surgical procedures, although very effective, are usually associated with patient dissatisfaction because of post-procedure penile shortening and palpable suture material and nodules (i.e. “dog ears”) under the skin [10] [23] -[27] . The insertion of the subcutaneous soft silicone implant in addition to removal of corporeal fibrotic tissue is an effective treatment option for penile curvature. More advanced cases of Peyronie’s disease may also benefit from our presented technique when combined with other traditional methods for prevention of penile shortening and the aforementioned subcutaneous nodularity. Furthermore, the presented technique can be especially beneficial for patients suffering from penile curvature and penile dysmorphic or small penis syndrome by providing them with correction of penile deviation, elimination of surgery-associated subcutaneous “bumps” resulting from the technique and suture material used, and the benefit of additional penile length and girth. Advanced Peyronie’s disease with the need for penile prosthesis insertion is another indication for the use of the subcutaneous soft silicone implant, preventing surgery-associated penile shortening and narrowing [28] . Insertion of the subcutaneous soft silicone implant can be performed at any time when a patient presents with complaints of penile curvature. It is recommended that the insertion be performed simultaneously with fibrotic tissue removal or any of the traditional techniques to guarantee full healing and to prevent fibrosis after the initial surgery.

As with any smooth-surface implant, the subcutaneous soft silicone implant may be prone to bacterial biofilm infection. Consequently, the prevention of intraoperative entry of bacteria into the pocket of the implant and rigorous irrigation with minocycline and rifampicin, and keeping both around the implant during surgery and

post-procedure follow-up, is advised to reduce risk. We recommend a minimum of 8 weeks for full recovery before reengaging in any kind of sexual activity.

The insertion of the subcutaneous soft silicone implant in addition to corporeal fibrotic tissue removal in patients with congenital or acquired penile curvature is an effective option that provides the patient with aesthetic improvements by correcting penile deviation, preventing post-surgical subcutaneous nodule formation that results from the technique and suture material used, and adding penile length and girth. Further prospective studies are required to validate our initial experience.