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Subcutaneous Penile Implants

By: Laurence A. Levine, MD, Rush University Medical Center, Chicago, Illinois UroPartners, LLC, Chicago, Illinois | Posted on: 09 Mar 2023

Figure 1. Lateral scrotal incision for implantation of Penuma shown prior to closure.
Figure 2. Penis everted through lateral scrotal incision with dissection exposing subcoronal sulcus.
Figure 3. Penuma device sutured to subcoronal sulcus with 2-0 Ethibond.
Figure 4. Example of pre- and postoperative result.

As many people reading this article are urologists, it is likely that you have been asked by your male patients, “Hey Doc, is there anything new to make my penis bigger?”

As a male sexual medicine specialist, this happens to me every week. Historically, my response was that there was nothing reliable available and that most of the reported options such as injections of fat, polymethyl methacrylate, hyaluronic acid, or fat grafts were compromised by reabsorption or significant complications.

Even if there are viable treatment options to enhance penile size, one persistent question remains among urologists: Is it not odd that men want a bigger penis? There are certainly many published papers examining this question.1-4 In fact, one study reported that up to 91% of men who believed their penis to be smaller than average desired a bigger penis.5 There is no doubt that most men if given the opportunity to magically have a bigger penis would gladly accept it, but what about the men who actually pursue this treatment? They have often been given the diagnosis of body dysmorphic disorder or, more specifically, penile dysmorphic disorder. Although there are men who are seriously obsessed with the appearance of their penis, that has not been my typical experience since I began offering Penuma implantation in early 2019. In fact, a recently published article showed that only 5.5% of 1,641 men surveyed had a severely low genital self-image, with 11.3% considering undergoing cosmetic genital surgery.3 Mondaini et al in their evaluation of men pursuing penile size augmentation found that 85% had a normal size penis.6 This suggests that these men simply want to be bigger as they feel this will enhance their self-esteem and sexual relationships.

Currently, the Penuma device is available as a surgically implanted soft silicone insert, which first came on the market well over a decade ago, and as of May 2022, it is the only Food and Drug Administration–cleared device to provide cosmetic enhancement of the penis. It is designed to enhance flaccid and erect penile girth as well as flaccid penile length. It is NOT designed or marketed to enhance erect length.

It appears that the ideal candidates for this procedure are circumcised men with normal erectile function who may also have a retractile penis, insecurity or embarrassment about penis size, mild penile curvature or shaft indentation, or a normal penile length with decreased girth.7 All men interested in Penuma surgery undergo an initial intake questionnaire and telephone screening to rule out those who are clearly not good candidates including those who expect increased erect length, have unrealistic expectations, are active smokers, have uncontrolled diabetes, have moderate to severe curvature caused by Peyronie’s disease, or have undergone any prior enhancement procedure such as subcutaneous injections or grafting. These men then fill out a series of validated questionnaires primarily focused on body dysmorphic disorder as well as a SHIM (Sexual Health Inventory for Men) survey to confirm satisfactory erectile function. If there are any questions about a man’s psychological candidacy for this cosmetic surgery of the penis, they are referred to a licensed sex therapist before seeing one of the surgeons in the Penuma Network.

To date approximately 5,000 Penuma devices have been implanted, the majority in Beverly Hills by Dr James Elist, who developed the device and has been offering this procedure since 2004. Dr Elist, has now trained 9 Penuma surgeons who are performing this surgery in the U.S.

As surgeons, we know any procedure has possible risks, and this is especially important when performing elective cosmetic surgery. Possible risks discussed with the patient include infection and erosion which would necessitate removal of the device. Other less severe complications include seroma formation, which is also encountered following other subcutaneous implants such as in the face, gluteal area, calf, and breast. Device dislodgment/displacement and visible distal flaring of the implanted device have become uncommon since enhancements have been made in the implantation technique. The Penuma Surgeons Network is quite interactive, and as a result of sharing personal modifications in technique, much progress has been made to improve cosmetic outcomes as well as reduce infection and erosion rates. For instance, a lateral scrotal incision has supplanted the original infrapubic incision and is now the preferred approach which has reduced seroma rates but also provides a more cosmetic concealed scar (Figures 1-4). The implantation technique is nicely described in the recently published article by Siegal et al.7 Cautery is not used when developing the plane between Dartos and Buck fascia, which likely has reduced seroma and erosion rates as well, and a variety of medications are given perioperatively and during irrigation of the field which has also reduced seroma, infection, and erosion. Infection and erosion have historically been reported at a combined 2%-4% rate requiring device removal, which is clearly devastating. To address this, a post-Penuma removal protocol was developed which can help return the penis to its pre-insertion state more efficiently.8

Part of the goal of the Penuma Scientific Advisory Board was to develop a registry of men undergoing this surgery so we could report on their outcomes. One difficulty with this is that because there are only a few implanters nationwide, postoperative assessment is often compromised as these men are frequently lost to follow-up. The manufacturer, International Medical Devices (Beverly Hills, California) is sponsoring the development of a more robust registry which should include outcomes from all Penuma surgeons.

In the meantime, the available published data indicate that men can expect to see an increase in postoperative flaccid length and girth of 52% and 40%, respectively, as found in the recently published, 49-patient study by Siegal et al.7 This study compared nicely to the 2018, 400-patient report by Elist et al, where flaccid length and girth increased 24% and 57%, respectively.9 In our Chicago experience, we developed a nonvalidated, Penuma-specific, postoperative satisfaction survey used in 40 men who were at least 6 months out from their surgery to allow for implant-related changes, including feel and sensation, to stabilize. We found that 55% were dissatisfied with their sexual relationship prior to surgery compared to 18% after the implant. Importantly, 68% endorsed being dissatisfied or very dissatisfied with the appearance of their penis prior to surgery, compared to 82% who reported being satisfied or very satisfied with the appearance of their penis after surgery.10

In conclusion, it appears that many men simply want a bigger penis and are willing to pay out of pocket for a variety of procedures to obtain that goal. Historically, injecting fillers and grafting procedures have been complicated with reabsorption and occasionally serious adverse results. The Penuma device is now being offered by well-trained urologists to men who are thoroughly evaluated to make sure they are appropriate candidates and counseled about the potential risks of the procedure, which like penile protheses for erectile dysfunction can still result in serious complications over 50 years since penile implants were first introduced. Relatively speaking, Penuma is early in its journey, and with further attention to surgical technique, device enhancements, as well as appropriate patient selection, we will see in upcoming reports evidence that men who want a bigger penis can realize this with the Penuma device. Currently, the Penuma device appears to provide a durable, natural-appearing penis with enhanced girth and flaccid length. It does not interfere with normal penile function including erection, sensation, orgasm, ejaculation, and urination. Most importantly, in the limited presented and published reports, there is evidence of high patient satisfaction.

  1. Gaither TW, Allen IE, Osterberg EC, et al. Characterization of genital dissatisfaction in a national sample of U.S. men. Arch Sex Behav. 2017;46(7):2123-2130.
  2. Veale D, Miles S, Read J, et al. Phenomenology of men with body dysmorphic disorder concerning penis size compared to men anxious about their penis size and to men without concerns: a cohort study. Body Image. 2015;13:53-61.
  3. Hustad IB, Malmqvist K, Ivanova E, Rück C, Enander J. Does size matter? Genital self-image, genital size, pornography use and openness toward cosmetic genital surgery in 3503 Swedish men and women. J Sex Med. 2022;19(9):1378-1386.
  4. Lever J, Frederick D, Peplau L. Does size matter? Men’s and women’s views on penis size across the lifespan. Psychol Men Masc. 2006;7(3):129-143.
  5. Sharp G, Oates J. Sociocultural influences on men’s penis size perceptions and decisions to undergo penile augmentation: a qualitative study. Aesthet Surg J. 2019;39(11):1253-1259.
  6. Mondaini N, Ponchietti R, Gontero P, et al. Penile length is normal in most men seeking penile lengthening procedures. Int J Impot Res. 2002;14(4):283-286.
  7. Siegal AR, Zisman A, Sljivich M, Razdan S, Valenzuela RJ. Outcomes of a single center’s initial experience with the Penuma® penile implant. Urology. 2023;171:236-243.
  8. Wilson SK, Picazo AL. Update on the Penuma an FDA-cleared penile implant for aesthetic enhancement of the flaccid penis. Int J Impot Res. 2022;34(4):369-374.
  9. Elist JJ, Valenzuela R, Hillelsohn J, Feng T, Hosseini A. A single-surgeon retrospective and preliminary evaluation of the safety and effectiveness of the Penuma silicone sleeve implant for elective cosmetic correction of the flaccid penis. J Sex Med. 2018;15(9):1216-1223.
  10. Salkowski M, Alter K, Levine LA. Outcomes and satisfaction after penile silicone implant surgery. J Urol. 2022;207(Suppl 5):e907.