Clinical UM Guideline

This document addresses the criteria for implantation of a penile prosthesis, which is an established technique for treating erectile dysfunction (ED).

Note: This document does not address gender affirming surgery or procedures. Criteria for gender affirming surgery or procedures are found in applicable guidelines used by the plan.

Note: For a high-level overview of this document, please see “Summary for Members and Families” below. 

This document describes clinical studies and expert recommendations, and explains whether a penile prosthesis is clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

A penile prosthesis is a medical device placed inside the penis to help individuals with erectile dysfunction (ED) get an erection firm enough for sex. ED means an individual cannot get or keep an erection that is firm enough for sexual activity. This device is usually considered after other treatments, such as pills, injections, or vacuum devices, have not worked or cannot be used. There are two main types. Semi-rigid rods keep the penis firm all the time. Inflatable devices use fluid-filled cylinders and a small pump placed in the scrotum to create an erection when desired. While many individuals report satisfaction after surgery, there are risks, including infection, pain, device problems, or the need for more surgery.

What the Studies Show

Penile prostheses have mostly been studied in case series, which are reports that follow groups of individuals who received the device but do not compare them to a group who have not. Many report being satisfied after surgery. In several studies, about 80 percent to 90 percent of people studied said they were satisfied or very satisfied. Some partners also reported satisfaction. Mechanical failure can occur over time. In one long-term study, about 11 percent of devices had mechanical failure. Infection rates ranged from about 1 percent with antibiotic-coated devices to higher rates in some reports. Infections sometimes required removal of the device.

Complications include infection, pain, wound problems, device erosion, or movement of the implant. Some need revision or replacement surgery. In one long-term study, about 30 percent of implants had a complication, and about 20 percent needed another surgery. Diabetes, obesity, suppressed immune systems, and certain other health problems may increase the risk of infection. Some studies were small or retrospective, meaning they looked back at past records. Because of this, better studies are needed to know how well penile prostheses compare with other treatments over time.

When is Penile Prosthesis Implantation Clinically Appropriate?

Penile prosthesis implantation may be appropriate in these situations:

• The person has had erectile dysfunction for more than 6 months; and
• They have tried less invasive treatments without success, or cannot use them because of medical reasons. These treatments include oral medicines such as sildenafil (Viagra) or tadalafil (Cialis), intracavernosal injections, or a vacuum constriction device.

Replacement of a penile prosthesis may be appropriate when:

• The person is likely to continue to benefit from the device; and
• The device has mechanical failure, or there is a medical reason that it must be removed.

Guidelines from groups such as the American Urological Association (AUA) and the European Urological Association (EAU) state that individuals should be told about the benefits and risks before surgery. Surgery should not be done if a person has a body-wide infection, skin infection near the area, or a urinary tract infection.

When is this not Clinically Appropriate?

Penile prosthesis implantation is not clinically appropriate when the conditions listed above are not met. In these cases, other treatments may be safer and effective. Surgery carries risks such as infection, device failure, and the need for repeat surgery. Choosing surgery without first trying appropriate less invasive treatments may expose a person to harm without clear added benefit. Penile prosthesis implantation is not clinically appropriate in scenarios other than those listed above.

(Return to Description)

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met.

Summary

Erectile dysfunction (ED), defined by the American Urological Association (AUA) as the consistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance, is strongly associated with cardiovascular risk factors such as diabetes, hypertension, dyslipidemia, obesity, and smoking, as well as conditions including heart failure, pelvic surgery, radiation, and neurologic injury. First-line treatment typically involves oral phosphodiesterase-5 (PDE5) inhibitors, with testosterone therapy added when indicated; vacuum devices and other noninvasive options are recommended before considering penile prosthesis implantation. Penile implants, either semi-rigid (Class II) or inflatable (Class III), are appropriate for men with medically refractory ED or those seeking a permanent solution, provided they are carefully selected, counseled on risks and expectations, and free of active infection. Clinical guidelines from the AUA and European Association of Urology (EAU) support prosthesis implantation when other treatments fail, emphasizing informed consent and optimization of comorbidities, particularly diabetes. Evidence from largely observational studies and registries suggests high satisfaction rates (generally 80-90%), durable mechanical performance, and acceptable complication rates, though risks include infection, mechanical failure, and need for revision surgery, with higher complication rates in high-risk populations such as men with uncontrolled diabetes, immunosuppression, or spinal cord injury.

Discussion

Recommendations

The AUA’s 2018 erectile dysfunction (ED) guideline defines ED as “…the consistent or recurrent inability to attain and/or maintain penile erection sufficient for sexual satisfaction, including satisfactory sexual performance.”

According to the AUA guideline, independent risk factors for ED are similar to those for cardiovascular disease. These include, among others, smoking, diabetes mellitus, hypertension, dyslipidemia and obesity. Between 20% and 85% of men with diabetes, and approximately 35% of men with dyslipidemia, experience ED (AUA, 2018). Moreover, approximately 75% of men with heart failure experience ED, and causes of ED in men with heart failure include arterial insufficiency, endothelial dysfunction, reduced cardiac capacity and side effects of medication for cardiovascular disease (Rastogi, 2005). In addition, surgery (especially radical prostate and bladder surgery for cancer) and radiotherapy can injure nerves and arteries near the penis, causing ED (Chung, 2014). Injury to the penis, spinal cord, prostate, bladder, and pelvis can lead to ED by harming nerves, smooth muscles, arteries, and fibrous tissues of the corpora cavernosa.

Penile prosthesis implantation is a treatment option for men with ED who have failed less invasive treatments. For those without other comorbidities, oral PDE5 inhibitors such as sildenafil and tadalafil are usually first-line therapies, unless contraindicated. Recent meta-analyses have found that all available oral PDE5 inhibitors are effective, compared with placebo, with similar efficacy of the various PDE5 inhibitors (Allen, 2019). For men with testosterone deficiency, PDE5 inhibitors can be supplemented with testosterone therapy (AUA, 2018). If oral medications are not sufficient, a vacuum device, which is a noninvasive modality, is often recommended before a penile prosthesis. Underlying causes for erectile dysfunction are important to identify and address, if possible, with appropriate interventions.

The U.S. Food and Drug Administration (FDA) considers the rigid penile implant as a Class II device. The semi-rigid rods are implanted into the corpora cavernosa of the penis to provide rigidity. Inflatable penile implants are considered Class III devices by the FDA. Inflatable cylinders are implanted in the penis and are connected to a reservoir filled with fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. Penile rigidity is achieved when the cylinders are filled with fluid.

In 2018, the AUA published an updated guideline on ED. Recommendations in this guideline that are specific to penile prosthesis implantation are as follows:

Men with ED should be informed regarding the treatment option of penile prosthesis implantation, including discussion of benefits and risks/burdens. (Strong Recommendation; Evidence Level: Grade C)

Men with ED who have decided on penile implantation surgery should be counseled regarding post-operative expectations. (Clinical Principle)

Penile prosthetic surgery should not be performed in the presence of systemic, cutaneous, or urinary tract infection. (Clinical Principle)

The guideline stated, “the potential risks and burdens of prosthesis surgery include the risks inherent in the surgical procedure, possible changes in the appearance of the penis, and the potential for device malfunction or failure”.

In 2022, an international group of key opinion leaders and prosthetic surgeons published a consensus statement on penile prosthesis (Chung, 2022). The group did not represent a recognized specialty society. The statement included the following recommendations regarding criteria for penile implantation surgery:

Clinical assessment and patient selection

• Penile prosthesis implantation is considered an appropriate treatment option for a man who is not achieving a satisfactory erection and wishes for a permanent solution for erectile dysfunction (Grade C).
• Proper patient selection, counselling and informed consent are essential, coupled with optimization of existing medical conditions especially diabetes (Grade B).
• Adequate prophylactic measures should be taken to minimize prosthetic infection and bleeding or thromboembolic risk to ensure good clinical outcomes (Grade B).

The document states:

Known patient factors that increase the risk of prosthetic complications and lower satisfaction rates are those with diabetes mellitus, the presence of pathological nasal and skin flora (for example, Staphylococcus spp.), long-term steroid use, poor personal hygiene, suboptimal antimicrobial practice, poor cardiovascular status, history of radiation therapy, spinal cord injury, urinary catheterization, immunosuppression and concurrent genitalia reconstructive surgery. Optimization of these risk factors and adequate patient counselling are essential before surgery…

Strong evidence suggests that high-risk patient populations, such as men with uncontrolled diabetes mellitus, corporal fibrosis (for example, PD or priapism) and those who are undergoing salvage penile implants are at a greater risk of prosthetic complications, especially device infection and erosion.

Additionally, Chung (2026) published Management of Peyronie's disease: recommendations from the Fifth International Consultation on Sexual Medicine, which provided the following recommendation:

26) Penile prosthesis implantation should be considered in patients with medically refractory ED with associated penile deformity or at high risk of developing postoperative ED. (Strong Recommendation and Good Quality of Evidence

In 2025 the EAU published updated guidelines on male sexual and reproductive health. In that document they offered the following recommendation: 

Implant a penile prosthesis if other treatments fail or depending upon patient preference. Patients should be fully informed of the benefits and harms associated with the procedure. Strong Recommendation.

Clinical Evidence

Penile prostheses have primarily been evaluated in uncontrolled case series. For example, Zermann and colleagues (2006) studied penile implant efficacy in 245 neurologically impaired men. Men were categorized into 3 groups based on the indication for penile prosthetic surgery. Group 1 consisted of 134 participants with urinary management only, Group 2 had 60 participants with erectile dysfunction only, and Group 3 had 51 participants with urinary management and erectile dysfunction. At a mean follow-up of 7.2 years (maximum 17 years), 195 participants were reevaluated in the clinic. Outcomes showed that in 122 participants (90.3%) urinary management problems were resolved, and erectile dysfunction treatment was successful in 76 participants (82.6%). A total of 43 revisions were performed for complications (e.g., infections and device perforation).

Sevinc and colleagues (2017) evaluated outcomes after penile prosthesis implantation in 181 men with ED of different etiologies. Primary causes of ED were diabetes in 81 men (44.7%), vascular disease in 45 men (25.4%), radical pelvic surgery in 29 men (16%) and a variety of other reasons in the remaining 25 men (13.8%). The most common post-operative complications were superficial wound infection (n=17, 9.4%), dehiscence of the glans penis (n=10, 5.5%), which resolved after 1 month, and pain during intercourse (n=10, 5.5%), which resolved within a few months. The mean time to first intercourse was 54 days (range: 9 to 150 days). Individuals were followed for at least 12 months. At follow-up, 104 individuals (57.5%) reported being very satisfied with the penile prosthesis, 48 (26.5%) were satisfied and 21 (11.6%) were not satisfied. A total of 21 prostheses (11.6%) were removed because of complications or patient dissatisfaction.

Khera and colleagues (2018) reported data from an industry-sponsored registry of individuals who were implanted with American Medical Systems (AMS) penile implants. A total of 1180 individuals with ED were included in the registry. Of these, 250 individuals (21.2%) had Peyronie disease (PD). At 1- and 2-year follow-ups, 88.6% and 88.5%, respectively, of individuals with PD stated that they were either satisfied or very satisfied with treatment. The rate of self-reported depression in individuals with PD decreased from 19.3% at baseline to 10.5% at the 1-year follow-up (p=0.02).

Topuz (2021) reported on 128 individuals who underwent penile prosthesis implantation due to ED. Median follow-up was 16 years (range, 2 to 25 years). Complications were experienced by 42 (30%) of individuals. Thirteen (9%) individuals had a prosthesis infection; most of these (n=8) occurred in the first 3 months after implantation. Other complications included pain, wound infection and dysuria. A total of 27 (19.7%) individuals underwent salvage or revision surgery.

In terms of complication rates, Minervini and colleagues (2006) studied 447 men who had 504 penile prosthetics implanted and found that infection was the most frequent complication. Other complications were implant migration and tissue erosion. In a review by Phe (2012), the rate of infection decreased to 1% with the utilization of antibiotic impregnated implants. In a report on 98 men in a national database who had penile prosthesis implantation between 2005 and 2013 (Palma-Zamora, 2017), the overall 30-day complication rate was 11% (n=11). The complications included surgical site infection (n=6), transfusion (n=3), urinary tract infection (n=1) and sepsis/shock (n=1).

Another study that focused on complication rates was published by Moncada (2025). The authors reported long-term follow-up in 426 adult men with drug-refractory ED who had inflatable penile prostheses. Overall, mechanical failure occurred in implants in 47 men (11%). The mechanical failure-free survival rates of the implants were 94.7% at 5 years, 87.3% at 10 years, and 72.9% at 15 years. A total of 17 (4%) individuals experienced infection of the prosthesis, leading to device removal.

Carvajal and colleagues (2020) published a systematic review of studies on factors associated with infection in individuals with penile prostheses. They included 40 studies with a total of 175,592 individuals. Fifteen studies focused on diabetes mellitus which was found in pooled analyses to be significantly associated with risk of infection (odds ratio [OR], 2.48; 95% confidence interval [CI], 1.38 to 4.47). Other factors significantly increasing risk of infection in individuals with penile prostheses were immunosuppression (3 studies, OR, 20.99; 95% CI, 0.71 to 622.34) and obesity (2 studies, OR, 18.24; 95% CI, 1.43 to 231.98). However, other than in the analysis on diabetes mellitus, numbers of studies and total sample sizes were small and thus estimates of increased risk were imprecise as indicated by wide confidence intervals. 

A 2020 systematic review by Dick and colleagues identified 14 studies reporting on outcomes after penile prosthesis implantation in individuals with solid organ transplant. Most of the studies were case reports or case series but there were also 2 retrospective cohort studies. Overall, the studies included 143 individuals with solid organ transplant and 191 controls without solid organ transplant, all of whom received penile prostheses. In a pooled analysis, the authors did not find a significant difference in the prosthetic infection rate among individuals with solid organ transplant (2.1%) and controls (3.7%), p=0.53. They also did not find a statistically significant difference in the rate of non-infective complications in individuals with solid organ transplant (9.8%) versus controls (4.7%), p=0.08. A limitation of the literature on this topic is that most studies were small and uncontrolled, and all were retrospective.

A systematic review of studies on penile prosthesis implantation in individuals with spinal cord injuries was published by Pang and colleagues in 2022. The authors identified 11 studies of adult men at least 18 years old with a diagnosis of ED secondary to spinal cord injury and who underwent penile prosthesis implantation. All of the studies were retrospective observational studies. The studies included a total of 1514 individuals, 475 931%) of which had spinal cord injuries. In individual studies, the complication rate was 4.2% to 61.1% in the spinal cord injury population. The explantation rate was 2.1% to 16.7%, and the revision/reimplant rate was 2.7% to 44.4%. Nine of the studies evaluated function after penile prosthesis implantation, but none used a validated questionnaire to assess the functional outcomes. The proportion of individuals who reported satisfaction with the penile implant used for sexual intercourse ranged from 79.2 to 92.9% and satisfactory sexual intercourse was reported in 35 to 86.1% of men. The authors did not pool study outcomes.

In 2015, Lleda-Garcia and colleagues published findings of a survey of 149 individuals who had received first (n=110) or replacement (n=39) inflatable penile prostheses at a single center. The most common reason for replacement of a device (n=30) was mechanical failure, followed by infection in 4 individuals, extrusion in 3 individuals and device intolerance in 2 individuals. The rates of satisfactory sexual intercourse after implantation were similar in individuals who had received first implants (79%) or replacement implants (80%). Satisfactory sexual intercourse was also reported by 74.1% of sexual partners after first implantation and 80% after replacement implantation.

Peer Reviewed Publications:

1. Allen MS, Walter EE. Erectile Dysfunction: an umbrella review of meta-analyses of risk-factors, treatment, and prevalence outcomes. J Sex Med. 2019; 16(4):531-541.
2. Carson CC, Mulcahy JJ, Harsch MR. Long-term infection outcomes after original antibiotic impregnated inflatable penile prosthesis implants: up to 7.7 years of followup. J Urol. 2011; 185(2):614-618.
3. Carvajal A, Benavides J, García-Perdomo HA, et al. Risk factors associated with penile prosthesis infection: systematic review and meta-analysis. Int J Impot Res. 2020; 32(6):587-597.
4. Chung E, Gilliman M. Prostate cancer survivorship: a review of erectile dysfunction and penile rehabilitation after prostate cancer therapy. Med J Aust. 2014; 200(10):582-585.
5. Dick B, Greenberg JW, Polchert M, et al. A systematic review of penile prosthesis surgery in organ transplant recipients. Sex Med Rev. 2021; 9(4):636-640.
6. Hellstrom WJ, Montague DK, Moncada I, et al. Implants, mechanical devices and vascular surgery for erectile dysfunction. J Sex Med. 2010; 7(1 Pt 2):501-523.
7. Henry GD, Wilson SK. Updates in inflatable penile prostheses. Urol Clin North Am. 2007; 34(4):535-547.
8. Khera M, Bella A, Karpman E, et al. Penile prosthesis implantation in patients with Peyronie's disease: results of the PROPPER study demonstrates a decrease in patient-reported depression. J Sex Med. 2018; 15(5):786-788.
9. Lee DJ, Najari BB, Davison WL, et al. Trends in the utilization of penile prostheses in the treatment of erectile dysfunction in the United States. J Sex Med. 2015; 12(7):1638-1645.
10. Lledó-García E, Jara-Rascón J, Moncada Iribarren I, et al. Penile prosthesis first and replacement surgeries: analysis of patient and partner satisfaction. J Sex Med. 2015; 12(7):1646-1653.
11. Minervini A, Ralph DJ, Pryor JP. Outcome of penile prosthesis implantation for treating erectile dysfunction: experience with 504 procedures. BJU Int. 2006; 97(1):129-133.
12. Moncada I, Krishnappa P, Martinez-Salamanca JI, et al. Excellent long-term device survival of inflatable penile prosthesis over 27 years. Asian J Androl. 2025; 28(1):38-42.
13. Mulcahy JJ, Austoni E, Barada JH, et al. The penile implant for erectile dysfunction. J Sex Med. 2004; 1(1): 98-109.
14. Ong WL, Hindson BR, Beaufort C, et al. Long-term erectile function following permanent seed brachytherapy treatment for localized prostate cancer. Radiother Oncol. 2014; 112(1):72-76.
15. Palma-Zamora I, Sood A, Dabaja AA. 30-day adverse event rates following penile prosthesis surgery: an American College of Surgeons National Surgical Quality Improvement Program-based evaluation. Trans Androl Urol. 2017; 6: S767-S773.
16. Pang KH, Muneer A, Alnajjar HM. A systematic review of penile prosthesis insertion in patients with spinal cord injury. Sex Med Rev. 2022;10(3):468-477.
17. Phé V, Rouprêt M. Erectile dysfunction and diabetes: a review of the current evidence-based medicine and a synthesis of the main available therapies. Diabetes Metab. 2012; 38(1):1-13.
18. Rastogi S, Rodriguez JJ, Kapur V, et al. Why do patients with heart failure suffer from erectile dysfunction? A critical review and suggestions on how to approach this problem. Int J Impot Res. 2005c; 17(Suppl 1):S25-36.
19. Selph JP, Carson CC. Penile prosthesis infection: approaches to prevention and treatment. Urol Clin North Am. 2011; 38(2):227-235.
20. Sevinc C, Ozkaptan O, Balaban M, et al. Outcome of penile prosthesis implantation: are malleable prostheses an appropriate treatment option in patients with erectile dysfunction causes by prior radical surgery? Asian J Androl 2017; 19:477-481.
21. Stember DS, Mulhall JP. The concept of erectile function preservation (penile rehabilitation) in the patient after brachytherapy for prostate cancer. Brachytherapy. 2012; 11(2):87-96.
22. Topuz B, Ebiloğlu T, Zor M, et al. Penile prosthesis implantation: a single center 25 years of experience. Prog Urol. 2021; 31(11):663-670.
23. Trost L, Wanzek P, Bailey G. A practical overview of considerations for penile prosthesis placement. Nat Rev Urol. 2016; 13(1):33-46.
24. Zermann DH, Kutzenberger J, Sauerwein D, et al. Penile prosthetic surgery in neurologically impaired patients: long-term follow-up. J Urol. 2006; 175(3 Pt 1):1041-1044.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Burnett AL, Nehra A, Breau RH et al. Erectile dysfunction: AUA guideline. J Urol. 2018; 200(3):633-641.
2. Chung E, Bettocchi C, Egydio P, et al. The international penile prosthesis implant consensus forum: clinical recommendations and surgical principles on the inflatable 3-piece penile prosthesis implant. Nat Rev Urol. 2022; 19(9):534-546.
3. Chung E, Ziegelmann M, Lin HC, et al. Management of Peyronie's disease: recommendations from the Fifth International Consultation on Sexual Medicine (ICSM 2024). Sex Med Rev. 2026; 14(1):qeaf068.
4. Darouiche RO, Bella AJ, Boone TB, et al. North American consensus document on infection of penile prostheses. Urology. 2013; 82(4):937-942.
5. Salonia A, Capogrosso P, Boeri L, et al. European Association of Urology guidelines on male sexual and reproductive health: 2025 update on male hypogonadism, erectile dysfunction, premature ejaculation, and Peyronie's disease. Eur Urol. 2025; 88(1):76-102.

1. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Treatment for erectile dysfunction. October 2024. Available at: https://www.niddk.nih.gov/health-information/urologic-diseases/erectile-dysfunction/treatment. Accessed on May 6, 2026.

Erectile Dysfunction
Penile Prosthesis, Insertion

Federal and State law, as well as contract language, and Coverage Guidelines take precedence over Clinical UM Guidelines. We reserve the right to review and update Clinical UM Guidelines periodically. Clinical guidelines approved by the Medical Policy & Technology Assessment Committee are available for general adoption by plans or lines of business for consistent review of the medical necessity of services related to the clinical guideline when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the member's card.

Alternatively, commercial or FEP plans or lines of business which determine there is not a need to adopt the guideline to review services generally across all providers delivering services to Plan’s or line of business’s members may instead use the clinical guideline for provider education and/or to review the medical necessity of services for any provider who has been notified that his/her/its claims will be reviewed for medical necessity due to billing practices or claims that are not consistent with other providers, in terms of frequency or in some other manner.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

© CPT Only – American Medical Association