Penile implant

Last updated
Penile implant
Penile Implant.png
Penile implant
Other namesPenile prosthesis
Specialty Urology
ICD-10-PCS 0VUS0JZ
CPT 54400, 54405

A penile implant is an implanted device intended for the treatment of erectile dysfunction, Peyronie's disease, ischemic priapism, deformity and any traumatic injury of the penis, and for phalloplasty or metoidioplasty, including in gender-affirming surgery. Men also opt for penile implants for aesthetic purposes. Men's satisfaction and sexual function is influenced by discomfort over genital size which leads to seek surgical and non-surgical solutions for penis alteration. [1] Although there are many distinct types of implants, most fall into one of two categories: malleable and inflatable transplants. [2]

Contents

History

The first modern prosthetic reconstruction of a penis is attributed to NA Borgus, a German physician who performed the first surgical attempts in 1936 on soldiers with traumatic amputations of the penis. He used rib cartilages as prosthetic material and reconstructed the genitals for both micturition and intercourse purposes. [3] Willard E. Goodwin and William Wallace Scott were the first to describe the placement of synthetic penile implants using acrylic prosthesis in 1952. [4] Silicone-based penile implants were developed by Harvey Lash and the first case series were published in 1964. [5] The development of a high-grade silicone that is currently used in penile implants is credited to NASA. [6] The prototypes of the contemporary inflatable and malleable penile implants were presented in 1973 during the annual meeting of the American Urological Association by two groups of physicians from Baylor University (Gerald Timm, William E. Bradley and F. Brantley Scott) and University of Miami (Michael P. Small and Hernan M. Carrion). [3] [7] [8] Small and Carrion pioneered the popularization of semi-rigid penile implants with the introduction of Small-Carrion prosthesis (Mentor, USA) in 1975. Brantley Scott described the initial device as composed of two inflatable cylindrical bodies made up of silicone, a reservoir containing radiopaque fluid and two pumping units. [7] The first generation products were marketed through American Medical Systems (AMS; currently Boston Scientific), with which Brantley Scott was associated. [6] [9] Many device updates have been released by AMS since the first generation implants. In 1983, Mentor (currently Coloplast) joined the market. [6] In 2017, there were more than ten manufacturers of penile implants in the world, however only a few now remain in the market. [10] The latest additions to the market are Zephyr Surgical Implants and Rigicon Innovative Urological Solutions. [11] [12] Zephyr Surgical Implants, along with penile implants for biological men, introduced the first line of inflatable and malleable penile implants designed for sex reassignment for trans men. In recent years, Rigicon Innovative Urological Solutions, a US-based company, has made significant advancements in the field of penile implants. In 2017, they released the 'Rigi10,' a malleable implant that expanded the market's options. Following this, in 2019, they introduced both the 'Infla10' series, which includes the Infla10 AX, Infla10 X, and Infla10 models, and the 'Rigi10 Hydrophilic.' These inflatable and hydrophilic-coated malleable models respectively were important additions to the range of penile implant technologies available. These advancements have contributed to the diversity and progress in the development of penile implants, offering patients more varied and tailored treatment solutions. [13] [14]

According to analysis of the 5% Medicare Public Use Files from 2001 to 2010 approximately 3% of patients diagnosed with erectile dysfunction opt for penile implantation. [15] Each year nearly 25,000 inflatable penile prostheses are implanted in the USA. [16]

The list shows penile implants available in the market in 2020.

ProductCompanyCountry of originType of the implantIntroduced in
AMS Spectra Boston Scientific (formerly American Medical Systems) United States of America Malleable2009
Tactra Boston Scientific (formerly American Medical Systems) United States of America Malleable2019
Genesis Coloplast United States of America Malleable2004
Shah Indian MalleableDr.Rupin Shah India Malleable2008
ZSI 100, ZSI 100 FtM and ZSI 100 D4 Zephyr Surgical Implants Switzerland Malleable2012
TubePromedon Argentina Malleable2007
AMS Ambicor Boston Scientific (formerly American Medical Systems) United States of America Inflatable1994
AMS 700 series (LGX, CX, CXR) Boston Scientific (formerly American Medical Systems) United States of America Inflatable1983
Titan Coloplast United States of America Inflatable2002
ZSI 475 and ZSI 475 FtM Zephyr Surgical Implants Switzerland Inflatable2012
Infla10 series (AX, X, NarrowBody)Rigicon Innovative Urological Solutions United States of America Inflatable2019
Rigi10 [17] Rigicon Innovative Urological Solutions United States of America Malleable2017
Rigi10 HydrophilicRigicon Innovative Urological Solutions United States of America Malleable2019

Types

Malleable penile implant

Comparison of penile implants (inflated cylinder diameter and length) Comparison of penile implants.jpg
Comparison of penile implants (inflated cylinder diameter and length)
Penile implant pump design comparison Penile implant pump design comparison.jpg
Penile implant pump design comparison

The malleable (also known as non-inflatable or semi-rigid) penile prosthesis is a pair of rods implanted into the corpora of the penis. The rods are hard, but 'malleable' in the sense that they can be adjusted manually into the erect position. [18] There are two types of malleable implants: one that is made of silicone and does not have a rod inside, also called soft implants, and another with a silver or steel spiral wire core inside coated with silicone. Some of the models have trimmable tails intended for length adjustment. [10] Currently, a variety of malleable penile implants are available worldwide. [19]

Inflatable penile implant

The inflatable penile implant (IPP), more recently developed, is a set of inflatable cylinders and a pump system. Based on the differences in structure, there are two types of inflatable penile implants: two-piece and three-piece IPPs. Both types of inflatable devices are filled with sterile saline solution which is pumped into cylinders when in process. The cylinders are implanted into the cavernous body of the penis. The pump system is attached to the cylinders and placed in the scrotum. [10] Three-piece implants have a separate large reservoir connected to the pump. The reservoir is commonly placed in the retropubic space (Retzius' space), however other locations have also been described, such as between the transverse muscle and rectus muscle. Three-piece implants provide more desirable rigidity and girth of the penis resembling natural erection. Additionally, due to the presence of a large reservoir, three-piece implants provide full flaccidity of the penis when deflated, thus bringing more comfort than two-piece inflatable and malleable implants. [6]

The saline solution is pumped manually from the reservoir into bilateral chambers of cylinders implanted in the shaft of the penis, which replaces the non- or minimally-functioning erectile tissue. This produces an erection. The glans of the penis, however, remains unaffected. Ninety to ninety-five percent of inflatable prostheses produce erections suitable for sexual intercourse. In the United States, the inflatable prosthesis has largely replaced the malleable one, due to its lower rate of infections, high device survival rate and 80–90% satisfaction rate. [2]

The first IPP prototype presented in 1975 by Scott and colleagues was a three-piece prosthesis (two cylinders, two pumps and a fluid reservoir). Since then, the IPP has undergone multiple modifications and improvements for device reliability and durability, including change in the chemical material used in implant manufacturing, using hydrophilic and antibiotic eluting coatings to reduce the rates of infections, introducing one-touch release etc. [10] Surgical techniques used for the implantation of penile prostheses have also improved along with evolution of the device. Inflatable penile implants were one of the first interventions in urology where the "no-touch" surgical technique was introduced. This has significantly reduced the rates of post-operative infections. [20]

Medical use

A diagram of an inflatable penile implant inserted into corpus cavernosum of the penis Inflatable penile implant.jpg
A diagram of an inflatable penile implant inserted into corpus cavernosum of the penis
Evoking an erection with an implanted penile implant Penile implant in action.gif
Evoking an erection with an implanted penile implant

Erectile dysfunction

In spite of recent rapid and extensive development of non-surgical management options for erectile dysfunction, especially novel targeted medications and gene therapy, the penile implants remain the mainstay and the gold standard choice for the treatment of erectile dysfunction refractory to oral medications and injectable therapy. [21] [6] Additionally, penile implants can be a relevant option for those with erectile dysfunction who want to proceed with a permanent solution without medical therapy. Penile implants have been used for the treatment of erectile dysfunction with various etiologies, including vascular, cavernosal, neurogenic, psychological and post-surgical (e.g. prostatectomy). The American Urological Association recommends informing all men with erectile dysfunction about penile implants as a choice of treatment and discussing the potential outcomes with them. [22]

Penile deformity

Penile implants can help recover the natural shape of the penis in various conditions that have led to penile deformity. These can be traumatic injuries, penile surgeries, disfiguring and fibrosing diseases of the penis, such as Peyronie's disease. [6] In Peyronie's disease, the change in penile curvature affects normal sexual intercourse as well as causing erectile dysfunction due to disruption of blood flow in the cavernous bodies of the penis. [23] Therefore, implantation of penile prosthesis in Peyronie's disease addresses several mechanisms involved in the pathophysiology of the disease.

Female-to-male sex reassignment

Although different models of penile prostheses have been reported to be implanted after phalloplasty procedures, [24] with the first case described in 1978 by Pucket and Montie, [25] the first penile implants designed and produced specifically for female-to-male gender reassignment surgery for trans men were introduced in 2015 by Zephyr Surgical Implants. [26] Both malleable and inflatable models are available. These implants have more realistic shape with an ergonomic glans at the tip of the prosthesis. The inflatable model has an attached pump resembling a testicle. The prosthesis is implanted with a sturdy fixation on pubic bone. Another, thinner malleable implant is intended for metoidioplasty.

Outcomes

Satisfaction

The overall satisfaction rate with penile implants reaches over 90%. [6] Both self- and partner-reported satisfaction rates are evaluated to assess the outcomes. It has been shown that implantation of inflatable penile prosthesis brings more patient and partner satisfaction than medication therapy with PDE5 inhibitors or intracavernosal injections. [21] Satisfaction rates are reported to be higher with inflatable rather than malleable implants, but there are no differences between two-piece and three-piece devices. [27] [28] The most frequent reasons for dissatisfaction are reduced penis length and girth, failed expectations and difficulties with device use. [21] [27] Thus, it is vital to provide patients and their partners with detailed preoperative counselling and instructions.[ citation needed ]

Curvature correction

33% to 90% of cases of patients with Peyronie's disease that have had an inflatable PI procedure have successfully corrected their penile deformity. [23] The residual curvature after penile implant placement usually requires intraoperative surgical intervention.

Progress in procedure

Dilation of the corpora cavernosa, typically with Hegar sounds, before inserting the device has been a common part of implantation procedures. This dilation destroys erectile tissue. It has been shown that a tissue-sparing technique, i.e. without dilation, correlates with superior outcomes –some remaining natural erectile response can be preserved, and post-operative pain is reduced as well. [29] [30]

Complications

The most common complication associated with penile implant placement appears to be infections with reported rates of 1–3%. [27] Both surgical site and device infections are reported. When the infection involves the penile implant itself, implant removal is required and irrigation of the cavities with antiseptic solutions. In this scenario, placement of a new implant is needed to avoid further tissue fibrosis and shortening of the penis. The rate of repeat surgeries or device replacements ranges from 6% to 13%. [23] Other reported complications include perforation of the corpus cavernosum and urethra (0.1–3%), commonly occurring in patients with previous fibrosis, prosthesis erosion or extrusion, change in glans shape, hematoma, shortening of penis length, and device malfunction. Due to continuous improvement of surgical techniques and modifications of implants, complication rates have dramatically decreased over time.[ citation needed ]

To overcome post-operative penile shortening and to increase the perceived length of the penis and patient satisfaction, ventral and dorsal phalloplasty procedures in combination with penile implants have been described. [21] Modified glanulopexy has been proposed to prevent supersonic transporter deformity and glandular hypermobility which are possible complications of penile implants. [31]

Sliding techniques in which the penis is cut and elongated with penile implants have been performed in cases of severe penile shortening. However, these techniques had higher rates of complications and are currently avoided.[ citation needed ]

Related Research Articles

Erectile dysfunction (ED), also referred to as impotence, is a form of sexual dysfunction in males characterized by the persistent or recurring inability to achieve or maintain a penile erection with sufficient rigidity and duration for satisfactory sexual activity. It is the most common sexual problem in males and can cause psychological distress due to its impact on self-image and sexual relationships.

<span class="mw-page-title-main">Peyronie's disease</span> Abnormal growth of scar tissue within the penis

Peyronie's disease is a connective tissue disorder involving the growth of fibrous plaques in the soft tissue of the penis. Specifically, scar tissue forms in the tunica albuginea, the thick sheath of tissue surrounding the corpora cavernosa, causing pain, abnormal curvature, erectile dysfunction, indentation, loss of girth and shortening.

<span class="mw-page-title-main">Penis enlargement</span> Technique aimed to increase the size of a human penis

Penis enlargement, or male enhancement, is any technique aimed to increase the size of a human penis. Some methods aim to increase total length, others the shaft's girth, and yet others the glans and foreskin size. Techniques include surgery, supplements, ointments, patches, and physical methods like pumping, jelqing, and traction.

Sexual dysfunction is difficulty experienced by an individual or partners during any stage of normal sexual activity, including physical pleasure, desire, preference, arousal, or orgasm. The World Health Organization defines sexual dysfunction as a "person's inability to participate in a sexual relationship as they would wish". This definition is broad and is subject to many interpretations. A diagnosis of sexual dysfunction under the DSM-5 requires a person to feel extreme distress and interpersonal strain for a minimum of six months. Sexual dysfunction can have a profound impact on an individual's perceived quality of sexual life. The term sexual disorder may not only refer to physical sexual dysfunction, but to paraphilias as well; this is sometimes termed disorder of sexual preference.

<span class="mw-page-title-main">Penile fracture</span> Rupture of the fibrous coverings that envelop the peniss erectile tissue

Penile fracture is rupture of one or both of the tunica albuginea, the fibrous coverings that envelop the penis's corpora cavernosa. It is caused by rapid blunt force to an erect penis, usually during vaginal intercourse, or aggressive masturbation. It sometimes also involves partial or complete rupture of the urethra or injury to the dorsal nerves, veins and arteries.

Phalloplasty is the construction or reconstruction of a penis or the artificial modification of the penis by surgery. The term is also occasionally used to refer to penis enlargement.

<span class="mw-page-title-main">Metoidioplasty</span> Surgical procedure used to create a penis from the clitoris

Metoidioplasty, metaoidioplasty, or metaidoioplasty is a female-to-male gender-affirming surgery.

Masculinizing gender-affirming surgery for transgender men or transmasculine non-binary people includes a variety of surgical procedures that alter anatomical traits to provide physical traits more comfortable to the trans man's male identity and functioning.

<span class="mw-page-title-main">Scrotoplasty</span> Type of surgery to create or repair the scrotum

Scrotoplasty, also known as oscheoplasty, is a type of surgery to create or repair the scrotum. Scientific research for male genital plastic surgery such as scrotoplasty began to develop in the early 1900s. The development of testicular implants began in 1940 made from materials outside of what is used today. Today, testicular implants are created from saline or gel filled silicone rubber. There are a variety of reasons why scrotoplasty is done. Some transgender men and intersex or non-binary people who were assigned female at birth may choose to have this surgery to create a scrotum, as part of their transition. Other reasons for this procedure include addressing issues with the scrotum due to birth defects, aging, or medical conditions such as infection. For newborn males with penoscrotal defects such as webbed penis, a condition in which the penile shaft is attached to the scrotum, scrotoplasty can be performed to restore normal appearance and function. For older male adults, the scrotum may extend with age. Scrotoplasty or scrotal lift can be performed to remove the loose, excess skin. Scrotoplasty can also be performed for males who undergo infection, necrosis, traumatic injury of the scrotum.

Nocturnal penile tumescence (NPT) is a spontaneous erection of the penis during sleep or when waking up. Along with nocturnal clitoral tumescence, it is also known as sleep-related erection. Colloquially, the term morning wood, or less commonly, morning glory is also used, although this is more commonly used to refer specifically to an erection beginning during sleep and persisting into the period just after waking. Men without physiological erectile dysfunction or severe depression experience nocturnal penile tumescence, usually three to five times during a period of sleep, typically during rapid eye movement sleep. Nocturnal penile tumescence is believed to contribute to penile health.

<span class="mw-page-title-main">Human penis size</span> Measurement of the human penis

Human penis size varies on a number of measures, including length and circumference when flaccid and erect. Besides the natural variability of human penises in general, there are factors that lead to minor variations in a particular male, such as the level of arousal, time of day, ambient temperature, anxiety level, physical activity, and frequency of sexual activity. Compared to other primates, including large examples such as the gorilla, the human penis is thickest, both in absolute terms and relative to the rest of the body. Most human penis growth occurs in two stages: the first between infancy and the age of five; and then between about one year after the onset of puberty and, at the latest, approximately 17 years of age.

<span class="mw-page-title-main">Buried penis</span> Male congenital condition

Buried penis, also called hidden penis or retractile penis, is a congenital or acquired condition in which the penis is partially or completely hidden below the surface of the skin. A buried penis can lead to urinary difficulties, poor hygiene, infection, and inhibition of normal sexual function.

<span class="mw-page-title-main">Penile artery shunt syndrome</span> Medical condition

Penile artery shunt syndrome (PASS) is an iatrogenic clinical phenomenon first described by Tariq Hakky, Christopher Yang, Jonathan Pavlinec, Kamal Massis, and Rafael Carrion within the Sexual Medicine Program in the Department of Urology, at the University of South Florida, and Ricardo Munarriz, of Boston University School of Medicine Department of Urology in 2013. It may be a cause of refractory erectile dysfunction in patients who have undergone penile revascularization surgery.

<span class="mw-page-title-main">Hegar dilators</span> Medical implement

Hegar dilators are dilators used to treat vaginismus and induce cervical dilation, and for inflatable penile implant procedures, though for penile implants it has been shown that outcomes are better without dilation.

<span class="mw-page-title-main">Miroslav Djordjevic</span> Serbian genital surgeon

Miroslav L Djordjevic is a Serbian surgeon specializing in sex reassignment surgery, and an assistant professor of urology at the School of Medicine, University of Belgrade, Serbia.

<span class="mw-page-title-main">Culley C. Carson III</span> American physician

Culley Clyde Carson III is an American retired urologist who specializes in Peyronie's disease, penile implants and erectile dysfunction. After serving two years as a flight surgeon with the United States Air Force, he took on a urology residency at the Mayo Clinic and then taught at the Duke University Medical Center as an assistant professor, subsequently gaining full professorship.

<span class="mw-page-title-main">Zephyr Surgical Implants</span> Swiss-based penile surgical implant manufacturer

Zephyr Surgical Implants (ZSI) is a Swiss-based medical device manufacturer that produces and distributes artificial urinary sphincters and penile implants worldwide. ZSI products are used in the management of moderate-to-severe urinary incontinence in men, erectile dysfunction, Peyronie's disease, penis enlargement, and female-to-male gender reassignment surgery.

A penis extender is an external medical device with tentative evidence as of 2019 for Peyronie's disease. It acts as a mechanical, traction device that stretches the human penis in the flaccid state to make it longer.

Penile implants may be employed to treat erectile dysfunction or urinary troubles after a spinal cord injury.

<span class="mw-page-title-main">Glans insufficiency syndrome</span> Medical condition

Glans insufficiency syndrome, also known as soft glans, cold glans, or glans insufficiency, is a medical condition that affects male individuals. This condition is characterized by the persistent inability of the glans penis to achieve and maintain an erect or turgid state during sexual arousal, remaining soft and cold. This condition can have an impact on a person's sexual function, including decreased sensitivity, difficulty in maintaining an erection, and overall quality of life.

References

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  2. 1 2 Perito, Paul. "Penile Implants". PeritoUrology.com. Perito Urology. Retrieved 12 November 2019.[ self-published source? ]
  3. 1 2 Carrion, Hernan; Martinez, Daniel; Parker, Justin; Hakky, Tariq; Bickell, Michael; Boyle, Alexander; Weigand, Luke; Carrion, Rafael (July 2016). "A History of the Penile Implant to 1974". Sexual Medicine Reviews. 4 (3): 285–293. doi:10.1016/j.sxmr.2016.05.003. PMID   27871961.
  4. ↑ Goodwin, Willard E.; Scott, William Wallace (December 1952). "Phalloplasty". Journal of Urology. 68 (6): 903–908. doi:10.1016/S0022-5347(17)68301-0. PMID   13000938.
  5. ↑ Lash, Harvey; Zimmerman, Donald C.; Loeffler, Robert A. (July 1964). "Silicone Implantation". Plastic and Reconstructive Surgery. 34 (1): 75–80. doi:10.1097/00006534-196407000-00011. PMID   14200523. S2CID   43779571.
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  20. ↑ Eid, J. Francois (July 2016). "Penile Implant: Review of a "No-Touch" Technique". Sexual Medicine Reviews. 4 (3): 294–300. doi:10.1016/j.sxmr.2016.01.002. PMID   27871962.
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  24. ↑ Falcone, Marco; Garaffa, Giulio; Gillo, Arianna; Dente, Dino; Christopher, Andrew N.; Ralph, David J. (January 2018). "Outcomes of inflatable penile prosthesis insertion in 247 patients completing female to male gender reassignment surgery". BJU International. 121 (1): 139–144. doi: 10.1111/bju.14027 . PMID   28940910.
  25. ↑ Puckett, Charles L.; Montie, Joseph E. (April 1978). "Construction of Male Genitalia in the Transsexual, Using a Tubed Groin Flap for the Penis and a Hydraulic Inflation Device". Plastic and Reconstructive Surgery. 61 (4): 523–530. doi:10.1097/00006534-197804000-00005. PMID   345304. S2CID   42344243.
  26. ↑ Neuville, Paul; Morel-Journel, Nicolas; Cabelguenne, Delphine; Ruffion, Alain; Paparel, Philippe; Terrier, Jean-Etienne (February 2019). "First Outcomes of the ZSI 475 FtM, a Specific Prosthesis Designed for Phalloplasty". The Journal of Sexual Medicine. 16 (2): 316–322. doi: 10.1016/j.jsxm.2018.11.013 . PMID   30638882.
  27. 1 2 3 Krzastek, Sarah C.; Smith, Ryan (8 January 2019). "An update on the best approaches to prevent complications in penile prosthesis recipients". Therapeutic Advances in Urology. 11: 175628721881807. doi: 10.1177/1756287218818076 . PMC   6329024 . PMID   30671142.
  28. ↑ Çayan, Selahittin; Aşcı, Ramazan; Efesoy, Ozan; Bolat, Mustafa Suat; Akbay, Erdem; Yaman, Önder (July 2019). "Comparison of Long-Term Results and Couples' Satisfaction with Penile Implant Types and Brands: Lessons Learned From 883 Patients With Erectile Dysfunction Who Underwent Penile Prosthesis Implantation". The Journal of Sexual Medicine. 16 (7): 1092–1099. doi:10.1016/j.jsxm.2019.04.013. PMID   31155387. S2CID   173992578.
  29. ↑ Zaazaa, Adham; Mostafa, Taylor (14 February 2019). "Spontaneous Penile Tumescence by Sparing Cavernous Tissue in the Course of Malleable Penile Prosthesis Implantation". The Journal of Sexual Medicine. 16 (3): 474–478. doi:10.1016/j.jsxm.2019.01.012. PMID   30773500 . Retrieved 14 January 2024.
  30. ↑ Moncada, Ignacio; Juan Ignacio, Martínez-Salamanca; José, Jara; Ramiro, Cabello; Mercedes, Moralejo; Carlos, Hernández (1 Mar 2010). "Inflatable Penile Prosthesis Implantation Without Corporeal Dilation: A Cavernous Tissue Sparing Technique". Journal of Urology. 183 (3): 1123–1126. doi:10.1016/j.juro.2009.11.048. PMID   20092840 . Retrieved 14 January 2024.
  31. ↑ Ziegelmann, Matthew J.; Alom, Manaf; Bole, Raevti; Kohler, Tobias; Trost, Landon (June 2018). "Modified Glanulopexy Technique for Supersonic Transporter Deformity and Glanular Hypermobility in Men With Penile Prostheses". The Journal of Sexual Medicine. 15 (6): 914–919. doi:10.1016/j.jsxm.2018.04.633. PMID   29731427. S2CID   24785737.
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