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A History of the Penile Implant to 1974

Hernan Carrion, MD,1 Daniel Martinez, MD,2 Justin Parker, MD,2 Tariq Hakky, MD,2 Michael Bickell, DO,2
Alexander Boyle, MD,2 Luke Weigand, MD,2 and Rafael Carrion, MD2
Key Words: Penile Prosthesis; History; Development

INTRODUCTION penile prosthesis and the birth of the “new era” of the penile
Impotence has plagued mankind for over a millennium. One prosthesis, respectively.
of the earliest references on record was found in India, in the
Sushruta Samhita, around the eighth century BC.1 Historically, it
BEFORE 1974
was an ailment believed to have its roots in psychogenic, reli-
gious, and supernatural etiologies. Therefore, the treatment of After a review of the literature, it was evident that there were
impotence involved the use of potions, aphrodisiacs, ointments, few pioneers using penile prostheses to correct organic impo-
and prayers, which to this day still play a large role in certain tence in patients during the first half of the 20th century. N.A.
cultures. This mindset of impotence secondary to non-organic Bogoras of Germany was one such pioneer. In 1936 he
causes remained the mainstay in the scientific community until described his technique of using rib cartilage for penile recon-
well into the 20th century. In fact, in the early to mid-1900s, struction in war victims with disfiguring amputation-type in-
psychologists or psychiatrists treated impotence more than juries to the phallus.5,6 He believed that it was not only
95% of the time, often with the use of empiric treatment with necessary to re-create the missing penis, but that its function
testosterone. As David Stafford-Clark,2 described in his article, should be restored. He described using rib cartilage as an os
“The Etiology and Treatment of Impotence,” published in 1954, penis for the patient to have an erection and engage in sexual
“A dogmatic, but reasonably safe generalization would be that at activity (Figure 1). The rationale for using an os penis for sexual
least 90% of all cases of impotence, relative or complete, are reconstruction was derived from observations of successful
psychogenic in origin.” Before 1974, very few urologists were evolutionary development in certain animals such as the walrus,
involved in the management and treatment of erectile dysfunc- whale, gibbon, and orangutan. These animals possess an os
tion (ED), because the underlying pathophysiology of impotence penis to provide the necessary rigidity to permit proper penile
remained to be elucidated. penetration secondary to poorly developed erectile tissue.
Bogoras theorized he could create an os penis for these men to
The lack of interest among urologists in the treatment of
restore the form and function of a human penis.
patients with ED was reflected in the participation at the annual
American Urological Association (AUA) meetings. In the annual Bogoras’ contribution was expanded on and enhanced by
AUA meeting in 1971, Robert Pearman3 presented the only Frumkin7 in 1944; a summary, as written in his article, of his
paper related to the surgical treatment of ED using a penile four-step operation follows:
prosthesis. In 1972, there also was only one paper by Morales 1. Formation of an abdominal skin tube into which rib cartilage
et al4 on this same topic, and in 1973 there was only one paper is inserted
by Reginald Hancock on his experience with prostheses. It was in 2. Transfer of the proximal pedicle of the tube and implantation
1974 that the birth of a new era in the treatment of impotence of the cartilage into the remnants of the cavernous bodies
began with the advent and widespread use of two safe and effi- 3. Division of the distal end of the tube and formation of the
cacious penile prostheses (Table 1). penis
In this article, we describe the history of surgical treatment of 4. Reconstruction of the urethral canal
ED by concentrating on the evolution of the penile prosthesis.
In his article, Frumkin went into detail to describe the surgical
This history is composed of two parts, before 1974 and the
technique. In the first stage, a harvested cartilage graft taken from
landmark year of 1974. We refer to this as the “old era” of the
the eighth or ninth rib was inserted into a phallic tubularized
skin flap made from the lateral abdominal wall. The second stage,
Received September 16, 2015. Accepted November 10, 2015. performed 3 to 4 weeks later, consisted of implanting the
1
University of Miami, Miami, FL, USA; cephalad portion of the cartilage-tubularized skin flap into the
2
University of South Florida, Tampa, FL, USA
remains of the cavernous bodies after they were carefully mobi-
lized. The upper pedicle of the tube was severed and mobilized
Copyright ª 2016, International Society for Sexual Medicine. Published by
Elsevier Inc. All rights reserved. down to the cavernous bodies. A small portion of the exposed
http://dx.doi.org/10.1016/j.sxmr.2016.05.003 cartilage (approximately 1 cm) was inserted into a pocket created
Sex Med Rev 2016;4:285e293 285
286 Carrion et al

Table 1. AUA annual meetings from 1971 through 1974 with submissions related to the surgical treatment of erectile dysfunction
66th AUA meeting, 1971 67th AUA meeting, 1972 68th AUA meeting, 1973 69th AUA meeting, 1974

Robert Pearman, Insertion P.A. Morales et al, Penile Reginald Hancock, Experience M.P. Small, Carrion Small-Carrion
of a Silastic Penile Prosthesis Implant for Erectile with Penile Prosthesis Penile Prosthesis: New Implant
for the Treatment of Organic Impotence for Management of Impotence
Sexual Impotence
M.P. Small, Carrion Small-Carrion
Penile Prosthesis
F.B. Scott et al, Management of
Erectile Impotence: Use of Implantable
Inflatable Prosthesis
AUA ¼ American Urological Association.

midline between the stumps of the cavernous bodies. Then, the by Bergman et al was the diversion of the urinary stream by cys-
pedicle of the skin flap and the cavernous bodies were fixed totomy during the second stage (which was performed 6 weeks
together. Three to 5 weeks lapsed before the third stage of the after the first stage), before transplantation of the tube graft with
procedure. This stage consisted of dividing the distal pedicle of cartilage to the penile stump. Bergman et al reported that patients
the tube, freeing the flap and cartilage, and subsequent formation could urinate normally and enjoy sexual gratification with coitus 4
of a new phallus. The fourth stage of the procedure consisted of months after completion of the surgery. Their patients reported
the creation of the new urethra and attaching it to the acquired return of sensation including pain, temperature, and pressure
hypospadias of the new phallus. Frumkin described multiple (Figure 3). The popularity of this technique continued for several
modifications to his technique, including a flap created by the years but was eventually abandoned because of a multitude of
anterior surface of the scrotum, a flap from the inner forearm, postoperative complications including, but not limited to, infec-
and an abdominal graft. Frumkin reported good outcomes tion, extrusion, and pain. Furthermore, the cartilage often was too
consisting of restoration of a normal-appearing male penis with firm, difficult to shape, and reabsorbed over time. This gave way to
adequate sexual function; however, he did not report long-term the development and incorporation of synthetic materials for the
follow-up in these patients. development of penile implant prototypes.
In 1947 Bergman et al,8 using the technique described by
Bogoras and Frumkin, also performed phallus reconstruction using
rib cartilage to allow for rigidity and sexual intercourse. He ACRYLIC IMPLANTS
described a four-stage procedure that required 9 months for its Goodwin and Scott9 were the first to describe the use of a syn-
completion (Figure 2). One difference described in this technique thetic material as an “artificial baculum” in 1952 (Figure 4). They

Figure 1. Harvesting rib cartilage and erection by os penis as shown in the 1936 article by Bogoras and Don.5

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A History of the Penile Implant to 1974 287

partnered with a dentist who had robust experience with the use of
acrylic, and it was he who constructed the acrylic penile implant
prototype. They described penile reconstruction and implantation
in a two-stage procedure. The first stage was to reconstruct the
urethra by midline tubular formation of the scrotal skin, followed
by lateral “zig-zag” scrotal skin and deep fascia incisions that were
elevated and tubularized (Figure 5). The second stage involved
insertion of the shaped acrylic splint into the dorsum of the newly
reconstructed penis. Based on Goodwin and Scott’s findings, the
acrylic implant led to improved results and fewer complications
than the cartilage graft.
In 1960 Robert Loeffler, a plastic surgeon, and Emile Sayegh,
a urologist, followed the concept perpetuated by Goodwin and
Scott by developing a penile implant made from perforated
acrylic.10-12 The penile prosthesis was a single unit that was
inserted into the dorsum of the penis, under the Buck fascia and
the tunica albuginea, between the corpora cavernosa. Perfora-
tions were made in the acrylic implant to help decrease
Figure 2. Depiction of the pocket made in the corpora cavernosa postoperative edema. The prosthesis was placed through a
for reception of rib cartilage as shown in the 1947 article by dorsal incision from the base of the glans penis to the pubic
Bergman et al.8 symphysis after ligation of the suspensory ligament of the penis.
Their series was limited to two patients, who reported a suc-
cessful response.

SILICONE IMPLANTS
In 1964 Harvey Lash13,14 was the first to develop and publish a
series on a penile prosthesis made from silicone. His series consisted
of 28 successfully placed functional silicone implants, with only
one case of erosion through the fossa navicularis (Figure 6).
In 1967 Pearman15 expanded on Lash’s experience with
silicone implants and he developed a novel technique of placing
the prosthesis beneath the Buck fascia and above the tunica
albuginea in the dorsum of the penis from the base of the glans to
the suspensory ligament (Figure 7). He used silicone to create the
implant, because he found it could be bent for ease of insertion,
produced minimum tissue reaction, and had “body and rigidity”
and “proper resiliency and lack of fatigue.” He found that a 3-5
circle rod of silicone worked best, because it provided the best
girth and strength against bending. In 1972, Pearman changed
his technique and began inserting the penile prosthesis through a
dorsal skin incision, between the undersurface of the tunica
albuginea and the two corpora cavernosa, because he found this
provided better cosmetic and functional results.
Acrylic and silicone implants, similar to implants made from
rib cartilage, were fraught with complications and patient
intolerance. Patients had a myriad of complaints consisting of
inadequate proximal support, difficulty with penetration, irri-
tation of the glans, intractable pain, and extrusion of the
implant through the skin or the urethra. In addition, acrylic and
silicone implants produced significant lymphatic edema. These
Figure 3. Depiction of the third stage, freeing of the abdominal difficulties ultimately led to the abandonment of these
attachment of tube graft, as described by Bergman et al.8 materials.

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288 Carrion et al

Figure 4. Acrylic implants used by Goodwin and Scott9 in 1952.

POLYETHYLENE RODS AND INTRACAVERNOSAL midline dorsal incision near the root of the penis (similar to an
PLACEMENT OF THE PROSTHESIS infra-pubic approach), the sheath of each corpus cavernosum was
G.E. Beheri16,17 was the first to describe the use of a paired opened followed by dilation using Hegar dilators (Figure 8). The
intracavernosal penile implant in 1966. This marks a pivotal thick distal portion of the implant was inserted through the
change in the surgical technique for implant insertion because all corporotomy and threaded distally to the glans of the penis.
future techniques would involve implantation into the corpora Then, he would thread the thin proximal portion down to the
cavernosal bodies. He published his results of 700 cases over 7 crus, thus completing his implantation. Interestingly, he was the
years 6 months using a polyethylene implant. After making a first to report aborting the procedure if blood was noted at the

Figure 5. Pictures of the second stage of the phallus reconstruction of Goodwin and Scott9 using scrotal skin and a deep fascia flap.

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A History of the Penile Implant to 1974 289

Figure 6. Insertion of the silicone implant by Lash et al13,14 and surgical closure.

meatus, because he noted that a tear to the urethra would cause a described by Beheri. Overall, they reported satisfactory outcomes
fistula if the implant were left in place. He also described cutting with adequate cosmetic and functional results; however, three
the suspensory ligament to provide more length and leaving a patients required explantation: two secondary to infection and
drain in the space between the penis and the symphysis pubis. one because of severe pain. Unfortunately, the polyethylene
Beheri reported the advantages of polyethylene as a hard and implants were quite stiff, even when they were made in smaller
resilient material that is simultaneously malleable and elastic. diameters, and did not provide enough flexibility. They also
In 1972, Morales et al4 modified the polyethylene implant, caused significant penile pain, crus perforation, and pain to the
making it smaller in diameter. They implanted their polyethylene partner during sexual activity. There was a high incidence of
implants in 15 patients using a technique similar to that infection in this type of prosthesis and eventually this, too, was
abandoned.
The contribution of Morales et al was the last of the major
contributions of the “old era” of prosthetic urologic surgery. The
work of these investigators helped to lay the groundwork for the
developments of the “new era” of prosthetic surgery that began
with the Small-Carrion semirigid prosthesis and the Scott-
Bradley-Timm inflatable prosthesis. We give them credit for

Figure 7. Depiction of the correct placement of the prosthesis


described by Pearman15 in 1967. Figure 8. The Beheri polyethylene implant.

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290 Carrion et al

this outstanding pioneering work in penile prosthetics that led to


the modern era of penile implants.

1974, THE BIRTH OF THE NEW ERA OF PENILE


IMPLANT SURGERY
The year 1974 marked the first time in the history of the
annual meeting of the AUA that groups from two U.S. in-
stitutions, the University of Miami and Baylor University, pre-
sented their experience using a penile prosthesis for the treatment
of patients with ED. The members from the Baylor group were
Gerald Timm, PhD, William E. Bradley, MD, and F. Brantley
Scott, MD, and the physicians from the Miami group were
Michael P. Small, MD, and Hernan M. Carrion, MD. The two
papers from the Miami group presented by Small and Carrion
were titled “Small-Carrion Penile Prosthesis: New Implant for
Management of Impotence” and “Small-Carrion Penile Pros-
thesis: A Report on 160 Cases and Review of the Literature.”18,19
The paper from Baylor was presented by Brantley Scott, titled
“Treatment of Erectile Impotence with an Inflatable Penile
Prosthesis.”19 The year 1974 marked a turning point, when the
penile prosthesis became mainstream, and more urologists took
on the task of treating impotence and treating it successfully.
The course of development of the inflatable penile prosthesis
began in 1969 while the Baylor team, consisting of Timm (en-
gineer), Bradley (neurologist), and Brantley Scott, were actively
involved in bladder physiology and neurophysiology research.
While experimenting with urethral compression devices that Figure 9. Prototype for the first inflatable penile prosthesis.
ultimately would become the artificial urinary sphincter, the Figure 9 is available in color online at www.smr.jsexmed.org.
team formulated the idea for the inflatable penile prosthesis. A
urology fellow asked if the same hydraulic technology used in the implant from IPI to AMS 700 and introduced several modifi-
sphincter device could be adapted to pressurize an expandable cations. Most importantly, the AMS 700 model replaced the
cylinder to inflate the corpora cavernosa.20,21 Despite the skep- single-layer silicone cylinders with a new cylinder that consisted
ticism of Scott and Bradley, it was Timm who initially embraced of three layers: two silicone outer layers and an inner fabric
this concept and convinced the group to proceed to develop an woven layer interposed between them. The cylinders were named
inflatable penile prosthesis prototype (Figure 9). The prototype PND (penile non-distensible); however, the woven fabric layer
originally consisted of paired expandable single-layer silicone limited the girth of the cylinder when inflated. This layer was
cylinders with two separate pumps, each with independent later replaced with a polypropylene layer that resembled Dacron
inflation and deflation functions and a pancake reservoir. and allowed for partial expansion of the cylinders.22 This new
cylinder was released in 1987 and termed CX (controlled
After the development of the prosthetic prototype, the team
expansion) and is currently in use today. The Baylor group, with
remained skeptical that the inflatable penile prosthesis would
the addition of Robert Buuck, a business associate of Timm,
function effectively in patients. Therefore, on Christmas Eve of
would form American Medical Systems with the inflatable penile
1972, when few were in the hospital, Brantley Scott went to the
prosthesis and artificial urinary sphincter as the cornerstone of
morgue in Baylor’s Methodist Hospital for a cadaveric trial. They
their medical devices.
were satisfied with the results and continued working with this
device. Fewer than 15 devices were implanted from February In Miami, the group was actively involved in the urologic
1973 through August 1974. The team experimented with mul- management of all voiding aspects of patients with spinal cord
tiple variables in the preoperative, intraoperative, and post- injury. Pathologies such as autonomic hyperreflexia, vesicoure-
operative management ranging from antibiotic choice to patient- teral reflux, and neurogenic bladder were researched, with their
sized laminar flow boxes. The AMS prototype would ultimately contributions published in the literature. An evolving focus in
go through several iterations before the development of the this cohort of patients was the management of their ED.
current model. The cylinders of the original prototype were Historically, the management of sexual dysfunction, including
prone to develop aneurysms at areas of tunica weakness and in patients with spinal cord injury, was under the control of
deficiency; therefore, in 1983 AMS changed the name of the psychologists. They endorsed and used standard techniques that

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A History of the Penile Implant to 1974 291

included teaching patients how to perform sexual activity using


the “touching only” technique. They also emphasized to the
patients they did not need penile penetration to have pleasure
during sexual activity. For several months, the members of the
Miami group tried to convince the psychologists that the etiology
of ED was of organic origin in most patients. The group
proposed that some form of surgical treatment should be
investigated to correct this dysfunction. Unfortunately, the
psychologists in the University of Miami were opposed to any
surgical treatment for the management of ED; fortunately, the
directors of the spinal cord injury service eventually authorized
this group to evaluate and provide a surgical therapy option.
After a review of the history of penile prosthesis, the Miami
group elected initially to use the single silicone rod published by
Pearman. They followed one of the two standard techniques of
inserting this prosthesis in between the Buck fascia and tunica
albuginea. The distal and proximal ends went from the base of
the penile gland to the suspensory ligaments through a dorsal
penile skin incision. They operated on six patients who were not
happy with this procedure. This was because there was a poor
proximal support resulting in difficulty with penetration and
poor sexual activity. Therefore, they chose to abort this
procedure.
In 1972, Carrion elected to use polyethylene rods as originally
described by Morales et al. He implanted this prosthesis in a
55-year-old African-American man who had ED secondary to a
radical cystoprostatectomy. Three weeks postoperatively, the
patient and his wife demanded immediate removal of his pros-
thesis because of significant pain with sexual activity and a
sensation of near vaginal perforation during intercourse. The Figure 10. Small-Carrion Penile Prosthesis. Figure 10 is available
in color online at www.smr.jsexmed.org.
prosthesis was promptly removed and the polyethylene rod
placement was discontinued shortly thereafter. base of the scrotum toward the anus (Figure 11). Meticulous
Motivated by the two early experiences at the University of dissection was performed to correctly identify the proximal
Miami, the search for a new type of penile prosthesis continued. corporal cavernosal bodies. A 2-cm incision was made in the
Following the lead of the early success with implantable breast proximal corpora bilaterally and the implants were placed. The
prosthesis in plastic surgery, the group believed that a silicone- corporotomies and perineal wound were closed in standard
gel-filled prosthesis placed in the corpora cavernosa would be a fashion. This prosthesis displayed excellent rigidity and flexi-
good option. This concept gave birth to the Small-Carrion Penile bility. In 1978, the Miami group changed their surgical tech-
Prosthesis (Figure 10). This prosthesis consisted of semirigid nique; the implantation was to be done under local anesthesia.
silicone material inserted into the corpora cavernosa, providing Xylocaine diluted with sodium bicarbonate was injected inside
excellent rigidity and flexibility of the penis. This was a simple the corpora cavernosa, creating an artificial erection for
yet highly effective solution to a patient’s ED. Excellent surgical 5 minutes. Then, a stronger solution of the mixture was injected
and functional outcomes were reported throughout the 1970 and at the level of the penile-scrotal junction. Next, a small vertical
1980s, with the Small-Carrion Penile Prosthesis becoming the penoscrotal incision was made and dissection was carried down
most widely placed penile prosthesis during that time. During to corpora. Corporotomies were made and the implants were
the AUA annual meeting in 1974, the Miami group received the placed according to the previous protocol. The augmented im-
first prize for this contribution. plantation technique decreased hospitalization and afforded an
The surgical technique for placement of this implant evolved excellent surgical result.
as quickly as the technology itself. A perineal surgical approach Building on the success of the semirigid and inflatable penile
was used to prevent an incision directly on the phallus with prosthesis, the production of different types of prosthesis from
resultant scar. The patient was placed in the dorsal lithotomy different companies became very popular; at one point, there
position, and a catheter was placed in the urethra for identifi- were at least 15 different types of penile prosthesis available for
cation. A 3- to 4-cm vertical midline incision was made from the the surgical management of ED. Currently, only two companies

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292 Carrion et al

specialist in the research, diagnosis, and management of


patients with ED. In the landmark year of 1974 at the AUA
national meeting, there were only five physicians presenting
their work in the treatment of patients with ED. Today, we
have a plethora of presentations at the AUA national meeting
and various societies dedicated to the study of sexual medicine.
As new technologies emerge and are applied to the surgical
treatment of ED, the future of penile implants will be as robust
as in the past.

ACKNOWLEDGMENTS
We acknowledge Gerald Timm, PhD, for his personal
communication and invaluable insight to the article. In addition,
Alejandro Carrion and Miguel Carrion are acknowledged for
their aid in data collection.
Figure 11. Perineal surgical approach for penile implant as
described by Hernan M. Carrion, MD, and Michael P. Small, MD. Corresponding Author: Rafael Carrion, MD, Department of
Figure 11 is available in color online at www.smr.jsexmed.org. Urology, 2 Tampa General Circle, Mail Stop STC 6, Tampa,
Florida 33606, USA. Tel: þ1-813-205-1820; E-mail: rcarrion@
manufacture penile prostheses in the United States: Coloplast health.usf.edu
and American Medical Systems.
Conflict of Interest: Rafael Carrion is a consultant for Coloplast,
When the oral phosphodiesterase type 5 inhibitors, such as
Endo, and Pfizer Global.
sildenafil citrate, vardenafil, and tadalafil, were released in the
market, many people considered that the era of the penile Funding: None.
prosthesis was over. Unfortunately, these medications did not
provide complete treatment of all ED cases. The penile prosthesis
remains the gold standard for the treatment of patients with STATEMENT OF AUTHORSHIP
medical refractory ED. Recently, there have been great techno- Category 1
logic advances in this field. The current three-piece inflatable (a) Conception and Design
penile prosthesis provides optimal tumescence and detumes- Hernan Carrion
cence, mimicking normal penile erectile physiology. This has (b) Acquisition of Data
made the use of a semirigid rod penile implant somewhat limited Hernan Carrion; Daniel Martinez
in the percentage of total penile implants placed in the United (c) Analysis and Interpretation of Data
Hernan Carrion; Daniel Martinez
States.
We emphasize that the process of implanting a penile pros- Category 2
thesis is not simply a matter of undergoing the surgical procedure (a) Drafting the Article
alone. The patients also must undergo proper counseling and Hernan Carrion; Daniel Martinez
education. Involvement of the patient and his partner should be (b) Revising It for Intellectual Content
Justin Parker; Rafael Carrion
encouraged and all the implications and risks of surgery should
be explained clearly to them. Above all, it is essential to have a Category 3
good rapport between the patient and the physician. (a) Final Approval of the Completed Article
In summary, what has been the true contribution of the new Hernan Carrion; Rafael Carrion
era of penile prosthesis in the management and treatment of
patients with ED? REFERENCES
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