History of Penile Prosthetics in the United States

Erectile dysfunction (ED) has long been described in medical literature, dating back to the writings of Hippocrates in 400 BC.¹. ED continues to be a growing problem that afflicts men of all ages, with a recent study indicating ED’s prevalence in the US to be nearly 18%.² Additionally, a study published in the Journal of Sexual Medicine demonstrated that one in four patients seeking first-time medical consultation for newly diagnosed ED was younger than forty.³ The psychological stress and anxiety ED presents can impair confidence and overall quality of life for patients. In the last century, however, major advancements in the surgical intervention for ED has led to improved function and overall satisfaction for countless patients. The contributions American surgeons and innovators have made to prosthetic technology for use in patients with ED, Peyronie’s disease, penile fractures, traumas, etc., has been invaluable in propelling the field forward to the modern technologies we widely use today.

The first American surgeon accredited with exploring surgical interventions for ED was James Duncan, who in 1895 attempted the first reported penile venous surgery by blocking venous flow through surgical ligation of the dorsal vein. Joe Wooten similarly attempted this in 1902 and Frank Lydston in 1908, both of whom were also unsuccessful.⁴ O. S. Lowsley is credited to have been the first to successfully perform the first dorsal vein plication in 1935, utilizing an advanced perineal crural technique in which he plicated the bulbocavernosus and ischiocavernosus muscles.⁵ In 1948, RT Bergman et al. furthered plication by utilizing inserted rib cartilage for improved rigidity in their reconstruction. There were disadvantages with the utilization of cartilage implantation, however, as the cartilage could curve on itself and become completely absorbed by the body within a decade.⁶

Oswald Swinney Lowsley

Dorsal vein plication

Though not officially published, the first person to implant synthetic material into the penis is thought to be Peter L. Scardino, who used an acrylic stent to treat ED in a spinal cord injury patient.⁷ Willard E. Goodwin and William Wallace Scott at Johns Hopkins Hospital are formally credited with the placement of the first synthetic implant in 1952, utilizing an acrylic stent positioned under Buck's fascia. Acrylic material was advantageous for mainstream use because it was easy to manipulate, not absorbable by the body, and readily available.⁸

Peter Scardino (l), Willard Goodwin (m) and WW Scott (r)

The modern-day silicone implant can trace its birth to research conducted by the National Aeronautics and Space Administration (NASA), which developed high-grade silicone for the purposes of their space program.⁹ Utilizing this cutting edge material, Lash et al. at Palo Alto Medical Clinic implanted silicone under the fascia of the penile shaft to improve outcomes for those suffering from Peyronie’s disease in 1964.⁷ RO Pearman at the University of California Medical Center revised the insertion of the single silicone rod implant in 1967 and changed the positioning from between Buck's fascia and the tunica albuginea to beneath the tunica albuginea to improve comfort for patients. Overall, these early prototypes of penile prostheses had high complication rates along with low durability and were not widely adopted.¹⁰

Scott/Timm/Bradley Device

Small-Carrion Implant

The development of the precursor to the widely used inflatable penile prosthesis (IPP) was by F. Brantley Scott in 1973, a urologist at Baylor College of Medicine. Dr. Scott used a hydraulic mechanism to transfer fluid from the reservoir to inflatable silicone cylinders via a pump. He later served as a founder of American Medical Systems (AMS), based in Minnetonka, Minnesota, to market and sell the device.¹⁰

In 1975 Michael Small and Hernan Carrion in Minneapolis, Minnesota, laid the foundation for malleable implants of the modern era by creating the Small-Carrion semirigid device, which consisted of two sponge-filled semirigid silicone-covered rods for the corporeal bodies. Small and Carrion utilized the perineal approach for implantation to avoid previously seen complications with the dorsal approach. With this implant, the penis remained in a semi-rigid state and could be bent upwards when engaging in sexual activity.¹¹

Subsequently, Finney at the University of South Florida Medical Center in 1977 introduced the Flexi-Rod prosthesis, a paired semirigid implant with a softer core that could be placed beneath the pubis for more comfort as well as a tail that could be trimmed.¹²

Finney Flexi Rod

The first marketable malleable device was introduced by Jonas and Jacob in 1980, consisting of paired silicone wrapped around a central silver core. The structure led to easy implantation and allowed the penis to be straightened without performing a simultaneous corporoplasty. The design also gave patients the ability to voluntarily bend the penis for concealment or straighten the penis when they desired an erection. This prototype enjoyed high overall satisfaction (around 90%) but had drawbacks, including difficulty with concealment. ^13,14 In 1983, AMS (now Boston Scientific) introduced their malleable penile prosthesis, the AMS 600M, which contained a stainless steel wire core with a silicone exterior and a design that better conformed to patient anatomy.¹⁵

Following this, Dacomed introduced the OmniPhase penile implant in 1986. The mechanically activated penile implant could alternate between the flaccid and rigid state and relied on a supporting cable running through the center. It was specifically designed to avoid a fluid pump mechanism. The OmniPhase was later replaced by the DuraPhase prosthesis, which provided better positioning. These devices, however, were not widely adopted as they suffered from cable breakage.⁷ Following this, the Duraphase II penile prosthesis was introduced in 1992, which incorporated a polyethylene disk surrounding a cable core and, along with the AMS 600M and 650 devices, stood as a popular option through the ’90s.¹⁶

In 2004, the Coloplast Genesis was introduced and incorporated a hydrophilic coating, serving as the only malleable implant with an antibiotic coating. Along with the AMS Spectra, the Genesis implant continues to be a popular option in the present day, particularly for those that prefer not to use pump prosthetics.¹⁵

With regards to the two-piece IPP, the release of the AMS Hydroflex inflatable one-piece in 1985 laid the foundation for this realm of penile prosthetics.¹⁷ Along with AMS, Mentor Corporation (now Coloplast), founded in Minneapolis, Minnesota, introduced the Mentor GFS two-piece inflatable prosthesis in 1988. This consisted of a pump and fluid reservoir implanted in the scrotum. The AMS Ambicor prosthesis was introduced in 1994, which replaced the traditional reservoir with a separate scrotal pump that could be used for achieving erections.¹⁸ This prototype continued to undergo multiple improvements, including reshaping of the rear tip extenders (RTE), and continues to be popular in the present day.

Within the realm of three-piece IPP devices, which account for over 80% of the penile implant market in the USA,¹⁹ foundational prototypes were released in the 1980s. Three-piece devices were made up of dual intra-corporal inflatable cylinders, a scrotal pump, and a fluid reservoir.²⁰ In 1983, the AMS 700 was introduced, which included a three-piece prosthesis with polytetrafluoroethylene (PTFE) sleeve covers to prevent additional wear. In 1987 the AMS 700 CX was introduced, which consisted of a silicone core covered by Dacron-Lycra. ²¹ AMS released the improved Ultrex cylinders in 1990, which enjoyed more durability and girth. Improving the function of 3-piece IPP pumps, the Tactile pump was introduced in 2004, and the AMS Momentary Squeeze was introduced to the market in 2006, both of which facilitated quicker and easier inflation and deflation.²² In addressing concerns regarding reservoir auto inflation, Coloplast introduced the Lock-out Valve in 2000, which decreased auto inflation complications down to 1.3%.²³

Advancements and contributions by American surgeons and innovators have laid vital groundwork for the creation of modern-day penile prosthetics. Increased rigidity, durability, and patient satisfaction, as well as decreased postoperative complications, have improved significantly since the first introduction of surgical innovations in 1895. Today, penile prosthetics continue to stand as a safe and effective option in treating patients suffering from ED.

Authors: Amrita Mohanty BS and Omer A Raheem MD
The University of Chicago Medical Center, Pritzker School of Medicine, Chicago, IL, USA

Correspondence: Omer Raheem MD, MSc
Assistant Professor of Surgery (Urology), Gynecology & Obstetrics
The University of Chicago Medical Center, Pritzker School of Medicine
5841 South Maryland Avenue, MC6038, Chicago, IL 60637
Email oraheem@bsd.uchicago.edu

References

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