MENTOR CFS INFLATABLE PROSTHESIS RAINER M. E. ENGEL, M.D. RICHARD L. FEIN, M.D. Baltimore, Maryland, and North Miami, Florida
t:iJsTRACT-A new inflatable penile prosthesis is described. The operative approaches, infrapuhie and scrotal, are discussed and compared. The results of 56 successive implants are presented. The simplicity of the device which combines the usual intra-abdominal reservoir and the scrotal pllmp illto a scrotal "resipump" is discussed. The device has shown a good performance and is a valuable addition to the varieties of penile implants.
Over the past decades, technical developments and refinements in penile prosthetic devices have proliferated. While some have not made it beyond initial trials, others-due to their simplicity-are finding increasingly wider acceptance. A relatively new device in this category is the GFS (girth, flaccidity, and simplicity) inflatable prosthesis by Mentor. The GFS prosthesis consists of a simplified inflatable component device which combines the intra-abdominal reservoir with the scrotal pump into a scrotal "resipump" of 20 or 25-ccholding capacity. The device also incorporates improved snap-lock connectors. Initial information discussing this prosthesis has been published. l Between September, 1987, and July, 1988, we have implanted 56 of these new prostheses. The patients ranged in age from forty-one to eighty-three years (average age 62 years). Patients opted electively for the implant or because they had failed less invasive therapeutic approaches. As in previous studies, the majority of the patients suffered from vasculogenic or diabetic impotence l - 4 (Table I). Twelve patients had previous penile prostheses and requested an exchange. Three of these patient~ had malleable devices. One of the Mentor devices was removed a year and a half earlier because of infection, the other two ll1alleable devices were found to be of poor performance as judged by the patients and their partners. The nine inflatable prostheses Illalfunctioned due to disconnections in the Mentor inflatable devices and aneurvsm forIllation in the AMS device~. '
MAY 1990
I
VOLn.IE XXX\'. :-.lUMBER ,S
Initially, a transscrotal approach was utilized since it offers the advantage of a direct approach to the corpora with easy visualization of the urethra and only minor dissection in the operative area. A disadvantage is the resulting bulge of the tubing in the scrotal area which is subject to manipulation by the patient and may present a cosmetically less acceptable result. A number of patients have been operated on through the infrapubic approach which protects tubing and connectors in the suprapubic fat pad. However, the procedure does require a deeper dissection which on occasion, particularly in very obese patients, may become somewhat difficult.
TABLE
1.
Reasons for implants
Reasons Impotence Vasculogenic Diabetic Psychogenic Unknown Postoperative impotence TURP RRP AP resection Exchange implant Malleable Mentor (2) (1) Jonas Inflatable Mentor (6) AMS (3)
No. 17 14 1 1 2 5 4
3 9
405
After choosing the appropriate approach, a corporotomy is done; the sutures for the closure are placed prior to inserting the cylinders. A scrotal pouch is created to accept the resipump. The four tubing segments are then connected with right-angle or U connectors, utilizing the snap connectors. We encountered a number of complications: scrotal abscess (1), connector separation (7), and tubing leak (2). Some of these probably will occur with lessened frequency since improvements have been suggested for the device. There have been six tubing connector disconnections. The rate of these has decreased rapidly after using either right-angle or U connectors. It is of interest that all of these occurred when a scrotal approach was used. It appears that the suprapubic approach-through the suprapubic fat pad and deeper positioning of connectors and tubing-may offer better protection for the connections. In addition, it is our impression that the curved connectors are less inclined to become disengaged. Also, we recommend that the tubing, particularly for the preconnected devices, be at least 4 cm long for the cylinder tubing and 3 cm for the resipump tubing. Dilation of the tubing using the "green syringe connectors" is probably safer than using the tubing preformer and may decrease the occasional tubing leak; however, this latter problem is more likely due to crushing of the nylon spiral with the shod clamps during assembly. The risk of infection is similar to that of other series in our previous reports 4 - 6 ; the one scrotal abscess seen in this patient group occurred twelve months postoperatively and is difficult to explain. The tubing leaks were very close to the connectors and were dealt with by shortening the tubing and reconnecting the device. Most of the connector disconnects were simply repaired; however, 3 of these patients requested a different device.
1. Fein RL: Clinical evaluation of inflatable penile prosthesIS with combined pump-reservoir, Urology 32: 311 (1988). 2. Small MP, and Carrion HH: A new penile prosthesis for treating impotence, Contemp Surg 7: 29 (1975). _f 3. Scott FB, Bradley WE, and Timm GW: Management 01 erectile impotence, use of implantable, inflatable prosthesis, Urology 2: 80 (1973). 4. Engel RME, Smolev JK, and Hackler R: Experience witl\ the Mentor inflatable penile prosthesis, J Urol 135: 1181 (1986). 5. Engel RME, Smolev JK, and Hackler R: The Mentor inflatable penile prosthesis, Urology 29: 5 (1987). 6. Engel RM: Experience with 300 implantations of the Men~ tor inflatable penile prosthesis, presented at the German Urologl. cal Congress, Stuttgart, West Germany, October 15, 1987.
406
UROLOGY
There were also some complaints of low Volume particularly in those patients where the 20mL resipump was used. Having seen this in 8 patients, we switched to the 2S-mL resipump for all prostheses and in addition, instill more fluid into the cylinders, filling them until the penis becomes full yet remains flaccid before connecting them to the filled resipump. Furthermore, we are contemplating the development of a postoperative injection port to be incorporated into the assembled device. There have been no mechanical problems with the Mentor cylinders, there was no aneurysm, leak, or rupture. Also, none of these complications has occurred with the resipump it. self. As with all implants, we expect that this new device also will undergo continued modifications and improvements. Overall, judging by ease of implant and assessment by patients and partners, the GFS inflatable prosthesis is, indeed, a fine addition to the field of penile pros· theses. Union Memorial Hospit~ 201 E. University Parkway Baltimore, Maryland 21218 (DR. ENGEL) References
I
MAY 1990
I
VOLUME XXXV, ;"IIU
MBEJl5
t:iJsTRACT-A new inflatable penile prosthesis is described. The operative approaches, infrapuhie and scrotal, are discussed and compared. The results of 56 successive implants are presented. The simplicity of the device which combines the usual intra-abdominal reservoir and the scrotal pllmp illto a scrotal "resipump" is discussed. The device has shown a good performance and is a valuable addition to the varieties of penile implants.
Over the past decades, technical developments and refinements in penile prosthetic devices have proliferated. While some have not made it beyond initial trials, others-due to their simplicity-are finding increasingly wider acceptance. A relatively new device in this category is the GFS (girth, flaccidity, and simplicity) inflatable prosthesis by Mentor. The GFS prosthesis consists of a simplified inflatable component device which combines the intra-abdominal reservoir with the scrotal pump into a scrotal "resipump" of 20 or 25-ccholding capacity. The device also incorporates improved snap-lock connectors. Initial information discussing this prosthesis has been published. l Between September, 1987, and July, 1988, we have implanted 56 of these new prostheses. The patients ranged in age from forty-one to eighty-three years (average age 62 years). Patients opted electively for the implant or because they had failed less invasive therapeutic approaches. As in previous studies, the majority of the patients suffered from vasculogenic or diabetic impotence l - 4 (Table I). Twelve patients had previous penile prostheses and requested an exchange. Three of these patient~ had malleable devices. One of the Mentor devices was removed a year and a half earlier because of infection, the other two ll1alleable devices were found to be of poor performance as judged by the patients and their partners. The nine inflatable prostheses Illalfunctioned due to disconnections in the Mentor inflatable devices and aneurvsm forIllation in the AMS device~. '
MAY 1990
I
VOLn.IE XXX\'. :-.lUMBER ,S
Initially, a transscrotal approach was utilized since it offers the advantage of a direct approach to the corpora with easy visualization of the urethra and only minor dissection in the operative area. A disadvantage is the resulting bulge of the tubing in the scrotal area which is subject to manipulation by the patient and may present a cosmetically less acceptable result. A number of patients have been operated on through the infrapubic approach which protects tubing and connectors in the suprapubic fat pad. However, the procedure does require a deeper dissection which on occasion, particularly in very obese patients, may become somewhat difficult.
TABLE
1.
Reasons for implants
Reasons Impotence Vasculogenic Diabetic Psychogenic Unknown Postoperative impotence TURP RRP AP resection Exchange implant Malleable Mentor (2) (1) Jonas Inflatable Mentor (6) AMS (3)
No. 17 14 1 1 2 5 4
3 9
405
After choosing the appropriate approach, a corporotomy is done; the sutures for the closure are placed prior to inserting the cylinders. A scrotal pouch is created to accept the resipump. The four tubing segments are then connected with right-angle or U connectors, utilizing the snap connectors. We encountered a number of complications: scrotal abscess (1), connector separation (7), and tubing leak (2). Some of these probably will occur with lessened frequency since improvements have been suggested for the device. There have been six tubing connector disconnections. The rate of these has decreased rapidly after using either right-angle or U connectors. It is of interest that all of these occurred when a scrotal approach was used. It appears that the suprapubic approach-through the suprapubic fat pad and deeper positioning of connectors and tubing-may offer better protection for the connections. In addition, it is our impression that the curved connectors are less inclined to become disengaged. Also, we recommend that the tubing, particularly for the preconnected devices, be at least 4 cm long for the cylinder tubing and 3 cm for the resipump tubing. Dilation of the tubing using the "green syringe connectors" is probably safer than using the tubing preformer and may decrease the occasional tubing leak; however, this latter problem is more likely due to crushing of the nylon spiral with the shod clamps during assembly. The risk of infection is similar to that of other series in our previous reports 4 - 6 ; the one scrotal abscess seen in this patient group occurred twelve months postoperatively and is difficult to explain. The tubing leaks were very close to the connectors and were dealt with by shortening the tubing and reconnecting the device. Most of the connector disconnects were simply repaired; however, 3 of these patients requested a different device.
1. Fein RL: Clinical evaluation of inflatable penile prosthesIS with combined pump-reservoir, Urology 32: 311 (1988). 2. Small MP, and Carrion HH: A new penile prosthesis for treating impotence, Contemp Surg 7: 29 (1975). _f 3. Scott FB, Bradley WE, and Timm GW: Management 01 erectile impotence, use of implantable, inflatable prosthesis, Urology 2: 80 (1973). 4. Engel RME, Smolev JK, and Hackler R: Experience witl\ the Mentor inflatable penile prosthesis, J Urol 135: 1181 (1986). 5. Engel RME, Smolev JK, and Hackler R: The Mentor inflatable penile prosthesis, Urology 29: 5 (1987). 6. Engel RM: Experience with 300 implantations of the Men~ tor inflatable penile prosthesis, presented at the German Urologl. cal Congress, Stuttgart, West Germany, October 15, 1987.
406
UROLOGY
There were also some complaints of low Volume particularly in those patients where the 20mL resipump was used. Having seen this in 8 patients, we switched to the 2S-mL resipump for all prostheses and in addition, instill more fluid into the cylinders, filling them until the penis becomes full yet remains flaccid before connecting them to the filled resipump. Furthermore, we are contemplating the development of a postoperative injection port to be incorporated into the assembled device. There have been no mechanical problems with the Mentor cylinders, there was no aneurysm, leak, or rupture. Also, none of these complications has occurred with the resipump it. self. As with all implants, we expect that this new device also will undergo continued modifications and improvements. Overall, judging by ease of implant and assessment by patients and partners, the GFS inflatable prosthesis is, indeed, a fine addition to the field of penile pros· theses. Union Memorial Hospit~ 201 E. University Parkway Baltimore, Maryland 21218 (DR. ENGEL) References
I
MAY 1990
I
VOLUME XXXV, ;"IIU
MBEJl5
