Use of CX cylinders in association with AMS700 inflatable penile prosthesis

Recently the triple-layered CX or controlled expansion cylinders were introduced, which consisted of a middle layer of expandable monofilament knitted polypropylene-like material sandwiched between 2 silicone layers. These cylinders provide uniform nonaneurysmal expansion to a girth of 18 mm. CX cylinders were implanted in 34 patients for a variety of situations. The results have been gratifying in each case and patient satisfaction has been high.     

Reliability of AMS M700 inflatable penile prosthesis

Two hundred ninety patients have been followed up for at least one year or longer after implantation of the AMS M700 inflatable penile prosthesis. One hundred twenty-seven males have been followed up for two years or longer. Eighty-six impotent men had a follow-up of eighteen months or longer. The remaining 77 patients were studied for at least twelve months or longer. There have been 3 mechanical failures of cylinders implanted secondary to nonabsorbable surgical sutures remaining from previous prosthetic surgery. There were no reservoir or pump malfunctions. Eight patients had a slow leak from the nonkinking tubing. Since a revision of the manufacturing process of the nonkinking tubing in September, 1983, there have been no further leaks. Life table analysis for survival in this group of patients showed a probability of survival at three years of 97.9 per cent. The satisfaction rate among patients is greater than 90 per cent.     

Cylinder problems with AMS 700 inflatable penile prosthesis

Six cases of cylinder problems encountered in 1986 with the AMS 700 Silastic inflatable penile prosthesis (IPP) were studied in detail. The problems included 1 case of significant penile bending, the development of a cylinder tear, and several cylinder aneurysms. Possible causes of the problems are explored, along with possibilities for prevention of future problems.     

Clinical experience with controlled expansion cylinders. The AMS 700 CX inflatable penile prosthesis

Device manufacturers continue to look for modifications in design to achieve specific objectives directed at improving overall reliability. Changes in design that do not address this extremely significant concern, namely, device reliability, fail in their commitment toward improvement in patient satisfaction. One of the most effective ways to assess the benefits provided by any change in device design is through the clinical trial and study group method, utilizing a large number of implanting surgeons from a variety of backgrounds and with a variety of patients. The results of the clinical trials with the AMS 700 CX cylinders were extremely encouraging. More importantly, the findings of the study group and our own findings have been substantiated through widespread clinical application among an even larger number of implanting physicians. Device reliability should continue to be under serious scrutiny. We, as implanting physicians, are constantly being asked by our patients, "How long can I expect this device to function?" The answer can only be given on the basis of reports such as this and others that address the results of implantation in a series of patients who are followed appropriately year after year. Each year these reports, if brought up to date, will become even more meaningful. Meanwhile, new designs continue to be evaluated in the laboratory and will become a reality only through the suggestions provided by implanting surgeons, whose observations, when relayed to the manufacturer, enable the design engineer to address the specific concerns of both patient and physician. The AMS 700 CX inflatable penile prosthesis with its new controlled expansion cylinders has certainly addressed those concerns for the present.     

Efficacy, safety and patient satisfaction outcomes of the AMS 700CX inflatable penile prosthesis: results of a long-term multicenter study. AMS 700CX Study Group

PURPOSE: We performed a long-term multicenter study of the AMS 700CX 3-piece inflatable penile prosthesis, focusing on longevity, morbidity and patient satisfaction in men implanted up to 134 months with a median followup of 47.7 months. MATERIALS AND METHODS: We performed a large scale retrospective multicenter study in 2 phases. Phase 1 was a medical record review of 372 men who underwent implantation with the AMS 700CX penile prosthesis from 1987 to 1996 by 7 frequent penile prosthesis implanters. Phase 2 included a structured telephone interview of 207 patients by a neutral observer. RESULTS: For the 372 men in phase 1 mean device mechanical reliability plus or minus standard deviation was 92.1% + or - 3.3% after 3 and 86.2% + or - 4.6% after 5 years. Patient age was 21 to 79 years (mean 57.6 + or - 11.0) at implantation. The etiology of erectile dysfunction was vascular in 27.7% of the cases, Peyronie's disease in 16.9%, diabetes mellitus in 12.9% and radical surgery in 11.6%. Of the men 55.6% received previous treatment for erectile dysfunction. Postoperative infection and device malfunction developed in 3.2% and 17.5% of the cases, respectively. Of the 207 men interviewed in phase 2, 86% still had an AMS 700CX penile prosthesis implanted, including 87.1% with erection suitable for coitus. Currently 79% of those with a device use it at least twice monthly and 88.2% would recommend an implant to a relative or friend. CONCLUSIONS: The AMS 700CX penile implant produced suitable erection and excellent patient satisfaction at long-term followup in the majority of men. Implant reliability is excellent and postoperative morbidity is low.     

Implantation of model AMS 700 penile prosthesis: long-term results

The American Medical Systems inflatable penile prosthesis has undergone periodic design changes to improve device reliability and longevity while maintaining a high degree of patient and partner satisfaction. Previous data reported from this institution did not consider these frequent design changes and the assessment of device reliability incorporated consecutive cases involving several different designs. This study was designed to evaluate followup data on 120 patients who received the model 700 inflatable penile prosthesis, permitting assessment of device reliability of a single design. Two groups were evaluated: a pre-fix group of 57 patients and a post-fix group of 63 patients. Over-all, 11.7 per cent of the total group required revision (21 per cent of the pre-fix and 3.2 per cent of the post-fix groups). Careful life-table analysis of the results with the current model 700 device (post-fix) reveals that this model has a 97 per cent chance of maintaining normal mechanical function for 3 years. Further assessment of these patients in the future will provide additional data on long-term reliability of this design.     

Implantation of AMS 700 LGX penile prosthesis preserves penile length without the need for penile lengthening procedures

Implantation of an inflatable penile prosthesis (IPP) is a well-established definitive solution for erectile dysfunction when conservative treatments fail. Penile implants may shorten the penis. The AMS 700 LGX IPP is in common use but reports on its mechanical reliability, medium-term postsurgical patient satisfaction, and mean penile length preservation are lacking. We investigate the mean penile length, mechanical reliability, and patient satisfaction at 6 and 12 months after implantation of the AMS 700 LGX. This prospective study consecutively enrolled men undergoing first-time IPP implant surgery from February 2009 to April 2012. Stretched flaccid penile length, penile length at 50% and 100% of stiffness (P50 and P100) and International Index of Erectile Function (IIEF) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores, were measured at 6 and 12 months postsurgery. Of 45 patients who underwent AMS 700 LGX implantation (median age 61 years) and completed 6 months’ follow-up, 36 (80%) completed the study. A significant difference in stretched flaccid penile length was seen between 6 and 12 months (P = 0.033). P100 was also significantly increased at 6 and 12 months, with a mean 10% increase (1.3 ± 0.4 cm) from baseline to 12 months. Differences in mean IIEF scores at 6 and 12 months were significant for the desired domain (P = 0.0001) and for overall satisfaction (P = 0.002); however, mean EDITS scores at 6 and 12 months were not significantly improved. AMS 700 LGX is a powerful tool for preserving penile length in men undergoing penile prosthesis implantation.     

Mechanical reliability of the AMS 700CXM inflatable penile prosthesis for the treatment of male erectile dysfunction

PURPOSE: The AMS 700CXM inflatable penile prosthesis with medium controlled expansion cylinders was introduced in 1990 to provide a device with controlled expansion in girth and fitness for Asian men. We reviewed our experience with the AMS 700CXM prosthesis with particular regard to postoperative complications and reliability. MATERIALS AND METHODS: From January 1991 to April 1999, 273 men with erectile dysfunction underwent primary penile prosthesis implantation with the AMS 700CXM. Functional status of the prosthesis was assessed retrospectively by reviewing the medical records and a telephone interview. RESULTS: Patient age was 24 to 78 years and mean followup was 49 months. Of the 28 complications (10.3%) 8 (3%) were nonmechanical and 20 (7.3%) were mechanical. Nonmechanical complications included infection in 2 cases, erosion in 3, surgical complications in 2 and tube kinking in 1. Mechanical complications involved a cylinder tear in 11 cases (4%), pump failure in 4 (1.5%) and a reservoir tear in 2 (0.7%). Mechanical reliability of the device was 98.2% after 2, 95.7% after 3 and 90.4% after 5 years. CONCLUSIONS: The AMS 700CXM is suitable for Asian men and its mechanical reliability is excellent. However, more device modifications are needed to guarantee good reliability during long-term followup.     

Patient and partner satisfaction with the AMS 700 penile prosthesis.

Patient and partner satisfaction with the use of an AMS 700 inflatable penile prosthesis was evaluated by reviewing the records from 387 patients and questionnaires completed by 272 of these patients. The evaluation demonstrated that 83% of the patients and 70% of the partners were satisfied with use of this device. Couples who reported the lowest levels of satisfaction were characterized by men who required more than 1 procedure for prosthesis implantation. Pain and appearance of the penis were the most common causes for dissatisfaction with the device. Results from this evaluation recognize the importance of careful surgical technique to avoid any surgical complications but, more importantly, they emphasize the need for physician-manufacturer interaction to maximize mechanical reliability of the prosthesis.     

Mentor inflatable penile prosthesis

The new Mentor prosthesis is similar in appearance to the Scott inflatable penile prosthesis, consisting of a pump, a reservoir, and two penile cylinders. The penile cylinders of the Mentor prosthesis are constructed of Bioflex polyurethane, a new polymer which is more durable and less elastic than silicone. The use of Bioflex cylinders should increase device longevity and eliminate cylinder aneurysms. It also may be possible to correct penile deformities produced by silicone cylinders which have formed aneurysms by replacing the dilated cylinders with Bioflex cylinders. The new Mentor prosthesis utilizes snap-on connectors which rely on plastic clamps rather than suture ties to fix tubings to connectors. This method of attaching tubing to connectors will reduce operating time and should reduce the incidence of connector leaks.     

Mentor inflatable penile prosthesis

Technical complications requiring frequent surgical revision of the most commonly used penile component prosthesis have led to the development of a new inflatable device that has been implanted in 202 patients. This hydraulic device provides excellent functional qualities; no connector separations, aneurysms, or ruptures have been encountered in these patients. Reoperations became necessary in 8 per cent of these patients. Cosmetic and functional results are good, and patient acceptance has been excellent.     

AMS malleable penile prosthesis

The American Medical Systems (AMS) malleable penile prosthesis was implanted in 57 patients from January, 1983 to 1985. Fifty-one per cent of the procedures were performed under local anesthesia, and 28 per cent in ambulatory (day) surgery. The prosthesis was evaluated in terms of cosmetic result, patient satisfaction and function, and postoperative complications. Ninety-one per cent of patients were satisfied with their decision to select the malleable prosthesis, and 66 per cent reported no difficulty with concealment. A comparison is made with data available from the alternative Jonas malleable prosthesis.     

A clinical evaluation of AMS 700 penile prosthesis in the treatment of impotence

The AMS 700TM & 700 CXTM penile prosthesis was implanted in 34 organic and mixed-type impotent patients between November, 1984 and July, 1988. The patients' ages ranged between 32 and 70, with an average age of 57.2. Twelve weeks after implantation, the prosthesis was evaluated in terms of patient satisfaction with sexual intercourse and postoperative complications. Twenty three patients (67.7%) were highly satisfied, 7 (20.3%) satisfied, 3 (8.8%) dissatisfied and 1 patient worsened (2.9%). Severe complication was found in two cases, both of them being complicated by infection; as a result the prosthesis was removed. Utility of the prosthesis, e.g. effectiveness and safety was; high utility in 26 cases (76.5%), moderate utility in 7 cases (20.6%), and no favorable in one case (2.9%). Thus, overall effectiveness and safety of the AMS 700 penile prosthesis, with its excellent cosmetic appearance upon implantation, were demonstrated by the above findings.     

Scott's inflatable penile prosthesis: evaluation of mechanical survival in the series 700 model

The series 700 penile prosthesis was implanted in 131 patients. Actuarial analysis revealed survival of the cylinders to be 98 per cent at 1 year and 92 per cent at 36 months. The only additional failures were leaks in the reinforced tubing in 9 cases. No tubing leaks have occurred since revisions were made by the manufacturer in October 1983.     

Outpatient 3-piece inflatable penile prosthesis

The 3-piece inflatable penile prosthesis was implanted in 74 consecutive organically impotent outpatients during the last 4 years. The classical infrapubic surgical approach required minor alterations to adapt to the outpatient setting. This cost-reducing technique is safe medically and cogent financially.     

Experience with the Mentor inflatable penile prosthesis

We present our experience with the new Mentor inflatable penile prosthesis for the treatment of organic impotence. Technical complications requiring frequent revision of the most commonly used inflatable prosthesis have led to the development of a new device, which we have used in 116 patients. This hydraulic device provides excellent functional qualities. No connector separations, aneurysms or ruptures have been encountered. Reoperations became necessary in 10.5 per cent of the patients. Cosmetic and functional results were good, and patient acceptance has been excellent.     

Five-year followup of the Scott inflatable penile prosthesis and comparison with semirigid penile prosthesis

The Scott inflatable penile prosthesis remains one of the most popular devices available for the surgical treatment of impotence despite high complication and reoperation rates. We present our 5-year followup of 116 inflatable prostheses placed before 1981 in 85 patients, with a 61 per cent overall 5-year complication rate. The incidence of complications by year after operation showed that most (22 per cent) devices failed within 1 year after implantation, with failure rates gradually decreasing to 6 and 7 per cent during years 4 and 5, respectively. Of 85 patients receiving an inflatable prosthesis 61 per cent underwent reoperation during the 5-year followup. A 5-year overall complication rate of only 14 per cent was seen in 29 Small-Carrion semirigid prostheses implanted during the same time. The results of numerous recent improvements in the design and structure of the Scott inflatable penile prosthesis to prevent mechanical device failure remain to be tested over the long term.     

An unusual complication of the inflatable penile prosthesis

We report a case of erosion of a corporeal cylinder of the Mentor penile prosthesis. The management and possible etiology are discussed.