Malleable Prosthesis Research Articles

Malleable Implant Substitution for the Management of Penile Prosthesis Pump Erosion: A Pilot Study

Managing isolated scrotal pump erosion or infection in patients with inflatable penile prosthesis (IPP) is a challenging problem. We describe our malleable implant substitution technique to address this problem. The aim of this study was to describe and assess the outcomes of the malleable implant substitution technique. In this retrospective case series, six patients underwent removal of the infected and/or eroded scrotal pump, and replacement of the entire IPP with a malleable prosthesis. This procedure was only performed in men in the absence of penile pain on palpation or overwhelming sepsis. The procedure utilized components of the Mulcahy washout protocol with loose scrotal wound approximation and drains as necessary. The main outcome is a recurrent infection rate and prosthesis functionality of the malleable implant substitution technique. All six men who underwent the procedure have done well and remain infection-free. Two men have undergone conversion from a malleable prosthesis back to IPP. Three are considering conversion to an IPP as they are satisfied with their current malleable prosthesis function. One man had a distal erosion of the malleable prosthesis that necessitated complete removal. We believe the malleable implant substitution technique provides an excellent option for management of isolated scrotal pump erosion or infection and prevents the problems associated with the other common management strategies.

Immediate Insertion of a Semirigid Penile Prosthesis for Refractory Ischemic Priapism

The insertion of a penile prosthesis for reduction of ischemic priapism has previously been described for cases of sickle cell disease, delayed presentation, or failure of previous shunt surgery. We report the first case of immediate insertion of a malleable prosthesis as primary surgical therapy for refractory ischemic priapism in a patient with known preexisting erectile dysfunction. We propose a novel management algorithm incorporating the acute insertion of a penile prosthesis as an effective option in the management of refractory ischemic priapism.

Peyronie's Disease: State of the Art and Future Perspectives

Peyronie's disease (PD) is characterized by the onset of a fibrous plaque within the tunica albuginea of the penile corpora cavernosa, resulting in pain and bending during the erection, which can make the intercourse difficult or impossible. Evidence from literature supports the autoimmune etiology of PD, and suggests genetic and familiar conditions, penile traumatisms and history of genital tract diseases as risk factors, even though no definitive conclusions arise about the pathogenesis of the disease. Few randomized trials demonstrated that medical therapies, such as Vitamin E, Colchicine, Potassium amminobenzoate, Tamoxifen and injection therapy with Verapamil are effective in stabilizing the acute phase of the disease. Extracorporeal shock wave therapy (ESWT) and ionophoresis cannot be considered as first line or gold standard therapies. Satisfactory results have been published about Nesbit operation in large number of cases with low-stage disease, whereas plication procedures have shown significant rates of relapse. High incidence of long-term penile retraction have been reported in high-stage disease treated with plaque incision and simple graft insertion. Malleable, soft or inflatable prostheses combined with graft implant have given the best results in terms of penile straightening and lengthening and patients’ satisfaction. In conclusion, the PD etiopathogenesis hasn't been clearly understood-yet, no medical therapy is fully effective; surgery remains therefore the gold standard in case of severe deformity and/or erectile dysfunction.

Penile Reconstruction by the Free Scapular Flap and Malleable Penis Prosthesis

: Penile reconstruction has always been a challenging problem for plastic surgeons while facing patients with severe congenital deformities and gender dysphoria and those who have suffered penile loss because of trauma, self-amputation, malignancy, and so on. Since 1936, when Bogoras first constructed a total penis, attempts have been made by different techniques, including skin flaps or myocutaneous flaps. And with development of free tissue transfer and microsurgical techniques, various free skin flaps, such as the radial free forearm flap, the superficial inferior epigastric artery flap, the superficial circumflex iliac artery flap, have been attempted for phallic construction, with the goal of functional (including a competent neourethra that allows voiding while standing and sexual intercourse) and cosmetic result. The purpose of our study was to evaluate the scapular free flap and implantation of malleable penile prosthesis for penile reconstruction. : Since March 2000, 20 patients with penile loss were reconstructed in a 1-stage procedure by transferring scapular flap and implantation of a malleable penile prosthesis. The age of the patients ranged between 21 and 36 years old. Of these patients, 12 had penile amputation resulting from an electric accident; the other 8 were self-amputated. : All the flaps remained 100% viable postoperatively. Follow-up ranged from 1 to 5 years. There were no cases of urethral fistula, urethral stenosis, prosthesis extrusion, or infection. The reconstructed penis yielded satisfactory function and esthetic appearance. : The scapular free flap is an ideal flap that achieves satisfactory function and esthetic appearance for penile reconstruction because of its adequate amount of tissue, reliable vascularity, acceptable donor-site morbidity, and reliable blood supply.

Peyronie’s disease: state of the art and future perspectives

Peyronie's disease (PD) is characterized by the onset of a fibrous plaque within the tunica albuginea of the penile corpora cavernosa, resulting in pain and bending during the erection, which can make the intercourse difficult or impossible. Evidence from literature supports the autoimmune etiology of PD, and suggests genetic and familiar conditions, penile traumatisms and history of genital tract diseases as risk factors, even though no definitive conclusions arise about the pathogenesis of the disease. Few randomized trials demonstrated that medical therapies, such as Vitamin E, Colchicine, Potassium amminobenzoate, Tamoxifen and injection therapy with Verapamil are effective in stabilizing the acute phase of the disease. Extracorporeal shock wave therapy (ESWT) and ionophoresis cannot be considered as first line or gold standard therapies. Satisfactory results have been published about Nesbit operation in large number of cases with low-stage disease, whereas plication procedures have shown significant rates of relapse. High incidence of long-term penile retraction have been reported in high-stage disease treated with plaque incision and simple graft insertion. Malleable, soft or inflatable prostheses combined with graft implant have given the best results in terms of penile straightening and lengthening and patients' satisfaction. In conclusion, the PD etiopathogenesis hasn't been clearly understood-yet, no medical therapy is fully effective; surgery remains therefore the gold standard in case of severe deformity and/or erectile dysfunction.

Factors influencing the outcomes of penile prosthesis surgery at a teaching institution

Objectives To evaluate the long-term outcomes of penile prosthesis surgery at a teaching institution. Methods Patients who had penile prosthesis surgery from 1988 to 1999 at a private teaching hospital and the Dallas Veterans Affairs Medical Center were identified and charts abstracted for age at first prosthesis, ethnicity, etiology of impotence, comorbid medical disease, previous treatments, surgeon, type of prosthesis, perioperative complications, social history, and outcome. Patient outcomes were determined either from recent clinical documentation within the prior year or by telephone survey of patients. Frequent implanters were defined as those surgeons who performed more than 10 procedures during the study period. Kaplan-Meier curves were used to evaluate survival for patients and prostheses; statistical significance was assessed by the log-rank test. Results A total of 152 patients were identified, 81 patients at the Veterans Affairs Medical Center and 71 patients at the private hospital. A total of 180 procedures were performed by 15 attending surgeons, 4 of whom performed most (n = 132) of these procedures. No statistically significant difference was noted in patient age between the two hospitals. No statistically significant differences were found in survival of the penile prostheses on the basis of a history of smoking, diabetes, hypertension, or coronary artery disease. First prostheses had statistically significant better survival compared with secondary prostheses (5-year rate 71% versus 42%; 10-year rate 60% versus 35%, P = 0.0002). The overall infection rate at final follow-up was 9.9% and 18.8% for primary and secondary prostheses, respectively ( P = 0.03). The 5-year survival outcomes with first prostheses for frequent implanters were superior to those of infrequent implanters (70% versus 63%, P = 0.034). Malleable prostheses had fewer complications than three-piece inflatable prostheses (10-year survival rate 87% versus 50%, P = 0.0081). Conclusions Superior penile prosthesis outcomes were achieved with first penile prostheses when implanted by higher volume implanters. Meticulous technique and experience are important in all penile prosthesis surgery; however, outcome analysis emphasizes that the differences in outcomes are most apparent with first prostheses, which represent the best opportunity for the patient to achieve good results.

Ventral, subcoronal, and penoscrotal penile approach for semirigid rod penile prostheses

Autologous cartilage and bone grafts that are used for internal splinting as prosthetic materials have been performed historically, but long-term results have been poor [1]. Advances in treatment enabled the use of synthetic materials (acrylic rods), as described by Goodwin and Scott in 1952 [3]. Semirigid rod penile prostheses were introduced in the early 1970s, relatively close to the advent of hydraulic prostheses. Initially, semirigid rod implants readily were accepted because of the relative simplicity of insertion and use. Although semirigid rod and hydraulic implants have a high rate of satisfaction, the inflatable or hydraulic prostheses now make up more than 90% of the market. Inflatable prostheses are more desirable in terms of increased rigidity and flaccidity. Nonetheless, semirigid rod penile prostheses are still applicable and have potential advantages, including: • Low rate of mechanical failure • Adequacy of erections • Ease of insertion • Extensive applicability to pelvic surgery patients • Little manual dexterity needed for operation • Less anxiety, compared with the anxiety of cycling a hydraulic device • Lower financial costs and operating time • Aid in placement of external condom catheter in spinal cord Disadvantages include a greater risk for pressure necrosis from the rods compared with the risk with inflatable devices, especially in patients with absent or decreased penile sensation. This problem results from the lack of flaccidity, a disadvantage that makes inflatable devices are more marketable. Another disadvantage is the increased difficulty in peforming endoscopy. Semirigid rod prostheses are available as malleable or mechanical types (Table 1). The mechanical prosthesis from Timm Medical Technologies (Eden Prairie, MN) primarily is composed of polyethylene segments and an outer layer of silicone. The malleable prostheses, available from American Medical Systems (Minnetonka, MN) and Mentor (Santa Barbara, CA), are designed as a core of bendable wire with a silicone sheath.

Penile Prosthesis Implantation and Couple’s Satisfaction

Objective: Implant surgery is the most acceptable curative choice for patients with erectile dysfunction and their partners, since the results are excellent with regard to the couple’s pleasure and the materials used are extremely manageable Materials and Methods: We performed 46 prosthesis implantations in patients with erectile dysfunction: in 22 patients we implanted soft prostheses; in 20 malleable prostheses; in 1 a mono-component prosthesis, and in 3 patients a tri-component model. All patients and partners were evaluated using a questionnaire. Results: We obtained a degree of satisfaction equal to 82% against 18% dissatisfaction due to a sensation of ‘unnaturalness’ report by the partner, with low perioperative and postoperative complications. Conclusion: In our opinion the degree of satisfaction of the patient is currently the only legitimate indicator to establish the effectiveness of therapy.

Infection control in outpatient unicomponent penile prosthesis surgery.

The aim of this work is evaluate the efficacy of infection control measures with unicomponent penile implants in two ambulatory surgery units in Cairo and Jeddah. This was a retrospective study of 117 consecutive cases. A patient selection and infection control protocol was followed to implant 12 hydraulic, 53 mechanical and 52 malleable prostheses under local bupivacaine penile ring anesthesia and intravenous propofol. No infection occurred that required prosthesis removal, none required hospitalization or urinary catheterization, one crural and two septal perforations were managed intraoperatively; one case was reoperated upon for mechanical failure, two for oversizing and one for undersizing the girth. We conclude that implantation of unicomponent penile implants under triple antibiotic coverage in an ambulatory surgery setting, with rigid infection control measures appears to be effective in preventing infection.

MANAGEMENT OF IMPENDING PENILE PROSTHESIS EROSION WITH A POLYTETRAFLUOROETHYLENE DISTAL WIND SOCK GRAFT

Purpose Erosion of penile prostheses can be calamitous, often leaving patients unable to accommodate further implants. There is a paucity of literature describing impending erosion of penile prosthesis. We report on 5 patients with impending erosion of a penile prosthesis who underwent polytetrafluoroethylene distal wind sock graft placement. Materials and Methods From 1993 to 1997, 5 patients with a mean age of 49 years and impending penile prosthesis erosion underwent 6 revisions using a polytetrafluoroethylene distal wind sock graft. Two patients underwent simultaneous bilateral grafts while 1 patient underwent separate right and left grafts 3 years apart. Indications for reconstruction included distal migration of the prosthetic cylinders into the glans in 4 patients and impingement of the distal urethra in 2. Of the patients 3 were spinal cord injured, 1 had lumbar radiculopathy and 1 had a history of pelvic irradiation. Inflatable prostheses were implanted in 4 patients, while 1 received a malleable prosthesis. Results Patients underwent a mean of 1.5 penile prosthetic revisions (0 to 4) before diagnosis of impending erosion. An interval of 8 to 144 months (mean 66) elapsed from the most recent penile prosthesis insertion until distal wind sock graft placement. Mean operative time was 1 hour 51 minutes (1.3 to 2.5 hours). Mean hospital stay was 6.3 days (3 to 12). At a mean followup of 32 months (0.7 to 5.2 years) all patients had satisfactory and functional erections with no pain or evidence of impending erosion or penile prosthesis infection. Conclusions Erosion of a penile prosthesis can have disastrous consequences. We describe a safe and effective technique for managing impending penile prosthesis erosion using a polytetrafluoroethylene distal wind sock graft.

Fifteen Years Experience of Penile Prosthesis Insertion

Introduction and objectives To review the outcome and patient satisfaction of penile prosthesis insertion over a 15 y period. Patients/materials and methods We reviewed the notes of 172 patients who underwent penile prosthesis insertion between January 1980 and May 1995. From the notes information was determined on age of the patient, type of prosthesis, surgical approach and length of stay. Also noted were risk factors for erectile dysfunction and the aetiology. Twenty patients were known to have died or moved away. To assess the impact the operation had on quality of life, 152 questionnaires were sent of which 103 were returned (67%). The questionnaire gained information about sexual activity, before and after the operation and the overall satisfaction of the patient and his partner and whether they felt the operation was a success. Results Overall 149 patients were known to have had malleable prostheses inserted and 23 had inflatables. The commonest organic groups were vascular disease, diabetes and Peyronies disease. Fifteen patients had two procedures. Four patients required revision of the prosthesis due to erosion, and there was one death due to pulmonary embolism. One hundred and three completed questionnaires have been returned to date the median time since operation was 4 y, the range being six months to 16 y and 78% thought the operation was a success. Conclusions The insertion of malleable prostheses is associated with low complication rates, good patient satisfaction and improved quality of life for the couple. Concealment was not a major problem.

Fifteen years experience of penile prosthesis insertion.

To review the outcome and patient satisfaction of penile prosthesis insertion over a 15 y period. We reviewed the notes of 172 patients who underwent penile prosthesis insertion between January 1980 and May 1995. From the notes information was determined on age of the patient, type of prosthesis, surgical approach and length of stay. Also noted were risk factors for erectile dysfunction and the aetiology. Twenty patients were known to have died or moved away. To assess the impact the operation had on quality of life, 152 questionnaires were sent of which 103 were returned (67%). The questionnaire gained information about sexual activity, before and after the operation and the overall satisfaction of the patient and his partner and whether they felt the operation was a success. Overall 149 patients were known to have had malleable prostheses inserted and 23 had inflatables. The commonest organic groups were vascular disease, diabetes and Peyronies disease. Fifteen patients had two procedures. Four patients required revision of the prosthesis due to erosion, and there was one death due to pulmonary embolism. One hundred and three completed questionnaires have been returned to date the median time since operation was 4 y, the range being six months to 16 y and 78% thought the operation was a success. The insertion of malleable prostheses is associated with low complication rates, good patient satisfaction and improved quality of life for the couple. Concealment was not a major problem.

Implant surgery in Peyronie's disease.

The etiology and evolution of Peyronie's disease are not well known, and this certainly affects patient management. If spontaneous regression or stabilization of the disease is lacking, actually all therapies, except surgery, seem to be only partially successful. We attended 88 patients affected by Peyronie's disease, and 21 patients (23.6%) were referred for surgery and penile implantation; plaque excision was necessary in 8 patients (38.1%). We implanted 10 malleable prostheses and 11 soft prostheses. So far, potency has been the only parameter for evaluating the results of surgery, but in our view both the patient and his partner should be satisfied aesthetically and functionally.

Clinical Experience with Inflatable and Malleable Penile Implants in 104 Patients

Penile prosthesis was implanted for erectile impotence of mainly organic origin in 104 patients. The AMS Dynaflex penile prosthesis was inserted in 39 cases, the AMS Malleable 600 prosthesis in 61 and the AMS Ultrex Plus prosthesis in 4. In 1 patient receiving a malleable prosthesis both rods had to be removed owing to erosion into the urethra and reimplantation was performed at the same operation. Only 1 patient who underwent implantation of the Dynaflex device had mechanical failure that necessitated surgical revision. After implantation of the new prosthesis both patients had satisfactory intercourse. One Dynaflex penile prosthesis, implanted into a juvenile-onset diabetic, became infected and required removal. Another complication was secondary to spontaneous erosion (noninfected) in 1 patient with malleable prosthesis who suffered loss of only one rod and who is still satisfied with the result. The overall complication rate in our series has been approximately 4%. The rest of the patients report satisfaction with the ability to move the penis voluntarily permitting normal sexual activities as well as normal appearance in the flaccid position. According to our experience, careful preoperative assessment from the views of both patient and device selection along with patient education, and strictly obeying the rules of sterility during implantation and applying systemic and local antimicrobial prophylaxis are essential in obtaining a successful result in prosthesis implantation for the individual patient.

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.

Experience with Jonas malleable penile prosthesis

Experience with the use of the Jonas penile prosthesis in 69 patients is presented, and the implantation of this prosthesis through a penoscrotal incision is described. Use of this prosthesis generally allows the penis to hang in a dependent position or to project outward from the body when coitus is desired. A malleable prosthesis such as the Jonas also has an additional advantage when it is used for treatment of impotence due to Peyronie disease, since its implantation allows the penis to be straightened without performing a simultaneous corporoplasty.