Complications and Problems of Penile Prosthetic Surgery in a Series of 530 Cases Operated on by the Same Surgeon in Italy
Diego Pozza1*, Carlotta Pozza2
Citation : Diego Pozza, Carlotta Pozza. "Complications and Problems of Penile Prosthetic Surgery in a Series of 530 Cases Operated on by the Same Surgeon in Italy". ARC Journal of Urology.2017;2(2):1–11.
Copyright : © 2017 . This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Penile prosthetic surgery enables completely spontaneous penetrative sex and hence is the definitive solution for men with erectility’s function. Like all procedures requiring the insertion of exogenous material into the body, penile prosthetic surgery is associated with potentially serious complications, mainly due to infection or malfunction of the implant. While major complications may lead to the removal of the implant and thus the unfortunate failure of the surgeon's proposed treatment and disappointment of the patient's expectations, a number of more minor problems may arise which can be resolved without having to resort to removal. The author presents a variety of medical and surgical procedures, based on his more than 30 years (1984-2016) of experience of penile prosthetic surgery, which may be implemented to avoid implant failure.
Erectile Dysfunction, Penile Prostheses, Semi rigid Prostheses, Inflatable Prostheses
Cf: Ceftriaxone
Cp: Ciprofloxacin
Gm: Gentamycin
AMI: Acute MyocardialInfarction
HPP: Hydraulic Penile Prosthesis
CVOD: Corporal Veno Occlusive Dysfunction
1. Introduction
2.Results
The volume of pus increased if the implant cylinders were inflated. Suspecting an infection, it was suggested to the patient that the implant should be removed. However, the patient refused categorically. A solution of iodopovidone in saline was injected into the pericavernous space (Figure. 2) and the cylinders were inflated to flush the solution out 2-3 times. Gentamycin (Gm) was then instilled and kept in loco with the cylinders partly inflated.
This procedure was performed every 8 hours for 7 days, and a progressive reduction in the volume and purulence of the secretion was observed. After 3 days Gm alone was injected, followed by the complete deflation of the implant cylinders. After 5 days no more pus was secreted and the Gm inoculation was stopped. The opening remained closed after 20 days (Figure. 3).
The cylinders were kept at maximum inflation. After another 4 days with no secretion, fever or pain, the cylinders were deflated. Since then the patient has had no further infections and has used the implant regularly from 1992 to date.
Patient, 52 years, with major Corporal- Veno-Occlusive-Dysfunction, (CVOD) received an SSDA GIS silicone implant in 2005. Unsatisfied with its rigidity, in December 2005 he requested a Mentor MARKII IPP. The patient had very intense, frequent sexual activity up to June 2013, when the cylinders suddenly stopped inflating. A new surgical procedure was performed, with antibiotic therapy with Cf, Cp and Gm. The scrotal pump was found to have malfunctioned, so the implant and reservoir were removed. A Coloplast Titan IPP was implanted. Aspiration and drainage were not used. The patient was discharged the next day with modest swelling, left scrotal haematoma and home antibiotic therapy. Onset of septic fever 8 days later. The patient did not present any significant general or local (penile or abdominal) symptoms, apart from slight pain on palpation of the left testis near the pump, which was functioning normally. X ray and US investigations were negative. The patient was hospitalised and given continuous intravenous antibiotic therapy with a mix of kanamycin, bacitracin, vancomycin, Gm, teicoplanin, piperacil lin/tazobactam, tobramycin, Cp, daptomycin and clarithromycin. However, the evening fever did not resolve. Blood cultures proved negative. The antibiotic therapy was modified for another 15 days without any effect on the fever or markers of inflammation (PCR, ESR, leucocytosis).
After 20 days of unsuccessful therapy (June 2013) it was decided to remove all components of the implant, which was apparently infected. No signs of infection were found in any of the removed components. The day after the removal the fever came down and over the next few days the blood chemical markers normalised and the patient's general condition improved.
The patient, who was strongly against having to give uphis sex life, requested another implant. It was considered dangerous to use another hydraulic system so, to avoid predictable scar tissue in his corpora cavernosa, a AMS Spectra malleable implant was implanted 15 days later, with a view to possible insertion of another IPP at a later date. The patient was unsatisfied with this implant and consulted another university hospital. After preoperative broad-spectrum antibiotic therapy for about 20 days, in December 2013 he underwent the removal of the Spectra implant and the implantation of an AMS700 CX IPP.A year later, the patient was well and satisfied with his erectile function.
The incidence of post-operative bleeding is not insignificant, especially in patients under treatment with aspirin and anticoagulants, even though they are normally instructed to stop taking these from 7 days before to 7 days after implantation. Bleeding may be caused by scrotal vascular lesions occurring during access to the corpora cavernosa, whether during positioning of the prosthetic pump or reservoir or from the corpora cavernosa themselves through incompletely closed corporotomy after semirigid or malleable penile prosthetic implant or through the necessarily incompletely closed corporotomy after IPP implantation. To avoid the risk of blood collections or postoperative haematoma, which could give rise to dangerous infections, the short term (24-36 hour) use of closed suction drainage has been proposed [12].
Patient, 52 years, who underwent reimplantation of an AMS 700CX after the breakdown of a similar IPP at the age of 45 years due to vascular problems. The patient had stopped taking aspirin 7 days previously. Following peno-scrotal incision, the cylinder and pump were removed and replaced (maintaining the reservoir) without any particular problems. Suction drainage was used, as with all the author's cases since 2006. The following morning (18 hours later) the drain had aspirated 30 mL; there was no scrotal swelling. The cylinders were deflated and it was decided to remove the drain in the afternoon, before discharge. Four hours later further examination revealed a large (10 x 10 cm) scrotal haematoma and blockage of the drain. Some suction manoeuvres were tried, but were unsuccessful. The patient was transferred to the operating theatre, where the bleeding was found to originate from the suture of the left corpus cavernosum. We inflate the cylinder fully and observed that the bleeding completely stopped. The blood collection was drained and the area flushed with antibiotics; a new suction drain was positioned and the penoscrotal incision re-stitched. The next day there were no signs of hematoma or drainage. The patient was discharged and instructed to keep the cylinders inflated for 10 days (which manoeuvre was facilitated by maintaining the previous reservoir) and to suspend aspirin for a further 15 days. Four years later the implant was still working well.
Patient, 31 years, with normal baseline coagulation parameters, underwent implantation of a Coloplast Genesis 11x22 cm implant via peno-scrotal access, without any particular difficulties. The following morning he presented a large ecchymosis involving the pelvic and genital area, without any hematoma (Figure.4).
The ecchymosis was successfully resolved through medical treatment and observation. A year later the same patient requested a Coloplast OTR IPP, as he was dissatisfied with the rigidity of the Genesis implant. Peno-scrotal access was used, and there were no particular problems with the removal of the Genesis cylinders and insertion of the reservoir, in the retropubic space, and the inter-testicular pump. Closed suction drainage was used. During the night, a large hematoma appeared, involving the scrotal sac and shaft (Figure. 5);
The drain was empty. An immediate exploratory procedure failed to identify the source of the bleeding. The area was flushed with antibiotic solution and a new suction drain positioned. The cylinders were kept fully inflated for two days. The drain, which was empty, was removed after 2 days and the cylinders were kept inflated for 5 days, until the first outpatient follow-up visit. The patient did not have any negative consequences. We referred the patient to a haematologist. Two years later he reported good penetrative activity.
In this case series, two (0.50%) scrotal haematomas were observed in 396 semi-rigid, malleable or single-component IPP, both resolved without surgery. Eight (5.9%) peno-scrotal haematoma were observed after 134 IPP. In a 52-year-old patient, a small, non-surgically-treated scrotal haematoma was thought to be the cause of subsequent IPP infection and removal.
Patient, 68 years, who hadacute myocardial infarction (AMI) at age 60; coronary angiogram at 65 years showed signs of coronary artery disease. He had an adequate erectile response with 5PDEis.At age 66, he underwent Video- Laparoscopic-Radical Prostatectomy for Gleason 6 (3+3) prostate cancer. Since then he experienced good urinary continence, no response to 5PDEis and very weak response to PGE1.He decided to have a ColoplastTitan OTR IPP. Anticoagulant therapy was suspended 7 days before the procedure and Cp begun. The implant was positioned through the peno-scrotal route after spinal anaesthesia. There was some difficulty in dilating the retropubic space, even with a Foley catheter inflated to100 c.c., but it was possible to position a 75 c.c. reservoir without reflux. The pump was positioned in the inter-testicular area and the aspirating drainage was removed after 24 hours. There was no shaft or scrotal problems at 5-day follow-up. The pump could easily be felt, although it was painful. No fever, urination normal. After 7 days the patient recommenced anticoagulant therapy. He began to notice a painless scrotal swelling; no fever. The patient found it difficult to locate the scrotal pump with his fingers. At 28 day follow-up: no fever but a taut, elastic swelling of the scrotum (15 x 15 cm), moderately painful. It was possible to locate the pump and get it to work, with inflation and deflation of the cylinders.US scan revealed that the pump was surrounded by an effusion with a corpuscular appearance. As the situation aroused concern, it was decided to operate. This involved local anaesthesia and deep sedation, antibiotic therapy with Cp; re-incision of the peno- scrotal wound revealed a bloody effusion, partly organised, surrounded by a thick capsule adhering to the surrounding tissue. A large part of the capsule was cautiously resected and the area was flushed with hydrogen peroxide and Gm solution. The pump was positioned in a subdartoic right scrotal pocket (treatment with Cf, amoxicillin-clavulanic acid).There was no secretion from the wound and after 7 days the patient was able to palpate the scrotum and easily identify the testicles and pump. After a month he was able to have satisfactory sexual intercourse.
Patient, 63 years, heavy smoker, who had Peyronie's disease with shaft deviation. An AMS700 Ultrex was implanted in 2008 (peno-scrotalincision, inter-testicular pump, reservoir in retropubic space, Wilson's manoeuvre to correct the curvature, no aspiration and drainage).The patient was discharged the day after surgery. No complications were found at 3-day follow-up. After the first follow-up the patient did not leave himself time to recuperate and took numerous long car trips. After 5 days he complained that he could not find the scrotal pump due to progressively increased scrotal volume (Figure.6);
No fever or pain. At 21-day follow-up a collection of scrotal fluid was found which impeded location and activation of the pump.US examination revealed a homogeneous, non-corpuscular fluid. It was decided to operate (treatment with Cf and Cp; re-incision of the peno-scrotal wound).The prosthetic pump was found to be surrounded by a clear, transparent fluid with the capsule under tension. The fluid was drained and the capsule was removed; bleeding was controlled. After verifying pump function, aspiration and drainage was performed and the scrotum was sutured. The next day the drain was removed and the patient was discharged.15 days later the cylinder inflation-deflation process began, with easy identification and activation of the prosthetic pump. The patient then enjoyed intense sexual activity until 2017, when a new problem developed.
The same patient now aged 73 and under treatment for hypertension, hyperuricaemia and obstructive pulmonary disease, complained of an acute pelvic pain with an episode of gross haematuria. An abdominal US examination performed in another hospital excluded kidney stones but found that the prosthetic reservoir was adjacent to the bladder and there were hyperechoic images in the bladder. From the following morning the patient presented urinary retention and pain in the distal part of the urethra. He returned to the author's surgery, where it was found that the penile implant was functioning correctly and there were no problems with the reservoir. A bladder US examination did not reveal any obvious stones. Solid, roundish formations obstructing the urethral canal could be seen in the distal part of the urethra. A small meatotomy was performed under local anaesthetic with lidocaine cream and two stones, of 5-7 mm diameter, were extracted (Figure.7).
A Foley CH16 catheter was inserted, which reached the bladder easily without encountering any obstructions. After 7 days of antibiotic therapy with Cp the patient underwent a flexible cystoscopy which revealed benign prostatic hyperplasia, detrusor hypertrophy and no bladder stones.
Patient, 68 years, with AMS700 LGX implanted through the infra-pubic route. There were no problems during surgery. The drain was removed after one day, on discharge. On postoperative day 7 the patient developed a significant oedema of the foreskin, with difficulty in retracting it from the glans and considerable local discomfort; no fever. Treatment with oral cortisone for 10 days led to a moderate reduction in the swelling, enabling the glans to be uncovered. After another 10 days the oedema had resolved fully.
Patient, 53 years, with Peyronie's disease, who had received an AMS700 LGX implant by the infra-pubic route. On postoperative day 7 the patient complained of the development of a significant oedema of the foreskin, impeding its retraction from the glans and causing considerable discomfort. After treatment with oral cortisone for 15 days the oedema normalized.
Patient, 52 years, arterial disease, with Coloplast Titan OTR implanted through the infra-pubic route. There were no problems during surgery. The patient developed a significant oedema of the foreskin 7-10 days after surgery. After 5 days the lymphoedema was still present and antibiotic and cortisone therapy were instigated. After 25 days the patient began using the implant. Five days later the foreskin oedema reappeared, creating problems with shaft rigidity. Cortisone therapy was recommenced, and the patient's condition normalised after 7 days. However, the foreskin lymphoedema returned (Figure.8) after his first sexual relations, tending to normalise after cortisone therapy. At this point a circumcision was performed, thus resolving the problem.
The infra-pubic incision could determine a blockage of local lymphatic drainage.
Patient, 51 years, with vascular dysfunction, poor response to PDEi5s and refusal to use PGE1. An AMS700 LGX IPP was inserted through the peno-scrotal route and the reservoir positioned as normal in the peri- vesical area; inter-testicular pump, no drainage. After 8 days the patient reported feeling an egg-shaped swelling in the right groin. This was found to be the reservoir, which had migrated there spontaneously. The implant worked perfectly although with the cylinders deflated it was possible to see the swelling in the right groin, which reduced in volume on inflation of the cylinders. It was suspected that the transverse fascia had not been fully perforated and that the reservoir had been inserted in a sub muscular position. It was decided to re-operate. The reservoir was emptied by inflating the cylinders and removed through a small infrapubic incision. It was then re-implanted in the retropubic space after opening the transverse fascia. To avoid migration of the reservoir tube it was fixed to the transverse fascia. The incision was closed. After 2 months the situation had regularised. The prosthetic system was performing perfectly after 3 years. The patient is satisfied.
Patient, 56 years, with longstanding Peyronie's disease and erectile dysfunc -tion. An AMS700 CXIPP, 18 cm long with+2.0 cm Rear Tip Extender (RTE) was inserted. After 6 months the patient complained of pain in the glans, which was deformed, due to suspected apical extrusion of the right cylinder (figure.9).
It was decided to perform exploratory surgery following antibiotic prophylaxis with Cf and Cp; this involved sub coronal incision,separation of the glans and liberation of the tip of the right corpus cavernosum, which seemed to have been perforated by the cylinder. The cylinder had not reached the outside and therefore there was no reason to suspect bacterial contamination (Figure.10).
Following a small re-incision at the base on the right of the penis and incision of the tunica albuginea, the right cylinder was extracted and the 2.0 cm RTE was replaced with a 1.0 cm extender. The margins of the apical laceration were removed and the wound was sutured with Vicryl 2/0. A small Marlex patch for hernia repair was affixed as a "hood". The right cavernous cylinder was reinserted. After verifying that there was no apical tension, the glans was fixed above the tip of the corpus cavernosum. The cylinders were kept inflated for 5 days and then alternately inflated and deflated for several hours. After 25 days the patient was authorised to recommence penetrative sex. Seven years later, the patient is satisfied and performs regular penetrative sex.
Patient, 36 years, with diabetes and CVOD. An Implantal PP120 silicone implant inserted in 2003. In 2009 the patient complained of pain in the glans and of being able to feel the tip of the left cylinder (Figure.11).
Surgery was performed to free the tip of the corpus cavernosum perforated by the cylinder, which was extracted, and the area was flushed with antibiotics. It was decided not to implant a new cylinder immediately due to the risk of infection. Aspiration and drainage was inserted and removed after 2 days. After discharge, the patient reported that he had acceptable sexual relations with just one cylinder, and preferred not to undergo further surgery.
Patient, 28 years, with CVOD. The procedure involved preparation with Cf and Cp and peno-scrotalaccess. During Hegar dilation of the right corpus cavernosum the crus of the penis was perforated. There was no perineal haematoma. A RTE was inserted in the crus and, with a small perineal incision, affixed to the tunica albuginea with 2 Vicryl 3/0 stitches. Eurogest 11 mm cylinders were inserted into the corpora cavernosa; 21 cm on the left and 19 cm on the right. No postoperative complications. The patient recommenced sexual activity after one month, and remained satisfied at 5 year follow-up.
Patient, 72 years, with diabetes and hypertension. An AMS 700 Ultrex IPP was inserted in 1999, permitting good sexual function. In 2004, the patient reported pain in the left groin at the base of the penis. A small skin swelling had formed which secreted serous fluid on opening. There was no fever, and the implant was working correctly. It was agreed with the patient to perform surgery to remove a small skin lozenge around the tube. The area was flushed with antibiotics (Cp and Gm).The tube was buried and the skin resutured. There were no local or general complications and the patient recommenced sexual activity after 20 days, with which he was still satisfied in 2011 (27).
Two patients, 58 and 64 years, with diabetes and AMS700 Ultrex IPP, presented scrotal inflammation, purulent reaction, skin erosion and emergence of the prosthetic pump 30 and 36 days after the implant procedure (Figure.12).
The patients' general and local condition led to the full removal of the implants. Neither patient wanted to undergo anew implantation procedure, due in part to financial motives [28, 29].
Patient, 53 years, a surgeon by profession, had been in a relationship with a hospital colleague for 10 years but had never had penetrative sex with her due to inadequate penile rigidity, even with 5PDEis.He specifically requested an IPP, and as quickly as possible. He had not informed his partner of his decision. A ColoplastTitan I, was implanted under standard antibiotic preparation through peno-scrotal incision. Aspiration and drainage were not used. The patient was discharged the next day, and there were no postoperative complications. At the first follow-up at 4 weeks the implant was working well and the patient was ready to use it. After 60 days, the patient stated that his partner's reaction was completely negative, that she had been fully satisfied with their non-penetrative sexual relations and that she was so offended by his actions that she had threatened to leave him. The patient therefore requested the implant's removal. It was suggested that he see a psychologist, but his decision was final. His reasoning was determined: "I'd rather have a woman without an implant than an implant and the risk of not finding another partner."The IPP was removed.
There are various "classic" complications which caused removal of the implant in this author's practice. Two distal extrusions were recorded with semi-rigid and malleable implants, but no case of significant infection. Mechanical breakdowns occurred in 14 of 18 single-component IPP(77.7%) and in 25 of 134 (Figure. 13,14).
3. Results and Discussion
References