Applicability of vaginal energy-based devices in urogynecology: evidence and controversy.

OBJECTIVE: This study aimed to analyze the evidence and controversies about the use of vaginal energy-based devices (laser and radiofrequency) for treatment of genitourinary syndrome of menopause, recurrent urinary tract infection, urinary incontinence, and genital prolapse through a literature review. METHODS: A search of literature databases (PubMed, Medline) was performed for publications in December 2022. Keywords included genitourinary syndrome of menopause, vaginal laxity, vaginal/vulvovaginal atrophy, urinary tract infection, urgency incontinence, frequency, urgency, stress urinary incontinence, genital prolapses AND energy-based devices, AND vaginal laser, AND vaginal radiofrequency, AND CO2 laser, AND Er:YAG laser. Publications in English from the last 7 years were reviewed and selected by the authors. RESULTS: The literature regarding vaginal energy-based devices in the treatment of urogynecological conditions is primarily limited to prospective case series with small numbers and short-term follow-up. Most of these studies showed favorable results, improvement of symptoms with low risk, or no mention of serious adverse events. Consensus statement documents from major medical societies suggest caution in recommending these therapies in clinical practice until more relevant data from well-designed studies become available. CONCLUSION: The potential of the vaginal laser and radiofrequency as a therapeutic arsenal for the evaluated urogynecological conditions is great, but qualified research must be done to prove their efficacy and long-term safety, define application protocols, and recommend the use of these technologies in clinical practice.

Applicability of vaginal energy-based devices in urogynecology: evidence and controversy

SUMMARY OBJECTIVE: This study aimed to analyze the evidence and controversies about the use of vaginal energy-based devices (laser and radiofrequency) for treatment of genitourinary syndrome of menopause, recurrent urinary tract infection, urinary incontinence, and genital prolapse through a literature review. METHODS: A search of literature databases (PubMed, Medline) was performed for publications in December 2022. Keywords included genitourinary syndrome of menopause, vaginal laxity, vaginal/vulvovaginal atrophy, urinary tract infection, urgency incontinence, frequency, urgency, stress urinary incontinence, genital prolapses AND energy-based devices, AND vaginal laser, AND vaginal radiofrequency, AND CO2 laser, AND Er:YAG laser. Publications in English from the last 7 years were reviewed and selected by the authors. RESULTS: The literature regarding vaginal energy-based devices in the treatment of urogynecological conditions is primarily limited to prospective case series with small numbers and short-term follow-up. Most of these studies showed favorable results, improvement of symptoms with low risk, or no mention of serious adverse events. Consensus statement documents from major medical societies suggest caution in recommending these therapies in clinical practice until more relevant data from well-designed studies become available. CONCLUSION: The potential of the vaginal laser and radiofrequency as a therapeutic arsenal for the evaluated urogynecological conditions is great, but qualified research must be done to prove their efficacy and long-term safety, define application protocols, and recommend the use of these technologies in clinical practice.

Testicular volume and Tanner stage: determinant factors for testicular torsion.

OBJECTIVE: To assess testicular volumes and sexual maturation in patients with testicular torsion. METHODS: A retrospective analysis of consecutively treated patients with testicular torsion between 2016 and 2018. Age, pubic hair staging (Tanner), and by ultrasonography, volume of the unaffected testis (in cubic centimeters) were evaluated either immediately before surgery or at the first postoperative visit. Patients with previous testicular disease, such as cryptorchidism, or with no records of testicular volume were excluded. The analysis included descriptive statistics and Bayesian regression. RESULTS: We treated 149 patients during the study period, and 141 (94.6%, median age 17.3 years) met the inclusion criteria. Median testicular volume was 13.0cm3 (interquartile range of 10.5-15.2), with similar right and left volumes (12.9cm3versus 13.3cm3; p=0.94). Sixty-five (46.1%) patients were Tanner stage IV, 17 (12.1%) stage III, and 59 (41.8%) stage V. CONCLUSION: In this study, we were able to estimate volumes of testicular torsion, which aggregated around late puberty values (13.0cm3 for the whole dataset, 12.2cm3 for patients <25 years), suggesting that testicular hypermobility, due to congenital anatomical abnormalities, remains quiescent until the organ reaches a critical volume, after which torsion becomes possible. These findings provide a tentative explanation for the disease's age distribution.

Testicular volume and Tanner stage: determinant factors for testicular torsion

ABSTRACT Objective To assess testicular volumes and sexual maturation in patients with testicular torsion. Methods A retrospective analysis of consecutively treated patients with testicular torsion between 2016 and 2018. Age, pubic hair staging (Tanner), and by ultrasonography, volume of the unaffected testis (in cubic centimeters) were evaluated either immediately before surgery or at the first postoperative visit. Patients with previous testicular disease, such as cryptorchidism, or with no records of testicular volume were excluded. The analysis included descriptive statistics and Bayesian regression. Results We treated 149 patients during the study period, and 141 (94.6%, median age 17.3 years) met the inclusion criteria. Median testicular volume was 13.0cm3 (interquartile range of 10.5-15.2), with similar right and left volumes (12.9cm3versus 13.3cm3; p=0.94). Sixty-five (46.1%) patients were Tanner stage IV, 17 (12.1%) stage III, and 59 (41.8%) stage V. Conclusion In this study, we were able to estimate volumes of testicular torsion, which aggregated around late puberty values (13.0cm3 for the whole dataset, 12.2cm3 for patients <25 years), suggesting that testicular hypermobility, due to congenital anatomical abnormalities, remains quiescent until the organ reaches a critical volume, after which torsion becomes possible. These findings provide a tentative explanation for the disease's age distribution.

Preliminary report of post-Ophira mini sling implantation voiding pattern: What to learn from pressure-flow studies?

BACKGROUND: The study is amined to correlate the voiding pattern after successful mini sling Ophira implantation with postoperative symptoms and satisfaction, in addition to identifying obstructions. MATERIALS AND METHODS: From 2012 to 2015 in a single institution, all consecutive patients who had stress urinary incontinence treated by using the mini sling Ophira had a pre- and 12 months postoperative urodynamic test. The International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF) and the International Consultation on Incontinence Questionnaire - Overactive Bladder (ICIQ-OAB) translated into Portuguese, were given. Patients were objectively considered cured when presenting no urinary incontinence at the Valsalva test and subjectively cured when the ICIQ-UI-SF was zero. RESULTS: Questionnaire scores were obtained from 29 patients and urodynamic data from 20 patients. Mini sling Ophira implantation resulted in a significant improvement of urinary symptoms evidenced by a significant mean reduction in ICIQ-UI-SF from 16 to 5 (p < 0.0001) and ICIQ-OAB from 8 to 4 (p = 0.0001). The subjective and objective cure rates were 55% and 45%, respectively. The urodynamic changes were not related to success even when adjusted for age, hormonal status, or anterior pelvic organ prolapse. The mean maximum flow decreased to 4.9 mL/s (95% CI: 0.62-10.8; p = 0.035), and the mean detrusor pressure at maximum flow increased to 11.4 cmH2O (95% CI: 4-18; p = 0.0078). CONCLUSIONS: Mini sling Ophira implantation decreased maximum urinary flow and increased the detrusor pressure at the maximum urinary flow and these urodynamic changes were not related to success.

Sacrospinous hysteropexy with an autologous rectus fascia sling for treatment of advanced apical pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: There is a great interest in avoiding mesh usage in vaginal surgeries. We propose using the autologous rectus fascia to repair apical vaginal prolapse in a similar way it has been successfully used in urinary stress incontinence surgery. This study aims to demonstrate the technique of sacrospinous hysteropexy using autologous rectus fascia for apical pelvic organ prolapse (POP) treatment. METHODS: We present a video of a 63-year-old female with stage IV pelvic organ prolapse and urinary obstruction. A rectus fascia sling of approximately 90 × 10 mm was harvested through a Pfannenstiel incision. It was used in vaginal surgery to suspend the cervix and fix the apical POP. RESULTS: The patient resumed her usual activities after 1 week and waited 2 months to resume physical activities and sexual intercourse. She is satisfied at 6 months follow-up, without complications or prolapse recurrence. CONCLUSION: The sacrospinous hysteropexy using autologous rectus fascia is a feasible technique with excellent results and low risk of complication. Further studies are required to compare POP repair using autologous rectus fascia and polypropylene meshes.

A systematic review of penile prosthesis infection and meta-analysis of diabetes mellitus role.

BACKGROUND: Infection is the most feared complication of a penile prosthesis. Diabetes mellitus (DM) is widely known to increase the risk of several infections, but its role in the penile prosthesis is still controversial. This systematic review aims to show the contemporary scenario of penile prosthesis infection and present a meta-analysis about DM contribution to penile prosthesis infection. METHODS: The review was performed with no language or time limitation, including ten databases. The included articles were about the male population who received a penile prosthesis with no model restriction, with a minimum follow up of 1 year, and outcomes adequately reported. RESULTS: The mean infection incidence of penile prosthesis ranged from 0.33 to 11.4%. In early 2000, the general incidence of infection was 3 to 5%, then, the introduction of coated materials decreased it to 0.3 to 2.7%. The meta-analysis showed that diabetes mellitus is related to an increased risk of penile prosthesis infection with an odds ratio of 1.53 (95% CI 1.15-2.04). CONCLUSIONS: Penile prosthesis infection decreased in the last decades but remains a significant cause of reoperation, and it is related to lower prosthesis survival. Meta-analysis concludes that diabetes mellitus is related to a higher risk of penile prosthesis infection.

Step-by-Step Approach for Nerve-sparing Reduction Clitoroplasty.

STUDY OBJECTIVE: To describe a stepwise demonstration of a vaginal approach for nerve-sparing reduction clitoroplasty. DESIGN: Video of a case report. SETTING: Tertiary, academic hospital (Women's Hospital, University of Campinas). INTERVENTIONS: An 18-year-old nulliparous woman consulted with complaints of primary amenorrhea, small development of breasts, and an increase of the clitoris in the last months. A physical examination revealed a 5-cm clitoromegaly, normal but small breasts, and normal vulvar pili. Laboratory examinations showed XY karyotype and increased levels of dehydroepiandrosterone sulfate and follicle stimulating hormone. Surgical planning for reduction clitoroplasty, laparoscopic bilateral gonadectomy, plus removal of the rudimentary uterus was done and performed. The main steps were as follows: The patient was discharged 20 hours after the procedure. The immediate and late postoperative periods occurred with no complications (wound dehiscence, hematoma), and clitoral sensitivity was restored according to the patient's self-report. CONCLUSION: This case shows the importance of nerve-sparing reduction clitoroplasty for reducing the risk of sensitivity loss and/or other complications.

Presentation delay, misdiagnosis, inter-hospital transfer times and surgical outcomes in testicular torsion: analysis of statewide case series from central Brazil

ABSTRACT Purpose To estimate statewide presentation delay, misdiagnosis rate, inter-hospital transfer times and testicular salvage for testicular torsion patients treated in our state's public health system. Patients and Methods Case series of consecutive testicular torsion patients treated in our state's public health system between 2012-2018. Predictors included presentation delay (time from symptoms to first medical assessment), facilitie's level-of-care (primary, secondary, tertiary), first diagnosis (torsion, epididymitis, other), Doppler-enhanced ultrasound request (Doppler-US) and inter-hospital transfer times, with surgical organ salvage as the main response. We used Bayesian regression to estimate the effect of first examining facilitie's level-of-care, first diagnosis, and Doppler-US on transfer time. Results 505 patients were included, most (298, 59%) with presentation delay >6 hours. Misdiagnosis at first examining facility raised transfer time from median 2.8 to 23.4 (epididymitis) and 37.9 hours (other) and lowered testicular salvage rates from 60.3% (torsion) to 10.7% (epididymitis) and 18.3% (other). Doppler-US had negligible effects on transfer time once controlling for misdiagnosis in the regression model. Although organ salvage in patients presenting before 6 hours at the tertiary facility was high (94.6%, and about 20% lower for those presenting at lower levels-of-care), the overall salvage rate was more modest (46%). Conclusion Our low overall testicular salvage rates originated from a large proportion of late presentations combined with long transfer times caused by frequent misdiagnoses. Our results indicate that efforts to improve salvage rates should aim at enhancing population-wide disease awareness and continuously updating physicians working at primary and secondary levels-of-care about scrotal emergencies.

Presentation delay, misdiagnosis, inter-hospital transfer times and surgical outcomes in testicular torsion: analysis of statewide case series from central Brazil.

PURPOSE: To estimate statewide presentation delay, misdiagnosis rate, inter-hospital transfer times and testicular salvage for testicular torsion patients treated in our state's public health system. PATIENTS AND METHODS: Case series of consecutive testicular torsion patients treated in our state's public health system between 2012-2018. Predictors included presentation delay (time from symptoms to first medical assessment), facilitie's level-of-care (primary, secondary, tertiary), first diagnosis (torsion, epididymitis, other), Doppler-enhanced ultrasound request (Doppler-US) and inter-hospital transfer times, with surgical organ salvage as the main response. We used Bayesian regression to estimate the effect of first examining facilitie's level-of-care, first diagnosis, and Doppler-US on transfer time. RESULTS: 505 patients were included, most (298, 59%) with presentation delay >6 hours. Misdiagnosis at first examining facility raised transfer time from median 2.8 to 23.4 (epididymitis) and 37.9 hours (other) and lowered testicular salvage rates from 60.3% (torsion) to 10.7% (epididymitis) and 18.3% (other). Doppler-US had negligible effects on transfer time once controlling for misdiagnosis in the regression model. Although organ salvage in patients presenting before 6 hours at the tertiary facility was high (94.6%, and about 20% lower for those presenting at lower levels-of-care), the overall salvage rate was more modest (46%). CONCLUSION: Our low overall testicular salvage rates originated from a large proportion of late presentations combined with long transfer times caused by frequent misdiagnoses. Our results indicate that efforts to improve salvage rates should aim at enhancing population-wide disease awareness and continuously updating physicians working at primary and secondary levels-of-care about scrotal emergencies.

Can the snapping sound discriminate true from false penile fractures? Bayesian analysis of a case series of consecutively treated penile fracture patients.

Some patients with clinically diagnosed penile fracture actually have a false fracture (no tunica albuginea tear found at surgery). Although previous reports indicate that these patients often do not report hearing a snapping sound (henceforth sound) at injury, there are no studies of the sound's role in this differential diagnosis. To assess if the sound's absence increased the likelihood of intraoperatively diagnosing a false fracture, we retrospectively analyzed 65 consecutive clinically diagnosed penile fracture patients between January 2008 and December 2017, using surgical diagnosis of penile fracture as outcome variable and sound as main predictor, including as covariates age, presentation delay, immediate detumescence after injury, and whether injury occurred during sexual intercourse. Fifty-six patients had penile fracture (86.2%), and most (40, 71.4%) reported the sound, whereas two of the nine patients with false fracture reported the sound (22.2%, p = 0.007, Fisher's exact test). Bayesian logistic regression revealed that the sound was associated with surgical diagnosis of penile fracture (relative odds ratio = 4.25), and the probability of penile fracture fell from 92 to 74% when the sound was not reported among patients injured during intercourse experiencing immediate detumescence. This study followed PROCESS (Preferred Reporting of Case Series in Surgery) guidelines.

Manganese dioxide coating reduces bacterial adhesion and infection in silicon implants in animal model.

PURPOSE: To propose a new coating to silicone implants using Manganese dioxide. We present bacterial adhesion and proliferation when implants are challenged with Escherichia coli. METHODS: Coated and control silicon implants were placed in two independent subcutaneous pouches in the dorsum of Wistar rats. After skin closure, 0.5 ml of E. coli solution was injected in each incision. The animals were euthanized at 7 and 28 days. Extracted material was cultured and analyzed by confocal microscopy. RESULTS: At 1 week, uncoated implants had a 17-fold higher infection rate (p < 0.001). Coated samples showed a mean bacterial count of 28,700 CFU/ml, while the control ones 503,000 CFU/ml, with a significant mean difference of 474,300 CFU/ml (95% CI 165,900-782,600). At 4 weeks, the mean bacterial growth in coated group was 7600; while in control one was 53,890. The mean difference between groups was 46,200 (95% CI 21,100-71,400). Confocal microscopy presented the percentage of implant's surface with attached bacteria: at 7 days, coated implants had 6.85% and controls 10.9% and the difference was not significant (p =0.32). At 4 weeks, the coated group showed 0.98% of the surface with attached bacteria, while control group showed 7.64%, which resulted in a significant 11-fold difference (p = 0.004). CONCLUSIONS: Manganese dioxide coating inhibits bacterial proliferation and adhesion in subcutaneous silicon implants in an animal model. These findings can be useful to improve development of biomaterials.

Predicting urine output after kidney transplantation: development and internal validation of a nomogram for clinical use

ABSTRACT Purpose: To analyze pre-transplantation and early postoperative factors affecting post-transplantation urine output and develop a predictive nomogram. Patients and Methods: Retrospective analysis of non-preemptive first transplanted adult patients between 2001-2016. The outcomes were hourly diuresis in mL/Kg in the 1st (UO1) and 8th (UO8) postoperative days (POD). Predictors for both UO1 and UO8 were cold ischemia time (CIT), patient and donor age and sex, HLA I and II compatibility, pre-transplantation duration of renal replacement therapy (RRT), cause of ESRD (ESRD) and immunosuppressive regimen. UO8 predictors also included UO1, 1st/0th POD plasma creatinine concentration ratio (Cr1/0), and occurrence of acute cellular rejection (AR). Multivariable linear regression was employed to produce nomograms for UO1 and UO8. Results: Four hundred and seventy-three patients were included, mostly deceased donor kidneys' recipients (361, 70.4%). CIT inversely correlated with UO1 and UO8 (Spearman's p=-0.43 and −0.37). CR1/0 inversely correlated with UO8 (p=-0.47). On multivariable analysis UO1 was mainly influenced by CIT, with additional influences of donor age and sex, HLA II matching and ESRD. UO1 was the strongest predictor of UO8, with significant influences of AR and ESRD. Conclusions: The predominant influence of CIT on UO1 rapidly wanes and is replaced by indicators of functional recovery (mainly UO1) and allograft's immunologic acceptance (AR absence). Mean absolute errors for nomograms were 0.08 mL/Kg h (UO1) and 0.05 mL/Kg h (UO8).

Predicting urine output after kidney transplantation: development and internal validation of a nomogram for clinical use.

PURPOSE: To analyze pre-transplantation and early postoperative factors affecting post-transplantation urine output and develop a predictive nomogram. PATIENTS AND METHODS: Retrospective analysis of non-preemptive first transplanted adult patients between 2001-2016. The outcomes were hourly diuresis in mL/Kg in the 1st (UO1) and 8th (UO8) postoperative days (POD). Predictors for both UO1 and UO8 were cold ischemia time (CIT), patient and donor age and sex, HLA I and II compatibility, pre-transplantation duration of renal replacement therapy (RRT), cause of ESRD (ESRD) and immunosuppressive regimen. UO8 predictors also included UO1, 1st/0th POD plasma creatinine concentration ratio (Cr1/0), and occurrence of acute cellular rejection (AR). Multivariable linear regression was employed to produce nomograms for UO1 and UO8. RESULTS: Four hundred and seventy-three patients were included, mostly deceased donor kidneys' recipients (361, 70.4%). CIT inversely correlated with UO1 and UO8 (Spearman's p=-0.43 and -0.37). CR1/0 inversely correlated with UO8 (p=-0.47). On multivariable analysis UO1 was mainly influenced by CIT, with additional influences of donor age and sex, HLA II matching and ESRD. UO1 was the strongest predictor of UO8, with significant influences of AR and ESRD. CONCLUSIONS: The predominant influence of CIT on UO1 rapidly wanes and is replaced by indicators of functional recovery (mainly UO1) and allograft's immunologic acceptance (AR absence). Mean absolute errors for nomograms were 0.08 mL/Kg h (UO1) and 0.05 mL/Kg h (UO8).

Treatment of Anterior Vaginal Wall Prolapse Using Transvaginal Anterior Mesh With Apical Fixation: A Prospective Multicenter Study With up to 2 Years of Follow-up.

PURPOSE: To evaluate the safety and efficacy of a surgical polypropylene mesh for correction of anterior vaginal prolapse, with or without apical defects, by providing simultaneous reinforcement at the anterior and apical aspects of the vagina with a single-incision approach. METHODS: This was a prospective, multicenter, single-arm study involving women with baseline stage ≥2 anterior and/or apical vaginal wall prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system. The primary endpoint was defined as achievement of POP-Q stage ≤1 status. Additionally, patient-reported outcomes were assessed using the International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS). The device under evaluation was Calistar A, which is fixed posteriorly to the sacrospinous ligaments with a novel tissue-anchoring system (TAS) and anteriorly to the obturator internus muscles. Postoperative follow-ups were scheduled at 7 days and at 6, 12, and 24 months. RESULTS: Ninety-seven women were treated and assessed for the primary outcome. They were followed for up to 2 years (n=43), with a median of 12 months. Objective cure was achieved in 86 of the 97 patients (88.7%) (P<0.0005). The mean reduction in the ICIQ-VS scores was in the range of 70%-90% for every time point (P<0.05). No bleeding or surgical revision was reported. Mesh exposure occurred in 7 patients (7.2%), urinary retention in 5 (5.2%), de novo dyspareunia in 3 (3.1%), and urinary tract infections in 7 (7.2%). CONCLUSION: This midterm follow-up showed that apical and anterior vaginal reinforcement with a polypropylene implant fixed with a TAS provided good anatomical correction, with no major complications.

Pro - inflammatory cytokines and metalloproteinase activation in polypropylene mesh implant in rat subcutaneous tissue

ABSTRACT Aims and Objectives: Polypropylene meshes have been increasingly adopted for correction of pelvic organ prolapse due to its lower recurrence rate when compared to surgeries without meshes. The study of the interaction of these materials with the host tissue may contribute to the development of materials with best biocompatibility and, consequently, less complication rates. Materials and Methods: The present study compares the inflammatory reaction of standard-weight (SW) and lightweight (LW) meshes (72 g/m216g/m2 respectively), implanted in the abdomen of 20 adult rats, which were euthanized in four or 30 days. Quantification of pro-inflammatory markers, IL-1 and TNF-α, and of metalloproteinases, MMP2 and MMP3, were carried out through immunohistochemistry with AxioVision® software. Results: There were no significant differences in the quantification of IL-1 and TNF-α in LW versus SW meshes. However, IL-1 quantification increased along time (30 days >4 days, p=0.0269). Also, MMP-2 quantification was similar to SW and LW and both presented a significant increase along time (30 days >4 days, p <0.0001). MMP-3 quantification also showed no difference between the SW and LW groups, but increased along time (30 days >4 days, p=0.02). Conclusions: Mesh's density did not influence the quantification of pro-inflammatory cytokines IL-1 and TNF-α and metalloproteinases 2 and 3. The increased expression of IL-1, MMP-2 and MMP-3 over time could represent a longstanding inflammatory response after PP mesh implantation. Possibly, the occurrence of adverse events following PP prosthetic implants can be influenced by other factors, not solely related to the amount of implanted material.

Pro - inflammatory cytokines and metalloproteinase activation in polypropylene mesh implant in rat subcutaneous tissue.

AIMS AND OBJECTIVES: Polypropylene meshes have been increasingly adopted for correction of pelvic organ prolapse due to its lower recurrence rate when compared to surgeries without meshes. The study of the interaction of these materials with the host tissue may contribute to the development of materials with best biocompatibility and, consequently, less complication rates. MATERIALS AND METHODS: The present study compares the inflammatory reaction of standard-weight (SW) and lightweight (LW) meshes (72 g/m216g/m2 respectively), implanted in the abdomen of 20 adult rats, which were euthanized in four or 30 days. Quantification of pro-inflammatory markers, IL-1 and TNF-α, and of metalloproteinases, MMP2 and MMP3, were carried out through immunohistochemistry with AxioVision ® software. RESULTS: There were no significant differences in the quantification of IL-1 and TNF-α in LW versus SW meshes. However, IL-1 quantification increased along time (30 days >4 days, p=0.0269). Also, MMP-2 quantification was similar to SW and LW and both presented a significant increase along time (30 days >4 days, p < 0.0001). MMP-3 quantification also showed no difference between the SW and LW groups, but increased along time (30 days >4 days, p=0.02). CONCLUSIONS: Mesh's density did not influence the quantification of pro-inflammatory cytokines IL-1 and TNF-α and metalloproteinases 2 and 3. The increased expression of IL-1, MMP-2 and MMP-3 over time could represent a longstanding inflammatory response after PP mesh implantation. Possibly, the occurrence of adverse events following PP prosthetic implants can be influenced by other factors, not solely related to the amount of implanted material.