ISI Impact Factor (2004): 1.096

Editor-in-Chief
Prof. Yi-Fei WANG,

Risk of connective-tissue disease in men with testicular or penile prostheses: a preliminary study

Ja Hyeon Ku¹, Yun Seob Song², Youn Soo Jeon³, Min Eui Kim⁴, Nam Kyu Lee³, Young Ho Park²

¹Department of Urology, Military Manpower Administration, Seoul; 
²Department of Urology, Soonchunhyang University School of Medicine, Seoul; 
³Department of Urology, Soonchunhyang University School of Medicine, Chonan; 
⁴Department of Urology, Soonchunhyang University School of Medicine, Pucheon, Korea

Asian J Androl  2002 Mar; 4:  67-72

Keywords: penis; testis; silicon; prosthesis

Abstract

1 Introduction

Disorders closely resembling autoimmune diseases have been reported in patients injected or implanted with various substances. In 1982, Van Nunen et al. [1] first indicated an association between breast implants and connective-tissue diseases. Women receiving breast implants have been shown to expose to many health risks, unknown to them at the time of surgery. Affected patients may have a variety of autoimmune diseases, including Sjogren's syndrome, progressive systemic scleroderma, rheumatoid arthritis, systemic lupus erythematosus and mixed connective tissue disorders. These patients typically experience certain combination of fatigue, myalgia, joint pain, sicca syndrome, synovitis, rash, alopecia, muscular weakness or lymphadenopathy, and autoantibody formation [2]. Recognition of health hazards has prom-pted the Food and Drug Administration to restrict the implantation of these devices before comprehensive safety studies have been undertaken.

While the exact mechanism is yet to be determined, silicone gel filled prostheses may have the potential to induce immune reactivity. In 1991, Barrett et al. [3] demonstrated silicone shedding from the genitourinary prostheses although no correlation was noted with connective-tissue diseases. To date, much attention has been given to the silicone gel filled breast implants but little is known regarding the penile and testicular prostheses. For this reason, we evaluated the possibility of the occurrence of connective-tissue diseases in men with penile or testicular prostheses clinically and immunologically.

2 Subjects and methods

Medical records of the patients underwent implantation of inflatable penile prostheses or silicone gel filled testicular prostheses from 1995 to 1999 were reviewed for information concerning preexisting medical conditions, age at implantation, reason for implant insertion and perioperative complications. Attempts were made by telephone to obtain current follow-up interview, physical examination and baseline serological examination. Telephone contacts were successful in 8 patients underwent inflatable penile prostheses (penile prosthesis group) and 15, silicone gel filled testicular prostheses (testicular prosthesis group). The study was approved by the Human Subjects Review Board of the Administration. Informed consent was obtained for the procedure and the study from all subjects.

Serological tests to identify human adjuvant disease were performed according to Henderson et al. [4] and Sergott et al. [5]. These tests included erythrocyte sedimentation rate (ESR, normal range: 0-9 mm/h), complement 3 (C3, normal range: 45-105 mg/dL), complement 4 (C4, normal range: 10-40 mg/dL) and quantitative serum immunoglobulin (Ig) levels including IgA (normal range: 0.9-3.8 g/L), IgE (normal range: 0-100 IU/mL), IgG (normal range: 7.5-17 g/L) and IgM (normal range: 0.6-2.95 g/L), antinuclear antibody titer (ANA, normally negative) and rheumatoid factor (RF, normally negative). During the follow-up interview, questions about the symptoms or signs of connective tissue diseases were asked to obtain the diagnostic details based on the classification criteria of the American College of Rheumatology for rheumatoid arthritis [6], systemic lupus erythematosus [7], and systemic sclerosis [8], and on Alarcon-Segovia and Cardiel's criteria for mixed connective-tissue disease [9], Bohan and Peter's criteria for inflammatory myositis [10] and Fox et al.'s criteria for Sjogren's syndrome [11].

Data are presented as the median (25th-75th percentile) for the variables. Mann-Whitney U-test and Fisher's exact test were used to compare continuous and nominal variables between two groups, respectively. A 5% level of significance was used for statistical testing and all statistical tests were two-sided. Statistical analyses were performed using a commercially available analysis program.

3 Results

The patients of the penile prosthesis group underwent implantation due to erectile dysfunction caused by spinal fracture, Peyronie's disease, or diabetes mellitus. Testicular implantation had been performed due to monoorchism secondary to cryptorchidism, testicular injury, torsion of spermatic cord or unknown etiology. The median age of surgery in penile and testicular prosthesis groups was 38 (range 26 to 84) and 23 (range 17 to 52) years, respectively. The median time since implantation in penile prosthesis group was 37 (range 2 to 86) months and that in testicular prosthesis group was 9 (range 1 to 69) months. One patient in the testicular prosthesis group experienced scrotal hematoma.

The results of serological tests in the 2 groups are shown in Table 1. In the penile prosthesis group, 2 patients (25.0%) had no abnormal item, 3 (37.5%) had a single abnormal item, 2 (25.0%) had 2 abnormal items and 1 (12.5%) had 4 abnormal items. Tabulating by serological results, 2 patients (25.0%) had elevated ESR, 1 (12.5%) abnormal RF, 2 (25.0%) abnormal C3 (de-creased and increased in one each) and 1 (12.5%) increased C4. One patient (12.5%) had decreased IgA, 4 (50.0%) elevated IgE and 1 (12.5%) decreased IgG. Nobody had abnormal ANA or IgM.

Table 1. Serological results of penile and testicular prosthesis groups.