Histologic Analysis of Zafirlukast’s Effect on Capsule Formation Around Silicone Implants

Background The most common complication experienced by patients who have undergone mammary implant surgery is capsular contracture. This matter concerns physicians and patients, but to date, there is no effective way to avoid this complication. Surgical intervention usually is required. In 2002, the use of zafirlukast, a leukotriene inhibitor (a drug used for asthma treatment), was reported for the treatment of capsular contracture, with good results. Methods For this study, 30 female Wistar rats were used. These animals received two silicone implants each: one with a smooth surface and one with a textured surface. All the animals received daily intraperitoneal injections for 90 days and were divided as follows: control group (C) receiving only saline solution, experimental group 1 (E-I) receiving 1.25 mg/kg/day of zafirlukast, and experimental group 2 (E-II) receiving 5 mg/kg/day of zafirlukast. Histologic analysis used hematoxilin and eosin to verify vessels, capsule thickness, and inflammatory cells. Immunoistochemical analysis with smooth muscle anti-actin antibody was used for myofibroblast verification. Picro-Sirius under polarized light was used for collagen analysis. Results Textured implant experimental groups presented smaller numbers of vessels, thinner capsules, lower collagen density, and smaller numbers of mastocytes and eosinophils than the control group. No significant differences were found in smooth surface implants, as compared with the control group. Conclusion Zafirlukast reduced the occurrence of factors directly and indirectly connected with capsular contracture.     

Effect of Implantation Surgery on the Strength Properties of Silastic® II Silicone Gel Breast Implants

Background: The causes of silicone gel–filled breast implant rupture are uncertain, and little research has been directed toward characterizing or quantifying the multiple factors that may contribute to device failure. Breast implants are subjected to some degree of stress and deformation during the surgical procedures of insertion. Thus implantation surgery itself could be a factor in affecting the durability of breast implants. Objective: The purpose of this study was to investigate whether the surgical procedure of insertion affects the mechanical properties of the silicone elastomer shell of gel–filled implants. We wanted to determine whether the procedure of inserting a breast implant might cause a decrease in the strength properties of the shell. Methods: Thirty-four Silastic^® II gel–filled breast implants manufactured by Dow Corning were tested. All implants were from the same lot and had a volume of 300 cc. Twenty of 34 implants were tested without implantation to investigate variability within a lot and establish a baseline of control data for comparison with implanted implants. Fourteen of the 34 implants were implanted through an inframammary incision in the right breast of a cadaver. The effect of implantation surgery was investigated by comparing the mechanical properties of the anterior and posterior sides of the cadaver explants with those of the controls. Results: Statistical analysis of the data indicated that the mechanical properties of elongation and tear resistance were essentially unaffected by implantation surgery. However, the average tensile strength of the explants was reduced 4.9% to 6.2% (for shells extracted with hexane and unextracted shells, respectively) compared with the controls. Breaking energy averages for the explants were also reduced 7.8% to 5.9% (for extracted and unextracted shells, respectively) when compared with the controls and average moduli decreased by a similar magnitude. Conclusions: The surgical procedure of implanting a breast implant has a small but statistically significant effect on the average strength properties of the elastomer shell of the implant. It is unlikely that this small reduction is sufficient to be a factor in implant durability.     

Effect of delayed diagnosis on severity of Pott’s disease

Purpose  

We analysed delay in diagnosis (DID) and disease severity in patients with vertebral tuberculosis (TB) in India.     

Effect of Roux-en-Y gastric bypass on Barrett’s esophagus: a systematic review

BackgroundRoux-en-Y gastric bypass (RYGB) has been recommended as the bariatric procedure of choice for morbidly obese patients with Barrett’s esophagus (BE).ObjectivesTo systematically review the effect of RYGB on BE.SettingUniversity hospital, Melbourne, Australia.MethodsA systematic review was performed. Studies were included of patients who had BE who underwent RYGB and had minimum 1 follow-up gastroscopy postoperatively. English language full-text articles were included, with case reports excluded. Endoscopic assessment methods of BE were compared to the American College of Gastroenterology (ACG) clinical guideline recommendations. A novel methodological quality assessment tool to assess risk of bias was developed. For each study, potential confounders for the effect of RYGB on BE were analyzed.ResultsOf 28 articles, 5 publications met inclusion criteria. Quality assessment did not demonstrate any high-quality publications. Of 63 patients, no cases showed progression of BE. Overall, regression rates of BE assessed at the postoperative endoscopy varied from 36%–62%. There was a lack of consensus between authors on definition of regression and short- versus long-segment BE. Eighty percent of patients with dysplasia had regression of dysplasia. Both studies that provided all required endoscopic information had poor compliance with ACG recommendations. Potential confounding factors for the effect of RYGB on BE included preoperative risk factors, selection bias based on length of BE, type of RYGB (resectional or nonresectional), concomitant hiatus hernia repair, postoperative use of proton pump inhibitor, and amount of weight loss.ConclusionRYGB has been shown to be associated with regression of BE and dysplasia in some patients, with no cases of progression after short-term postoperative endoscopic assessment. A clearer definition of regression of BE and following ACG recommendations is necessary to allow standardized reporting and comparison of future results. Long-term, larger, multicenter high-quality studies, including assessment of all potential contributing factors for BE regression, are required.     

Mild Degree of Poland’s Syndrome Reconstruction with Customized Silicone Prosthesis

Polands Syndrome consists of unilateral absence of the pectoralis major muscle, ipsilateral symbrachydaktylia, and occasionally associated other malformations of the anterior chest wall and breast. Mild Polands Syndrome is characterized by asymmetry of the breasts with partial absence of the pectoralis major muscle. This report describes a 19-year-old man with unilateral hypoplasia of the breast, absence of the anterior axillary fold, and absence of the pectoralis major muscle. The patients chest wall was reconstructed with a customized silicone prosthesis. This reconstructive technique is a simple alternative to more complex surgeries or muscle transposition.     

Safety and Effectiveness of Mentor’s MemoryGel Implants at 6 Years

Background  In November 2006, the FDA approved the Premarket Approval PMA applications for the round, cohesive, silicone gel-filled breast implants of Mentor (MemoryGel) and Allergan. Since that time, the devices have been widely available to plastic surgeons and their use is rapidly eclipsing that of the saline breast implants. Patients in the Core clinical studies supporting these approvals continue to be followed through for 10 years, with comprehensive annual patient and physician-reported evaluations of safety and efficacy. Methods  One thousand and eight (1,008) female patients had data collected on 1,898 implants, and were enrolled at 48 sites. Key complication rates were recorded with Kaplan–Meier estimated cumulative incidence calculation for each. Results  Rupture rate, suspected and confirmed, for primary augmentation was 1.1% (95% CI, 0.3–4.3), and that for primary reconstruction patients was 3.8% (95% CI, 1.4–9.8). Capsular contracture rates for clinically significant Baker III/IV contracture for primary augmentation was 9.8% (95% C I, 7.6–12.7), and that for primary reconstruction was 13.7% (95% CI, 9.7–19.1). The reoperation incidence for primary augmentation and primary reconstruction was 19.4 and 33.9%, respectively, with explantation and replacement with a study device in 3.9% of primary augmentations and 10.4% of primary reconstructions. Conclusions  Mentor MemoryGel Silicone Breast implants represent a safe and effective choice for women seeking breast augmentation or breast reconstruction following mastectomy.

Does the Surface Structure of Implants Have an Impact on the Formation of a Capsular Contracture?

Background The formation of a fibrous capsule around a silicone breast implant is part of a physiologic foreign body reaction after breast augmentation. In contrast, the formation of a capsular contracture is a local complication of unknown cause. This study aimed to discover whether the surface structure of the implant (textured vs smooth) has any impact on the formation of a capsular contracture. Methods This prospective study included 48 female patients with unilateral capsular fibrosis grades 1 to 4 in Baker’s clinical scaling system. Of these patients, 14 received implants with a textured surface (Mentor), and 34 received implants with a smooth surface (Mentor). The implants all were placed in a submuscular position by the same experienced plastic surgeon. The clinical data were assessed using standardized patient questionnaires. For histologic diagnosis, operatively excised capsular tissue was examined. Preoperatively, venous blood samples for determining serum hyaluronan concentrations were taken from the patients. The control group consisted of 20 patients without capsular fibrosis. Results The separate analysis of clinical data for the patients with textured and those with smooth-surfaced breast implants showed a slightly reduced degree of symptoms for the patients with textured silicone breast implants, as compared with those who had smooth-surfaced implants. The histologic assessment of the fibrosis showed a symmetric distribution for Wilflingseder scores 1 to 3 (29% each), whereas 13% of the capsular tissues could be assigned to Wilflingseder score 4. In contrast, the histologic assessment of the patients with smooth-surfaced implants predominantly showed a Wilflingseder score of 3 (65%). The serologic investigations via enzyme-linked immunoassay (ELISA) showed serum hyaluronan concentrations of 10 to 57 ng/ml (25.0 ± 11.7 ng/ml). Therefore, no statistically significant differences in terms of serum hyaluronan levels could be determined between the two groups of patients. In comparison with the control group, the patients with implants showed elevated serum hyaluronan levels (p < 0.05). Conclusions The histologic examination and serum hyaluronan concentration analysis showed no statistically significant difference between smooth-surfaced and textured implants (Mentor) with respect to the development of capsular contracture. On the other hand, the severity of capsular contracture showed a positive linear correlation with the degree of local inflammatory reactions, which were independent of the implant surface.     

Effect of subthalamic stimulation on mood state in Parkinson’s disease: evaluation of previous facts and problems

In an attempt to clarify the effect of deep brain stimulation (DBS) to the subthalamic nucleus (STN) on mood state, previous evidence and problems were evaluated through a systematic literature search. Twenty three articles reported the effect of STN DBS on mood state in Parkinsons disease (PD), and antidepressant, depressant, and mania-induced effects were reported in 16.7–76%, 2–33.3%, and 4.2–8.1% of the patients treated with STN DBS, respectively. Most articles reported larger subgroups showing antidepressant effects than those showing depressant effects. The average depression scale score of all subjects was improved or unchanged after STN DBS. Although there was a limitation due to the varied results, it was suggested that, in general, STN DBS had an antidepressant effect in PD. However, the studies reporting severe depressant symptoms, such as suicidal attempts, after STN DBS indicated the importance of careful attention to mood state as well as to motor symptoms after STN DBS. It may be crucial to reduce the variation in the results by, for example, the use of standardized protocols and the precise verification of the stimulated region in further investigations to address this issue.     

Effect of Parkinson’s Disease on Hemiarthroplasty Outcomes After Femoral Neck Fractures

BackgroundThe purpose of this study was to evaluate the outcomes following hemiarthroplasty (HA) for femoral neck fractures (FNFs) in patients with Parkinson’s disease (PD) compared with patients without PD.MethodsThis was a retrospective review utilizing the Nationwide Readmissions Database, a national database incorporating inpatient hospitalization information. Using the Nationwide Readmissions Database, patients who underwent HA for FNF between 2010-2014 were identified. International Classification of Diseases, 9th Revision, codes were used to find a subset of patients with PD. Primary outcomes of interest included death, hospital readmission, periprosthetic fracture, postoperative dislocation, any revision surgery, and revision surgery for instability, fracture, or infection.ResultsThere were a total of 7721 (4%) patients with PD. There was no difference in the risk of death or any postoperative complications during index hospitalization for these patients. However, PD patients had an increased risk of hospital readmission (odds ratio [OR] = 1.13, 95% confidence interval [CI]: 1.02-1.26) and postoperative dislocation (OR = 2.10, 95% CI: 1.58-2.80) within 90 days of surgery. PD patients also had an increased risk of revision surgery for instability (OR = 2.20, 95% CI: 1.48-3.28), despite no difference in the risk of any revision surgery, revision surgery for fracture, or revision surgery for infection.ConclusionIn this retrospective cohort study, PD patients who underwent a HA for FNF had a greater risk of postoperative dislocation and revision surgery for instability within 90 days. These findings are not only important to consider when managing these at-risk patients but also stress the need to allocate operative and postoperative resources to prevent and treat instability.Level of Evidence3 (Retrospective cohort study).     

Filling of Adjustable Breast Implants Beyond the Manufacturer’s Recommended Fill Volume

BACKGROUND: Adjustable breast implants are widely used for both reconstructive and cosmetic breast surgery. They provide unique postoperative versatility and allow for more effective management of numerous conditions that would otherwise require surgical intervention. Findings have shown that in a clinical setting, it often is necessary to overexpand saline implants beyond the manufacturer's recommended fill volumes for positive results and optimal patient satisfaction. The authors investigated their breast-augmentation patients, comparing implants expanded beyond the manufacturer's fill volume with implants that remained within the recommended parameters. METHODS: A total of 138 patients (270 implants) undergoing breast augmentation mammoplasty with Smooth Round Spectrum implants were evaluated postoperatively. To determine the effects of overexpansion, the incidence of leakage was assessed as well as the possibility of increased firmness. Patients completed a satisfaction questionnaire. RESULTS: The findings showed no evidence of increased leakage with implants expanded beyond recommended fill volumes, and 97% of the patients reported a perfect score for satisfaction ratings. Of the 270 implants evaluated in the study, only 7 were given a less than perfect score. CONCLUSIONS: By exceeding the recommended fill volume, the authors were able to use the implant to its maximal potential, with increased patient satisfaction. The authors were able to correct problems and avoid complications that could not have been resolved without deviating from the manufacturer's recommended fill volumes. Nonvalidated restrictions on fill volumes severely limit the efficacy of adjustable implants.     

Serologic and Histologic Findings in Patients with Capsular Contracture After Breast Augmentation with Smooth Silicone Gel Implants: Is Serum Hyaluronan a Potential Predictor?

Background In this study, breast implant capsular tissues and blood samples from 25 cases were studied to characterize the relationship between capsular findings and serum analysis. The serum fibrosis indexes hyaluronan and the aminoterminal propeptide of procollagen type III (PIIINP) are fairly well correlated in several other studies with the inflammation grade and fibrosis in patients with progressive fibrotic disorders such as liver cirrhosis. Methods The study enrolled 25 female patients (average age, 40 ± 12 years) with capsular contracture after bilateral cosmetic breast augmentation using smooth silicone gel implants (Mentor). The implants were placed in a submuscular position through an incision in the inframammary fold. The implant removals were prompted by development of capsular fibrosis (Baker grades 1–4). Samples of capsular tissue were obtained from all the patients for standard histologic and immunohistochemical analyses. Blood samples were drawn from all the patients immediately before surgery. Sera from 20 healthy female patients (average age, 34 ± 9 years) who had undergone plastic surgery for reduction mammaplasty were used as controls. Results Histology. Capsular tissue was significantly thicker in patients with grades 3 and 4 contracture than in women with grade 2 contracture according the classification by Baker. There was a moderate (n = 15) or severe (n = 10) chronic inflammatory reaction in the capsules around the implants. Fibroblasts and macrophages represented the major cell population found in the fibrous capsules. In addition, activated CD4+ cells were detected. An inner layer with synovia-like metaplasia and multinucleated giant cells was found. Fibroblast-like cells formed the most common cell type in the capsules, along with macrophages, scattered polymorphonuclear leukocytes, lymphocytes, plasma cells, and mast cells. Serum analysis. There was a significantly higher level (p < 0.05) of hyaluronan serum concentration in patients with capsular contracture (26 ± 14 μg/l) than in control subjects (12 ± 6 μg/l). There was a positive correlation between the grade of capsular contracture (Baker 1–4) and the hyaluronan serum concentration (Baker 1–2: 15 ± 3 μg/l; Baker 3–4: 35 ± 12 μg/l) (r² =0.73; p < 0.05). Conclusion : In this study, serum hyaluronan levels were significantly elevated in patients with constrictive fibrosis after breast augmentation, and there was a positive correlation with the stage of capsular contracture. Serum hyaluronan concentration may help in defining patients at risk for capsular fibrosis. If treatment with new drugs can be started as a preventive measure, it may be possible to reduce the rate of patients who require surgical intervention.     

Surgical Considerations in the Treatment of Small Bowel Crohn’s Disease

Journal of Gastrointestinal Surgery - Surgery remains a cornerstone of the management of Crohn’s disease (CD). Despite the rise of biologic therapy, most CD patients require surgery for...     

Effect of bilateral subthalamic nucleus stimulation on levodopa-unresponsive axial symptoms in Parkinson’s disease

Summary Background. The levodopa responsiveness of motor, particularly axial symptoms is a good predictor of the effectiveness of subthalamic nucleus (STN) stimulation in patients with Parkinson’s disease (PD). However, many Japanese PD patients are intolerant of higher doses of antiparkinsonian drugs and some aspects of their axial symptoms may remain unresponsive to treatment. We retrospectively investigated the effects of bilateral STN stimulation on the axial signs unresponsive to levodopa in Japanese patients with PD. Methods. We enrolled 29 consecutive patients into this study. Six independent axial symptoms, i.e. falling, freezing, gait, standing, posture, and postural instability, were scored on the Unified Parkinson’s Disease Rating Scale (UPDRS), before and 3 months after bilateral STN stimulation and differences were statistically analysed. Findings. Postoperatively, the mean levodopa dosage was decreased by 27%. The preoperative responsiveness to antiparkinsonian drugs with respect to freezing, gait, posture, and postural instability were positively correlated with postoperative off-medication improvement (p < 0.05). For each individual axial symptom, some patients showed an excellent response to STN stimulation, despite preoperative unresponsiveness to levodopa. These selected patients were not always treated with lower doses of antiparkinsonian drugs preoperatively, but they had milder preoperative scores on the UPDRS with respect to daily activities and overall axial function. Conclusions. The axial symptoms of PD unresponsive to levodopa were ameliorated by bilateral STN stimulation in patients manifesting a milder degree of preoperative axial signs. Our findings suggest that STN stimulation exerted a definite but limited effect on levodopa-unresponsive axial features, pointing to the need to identify different target structures that control axial functions via non-dopaminergic systems. Correspondence: Kazumichi Yamada, M.D., Ph.D., Department of Neurosurgery, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Kumamoto City, 860-8556 Kumamoto, Japan.     

Continuing Medical Education Examination—Breast Surgery: Secondary Surgery and Silicone Implants: One Center’s Experience Before and After the Food and Drug Administration Hearings of 1991 and 1992

Learning Objectives: The reader is presumed to have a broad understanding of plastic surgical procedures and concepts. After studying this article, the participant should be able to:

• 1.Define the changes in the practice of breast implant surgery that followed the FDA hearings on silicone gel-filled breast implants.
• 2.Characterize the expected life span of breast implant devices, which can be predicted from historical data.

Physicians may earn 1 hour of Category 1 CME credit by successfully completing the examination based on material covered in this article. The examination begins on page 175. A retrospective study was performed to compare reoperative breast implantation surgery before and after the Food and Drug Administration (FDA) hearings in 1991 and 1992 on silicone breast implants. The two groups were compared regarding the motivation, findings, and procedures associated with the operations. One hundred seventy-one patient records were reviewed covering the years 1989 to 1994, evenly straddling 1991; of those, 146 charts had sufficient data to be included in the study. Each implant and each implantation operation were counted as a separate event. Before November 1991, 64% of reoperations were performed on the senior author’s own original patients, whereas after 1991, only 33% were. Fifty-seven percent of the reoperations performed before November 1991 were performed on patients requiring augmentation in contrast to those patients requiring reconstruction; after 1991, 78% of the reoperations were augmentation mammaplasties. In the early period, reoperation was primarily performed to correct asymmetry (47%) or capsular contracture (47%); it was rarely performed for rupture (3%) or infection (3%) and never for anxiety or pain. In the later period, contracture (44%) and asymmetry (18%) remained as common causes, but anxiety (11%) and pain (8%) appeared as new factors, and rupture was suspected more often (21%). One of the most dramatic, if not surprising, findings was the choice for replacement implant. In the earlier period, saline solution-filled implants were used 12% of the time, whereas in the later period, they were used 80% of the time. Finally, implants removed that were more than 15 years old had ruptured nearly 50% of the time.     

Effect of vas ligation on testicular sperm extraction results in nonobstructive azoospermic rats: Shaeer’s lock-in technique

This study evaluates the efficacy of vas ligation in enhancing sperm retrieval in nonobstructive azoospermia cases, by accumulating intratesticular spermatozoa. Fifty-six mature male rats with equally sized testes were included in this study. Forty-six were in the study group, and 10 were in the control group. Bilateral testicular fine needle aspiration was performed for all, to confirm presence of spermatozoa in all testes. Nonobstructive azoospermia was induced in all 56 rats, using Dienogest (40 mg/kg) + Testosterone Undecanoate (25 mg/kg) every month for three months. Monthly aspirations confirmed nonobstructive azoospermia from all rats, within the three months treatment. This was followed by unilateral vas ligation and was performed for 46 rats of the study group, with no ligation performed in the control group. After a further period of 90 days (2 spermatogenic cycles) with the same medical treatment maintained, bilateral testicular sperm extraction was performed. Sperm retrieval was evaluated, comparing the outcome of vas-ligated testicles to the nonligated. Upon evaluation, spermatozoa were found in 14/46 of the vas-ligated testes (30.4%), compared to none of the nonligated (0/66), p = .0005. Ligation of the vas deferens in rats with nonobstructive azoospermia may enhance the results of sperm retrieval via sperm accumulation.