External Ultrasonic Treatment of Capsular Contractures in Breast Implants

The authors report their experience on the nonsurgical treatment of capsular contractures due to breast implant augmentation mammaplasty. External ultrasonic repeated applications have been applied to 24 patients after closed capsulotomy procedures in order to reduce the recurrency rate. The new ultrasonic device used was based on a 2-MHz generator with a timing adjustable power emission connected to eight transducers designed for breast anatomy. The authors report significant improvement of the closed capsulotomy technique demonstrating a persistent stability of the achieved results in 82% of the treated contractures, even in severe cases (Baker's IV), after a minimum follow-up period of 12 months. Methods of application, technical features of the ultrasonic device, experimental charts, and results obtained on 34 breast implant capsular contractures are reported and discussed.     

Textured Surface Silicone Breast Implants: Histology in the Human

Previous studies on the interaction of textured silicone breast implants has analyzed tissue expanders or used animal models. To date, the data on long-term results of the textured silicone breast implants have not examined permanent implants or in vivo effects in the human. A prospective study was designed to examine the interaction of textured silicone breast implants in a human over several years. A single surgeon, standard surgical technique, and single-type implant design were included. The results revealed 78% had silicone particles in the tissue immediately adjacent to the implant interface. No distant migration, metaplasia, or adverse effects were noted. Our results indicate that silicone fragmentation is common but appears to be confined to the local environment.     

Five-Year Experience on Ultrasonic Treatment of Breast Contractures

The authors report their experience in five years of treating breast implant capsular contractures with an external ultrasonic device that facilitates the closed capsulotomy technique. A set of 52 patients have been treated with a 82.6% of improvement at a year follow up. Methods of application and results are discussed.     

Effect of Slow-Release 5-Fluorouracil on Capsule Formation Around Silicone Breast Implants: An Experimental Study with Mice

Background Capsule formation around breast implants, development of tendon adhesions after tendon repair, intestinal brits after laparatomies, hypertrophic scars in skin incisions all are the results of excessive collagen synthesis to the extracellular matrix by fibroblasts. Any intervention that leads to cessation of collagen synthesis in these clinical situations may help to prevent these untoward results of wound healing. Although 5-fluorouracil (5-FU) is used mainly as a cytotoxic drug in chemotherapy protocols, it decreases cellular metabolism and blocks protein synthesis only at lower concentrations. Findings have shown that 5-FU downregulates fibroblast proliferation and differentiation in vitro. It has been used to treat fibroproliferative disorders of the eye and skin and is thought to inhibit thymidylate synthetase, blocking DNA replication. Methods This study used five treatment groups: (1) gelatin only, (2) silicone only, (3) silicone + gelatin, (4) silicone + gelatin containing 1 mg of 5-FU, and (5) silicone + gelatin containing 5 mg of 5-FU. The release kinetics of 5-FU from gelatin have been investigated by means of ultraviolet spectrophotometric analysis. Specimens were obtained on postoperative day 30. Gross evaluation and histopathologic examination were conducted for capsule formation and the development of inflammation. Results The silicone group had the most prominent capsule formation among all the groups. The gelatin group was second, and the silicone + gelatin group was third. As compared with the other groups, the 5-FU–containing groups had the least capsule formation. The 5-mg 5-FU–containing group had the most inflammation. The silicone + gelatin group was second in inflammation. Although the silicone, gelatin, and 1-mg 5-FU–containing groups had the same means, the results of the silicone group showed the most divergent data within the group. Conclusions Because 5-FU loaded to a gelatin carrier for its slow release seems to prevent capsule formation around silicone blocks, it may be used to prevent capsule formation around silicone breast implants.     

Endoscopic Transaxillary Subglandular Breast Augmentation Using Silicone Gel Textured Implants

We present our experience with endoscopic transaxillary subglandular breast augmentation using textured silicon gel implants. Fourteen implants were placed in seven patients through a 4 cm axillary incision, in a subglandular pocket, with the help of a 10 mm, 30° endoscope with a subcutaneous retractor and endoscopic diathermy. The implant was inserted with the help of a plastic bag. No drains were left in place. The duration of the procedure was 1 h 30 min in the most recent cases. Bleeding during surgery was kept to a minimum, and there were no complications such as capsular contracture, hematoma, or hypertrophic scar. Infection occurred in one implant and it was necessary to extract it. This technique is an excellent tool for patients requiring subglandular implants who prefer a distant incision. It provides good control over dissection and allows the use of silicone gel implants, thus avoiding the risk of deflation. In addition, recovery is faster and there is less bruising and pain.     

Partial Myotomy of the Pectoralis Major in Submuscular Breast Implants

Several authors report that retropectoral or submuscular placing for prostheses reduces the incidence of capsular contracture, preserves the sensitivity of the areola, and gives the breast a more natural look; however, displacement of the prosthesis when contracting the arm, shoulders, and thorax muscles is often observed. In order to prevent this deficiency, partial thickness myotomy was performed in the pectoralis major muscle. Since 1987, our team has carried out 120 subpectoral augmentation mammoplasties by submammary approaches using this procedure. The ages of the patients ranged from 19 to 44 years old. In all cases, physiological saline microtextured prostheses were used. Volumes were between 225 and 275 cc. The results were satisfactory in all cases, with no hematomas, infections or capsular contractures. The main advantage of this technique is that it prevents displacement of the prostheses after movements of the arms or shoulders.     

A Review of the Literature on the Etiology of Capsular Contracture and a Pilot Study to Determine the Outcome of Capsular Contracture Interventions

The etiology of capsular contracture is unclear and probably multifactorial. This review covers the literature on several proposed contracture factors, including filler material, implant placement, surface texture, and bacterial infection. The pilot study's goal was to test the feasibility of a data collection form, which could be used in a scaled-up study analyzing multiple surgeon's records. The goal of the expanded version of this study will be to determine the efficacy of available interventions for capsular contracture, including surveillance. The Breast Implant Public Health Project, LLC (BIPHP), piloted a retrospective review of outcomes in women who had interventions to relieve capsular contracture or had chosen a wait-and-watch approach. An evaluation of the efficacy of various treatments can help women decide if they want to pursue treatment at all and, if so, which treatment might offer them the best solution. BIPHP researchers (E.E.A., M.E.) developed a data collection form after reviewing records of three surgeons (B.C., W.P., V.L.Y.). During the data collection using the same records, we tested a randomization process to identify women with capsular contracture who underwent various interventions, including a wait-and-watch strategy, and those who had no mention of any intervention or waiting approach. Data were gathered on a total of 90 breasts with capsular contracture (scored Baker I–IV or qualitatively), of which 45 underwent a total of 102 interventions for capsular contracture. Interventions were classified as ``closed capsulotomy,' ``surgical,' or ``watchful waiting.' Closed capsulotomy was performed most often (47%), followed by surgery (29%) and watchful waiting (21%). Presurgical Baker scores averaged higher in breasts that underwent surgery (3.1) than for watchful waiting (2.5) or closed capsulotomy (2.3). Though closed capsulotomies had 100% of outcomes scoring ``improved' or ``same,' 58% of the breasts underwent the procedure more than once, suggesting that the favorable outcome was short-lived. The wait-and-watch approach resulted in scores of either ``same' or ``worse'; surgery (open capsulotomy, repsoitioning, or capsulectomy) resulted in 79% improved, 16% same, and 5% worse outcomes in breasts with outcomes listed. In all intervention procedure categories, outcomes were frequently unavailable; they were noted only 60% of the time (52/87). The missing 40% may have resulted from the doctor's failure to note it in the chart, satisfied patients not returning for additional treatment, or dissatisfied patients seeking treatment elsewhere. Generally, the data collection forms and procedures were workable; however, we uncovered issues to address in the scale-up of this pilot study: (1) the outcome report rate was 60%; (2) though Baker scores are commonly used to evaluate the degree of capsulaar contracture, it seems that grade I may have different meanings for different surgeons, which would need to be clarified; (3) participating surgeons will need to divulge standard-of-care items that they may not have included in medical records, but routinely performed (e.g., patient massage, use of prophylactic antibiotics); and (4) records were initially separated by ``implant,' then researchers realized that a more useful collection would be by ``breast.' The latter approach captures the history of the breast in one record, which may be more important to contracture than the differences in implants. With the modifications discussed, the study can be scaled up to encompass as many records as necessary to achieve robust statistical power. These data will add to the existing literature regarding factors associated with capsular contracture and identify factors that affect the successful outcome of capsular contracture interventions.     

A New Concept in Male Chest Reshaping: Anatomical Pectoral Implants and Liposculpture

A new concept of male chest reshaping has been developed. In a population of 12 patients, 10 had a male chest enhancement using only a new shaped silicon gel implant, and two had a combination of liposuction and pectoral implants. The very natural appearance of this new implant, with or without a liposuction, seems to dramatically improve the quality of the cosmetic results.     

A Different Strategy in the Surgical Treatment of Capsular Contracture: Leave Capsule Intact

The authors present their experience with the surgical treatment of capsular contracture to achieve better results in a safe, predictable, and practical way, and discuss the possible treatment modalities. They simply advise leaving the capsule intact, even if it is calcified, and create another pocket, rarely in the front or, more typically, at the back of the capsule. If the breast tissue is also ptotic, a mastopexy procedure may be added to the procedure, in addition to augmentation, with a rather small prosthesis placed in the new pocket or, occasionally, in the old one. External, forceable massage is not advisable to treat the capsule. Open capsulotomy and/or partial capsulectomy can be applied to release the capsule. However, it is not advisable since recurrence is usually inevitable. The purpose of this paper is to present a series of surgical procedures to avoid the problems created by the capsule and present different cases with good results.     

The Influence of External Ultrasound on the Histologic Architecture of the Organic Capsule Around Smooth Silicone Implants: Experimental Study in Rats

BACKGROUND: Capsular contracture is the main complication related to breast silicone implants, and its prevention remains a medical challenge. The authors present experimental research examining the effect of external ultrasound on the formation and contracture of peri-implant capsules. METHODS: In this study, 42 male Wistar rats had a 2-mm smooth surface implant placed in a dorsal submuscular pocket. They then were separated into "ultrasound" and "control" groups that received repeated external applications either with or without the ultrasound power on. Ultrasound applications were given three times a week for a period of 90 days. After that, both groups were housed under the same conditions with no application scheduled. Five animals of each group, killed at 30, 60, 90, and 180 days, had their implants removed along with the capsule, which received a special histologic preparation via annular sectioning that provided wide circumferential observation of the capsular tissue. Sections were stained with hematoxylin/eosin stain, Masson's trichrome stain, and Pricrosirius Red stain for regular microscopic evaluation under normal and polarized light. RESULTS: Histologic data showed that capsules from the ultrasound and control groups had statistically significant differences. Ultrasound application developed a capsular architecture similar to that shown within textured silicone implants, and its effect had an early definition with subsequent stabilization. CONCLUSION: The authors conclude that early and repeated external ultrasound application enhances the thickness, cellular count, and vascularity of smooth silicone capsular tissue, whereas it diminishes the pattern of parallel orientation of collagen fibers.     

Breast Implantation and the Incidence of Upper Extremity Somatic Complaints

Attention has been drawn to elevated laboratory tests of inflammation as indicators of a possible reaction to silicone breast implants. These patients have complaints of joint pain, pain, and myalgia that were possibly caused by a reaction to silicone. This study is a retrospective review of 100 consecutive patients (79 female, 21 male) who were evaluated because of a purported industrial injury to the upper extremity. Patients were examined by a single examiner and all had laboratory screening for indicators of inflammation (sedimentation rate, anti-nuclear antibody levels, C-reactive protein, anti-streptolysin, rheumatic factor), endocrine abnormalities (thyroid panel), and serum glucose. None of the patients had any history of breast augmentation with any implant. Of the 79 female patients, 50 had an identifiable clinical diagnosis and 18 of them had elevation of at least one of the indicators of inflammation. The remaining 29 did not have an identifiable diagnosis and 21 of them had elevation of at least one indicator of inflammation (P < 0.01). There were 74 out of 79 females with subjective complaints of upper extremity pain, joint pain, and aching. Forty-five of these patients had an identifiable diagnosis and 17 of them had elevation of at least one inflammatory indicator. Of the 74 female patients, 29 had no identifiable diagnosis and 21 of them had elevation of at least one inflammatory indicator (P < 0.01). In summary, there were a high number of female patients with complaints of upper extremity symptoms with no prior exposure to silicone from breast implantation. There was a statistically significant correlation in these patients who had no identifiable diagnosis and elevated indicators in inflammation. This study suggests these markers of inflammation should not be used as indicators of a reaction to silicone from breast implantation in patients with upper extremity subjective complaints.     

Unilateral Osmotic Swelling in Textured,Single-Lumen,Saline-Filled Mammary Implants: Clinical and MRI Findings

An odd complication following routine breast augmentations was observed in two patients. Single-lumen, textured, high-profile, saline-filled mammary implants were placed in the submuscular plane and postoperative course was uneventful in the presented cases. Unilateral, gradual, and spontaneous swelling in one of the operated breasts was observed 6–14 months after surgery that prompted patients for examination. MRI showed regular external contours of the mammary implants without any evidence of rupture or extracapsular leakage. However, a substantially volumetric increase in the auto-inflated implant was noted since transverse diameter of the right breast implant was twice the left normal implant. All cases had to be re-operated and implants were explanted. Auto-inflated implants were checked and were found to be intact. Intraoperative findings included swelling of the implant and brown discoloration of the previously-transparent saline solution. Furthermore, composition of the fluid inside the expanded implant was found to have changed, possibly through an osmotic gradient. Several mechanisms such as osmotic swelling, defect at the valvular system of the implant, and inorganic salts yielded from texturization process in the shell are suggested but further research with more refined techniques should be done. The present study provides supplementary MRI and confirmatory clinical findings on this bizarre phenomenon and other factors apart from the disruption of the implant integrity may play a role.     

An Analysis of Breast Sensation Following Inferior Pedicle Mammaplasty and the Effect of the Volume of Resected Tissue

The aim of our study was to evaluate if the amount of resected breast tissue has an influence on breast sensitivity after inferior pedicle mammaplasty. In the prospective study, 15 patients (30 breasts) were divided into two groups: group I (less than 400 g resection) and group II (more than 400 g resection). Preoperatively and six months postoperatively a touch test (Semmes-Weinstein monofilaments) and temperature (warm and cold) tests were performed. The study showed that all patients had increased touch sensitivity six months after inferior pedicle mammaplasty regardless of the amount of resection. In group I an average of 65% and in group II an average of 83% retained sensitivity for temperature postoperatively. These results suggests that this mammaplasty technique preserves intercostal nerves within the inferior pedicle and reliefs chronic nerve traction injury and improves thereby breast sensibility.     

Effect of Ultrasonic Assisted Lipectomy (UAL) on Breast Tissue: Histological Findings

As the use of ultrasound-assisted liposuction (UAL) increases, the technique grows more popular in breast surgery, especially in reduction mammaplasty and treatment of gynecomastia. The aim of our study was to investigate the effect of UAL on breast tissue using histological examinations, and analyze the effect of this technique on a cellular level. Biopsies from 10 patients undergoing ultrasonically assisted lipectomy prior to classic reduction mammaplasty were taken from the treated areas of the breast. Biopsies were fixed in formalin and embedded in paraffin. Sections were stained with hematoxilin-eosin, and analyzed for defective adipocytes, and the effects of UAL on breast tissue. Untreated breast tissue and breast tissue that had been treated only with conventional aspiration lipectomy served as controls. Sections were analyzed using light microscopy. Compared to the breast tissue treated only with conventional lipectomy, a stronger destruction of the cellular structure of adipocytes could be detected. The destruction was visible even in areas more distant from the aspiration channel. In contrast, the breast tissue was mostly intact, no signs of ultrasonic-induced cellular destruction were visible. The glandular structure was kept intact. Beside the direct mechanical destruction by the probe and the canula, no further alterations of the cellular integrity of the glandular parts were visible. In conclusion our results indicates that UAL is also a safe technique for use in breast surgery. Besides easy handling and improved modelling, the destructive effect of the ultrasound does not include the glandular breast tissue.     

Rupture of Trilucent-Type Breast Implants: A Clinical Case

We present the case of a patient who underwent cosmetic breast augmentation in 1996, with Trilucent-type implants. Four years later, there were delayed complications inherent in the implants, which caused serious clinical problems.     

Augmentation Mammoplasty: Personal Evolution of the Concepts Looking for an Ideal Technique

The purpose of this paper is to report our personal experience in the field of augmentation mammoplasty. This experience is based on over 15 years in practice and working with more than 400 cases using different types of prostheses (single-lumen gel-filled, single-lumen saline-filled, double-lumen, smooth or texturized surfaces), different routes (submammary, periareolar, transaxillary), and different locations of the implant (complete submuscular, subglandular, subpectoral). Our present preference is for a partial submuscular (subpectoral) augmentation mammoplasty through an inferior periareolar route. The results of 91 consecutive patients operated on with this technique from January, 1990 to December, 1994, during the blow-up of the controversy on silicone, are reported.     

Influence of Rifampin on Capsule Formation Around Silicone Implants in a Rat Model

This study investigated the effect of rifampin on the thickness of capsules around silicone implants by bactericidal activity against Stapylococcus epidermidis. Silicone blocks (1 × 1 cm) were placed into pockets created for each of the 40 rats included in the study. In group 1, the operation was performed under aseptic conditions. In group 2, standard S. epidermidis was inoculated into the pocket, whereas rifampin and S. epidermidis were applied in group 3. In group 4, only rifampin was applied topically on implants. After 12 weeks, the peri-implant capsules were removed and examined under a photomicroscope and a scanning electron microscope. The mean thickness of the capsules was 63.307 μm in group 1, 111.538 μm in group 2, 43.076 μm in group 3, and 30.384 μm in group 4. The differences between groups 2 and 3 and groups 2 and 4 were found to be statistically significant (p < 0.001). Rifampin appears to be an agent for preventing peri-implant capsule formation.     

Factors Associated with Breast Implant Rupture: Pilot of a Retrospective Analysis

This pilot study's goal was to test the feasibility of a data collection form which will be used in a scale-up study analyzing multiple surgeons' records. The goal of this expanded study will be to develop identifying factors for women who are at greater risk for having ruptured implants and, if necessary, target them for screening, surveillance, or intervention. In the pilot study, we compared factors associated with implant rupture in women with and without rupture. Similar studies have considered one or a few factors at a time and, generally, have given little attention to implant generation. We developed a data collection form after reviewing records of three surgeons. A total of 92 records was collected and analyzed. An important feature in the pilot was to compare the results of patients whose implants the surgeons had both implanted and explanted (n= 34) with those of patients whose implants the surgeons had only explanted (n= 55) (unknown = 3). This comparison could show if including all explantation patients in a surgeon's practice would bias the sample; however, based on this pilot data, concerns regarding this type of bias seem to be minimal. Similar amounts of data (e.g., implant information, history of capsular contracture, etc.) were collectible on patients whose surgeons both implanted and explanted them (87%) and who had different surgeons for implantation and explantation (84%). Though the data from this limited sample cannot offer firm conclusions on rupture associations, a few factors stood out: size of implants (38.3% of ruptured versus 15.9% of intact implants were 100–200 cm³), history of mammography (46.8% of ruptured versus 24.4% of intact had mammograms, which is likely due to older women with older implants having more mammograms), and history of closed capsulotomy (85.1% of ruptured versus 68.9% of intact). Interestingly, additional procedures performed on the breast (e.g., scar revision, wound repair, etc.) did not affect rupture: both the ruptured and the intact groups had an average of 1.7 procedures performed. The data collection form tested very well in this pilot study. Also, including all patients in the study sample, instead of excluding those who received their implants elsewhere, did not change the results. Though there are not enough data to draw any firm conclusions regarding rupture factors, the collection instrument was rigorously tested and should perform well in an expanded study.     

Immediate Reaugmentation of the Breasts Using Bilaterally Divided TRAM Flaps After Removing Injected Silicone Gel and Granulomas

The authors present eight cases of reconstruction of the breasts using bilaterally divided TRAM flaps after removing the injected silicone gel and granulomas. In Japan, we have the opportunity to examine many patients who have had foreign substance injections to the breasts for purposes of augmentation, however, most of them are now suffering from delayed complications. Until now we have reconstructed breasts such cases by use of silicone bag prostheses after removal of granulomas; however, now it is difficult to obtain silicone prostheses. Thus, we have decided to reconstruct by the use of autogenous cutaneous and adipose tissue flaps as presented by us in this article.