Detection of subclinical infection in significant breast implant capsules

The pathogenesis of fibrous capsular contracture after augmentation mammaplasty is still debated. One hypothesis implicates low-grade bacterial infections as a cause. The presence of a staphylococcal biofilm in a patient with recurrent capsular contracture was previously reported. A comparative, prospective, blinded, clinical study of implants and capsules removed from patients with or without significant capsular contracture was conducted to investigate the association of biofilm contamination, breast implants, and capsular contracture.Capsule and implant samples obtained during explantation were tested by routine microbiological culture, sensitive broth culture (after maceration and sonication), and scanning electron microscopy. Clinical parameters were correlated with microbiological findings. A total of 48 implant and/or capsule samples were obtained from 27 breasts during a 22-month period. Of the 27 breasts, 19 exhibited significant contracture (Baker grade III/IV). The mean duration of implantation was 9.2 years (range, 0.4 to 26.0 years). Routine swab cultures obtained at the time of explantation were negative for bacterial growth for all samples. The sensitive broth culture technique yielded 24 positive samples (50 percent, n = 48). An analysis of capsules demonstrated that 17 of 19 samples obtained from patients with significant contracture were positive, compared with only one of eight samples obtained from patients with minimal or no contracture (p = 0.0006). Fourteen of the 17 positive cultures from significantly contracted breasts yielded coagulase-negative staphylococci, mainly, species of the Staphylococcus epidermidis group. The presence of coagulase-negative staphylococci was also significantly associated with capsular contracture (p = 0.01). There was no significant difference in the frequency of culture positivity for saline versus silicone implants (p = 0.885). Scanning electron microscopy confirmed the presence of extensive biofilm on implants and within capsules.Biofilm, in particular, S. epidermidis biofilm, was detected for a significant proportion of patients with capsular contracture. This implicates biofilm disease in the pathogenesis of contracture, and strategies for its prevention should be explored.     

Capsular contracture in silicone gel and saline-filled breast implants after reconstruction

Comparisons between results with randomly allotted silicone-gel and saline-filled prostheses in breast reconstruction after mastectomy led to the following conclusions. Neither prosthesis type is ideal. Leakage from saline-filled implants occurred in 2 of the 37 implants, with resultant deflation. Silicone prostheses had a significantly higher rate of capsular contracture [surgeon's evaluation: 54 percent capsular contracture for silicone-gel compared with 20 percent for saline-filled prostheses (p = 0.006); patients' evaluation for the same figures: 54 percent compared with 29 percent (p = 0.03)]. Other authors have shown the presence of silicone in the tissue around silicone-gel-filled silicone implants, but less or none around saline-filled silicone implants. Since the only difference between the two groups was the randomly allotted implants, we assume that the free silicone around silicone-gel-filled prostheses is the major cause of capsular contracture. Since the saline-filled implants showed a 20 percent capsular contracture rate, there could be other causes of capsular contracture in this study. For prevention of contracture, improved implant encapsulation and use of a less reactive filling substance seem to offer possibilities. Surgical technique should aim to preserve the integrity of the prosthesis.     

Radiation therapy after immediate breast reconstruction with implants

The use of implants in immediate breast reconstruction is presently a common option. However, the practice should be evaluated in consideration of possible adjuvant therapies needed to control disease and to rule out negative interactions. This article discusses the effects of radiotherapy on breast implants with regard to the final cosmetic result. Six out of 124 cases of immediate breast reconstruction with implants were followed and evaluated in terms of capsular contracture and final aesthetic result after adjuvant radiotherapy and compared with the results of 118 patients who did not require irradiation. All of the patients who received irradiation demonstrated poor to fair results, with grade III to IV capsular contracture. Two patients received radiation therapy for local recurrences, which worsened their capsular contracture, emphasizing the deleterious effect of irradiation on breast implants. Statistical analysis of the results demonstrated a significant difference between the two groups in terms of capsular contracture and breast symmetry. In the selection of patient candidates for immediate breast reconstruction with implants, adjuvant radiation therapy must be considered as a contraindication, at least from an aesthetic point of view.     

A clinical comparison of the tendency to capsular contracture between smooth and textured gel-filled silicone mammary implants.

The aim of this prospective, controlled clinical investigation was to find out if there is a difference in the capsular contracture rate between silicone implants with a smooth or textured surface as the only difference. Twenty-five women with bilateral mammary hypoplasia underwent mammary augmentation. All got a textured implant on one side and a smooth implant on the other. The implants were placed subglandularly. Follow-up examinations were done on six occasions. Three parameters were used for estimation of the tendency to capsular contracture: (1) the patient's opinion on differences in hardness of the breasts, (2) the investigator's classification of capsular contracture, and (3) applanation tonometry. At the end of the follow-up period, after 1 year, all parameters showed with no doubt that the breasts augmented with textured implants had a lower tendency to develop contracting capsules than the breasts augmented with smooth implants.     

Ten-year review of a prospective randomized controlled trial of textured versus smooth subglandular silicone gel breast implants

Although textured silicone breast implants have been shown to reduce the incidence of capsular contracture, there is little evidence if this effect is maintained in the long term. It has been 10 years since the double-blind randomized trial in which 53 patients received either Mentor smooth (26) or textured silicone gel implants (27). Of the 14 patients who were not known to have developed a contracture in the smooth group, 11 were reviewed. Three had bilateral contractures. In the textured group, 18 of the 24 patients not known to have contractures were reviewed. None had developed contractures. At 10 years, the incidence of capsular contracture was 65 percent of patients with smooth implants (an increase of 6 percent on the 3-year results) and 11 percent for the textured implant patients (no change on the 3-year results). A database containing the details of 1100 patients reinforces these results by examining the differences in contracture rates of textured, smooth, and polyurethane-coated implants. The effect of submuscular placement on reducing contracture rates regardless of texturing is discussed, as is the apparent increase in capsular contracture in patients who smoke.     

Textured-surface saline-filled silicone breast implants for augmentation mammaplasty

The earliest silicone breast implants were smooth-surface, silicone rubber devices filled with either silicone gel or saline. Because of persistent problems with capsular contracture, polyurethane-covered silicone implants were developed as an alternative. Particularly in the short run, these alternatives proved highly successful at reducing the incidence of capsular contracture. By 1990, polyurethane-covered implants were rapidly becoming the preferred implant choice of many plastic surgeons, but for legal, regulatory, financial, and safety reasons they were withdrawn from the market by Bristol-Myers in 1991. Meanwhile, during the late 1980s, surface texturing and improved materials became available on other silicone breast implants and expanders. Most studies suggest that textured-surface silicone gel-filled implants, saline-filled implants, and tissue expanders have less frequent capsular contracture than their smooth-surface counterparts.     

Capsular contracture around saline-filled fine textured and smooth mammary implants: a prospective 7.5-year follow-up.

In a previous prospective randomized clinical study comparing in the same patient textured and smooth saline-filled mammary implants (Biocell) with large pore size (300 to 600 microm), we saw no difference in capsular contracture. This study was undertaken in a similar way to compare capsular contracture around smooth and textured saline-filled prostheses with pores of small size. During a period of 7.5 years, the breast hardness was followed up, and at the end of the study patient satisfaction was evaluated.Twenty healthy women with a mean age of 30 years were operated on for breast augmentation. Two surgeons performed all operations in a standardized way. Each patient received subglandularly a Siltex textured saline-filled prosthesis with a pore size of 30 to 70 microm in one breast, and a smooth saline-filled prosthesis in the other. The hardness of the breasts was evaluated after 0.5, 1, and 7.5 years using Baker grading and applanation tonometry. Eighteen patients completed 1-year and 7.5-year follow-up. Two breasts with smooth prostheses were contracted after 6 months (Baker III or IV). After 1 year, four patients with smooth prostheses and one with a textured prosthesis had capsular contracture (p = 0.34). Seven and one-half years after surgery, six patents with smooth and four with textured implants had contracture (p = 0.66). On two patients with smooth prostheses and one patient with a textured prosthesis, the capsule around the implant hardened between 6 and 12 months. Between 1 year and 7.5 years, three breasts with smooth and textured implants contracted and one with a textured implant softened.The patients reported on a Visual Analogue Scale (1 to 10) the impact of the augmentation on their quality of life to be 9 +/- 1. Four patients preferred the breast with the smooth prosthesis, three preferred the breast with the textured prosthesis, and the others found both breasts equal. This study showed no significant difference of contracture with smooth versus fine textured implants. The majority of the patients preferred the smooth implants. The patients reported that the breast augmentation had had an extremely high impact on their quality of life.     

The correction of capsular contracture by conversion to "dual-plane" positioning: technique and outcomes

Little has been published regarding the treatment of patients with long-established capsular contracture after previous submuscular or subglandular breast augmentation. This study reviews 7 years of experience in treating established capsular contracture after augmentation mammaplasty by relocating implants to the "dual-plane" or partly subpectoral position. A retrospective chart review was performed on all patients who were treated for capsular contracture using this technique between 1993 and 1999. Data collected included the date of the original augmentation, the original implant location, date of revision and type of implant used, length of follow-up, outcome, and any ensuing complications. Different surgical techniques were used, depending on whether the prior implant was located in a subglandular or submuscular plane. All patients had revisions such that their implants were relocated to a dual plane, with the superior two thirds or so of the implant located beneath the pectoralis major muscle and the inferior one third located subglandularly. Of 85 patients reviewed, 54 had their original implants in a submuscular position and 31 had their initial augmentation in a subglandular position. Of the 54 patients whose implants were initially submuscular, 23 patients (43 percent) had silicone gel implants, 15 patients (28 percent) had double-lumen implants, and the remaining 16 patients (30 percent) had saline implants. Of the 31 patients whose implants were initially subglandular, 20 patients (65 percent) had silicone gel implants, three patients (10 percent) had double-lumen implants, and the remaining eight patients (26 percent) had saline implants. Fifty-one patients (60 percent) had replacement with saline implants (37 smooth saline, 14 textured saline), whereas 34 (40 percent) had silicone gel implants (seven smooth gel, 27 textured gel). The average time from previous augmentation to revision was 9 years 9 months. The average follow-up time after conversion to the dual-plane position was 11.5 months. Only three of 85 patients required reoperation for complications, all of which involved some degree of implant malposition. Of patients converted to the dual plane, 98 percent were free of capsular contracture and were Baker class I at follow-up, whereas 2 percent were judged as Baker class II. There were no Baker level III or IV contractures at follow-up. The dual-plane method of breast augmentation has proved to be an effective technique for correcting established capsular contracture after previous augmentation mammaplasty. This technique appears to be effective when performed with either silicone or saline-filled implants.     

Preoperative antibiotics and capsular contracture in augmentation mammaplasty

The main drawback with augmentation mammaplasty using implants is capsular contracture. The cause of this complication is still unknown. Silicone particles, hematoma, and bacterial contamination are some of the etiologic factors discussed. In this randomized, double-blind study on 76 breast-augmented women, 50 percent of the patients had preoperative prophylaxis with benzylpenicillin and dicloxacillin. Bacteria samples were taken intraoperatively. The number of negative cultures increased significantly with antibiotic prophylaxis. In four follow-ups during the first postoperative year, the rate of contractures was evaluated by subjective and objective methods. The results showed no statistically significant difference between the placebo and the antibiotic group with respect to the incidence of capsular contracture.     

Comparison of the Postoperative Incidence Rate of Capsular Contracture among Different Breast Implants: A Cumulative Meta-Analysis

BackgroundA large number of clinical studies have reported that the different materials used in breast implants were a possible cause of the different incidence rates of capsular contracture observed in patients after implantation. However, this theory lacks comprehensive support from evidence-based medicine, and considerable controversy remains.ObjectivesIn this study, a cumulative systematic review examined breast augmentation that used implants with textured or smooth surfaces to analyze the effects of these two types of implants on the occurrence of postoperative capsular contracture.MethodsWe conducted a comprehensive search of literature databases, including PubMed and EMBASE, for clinical reports on the incidence of capsular contracture after the implantation of breast prostheses. We performed a cumulative meta-analysis on the incidence of capsular contracture in order from small to large sample sizes and conducted subgroup analyses according to the prosthetic material used, the implant pocket placement, the incision type and the duration of follow-up. Relative risks (RR) and 95% confidence intervals (CI) were used as the final pooled statistics.ResultsThis meta-analysis included 16 randomized controlled trials (RCTs) and two retrospective studies. The cumulative comparison of textured and smooth breast implants showed statistical significance at 2.13 (95% CI, 1.18-3.86) when the fourth study was entered into the analysis. With the inclusion of more reports, the final results indicated that smooth breast implants were more likely to be associated with capsular contracture, with statistical significance at 3.10 (95% CI, 2.23-4.33). In the subgroup analyses, the subgroups based on implant materials included the silicone implant group and the saline implant group, with significant pooled statistical levels of 4.05 (95% CI, 1.97-8.31) and 3.12 (95% CI, 2.19-4.42), respectively. According to implant pocket placement, a subglandular group and a submuscular group were included in the analyses, and only the subglandular group had a statistically significant pooled result of 3.59 (95% CI, 2.43-5.30). Four subgroups were included in the analyses according to incision type: the inframammary incision group, the periareolar incision group, the transaxillary incision group and the mastectomy incision group. Among these groups, only the pooled results of the inframammary and mastectomy incision groups were statistically significant, at 2.82 (95% CI, 1.30-6.11) and 2.30 (95% CI, 1.17-4.50), respectively. Three follow-up duration subgroups were included in the analyses: the one-year group, the two- to three-year group and the ≥five-year group. These subgroups had statistically significant results of 4.67 (95% CI, 2.35-9.28), 3.42 (95% CI, 2.26-5.16) and 2.71 (95% CI, 1.64-4.49), respectively.ConclusionIn mammaplasty, the use of textured implants reduces the incidence of postoperative capsular contracture. Differences in implant pocket placement and incision type are also likely to affect the incidence of capsular contracture; however, this conclusion awaits further study.     

Comparative experience with smooth and polyurethane breast implants using the Kaplan-Meier method of survival analysis.

Smooth-walled silicone implants have been widely used in breast surgery. Capsular contracture, causing undesirable firmness and spherical deformity, has been a common problem. Recent studies suggest that polyurethane-covered breast implants are associated with a lower incidence of capsular contracture. The statistical methodology employed in some of these studies, however, may be subject to criticism. Between July of 1984 and June of 1990 (72 months), 427 polyurethane breast implants were used in 279 patients and 439 smooth prostheses were used in 250 patients for a variety of aesthetic and reconstructive procedures. The occurrence of capsular contracture was carefully monitored and then analyzed using the Kaplan-Meier method of survival analysis. This method is particularly well suited to analysis of these types of clinical data because it allows for the fact that contractures occur at varying intervals after surgery and that follow-up of patients is incomplete. The probability of capsular contracture with smooth-walled prostheses was found to be significantly greater than with polyurethane-covered implants in each group of patients studied (p less than 0.05). Other complications occurred at a similar rate regardless of prosthesis type. This study supports the belief that polyurethane breast implants have a lower contracture rate; furthermore, it introduces the Kaplan-Meier method for analyzing the outcome of alternative plastic surgical therapies.     

Self-reported diseases and symptoms by rupture status among unselected Danish women with cosmetic silicone breast implants

Epidemiologic evidence does not support an association between silicone breast implants and connective tissue or other rheumatic diseases. However, a recent study has suggested that women with ruptured implants may be at increased risk of developing fibromyalgia. An analysis of adverse health outcomes according to breast implant rupture status was conducted in 238 unselected Danish women with cosmetic silicone breast implants. Ninety-two of the women had definite implant rupture, and 146 had intact implants as determined by magnetic resonance imaging. Before undergoing imaging, the women provided blood samples and completed a self-administered questionnaire. Women with ruptured implants overall, and the subgroup with extracapsular ruptures (n = 23), were compared with women with intact implants regarding a number of self-reported diseases and symptoms and the presence of specific autoantibodies, such as antinuclear antibodies, rheumatoid factor, and cardiolipin immunoglobulin G and M antibodies. Overall, there were no differences in the occurrence of self-reported diseases or symptoms or in the presence of autoantibodies between women with intact implants and women with ruptured implants, including extracapsular rupture. The only exception was capsular contracture, which was reported six times more frequently by women with extracapsular ruptures than by women with intact implants (OR, 6.3; 95 percent CI, 1.7 to 23.5). In conclusion, this study of unselected women with silicone breast implants could establish no association between silicone implant rupture and specific diseases or symptoms related to connective tissue disease or other rheumatic conditions, except for an excess of capsular contracture among women with extracapsular rupture.     

Influence of some operative and postoperative factors on capsular contracture around breast prostheses.

In a follow-up of 490 patients with breast implants, neither the size of the prosthesis nor the nature of the surgical procedure (simple augmentation mammaplasty or after subcutaneous mastectomy) increased the incidence of capsular contracture. Hematoma or infection were followed by a higher incidence of capsular contracture. Drainage with suction and the instillation of steroid around the prostheses seemed to be effective in reducing the incidence of capsular contracture. In the steroid-treated group, the need for open surgical treatment was reduced. The recurrence rate after closed capsulotomy, or open capsulotomy, was not significantly different from that following the more extensive procedure of capsulectomy.     

Recurrence of subglandular breast implant capsular contracture: anterior versus total capsulectomy

The objective of this study was to determine whether the type of capsulectomy, anterior or total, affects the recurrence of capsular contracture around subglandular silicone-gel breast implants. A retrospective analysis was performed of patients who underwent either anterior or total capsulectomy for Baker grade 3 or 4 subglandular capsular contracture in our unit. All patients were invited to a review clinic where their capsular status was assessed. There were 100 anterior- disc capsulectomies in 60 patients between 1988 and 1997 and 99 total capsulectomies in 60 patients between 1990 and 1998. The follow-up in the former group was a median of 7 years and mean 6.9 years, compared with median 2.5 and mean 3.1 years in the latter group. Eighty-six percent of the implants removed from both groups at capsulectomy were smooth-walled gel-filled implants. Sixty-nine breasts in the anterior group received textured gel implants at capsulectomy; the remaining 31 received polyurethane-coated Meme implants. In the total capsulectomy group, all but two breasts (one patient) received textured gel implants. After review, the capsular status was known in 80 percent of the anterior and 92 percent of the total capsulectomy group. The review clinic found eight new contractures in five patients to have developed in the anterior compared with none in the total group. Recurrent contractures affected 50 percent of patients (46 percent of breasts) in the anterior and 11 percent of patients (10 percent of breasts) in the total capsulectomy group. Kaplan-Meier survival analysis was applied to the data. By including only patients who received textured gel implants at capsulectomy, the Logrank found a statistical difference between the two treatment groups (0.01 < p < 0.5). We believe that this study provides some evidence that total capsulectomy for subglandular silicone breast implant capsular contracture results in a lower capsular recurrence than anterior- disc capsulectomy. The pattern and risk of recurrence after total capsulectomy and exchange for a modern textured prosthesis appear to approach those following primary augmentation.     

Methyl prednisolone in double-lumen gel-saline submuscular mammary prostheses: a double-blind, prospective, controlled clinical trial

At the time of immediate breast reconstruction with submuscular implants, 76 consecutive patients (89 breasts) were randomized into two groups. One received a gel-saline, double-lumen implant with 40 cc of saline added to the outer lumen, while the other received the same implant plus 40 cc of saline and 16 mg methyl prednisolone (40 mg%). Patients were followed for a minimum of 3 years. The groups, which were matched for patient age and implant size, were evaluated at 3, 12, 24, and 36 months for capsular contracture, steroid atrophy, and other complications. With completion of the double-blind study, the patients with submuscular gel-saline implants with only saline added had an overall capsular contracture rate of 38 percent at 3 months, 38 percent at 12 months, and 44 percent at 24 and 36 months. Those with methyl prednisolone had an overall capsular contracture rate of 14 percent at 3 months, and this remained unchanged through the end of the study. The rates of all other complications were comparable. Methyl prednisolone in a dose of 16 mg in 40 cc saline (concentration 40 mg%), when used in the outer lumen of a double-lumen gel-saline implant in a submuscular pocket, is both safe and efficacious in reducing the risk of capsular contracture for a minimum of 3 years in patients undergoing immediate breast reconstruction with submuscular mammary implants.     

The effectiveness of sodium 2-mercaptoethane sulfonate (mesna) in reducing capsular formation around implants in a rabbit model

The development of capsular contracture is the most common complication associated with the insertion of breast implants. The authors studied the role of sodium 2-mercaptoethane sulfonate (mesna) in reduction of capsular formation in a rabbit model. Two 40-cc textured saline implants were placed dorsally into each of the 20 rabbits in the study. At the time of insertion of the implants, 10 ml of a 10% solution of mesna was instilled into one of the pockets and normal saline was instilled into the other. The implants were removed and a capsulectomy was performed at 5 months. The capsules were examined histologically for qualitative differences between the two groups. Quantitative analysis of the thickness of the capsule and the myofibroblast populations was also performed and compared between the two groups. The mean total thickness of the capsule around the implants was 496.8 microm in the mesna-treated group compared with 973.7 microm in the saline-treated group (p < 0.001). Likewise, the thickness of the myofibroblast layer was reduced in the mesna-treated group at 283.2 microm versus 555 microm in the saline-treated group (p < 0.0001). The capsules were also relatively less vascular in the mesna-treated group. Because of its ability to reduce the extent of capsular formation and to diminish development of myofibroblasts in the capsules, mesna would appear to be a useful adjunct in the prevention of capsular contracture formation.     

"Saline float" positioning of the polyurethane-covered breast prosthesis

The use of the "saline float" technique has enabled us to more easily position the foam-covered breast implants through a short aesthetic incision. Of 34 patients in whom this has been used, one breast has been complicated by wrinkling of the prosthesis noted early after surgery. At 6 months this is no longer evident. Retained saline has caused no problems, and no infections have been encountered. This technique offers a safe and simple solution to overcome the tissue friction associated with use of the polyurethane foam-covered prosthesis.     

Acceleration of capsule formation around silicone implants by infection in a guinea pig model

Fibrous capsules surrounding silicone implants were investigated in a new guinea pig model to delineate some of the factors leading to capsular contracture. Both the implant surfaces and tissue capsules were examined by light and scanning transmission electron microscopy (STEM + SEM) with x-ray energy spectroscopy (XES). The capsular tissues were qualitatively similar to those recovered clinically, showing dense parallel collagen deposits, fibroblasts, myofibroblasts, macrophages, and foreign-body giant cells. Silicone was positively identified within intercellular vacuoles and the rough endoplasmic reticulum of macrophages by XES. Tissue recovered from the capsules that surrounded implants that were contaminated with S. aureus presented a qualitatively similar histologic spectrum. The contaminated specimens did show an accelerated response. SEM showed a cellular invasion of the silicone envelopes. We conclude that the model accurately simulates the clinical situation and suggests that immune mechanisms may play a key role in capsular contracture.     

A comparison of conventional and low-bleed implants in augmentation mammaplasty.

We conducted a double-blind, retrospective comparison between low-bleed and non-low-bleed (conventional) mammary implants because no controlled study has shown a difference in the degree of capsular contracture between the two types of implants. Twenty-five patients had conventional implants and form group A; twenty-eight patients had low-bleed implants and form group B. All patients had submuscular augmentation. The mean Baker score was 1.51 for group A and 1.04 for group B for the entire patient population and 1.65 for group A and 1.07 for group B for patients with more than 1 year of follow-up. For the entire population, 34 percent of group A and 3.6 percent of group B had a Baker score of 2 or greater. For the population with more than 1 year of follow-up, 42 percent of group A and 7 percent of group B had a Baker score of 2 or greater. There was significantly (p less than 0.007) less contracture with the low-bleed implants for the entire population as well as for those patients with greater than 1 year of follow-up (p less than 0.015).     

Breast augmentation: compression--a very important factor in preventing capsular contracture

The incidence of capsular contracture is reduced when smooth-surfaced, saline-filled implants are placed subpectorally, avoiding contamination and the presence of blood. In addition, since the authors began using compression, they have not had one single capsular contracture requiring surgery. The authors' technique, their preoperative and postoperative regimens, an explanation of how they use compression, and the scientific and mathematical explanation of why compression could be the most important factor in preventing capsular compression are described. Of more than 1700 augmentations performed in our private clinic, only 830 could be included in the study. The patients were followed clinically for 1 year, after which time they completed a questionnaire, the results of which showed the authors that capsular contracture had not developed.