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.     

Incidence of capsular contracture in silicone versus saline cosmetic augmentation mammoplasty: A meta-analysis

INTRODUCTION:

Capsular contracture after augmentation mammoplasty occurs at a rate of 15% to 45%. The purpose of the present study was to determine the effect of implant core type (silicone versus saline) on the rate of capsular contracture in augmentation mammoplasty.

METHODS:

A systematic review was conducted through a search of three electronic databases. Two reviewers independently scanned titles yielded by the search and identified potentially relevant papers. Inter-reviewer variability and the scientific quality of the articles were assessed. Meta-analysis was performed.

RESULTS:

Eighty-eight titles of potential relevance were selected from the 393 articles yielded by the search. Inter-rater agreement for selection of potentially relevant articles was 84% (κ=0.54). Four comparative studies were included in the analysis. Scientific quality scores of the included studies ranged from 5 of 14 to 9 of 14. Three of the four studies reported a higher rate of capsular contracture in patients with silicone implants. A combined odds ratio calculated on two of the studies found a 2.25-fold increased risk of capsular contracture in patients who received silicone implants. Eight series of patients who received cohesive gel silicone implants reported rates of capsular contracture from 0% to 13.6%.

CONCLUSIONS:

Higher rates of capsular contracture were found in patients who received silicone implants when compared with those who received saline implants. However, the scientific quality of the comparative studies to date on this subject is poor. Recent series evaluating cohesive gel implants report relatively low rates of capsular contracture. A randomized controlled trial comparing rates of capsular contracture in cohesive gel and saline implants is recommended.     

Subclinical infection of the silicone breast implant surface as a possible cause of capsular contracture

In order to reexamine the possible association between bacterial presence and capsular contracture, 55 silicone devices (mammary implants or tissue expanders) were cultured at the time of their removal from 40 patients. Special culture techniques were used in an attempt to recover bacteria adhering to the smooth-surfaced implant and encased in glycocalyx biofilm. Bacteria were detected on 56% (15 of 27) of implants surrounded by contracted capsules and on 18% (5 of 28) of those without capsular contracture (p < 0.05). Only three implants tested positive using routine plating techniques. The predominant isolate was Staphylococcus epidermidis. The concept that capsular contracture is associated with subclinical infection of silicone implants is supported by this study. With changes in the microbiological technique, bacterial recovery and growth occurs at a frequency greater than previously thought.This study was supported by a grant from the American Society for Aesthetic Plastic Surgery, Inc.     

Preliminary (3 years) experience with smooth wall silicone gel implants for primary breast augmentation

The goal of this study is to obtain data concerning the incidence of capsular contracture and reoperation rates in patients having primary breast augmentation utilizing modern low-bleed smooth-wall silicone gel implants. Data were collected retrospectively and consisted of 44 patients who underwent primary breast augmentation using smooth silicone gel implants (Mentor Corporation) in the period between 2001 and 2003. Of the 131 patients identified, 44 patients fit the criteria of primary breast augmentation. Secondary cases and primary augmentation with mastopexy were excluded from this study. This group of patients is still followed, and the data are being updated periodically. A total of 44 patients underwent primary breast augmentation. Average age was 32 years (range, 19-57). Average follow-up was 34 months (range, 28-40). Average operative time was 52 minutes. The inframammary incision was used in 65% of patients and the areolar incision in 35%. The subglandular position was used in 35% of patients versus the submuscular position in 65%. Nine patients (20%) developed capsular contracture. Six patients (13.6%) had Baker 3 capsular contracture, which required revision. Four of the 9 patients with capsular contracture had implants placed in the submuscular space and 5 in the subglandular position. Relative to the implant position, 4 patients (9%) with implants placed in the submuscular position developed capsular contracture. Relative to the subglandular position, 5 patients (11.3%) with implants placed in the subglandular position developed capsular contracture. Eight patients (19%) required implant revision, 6 patients for capsular contracture, and 2 patients requested size change. Preliminary data from this study indicate that the use of the new generation of gel implants yields less capsular contracture, as well as decreased revision rates. Subglandular placement of gel implants did not significantly increase the risk of capsular contracture. Longer follow-up and multicenter studies are still needed to confirm these findings. This cumulative data could challenge the current status of gel implant moratorium imposed by the incidence of capsular contracture and revision rates.     

Histological analysis of capsule formation around silicone implants and comparison with titanium-coated silicone implants in rats

Silicone implants have been used for breast augmentation for more than 45 years. Complications, in particular capsular contracture, occur with an incidence of <10% and up to 60%. We investigated the influence of the surface of breast implants on the formation of capsular contracture by comparing silicone with titanium-coated silicone. Seventeen smooth saline-filled silicone (group A) and 14 saline-filled titanium-coated silicone (group B) implants were implanted in female Wistar rats. After 12 and 36 weeks, the implants and capsules were extracted; histological and immunohistochemical staining was performed. The evaluation of the capsules was performed by two examiners in a double-blinded manner. Histologically, no significant difference in total capsule thickness was found. There was a significant difference in synovial-like metaplasia layer (SLM) thickness between groups A and B (p = 0.041). Regarding implantation time (12 vs. 36 weeks), a significant difference was found in SLM thickness (p = 0.021). Immunohistochemical staining indicated a significantly lower infiltration with inflammatory cells in group B. A significant correlation (p = 0.019) between a thick SLM layer and inflammatory cell infiltration was detected. Titanium-coated silicone implants reduce SLM thickness and capsular inflammatory cell infiltration. These findings postulate that titanium-coated silicone implants might point out a new chance in the prevention of capsular contracture.     

Titanium-coated polypropylene mesh (TiLoop Bra®)—an effective prevention for capsular contracture?

Background

Silicone implants have been used in breast augmentation for more than 45 years. Complications, in particular, capsular contracture, still occur with a high incidence. Titanium-coated polypropylene mesh (TCPM; TiLoop Bra®, pfm medical, Cologne, Germany) provides new opportunities for implant-based breast reconstruction. We investigated the influence of the surface of silicone implants on the formation of capsular contracture by comparing textured silicone with TCPM-covered smooth silicone implants.

Methods

Twenty textured silicone gel-filled (group A) and twenty TCPM-covered smooth silicone gel implants (group B) (Silimed®, Rio de Janeiro, Brazil) were implanted in female Wistar rats. After 60 days, the implants and capsules were extracted, and histological and immunohistochemical staining was performed. The double-blind evaluation of the capsules was performed by two examiners.

Results

We were able to detect a thinner, but stiffer, capsule and a less development of an inner synovia metaplasia layer as well as a lower vascularity in capsules around TCPM-covered silicone implants. We found a higher percentage of myofibroblasts within the capsule structure and more inflammatory cell infiltration.

Conclusions

The quality of capsule structure around both tested implants differs significantly. Although capsules around TCPM-covered implants presented were thinner, they integrated with the mesh in a rigid cage structure capsule with higher infiltration of inflammatory cells caused by a significant foreign body reaction. TCPM-covered silicone implants showed no apparent advantage in the reduction of capsular contracture. On the other hand, the indication for using this material as a supportive soft tissue structure can be confirmed. Level of Evidence: not ratable, experimental study.     

Changes over Time in Mammary Compliance Values After Breast Augmentation

Capsular contracture is the most troublesome and distressing complication after breast augmentation for both the surgeon and patient. The etiology of capsular contracture remains unclear. Clinical treatment for this complication is based on the surgeon’s evaluation, the condition of the breast, and a number of other factors. In a previous study, the authors investigated whether measurement of mammary compliance as a means of assessing capsular contracture was comparable with other methods described for the assessment of capsular contracture. The purpose of this study was to evaluate whether capsular contracture varies significantly over time. A prospective study was performed to measure mammary compliance in 60 female patients who received a total of 120 implants between 2000 and 2002. The implants used were anatomic prostheses filled with cohesive silicone gel and round double-lumen prostheses filled with silicone gel and saline solution. All the patients were followed up for at least 2 years. Statistical analysis of the data also was performed to assess significance. The results showed a general trend in mammary compliance values over time.     

微小组合乳房假体与传统单一假体包膜挛缩的比较研究

目的 了解微小组合硅凝胶乳房假体置入肌层下的包膜挛缩特点,并与传统单一大假体进行比较.方法 30只大白兔,每只大白兔背部两侧肌层下分别置入10ml微小硅凝胶假体4个、40 ml传统硅凝胶乳房大假体1个.3个月时进行包膜挛缩Baker评级,压缩实验,包膜切开后裂开宽度,包膜厚度的比较,取包膜样本切片进行HE染色,镜下观察比较包膜特点.结果 微小组合假体Baker评级、包膜裂开最大宽度、包膜厚度均明显低于大假体组（P＜0.01）.假体压缩率明显高于大假体组（P＜0.01）.微小组合假体形成的包膜较传统假体包膜凸凹不平,胶原排列较屈曲且膜薄.结论 微小组合假体较传统假体有更低程度的包膜挛缩,有一定的隆乳术应用前景.     

Capsular contracture after cosmetic breast implant surgery in Denmark

The authors investigated the association between the occurrence of capsular contracture and implant and patient characteristics. All women with breast implants from 1977 to 1997 were identified from the files of two private plastic surgery clinics in Denmark. Information on implant and patient characteristics, surgical procedure, and complications was obtained through medical records and self-administered questionnaires. Of 754 women (1,572 implants), average age at implantation was 32 years. Implant types were silicone double lumen, textured, 31.2%; silicone single lumen, textured, 27.8%; silicone single lumen, smooth, 24.5%; silicone double lumen, smooth, 0.8%; and other or missing, 15.7%. Placement was submuscular for more than 90% of implants. Capsular contracture occurred in 7.9% of implanted breasts, on an average of 621 days postoperatively, with 51.6% being bilateral. Overall, 66.1% of capsular contractures were recorded within the first 12 months postoperatively, and 79.0% were recorded within 24 months. Double-lumen implants were associated with a significantly (p < 0.01) reduced occurrence of capsular contracture. In summary, capsular contracture typically occurs within the first 2 years of implantation. Host factors may be important because more than half the capsular contractures in the current study were bilateral. Occurrence of capsular contracture did not appear to be associated with implant surface or placement, occurrence of local complications, or patient characteristics, although these findings should be interpreted cautiously.     

Subjective and objective assessment of capsular contracture

Summary Contraction of the fibrous capsule around an implant after prosthetic breast surgery is a serious complication, which can adversely effect the outcome and spoil the overall result. Textured silicone implants are reported to have reduced rates of capsular contraction, but their exact mechanism, especially at the interface, remains unclear. Over a period of 21/2 years, 94 textured silicone implants were used in augmentation mammoplasty. A follow-up examination was possible in 74 cases. The clinical assessment of results was based on Baker's classification. In addition to the subjective assessment of breast firmness, objective measurements (mamma compliance) were obtained. The average follow-up period was 55.6 weeks. 79.7% of augmented breasts were classified as Baker I, 16.2% as Baker II, 4.1% as Baker III and 0% Baker IV In comparison to previous results reported in the literature, the incidence of capsular contracture obtained with textured implants was significantly lower. All Baker III cases were replacements of the original implant following advanced capsular contraction. The compliance measurements were found to correlate well with Baker's classification. Sixty-one of 72 cases of augmented breasts showed compliance values similar to normal breasts, which ranged between 0.64 and 3.7 cm at D20n. This measurement proves that 82.4% of the augmented breasts are as soft as normal breasts. A partial comparison between our clinical data and histological examination was possible. Firm adhesion of the capsule to the surface of the implant was characteristic of those breasts which showed no capsular contracture, while in breasts showing advanced capsular contraction, implant and capsule were separated by a liquid film. The use of surface textured silicone implants has led to a significantly decreased rate of capsular contraction without having to employ steroids. Close contact between implant and capsule seems to be the most important factor for reduced capsular contraction.     

Buckled Upper Pole Breast Style 410 Implant Presenting as a Manifestation of Capsular Contraction

Recent experience with the cohesive gel implant has shown an interesting variation of capsular contracture. Instead of spherical contraction, the capsule formation around the 410 implant seems to cause a buckling of the superior pole of the implant. This buckling has been observed in four implants and presented clinically in 2 of 50 patients with a superior pole mass. The capsular contraction around the implant and the buckling are probably camouflaged by a subpectoral implantation and this presentation should be recognized by the surgeon, especially when considering placement of the cohesive gel implant in a subglandular position. Histological sections of a capsule around the implant show fragmented silicone, with a cellular reaction around the fragmented silicone.     

Submuscular Calf Implants

Since the first report of calf augmentation in 1979, two kinds of implants have been used—silicone-gel filled implants and firm silicone rubber implants. Usually placed in the plane below the deep fascia of the calf, the first implants had problems with visible capsular contracture. In addition, the firm silicone rubber implants could be felt by the patients when they touched their calves. As a result, we looked for another plane in which to place the calf implants. In this paper we present our experience with the placement of the calf implants between the gastrocnemius muscle and the soleus in a series of six patients. Results and complications in these patients are presented over follow-up periods of six months to two years.     

Effect of cortisone on capsular contracture in double-lumen breast implants: Ten years' experience

Two groups of patients are compared with respect to capsular contracture after insertion of silicone breast prostheses. Six hundred seventy four women received single-lumen gel prostheses and 700 received double-lumen prostheses with cortisone. The addition of 12.5 mg of prednisolone to double-lumen prostheses diminished capsular contracture (Baker II to IV) dramatically; in patients with simple augmentation from 19% to 4.9%, in patients with subcutaneous mastectomy from 54% to 14.9%, and in patients with breast reconstruction from 64% to 24.4%. The use of double-lumen implants has three distinct advantages: (l) There is no bleeding and therefore no contact of the body with the silicone gel. (2) There is no danger of ruptured implants, even if the outer shell shows leakage. (3) if prednisolone is administered, capsular contracture is prevented to a significant degree.     

Textured or smooth implants for breast augmentation? A prospective controlled trial

This study examines the hypothesis that textured surface silicone implants reduce the incidence of adverse capsular contracture in breast augmentation. A total of 53 patients were entered into a prospective study; they were randomly assigned to receive either smooth or textured implants which were placed in the submammary plane. Of these, 50 patients were assessed at 12 months by a panel of observers who did not know which type of implants had been used. Adverse capsular contracture (Baker grades 3 and 4) was found in 28 breasts augmented with smooth surface implants (58%) and in 4 breasts in the textured surface implant group (8%). This reduction in adverse contracture using textured surface implants was highly significant (p less than 0.0001). Careful trial design is essential in studies of this sort in order that we can obtain useful data regarding the causes and prevention of adverse capsular contracture.     

Silicone breast prostheses: A cohort study of complaints,complications, and explantations between 2003 and 2015

Background

Complications after silicone implantation, with silicone extravasation being the most severe, remain a safety issue in breast implantation surgery. The purpose of our study was to determine the incidence of medium- and long-term postoperative complaints and complications and indications for explantation in patients with a silicone breast implant.

Silicone Gel-Filled Breast Implants: Is Local Inflammation Associated With Fat Necrosis?

Abstract: Granuloma formation and chronic inflammation are local reactions that are associated with implantation of medical grade silicone. These responses lead to capsular contraction, pain, and cosmetic problems. In addition, there have been a few reports of connective tissue disease in patients with silicone gel-filled implants. The purpose of this paper is to raise the possibility that local responses to silicone gel-filled implants are mediated by fat necrosis. Results of histologic findings and patient records in six patients indicate that patients experiencing implant leakage or failure exhibited classic signs of a foreign-body response, including the presence of giant cells and foamy macrophages. Most of the observed vacuoles were empty and appeared similar to enucleated fat cells, although some contained foreign material. These observations suggest that the physical presence or degradation products of the implants may have elicited fat cell necrosis that contributed to the chronic inflammatory response. In contrast, patients with intact implants showed no signs of a chronic foreign-body response. None of the patients in this study demonstrated any systemic complications. It is concluded that although there have been numerous reports of empty vacuoles containing silicone that are either derived from the membrane that surrounds the implant or from the gel, there are no reports linking these vacuoles to the vacuoles seen in fat tissue necrosis, even though histologically the two processes are morphologically similar. Therefore, it is important to ask whether some of the adverse reactions observed with silicone gel-filled implants may be mediated via fat cell necrosis.     

Talc and capsular contracture

Capsular contracture, constrictive tightening of scar tissue around implants, was historically the primary reason for reoperating breast-implanted women. Yet, capsular contracture remains of unknown etiology. Contamination with foreign material is one of several suspected causes. Talc, a known fibrogenic agent, was recently found in peri-implant scars. A comparison of 192 explanted women was designed to investigate the role of talc in the induction of capsular contracture. This study included women implanted with silicone gel-filled implants for whom tissue samples were available. Patients were evaluated for the occurrence of capsular contracture and the presence of intracellular talc particles in peri-implant tissues. There was a significant association between talc and capsular contracture (odds ratio = 18.0, 95% confidence interval = 5.9-55, P < 1 x 10(-9)). This study indicates that talc was a major risk factor for capsular contracture in women augmented before 1992.     

Smooth or textured implants: what to select?

Envelope structure has evolved since the seventies. Indeed, low-bleed implants allow an important reduction of capsular contracture for silicone filled implants. Later, textured implants permit an additional reduction of capsular contracture, especially when positioned in a retroglandular pocket. Whereas many studies confirm these findings, the interest of textured implants in the retromuscular plane is not really clear, even if some authors recommend it. Due to the need of a tissular anchorage, anatomical implants are not manufactured with smooth envelopes.