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.     

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.     

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.     

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.     

毛面乳房假体和光面乳房假体隆乳术后包膜挛缩率的Meta分析

目的 利用Meta分析方法定量比较光面乳房假体和毛面乳房假体隆乳术后的包膜挛缩发生率.方法 以breast augmentation、capsular contracture、smooth implant、textured implant、隆乳、乳房假体等检索词在MEDLINE数据库、EMBASE数据库、Cochrane图书馆、中国生物医学文献数据库、维普生物数据库等检索,最大限度地收集毛面乳房假体和光面乳房假体隆乳的文献,提取其包膜挛缩和其他并发症的数据进行整合,以获得比值比（odds ratio,OR）合并值.各合并数据使用RevMan 5.2软件进行分析.结果 对11项研究毛面乳房假体和光面乳房假体的临床对照试验进行Meta分析后得出,包膜挛缩发生率的合并OR值为0.32,95％可信区间（CI）为0.18～0.58,P=0.0002.除包膜挛缩外,其他并发症发生率的合并OR值为1.31,95％ CI为0.96～1.77,P=0.09.结论 毛面乳房假体隆乳术后发生包膜挛缩风险低于光面乳房假体.     

Complete Submuscular Breast Augmentation: 650 Cases Managed Using an Alternative Surgical Technique

Background An alternative complete submuscular surgical technique for primary breast augmentation is presented. Since 1998, the author has refined the procedure for total submuscular placement of textured silicone gel implants, with good results for more than 650 patients. Methods The submuscular plane is accessed via a semicircular periareolar incision. Round or anatomic implants are placed beneath the pectoralis major and external oblique muscles, the rectus sheath, and the serratus anterior muscle fascia, which together create a contiguous structure that completely separates the implant from the breast tissue. Results High-riding implants were the main complication in early cases, through creation of an insufficiently large submuscular pocket. Only a very low incidence of Baker II capsular fibrosis was observed, and there were no Baker III or IV capsular contracture revisions. There were no cases of infection or “bottoming out.” Areolar scarring was well concealed, and rippling and implant distortion were virtually nonexistent. Even in thin women, the implant edge was scarcely visible or palpable. Patient satisfaction levels were very high, with the majority viewing the implants as their own tissue in terms of natural feel and appearance. Conclusions The advantages of the described surgical method are several-fold, particularly for lean patients. It offers a promising alternative to subglandular and partial submuscular implant placement and to other total submuscular techniques for primary breast augmentation. Furthermore, it provides a solution for tuberous and ptotic breasts, coupled with mastopexy as required, and good results have been achieved with correctional surgery for subglandular capsular contracture, bottoming out, and rippling.     

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.     

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.     

Latissimus dorsi breast reconstruction utilizing functional muscle transfer and tissue expansion

Latissimus dorsi breast reconstruction with implants has been criticized for Baker III or IV capsular contractures in as many as 30% of patients. Also criticized is muscle atrophy and loss of breast volume and definition. This study evaluated 2 modifications of the classic latissimus reconstruction: muscle transferred as an innervated functional unit and tissue expansion posterior to the latissimus but anterior to the pectoralis muscle. After expansion, a permanent prosthesis was placed (46 silicone gel and 3 saline). Forty-nine such reconstructions were done in 32 patients (17 bilateral and 15 unilateral), with average follow-up of 19 months. Only 4 Baker III capsular contractures (8%) and no Baker IV contractures occurred. All patients demonstrated excellent retention of breast shape/definition. This study demonstrates that functional muscle transfer and tissue expansion results in low capsular contracture rates and excellent retained breast shape.     

不同类型乳房假体隆乳术后并发症的临床分析

目的 统计不同类型的乳房假体置人人体后，远期并发症发生的几率，并分析其原因。方法 总结1993年至2002年间假体隆乳573例，随访到手术方法相同、假体放置位置相同、同一医生组手术的隆乳妇女427例共852只乳房，使用4种不同类型乳房假体：毛面硅凝胶、光面硅凝胶、毛面生理盐水充注式、光面生理盐水充注式乳房假体。出现的远期并发症有纤维包膜挛缩、假体破裂渗漏、疼痛移位等，对各种假体并发症发生率进行统计分析，比较各类假体的优劣。结果 427例852只中803只效果满意，无明显并发症，占94．24％。发生并发症者42例49只乳房，占5．76％。并发症中乳房硬化属Baker‘s分级Ⅲ～Ⅳ级的有26只，缩小变形24只，移位疼痛10只，经手术取出发现假体破裂渗漏的有30只。其中纤维包膜挛缩引起乳房硬化多发生于硅凝胶假体，假体渗漏引起乳房缩小变形多发生于生理盐水充注式假体；假体在体内放置时间越长，发生并发症的几率越高。结论 经统计学处理发现，光面生理盐水假体并发症明显少于光面硅凝胶假体，毛面硅凝胶假体和毛面生理盐水假体并发症发生率没有明显差异。49只有不同并发症的乳房假体中有30只假体破裂渗漏，占61．22％，假体破裂渗漏后又容易引发其它并发症，说明假体质量的提高是减少并发症的关键，长期留置体内假体的老化是目前的难题。     

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.     

Immediate Breast Reconstruction after mastectomy with polyurethane implants versus textured implants: A retrospective study with focus on capsular contracture

BackgroundCapsular contracture (CC) is the most common complication following Immediate Breast Reconstruction (IBR) with breast implants. Different implant surfaces were developed aiming to reduce the incidence of CC. We evaluated the incidence and degree of CC after Direct-to-Implant (DTI) IBR with insertion of textured (TE) or polyurethane (PU) covered implants.MethodsA retrospective review of consecutive patients treated at our Institution with mastectomy and one-stage IBR and implant reconstruction between 2013 and 2018, with or without post mastectomy radiation therapy (PMRT), was conducted. Immediate breast reconstruction was performed by implanting 186 PU covered implants and 172 TE implants.ResultsThree-hundred-twelve women underwent 358 DTI IBR with PU or TE implants, were analyzed with a median follow-up time of 2.3 years (range 1.0–3.0). The overall rate of CC Baker grade III and IV was 11.8% (95%CI: 8.4–16.3), while, after PU and TE implant placement it was 8.1% (95% CI: 4.1–15.7) and 15.8% (95% CI: 4.1–15.7) [p = 0.009]), respectively. Irradiated breasts developed CC more frequently rather than non-irradiated breasts (HR = 12.5, p < 0.001), and the relative risk was higher in the TE group compared with the PU group (HR = 0.3, p = 0.003).ConclusionsAfter mastectomy and one-stage IBR, the use of PU covered implants is associated with a lower incidence of CC compared to TE implants. This advantage is amplified several folds for patients who necessitate PMRT. Footnote: Capsular contracture (CC); Immediate Breast Reconstruction (IBR); Directto- Implant (DTI); Textured (TE); Polyurethane (PU); Post mastectomy radiation therapy (PMRT); Nipple Sparing mastectomy (NSM).     

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.     

Sonication of Removed Breast Implants for Improved Detection of Subclinical Infection

Background  Capsular fibrosis is a severe complication after breast implantation with an uncertain etiology. Microbial colonization of the prosthesis is hypothesized as a possible reason for the low-grade infection and subsequent capsular fibrosis. Current diagnostic tests consist of intraoperative swabs and tissue biopsies. Sonication of removed implants may improve the diagnosis of implant infection by detachment of biofilms from the implant surface. Methods  Breast implants removed from patients with Baker grades 3 and 4 capsular contracture were analyzed by sonication, and the resulting sonication fluid was quantitatively cultured. Results  This study investigated 22 breast implants (6 implants with Baker 3 and 16 implants with Baker 4 capsular fibrosis) from 13 patients. The mean age of the patients was 49 years (range, 31–76 years). The mean implant indwelling time was 10.4 years (range, 3 months to 30 years). Of the 22 implants, 12 were used for breast reconstruction and 10 for aesthetic procedures. The implants were located subglandularly (n = 12), submuscularly (n = 6), and subcutaneously (n = 4). Coagulase-negative staphylococci, Propionibacterium acnes, or both were detected in the sonication fluid cultures of nine implants (41%), eight of which grew significant numbers of microorganisms (>100 colonies/ml of sonication fluid). Conclusions  Sonication detected bacteria in 41% of removed breast implants. The identified bacteria belonged to normal skin flora. Further investigation is needed to determine any causal relation between biofilms and capsular fibrosis.     

How Reliable Are Textured Implants Used in Breast Surgery? A Review of 510 Implants

Five hundred ten implants were used in 273 patients. The follow-up was between 3 months and 8 years. Four hundred nineteen prostheses were used for subglandular breast augmentation, 91 for subpectoral breast reconstruction. All the breasts were checked personally: 397 augmented breasts and 86 reconstructed breasts—94.7%. The objective criterion was the Baker classification: grades I and II, good result; and grades III and IV, poor result. Results were as follows: Baker I, 397 breasts; Baker II, 78 breasts (I + II, 98.3%); Baker III, 5 breasts; Baker IV, 3 breasts (III + IV, 1.7%). Three prostheses were removed after 3, 4, and 6 years because the textured surface was totally damaged. Two bilumen prostheses lost the saline fluid. The complication rate due to the implants was very low.     

Surgical intervention and capsular contracture after breast augmentation: a prospective study of risk factors

Epidemiologic data on local complications after breast augmentation are scarce. In particular, few prospectively collected data are available on modern breast implants on this issue. Using data from the Danish Registry for Plastic Surgery of the Breast, the authors examined determinants of surgery-requiring complications and capsular contracture grades III to IV among 2277 women who underwent cosmetic breast implantation from June 1999 through April 2003. During an average follow-up period of 1.6 years after implantation, 4.3% of these women (3% of implants) required secondary surgery as a result of short-term complications. The most frequent clinical indications for surgery were displacement of the implant (38%), capsular contracture grades III to IV (16%), ptosis (13%), and hematoma (11%). Overall, the authors found that inframammary incision and subglandular placement were associated with decreased risks of developing complications requiring surgical intervention, whereas implants larger than 350 mL increased the risk of such complications (relative risk [RR], 2.3; 95% confidence interval [CI], 1.3-4.0). Thirty-nine Baker III to IV capsular contractures were identified, of which 22 were treated surgically within the study period. Submuscular placement of the implant decreased the risk of capsular contracture grades III to IV (RR, 0.3; 95% CI, 0.2-0.8), whereas surgical routes other than inframammary and drainage of implant cavity were associated with increased risk of capsular contracture. Current surgical practices and modern implants used for breast augmentation produce fewer short-term complications than procedures and devices of the past. This prospective study indicates that surgical procedures are more important predictors for local (short-term) complications than implant or patient characteristics.     

毛面与光面乳房假体隆乳术后并发包膜挛缩的系统评价

目的 对毛面乳房假体与光面乳房假体隆乳术后并发BakerIII级以上包膜挛缩的发生率进行系统评价.方法 计算机检索Medline(1966年5月至2006年5月)、Embase(1966年5月至2006年5月)、Cochrane图书馆(2005年第2期)和中国生物医学文献数据库(1979年5月至2006年5月),人工检索《中华整形外科杂志》(1985年创刊至2006年5月)和《Plastic and Reconstructive Surgery》(新疆医科大学图书馆馆藏期次),收集所有相关随机对照及半随机对照试验,采用RevMan 4.2.8进行Meta分析.结果 通过对6个随机对照试验进行系统评价,采用毛面乳房假体隆乳术后1、10年并发Baker Ill级以上包膜挛缩发生率明显低于光面乳房假体(P＜0.05).结论 毛面乳房假体隆乳术Baker III级以上包膜挛缩的发生率明显低于光面乳房假体.     

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.     

A new biologically,osmotically, and oncotically balanced gel that shows calcifications blocked by silicone

The radiodensity of silicone gel-filled breast implants is well documented. It has been suggested that silicone gel may block the transmission of x-rays sufficiently to prevent visualization of microcalcifications that are frequently an indicator of malignancy. A new biologically, oncotically balanced gel has been developed that has increased radiotranslucency to approximately the density of normal breast tissue, increased lubrication qualities, and is quickly and safely eliminated by the body should the shell rupture. We present a case wherein a patient's mammogram was read as negative two years prior to breast reaugmentation due to Baker IV capsular contracture. During surgery, complete calcification of the capsule was discovered, as well as two ruptured prostheses; neither condition had been detected by the mammogram. These capsules, with their calcifications and scar intact, were removed in toto and radiographically compared through standard silicone gel-filled breast implants and through implants containing the new biologically, osmotically, oncotically balanced gel. The calcifications were completely obscured by the silicone gel-filled prosthesis and completely visible when viewed through the bio-oncotic gel-filled prosthesis. Postoperative mammograms confirmed the radiolucency of the new gel-filled prostheses. This new gel appears to be a reasonable alternative to silicone gel for filling breast implants. Note: Dr. Ersek is a shareholder of Bioplasty, Inc. and therefore has a financial interest in this gel.