Significant Capsular Contracture Research Articles

A Pericardium Bovine Matrix Pocket in DTI Prepectoral Breast Reconstruction

Breast reconstructive surgery has evolved significantly over the years. One of the recent advancements is the use of prepectoral implants in combination with synthetic and biological material as a natural and effective coverage. To date, there is little published data on breast reconstruction using acellular bovine pericardium matrix and most concern submuscular breast reconstruction. This study aimed to describe the multicentric-multisurgeon experience in performing direct to implant (DTI) prepectoral breast reconstructions using acellular bovine pericardium matrix (ABPM) pocket.A retrospective multicentric data collection of the all the immediate prepectoral breast reconstructions using acellular bovine pericardium was carried out by the authors. Surgical data including type of mastectomy, axillary surgery, type and size of implant, size of ABPM, duration of surgery were collected for each patient. Postoperative data including adjuvant treatments, complications, necessity to perform other interventions, patient's satisfaction were collected. Cosmetic results were also evaluated by 7 different observers at minimum 1 year follow-up.A total of 65 breast reconstruction were included in the study. Mean follow up was 21.3 months.Average surgical time was 1,42 hours. Minor complications occurred in 4 breasts; major complications occurred in 2 breasts. After 6 months follow-up, 7 patients underwent fat grafting to correct any rippling and /or wrinkling. Breast aesthetic and patients reported outcomes were satisfactory.Not significant capsular contracture was noted at the follow up control.To date, this is the largest study about prepectoral breast reconstruction with ABPM. On the basis of our results, prepectoral breast reconstruction ABPM assisted is a reliable, safe and suitable option providing good patient satisfaction outcomes.

Silicone Lymphadenopathy Following Augmentation Mammoplasty With Silicone Implants.

Silicone implants are by far the most widely used implant globally for breast augmentation. Despite technological advancements, complications persist, with silicone lymphadenopathy (siliconoma) being a noteworthy concern. This phenomenon has been inadequately addressed in the existing literature. The aim of this study was to characterize axillary siliconomas and identify potential risk factors to help reduce their occurrence. The authors conducted a retrospective observational cross-sectional study spanning between 2011 and 2021 at the Shamir Assaf Harofeh Medical Center, Israel. Preoperative ultrasound examination was conducted, categorizing patients into those with siliconomas and those without. A total of 614 women (1209 breasts) met the inclusion criteria. The incidence of siliconomas was 13.6% (165 breasts). In univariate analysis, older age (47 years vs 43 years, P < .001), older implant age (12.2 years vs 11 years, P = .026), ruptured implants (59.4% vs 17.7%, P < .001), subpectoral placement (P = .019), severe capsular contracture, and the use of Mentor implants (Irvine, CA; P = .007) and Poly Implant Prothèse implants (PIP; La Seyne-sur-Mer, France; P = .001) correlated significantly with the presence of siliconomas. In a multivariate analysis, implant rupture (odds ratio [OR] = 6.342), and implant manufacturer-Mentor (OR = 3.047) and PIP (OR = 3.475)-were identified as independent risk factors associated with a higher incidence of siliconomas. Severe capsular contracture was also associated with a higher incidence of siliconomas (OR = 1.65). Surgeons should inform candidates about the potential risk of silicone migration. Patients with ruptured implants, significant capsular contracture, and Mentor and PIP implants face an increased risk for developing siliconomas. Closer monitoring for the detection of siliconomas in the axilla for these patients is advisable, and potential prophylactic replacement or removal of implants may be warranted to mitigate siliconoma risk.

Synthetic Reabsorbable Mesh (GalaFLEX) as Soft Tissue Adjunct in Breast Augmentation Revision Surgery.

A significant number of patients with a previous submuscular breast augmentation require a revision surgical procedure during their long-term follow-up period that involves changing the implant pocket from submuscular to subglandular. Reduced soft tissue thickness represents a major concern, discouraging surgeons from undertaking this approach. The aim of this study was to determine whether a synthetic resorbable mesh used as a supplemental covering device was safe and yielded improved soft tissue thickness and protection against capsular contracture in patients undergoing implant plane shift to subglandular. A retrospective review of 34 patients who underwent revision of a previous breast augmentation involving implant change in a subglandular pocket and upper pole GalaFLEX (Galatea Surgical, BD; Franklin Lakes, NJ) mesh coverage was conducted. Onset of minor and major complications was recorded during short- and medium-term follow-up. Patient satisfaction was assessed via an anonymous questionnaire administered 6 months postoperatively. During the follow-up period, which ranged from a minimum of 6 months to a maximum of 28 months, no minor or major complications were reported. In particular, no wrinkling/rippling or significant capsular contracture onset was observed. High levels of patient satisfaction were determined, according to self-reporting questionnaires. The initial results of this preliminary report from this case series demonstrate the safety of GalaFLEX as a supplemental device in terms of improved soft tissue coverage of the implant for complex revisional cases in breast augmentation.

Keller Funnel Efficacy in "No Touch" Breast Augmentation and Reconstruction: A Systematic Review.

A systematic review of PubMed, Embase, the Cochrane database, and Google Scholar was performed between 2005 and 2021. All clinical-based, retrospective and prospective studies utilizing the Keller funnel method for breast implant insertion were selected. Six studies were identified for evaluation: five were retrospective cohorts and one was a prospective trial. No randomized controlled trials were found. Outcomes reported included lower rates of capsular contracture (RR, 0.42; P = 0.0006; 95% CI, 0.25-0.69), shorter incision lengths (35.5 ± 2.1 mm), less insertion time (mean = 6 seconds), and decreased complications, and one paper reported ultimately greater patient satisfaction with outcomes (BREAST-Q Score: 92%). This review suggests that the Keller funnel is a useful method for no-touch breast augmentation and reconstruction surgery. The Keller funnel reduces subsequent capsular contracture rate, surgical time, and incision length and allows for easier insertion. However, our findings support recommendation of a prospective randomized controlled clinical trial with larger population size and follow-up intervals.

Aesthetic Limitations in Direct-to-Implant Prepectoral Breast Reconstruction.

Prepectoral direct-to-implant reconstruction has become an alternative to staged subpectoral expander-based reconstruction. Although the surgical safety of this technique has been shown, aesthetic limitations have not been well-described. This article reports aesthetic limitations and elucidates risk factors that may predispose patients toward developing unfavorable outcomes following direct-to-implant prepectoral breast reconstruction. A retrospective chart review was performed, identifying patients who underwent prepectoral, direct-to-implant breast reconstruction from June of 2016 to June of 2019. Aesthetic limitations assessed included capsular contracture, rippling, implant malposition, and implant flipping. Two hundred twenty-four consecutive women representing 334 breasts underwent immediate reconstruction performed by a single plastic surgeon. A midlateral incision was used in 185 breasts (55.4 percent) and the Wise pattern in 95 breasts (28.8 percent). The mean follow-up time was 30.5 months (45.3 to 18.3 months). Significant capsular contracture (grade 3 to 4) was noted in 27 breasts (8.1 percent), implant flipping in four breasts (1.2 percent), implant displacement in five breasts (1.5 percent), major rippling in nine breasts (2.7 percent), and minor rippling in 17 breasts (5.1 percent). The use of acellular dermal matrix had no significant effect on the aesthetic outcomes. In comparing breasts with postmastectomy radiation, there was a significant difference in the presence of minor rippling and capsular contracture ( p < 0.05). This cohort represents the largest, single-surgeon, direct-to-implant prepectoral database in the literature. This report shows that aesthetic limitations were comparable to those seen with other forms of reconstruction. Complications did not differ in terms of acellular dermal matrix use. Certain factors can predispose patients to developing unfavorable aesthetic outcomes. Therapeutic, IV.

Breast-conserving therapy can be offered to women with prior breast augmentation

IntroductionBreast cancer in women with cosmetic breast implants is increasingly common. Over the past decade, there has been a push for mastectomy and reconstruction in these patients, based on a fear of poor aesthetic results from small breast volume, and radiation-induced capsular contracture. At the Paris Breast Centre, augmented women routinely undergo lumpectomy with whole-breast irradiation (BCT). Materials and methodsA consecutive cohort of 50 augmented women, who had attempted BCT for early breast cancer at our institution between 2003 and 2018, were retrospectively identified. Post-treatment complications, oncologic outcomes, capsular contracture rates, long-term cosmetic outcomes, and patient-reported outcomes were evaluated. ResultsThe median follow-up was 51 months. Margins were involved in 7 women (14%); 4 of whom underwent successful re-excision, and 3 had a mastectomy, for an early mastectomy rate of 6%. There were no early complications, nor cases of early implant loss. Long-term aesthetic results were evaluated using our 5-point scale: An excellent (5), or good (4) result was obtained in 68%. Significant capsular contracture (Baker grade 3 or 4) developed in 34%, of which, 5 women underwent capsulotomy and fat grafting; 4 of 5 downstaging their Baker grade. The estimated 5-year local recurrence rate was 2.3%. Ninety-five percent of participants would recommend BCT to augmented women. ConclusionBCT is feasible and safe in augmented women with good long-term aesthetic results, and should be considered to avoid unnecessary mastectomy.

Does Implant Surface Texture Affect the Risk of Capsular Contracture in Subglandular Breast Augmentation and Breast Augmentation-Mastopexy?

Previous studies have reported decreased rates of capsular contracture associated with the use of textured surface breast implants placed in the subglandular plane during breast augmentation. However, since the publication of these studies, our understanding of the pathophysiology of capsular contracture, as well as the surgical techniques utilized to minimize bacterial contamination of the implant, have advanced considerably. The purpose of this study was to re-evaluate the relation between implant surface texturization and capsular contracture rates for breast implants placed in the subglandular plane during primary breast augmentation. Retrospective chart review was performed of all primary subglandular breast augmentation procedures involving the use of either smooth or textured round silicone gel implants, with or without simultaneous mastopexy. The primary outcome measures included clinically significant capsular contracture (Baker grade III/IV) and revision surgery for capsular contracture. Between 2010 and 2017, 526 patients underwent primary subglandular breast augmentation with either smooth (n = 212) or textured (n = 314) round silicone gel implants; 248 patients underwent breast augmentation, whereas 278 underwent breast augmentation-mastopexy. Average follow-up was 756 days in the textured group and 461 days in the smooth group. Five cases of capsular contracture were observed in the textured group, and 7 cases of capsular contracture were observed in the smooth group (P = 0.20). Smooth surface implants placed in the subglandular plane were not at a significantly increased risk of capsular contracture compared with textured surface implants. We suggest that adherence to a surgical technique focused on minimizing bacterial contamination of the implant is of greater clinical significance than implant surface characteristics when discussing capsular contracture.

Acellular Dermal Matrix Reduces Myofibroblast Presence in the Breast Capsule.

Background:Capsular contracture remains a common complication after implant-based breast reconstruction. Previous work has suggested that the use of acellular dermal matrix (ADM) reduces the rate of capsular contracture, though little is understood about the underlying mechanism. As myofibroblasts are believed to be the key cells implicated in contracture formation, we hypothesized that ADM would result in a reduction in periprosthetic myofibroblast concentration.Methods:Five patients who underwent immediate prepectoral tissue expander placement with anterior ADM coverage and an inferior cuff were included. At the second stage, tissue samples were obtained of both ADM and capsule from each reconstructed breast. Samples were then prepared for hematoxylin and eosin staining and immunohistochemistry for myofibroblast identification (alpha smooth muscle actin and vimentin positive and desmin negative) and analysis. Experimental values are presented as mean ± SD unless otherwise stated. Statistical significance was determined using unpaired t test.Results:Successful incorporation of ADM was noted in all cases. A significant reduction in myofibroblast concentration was noted in the ADM versus the capsule (P = 0.0018). This was paralleled by significantly thicker periprosthetic capsule formation overlying the formerly raw pectoralis major muscle, that is, not covered by ADM (P < 0.0001).Conclusions:In the presence of ADM, there are significantly fewer myofibroblasts in breast capsules and thinner capsules on histology. Given the central role of myofibroblasts in the development of clinically significant capsular contracture, this study unmasks a possible mechanism for the protective effect of ADM with respect to capsular contracture development.

Abstract P5-16-03: The long-term outcomes of the BROWSE multicentre cohort study comparing Strattice™-assisted implant based reconstruction and submuscular reconstruction

Abstract Introduction Implant based reconstruction accounts for approximately 85% of reconstructions in the UK and 80% in the US with an increase in use of acellular dermal matrices (ADM) e.g. Strattice™. There is little long-term data on the outcomes of ADM reconstructions and its efficacy. Our aim was to establish the most comprehensive long-term surgical, cost-effectiveness, quality of life and cosmetic outcomes in three large UK reconstructive centres. Methods All women who had undergone immediate implant based breast reconstruction with Strattice™ or a submuscular technique between 2009 and 2015 across three tertiary centres in the UK were invited for prospective clinical (examination and tonometry), cosmetic and quality of life assessment. An eight year retrospective review of case notes, theatre database and implant log was performed. Results 601 patients underwent 837 reconstructions. 589 Strattice™-assisted (331 therapeutic, 258 risk reduction) and 248 submuscular (152 therapeutic, 96 risk reduction). Revision surgery was performed in 43% of Strattice™-assisted reconstructions and 35% of submuscular within the follow-up period (p=0.034). Strattice™-assisted reconstructions were revised significantly sooner than submuscular, median time to first revision of 12 months vs. 21 months (p&amp;lt;0.0001).There was a significant reduction in the need for revision surgery for capsular contracture in the Strattice™-assisted group (Strattice™ n=19, submuscular n=16, p=0.04). Revision rates for capsular contracture in those having prior or adjuvant radiotherapy were 33% (n=9) in the Strattice™-assisted group and 66% (n=2) in the submuscular. At a median time of 58 months from initial procedure, 10% in the Strattice™-assisted group and 14% in the submuscular had significant capsular contracture (Baker 3/4). At the time of assessment 7% of the Strattice™-assisted group and 17% of the submuscular had already undergone revision surgery for capsular contracture. Therefore, overall there was significantly more capsular contracture in the submuscular group (17% vs. 31%, p=0.047). There was no difference between the mean (of the four quadrant readings) breast tonometry reading between the two groups (0 hard – 10 soft). The median reading was 5.3 in the Strattice™-assisted group, 5.4 in the submuscular and 6.6 in native breasts. Those with Baker 1/2 had a median reading of 5.4 compared to 4.8 in those with a Baker 3/4 capsule. Quality of life was equivalent between the two groups at a median time of 58 months. There was no difference in median Breast Q score for satisfaction with breasts, Strattice™-assisted 62 vs. submuscular 58 or satisfaction with outcome 67 vs. 75. The mean cost of the index reconstructive procedure was less in the Strattice™-assisted group (£3634 vs. £4230) but there were no significant differences in long-term cost. Conclusion Long-term clinical outcomes support the use of Strattice™ in breast reconstruction. It reduces capsular contracture and enables patients to have their surgery in one rather than two procedures. The increased revision rate in the Strattice-assisted group was multi-faceted e.g. patient request to upsize and correction of contouring defects. Strattice™ reduces healthcare cost. Citation Format: Wilson RL, Kirwan CC, O'Donoghue JM, Linforth RA, Johnson RK, Harvey JR. The long-term outcomes of the BROWSE multicentre cohort study comparing Strattice™-assisted implant based reconstruction and submuscular reconstruction [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-16-03.

Prepectoral breast reconstruction and radiotherapy-a closer look.

Prosthetic breast reconstruction in the setting of post-mastectomy radiation therapy (PMRT) has historically been plagued by complications and poor outcomes. We study the effects of PMRT in the setting of prepectoral prosthetic breast reconstruction in an attempt to ascertain the value of this muscle sparing technique as it relates to complications and outcomes. A retrospective analysis was performed on patients who underwent immediate, prepectoral, direct-to-implant or two-staged expander/implant breast reconstruction following skin-sparing mastectomy (SSM) or nipple-sparing mastectomy (NSM) and had postmastectomy radiotherapy. Results and complications were recorded. In patients who underwent two-staged reconstruction, at the second stage, on visual inspection, the acellular dermal matrix was noted to be completely integrated in all breasts, including those that had been irradiated after expander placement. Postoperative complications in irradiated breasts were limited to two breasts. In one breast, there was one incidence of wound dehiscence after expander irradiation, which led to expander removal and salvage with transverse rectus abdominis musculocutaneous (TRAM) flap reconstruction. In the second breast, there was one incidence of seroma after implant irradiation, which was managed conservatively as an outpatient. The seroma was drained and the patient treated with oral antibiotics. There were no complications in nonirradiated breasts. There was no incidence of clinically significant capsular contracture (grade III/IV) in irradiated or nonirradiated breasts. Prepectoral breast reconstruction has been an important addition to our reconstructive armamentarium and is proving to be a safe and effective means of performing prosthetic breast reconstruction in a wide array of patient populations. We have seen excellent physiologic and aesthetic outcomes in our patients following PMRT with minimal complications. Indeed, long-term follow-up will be required to elucidate the true effectiveness of this technique but preliminary results are quite promising.

Prepectoral Revision Breast Reconstruction for Treatment of Implant-Associated Animation Deformity: A Review of 102 Reconstructions.

Animation deformity is a direct consequence of subpectoral implant placement for breast reconstruction following mastectomy. Current treatment options ameliorate but do not address the source of the problem. Moving the implant from subpectoral to prepectoral has the potential to eliminate animation deformity. Describe the technique and outcomes of prepectoral revision reconstruction in over 100 cases and discuss patient selection criteria for a successful outcome. Patients who presented with animation deformity following two-stage implant reconstruction were included in this retrospective study. Revision surgery involved removal of the existing implant via the previous incision site along the inframammary fold, suturing of the pectoralis major muscle back to the chest wall, creation of a prepectoral pocket for the new implant, use of acellular dermal matrix to reinforce the prepectoral pocket and completely cover the implant, and fat grafting to enhance soft tissue. Patients were evaluated for resolution of animation deformity and occurrence of complications during follow up. Fifty-seven patients (102 breasts) underwent prepectoral revision reconstruction with complete resolution of animation deformity. Complications occurred in 4 breasts (3.9%) and included seroma (2 breasts), skin necrosis (3 breasts), and wound dehiscence (1 breast). All 4 breasts with complications had their implants removed and replaced. There were no incidences of infection or clinically significant capsular contracture in this series. Revision reconstruction with prepectoral implant placement and complete coverage with acellular dermal matrix resolves animation deformity and results in aesthetically pleasing soft breasts. Patient selection is critical for the success of this technique.

Acellular Dermal Matrix-Assisted Direct-to-Implant Breast Reconstruction and Capsular Contracture

BACKGROUND: Clinically significant capsular contracture (CC) (Baker Grade III/IV) is one of the most frequent long-term complications associated with implant-based breast reconstruction, with incidence increasing over time. Post-Marketing Approval (PMA) studies of implant manufacturers indicate an incidence ranging from 8%-25% over a 3 to 10 year follow-up.1,2 In reconstructions using acellular dermal matrix (ADM), the incidence appears to be lower, ranging from 0%-10% (in predominantly non-radiated patients).3-5 Follow-up in the ADM studies was short (~2 years), however, so the long-term rate of capsular contracture in this population are unknown. The purpose of this study is to assess the cumulative incidence of CC in ADM-assisted direct-to-implant reconstruction over a 12-year period. METHODS: Patients undergoing immediate, direct-to-implant, breast reconstruction with ADM assistance from December 2001 to December 2013 at two practices were evaluated. The cumulative incidence of capsular contracture over the 12-year period was determined as diagnosed by the performing surgeon. RESULTS: A total of 1478 breast reconstructions (673 bilateral, 132 unilateral) in 804 patients were performed; 36% were for oncologic and 64% for prophylactic reasons. Among oncologic breasts, 106 (7.2% of total breasts) were irradiated. Mean follow-up of patients was 4.1 ± 2.6 years (range, 0.2-12.2 years); 87% of patients had at least 1 year, 74% at least 2 years, 62% at least 3 years, and 51% at least 4 years of follow-up. There were 15 cases of clinically significant CC during the follow-up period, for an overall CC rate of 1.0%. All CCs occurred within the first 2 years. CC was 3-fold higher in oncologic versus prophylactic breasts but the difference did not reach statistical significance (1.7% vs 0.6%, P=. 0.06). When stratified by radiotherapy use, irradiated breasts had a statistically significant 7-fold higher incidence of CC versus non-radiated breasts (4.7% vs 0.7%, P=. 0.003) (Figures 1 and 2).Figure 1: 43-year-old female with right breast cancer.Figure 2: 2-year follow up.CONCLUSIONS: In this long-term study spanning 12 years, the cumulative incidence of CC with ADM-assisted direct-to-implant reconstruction appears to remain low, even in irradiated breasts. All CCs occurred within the first 2 years after reconstruction and longer follow-up does not appear to increase the incidence.

Breast Augmentation in Bangladesh with Silicone Gel Implants -A Short Term Experience

Background:. The primary breast augmentation surgery was not popular for a long time in Bangladesh but with the gradual economic and educational development, as well as availability of silicone gel implant and skilled surgeons, the demand, popularity and acceptance of this surgery is increasing. Objective:This study was done to assess the efficacy of the implants in 30 consecutive patients who presented for breast augmentation . Methods:Data were prospectively collected for all patients who underwent bilateral breast augmentation between July 2011 to November 2012 . Breast augmentation was performed by placing textured, round, silicone gel implant in subglandular position via inframammary approach. The 30 patients included in this series were analyzed according to demographic details, preoperative findings, postoperative patient and observer satisfaction scores, and complications. Standard pictures were taken before surgery and during follow-up visits over 6 month; standardised objective measurements of breast and chest were also taken. The test statistics used to analyze the data were descriptive statistics and repeated measure ANOVA .A Visual Analogue Scale (VAS) was used to evaluate the subjects’ global impression of clinical improvement and one independent observer visually reviewed pre and postoperative result to grade aesthetic results Results: Observers evaluation by predefined criteria (volume, shape, consistency, inframammry fold and scar) rated 60 % of patients with excellent outcome, 30% good, 10% fair and none had poor score .A significant percentage (63.3%) of the 30 patients rated their satisfaction as very good and nine (30%) patient rated as good. None of the patients responded the result as poor or as very poor. No serious complications such as implant malposition or significant capsular contracture were observed Conclusions: We conclude that round textured cohesive gel implants provide excellent results, are well accepted by patients and most short-term postoperative adverse effects following cosmetic implantation are clinically insignificant and do not require treatment. DOI: http://dx.doi.org/10.3329/bdjps.v4i1.18689 Bangladesh Journal of Plastic Surgery January 2013, 4(1): 20-28

Revisiting Triple Antibiotic Irrigation of Breast Implant Pockets: A Placebo-controlled Single Practice Cohort Study.

Background:Capsular contracture is the most common complication following primary augmentation mammoplasty. It remains poorly understood but is attributed to subclinical infection, immunologic response to breast implants, and chronic inflammatory changes caused by the presence of the implants. The infectious theory of contracture has lead to the practice of irrigating implant pockets with a triple antibiotic solution. The purpose of this study was to determine if antibiotic irrigation reduced the incidence and severity of capsular contracture compared with saline irrigation.Methods:A cohort study enrolling all patients having undergone primary augmentation mammoplasty performed by surgeon A and surgeon B between 2011 and 2012 for all women satisfying inclusion and exclusion criteria was conducted. The only difference in surgical technique was the use of antibiotic irrigation by surgeon B. A chi-square test and analysis of variance with predetermined 95% confidence intervals were performed.Results:Fifty-five patients were operated on. Twenty-eight of surgeon A’s patients were included, ranging in age from 22 to 50 with a mean follow-up time of 1.8 years. Twenty-seven of surgeon B’s patients were included, ranging in age from 22 to 56 with a mean follow-up time of 1.6 years. Rate of capsular contracture was 3.6% (surgeon A) and 3.7% (surgeon B). Chi-square statistic was found to be 0.0014 (P = 0.97) and analysis of variance F value was 1 (P = 0.39).Conclusions:Triple antibiotic breast irrigation is not associated with a significant reduction in the incidence or severity of capsular contracture compared with sterile saline when high-quality surgical technique is used.

Multicenter Study on Breast Reconstruction Outcome Using Becker Implants

The use of tissue expanders and implants is the simplest option for breast reconstruction following mastectomy. In the 1980s, Hilton Becker introduced a round, inflatable breast implant that could be used as a permanent implant. Since then, the original implant has been improved in both design and architecture. The new Becker device consists of an anatomical implant composed of 35% cohesive silicone gel in the outer chamber and 65% normal saline in the inner chamber. This multicenter study describes our experience with the new anatomical Becker implants in a large series of patients, in both immediate and delayed breast reconstruction. We reviewed the clinical records of 204 patients who underwent a breast reconstruction with an anatomical Becker-type implant in the sub-muscular position between November 2004 and December 2006. Data on the patients' characteristics, indications for reconstruction, operative technique, device size used, complications, and need for further operations were collected and analyzed. A total of 248 breast reconstructions were performed in 204 patients. One hundred forty-three patients (70%) underwent an immediate reconstruction; in the remaining 61 cases (30%), the breast reconstruction was performed later. The patients' age ranged from 26 to 66years, with a median age of 47.5years. The implant was placed unilaterally in 160 women (78.5%) and bilaterally in the remaining 44 (21.5%). Complications occurred in 85 cases (34.2%), in both the immediate and delayed reconstruction groups, and were related to wound healing, bleeding, seroma, and problems with the inflatable expanders. Iatrogenic implant rupture was documented in one case (0.4%). Inflation was impossible in 7 cases (2.8%) as a result of valve obstruction (3 cases, 1.2%) and valve displacement (4 cases, 1.6%). Implant malposition was the most troublesome complication; indeed, 34 patients (13.7%) complained of device malposition. Capsular contracture was assessed in all the patients. Significant capsular contracture (Baker grade III and IV) was detected in 6 cases (2.4%) at the follow-up approximately 1year after surgery. Breast reconstruction with permanent inflatable expanders is widely acknowledged as a useful technique for breast cancer patients undergoing simple or modified radical mastectomy. The use of this device eliminates the need to replace a temporary tissue expander with a breast implant, thus avoiding a second operation. Although we believe autologous tissues afford the best method of reconstruction in the majority of patients, the results of our study show that expander implant placement may yield a reasonable reconstruction.

Experience with the Mentor Contour Profile Becker-35 expandable implants in reconstructive breast surgery

Round expander-implants (Beckers 25 and 50) and anatomical expander-prostheses filled with firm cohesive gel (McGhan Style 150) are established choices for single-stage expander breast reconstruction. Because of their drawbacks we selectively adopted the anatomical Becker-35 expander-implant filled with soft cohesive gel from January 2005. All patients undergoing reconstructive breast surgery using the Contour Profile Becker-35 expandable implant over a two-year period were retrospectively reviewed with respect to indication, implant sizes, inflation details, complications and outcomes. 36 patients, mean age 48.9 years (r=14-69), received 39 anatomical Becker-35 expanders (three bilaterally). Three quarters of these implants (29) were used for immediate breast reconstruction while the remainder were equally divided between delayed postmastectomy reconstruction (5) and correction of congenital breast asymmetry (5). Half of the patients had simultaneous latissimus dorsi myocutaneous flap coverage of the implants. The median numbers of inflations and deflations needed to achieve the target expansion size and shape were 3 (r=0-7) and 0 (r=0-4), respectively. The mean time from expander insertion to completion of reconstruction was 4.6 months (r=0-13 months). Four patients required surgical intervention for haematoma, implant infection, severe capsular contracture, and palpable rippling. Additionally there were three injection port adjustments, giving a 20% overall revisional surgery rate (8/39 breasts) after a median follow-up of 20 months (r=6-38 months). Four implants (10%) developed significant but asymptomatic rippling. The significant capsular contracture rate was 21% (8/39 breasts), which was related to chest wall radiotherapy. In this short-term study, the Becker-35 expander was successfully used for single-stage prosthetic breast reconstruction with an incidence of early complications comparable to alternative prostheses. Although it has expanded the range of implants available to the breast surgeon, its exact role in reconstructive breast surgery has yet to be established.

Pilot Study of Association of Bacteria on Breast Implants with Capsular Contracture

Capsular contracture is the most common and frustrating complication in women who have undergone breast implantation. Its cause and, accordingly, treatment and prevention remain to be elucidated fully. The aim of this prospective observational pilot study was to test the hypothesis that the presence of bacteria on breast implants is associated with capsular contracture. We prospectively studied consecutive patients who underwent breast implant removal for reasons other than overt infection at the Mayo Clinic from February through September 2008. Removed breast implants were processed using a vortexing/sonication procedure and then subjected to semiquantitative culture. Twenty-seven of the 45 implants collected were removed due to significant capsular contracture, among which 9 (33%) had >or=20 CFU bacteria/10 ml sonicate fluid; 18 were removed for reasons other than significant capsular contracture, among which 1 (5%) had >or=20 CFU/10 ml sonicate fluid (P = 0.034). Propionibacterium species, coagulase-negative staphylococci, and Corynebacterium species were the microorganisms isolated. The results of this study demonstrate that there is a significant association between capsular contracture and the presence of bacteria on the implant. The role of these bacteria in the pathogenesis of capsular contracture deserves further study.

Reply

Sir: On reading the queries on the original article, we would like to clarify certain facts. It has been clearly stated that the control material was a siloxane-integrated poly(carbonate-urea)urethane and not polydimethylsiloxane or silicone. This has been reported on page 1654, the last four lines of polymer synthesis, for your reference. As the biocompatibility characteristics of silicone, including its potential to form significant capsular contracture in certain cases, are well described, we decided that using a siloxane-integrated poly(carbonate-urea)urethane (PCU) counterpart to polyhedral oligomeric silsesquioxane (POSS)-PCU is a more suitable control. Regarding the attenuated total reflectance (ATR)–Fourier transform infrared (FTIR) spectra, it has been well documented in the literature that silsesquioxanes show a characteristic peak at approximately 1100 cm–1, and this absorbance is clearly evident in our POSS-modified PCU. As is shown on page 1655, the higher than expected intensity of the Si-O-Si peak from the POSS-PCU is attributable to a high POSS surface effect, which has been discussed in an earlier published work of ours.1 This surface effect enhances the biological biocompatibility properties of the POSS-PCU. Furthermore, our studies on AFM and FTIR on increasing concentrations of POSS show2 an increasing peak at 1108 cm–1. In contrast, if bulk FTIR spectra are performed, a significant reduction of this signal would be identified. The before-and-after implantation ATR-FTIR results for the control show a distinct change in surface chemistry, which would imply some sort of surface degradation. The exact mechanism for this is not clear, but initial interpretation would imply a reduction of Si-O-Si at the surface of the control after implantation. This could also be caused by some phase separation of the siloxane soft segments and a reduction in integrity of the polymer. This may be explained by the fact that polydimethylsiloxane-modified polyurethanes are known to be problematic in terms of phase incompatibility. Next, the polyurethane component of this nanocomposite is a specifically designed polycarbonate-urea based urethane, the ATR-FTIR spectra of which is illustrated in an earlier work.3 Based on the references of the letter, it would suggest that the author was using ester- and ether-based conventional polyurethanes as comparison, which is incorrect. As regards “silicone-osis,” it was a contentious diagnosis at the time of our submission, but in the 3 years since our work, the weight of evidence has shifted against a systemic manifestation of silicone. With the advantage of hindsight, it would thus be very convenient to comment. However, the point we tried to make in making that statement is that silicone has its attendant disadvantages, the main one being capsular contracture. POSS-PCU would possibly provide us with a better solution. Ruben Y. Kannan, M.D. Henryk J. Salacinski, Ph.D. Biomaterials and Tissue Engineering Centre Academic Division of Surgery and Interventional Sciences University College London London, United Kingdom Jalal-edin Ghanavi, M.D. Nanomedicine Research Centre Shaheed Beheshti University of Medical Sciences Tehran, Iran Ashish Narula, Ph.D. Department of Histopathology Royal Free Hampstead NHS Trust London, United Kingdom Marianne Odlyha, Ph.D. Department of Materials Chemistry Birkbeck College, University of London London, United Kingdom Habiballah Peirovi, M.D. Nanomedicine Research Centre Shaheed Beheshti University of Medical Sciences Tehran, Iran Peter E. Butler, M.D. Department of Plastic and Reconstructive Surgery Royal Free Hampstead NHS Trust London, United Kingdom Alexander M. Seifalian, Ph.D. Biomaterials and Tissue Engineering Centre Academic Division of Surgery and Interventional Sciences University College London London, United Kingdom

Long-Term Cosmetic Outcome After Breast Implantation

All women who underwent breast augmentation at 1 public and 1 private clinic in Denmark from 1973 to 1988, and available for follow-up, were invited to participate in a clinical study including a self-administered questionnaire, medical record abstraction, and a clinical examination. One hundred ninety (52%) out of 368 eligible women participated. Mean time with implants in situ was 19 years (range, 5-35). Sixty-one percent of the women had 1 implantation, 23% had 2 implantations, 16% had 3 or more implantations. Nineteen women (10%) had no implants at the time of examination. A large proportion of the women (62%) had clinically significant capsular contracture, and only half of the study women were found to have satisfactory overall breast appearance at examination. In contrast, the majority of women reported satisfaction with their implant surgery (60%). The women tended to grade themselves more positively than the examining physicians.

Early Experience With an Anatomical Soft Cohesive Silicone Gel Prosthesis in Cosmetic and Reconstructive Breast Implant Surgery

Recently, an anatomic breast implant filled with soft cohesive silicone gel was introduced by Mentor Medical Systems onto the European market. This study reports the early experience of a single surgeon with this implant. All patients who received a Contour Profile Gel (CPG) implant from March 2001 to October 2002 were studied. Patient satisfaction with breast shape and consistency was assessed using linear analogue scales with a maximum score of 10. Thirty-five patients received CPG implants for cosmetic (10 patients, 20 breasts) and reconstructive (25 patients, 31 breasts) surgery purposes. Patients were satisfied with their breast shape (mean score: 8.3). Eighty-five percent of the breasts were rated as soft (score >/=6). No serious esthetic complications such as implant malposition or significant capsular contracture were observed. Anatomic soft cohesive gel implants provide excellent results in selected cases. They are well accepted by patients and not associated with an increased rate of complications.