Baker Grade Research Articles

Use of Dermal Matrix to Prevent Capsular Contracture in Aesthetic Breast Surgery

Capsular contracture remains a challenging complication of implant-based aesthetic breast surgery despite improvements in implant design. The lowering of capsular contracture rates noted with the past use of polyurethane foam-covered implants has increased awareness of the importance of the biologic response at the interface between the implant surface and breast tissue. Emerging evidence indicates that much like the polyurethane foam, acellular dermal matrices alter the biologic response at the surface interface, resulting in a more vascular and less constrictive pattern of collagen deposition. This study reports on the authors' clinical experience using Strattice Reconstructive Tissue Matrix (LifeCell Corporation, Branchburg, N.J.) for the treatment of capsular contracture in patients with established capsules and for prevention in patients undergoing primary augmentation or augmentation/mastopexy. Of 80 patients (154 breasts) in whom Strattice was used, clinically significant contracture (Baker grade III/IV) occurred in three breasts (3.75 percent), all of which were in the treatment of previous contracture group. In addition, the authors noted two seromas requiring implant removal (both patients developed capsules, as mentioned above) and two hematomas requiring revision, for an overall failure rate of 6.25 percent for Strattice-assisted surgery. The data confirm that the use of Strattice significantly lowers the incidence of capsular contracture in the first 3.5 years after implant placement.

Prevention of Biofilm-Induced Capsular Contracture With Antibiotic-Impregnated Mesh in a Porcine Model

A growing body of evidence implicates subclinical (biofilm) infection around breast implants as an important cause of capsular contracture (CC). The authors use an in vivo porcine model to investigate the potential of antibiotic-impregnated mesh as a prophylactic measure against biofilm formation and CC. A total of 28 implants (14 untreated controls, 14 treated with antibiotic mesh) were inserted into 5 adult female pigs. All implants and pockets were inoculated with a human clinical strain of Staphylococcus epidermidis. The implants were left in situ for 16 weeks and then analyzed for contracture using both Baker grading and applanation tonometry. The presence of biofilm infection was assessed by subsequent microbiological analysis of implants and capsules. One untreated implant had extruded and was excluded from analysis. The tissue surrounding the 13 untreated control implants had Baker Grade III/IV CC, whereas no CC was identified around the 14 antibiotic mesh-treated implants. This difference was highly significant (P < .001). Tonometry findings were consistent with the Baker assessments. Although bacterial biofilm was detected on all implants and capsules, the biofilms on the antibiotic-treated implants and surrounding capsules were generally single-layered or isolated in contrast to the multilayer biofilms found on untreated implants and capsules. Based on the findings from this study of a porcine model, the use of antibiotic-impregnated mesh reduces bacterial access to breast implants at the time of surgical insertion and may subsequently protect against subclinical infection and CC.

Two-Year Outcomes With a Novel, Double-Lumen, Saline-Filled Breast Implant

A double-lumen, saline-filled breast implant with a baffle structure (IDEAL IMPLANT Saline-Filled Breast Implant; Ideal Implant Incorporated, Irving, Texas) was developed to overcome the limitations of single-lumen saline implants by controlling saline movement and providing internal support to the implant edge and upper pole. The authors report 2-year data from a 10-year US clinical trial evaluating the safety and effectiveness of this investigational implant. Women seeking primary breast augmentation or replacement of existing augmentation implants were enrolled between February 2009 and February 2010 at 35 private practice sites, where the women underwent surgery to receive the new technology implant. Data collection included incidence and grade of capsular contracture (CC) and wrinkling as well as patient- and surgeon-reported satisfaction measures. All clinical data were reported as Kaplan-Meier risk rates of first occurrence, per patient, in each cohort. Two-year follow-up visits were completed by 472 of 502 enrolled women (94.0%), 378 of whom had undergone primary breast augmentation and 94 of whom had received replacement augmentation. Patient-reported satisfaction with the outcome was 94.3% for primary augmentations and 92.3% for replacement augmentations; surgeon-reported satisfaction was also high (96.5% and 93.4%, respectively). Baker Grade III and IV CC rates were 3.8% (primary) and 8.2% (replacement), whereas moderate-to-severe wrinkling was 3.8% (primary) and 12.0% (replacement). Deflations occurred in 4.8% of primary augmentations and 3.3% of replacement augmentations. No deflations were caused by a shell fold flaw. Two-year data from 472 women indicate that this double-lumen saline implant containing a baffle structure has a low rate of wrinkling and a lower rate of CC at 2 years than was reported for current single-lumen saline implants at 1 year.

Reply

Sir:FigureWe thank Dr. Gedge D. Rosson and colleagues for their comments and interest in our recent article, “Fat Grafting and Breast Reconstruction with Implant: Another Option for Irradiated Breast Cancer Patients.”1 The reconstructive issues faced in breast implant reconstruction for irradiated breast cancer patients are mainly two: a high risk of implant-related complications and unpleasant cosmetic results caused by soft-tissue thinness, extensive scarring, and contour defects as sequelae of oncologic surgery. The concept behind the “lipobed” is to address both issues. Fat grafting is used for its regenerative properties with the aim of transforming a hostile recipient site, such as irradiated tissues, into a “cozy bed” for implant placement. At the same time, lipofilling is also exploited as filler by correcting contour defects in quadrantectomy/lumpectomy patients, by releasing scarred tissues, and by enhancing soft-tissue thickness.1 Lipobed surgery has been intended as a further option for the small subset of irradiated breast cancer patients who present contraindications to or refuse autologous tissue reconstruction. In our tertiary care center, we routinely offer perforator free flap breast reconstruction (mainly deep inferior epigastric perforator flap) to irradiated breast cancer patients. Thus, we cannot say how many irradiated patients who underwent reconstruction with implants had complications, as we do not perform this reconstruction in an irradiated field. These, along with the time needed to finish the protocol, are the reasons why the number of patients treated is limited to 16 over a period of 3 years. We did report our two preliminary cases in 2009.2 Along with another case, these three patients are the ones with the longest follow-up of more than 30 months. The surgical outcomes are preserved, with Baker grade I capsular contracture, and surgeons' and patients' satisfaction was very high (Fig. 1). These findings make this approach promising. However, we agree with Dr. Rosson and colleagues that our surgical protocol is now better offered in an advanced breast cancer center where all possible reconstructive options can be discussed comprehensively with the patient.Fig. 1: (Above) Patient with a history of left breast inferior quadrant lumpectomy, left axillary sentinel node biopsy, and radiation therapy was seeking correction of the deformity and bilateral breast augmentation with implants. She underwent the lipobed surgical protocol on the left side (two sessions of fat grafting with a 3-month interval in between, and 60 cc of fat transplanted at each session) and augmentation mammaplasty after 6 months from the last fat graft. (Center) Photographs obtained 48 months postoperatively show Baker grade I capsular contracture. The patient is very satisfied (postoperative BREAST-Q score, 94.1). The result has been classified as excellent. (Below) The pinch test on the right side (healthy breast) and on the left side (previous inferior quadrantectomy and radiation therapy) shows the same soft-tissue thickness on the superior and inferior poles. The breast tissues are equally soft on the right and left sides, and the breast shape is very pleasant.In designing the lipobed surgical protocol, we did decide to limit the indications to patients with a Late Effects Normal Tissue Task Force/Subjective, Objective, Management, Analytic score of maximum 2. These patients show radiation sequelae that can be correctly addressed by fat grafting. We are now focusing also on patients with a Late Effects Normal Tissue Task Force/Subjective, Objective, Management, Analytic score between 2 and 3, the ones that Dr. Rosson and colleagues refer to as patients with “already too damaged irradiated skin.” Patients with a Late Effects Normal Tissue Task Force/Subjective, Objective, Management, Analytic score of 3 or even 4 are the ones with chronic radiodermatitis ulceronecrotic type that show different degrees of loss of substance, until bone exposure. Because of advances in radiotherapy, this subset of patients is seldom encountered today. However, in our opinion, the implant reconstruction plays no role in these cases, as what these patients need is wound care and/or surgical intervention for débridement and coverage. This can be successfully addressed only by flap surgery. A further interesting issue addressed by our protocol is the quadrantectomy/lumpectomy irradiated patients being referred to aesthetic surgeons for augmentation mammaplasty. After in-depth counseling with the patient about the risk of placing an implant in an irradiated field, we routinely offer lipobed surgery to maximize cosmetic results and to minimize implant complications. We are thankful again for the useful comments provided by Dr. Gedge D. Rosson and colleagues. We are continuing with our protocol and we hope for a larger volume of patients with longer follow-up and other future reports worldwide to increase the knowledge and experience regarding lipobed surgery. Marzia Salgarello, M.D. Giuseppe Visconti, M.D. Department of Plastic and Reconstructive Surgery Liliana Barone-Adesi, M.D. Breast Unit, Catholic University of “Sacro Cuore”, University Hospital “A. Gemelli”, Rome, Italy DISCLOSURE The authors have no financial interest to declare in relation to the content of this communication.

Periprosthetic breast capsules and immunophenotypes of inflammatory cells

BackgroundSilicone gel-containing breast implants have been widely used for aesthetic and reconstructive mammoplasty. The development of a periprosthetic capsule is considered a local reparative process against the breast implant in which a variety of inflammatory cells may appear. Nevertheless, only few reports have evaluated the immunophenotypes of those inflammatory cells. Herein, we aim to provide more information in this regard evaluating 40 patients with breast implants.MethodsWe studied the immunophenotype of the inflammatory cells of capsular implants using antibodies against lymphocytes (CD3, CD4, CD8, CD20, CD45, and CD30) and histiocytes (CD68). Percentages of CD3 and CD20 positive cells were compared using the unpaired Student's t test. Fisher's test was also used to compare Baker grades by implant type, implant profile, and location and the presence of inflammatory cells by implant type.ResultsThe associations between Baker grades and implant type and location were statistically nonsignificant (p = 0.42 in both cases). However, the use of low profile implants was significantly associated (p = 0.002) with a higher proportion of Baker grades 3 and 4. We found evidence of inflammation in 92.5 % of all implant capsules, with a statistically significant (p = 0.036) higher proportion in textured breast implants. T cells predominated over B cells. Textured implants elicited a more marked response to T cells than smooth implants, with a similar proportion of helper and cytotoxic T cells. Textured implants showed statistically significant higher percentages of CD3 positive cells than smooth implants. Percentages of CD20 positive cells were similar in textured and smooth implants.ConclusionsThese results suggest that textured breast implants might induce a stronger local T cell immune response. Our findings could shed some light to understand the association of silicone breast implants and some cases of anaplastic large cell lymphomas.Level of Evidence: Level III, prognostic study.

Is Ultracision Knife Safe and Efficient for Breast Capsulectomy? A Preliminary Study

Silicone breast implants are used to a wide extent in the field of plastic surgery. However, capsular contracture remains a considerable concern. This study aimed to analyze the effectiveness and applicability of an ultracision knife for capsulectomy breast surgery. A prospective, single-center, randomized study was performed in 2009. The inclusion criteria specified female patients 20-80 years of age with capsular contracture (Baker 3-4). Ventral capsulectomy was performed using an ultracision knife on one side and the conventional Metzenbaum-type scissors and surgical knife on the collateral side of the breast. Measurements of the resected capsular ventral fragment, operative time, remaining breast tissue, drainage time, seroma and hematoma formation, visual analog scale pain score, and sensory function of the nipple-areola complex were assessed. In addition, histologic analysis of the resected capsule was performed. Five patients (median age, 59.2 years) were included in this study with a mean follow-up period of 6 months. Three patients had Baker grade 3 capsular contracture, and two patients had Baker grade 4 capsular contracture. The ultracision knife was associated with a significantly lower pain score, shorter operative time, smaller drainage volume, and shorter drainage time and resulted in a larger amount of remaining breast tissue. Histologic analysis of the resected capsule showed no apoptotic cells in the study group or control group. The results suggest that ventral capsulectomy with Baker grade 3 or 4 contracture using the ultracision knife is feasible, safe, and more efficient than blunt dissection and monopolar cutting diathermy and has a short learning curve. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors at www.springer.com/00266.

Fat Grafting and Breast Reconstruction with Implant

In postmastectomy radiated patients, autologous tissue reconstruction is preferred over implant reconstruction, because the latter is associated with a higher rate of postoperative complications. Autologous tissue reconstruction, however, is not always feasible and is sometimes refused by the patient. A challenge also arises in breast-conserving surgery patients seeking breast augmentation with an implant. In this article, the authors present a further reconstructive option for irradiated breast cancer patients consisting of fat grafting followed by implant placement. The authors retrospectively reviewed 16 cases of irradiated breasts treated with fat grafting and subsequent alloplastic reconstruction/breast augmentation. The evaluation methods were clinical and photography-based assessments. The BREAST-Q was used to quantify patient satisfaction. Sixteen patients, with a pretreatment Late Effects on Normal Tissues-Subjective, Objective, Management, Analytic (LENT-SOMA) score of 1 or 2, underwent two to three fat grafts to achieve a LENT-SOMA score of 0. The placement of the breast implant had been performed in a separate stage at least 3 months after the last grafting session. The average follow-up was 15 months. Reconstructive outcomes were graded from excellent to good in 93.7 percent of patients. Patient satisfaction was marked as high to very high. There were no short-term complications. A Baker grade 1 capsule contracture was found in all patients. The authors' experience shows that breast fat grafting followed by implant placement may represent a feasible reconstructive option in highly selected patients with irradiated breasts. Fat grafting seems to reduce radiation-induced complications in implants. Larger studies with a longer follow-up are needed. Therapeutic, V.

Five Year Results of Radiation Therapy in Patients with Previous Breast Silicone Implants

To evaluate results of local control and aesthetic outcome in cosmetically augmented breast cancer patients. We retrospectively reviewed the records of 40 patients with Stage I and II invasive carcinoma of the breast who underwent breast conserving surgery and radiation therapy (RT) between 2000 and 2006. All patients were treated with lumpectomy, sentinel lymph node biopsy and/or axillary dissection followed by RT. All patients had previously placed silicone implants. Each patient's cosmetic outcome was scored by Baker classification grading system (grade 1 to 4) prior and post radiotherapy. Each patient was treated with 3D planning. Median dose to the whole breast was 50 Gy and 16 Gy for the boost. Chi-squared test and univariate and multivariate Cox regression analyses were also performed. The median follow up for all patients was 60 months and the median age was 46 years (range 35 - 60). Thirty four patients (75%) had a favorable cosmetic outcome (Baker grades 1 - 2) following breast conserving therapy. Six patients (15%) had an unfavorable cosmetic outcome (Baker grades 3 - 4). Only one patient had her implants exchanged. On univariate analysis when comparing Baker grades 1 - 2 vs. Baker grades 3 - 4 categories, no significant correlation was found between the degree of contracture. (p = 0,981). Multivariate analysis didn't show correlation with other variables such us chemotherapy, hormone therapy and smoking (p = 0,604). There were two local failures (T2 size and closer margins) and two patients had distant metastasis without local relapse. At five years follow up, the majority of patients had excellent cosmetic results with minimal late skin changes or contracture. We concluded that with proper radiotherapeutic techniques good cosmetic and local control rates can be obtained in these patients without compromising their therapy. Therefore, previous breast implants should not be a contraindication to breast conserving therapy among these patients.

Calf Implants: A 25-Year Experience and an Anatomical Review

Body contouring in the calf region is becoming a more frequently requested procedure. There are several techniques for calf enhancement, including implants, liposuction, and free flaps. Alloplastic augmentation can be performed with several implant types and several layers of pocket dissection. We present our 25 years of experience using the subfascial technique for calf implantation along with an anatomical study to illustrate all the important steps and relevant anatomy of this augmentation technique. The subfascial technique was performed in 25 cadavers, in which the important layers were dissected for high-resolution photos of the surgery to learn about the relevant anatomy of the region. Also, we did a retrospective study of our experience with calf implants, studying the aesthetic outcome, the presence of early complications, and the presence of late complications. We performed dissections in 25 cadavers and surgery in 63 patients (126 implants). In our series of patients the final aesthetic index was of 9.8. The early complications were severe postoperative pain (11.11%), infection (0.79%), seroma (21.42%), hematoma (0%), and wound dehiscence (7.14%). The late complications were capsular contracture (Baker grades III and IV) (3.17%), implant rupture (1.58%), implant leaking (0%), implant displacement (3.96%), numbness at the ankle (2.38%), and palpability of the implant (0%). The subfascial technique for calf augmentation has complication rates low enough and surgical outcomes good enough to recommend it as the gold standard for alloplastic calf augmentation.

An Analysis of 277 Consecutive Latissimus Dorsi Breast Reconstructions: A Focus on Capsular Contracture

Breast reconstruction by means of a latissimus dorsi myocutaneous flap in combination with a prosthesis is a well-established technique. Previous published series have highlighted significant rates of local complications, including capsular contracture. A retrospective analysis of latissimus dorsi myocutaneous flap reconstructions performed between 2000 and 2010 was undertaken. A standardized preoperative, perioperative, and postoperative clinical protocol was applied to all cases, which included the use of textured, cohesive-gel silicone implants. Two hundred seventy-seven procedures were performed in 243 patients, with one-third being immediate reconstructions. The mean age at reconstruction was 50.4 years. Mean follow-up was 47 months, and 3.6 percent of patients developed Baker grade III capsular contracture requiring capsulotomy. Chemotherapy provided a protective effect (p = 0.0197) against capsular contracture formation. Previous radiotherapy had no significant influence on symptomatic capsule formation. The rate of infection requiring implant removal was 1.1 percent, and 0.7 percent of mastectomy scars showed evidence of recurrent disease. The use of textured, cohesive-gel silicone implants, combined with a standardized surgical approach, can reduce complications in the short- and long-term postoperative period, independent of radiotherapy.

Animal Model of Implant Capsular Contracture: Effects of Chitosan

The mechanism(s) responsible for breast capsular contracture (CC) remain unknown, but inflammatory pathways play a role. Various molecules have been attached to implant shells in the hope of modifying or preventing CC. The intrinsic antibacterial and antifungal activities of chitosan and related oligochitosan molecules lend themselves well to the study of the infectious hypothesis; chitosan's ability to bind to growth factors, its hemostatic action, and its ability to activate macrophages, cause cytokine stimulation, and increase the production of transforming growth factor (TGF)-β1 allow study of the hypertrophic scar hypothesis. The authors perform a comprehensive evaluation, in a rabbit model, of the relationship between CC and histological, microbiological, and immunological characteristics in the presence of a chitooligosaccharide (COS) mixture and a low molecular weight chitosan (LMWC). Eleven adult New Zealand rabbits were each implanted with three silicone implants: a control implant, one impregnated with COS, and one impregnated with LMWC. At four-week sacrifice, microdialysates were obtained in the capsule-implant interfaces for tumor necrosis factor alpha (TNF-α) and interleukin-8 (IL-8) level assessment. Histological and microbiological analyses were performed. Baker grade III/IV contractures were observed in the LMWC group, with thick capsules, dense connective tissue, and decreased IL-8 levels (p < .05) compared to control and COS groups. Capsule tissue bacterial types and microdialysate TNF-α levels were similar among all groups. Chitosan-associated silicone implantation in a rabbit model resulted in Baker grade III/IV CC. This preclinical study may provide a model to test various mechanistic hypotheses of breast capsule formation and subsequent CC.

Null-Type Anaplastic Lymphoma Kinase–Negative Anaplastic Large Cell Lymphoma Arising in a Silicone Breast Implant Capsule

Null-Type Anaplastic Lymphoma Kinase–Negative Anaplastic Large Cell Lymphoma Arising in a Silicone Breast Implant Capsule

Correction of Capsular Contracture by Insertion of a Breast Prosthesis Anterior to the Original Capsule and Preservation of the Contracted Capsule: Technique and Outcomes

This study aimed to explore the treatment of capsular contracture after augmentation mammaplasty by insertion of a breast prosthesis anterior to the original capsule. Through transaxillary or submammary incisions and small capsular incisions, 14 patients (18 breasts) with Baker grades 3 and 4 capsular contractures had their breast implants removed and repositioned anterior to the primary capsule. The primary capsules were preserved. Satisfactory results (Baker 1) were achieved for all 14 patients during the 29-month follow-up period. The described method offers numerous advantages for the treatment of capsular contracture. It is minimally invasive and performed through a small axillary or submammary incision. It is simple, offers little trauma, has less bleeding, and results in a good outcome based on our follow-up assessment in the medium term. It is our preferred method for the treatment of capsular contracture.

Perforator Flap Breast Reconstruction After Unsatisfactory Implant Reconstruction

In 2009, 86,424 breast reconstructions were performed in the United States, with 76% being implant-based procedures. Capsular contracture and infection are the 2 most cited indications for implant explantation, resulting in a reconstruction failure. However, several patients are dissatisfied with implant reconstruction even without the aforementioned complications. We hypothesize that microvascular autologous tissue transfer with perforator free-flap breast reconstruction provides an excellent salvage modality in the face of an unsatisfactory implant reconstruction, resulting in an improved cosmetic and functional outcome, with low risk of complications. We retrospectively reviewed the charts of patients in the senior author's practice who underwent perforator flap breast reconstruction between the years 1998 through 2008, and identified all patients who had prior implant reconstruction. Indications for implant explantation, medical history, operative procedure, and postoperative complications were reviewed. During the study period, 1846 perforator flaps were performed. We found 191 patients who underwent autologous breast reconstruction after implant reconstruction with a total of 284 flaps (15.4%). The most frequent patient complaint was unnatural appearance and feel of the implants (Baker I or Baker II), and the majority of patients had not undergone radiation. Most patients were reconstructed using abdominal flaps with 164 deep inferior epigastric perforators, 50 superior gluteal artery perforators, 30 superficial inferior epigastric arteries, 35 inferior gluteal artery perforators, and 5 transverse upper gracilis. The total complication rate was 7.4%, with most complications related to wound healing at the donor site. There were 3 flap losses (1%), all of which were later successfully reconstructed with another perforator flap. Implant failures are traditionally thought to be in patients with Baker grade III/IV capsular contractures and in patients status post radiation therapy. However, in our study, the majority of patients seeking perforator flap reconstruction after implant reconstruction complained of an unnatural feel and appearance of their breasts, and did not have a severe capsular contracture deformity (Baker III/IV), nor had they undergone radiation. This suggests that implant reconstruction can lead to patient dissatisfaction severe enough to warrant removal even with Baker I/II results, and not in the setting of postradiation changes.

Effects of Coagulase-Negative Staphylococci and Fibrin on Breast Capsule Formation in a Rabbit Model

The etiology and ideal clinical treatment of capsular contracture (CC) remain unresolved. Bacteria, especially coagulase-negative staphylococci, have been previously shown to accelerate the onset of CC. The role of fibrin in capsule formation has also been controversial. The authors investigate whether fibrin and coagulase-negative staphylococci (CoNS) modulate the histological, microbiological, and clinical outcomes of breast implant capsule formation in a rabbit model and evaluate contamination during the surgical procedure. Thirty-one New Zealand white female rabbits were each implanted with one tissue expander and two breast implants. The rabbits received (1) untreated implants and expanders (control; n = 10), (2) two implants sprayed with 2 mL of fibrin and one expander sprayed with 0.5 mL of fibrin (fibrin; n = 11), or (3) two implants inoculated with 100 µL of a CoNS suspension (10(8)CFU/mL-0.5 density on the McFarland scale) and one expander inoculated with a CoNS suspension of 2.5 × 10(7) CFU/mL (CoNS; n = 10). Pressure/volume curves and histological and microbiological evaluations were performed. Operating room air samples and contact skin samples were collected for microbiological evaluation. The rabbits were euthanized at four weeks. In the fibrin group, significantly decreased intracapsular pressures, thinner capsules, loose/dense (<25%) connective tissue, and negative/mild angiogenesis were observed. In the CoNS group, increased capsular thicknesses and polymorph-type inflammatory cells were the most common findings. Similar bacteria in capsules, implants, and skin were cultured from all the study groups. One Baker grade IV contracture was observed in an implant infected with Micrococcus spp. Fibrin was associated with reduced capsule formation in this preclinical animal model, which makes fibrin an attractive potential therapeutic agent in women undergoing breast augmentation procedures. Clinical strategies for preventing bacterial contamination during surgery are crucial, as low pathogenic agents may promote CC.

A 15-year experience with primary breast augmentation.

This study evaluated patients who underwent primary breast surgery within a single group practice from 1994 to 2009. Reoperations were divided by reoperation reason into total reoperations and implant-specific reoperations. The authors hypothesized that the implant-specific reoperation rate will provide the most accurate measurement of complications caused by the breast implant device. A total of 812 patients received the same brand of breast implant for primary breast augmentation or augmentation/mastopexy. Safety and efficacy data were recorded and complication rates were calculated. Statistics were applied using Kaplan-Meier estimated cumulative incidence calculations. This study included 482 patients with saline and 330 patients with silicone implants. The most common complications included capsular contracture, rippling, rupture, infection, and hematoma. A total of 8.2 percent of patients developed Baker grade III/IV capsular contracture by 6 years. The raw incidence of rippling was 7.1 percent, and the rate was significantly increased in underweight patients with subglandular saline implants (p = 0.045). The rate of total reoperation at 1 year was 14.2 percent. While a significantly increased rate of total reoperation was seen for silicone compared with saline implants (p < 0.01), no difference was seen in the rate of implant-specific reoperation for saline compared to silicone implants (p = 0.582). The use of total reoperation rates as an indication of complications of breast implants can lead to both an overestimation of implant-related complications and the inaccurate conclusion that silicone implants result in higher complication rates than saline implants. The implant-specific reoperation rate may provide a more accurate incidence of implant complications than the total reoperation rate, which includes reoperations for factors unrelated to the implant.

Bilateral Transaxillary Subfascial Breast Augmentation with Smooth Saline Implants: A Retrospective Analysis of Short-Term Complications

Introduction: To determine, by means of a retrospective study, the short-term complication rate of primary, transaxillary, subfascial breast augmentation using smooth, high-profile, saline implants. Comments and comparisons on observations will be made. Materials and Methods: A retrospective, private practice, medical chart review of primary, transaxillary breast augmentation surgeries with smooth, high-profile, saline implants done from 2004 to 2008 was performed. A list of short-term complications was compiled. We reviewed 273 charts, and complications were assessed at 1 week, 1 month, 3 months, and 6 months. The patients' and surgeons' comments in the medical charts and full preoperative and postoperative photographic documentation were evaluated. Adverse events were noted. These included surgical wound infection, breast pocket infection, wound dehiscences, hematomas/seromas, clinically significant Baker grade III to IV capsular contractures (grade III to IV firm with visible/obvious spherical distortion), rippling, asymmetries, nipple/areola sensory losses or deficits, and reoperations. Results: The short-term complications for bilateral, transaxillary, subfascial breast augmentation with smooth saline implants in this private practice occurred in the following percentage of patients: breast asymmetry, 6.95%; reoperation, 4.76%; clinically significant Baker grade III to IV capsular contracture, 2.56%; wound dehiscence, 2.19%; rippling, 1.83%; hematoma/seroma, 1.83%; and wound infection, 1.09%. It should also be noted that bleeding from the incision site, galactorrhea, formation of a hypertrophic scar, breast ptosis, and a breast pocket infection rate occurred in less than 1% of the patients. Conclusions: Primary, transaxillary, subfascial breast augmentation with smooth saline implants is both safe and effective. It offers the advantage of fewer scarring problems, and it protects nipple/areola sensation. The patients in this study seemed to experience fewer complications from this procedure than patients in other studies, but more studies are needed.

Hyaluronan, TSG-6, and inter-α-inhibitor in periprosthetic breast capsules: reduced levels of free hyaluronan and TSG-6 expression in contracted capsules.

The exact mechanism of capsular contracture (CC) is still unknown. The covalent modification of hyaluronan (HA) with the heavy chains (HC) of inter-α-inhibitor (IαI) has been identified as an important pathway in inflammation and tissue remodeling, where HC·HA formation is catalyzed by TSG-6 (the protein product of tumor necrosis factor stimulated gene-6). The authors quantitatively assess the correlation between severity of CC (measured by Baker grade) and expression of HA, TSG-6, and IαI (ie, the polypeptides HC1, HC2, and bikunin) in periprosthetic breast capsules. Immunofluorescent staining for HA, TSG-6, HC1, HC2, and bikunin was carried out on periprosthetic breast capsules (n = 7) of each Baker grade from four anatomical locations. Quantitative analysis was performed to identify differences in staining intensity. Real-time quantitative polymerase chain reaction (RT-qPCR) was performed to determine differences in TSG-6 gene expression levels. Severity of contracture was associated with reduced staining for both free HA (Pearson correlation coefficient, r = -0.645, P < .001) and TSG-6 (r = -0.642, P = .002). RT-qPCR showed a significant negative correlation between severity of contracture and TSG-6 gene expression levels (r = -0.750, P = .001). The negative correlation between TSG-6 expression levels and severity of CC suggests a possible protective role for TSG-6 in the context of CC formation, and this may have a clinically relevant role in prevention of breast CC.

Tumour Necrosis Factor-α Expression Is Associated with Increased Severity of Periprosthetic Breast Capsular Contracture

Background: The pathogenesis of periprosthetic capsular contracture following breast implant surgery is unclear. The aim of this study was to identify the expression of tumour necrosis factor-α (TNF-α), collagen type III α₁ (COL3A1), transforming growth factor-β₁ (TGF-β₁) and connective tissue growth factor (CTGF) in different Baker grades of breast capsular contracture. Methods: Seven periprosthetic breast capsule specimens were collected from 6 patients. TNF-α, COL3A1, TGF-β₁ and CTGF gene expression were analysed using real-time quantitative polymerase chain reaction. Immunohistolocalisation of TNF-α was performed on paraffin-embedded sections. Significant correlations were analysed using the Pearson correlation coefficient. Results: TNF-α expression was associated with increased Baker grade of capsular contracture (Pearson correlation, r = 0.558; p = 0.02). COL3A1 gene expression was reduced with increasing severity of contracture (r = –0.490; p = 0.05). There were no significant correlations between TGF-β₁ and CTGF expression with Baker grade. Positive TNF-α staining in breast capsules was localised to fibroblasts, macrophages, and extracellularly close to the prosthesis. Conclusion: The increased expression of TNF-α may play a key role in the inflammatory response associated with capsular contracture. The corresponding decrease in COL3A1 may contribute to the change in capsular physical properties seen in capsular contracture.

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.