Defining the Relationship between Pocket and Breast Implant Surface Area as the Basis for a New Classification System for Capsular Contracture.

BACKGROUND: The precise cause of and treatment for capsular contracture remains uncertain, at least partially because there is no reliable quantitative measurement tool. To address this, it is postulated that the surface area of an implant as defined by the surrounding pocket may provide a quantifiable variable that can be measured to evaluate the degree of capsular contracture. METHODS: A bench model for capsular contracture was developed. The surface area of a series of spherical test objects and noncontracted and contracted breast implants was measured using a wax-coating technique and three-dimensional reconstructions created from computed tomographic scan images. RESULTS: Comparison of the mathematically calculated surface areas to the wax and computed tomographic scan results for spheres of known dimension provided nearly identical values, documenting the accuracy of the two experimental methods. Comparison of the surface area measurements between the test groups showed that the average decrease in surface area for all implants was 20 percent, ranging from a high of 30.9 percent for a low-profile implant to a low of 14.1 percent for a high-profile implant. The anatomically shaped devices demonstrated nearly uniform degrees of surface area change over three different heights with volume and projection held relatively constant. CONCLUSIONS: The described bench model provides a useful tool for the study of capsular contracture. Surface area is a descriptive variable that can assess the degree of capsular contracture that is present. A classification system based on surface area is presented. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.

Complicaciones infrecuentes de las prótesis de mama / Uncommon complications of breast prostheses

Los implantes mamarios se asocian a complicaciones frecuentes ampliamente conocidas y estudiadas como la rotura y la contractura capsular. Sin embargo, debido al número cada vez mayor de pacientes portadoras de implantes mamarios, podemos encontrarnos con patología más infrecuente como la presencia de seroma o infección tardía, adenopatías en la cadena mamaria interna, granulomas en la cápsula del implante -que en algunos casos pueden extenderse más allá de la cápsula fibrosa-, tumores desmoides asociados a los implantes y el linfoma anaplásico de células grandes asociado a implantes mamarios. El objetivo de este artículo es revisar las principales complicaciones infrecuentes asociadas a los implantes mamarios y sus hallazgos radiológicos en las diferentes técnicas. Es importante un correcto manejo de esta patología, principalmente del seroma tardío, para diagnosticar precozmente el linfoma anaplásico de células grandes por su mayor transcendencia

Breast implants are associated with well-known common complications that have been widely studied, such as rupture and capsular contraction. However, the increasingly growing number of patients with breast implants has led to the increased likelihood of coming across less common complications; these include seromas or late infection; adenopathies in the internal mammary chain; granulomas in the capsule of the implant, which in some cases can extend beyond the fibrous capsule; desmoid tumors associated with the implants; and breast implant-associated large cell anaplastic lymphoma. This article aims to review the main uncommon complications associated with breast implants and to describe and illustrate their findings in different imaging techniques. Proper management of these complications is important; this is especially true of late seroma and the diagnosis of breast implant-associated large cell anaplastic lymphoma for their repercussions

Breast Implant Imaging Surveillance among U.S. Plastic Surgeons: U.S. Food and Drug Administration Recommendations versus Clinical Reality.

BACKGROUND: Device rupture is considered a major complication associated with breast implants. The U.S. Food and Drug Administration recommends magnetic resonance imaging (MRI) surveillance 3 years after implantation and then every 2 years, but adherence to these recommendations is poor. The authors identified current practice management for breast implant rupture surveillance by surveying practicing U.S. plastic surgeons. METHODS: An online survey of all active members of the American Society of Plastic Surgeons was performed. Questions analyzed imaging practice patterns related to breast implants. Logistic regression models were used to analyze determinants for radiographic imaging in breast implant patients. RESULTS: The survey had a response rate of 16.5 percent. For patients with breast implants, 37.7 percent of respondents recommended MRI at the recommended intervals. Fifty-five percent perform imaging only if there is a problem with the implant. Academic surgeons more frequently recommended MRI (56.3 percent and 39.3 percent; p = 0.0002). Surgeons with less than 5 years of experience are four times more likely to order MRI than surgeons with over 25 years' experience (60.8 percent and 28.1 percent; p < 0.0001). Furthermore, lower volume surgeons recommend significantly more MRI (45.2 percent and 27.3 percent; p = 0.001). Respondents are almost two times more likely to recommend MRI in reconstructive versus cosmetic patients (51.2 percent and 35.6 percent; p = 0.0004). CONCLUSIONS: MRI limitations include high costs, time commitments, and equipment constraints. Fewer than 40 percent of survey respondents suggest the recommended screening frequency to their patients; however, academic, low-volume, early-career surgeons are more likely to recommend MRI implant monitoring. Screening recommendations need to be evidence based and align with common practices to prevent undue system, provider, and patient burden.

Management of Capsular Contracture in Cases of Silicone Gel Breast Implant Rupture with Use of Pulse Lavage and Open Capsulotomy.

INTRODUCTION: Pulse lavage (PL) irrigation of prosthesis pockets has prior been described for breast implant salvages. However, PL for removal of leaked silicone from prosthesis pockets after implant ruptures has not been studied yet. Since open capsulotomies are regarded as equal treatment of capsular contracture (CC) than capsulectomies, this study analyzed the clinical outcome of PL for silicone removal and subsequent capsulotomy in cases of concurrent CC and breast implant rupture. METHODS: Between 2012 and 2017, 55 patients (75 breasts) with suspected silicone implant rupture and CC (Baker grade III/IV), after primary breast augmentation or implant-based breast reconstruction, were included in a retrospective, observational study. Mean patient follow-up was 12.2 ± 3.6 months. RESULTS: In all preoperatively suspected ruptured silicone breast implants, around a quarter were intact. In contrast to previously published data, implant exchanges in cases of implant ruptures did not lead to significantly higher CC recurrence rates (27.6% vs. 22.2% in cases of intact implants, p = 0.682), if the prosthesis pockets were treated with PL irrigation followed by open capsulotomy. PL reduced the amount of encapsulated silicone remnants histologically. The age of patients with CC after failed implant-based reconstruction was significant lower for salvage surgeries with flap reconstruction than for implant exchanges, p < 0.05. CONCLUSIONS: PL irrigation of prosthesis pockets prior to open capsulotomy is a safe and effective treatment of CC with concurrent silicone leakage. Remaining silicone remnants in breast capsules may affect the development of a recurrent CC. To avoid CC recurrences, patients should consider conversion to autologous tissue. LEVEL OF EVIDENCE IV: 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 www.springer.com/00266 .

Rotura extracapsular de prótesis mamaria imitando recidiva neoplásica en PET/TC con 18F-FDG / Extracapsular breast implant rupture mimicking local cancer recurrence on 18F-FDG PET/CT

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Sonography in capsular contracture after breast augmentation: value of established criteria, new techniques and directions for research.

Capsular contracture or capsular fibrosis is the most common complication following breast augmentation with implants. Sonography is usually the initial imaging test performed to examine a suspicious implant. In contrast to the large number of patients developing capsular fibrosis there is only sparse literature reporting about sonographic findings. In this letter after a brief review of normal sonographic findings after breast augmentation, established ultrasound findings suggestive of capsular fibrosis (deformity, increased number of radial folds and thickening of the fibrous capsule) are discussed. The possible value of new techniques and possible directions for further research are addressed.

Long-Term Effects of the Collagenase of the Bacterium Clostridium histolyticum for the Treatment of Capsular Fibrosis After Silicone Implants.

BACKGROUND: Capsular contracture remains the most frequent long-term complication after augmentation mammoplasty with silicone implants. Thereby, the main part of the fibrotic capsule is collagen. The collagenase of the bacterium Clostridium histolyticum is approved for the treatment of fibrotic diseases and has been demonstrated to be effective for capsular fibrosis treatment in the short term. However, long-term effectiveness is currently unknown but mandatory for clinical utilization. MATERIALS AND METHODS: Forty-eight rats received miniature silicone implants and an injection with either collagenase (treatment group) or plain solvent solution (control group) 120 days post insertion. Ten and 60 days after the injections, the rats underwent 7-Tesla magnetic resonance imaging (MRI) and high-resolution ultrasound (HR-US). Capsule tissue was harvested, and capsule thickness and collagen density were evaluated through histology. Furthermore, the expression levels of inflammatory (CD68, IL4, IL10, IL12, IL13), pro-, and anti-fibrotic (TGFb1, TGFb3, Smad3, Col1-4) genes were analyzed using qRT-PCR. RESULTS: On days 10 and 60 after injection of collagenase, histology showed that capsule thickness was significantly reduced in the treatment group when compared with the control (p < 0.05). Thickness measurements were verified by MRI and HR-US analysis. Skin perforation occurred in two cases after collagenase injection. The initial up-regulation of pro-fibrotic and inflammatory genes 10 days after collagenase injection did not persist in the long term. Contrarily, on day 60, a slight trend towards lower expression levels with a significant down-regulation of TGFb3 was detected in the treatment group. CONCLUSION: The collagenase of the bacterium C. histolyticum effectively degrades capsular fibrosis around silicone implants with stable outcomes throughout 60 days post injection. Skin perforation and adequate and uniform drug distribution within the implant pocket are issues that need to be addressed. Further studies are warranted to clarify whether collagenase injections have the potential to become a viable treatment option for capsular contracture. NO LEVEL ASSIGNED: This journal requires that authors 46 assign a level of evidence to each article. For a full 47 description of these Evidence-Based Medicine ratings, 48 please refer to the Table of Contents or the online 49 Instructions to Authors. www.springer.com/00266 .

Poly Implant Prothèse and Rofil Substandard Breast Implant Explantations from a Large German Single Centre from 2011 to 2014: A Comparative Study.

BACKGROUND: Following a Europe-wide scandal, substandard breast implants containing silicone for industry purposes produced by Poly Implant Prothèse (PIP&Rofil) were explanted due to its potential health risks. OBJECTIVE: We investigated whether these implants actually imposed a threat to patients' health. METHODS: In this retrospective single-centre case-control study, we compared patients with breast augmentation receiving implant explantation (01/2011-01/2015). Data were collected retrospectively from the patients' records. Patients were split into two groups: PIP&Rofil and implants of other manufacturers. RESULTS: A total of 307 patients with 495 breast implants met the inclusion criteria, 64 patients with 115 PIP&Rofil implants and 243 patients with 380 implants of other manufacturers. Comparison of descriptive statistics between the two groups revealed that for a variety of indicators (e.g. patient age, breast cancer, aesthetic vs. reconstructive indication, implant volume, submuscular vs. subglandular implant position) PIP implants differ from non-PIP implant patients. Raw mean comparison showed higher rupture rates for non-PIP implants, 28.42 % (PIP 23.48 %). However, when controlling for implant indwelling time, PIP implants had shown higher rupture rates. Both groups had similar rates of capsular contracture (PIP: 71.30 %, Others: 72.63 %) with different distribution of Baker Scores (Baker 2/3/4: PIP 5/8/13 and non-PIP 3/24/135). CONCLUSION: Concerning patient symptoms, we did not find any objective reason to justify implant explantation of PIP&Rofil implants as a solely precautionary measure. As PIP&Rofil implants showed shorter retention periods until rupture and ruptured implants can cause symptoms or health problems, PIP&Rofil implants should be regularly monitored and explanted if there is evidence of rupture. LEVEL OF EVIDENCE III: 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 www.springer.com/00266.

The Prevalence of Tuberous/Constricted Breast Deformity in Population and in Breast Augmentation and Reduction Mammaplasty Patients.

BACKGROUND: The exact prevalence of tuberous breast deformity (TBD) has not been properly investigated and still remains undetermined. We report our data about TBD prevalence with the aim of demonstrating its high prevalence. MATERIALS AND METHODS: A retrospective analysis was performed on preoperative photographs of 1600 Caucasian female patients admitted to our department from January 2009 to July 2014 for augmentation or reduction mammaplasty and other breast clinical conditions. The main features of TBD included a contracted skin envelope, a reduction in breast parenchyma of the lower medial and lateral quadrants, a constricted breast base, abnormal elevation of the inframammary fold, herniation of the breast into the areola with a constricted breast base, and nipple areola complex herniation with a normal breast base. Patients were classified into three groups: breast augmentation group (AUG group), breast reduction group (RED group), and general population group (POP group). RESULTS: Four hundred patients were analyzed for each group (AUG and RED group); 194 patients (48.5 %) and 189 cases (47.3 %), respectively, demonstrated at least one tuberous breast deformity; in 800 patients of the POP group, we found 221 patients (27.6 %) with at least one tuberous breast deformity. CONCLUSIONS: Retrospective analysis reveals a high prevalence of TBD in the general population and in particular in women seeking breast augmentation or breast reduction (about 50 %). TBD is characterized by a wide range of clinical features with a spectrum of degrees. Preoperative evaluation is crucial to achieve an optimum outcome and patient satisfaction. LEVEL OF EVIDENCE II: 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 www.springer.com/00266 .

Management of Breast Deformity After Removal of Injectable Polyacrylamide Hydrogel: Retrospective Study of 200 Cases for 7 Years.

BACKGROUND: Polyacrylamide hydrogel (PAAG), once used as an injection for breast augmentation, has been banned in the medical field for cosmetic purposes for more than 10 years in China. But a large number of breasts have characteristic deformities due to the gel's feature of erosion. Our aim is to explore a retrospective study on PAAG's long-term effects on women, ensuing breast deformity and the strategy for breast plasticity after removing the gel in our center from 2007 to 2014. METHODS: From 2007 to 2014, 200 patients, whose breasts were injected with PAAG, underwent the operation to remove the injectable material. Complications were summarized. Ultrasound or MRI was performed before the operation to disclose the general distribution of the gel and the muscle and gland infiltration. According to the gel distribution, muscle and gland infiltration, infection, gel residue, and other factors, the patients were treated, respectively, with or without prosthesis implantation surgery after the removal of the gel. According to the decision about whether or when to undergo prosthesis implantation, the patients were classified into three types: group I-prosthesis implantation at the first stage, group II-prosthesis implantation at the second stage, and group III-only removing the material without prosthesis implantation. The scores of the BREAST-Q program were used to evaluate the preoperative and postoperative differences. RESULTS: Seventy-seven patients underwent prosthesis implantation at the first stage and 61 patients were operated on by placing the prosthesis at the second stage. A total of 62 patients only underwent the PAAG removal operation. By BREAST-Q evaluation, changes are summarized in Tables 1, 2, and 3 between mean preoperative scores and mean postoperative scores through categories of satisfaction with appearance of breasts, psychosocial wellbeing, sexual wellbeing, and physical wellbeing, in which all categories were presented with statistical significance (p < 0.001). Table 1 Patient demographics General patient data Number Number of patients 200 Age range 25-48 Follow-up period 6-12 months Injection material  Domestic material 84 (42 %)  Imported material 93 (46.5 %)  Domestic + imported 23 (11.5 %) Injection site  Regular hospital 47 (23.5 %)  Clinics 153 (76.5 %) Complication  Inflammation 10 (2 %)  Pain 75 (37.5 %)  Induration 155 (77.5 %)  Shift 50 (25 %)  Deformation 17 (8.5 %)  Bilateral asymmetry 48 (24 %)  Deposition milk 2 (1 %)  Psychological fear 150 (75 %)  Systemic symptoms 34 (17 %)  Single complication 25 (16.97 %)  Two or more complications 160 (80 %)  Preoperative aspiration 48 (24 %) Table 2 Group I-changes in mean preoperative scores and mean postoperative scores Category Preoperatively (n = 77) Postoperatively (n = 77) p Satisfaction with appearance of breasts 18.8 ± 16.2 81.6 ± 13.1 <0.001 Psychosocial wellbeing 39.5 ± 20.2 84.5 ± 19.3 <0.001 Sexual wellbeing 38.7 ± 23.1 77.2 ± 20.5 <0.001 Physical wellbeing 42.4 ± 16.3 81.7 ± 10.5 <0.001 Table 3 Group II-changes in mean preoperative scores and mean postoperative scores Category Preoperatively (n = 61) Postoperatively (n = 61) p Satisfaction with appearance of breasts 19.6 ± 15.3 82.5 ± 11.1 <0.001 Psychosocial wellbeing 38.9 ± 19.3 83.6 ± 20.1 <0.001 Sexual wellbeing 37.6 ± 22.4 79.3 ± 20.4 <0.001 Physical wellbeing 41.3 ± 15.1 82.2 ± 9.9 <0.001 CONCLUSIONS: Timely removal is critical for women who have received the PAAG removal operation. However, the surgery may destroy the shape of the breast. It is recommended that preoperative communication and local tissue condition are guidelines for surgeons to choose conservative or aggressive surgery. A balance must be maintained between removing the gel as much as possible and retaining soft tissue to reshape breasts. LEVEL OF EVIDENCE IV: 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 www.springer.com/00266 .

Noninvasive Shock Wave Treatment for Capsular Contractures After Breast Augmentation: A Rabbit Study.

BACKGROUND: Capsular contracture is the most common complication of breast augmentation. Although numerous procedures are intended to prevent capsular contracture, their efficacy does not satisfy surgeons or patients. In the present study, we used shock waves to develop innovative protocols to treat capsular contracture in rabbits. METHODS: We used shock waves to treat capsular contracture in a rabbit model. Six clinical parameters were evaluated to determine the treatment efficacy of shock waves on the pathological histology of capsular contracture. Dual-flip-angle T1-mapping magnetic resonance imaging was used to confirm the pathological findings. RESULTS: Among the parameters, myxoid change, vascular proliferation, and lymphoplasma cell infiltration around the capsule increased more after treatment than they did in a control group. Capsular thickness, inner thinner collagen layer, and capsule wall collagen deposition decreased after shock wave treatment; only the inner thinner collagen layer and capsule wall collagen deposition changed significantly. The MRI findings for both scar thickness and water content were consistent with pathological biology findings. CONCLUSION: This was the first pilot study and trial to treat capsular contractures using shock waves. We found that shock waves can cause changes in the structure or the composition of capsular contracture. We conclude that the treatment could decrease water content, loosen structure, decrease collagen deposition, and might alleviate scar formation from capsular contracture. We believe that the treatment could be a viable remedy for capsular contractures. NO LEVEL ASSIGNED: 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 www.springer.com/00266 .

Nine-Year Core Study Data for Sientra's FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel.

BACKGROUND: Since approval in March 2012, data on Sientra's (Santa Barbara, CA) silicone gel implants have been updated and published regularly to provide immediate visibility to the continued safety and performance of these devices. The 9 year follow-up data support the previously published data confirming the ongoing safety and efficacy of Sientra silicone gel breast implants. OBJECTIVES: The authors provide updated 9 year study data for Sientra's round and shaped silicone gel breast implants. METHODS: The Core Study is an ongoing 10 year study that enrolled 1788 patients with 3506 Sientra implants across four indications (primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction). For the safety analysis, Kaplan-Meier risk rates were calculated to evaluate postoperative complications, including all breast implant-related adverse effects. For the effectiveness analyses, results were presented through 8 years as patient satisfaction scores were assessed at even years. RESULTS: Through 9 years, the overall risk of capsular contracture was 12.6%. Smooth devices (16.6%, 95% CI, 14.2%, 19.5%) had a statistically significantly higher rate of capsular contracture compared to textured devices (8.0%, 95% CI, 6.2%, 10.4%). Out of the 610 reoperations in 477 patients, over half of all reoperations were due to cosmetic reasons (n = 315; 51.6%). Patient satisfaction remains high through 8 years, with 90% of primary augmentation patients indicating their breast implants look natural and feel soft. CONCLUSIONS: The 9-year follow-up data from the ongoing Core Study of the Sientra portfolio of HSC and HSC+ silicone gel breast implants reaffirm the very strong safety profile as well as continued patient satisfaction. LEVEL OF EVIDENCE: 2 Therapeutic.

Radiographic Implications of Fat Grafting to the Reconstructed Breast.

Autologous fat transfer is often used to smooth contour irregularities in the reconstructed breast. A potential concern with this technique is that it results in calcified lesions in the breast that can complicate subsequent cancer surveillance. The purpose of this review was to determine how fat grafting to the reconstructed breast impacts postoperative breast imaging. This is a matched cohort analysis of patients who underwent postmastectomy breast reconstruction with and without fat grafting as a secondary procedure. Nonfat grafted reconstructive patients were matched based on age, year of initial reconstruction, and type of reconstruction. Postoperative imaging at our institution was required for inclusion. The two groups were compared in terms of incidence and distribution of radiographic studies performed in follow-up and the need for biopsies. Fifty-one reconstructed breasts with a history of fat grafting were compared to 51 nonfat grafted, reconstructed breasts. The fat grafted group underwent a total of 204 breast imaging studies over a mean follow-up of 4.2 years, while the nonfat grafted group underwent 167 studies over 4.1 years (p = 0.21). More mammograms, ultrasounds, and magnetic resonance images were performed after fat grafting, but a significant difference was evident only for mammography (34 versus 12, p = 0.05). The incidence of breast biopsy to clarify abnormal imaging was nonsignificantly higher in the fat grafted group (17.6% versus 7.8%, p = 0.14). Fewer than 10 percent of imaging studies in the fat grafted cohort were performed to investigate a clinical or radiographic abnormality occupying the same breast quadrant as prior fat injection. Breast cancer patients treated with fat grafting required more breast imaging and biopsies than their nonfat grafted counterparts, but the areas of suspicion poorly corresponded to the site of prior fat grafting. Multimodal breast reconstruction may drive the additional diagnostic burden and not the fat grafting technique itself.

Silicone Implants with Smooth Surfaces Induce Thinner but Denser Fibrotic Capsules Compared to Those with Textured Surfaces in a Rodent Model.

PURPOSE: Capsular contracture is the most frequent long-term complication after implant-based breast reconstruction or augmentation. The aim of this study was to evaluate the impact of implant surface properties on fibrotic capsule formation in an animal model. MATERIALS AND METHODS: Twenty-four rats received 1 scaled down silicone implant each; 12 of the rats received implants with textured surfaces, and the other 12 received implants with smooth surfaces. After 60 and 120 days, rats in each group underwent 7-Tesla Magnetic Resonance Imaging (MRI) and high-resolution ultrasound (HR-US), and specimens of the capsules were acquired and used to measure capsule thickness through histology, collagen density through picro sirius red staining, and analyses of expression of pro-fibrotic and inflammatory genes (Collagen1-4, TGFb1, TGFb3, Smad3, IL4, IL10, IL13, CD68) through qRT-PCR. Furthermore, MRI data were processed to obtain capsule volume and implant surface area. RESULTS: On day 60, histology and HR-US showed that fibrotic capsules were significantly thicker in the textured implant group with respect to the smooth implant group (p<0.05). However, this difference did not persist on day 120 (p=0.56). Capsule thickness decreased significantly over the study period in both smooth and textured implant groups (p<0.05). Thickness measurements were substantiated by MRI analysis and volumes changed accordingly. Implant surface area did not vary between study dates, but it was different between implant types. On day 60, the density of collagen in the fibrotic capsules was significantly lower in the textured implant group with respect to the smooth group (p<0.05), but again this difference did not persist on day 120 (p=0.67). Collagen 1 and CD68 were respectively over- and under expressed in the textured implant group on day 60. Significant differences in the expression of other genes were not observed. CONCLUSION: Silicone implants with textured surfaces led to temporarily thicker but less dense fibrotic capsules compared with smooth surfaces. 7-Tesla MRI and HR-US are capable for non-invasive in-vivo assessment of capsular fibrosis in an animal model and can provide unique insights into the fibrotic process by 3D reconstruction and surface area measurement.

PIP implant biodurability: a post-publicity update.

INTRODUCTION: in the year since Poly Implant Prothèse (PIP) found itself the epicentre of intense, global media attention initial studies have started to evaluate the abnormally high premature device failure rate suspected for their mammary prostheses. A cohort free from most of the usual confounding variables affords opportunities to improve upon previous estimates of rupture prevalence, assess the media effect and evaluate contemporary ultrasound scan (USS) accuracy. PATIENTS & METHODS: 460 patients who underwent cosmetic breast augmentation (BA) with PIP silicone prostheses (January 2000-August 2005) have now been followed since their withdrawal in 2010. Initial recall study generated a crude rupture rate of 15.9-33.8% over 6-11 years. Global publicity that followed the lymphoma-related death of a French patient in December 2011 led to 127 patients (27.4%) of our original cohort making de novo or further contact as a direct result. To date, 283 (61.5%) have been reviewed of whom 167 (59%) have undergone breast USS. In toto, 163 (35.4%) have had their implants replaced or removed. RESULTS: Kaplan-Meier analysis places 10-year PIP mammary implant survival between 60 (95% confidence interval (CI): 54-67) and 81% (95% CI: 78-85). Post-publicity evaluees were found to have occult device failure in 31.6%. Of 85 patients who had definitive confirmation of USS findings by surgical exploration, 79 (92.9%) were completely accurate. USS in our series had a sensitivity of 97.3% and specificity of 93.1%. DISCUSSION: this study not only reaffirms PIP's rupture prevalence to be higher than comparative breast prostheses, but also records the media's beneficial effect in improving recall. Importantly, there is a relatively high proportion of patients with ruptured devices of which they are otherwise unaware. Ultrasonography, at least in PIP-augmented women, seems to be a more accurate tool than previously measured, especially in the presence of rupture. Finally, 35.2% resisted all attempts at review despite repeated efforts and widespread media coverage.

Controlled clinical trial with pirfenidone in the treatment of breast capsular contracture: association of TGF-ß polymorphisms.

BACKGROUND: Breast capsular contracture (BCC) is a commonly adverse event postmammoplastly characterized by an immune response mediated by cytokines and transforming growth factor (TGF)-ß1 resulting in excessive synthesis and deposit of extracellular matrix around the breast implant. Presence of TGF-ß1 polymorphisms has been associated as a risk factor to develop fibroproliferative diseases. METHODS: This open, controlled, prospective, and pilot clinical trial with 6 months duration was carried out to evaluate the efficacy of 1800 mg a day, of oral Pirfenidone (PFD) in the treatment of BCC (Baker Score III/IV) postmammoplasty. Twenty BCC cases received PFD and 14 BCC control cases underwent capsulectomy after 6 months of enrollment. Both groups were followed up for 6 more months up to 12 months to determine the relapse in the absence of PFD. Determination of TGF-ß1 polymorphisms was performed to establish a correlation with capsular contracture. RESULTS: PFD group experienced BCC-reduction in all breasts 6 months after enrollment. Only 1 of 20 cases relapsed after follow-up. In capsulectomy group, 2 of 14 cases presented progression to grade IV during presurgical period. All capsulectomy cases relapsed at end of follow-up. Nearly hundred percent of all patients studied in this protocol had a profibrogenic homozygous TGF-ß1 polymorphism (codon 25; genotype Arg25Arg). CONCLUSIONS: PFD is useful to improve BCC (Baker Score III/IV) postmammoplasty with no relapse after drug administration. There is also an association between capsular contracture and the presence of homozygous G/G TGF-ß1 genotype.

The impact of Smad3 loss of function on TGF-ß signaling and radiation-induced capsular contracture.

BACKGROUND: Capsular contracture remains a major problem following prosthetic breast implantation, especially in patients undergoing irradiation. Recent studies suggest that such radiation injuries are a cascading process of cytokine activation, with transforming growth factor (TGF)-ß acting as the "master switch." Because TGF-ß signals through phosphorylation of Smad3, a plausible approach to abate TGF-ß-induced capsular contracture would be to interrupt Smad3 signaling. To test this hypothesis, capsular contracture formation in wild-type and Smad3 knockout mice was compared using micro-computed tomographic and histologic examination. METHODS: On day 0, 48 mice were implanted with bilateral silicone gel implants. Postoperatively, animals were imaged using live-scan micro-computed tomographic scanning. Animals in the radiation arm then received a 10-Gy directed radiation dose. On postoperative days 21, 28, 35, and 42, animals were imaged again. Histologic evaluation was performed at necropsy. RESULTS: Irradiated implants in the wild-type mice demonstrated shape and contour deformation on micro-computed tomographic scanning beginning on postoperative day 21 and progressing through day 42. Conversely, micro-computed tomographic scanning of irradiated implants in knockout mice demonstrated few changes from day 0 through day 42. Corresponding histologic specimens from wild-type mice demonstrated irregular capsules composed of disorganized collagen that became thicker from day 21 to day 42. Irradiated knockout specimen maintained thin capsules from day 21 through day 42. CONCLUSIONS: In this work, inhibiting TGF-ß signaling led to a reduction in radiation-induced capsular contracture as measured by micro-computed tomographic and histologic evaluation. The results of this study suggest a promising target for the prevention of capsular contracture through the development of anti-Smad3/TGF-ß-based therapies.