Why Do We Need Anatomical Implants? the Science and Rationale for Maintaining Their Availability and Use in Breast Surgery.

The choice between anatomical and round implants is an important decision in breast augmentation surgery; however, both have their place and the decision between them that should be made on a patient-by-patient basis, taking into account the patient's desires, anatomy, and surgical history. In some individuals, there are clear indications for using either anatomical or round devices, and there is good evidence that aesthetic outcomes are better with anatomical implants in some instances. When both types are an option, anatomical devices may offer increased flexibility and, despite a longer learning curve needed to properly manage them, they are associated with positive long-term outcomes and high levels of patient satisfaction. Concerns about implant rotation can be minimized with proper patient selection and surgical technique, and the overall complication rate may favor anatomical over round devices in appropriate patients. Breast implant-associated anaplastic large-cell lymphoma is an important issue, and while rare, it must be considered in the context of the entire patient risk profile. Both anatomical and round implants remain key elements of a complete surgical toolbox in breast augmentation. 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.

Different types of implants for reconstructive breast surgery.

BACKGROUND: Breast cancer is the most common cancer in women worldwide, and is a leading cause of cancer death among women. Prophylactic or curative mastectomy is often followed by breast reconstruction for which there are several surgical approaches that use breast implants with which surgeons can restore the natural feel, size and shape of the breast. OBJECTIVES: To assess the effects of different types of breast implants on capsular contracture, surgical short- and long-term complications, postoperative satisfaction level and quality of life in women who have undergone reconstructive breast surgery after mastectomy. SEARCH METHODS: We searched the Cochrane Breast Cancer Group's Specialised Register on 20 July 2015, MEDLINE (1985 to 20 July 2015), EMBASE (1985 to 20 July 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 8, 2015). We also searched the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov on 16 July 2015. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs that compared different types of breast implants for reconstructive surgery. We considered the following types of intervention: implant envelope surfaces - texturised versus smooth; implant filler material - silicone versus saline, PVP-Hydrogel versus saline; implant shape - anatomical versus round; implant volume - variable versus fixed; brands - different implant manufacturing companies and implant generation (fifth versus previous generations). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed methodological quality and extracted data. We used standard Cochrane methodological procedures. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. MAIN RESULTS: Five RCTs with 202 participants met the inclusion criteria. The women participants were typically in their 50s, and the majority of them (about 82%) received reconstructive surgery following breast cancer, while the others had reconstructive surgery after prophylactic mastectomy. The studies were heterogenous in terms of implant comparisons, which prevented us from pooling the data.The studies were judged as being at an unclear risk of bias for most risk of bias items owing to poor quality of reporting in the trial publications. Three of the five RCTs were judged to be at high risk of attrition bias, and one at high risk of detection bias.Textured silicone versus smooth silicone implants: textured implants were associated with worse outcomes when compared to smooth implants (capsular contracture: risk ratio (RR) 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence; reintervention: RR 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence). No results in this comparison were statistically significant.Silicone versus saline implants: saline-filled implants performed better than silicone-filled implants for some outcomes; specifically, they produced less severe capsular contracture (RR 3.25, 95% CI 1.24 to 8.51; 1 study, 60 participants; very low quality evidence) and increased patient satisfaction (RR 0.60, 95% CI 0.41 to 0.88; 1 study, 58 participants; very low quality evidence). However reintervention was significantly more frequent in the saline-filled implant group than in the silicone-filled group (OR 0.08, 95% CI 0.01 to 0.43; 1 study, 60 participants; very low quality evidence).Poly(N-vinyl-2-pyrrolidone) hydrogel-filled (PVP-hydrogel) versus saline-filled implants: PVP-hydrogel-filled implants were associated with worse outcomes when compared to saline-filled implants (capsular contracture: RR 3.50, 95% CI 0.83 to 14.83; 1 study, 40 participants; very low quality evidence; short-term complications: RR 2.10, 95% CI 0.21 to 21.39; 1 study, 41 participants; very low quality evidence).Anatomical versus round implants: anatomical implants were associated with worse outcomes than round implants (capsular contracture: RR 2.00, 95% CI 0.20 to 20.15; 1 study, 36 participants; very low quality evidence; short-term complications: RR 2.00, 95% CI 0.42 to 9.58; 1 study, 36 participants; very low quality evidence; reintervention: RR 1.50, 95% CI 0.51 to 4.43; 1 study, 36 participants; very low quality evidence). No results in this comparison were statistically significant.Variable-volume versus fixed-volume implants: data about one-stage reconstruction using variable-volume implants were compared with data about fixed-volume implants positioned during the second surgical procedure of two-stage reconstructions. Fixed-volume implant reconstructions were possibly associated with a greater number of women reporting that their reconstruction corresponded with expected results (RR 0.25, 95% CI 0.10 to 0.62; 1 study, 40 participants; very low quality evidence) and fewer reinterventions (RR 7.00, 95% CI 1.82 to 26.89; 1 study, 40 participants; very low quality evidence) when compared to variable-volume implants. A higher patient satisfaction level (rated from 1 to 6, with 1 being very bad and 6 being very good) was found with the fixed-volume implants for overall aesthetic result (mean difference (MD) -1.10, 95% CI -1.59 to -0.61; 1 study, 40 participants; very low quality evidence).There were no studies that examined the effects of recent (fifth) generation silicone implants versus previous generations or different implant manufacturing companies. AUTHORS' CONCLUSIONS: Despite the central role of breast reconstruction in women with breast cancer, the best implants to use in reconstructive surgery have been studied rarely in the context of RCTs. Furthermore the quality of these studies and the overall evidence they provide is largely unsatisfactory. Some of our results can be interpreted as early evidence of potentially large differences between different surgical approaches, which should be confirmed in new high-quality RCTs that include a larger number of women. These days - even after a few million women have had breasts reconstructed - surgeons cannot inform women about the risks and complications of different implant-based breast reconstructive options on the basis of results derived from RCTs.

Benefits and Limitations of Macrotextured Breast Implants and Consensus Recommendations for Optimizing Their Effectiveness.

Implant texture is an important factor influencing implant selection for breast augmentation. Natrelle Biocell implants are characterized by macrotextured shell surfaces containing irregularly arranged concavities with large open-pore diameters and depths. These properties facilitate adhesion of the implant to the surrounding tissue, thereby promoting implant immobilization. Relative to implants with other surfaces, macrotextured implants offer low rates of capsular contracture; low rates of malposition, rotation, and rippling; and high rates of patient satisfaction. However, macrotextured implants are associated with a slightly higher risk of double capsule and late seroma. The surgeon can minimize these risks with straightforward techniques that encourage tissue adhesion. This report presents experience-based recommendations to optimize the effectiveness of Biocell anatomic implants. The authors discuss the application of best practices to all aspects of the breast implantation process, from implant selection and surgical planning to operative technique and postoperative management. LEVEL OF EVIDENCE 3.

Oncologic surveillance of breast cancer patients after lipofilling.

BACKGROUND: The regenerative effects of fat injections are based on the same hormones, growth factors, and stem cells that stimulate neoplastic angiogenesis and cancer progression in basic research. Few studies have analyzed the oncologic risk. No report has covered 5 years of oncologic surveillance, and no long-term risk has been estimated. The in vivo relationship between lipofilling and breast cancer remains unclear and controversial. This observational study focused on locoregional recurrence (LR) risk after lipofilling. METHODS: The study enrolled 60 patients after breast cancer surgery (total mastectomy) from 2000 to 2007 treated by lipofilling (82 single-surgeon procedures with the same fat-decanting technique). The study ended when follow-up observation reached 10 years. RESULTS: The study included invasive carcinoma (55 cases), in situ carcinoma (five cases), T1 (71.6 %) and T2 (23.3 %) carcinoma, N+ carcinoma (45 %), and stages 1 (43.3 %) and 2 (45 %) carcinoma. The overall 12-year incidence of LR was 5 % (1.6 % before and 3.3 % after lipofilling). The incidence of local relapse per 100 person-years was 0.36 in the first observation period and 0.43 after lipofilling. All LRs were stage 2, and the same rate, limited to stage 2, was 1.04. The crude cumulative incidence after lipofilling was 7.25 % (95 % confidence interval [CI], 0-15.4 %) for LR and 7.6 % (95 % CI, 0.2-15 %) for distant metastases. DISCUSSION: Clinical data and recurrence incidences were compared with those of prior publications concerning lipofilling oncologic risk and discussed in relation to the inherent cancer literature. CONCLUSIONS: Lipofilling may be used safely to treat tumor node metastasis stage 1 subjects after mastectomy. The local risk is low. For stage 2 patients, local failure was not significantly higher. Compared with institutional data and prior publications, the risk still is reliable. Breast conservative treatment must be investigated further because of the high risk for local relapse. 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.

Evaluation of Different Breast Implant Shapes in the Same Patient: Is There Really a Difference between Round and Anatomical Implants?

Background: The choice of the right implant shape is one of the most frequent debates in cosmetic breast augmentation. In current literature, the question of whether there is a difference in the appearance of different implant shapes is still an argument of highly controversial discussion. The aim of the present work was, therefore, to analyze whether any difference exists in terms of aesthetic outcome between round and anatomical implants, and if they can be distinguished from each other in a like for like swap, making sure the evaluation was made in exactly similar conditions. Methods: Fourteen consecutive patients who underwent aesthetic breast augmentations received primarily an implant of a given volume, projection, and shape (round or anatomical) and then decided to undergo implant replacement to a different shape but maintaining the same volume and projection. At 12-months follow-up, standardized photographs were taken, blinded and randomized. They were evaluated by 10 plastic surgeons and 10 nurses. Results: All 20 observers could distinguish between round and anatomical shape in all 14 cases (100%), which was highly significant (P < 0.0001) for each observer. Conclusions: The present data indicate that there is a clear difference between anatomical and round-shaped implants in terms of aesthetic appearance, when a comparison is properly performed. With the use of both round and anatomical implant shapes, aesthetically appealing results can be achieved in cosmetic breast augmentation. The right implant choice must be made, based on patients' anatomy and desires.

Effects of the magnetic resonance field on breast tissue expanders.

BACKGROUND: Tissue expansion for breast reconstruction after mastectomy is a safe and effective procedure. A magnetic resonance imaging (MRI) scan can be requested for patients with a breast expander to evaluate concurrent diseases. The electromagnetic field of the MR can interfere with biomedical devices, resulting in potential hazards, compromising the diagnosis, or creation of artifacts. METHODS: Four tissue expanders with an integrated magnetic valve were tested. The temperature increase was measured using an infrared camera in the MR scanner. The expanders were tested (half-full and full of saline solution) both free in air and immersed in a phantom. The ferromagnetic properties of the devices were assessed using the deflection angle method. To evidence artifacts due to the presence of the expander, MR images were acquired for expanders tested in air and in the phantom. A valve localization test was performed after MRI analysis. RESULTS: A slight increase in temperature was demonstrated, without any clinical significance. The deflection angle due to the magnetic field depends on the distance from the bore of the magnet. The angle is higher when the device is closer to the bore. The presence of the magnetic valve influences the MRI signal, creating artifacts on the acquired images, even far from the valve itself. The valve localization test allowed verification of correct valve functioning for all the expanders after the MRI analysis. CONCLUSIONS: Under selected conditions, MRI scans can be feasible. Heating is not expected to be a major concern, whereas valve displacement could happen in certain clinical conditions. The presence of artifacts is almost unavoidable. 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.

Conservative mastectomies.

Nowadays, oncological breast surgery has to be performed to maximize cosmetic results, and even mastectomies, when unavoidable, should conform to acceptable aesthetics. We investigated surgical approaches to skin-sparing mastectomies. Scar positioning and volume replacement were evaluated. We also discuss nipple-sparing mastectomy (NSM), probably the most outstanding item in the current debate on breast shape preservation. We give suggestions for safe admission criteria and effective treatment.

New technologies for the assessment of breast surgical outcomes.

BACKGROUND: Although interest in objective and quantitative breast surgical outcome assessment is rapidly increasing, published reports have yet to make a real impact on everyday clinical practice. OBJECTIVE: The authors offer a preliminary report on an innovative methodology customized for breast shape evaluation that, in our opinion, could overcome most of the technical and conceptual limitations of previous studies. METHODS: Three-dimensional/four-dimensional breast scanning was performed using a breast-dedicated prototype laser scanner made up of a handheld device, including a charge-coupled device (CCD) camera coupled to a spot laser source. Two additional motion analyzer cameras were used for handheld device tracking and the acquisition of patient motion. RESULTS: Seven female volunteers, including both subjects who had undergone cosmetic or reconstructive breast surgery and those with no such history, underwent a dynamic breast shape survey. Curvature mapping on three-dimensional mesh warranted precise measurements of local geometric properties of the breast surface. Elaboration and representation of breast dynamic behavior during common motor tasks (eg, walking, running, sitting, and lying) was also possible. CONCLUSIONS: The scanning methodology reported here reliably describes the breast surface not only in a static position, but also at specific postures or during motion of the body. It also opens the door for quantitative static and dynamic assessment of surgical outcomes, the intraoperative assessment of breast shape, and other applications. Limitations include the relatively long amount of time required for each scan and the need for technical and clinical validation, particularly with respect to four-dimensional assessment.

Visualized oncoplastic surgery of the breast I: inferior and medial quadrantectomy.

Surgical treatment of breast cancer has changed during the last few decades. Long-term evaluation of several studies performed worldwide have confirmed that conservative surgery (CS) and radical mastectomy have similar survival rates. Due to CS being the gold standard for treatment for most women with breast cancer, advances in materials, mastectomy and reconstructive surgery techniques, now give us the possibility to perform on our patients a great outcome with oncological security. Both advances, in plastic and oncologic surgery, created a new discipline, called oncoplastic breast surgery, that allow surgeons to resect large breast specimens preventing subsequent deformities with the correct previous planning. This is particularly important when more than 30% of the breast volume will be resected because it allows for planning CS depending on the site of the lesion and for establishing the limits between CS and mastectomy.

International Expert Panel Consensus on Fat Grafting of the Breast.

BACKGROUND: Autologous fat grafting has broad applications in reconstructive and aesthetic breast surgery as a natural filler and for its regenerative purposes. Despite the widespread use of fat grafting, there remains no shared consensus on what constitutes the optimal fat grafting technique and its oncological safety. For this reason, the authors of this study have organized a Survey and an International Consensus Conference that was held at the Aesthetic Breast Meeting in Milan (December 15, 2018). METHODS: All studies on fat grafting, both for breast aesthetic and reconstructive purposes, were electronically screened. The literature review led to 17 "key questions" that were used for the Survey. The authors prepared a set of 10 "key statements" that have been discussed in a dedicated face-to-face session during the meeting. RESULTS: The 10 key statements addressed all the most debated topics on fat grafting of the breast. Levels of evidence for the key statements ranged from III to IV with 2 statements (20%) supported by a level of evidence III and 6 statements (60%) by level of evidence IV. Overall consensus was reached for 2 statements (20%) with >75% agreement reached for 7 statements. CONCLUSIONS: The survey demonstrated a diversity of opinion and attitude among the panelists with regard to technique. Clear recommendations for evidence-based clinical practice for fat grafting use both in aesthetic and reconstructive breast surgery could not be defined due to the scarcity of level 1 or 2 studies.

Extra-projected implants as an alternative surgical model for breast reconstruction. Implantation strategy and early results.

The present study reports on patients who underwent breast reconstructions with extra-projection implants. Two-hundred and thirty-four women were treated for 238 breast reconstructions irrespectively of breast shape and size. In this series we aimed to reconstruct for all women a bilateral cosmetic medium-size breast (between 400 and 500 cc), highly projected, with a little to moderate ptosis rather then a ptotic one exactly matching the contra-lateral. This is demonstrated by volume of implants that ranged from 397 cc for ladies with small breast who received an augmentation, to 533 cc for those who side required a reduction surgery. Eighty-six percent of patients received contra-lateral procedures. Complication rate was 8.4% and 66% of reconstructions were rated as good in the patients' opinion. Extra-projection implants, coupled with contra-lateral breast surgery, provide a good aesthetic outcome and avoid myocutaneous flaps only on the basis of breast size and shape.

Radiotherapy and breast reconstruction.

Indications for post mastectomy radiotherapy are widening to a larger group of mastectomy patients and breast reconstruction rates following mastectomy are rising all over the world, this leading breast surgeons to face breast reconstruction in a growing number of patients who will undergo radiotherapy. Increased morbidity is associated with all forms of breast reconstruction in the setting of postmastectomy radiotherapy and in patients who previously underwent chest wall radiotherapy. Different attitudes towards breast reconstruction in the radiotherapy setting are presented in literature. The level of evidence and quality of studies investigating breast reconstruction in the setting of PMRT and in patients who previously underwent chest wall radiotherapy are low. The reconstructive option in the radiotherapy setting must be tailored on the single patient according with patients' characteristics and wishes, always considering that the best reconstructive timing must be driven by the best oncological timing.

Hybrid breast reconstruction.

We present a new reconstructive system encompassing prostheses and fat grafting as integrated tools to improve the final reconstructive outcome. Fat grafting in our view is a preoperatively planned part of the reconstruction. The final volume we achieve will be made up of fat and implants in a variable percentage according to patient's body contour and breast morphology. We used the hybrid breast reconstruction technique in more than 350 reconstructions, both immediate and delayed, two-stage and DTI, without experiencing higher loco-regional recurrence and complication rates when compared with conventional two-stage reconstructions, obtaining excellent aesthetic results and high patients' satisfaction levels.

Management of ductal carcinoma in situ in the modern era.

Ductal carcinoma in situ (DCIS) has been the subject of much controversy since the advent of population based breast screening programs. An increasing number of asymptomatic women are being diagnosed with this condition and there is uncertainty over the best treatment algorithm for this condition if treatment is to be considered at all. Different subtypes of DCIS show innate differences in developmental pathways and biological behavior. This is not only determined by pathological subtypes but there is increasing understanding of molecular biomarkers related to DCIS progression. The ultimate management aim is to identify a subgroup of patients in whom DCIS will not progress to invasive disease such that they can avoid morbidity from surgical and adjuvant therapies. This has to be balanced by the potential risk of undertreatment of patients in whom DCIS is likely to progress to invasive cancer and hence a reduced life expectancy. Results of current ongoing prospective randomized trials assessing the safety of omitting surgery for what is considered to be low risk DCIS are eagerly awaited for by patients and clinicians. However the definition of what is considered to be "low risk" DCIS is still to be ascertained.

Axillary surgery in breast cancer: the beginning of the end.

Axillary surgery in breast cancer patients has shifted from more extensive to minimalist approaches with re-evaluation of the risks versus benefits of available treatment options which are increasingly tailored to individual patient characteristics. A radical axillary node dissection is rarely indicated nowadays due to several factors including screening with detection of small node negative cancers, introduction of targeted node sampling, less reliance on information from nodal staging for adjuvant therapy decision making and evidence that non-surgical treatments such as systemic therapies (chemotherapy, hormonal therapy, biological therapy) together with radiotherapy can safely treat low burden axillary disease. Sentinel lymph node biopsy (SLNB) alone with omission of further axillary surgery for nodal macrometastases (>2 mm) might be sufficiently extirpative to achieve local control when combined with adjuvant treatments. There remain unanswered questions on the safety of SLNB post chemotherapy in patients with biopsy-proven nodal disease at presentation and whether omission of axillary node dissection is feasible in selected cases. Emerging evidence suggests that a complete radiological response with removal of at least 3 nodes (including clipped nodes at time of biopsy) can yield false negative rates of <10% and be a safe option. New technologies involving percutaneous biopsy of sentinel nodes under radiological guidance are under investigation and could potentially replace surgical staging of the axilla in the future. Moreover, omission of any type of node biopsy might be a potential option in more favorable tumors and could herald the beginning of the end for histological axillary sampling in selected cases.

Augmented reality for breast imaging.

Augmented reality (AR) enables the superimposition of virtual reality reconstructions onto clinical images of a real patient, in real time. This allows visualization of internal structures through overlying tissues, thereby providing a virtual transparency vision of surgical anatomy. AR has been applied to neurosurgery, which utilizes a relatively fixed space, frames, and bony references; the application of AR facilitates the relationship between virtual and real data. Augmented breast imaging (ABI) is described. Breast MRI studies for breast implant patients with seroma were performed using a Siemens 3T system with a body coil and a four-channel bilateral phased-array breast coil as the transmitter and receiver, respectively. Gadolinium was injected as a contrast agent (0.1 mmol/kg at 2 mL/s) using a programmable power injector. Dicom formatted images data from 10 MRI cases of breast implant seroma and 10 MRI cases with T1-2 N0 M0 breast cancer, were imported and transformed into augmented reality images. ABI demonstrated stereoscopic depth perception, focal point convergence, 3D cursor use, and joystick fly-through. ABI can improve clinical outcomes, providing an enhanced view of the structures to work on. It should be further studied to determine its utility in clinical practice.

Oncoplastic breast reduction in conservative surgery.

Advances in reconstructive breast surgery with new materials and techniques now allow us to offer patients the best possible cosmetic results without the risks associated with oncological control of the disease. These advances, in both oncological and plastic surgery, have led to a new field, oncoplastic breast surgery, which enables us to undertake large resections and, with advance planning, and prevent subsequent deformities. This is particularly important when more than 30% of the breast volume is removed, as it allows us to obtain precise information for conservative surgery according to the site of the lesion and to set the boundary between conservative surgery and mastectomy.

Decisional pathways in breast augmentation: how to improve outcomes through accurate pre-operative planning.

Breast augmentation is the most commonly performed surgical procedure in aesthetic plastic surgery. Accurate pre-operative planning is crucial to obtain the best outcomes. We present our planning method deriving from a more than 30-year experience in aesthetic breast surgery, matching together patients tissues' characteristics and patients' wishes. We schematized our planning method in an easy-to-use flow diagram to help the decisional process in breast augmentation.