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OBJECTIVE: In this pilot study, we verified safe practices for breast milk expression, storage, and duration, based on bacteriological results. RESULTS: We collected breast milk samples from three healthy lactating volunteers and analyzed the bacterial flora and changes in the viable bacterial counts (including those of Staphylococcus) of the samples. Although no consistent change could be observed in the abundance of a particular bacterial group in samples expressed under hygienic control conditions, viable bacterial counts were higher in self-expressed milk than in milk expressed under hygienic control conditions. In conclusion, increased hygiene awareness is vital during breast milk expression and storage.

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BACKGROUND: Nipple-sparing mastectomy (NSM) and skin-sparing mastectomy (SSM) are challenging for surgical training among fellow trainees. We developed a surgical training course with novel concept of breast modular resection (BMR) for NSM/SSM procedure, and performed this study to investigate whether BMR could improve surgical outcomes compared to classical procedure resection (CPR). METHODS: The records of 105 breast cancer patients undergoing NSM/SSM with immediate reconstruction performed by fellow trainees were reviewed. Clinicopathological characteristics and surgical outcomes were compared between 2 groups. Laser speckle contrast imaging (LSCI) was performed to intraoperatively evaluate the blood supply of the NAC, and the absolute perfusion unit (PU) values and relative perfusion unit (rPU) values were further compared. RESULTS: Surgical training outcomes of BMR group (N = 52) were insignificantly improved compared to CPR group (N = 53). The rates of NAC necrosis, flap necrosis and implant removal all reduced respectively. Among the 60 NSM patients, the blood loss (P = .011) and surgery time (P < .001) was significantly reduced in BMR group (N = 30) and all the other outcomes were insignificantly improved. Both the absolute PU values and rPU values were significantly higher among patients without NAC necrosis (P < .001). The absolute PU values were significantly higher in BMR group (P = .002). CONCLUSION: Compared to CPR, the BMR-based surgical training course for NSM demonstrated the reduction in complications and operating time, offering a potential streamlined, efficient, and safe method for NSM procedure. LSCI was effective for intraoperative visualized evaluation of NAC blood supply and could provide effective real-time feedback for fellow trainees.

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Background: Nipple areola complex reconstruction is often the last procedure offered to patients undergoing breast reconstruction. Although comparatively minor, this final step creates the focal point of the breast while signifying the end of an often long and difficult journey for patient and surgeon. The literature demonstrates that nipple areolar complex (NAC) reconstruction conveys a positive impact on overall body image while defining the final aesthetic outcome. This paper presents a novel technique for NAC reconstruction developed at a UK tertiary referral center. It is supported by a systematic review of the current literature. Methods: Between 2014 and 2022, a new technique was used to reconstruct the NAC using a modification of the C-V flap with a full-thickness skin graft (FTSG) and later nipple tattoo, if required. Patients were followed up in clinic noting complications, satisfaction, and need for revision surgery. The study was completed by conducting a systematic review of the literature assessing areolar reconstruction with skin grafts, according to PRISMA guidelines. Discussion: This technique provides excellent results in terms of patient satisfaction and objective outcomes (complication rate, need for revision procedures, and loss of projection requiring further surgery). This literature review reflects alternative techniques and highlights the advantages of using a modified C-V flap with FTSG, in terms of morbidity and patient satisfaction. Conclusions: NAC reconstruction is the "cherry on top" at the end of the breast reconstructive journey. This paper advocates a technique that is reproducible, with minimal complications, excellent outcomes, and long-standing results.

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Breast cancer typically arises from the terminal duct-lobular unit of the mammary gland and rarely from the ducts inside the nipple. The present paper reports a rare case of primary invasive ductal carcinoma of the papilla, which was a locally advanced triple-negative breast cancer that was treated with 6 cycles of neoadjuvant chemotherapy with a nab-paclitaxel, epirubicin and cyclophosphamide regimen. Surgical pathology confirmed that a pathological complete response was achieved and adjuvant radiotherapy was performed postoperatively. No recurrence or metastasis occurred as of April 2024. A review of previous similar cases revealed that primary invasive breast cancer of the nipple has several manifestations. Changes in the nipple should be treated cautiously and a pathological biopsy should be performed in a timely manner. Breast cancer occurring in the nipple can be treated with reference to the same type of common breast cancer, and neoadjuvant chemotherapy can also be performed first if neoadjuvant chemotherapy is indicated.

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BACKGROUND: Due to the superficial location, suspicious findings of the nipple-areolar complex (NAC) are not amenable to stereotactic or MRI-guided sampling and have historically necessitated surgical biopsy or skin-punch biopsy. There are limited reports of US-guided core biopsy of the nipple (US-CBN). OBJECTIVE: We report our nearly 3-year pilot experience with US-CBN at an academic breast imaging center. METHODS: An institutional review board-exempt and HIPAA-compliant retrospective review was performed. We assessed patient demographics, breast imaging characteristics, procedural data, pathology, and outcomes. RESULTS: Nine female patients aged 27 to 64 underwent US-CBN from January 2021 to October 2023. Initial imaging abnormalities included abnormal MRI enhancement, mammographic calcifications, and sonographic masses. After initial or second-look US, all imaging findings had sonographic correlates for biopsy specimens, the majority of which were sonographic masses (8/9). US-CBN was performed by 6 breast radiologists using a variety of devices. All biopsy specimen results were concordant with sonographic abnormalities, although 1 was considered discordant from the initial abnormality seen on MRI. There were no complications, and discomfort during the procedure was well-treated. Two patients (22%, 2/9) were diagnosed with malignancy. CONCLUSION: This pilot study demonstrated that US-CBN can be performed by a breast radiologist for definitive diagnosis of suspicious nipple abnormalities seen on breast imaging, avoiding surgery, and maintaining nipple integrity. In our population, 22% (2/9) of US-CBNs revealed malignancy.

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BACKGROUND: Robot-assisted nipple sparing mastectomy (RANSM) is emerging because it offers hidden incisions and ergonomic movements. In this study, we report the learning curve and feasibility of RANSM. METHODS: A retrospective study was conducted among women who underwent RANSM with immediate breast reconstruction from July 2019 to June 2022. All RANSM procedures were performed by a single surgeon. We divided all the cases into two phases: the early phase (cases 1 to 21) and the late phase (cases 22 to 46). The total operation time, breast operation time, docking time, and console time were analyzed, and the cumulative sum (CUSUM) method was used to evaluate the effects of case experience accumulation on the time required for RANSM. Postoperative complications were analyzed according to their Clavien-Dindo grade. RESULTS: Overall, 42 women underwent 46 RANSM procedures. In the early and late phases, the mean console times were 78.1 min and 60.1 min (p = 0.011), respectively. In learning curve analysis, 21 RANSM procedures were required to reduce the breast operation time. Two cases of Clavien-Dindo grade III postoperative complications occurred (4.3 %). One case was an implant removal caused by infection, and the other was partial nipple ischemia; both occurred in the early phase, with none in the late phase. CONCLUSIONS: The breast operation time improved after the 21st RANSM procedure, and only two cases had Clavien-Dindo grade III or higher postoperative complications. RANSM is thus technically feasible and acceptable, with a short learning curve.

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Background: The continuous increase in the rate of nipple sparing mastectomy (NSM), the development of several reconstructive techniques and the following introduction of acellular derma matrix (ADM) has revolutionized implant-based breast reconstruction. This study aimed to investigate postoperative complications, health-related quality of life (HRQoL) and patients' satisfaction in patients undergoing NSM and breast reconstruction with or without ADM. Methods: Enrolled patients were divided into three groups: immediate breast reconstruction (IBR) with definitive implant and ADM (Group A), IBR only with definitive prosthesis (Group B), and two-stage breast reconstruction (Group C). The postoperative complications, BREAST-Q outcomes and reoperations were compared. Results: A total of 105 BC patients were enrolled and a total of 139 post-mastectomy breast reconstructions were performed. Seroma was the most prevalent complication observed: 8.3% in Group A, 2.9% in Group B and 5.7% in Group C. Postoperative infection occurred in two patients of Group A (5.6%), one patient of Group B (2.9%) and one of Group C (2.9%). Group A reported larger drain volume (1,125±243.5 cc), longer drain period (13.2±2.8 days), and the lowest incidence of capsular contracture (5.6%). The BREAST-Q patient-reported outcome measures document that all patients aged ≥50 years presented a higher score in "Satisfaction with breast" (P<0.001) and "Satisfaction with outcome" domains (P<0.05). Performing a bilateral breast reconstruction was associated to higher scores in "Physical wellbeing chest domain" (P<0.05). In addition, patients in Group A and Group B reported higher score in "Satisfaction with the breast" domain (P<0.001) but only in Group B we reported a higher score in "Satisfaction with outcome" (P<0.001). Conclusions: Subpectoral IBR results in manageable complications and greater personal satisfaction. The ADM could improve breast reconstruction reducing the rate of capsular contracture. The prepectoral placement of ADM could minimize complications and optimize aesthetic results.

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PURPOSE: Acute nipple inversion can be unsettling for patients and is sometimes associated with an underlying breast malignancy. It also poses a diagnostic challenge with lack of consensus management guidelines. This study reviewed institutional experience with new nipple inversion, including malignant association, imaging utilization, and outcomes, in an effort to improve management. METHODS: A multisite institutional retrospective review was conducted of all breast imaging reports from 1/2010 to 6/2022 mentioning nipple inversion as an indication or finding. Patients with new nipple inversion, defined as arising since the time of last breast imaging exam or if reported as new by the patient/provider, were included for analysis. Retroareolar imaging findings, BI-RADS assessments/recommendations, pathology obtained from percutaneous or excisional biopsies, and follow-up imaging and clinical exams were collated. Cases of chronic or stable nipple inversion were excluded. Descriptive statistics were performed. RESULTS: A total of 414 patients had new nipple inversion, 387/414 (93.5 %) with benign or negative results at initial imaging and 27/414 (6.5 %) with malignant lesions. Diagnostic mammography/ultrasound detected 25/27 (92.6 %) cancers (sensitivity 92.6 %, specificity 75.5 %, PPV 20.8 %, NPV 99.3 %). Of 62 breast MRI exams performed in patients with negative mammogram/ultrasound, no cancers were detected in the retroareolar space with 2 incidental malignant lesions discovered distant from the nipple. CONCLUSION: Diagnostic mammography/ultrasound is reliable in workups of acute nipple inversion, with a high sensitivity and NPV for excluding malignancy. Breast MRI and surgical referral should be reserved for patients with suspicious associated symptoms or clinical findings.

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Nipple adenomas are rare, benign breast lesions that present similarly to breast malignancies, often manifesting with unilateral bloody discharge, a palpable mass, and/or nipple distortion. Imaging techniques have limited specificity in distinguishing nipple adenomas from malignancy; therefore, clinicians must rely on histologic and immunohistochemistry evaluation. Here, we highlight the case of a 69-year-old woman with bilateral nipple adenomas presenting as an enlarging nipple mass with chronic nipple discharge. Complete lesion resection with clear margins stands as the primary route of management and complete avoidance of re-occurrence. However, partial excision with nipple preservation has been reported to be successful in selected cases.

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AIM: To describe the timing and characteristics of midwives' hands-on interruptions of newborns' behavior while in skin-to-skin contact during the first hour after birth and to elucidate the relationship between these hands-on interruptions and the incidence of nipple pain during the first 4 days postpartum. METHODS: An observational pilot study was conducted at a Baby-Friendly® hospital in Japan from 2016 to 2018. Iterative analysis of video recordings from a larger study of the behavior of newborns while skin-to-skin with their mothers in the first hour after birth found 16 full-term newborns who were born vaginally and that met the inclusion criteria of a midwife's hands-on intervention (HOI) interrupting the infant's progress toward breast self-attachment. The timing of the HOI and the stage of the newborn's progress through Widström's 9 Stages was noted by two research assistants who had been blinded to the medical records. The degree of nipple pain after breastfeeding was self-evaluated by mothers each day during their hospitalization. All data were statistically analyzed. RESULTS: Interrupting the infant's progressive behaviors in the first hour after birth by midwives' hands-on "help" to breastfeed,  may increase nipple pain during the 4 days after birth. One hundred percent of the mothers reported nipple pain in the postpartum with the highest pain reports occurring on day 4. CONCLUSION: Interrupting skin-to-skin contact with HOI does not decrease the incidence of nipple pain during the first days postpartum. HOI for newborn infants was not shown to support breastfeeding in the early postnatal period.

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Background The purpose of this study was to clarify fading, red, green, and blue values (RGB) change, and color reproducibility for nipple-areola complex (NAC) tattoos. Methods NAC tattooing was performed on 60 sites in 59 Japanese patients prospectively. The evaluation was assessed using digital photo, Casmatch standardization, and RGB and luminance values preoperatively, immediately after, 1 week, 1, 3, 6, and 12 months after tattooing. RGB and luminance values changes over time, time-adjusted fading rate, and the rate of luminance at 12 months were calculated. In color reproducibility study ( n = 34), RGB values after 12 months were compared with the color sample about dark/reddish and light/less reddish pigments. Results RGB varied widely from immediately after to 1 month after tattooing. For RGB and luminance, significant differences were seen between pre and immediate after, 1 and 3 months, 3 and 6 months, and 6 and 12 months. In G values, significant differences were seen between all neighboring points. The fading rate tended to decrease as time progresses, but was not significant, that is, fading continued even between 6 and 12 months. Luminance was 9% brighter than contralateral NAC at 12 months. Color reproducibility tended to be higher with dark/reddish pigments, despite no significant differences. Conclusion The fading rate of tattooed NACs tended to decrease as time progresses, but fading still occurs between 6 and 12 months. Luminance was 9% brighter than contralateral NAC at 12 months after.

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The unitary mammary gland is a synapomorphy of therian mammals and is thought to have evolved from the pilosebaceous organ in the mammalian stem lineage from which the lactogenic patch of monotremes is also derived. One of the key lines of evidence for the homology of the nipple and the lactogenic patch is that marsupials have retained a transient hair associated with developing mammary glands. However, these structures have not been documented since the early 20th-century drawings of Ernst Bresslau. In this study, we examine the developing mammary organs of Monodelphis domestica and document the presence of mammary hairs in 12-week-old females, as well as their absence after 18 weeks of age. Histochemical staining for cystine confirms the structures as keratinized hairs. Milk ducts of both juvenile and adult nipples show a division between KRT18+ luminal epithelium and KRT14+ ACTA2+ myoepithelium. These patterns match those in eutherians and suggest a conserved ductal morphology and mechanism of milk expulsion. Finally, PTHLH, a peptide hormone which promotes homeotic transformation of hairy skin into hairless nipples in the mouse, was detected in the Monodelphis milk duct during the mammary hair stage, suggesting that the mutual exclusivity of "hairless nipple" and "hair" organ identity is derived in eutherian mammals. These results reveal shared characteristics of the M. domestica nipple with both the eutherian nipple and the pilosebaceous organ, consistent with the evolutionary derivation of the mammary gland from an ancestral hair organ via developmental individualization of pilosebaceous and mammary identities.

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Nipple reduction is a well-established procedure that is widely used and can improve the self-confidence of male transgender individuals. The nipple reduction procedure in male transgender individuals differs from that in cisgender females due to a greater disparity in postoperative nipple sizes compared to preoperative sizes. Flaps used in male transgender nipple reduction should be simple to avoid skin necrosis. We present the nipple reduction of a 25-year-old male transgender patient using the mushroom technique. A 6 mm circular line was drawn at the most prominent part of the apex of the nipple. Another circular line was created at the base of the nipple. The skin and subcutaneous tissue were removed. The original diameter of the nipple was reduced. The two circular lines were re-approximated and sutured. Both right and left nipple height was 7 mm, and the width of the right and left nipple was 12 and 13 mm, respectively. The new nipple height and width of both sides at six months postoperative were 3 mm and 6 mm, respectively. The nipples were healed uneventfully, and the patient reported high satisfaction and self-confidence. This method can be used as a promising alternative to previously described techniques.

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KCTD family proteins typically assemble into cullin-RING E3 ligases. KCTD1 is an atypical member that functions instead as a transcriptional repressor. Mutations in KCTD1 cause developmental abnormalities and kidney fibrosis in scalp-ear-nipple syndrome. Here, we present unexpected mechanistic insights from the structure of human KCTD1. Disease-causing mutation P20S maps to an unrecognized extension of the BTB domain that contributes to both its pentameric structure and TFAP2A binding. The C-terminal domain (CTD) shares its fold and pentameric assembly with the GTP cyclohydrolase I feedback regulatory protein (GFRP) despite lacking discernible sequence similarity. Most surprisingly, the KCTD1 CTD establishes a central channel occupied by alternating sodium and iodide ions that restrict TFAP2A dissociation. The elucidation of the structure redefines the KCTD1 BTB domain fold and identifies an unexpected ion-binding site for future study of KCTD1's function in the ectoderm, neural crest, and kidney.

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BACKGROUND: More than 1 million women have their labor induced in the United States each year, and synthetic oxytocin infusion is the most common method used. However, compared to spontaneous labor, medical induction is resource intensive, has increased obstetric risks, and is associated with less successful breastfeeding. In contrast to the endogenous oxytocin hormone, which is released in a pulsatile fashion in the brain, synthetic oxytocin is continuously infused intravenously, resulting in important limitations related to efficacy, safety, and cost. Akin to spontaneous labor contractions, infant suckling of the breast nipple is known to stimulate the pulsatile release of endogenous oxytocin from the posterior pituitary gland. Nipple stimulation therapy via an electric breast pump similarly stimulates endogenous oxytocin release and may be a favorable inpatient method for patients undergoing labor induction. OBJECTIVE: This study aims to examine whether inpatient nipple stimulation therapy is an efficacious labor induction method that increases the likelihood of spontaneous vaginal delivery and sustained breastfeeding and determine whether it is a cost-effective approach. METHODS: This is a multicenter, pragmatic, open-label, parallel-group randomized controlled trial of nulliparous patients with singleton gestations ≥36 weeks undergoing labor induction. This trial compares inpatient nipple stimulation therapy via an electric breast pump versus immediate synthetic oxytocin infusion without nipple stimulation. This trial including 988 nulliparas will provide adequate statistical power to detect clinically meaningful differences in delivery mode and breast milk as the sole source of nutrition for newborns at hospital discharge or 72 hours after birth. RESULTS: The project received pilot funding in 2021 and full funding in 2023. Enrollment for this study began in November 2021 at a single site, and as of May 2024, recruitment is underway at 3 study sites. It is anticipated that enrollment will be completed by late 2026. CONCLUSIONS: Successful completion of this trial will provide rigorous data to determine whether inpatient nipple stimulation therapy with an electric breast pump can improve the way we induce labor and positively impact breastfeeding success and early infant nutrition through lactation. TRIAL REGISTRATION: ClinicalTrials.gov NCT05079841; https://clinicaltrials.gov/study/NCT05079841. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63463.

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Members of the KCTD protein family play key roles in fundamental physio-pathological processes including cancer, neurodevelopmental/neuropsychiatric, and genetic diseases. Here, we report the crystal structure of the KCTD1 P20S mutant, which causes the scalp-ear-nipple syndrome, and molecular dynamics (MD) data on the wild-type protein. Surprisingly, the structure unravels that the N-terminal region, which precedes the BTB domain (preBTB) and bears the disease-associated mutation, adopts a folded polyproline II (PPII) state. The KCTD1 pentamer is characterized by an intricate architecture in which the different subunits mutually exchange domains to generate a closed domain swapping motif. Indeed, the BTB of each chain makes peculiar contacts with the preBTB and the C-terminal domain (CTD) of an adjacent chain. The BTB-preBTB interaction consists of a PPII-PPII recognition motif whereas the BTB-CTD contacts are mediated by an unusual (+/-) helix discontinuous association. The inspection of the protein structure, along with the data emerged from the MD simulations, provides an explanation of the pathogenicity of the P20S mutation and unravels the role of the BTB-preBTB interaction in the insurgence of the disease. Finally, the presence of potassium bound to the central cavity of the CTD pentameric assembly provides insights into the role of KCTD1 in metal homeostasis.

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BACKGROUND: Surgeons meticulously perform breast reductions, while ensuring vascular integrity of the pedicle and Nipple-Areolar complex (NAC) to prevent any complication. It is crucial to remember that loss of sensation is also substantial complication, mainly due to unique characteristic features of the NAC. This study aimed to compare early and long-term sensory results by performing topographic analysis of NAC sensation after superomedial pedicle breast reduction. METHODS: A prospective study was conducted by including nonrandomized female patients who underwent breast reduction surgery with wise pattern excision superomedial pedicle technique between January 2019 and June 2022. Semmes-Weinstein Monofilament (SWM) test performed at preoperatively, 3-6 months and 15-18 months postoperatively. NAC complex was divided into four equal quadrants and nipple: superomedial (SM), inferomedial (IM), inferolateral (IL), superolateral (SL) and Nipple (N). Touch-Test® Sensory Evaluator Chart was used to evaluate sensory results. RESULTS: None of the patients had any loss of sensation during preoperative SWM test. In postoperative 3-6 months, statistically significant differences were observed between N and SL (p = 0.002), SL and IM (p < 0.05), SM and IM (p < 0.05). In postoperative 15-18 months, there was no difference between the quadrants and nipple (p = 0.07). In early and long-term comparisons of the same quadrants, IL less pronounced than other quadrant comparisons (p = 0.034). A statistical difference was observed in overall NAC score (p < 0.05). CONCLUSIONS: It would be beneficial to inform patients overall NAC sensation in the postoperative may not be as good as preoperative, there might be variations in NAC sensation across different quadrants in early period. 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 .

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Breast complaints are frequent reasons for consultations in primary care or breast clinics. Breast pain, breast lumps, and nipple discharge are the most common complaints. Less common symptoms such as skin changes and axillary abnormalities also require specific diagnostic approaches. Imaging the symptomatic breast should be performed by appropriately trained breast radiologists following the best practice guidelines and quality standards. Full-field digital mammography (FFDM), digital breast tomosynthesis (DBT), and breast ultrasound (US) are the main modalities used in this primary setting. The choice depends on the patient's age and symptoms. Women younger than 30-years-old are first imaged by US, whereas women over 40-years-old usually require both FFDM or DBT and US. For women between 30-years-old and 40-years-old, the US is the modality of choice, whereas FFDM or DBT might also be performed if needed. Pregnant or lactating women with palpable lesions or nipple discharge are imaged with US as the first method; FFDM or DBT can also be performed depending on the degree of suspicion as the dose to the fetus is minimal, and shielding may even further reduce the dose. More advanced techniques such as breast magnetic resonance imaging or contrast-enhanced mammography are not indicated in this first diagnostic setting and are reserved for cases of established malignancy (local staging) or rare cases of equivocal findings not otherwise resolved or inflammatory breast cancer. Last, but not least, male breast symptoms should also be addressed with US and/or FFDM. CLINICAL RELEVANCE STATEMENT: It is equally important to correctly diagnose an underlying malignancy and to avoid false positives that would lead to unnecessary biopsies, increased costs, and anxiety for the patient. Proper use of imaging modalities ensures optimal diagnostic approach and minimizes false negatives. KEY POINTS: Ultrasound, full-field digital mammography, or digital breast tomosynthesis are the main imaging modalities in the diagnostic setting, while MRI or contrast-enhanced mammography should be reserved to selected cases. Initial imaging modality includes ultrasound combined with mammography or digital breast tomosynthesis depending on women's age and the presence (or not) of inconclusive findings. A negative imaging evaluation should not deter biopsy when a highly suspicious finding is found on physical examination.

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Hyperplasia of mammary glands (HMG) is considered a precancerous condition with a risk of malignant transformation, highlighting the necessity of proactive treatment in the early stages. Transdermal drug delivery offers significant advantages such as painlessness, absence of first-pass effect, and good patient compliance. However, the unique structure of the breast requires transdermal formulations for treating mammary hyperplasia to exhibit higher levels of safety and comfort. We have formulated an ancient topical formula called 'Muxiang Bing,' comprising traditional Chinese medicines Aucklandiae Radix (AR) and Rehmanniae Radix (RR), for the treatment of HMG. This formula has been transformed into a gel paster in the form of nipple cover for trans-nipple-areola delivery. In our investigations, we observed that the optimal formulation of the Muxiang gel plaster demonstrated enhanced permeation facilitated by AR's effect on RR. Furthermore, pre-treatment with the Muxiang gel plaster improved mammary tissue morphology, hormone levels, oxidative stress, aberrant cell proliferation, and damage in rat models, thus preventing and ameliorating mammary hyperplasia. The Muxiang gel plaster exhibited low skin irritability in rats, and long-term use did not cause harm to their internal organs or blood cells, indicating its safety and efficacy.

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