Breast Implants Research Articles

Increasing the Safety of Patients Undergoing Breast Implant Surgery Using an Electronic Health Record Enhancement.

Breast implant surgery is a popular plastic surgery procedure performed worldwide. Despite its global popularity, patients undergoing breast implant surgery are at risk for systemic illness and more than one form of cancer. We conducted a nursing workflow analysis at our facility and determined that it is not standard practice to screen patients for the presence or absence of breast implant devices at every health care encounter. This lack of screening for breast implant devices may adversely affect patient safety by hindering the rapid identification of systemic illness or cancer related to breast implant devices and delaying effective medical intervention. Based on the results of the workflow analysis, we initiated a formal call for nursing action. We identified a nursing workflow process to increase patient safety and developed a universal screening tool for implantable devices. We defined universal screening for implantable devices as assessing all patients for the presence or absence of an implantable device, specifically breast implant devices, at every health care encounter. Implementing a universal process for screening patients for implantable devices at every health care encounter can be easily formulated into a policy and procedure and/or an electronic health record (EHR) update or enhancement. This article discusses how we utilized a workflow process map to translate universal screening for implantable devices into an EHR enhancement.

Combined superior and inferior dermoglandular flaps for projection enhancement in giantic breast amputation and free nipple areola graft

Giantomastia has been a pathological condition in which excised breast tissue weighs more than1.5 kg per breast or when breast weight surpasses three percent of body weight. epidermis & Cooper's ligaments, which support breast tissue, expand as a result of breasts becoming heavier & larger, which causes breast ptosis. Numerous methods for correcting gigantomastia have been discovered. amputation for decreased studied cases who complain of gigantomastia & severe ptosis (space among nipple & inframammary fold exceeds twenty-five cm) are only eligible for mammaplasty with free nipple-areola grafting. purpose of that surgery is to achieve breast shape size that is acceptable while also relieving pain & suffering brought on by excessive breast tissue hypertrophy. flat, boxy breasts with poor projection is the main drawback of that treatment. Several flaps, including superior, inferior, medial, superomedial,& lateral-based flaps combined with wise-pattern skin excision, are employed to address this drawback.

Assessing Readability of US Food and Drug Administration-Required Labeling for Breast Implants.

Assessing Readability of US Food and Drug Administration-Required Labeling for Breast Implants.

Spontaneous Fracture of a Silicone Implant: A Delayed Complication of Rhinoplasty.

Silicone implants are commonly used alloplastic materials for rhinoplasty in Asia, as they are easy to manipulate, provide adequate volume augmentation, and exhibit excellent biocompatibility. However, they are associated with complications such as infection, displacement, and extrusion. Recently, we encountered an interesting complication in a 53-year-old woman presenting with palpable and visible stepping of the nasal dorsum. The patient had previously undergone rhinoplasty with an L-shaped silicone implant, and symptoms had been noticeable for approximately 1 year. Lateral nasal computed tomography revealed a fractured silicone implant. Because the patient reported no history of nasal trauma since rhinoplasty, we assumed that the silicone implant might have fractured spontaneously. The findings in this case suggest that spontaneous implant fracture can be a late complication of rhinoplasty with silicone implant.

Rupture of 40-year-old silicone gel breast implants: a case report

BackgroundImplant rupture is one of the complications of breast augmentation surgery. The rupture of silicone implants is often insidious, potentially causing problems at any time. This is a case report of the rupture of 145-cc breast implants manufactured by Dow Corning Corporation and their removal at 40 years after augmentation.Case PresentationA 70-year-old female patient was admitted for the removal of a lump in the upper and inner quadrants of the right breast. After a detailed examination, a rupture of the bilateral breast implants was diagnosed. Explantation without replacement was performed; the entire procedure proceeded smoothly. Immunohistochemical staining revealed siliconoma with lymphoid hyperplasia and calcification in the bilateral breasts with no signs of malignancy.ConclusionsSilicone breast augmentation is one of the most popular aesthetic surgical procedures worldwide. Therefore, it is important to educate patients on the need for close monitoring of their implants after augmentation through magnetic resonance imaging or ultrasound to facilitate early detection of any changes before a rupture occurs. Early detection of the implant rupture, in turn, will facilitate early and effective management.

Prevalence of women with breast implants in Sweden: a study based on the population-based mammography screening programme.

Knowledge about the prevalence of women with breast implants is paramount in calculations of risks and in estimations of effects on screening and breast cancer treatment. Most of the estimations of prevalence made to date are rough and often based on sales data. The main aim of this study was to calculate the prevalence of breast implants in Swedish women. The secondary aim was to investigate if it is feasible to establish the occurrence of breast implants with the help of the public mammography screening programme, in a country with a publicly funded welfare-type healthcare system and with a clear documentation of screening. Information on implants was prospectively collected from all screening attendants from 1st of February 2022 to 1st of August 2022 based on a question from the radiographer to the woman and later verified on the mammogram. During the study period 4,639 women were screened, of which 182 had implants (3.9%). The frequency varies between 1.6 and 6.4% in different age groups. The prevalence of breast implants in Swedish women is estimated to be around 4%. The population-based mammography screening programme in countries with a publicly funded welfare-type healthcare system and a clear documentation of mammography screening attendance, seems to be a feasible way to establish the prevalence of breast implants in the population. The large number of women with breast implants warrants further studies regarding the best diagnostic and treatment alternatives for this group. Pre-registration: ClinicalTrials.Gov identifier NCT05222100.

Functionalization of breast implants by cyclodextrin in-situ polymerization: a local drug delivery system for augmentation mammaplasty.

Mammaplasty is a widely performed surgical procedure worldwide, utilized for breast reconstruction, in the context of breast cancer treatment, and aesthetic purposes. To enhance post-operative outcomes and reduce risks (hematoma with required evacuation, capsular contracture, implant-associated infection and others), the controlled release of medicaments can be achieved using drug delivery systems based on cyclodextrins (CDs). In this study, our objective was to functionalize commercially available silicone breast implants with smooth and textured surfaces through in-situ polymerization of two CDs: β-CD/citric acid and 2-hydroxypropyl-β-CD/citric acid. This functionalization serves as a local drug delivery system for the controlled release of therapeutic molecules that potentially can be a preventive treatment for post-operative complications in mammaplasty interventions. Initially, we evaluated the pre-treatment of sample surfaces with O2 plasma, followed by chitosan grafting. Subsequently, in-situ polymerization using both types of CDs was performed on implants. The results demonstrated that the proposed pre-treatment significantly increased the polymerization yield. The functionalized samples were characterized using microscopic and physicochemical techniques. To evaluate the efficacy of the proposed system for controlled drug delivery in augmentation mammaplasty, three different molecules were utilized: pirfenidone (PFD) for capsular contracture prevention, Rose Bengal (RB) as anticancer agent, and KR-12 peptide (KR-12) to prevent bacterial infection. The release kinetics of PFD, RB, and KR-12 were analyzed using the Korsmeyer-Peppas and monolithic solution mathematical models to identify the respective delivery mechanisms. The antibacterial effect of KR-12 was assessed against Staphylococcus epidermidis and Pseudomonas aeruginosa, revealing that the antibacterial rate of functionalized samples loaded with KR-12 was dependent on the diffusion coefficients. Finally, due to the immunomodulatory properties of KR-12 peptide on epithelial cells, this type of cells was employed to investigate the cytotoxicity of the functionalized samples. These assays confirmed the superior properties of functionalized samples compared to unprotected implants.

A Case of Isolated Morphea Secondary to Silicone Breast Implantation

A Case of Isolated Morphea Secondary to Silicone Breast Implantation

Silicone Shell Breast Implants in Patients Undergoing Risk-Reducing Mastectomy With a History of Breast-Conserving Surgery and Adjuvant Radiotherapy: A Long-term Study.

Indications for breast-conserving surgery and adjuvant radiotherapy (BCSAR) in patients with breast carcinoma are increasing, as are indications for risk-reducing mastectomy (RRM) in healthy subjects. Most of these cases are reconstructed with silicone shell breast implants (SSBIs). The aim of this work was to study complications of SSBIs in breast reconstruction in patients undergoing RRM with previous BCSAR. A prospective cohort study was designed. The study group included cases of RRM reconstructed with SSBI in patients who had previously undergone BCSAR in the same breast. The control group consisted of patients with high-risk breast cancer who had undergone RRM and immediate SSBI reconstruction without previous BCSAR. There was a history of BCSAR in 15.8% of cases. The first SSBI used in immediate reconstruction after RRM was replaced in 51.5% of cases with a mean [standard deviation] survival of 24.04 [28.48] months. BCSAR was significantly associated with pathological capsular contracture (P = .00) with this first SSBI (37.5% vs 5.9%). Of the cases requiring the replacement of the first SSBI, 44.23% suffered failure of the second SSBI, with a mean survival of 27.95 [26.53] months. No significant association was found between the consecutive development of capsular contracture in the second SSBI and a previous history of BCSAR (P = .10). BCSAR prior to RRM reconstructed with an SSBI is associated with a significant increase in pathological capsular contracture. Patients should be warned of the high rate of SSBI complications and reconstruction failure. Polyurethane-coated implants may provide an alternative in cases in which alloplastic reconstruction is considered in patients with previous BCSAR.

Breast silicone implants' pericapsular impairment: current underdiagnosed status.

Many complications related to silicone implants have been reported recently, from clinical symptoms manifestations to association with some specific types of cancer. During the early 2010s, it was believed that implants were biocompatible and inert to the human body and that gel bleeding/leakage events were rare and without repercussions for the human body. However, at the end of 2010s, several studies pointed out that gel bleeding was more frequent than previously believed, and the pathogenic potential of free silicone should not be ignored. The Food and Drug Administration recommends performing magnetic resonance imaging in asymptomatic patients 5-6 years after implant placement. The descriptors in the Breast Imaging and Reporting Data System lexicon seem outdated for classifying the new generations of implants with cohesive gel, which hinders the diagnosis of device complications. In this review, supported by our research data publications related to silicone implants for 6 years on a prospective study protocol, most of them being original articles, we summarized the main complications observed in clinical practice and discuss the impact of these changes on patients' outcomes focusing on the pericapsular space.

A Systematic Review of Breast Implant-Associated Squamous Cell Carcinoma.

Breast augmentation is considered safe, but rare cases of breast implant-associated squamous cell carcinoma (BIA-SCC) have been reported. This study aimed to systematically review published cases of BIA-SCC, providing valuable clinical data. The review included 14 articles and 18 cases of BIA-SCC. An increasing trend in reported BIA-SCC cases was observed, with four cases in the 1990s and 14 cases since 2010. The mean age of affected patients was 56 years, and symptoms typically appeared around 21 years after breast augmentation. Silicone implants used in cosmetic procedures were most commonly associated with BIA-SCC. Implant removal was necessary in all cases, and some patients required a mastectomy. Treatment approaches varied, with the selective use of chemotherapy and/or radiotherapy. The estimated 6-month mortality rate was 11.1%, while the 12-month mortality rate was 23.8%. The estimated 6-month mortality rate should be cautiously interpreted due to the limited sample size. It appears lower than the rate reported by the American Society of Plastic Surgeons, without clear reasons for this discrepancy. This study highlights the importance of enhanced monitoring and information sharing to improve detection and management of BIA-SCC. Healthcare providers should maintain vigilance during the long-term follow-up of breast augmentation patients.

Horizontal pillar technique: A single pedicle septum-based approach in reduction mammaplasty with a twist

Breast reduction surgery has proven to be a successful treatment for various conditions such as postural disorders, anxiety, dermatological problems, and body image disorders, and is tailored to accommodate each patient's needs and anatomical variations. The author presents a modified approach for reduction mammaplasty using a septum-based superomedial pedicled nipple-areola complex (NAC) flap combined with horizontal dermoglandular pillars. This adjustment enhances desired breast projection, potentially eliminating the need for alternative pedicles in most cases. The limitations and disadvantages of this new technique are discussed. Between July 2015 and July 2021, 85 patients underwent surgery using the horizontal pillar reduction mammaplasty. Clinical data obtained during follow-up visits were recorded. Patients were asked to answer the local version of the Breast-Q, version 2.0, reduction module postoperative scale questionnaire to evaluate breast shape contentment and patient satisfaction at the 1-year follow-up. Necrosis of the NAC was not observed in any patient. The most common complaints in the early postoperative period were pain along the inframammary fold and swelling that extended into the axillary region. The mean values and standard deviations of the postoperative Breast-Q scores were calculated. The postoperative satisfaction with breasts scale mean value was 84.11±12.86, and the postoperative satisfaction with outcomes scale mean value was 81.08±9.97. The horizontal pillar reduction mammaplasty technique is safe, reliable, and easy to perform in breast reduction. Although the initial findings are encouraging, future anatomical and clinical studies are necessary to fully explore this modified technique's functional limitations and long-term outcomes.

Transcriptomic and machine learning analyses identify hub genes of metabolism and host immune response that are associated with the progression of breast capsular contracture

Capsular contracture is a prevalent and severe complication that affects the postoperative outcomes of patients who receive silicone breast implants. At present, prosthesis replacement is the major treatment for capsular contracture after both breast augmentation procedures and breast reconstruction following breast cancer surgery. However, the mechanism(s) underlying breast capsular contracture remains unclear. This study aimed to identify the biological features of breast capsular contracture and reveal the potential underlying mechanism using RNA sequencing. Sample tissues from 12 female patients (15 breast capsules) were divided into low capsular contracture (LCC) and high capsular contracture (HCC) groups based on the Baker grades. Subsequently, 41 lipid metabolism-related genes were identified through enrichment analysis, and three of these genes were identified as candidate genes by SVM-RFE and LASSO algorithms. We then compared the proportions of the 22 types of immune cells between the LCC and HCC groups using a CIBERSORT analysis and explored the correlation between the candidate hub features and immune cells. Notably, PRKAR2B was positively correlated with the differentially clustered immune cells, which were M1 macrophages and follicular helper T cells (area under the ROC = 0.786). In addition, the expression of PRKAR2B at the mRNA or protein level was lower in the HCC group than in the LCC group. Potential molecular mechanisms were identified based on the expression levels in the high and low PRKAR2B groups. Our findings indicate that PRKAR2B is a novel diagnostic biomarker for breast capsular contracture and might also influence the grade and progression of capsular contracture.

Artificial intelligence for breast cancer detection in screening mammography in Sweden: a prospective, population-based, paired-reader, non-inferiority study

Artificial intelligence (AI) as an independent reader of screening mammograms has shown promise, but there are few prospective studies. Our aim was to conduct a prospective clinical trial to examine how AI affects cancer detection and false positive findings in a real-world setting. ScreenTrustCAD was a prospective, population-based, paired-reader, non-inferiority study done at the Capio Sankt Göran Hospital in Stockholm, Sweden. Consecutive women without breast implants aged 40-74 years participating in population-based screening in the geographical uptake area of the study hospital were included. The primary outcome was screen-detected breast cancer within 3 months of mammography, and the primary analysis was to assess non-inferiority (non-inferiority margin of 0·15 relative reduction in breast cancer diagnoses) of double reading by one radiologist plus AI compared with standard-of-care double reading by two radiologists. We also assessed single reading by AI alone and triple reading by two radiologists plus AI compared with standard-of-care double reading by two radiologists. This study is registered with ClinicalTrials.gov, NCT04778670. From April 1, 2021, to June 9, 2022, 58 344 women aged 40-74 years underwent regular mammography screening, of whom 55 581 were included in the study. 269 (0·5%) women were diagnosed with screen-detected breast cancer based on an initial positive read: double reading by one radiologist plus AI was non-inferior for cancer detection compared with double reading by two radiologists (261 [0·5%] vs 250 [0·4%] detected cases; relative proportion 1·04 [95% CI 1·00-1·09]). Single reading by AI (246 [0·4%] vs 250 [0·4%] detected cases; relative proportion 0·98 [0·93-1·04]) and triple reading by two radiologists plus AI (269 [0·5%] vs 250 [0·4%] detected cases; relative proportion 1·08 [1·04-1·11]) were also non-inferior to double reading by two radiologists. Replacing one radiologist with AI for independent reading of screening mammograms resulted in a 4% higher non-inferior cancer detection rate compared with radiologist double reading. Our study suggests that AI in the study setting has potential for controlled implementation, which would include risk management and real-world follow-up of performance. Swedish Research Council, Swedish Cancer Society, Region Stockholm, and Lunit.

Rotational gland dissection for refractory granulomatous mastitis: A single-center retrospective study

BackgroundRefractory granulomatous mastitis (RGM) is a chronic benign breast disease that commonly occurred in women of childbearing age and is usually treated with surgery, with numerous cases suffering from unsatisfied postoperative recovery of breast shape, high rates of surgical complications, and even high recurrence. This study tries to evaluate the efficacy of an innovative surgical procedure, the rotational gland dissection for the treatment of RGM. Methods129 patients with RGM who underwent surgical treatment at the Second Affiliated Hospital of Xi'an Jiaotong University between Apr. 2017 and May. 2021 were retrospectively included in this study. The article analyzed the age, local symptoms, lesion location, and size, days in hospital, recurrence rate, and satisfaction rate of the patients. ResultsPatients ranged in age from 19 to 58 years, with a median age of onset of 32 years. In 63 patients (48.84%), their lesions coverage exceeded two quadrants, and 52.71% of patients had lesions larger than 10 cm2. The average days in hospital of patients was 7.5 days, and 85.27% of them were satisfied with their post-surgery breast appearance. Within the median follow-up of 56 months, only 3.10% of patients experienced a recurrence of mastitis on the operation side. ConclusionThis novel surgical procedure we created is an effective treatment for RGM with a high success rate, high patient satisfaction, and low recurrence rate, and is significantly superior to other studies for it has the largest sample size and longest follow-up in this field.

Navigating Food and Drug Administration Mandated Breast Implant Patient Literature: A Call to Increase Equitable Healthcare Access Within Plastic Surgery.

In October 2021, the US Food and Drug Administration mandated patient decision checklists and new labeling for breast implants with the goal of improving the informed decision-making process for patients considering breast implantation. Given growing concerns over breast implant-associated anaplastic large cell lymphoma, breast implant-associated squamous cell carcinoma, and breast implant illness, patients should be able to easily review these resources to make a fully informed decision when considering surgery. This study seeks to elucidate the accessibility, and therefore the utility of the newly mandated literature for the average breast implant patient. Patient decision checklists and breast implant boxed warnings were obtained from the most used breast implant manufacturers in the United States-Allergan, Mentor, and Sientra. Readability analysis of all Food and Drug Administration required documents was performed using the Flesch Reading Ease Score, Flesch Kincaid Grade Level, Gunning-Fog Index, Coleman-Liau Index, Simplified Measure of Gobbledygook, and Automated Readability Index. The overall readability of all Allergan, Mentor, and Sientra patient materials correlates with a college reading level. Documents from all 3 implant manufacturers were of a statistically significantly higher reading level than that recommended by the American Medical Association and US Department of Health and Human Services. No materials were found to be at or below the recommended sixth-grade level. The newly mandated breast implant patient decision guides are written at a college reading level. These materials should be simplified to improve health literacy shared decision making.

Scaffold-guide breast tissue engineering: the future of breast implants

In this editorial the authors argue that a fresh approach to breast implant manufacture and materials is warranted.

Kite Mastopexy: Small Scar and Tissue-conserving Technique.

Breasts are considered one of the most physically and sexually appealing features of the female body. Reduction/augmentation techniques have greatly evolved in the last decades.We are reporting our experience with an innovative technique for mastopexy that recovers the aesthetics of the breast and avoids over-resection of its lower pole. Inclusion criteria were women who underwent kite mastopexy with or without implants between January 2018 and May 2022 in a single center (Bogota, Colombia). Exclusion criteria were patients with American Society of Anesthesiology score more than II, with any uncontrolled chronic illness and/or medical history of diabetic mellitus, metabolic syndrome, body mass index more than 32 kg per m2, and active smokers. We found 133 consecutive female patients. Age range was 18 and 67 years (median 39). Breast implants were used for the purpose of kite mastopexy in 52% cases. Patients were divided into two groups: implants (group 1) versus no implants (group 2). Procedure 1 involved mastopexy without implants; procedure 2 included current implant users who underwent either implant removal or in whom implants were not used for the sake of mastopexy. Procedures 3 and 4 included patients who underwent either new implant placement or implant exchange, respectively. Average time of surgery was 1.5 hours. Minor complications were mostly related to wound dehiscence. No major complications were reported. Kite mastopexy restores the breast aesthetics by following specific markings, a new plication of breast pillars, and a reduced scar. Our technique demonstrates a very low rate of complications while entailing natural and appealing results.

The Ergonomic FALD Flap for One-stage Total Breast Reconstruction.

The fat-augmented latissimus dorsi (FALD) flap combines this pedicled flap with immediate intraoperative fat transfer. Very little is described concerning its inset at the mammary site. Our efforts have concentrated on seeking the best flap orientation and skin-adipose paddle shaping, to improve the aesthetic outcome and to obtain a complete breast reconstruction (BR) in one stage. A prospective clinical study was performed in patients who underwent BR with FALD flaps, between December 2020 and March 2022. Patients were randomly enrolled into two groups: ergonomic inset of the FALD flap with vertical orientation of the skin-adipose paddle (group A) and FALD flap with traditional horizontal paddle orientation (group B). The study's endpoints were the evaluation of the aesthetic outcomes (from patients' and surgeon's perspectives) and complications. Thirty-two FALD flaps (23 patients) were performed for group A, and 31 FALD flaps (25 patients) for group B. The two groups were homogeneous in terms of demographic and surgical data (P > 0.05). The overall complication rate was homogeneous among the groups, without statistically significant differences (P = 1.00). The surgeon's assessments showed a statistically significant superior aesthetic outcome in group A regarding volume, symmetry, and shape (P < 0.05). Higher satisfaction was observed in group A patients, in terms of breast size (P < 0.00001), shape (P = 0.0049), and overall satisfaction (P = 0.00061). The ergonomic vertical FALD flap technique enables surgeons to perform one-stage total BR, with excellent breast projection and upper pole fullness. These refinements in flap shaping and molding reduced the need for further autologous fat transfer, obtaining a brilliant totally autologous BR without the need for microsurgical experience.

One-step Glandular Reconstruction after Breast Implant Removal: Technical Refinements and Grafting of the Inferior Dermoglandular Flap.

The number of breast implant removal procedures are rising. Among the reasons why patients seek breast implant removal, the autoimmune/inflammatory syndrome induced by adjuvants (ASIA), also named breast implant illness, is increasingly common. ASIA is an entity that incorporates diverse autoimmune conditions induced by the exposure to various adjuvants, including silicone, and it is characterized by systemic symptoms reminiscent of autoimmune disorders. Implant removal has the most effective treatment for ASIA. We describe a technique for glandular cone reconstruction after complete capsulectomy and implant removal. It combines an inverted-T superomedial pedicled mastopexy with fat grafting of the breast quadrants and of the inferior dermoglandular flap in two patients affected by ASIA. Implant removal allowed symptom resolution in both patients at 10 and 12 months follow-up. Both patients were satisfied with the aesthetic outcome after implant removal in terms of breast softness, projection, and volume. Our technique is easy, reproducible, and allowed for restoration of breast contour, volume, and shape after implant removal. Although initially conceived in patients with ASIA, this technique can be used for patients seeking implant removal for any indication.