- Research Article
76
- 10.1016/j.bjps.2012.02.019
The PIP mammary prosthesis: A product recall study
- Mar 09, 2012
- Journal of Plastic, Reconstructive & Aesthetic Surgery
- Mg Berry + 1 more +1
The PIP mammary prosthesis: A product recall study
Primary breast augmentation is one of the most commonly requested aesthetic procedures. Considering the large number of procedures performed in connection with a high demand, it is crucial to prevent complications. For this reason, finding and avoiding possible sources of complications is decisive. Between January 2010 and December 2021, 1625 female patients underwent an aesthetic breast augmentation performed by a single surgeon. The data collected were analyzed through a machine learning technique for binary recursive partitioning. This made it possible to detect unknown sources of a complication and determine a vertex for the various features. When analyzing the data, for most features a high importance score with low entropy was achieved, concluding a high significance. In addition, reproducibility was demonstrated through detailed testing and training accuracies in the algorithm. With this procedure, in addition to known risks such as a high BMI and round implant shape, a larger than A preoperative bra-cup size (OR: 2.7) and a taller body could also be identified as most significant influencing factors for complications. Preoperative breast size plays an exceptionally important role in the occurrence of complications and should be a factor held in a surgeon's considerations. In addition, this study shows ways to transfer artificial intelligence into plastic surgery to increase medical quality. 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 PIP mammary prosthesis: A product recall study
The PIP mammary prosthesis: A product recall study
Subfascial Transaxillary Breast Augmentation: Critical Evaluation of a 25-Year Review of 1015 Consecutive Cases.
Subfascial (SF) pocket breast augmentation (BA) has gained popularity, whereas the transaxillary approach (TAA) offers the benefit of an inconspicuous scar. Previous reports on both techniques involved limited follow-up/samples, and few clinical studies specifically address surgical technique and outcomes following primary and secondary BA. The purpose of this study was to assess outcomes from the SF TAA technique in a large series of patients who underwent primary and secondary BA. A retrospective cohort of patients who underwent BA between 1999 and 2024 was identified. The primary outcome was occurrence of incision and implant/pocket complications. Regression logistic analysis evaluated risk factors including age, body mass index, smoking, implant surface/volume, and fat grafting. The cohort contained 1015 patients (mean age, 28.5 ± 7.3 years), and the average follow-up was 77.6 ± 38.6 months. In primary BA, 212 patients (23.4%) experienced at least 1 complication, most frequently capsular contracture. More complications were seen in secondary BA ( P = 0.016). Multivariate regression identified body mass index less than 18.5 kg/m 2 as a significant risk factor for incision complications, whereas textured surface (OR, 2.70; P < 0.001) and implant volume greater than 350 cc (OR, 2.79; P < 0.001) were risk factors for implant/pocket complications. Despite extensive research on BA procedures, studies on SF TAA procedures are limited and have not analyzed long-term outcomes following primary/reoperative operations. These results demonstrate that SF TAA is a reliable technique, and the data are compatible with other studies using different BA approaches. Knowledge of the axillary and pectoralis fascia anatomy allows surgeons to safely implement the SF TAA technique and minimize risk. Therapeutic, III.
Read moreA Comprehensive Evaluation of Primary Breast Augmentation Education Videos for Surgical Trainees
Goals/Purpose Aesthetic breast augmentation surgeries were the second most common surgical aesthetic procedure in the US in 2023.1 In a survey of residents and 4th-year medical students, 95% reported using online videos as a tool to learn about surgical procedures, the majority citing YouTube as the most common source.2 While videos can be a crucial learning tool for trainees, it is important that these resources undergo a thorough evaluation to establish their educational value. While prior studies in the otolaryngology and general surgery literature have investigated the quality of surgical YouTube videos,3,4 no studies have examined the quality of videos related to breast augmentation. Thus, the objective of this study is to compare the quality of breast augmentation educational videos. Methods/Technique A total of 640 intraoperative primary breast augmentation YouTube videos and 3,527 videos published in the Journal of Plastic and Reconstructive Surgery (PRS) video gallery were screened using predefined search terms. With the help of 3 attending surgeons who routinely perform breast augmentation, a 14-point rubric was created to identify critical perioperative and intraoperative surgical criteria that should be included in educational videos regarding primary breast augmentation. Each video was also assessed on audiovisual quality. All included videos were graded on a binary scale by two independent reviewers and interrater reliability was assessed using Kappa’s coefficient. Statistical significance was defined as a P &lt; 0.05. Results/Complications A total of 11 Youtube videos, and 7 PRS videos met inclusion criteria. All PRS videos were deemed high quality, while only 45% of YouTube videos were rated as high quality. Moreover, the PRS videos were of a statistically significant higher quality than the YouTube videos, with an average score of 11.1 out of the 14 criteria compared to 9.0 respectively (P = 0.03). The videos posted to the academic video gallery were rated as higher quality in all three categories; audiovisual, perioperative and intraoperative criteria. The number of views, likes, duration, time since upload or channel subscribers were not strong predictors of the quality of YouTube videos. A high degree of interrater reliability was confirmed using Kappa's coefficient, with κ = 0.97. Conclusion This study found that the quality of surgical education videos on breast augmentation greatly varied from video to video within both Youtube and the PRS website. Videos within the peer-reviewed journal scored higher than those on Youtube. Trainees in prior studies have cited Youtube as a major source for educational content, and thus, are especially vulnerable to this low quality, as they may not be able to differentiate between good quality and inadequate content. Additionally, there was not a strong correlation with any of the commonly used metrics such as views and likes that a trainee might use to help identify higher quality content on Youtube. Thus, surgical trainees should use caution when deciding how to supplement their learning with online videos. A more reliable option for high quality surgical content is to watch videos posted to a peer-reviewed academic journal. Even with this, setting standards for video quality and essential criteria is useful for creating educational content through video content.
Read morePractice Patterns in Primary Breast Augmentation: A 16-Year Review of Continuous Certification Tracer Data from the American Board of Plastic Surgery.
As part of the continuous certification process, the American Board of Plastic Surgery collects case data for specific tracer procedures in aesthetic surgery to assess practice improvement by the diplomates. These case-based data provide valuable information on national trends in clinical practice. The current study was performed to analyze practice patterns in aesthetic primary breast augmentation. Breast augmentation tracer data were reviewed from 2005 to 2021 and grouped into an early cohort (EC), from 2005 through 2014, and a recent cohort (RC), from 2015 through 2021. Fisher exact tests and two-sample t tests compared demographic characteristics of the patients, surgical techniques, and complication rates. Patients in the RC were slightly older (34 versus 35 years; P < 0.001), more likely to have ptosis greater than 22 cm (20% versus 23%; P < 0.0001), less likely to smoke (12% versus 8%; P < 0.0001), and less likely to undergo a preoperative mammogram (29% versus 24%; P < 0.0001). From a technical standpoint, inframammary incisions have become more common (68% versus 80%; P < 0.0001), whereas periareolar incision use has decreased (24% versus 14%; P < 0.0001). Submuscular plane placement has increased (22% versus 56%; P < 0.0001), while subglandular placement has decreased (19% versus 7%; P < 0.0001). Silicone implants are most popular (58% versus 82%; P < 0.0001). Textured implant use increased from 2011 (2%) to 2016 (16%), followed by a sharp decline to 0% by 2021. Trends follow U.S. Food and Drug Administration approvals and warnings. This study highlights evolving trends in aesthetic breast augmentation over the past 16 years. The most common technique remains a smooth silicone prosthesis placed in the subpectoral plane through an inframammary incision.
Read moreNagor Impleo Round Silicone Gel Breast Implants: Early Outcome Analysis after 340 Primary Breast Augmentations.
For decades, implant-based breast augmentation has been one of the most performed surgical procedures for cosmetic purposes around the world. Hence, novel manufactured implants should be critically investigated to prove them safe and effective. Here, the authors describe the first independently conducted clinical study on Nagor Impleo textured round breast implants. For this retrospective study, outcomes of 340 consecutive female patients undergoing primary cosmetic breast augmentation were analyzed. Demographic and surgical data as well as outcomes and complications were evaluated. Furthermore, a survey concerning effectiveness and aesthetic satisfaction after breast augmentation was examined. All 680 implants were placed in a submuscular plane with incisions at the inframammary fold. The main indications for surgery were hypoplasia and hypoplasia with asymmetry. The mean implant volume was 390 cc and the main type of projection was high profile. The most common complications were hematoma and capsular contracture (0.9 percent, respectively). The overall revision rate for complications was 2.4%. Additionally, almost all patients showed increased quality of life and aesthetic satisfaction after a breast augmentation. Hence, all patients would undergo breast augmentation again with these newly launched devices. Nagor Impleo implants demonstrate a low complication rate and high safety profile. Although high aesthetic satisfaction and quality of life results were achieved, analysis of an even larger series over a longer period of time would be beneficial to evaluate the reliability of this implant.
Read morePatients' and Surgeons' Perceptions of Social Media's Role in the Decision Making for Primary Aesthetic Breast Augmentation.
Social media (SoMe) has evolved to be a platform that patients use to seek information prior to an operation, share perioperative and postoperative journey, provide feedback, offer and receive support. While there have been studies looking at the evolution and usage of SoMe either by patients or by surgeons, there is no information that compares its usefulness for both the groups. The aim of this study was to compare the views held by patients and surgeons, towards social media and other internet resources, in relation to one commonly performed operation. A questionnaire was presented to 648 consecutive patients who attended our clinic for consultation for primary breast augmentation from September 2016 to March 2017. A separate "surgeons' questionnaire" was answered by a group of 138 plastic surgeons who were either practicing in branches of our clinic, had previously done fellowship with us, or were visiting the clinic. All 138 surgeons and 648 patients responded to the questionnaire. A total of 91.4% of patients said that they had searched online and 61.4% had searched in specific online groups for information on breast augmentation. A total of 88.9% of patients had specifically looked for clinical photographs and 73.4% had specifically searched for unfavorable reviews of the surgeon. In comparison, 72.5% of surgeons thought that over three quarters of patients gather information on the internet while only 20.3% thought that over three quarters of patients use social media for their information. A total of 52.5% of surgeons have noticed that social media affected their consultations. With the evolution of the internet and related technologies, the role of social media continues to increase. While patients use social media to help make their decisions, it is not the only deciding factor. Surgeons appear to underestimate the patients' use of these technologies. There is concern in each group about the amount of inaccurate information on the social media. This underlines the importance of providing factual, evidence-based information to the patients.
Read moreGalactorrhea After Aesthetic Breast Augmentation With Silicone Implants: Report of Two Cases and Management of Postoperative Galactorrhea
Galactorrhea is a rare event after breast augmentation. The physiopathologic bases of galactorrhea depend on the central secretion of prolactin. These physiopathologic bases must be clearly understood for the prevention and treatment of postoperative galactorrhea. This report describes two cases of a postoperative galactorrhea after aesthetic breast augmentation with silicone implants. The clinical appearance closely resembles a postoperative sepsis without hyperthermia. Bacteriologic samples are negative. Endocrinologic examination finds a characteristic hyperprolactinemia. The evolution is favorable under dopaminergic agonists.
Read moreHow to prevent complications in breast augmentation.
No high-level evidences about the best technique or the best implant to use for obtaining the best outcomes in aesthetic breast augmentation, with low complications and re-interventions rates exist from available literature. In this paper we present the actual best evidence about the etiopathogenesis of main complications in aesthetic breast augmentation, identifying some basic rules to follow in order to reduce complication rates in our daily activity, minimizing re-interventions, obtaining long lasting results and high women's satisfaction levels.
Read moreAugmentation
Aesthetic breast augmentation with implants remains the single most popular and demanded aesthetic surgery when compared with the wide range of procedures breast plastic surgeons. Patients of a wide variety of ages and backgrounds seek breast augmentation. A subgroup of patients with a degree of body dysmorphic disorder may also present without any clinical or aesthetic objective rationale for breast augmentation and these have to be carefully detected to ensure that they are managed appropriately. All patients require a careful clinical examination and assessment following a thorough history that should include psychological background for seeking breast augmentation, a specific breast medical history as well as a general medical history, current medications and allergies. Coupled with this is an assessment regarding the infra-mammary crease, and whether this might change with breast augmentation, or indeed be lowered as part of the planning process.
Read moreEvaluation of a Technique to Minimize Complications in Breast Augmentation Surgery with Anatomical Implants: A Single Surgeon's, 10-Year Experience.
Breast augmentation surgery (BAS) is one of the commonest plastic surgery procedures worldwide. A long-standing debate on the use of anatomical implants versus round implants in terms of complications, especially implant rotation, monopolizes relevant bibliography in recent years. A retrospective cohort study was conducted. All patients' records undergoing primary breast augmentation with anatomical implants from January 2010 to December 2023 by a single surgeon (V.K.), who implemented a novel surgical technique, were assessed for eligibility. Patients' demographics, and preoperative and operative data were recorded. Statistical analysis was conducted using IBM® SPSS® Statistics version 25.0. In total, 622 patients underwent breast augmentation surgery with anatomical implants during the study period (median age 34years, median body mass index 22.3, median follow-up time 43.8months). Ten implants were rotated (0.8%) and correlated in univariate analysis with implant projection type (p=0.003). Twelve implants (0.96%) were complicated by capsular contracture, six (0.48%) by bottoming-out deformity, two patients (0.32%) developed a unilateral hematoma in the first 24h and one patient (0.16%) developed a double-bubble deformity. The use of the proposed surgical technique minimizes complication rates, making anatomical implants an optimal choice for breast augmentation surgery. 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 .
Read moreEfficacy of Acellular Dermal Matrix Type in Treatment of Capsular Contracture in Breast Augmentation: A Systematic Review and Meta-Analysis.
Capsular contracture is a known complication of breast augmentation and is among the top reasons for revisional breast augmentation procedures. The use of acellular dermal matrix (ADM) has been shown to reduce the rate of capsular contracture in breast reconstruction and augmentation, theorizing that it acts as a protective barrier between the implant capsule and inflammatory process responsible for capsular contracture. The role of ADM in treatment of capsular contracture has been investigated in numerous studies, with a variety of ADMs. The aim of this study was to perform a systematic review of existing literature on the use of ADM for treatment of capsular contracture in aesthetic breast augmentation patients to investigate differences in efficacy of ADM types. The PubMed, Embase, and CINAHL databases were systematically reviewed for articles pertaining to capsular contracture, acellular dermal matrices, and breast augmentation. Number of patients, type of ADM, Baker grade, follow-up time, complication rate, and capsular contracture rate were recorded from identified articles. Data was pooled from studies to calculate a capsular contracture rate for each ADM type, with a chi-squared test performed for analysis. Identified studies with a comparative group were included in a meta-analysis utilizing risk ratio (RR) to assess the efficacy of ADM. Nine articles including ADM for treatment of capsular contracture in breast augmentation met criteria for inclusion, with a total of 481 breasts. Strattice was the most commonly utilized ADM (n = 391), followed by AlloDerm (n = 57). There was a statistically significant difference in efficacy of ADM among the studied ADM types (P < .001). AlloDerm, FlexHD, and DermaMatrix had the lowest capsular contracture rates (0%). NeoForm and SurgiMend had the highest capsular contracture rates (each 25%, but with n = 4 and n = 8, respectively). Strattice had a capsular contracture rate of 1.53% in the pooled data, and meta-analysis showed that Strattice reduced the risk of capsular contracture (RR 0.14 [95% CI 0.06, 0.31]) compared with conventional treatment. Acellular dermal matrices appear to be effective at treating capsular contracture after breast augmentation while maintaining a low complication rate. Overall capsular contracture rates are low with the use of ADM. There is a statistically significant difference in efficacy among ADM types. Meta-analysis shows that Strattice is effective at reducing the risk of capsular contracture in breast augmentation patients when compared to conventional treatment. Future research, especially in the form of randomized controlled trials, is needed to further investigate the efficacy of various ADMs in the treatment of capsular contracture.
Read moreResponse to "Can We Really Control the Inframammary Fold (IMF) in Breast Augmentation?"
In a recent letter to the Aesthetic Surgery Journal , “Can We Really Control the Inframammary Fold (IMF) in Breast Augmentation?” Dr Swanson made claims regarding the inability to control the IMF during primary breast augmentation.1 We were surprised by the comment and almost decided not to respond, however, we decided to offer the following. Controlling IMF position and nipple: fold length is the single most important aspect of breast surgery and is often disregarded. The surgeon, who pays no attention to this philosophy, is sure to have poor results; and the surgeon, who makes this a priority, will enhance results; however, controlling the IMF can never be 100% successful as many variables exist, the most unpredictable being – living tissue. Our clinical practice has demonstrated an easily adaptable, low-risk, three-point IMF suture …
Read moreSubfascial versus Subglandular Breast Augmentation: A Randomized Prospective Evaluation Considering a 5-Year Follow-Up.
Subfascial breast augmentation is becoming popular because of a better understanding of breast anatomy. However, because the subglandular approach is also another popular method, it is critical to assess the influence of the superficial fascia of the pectoralis major muscle on the subfascial and subglandular pockets to determine if one method is superior to another. This study investigated whether there are clinical/radiological differences between subfascial and subglandular pockets following primary breast augmentation. Twenty patients were recruited, and each was randomly sorted to the subfascial and/or subglandular pocket per breast. Both patients and surgeons were blinded. Differences were evaluated through five independent surgeons and by magnetic resonance imaging scans. Subsequently, 1-year and 5-year follow-ups were conducted. The results of the 5-year follow-up considering the aesthetics of the breast contour were significantly different between groups, with more good and excellent evaluations in the subfascial group. Regarding breast shape, there were also statistical differences, also with more good and excellent evaluations in the subfascial group. For breast consistency, subglandular had 84.20 percent of patients classified into Baker I and II, whereas subfascial had 100 percent. Magnetic resonance imaging scans showed a smaller implant base in the subglandular pockets, which was a significant result. There were no significant differences in implant projection. Comparison of the number of folds revealed significant differences between groups, with more folds in the subglandular group. Statistical differences between methods were found regarding breast shape and contour, capsular contracture, implant base, and the number of folds, showing that subfascial breast augmentation is superior to subglandular breast augmentation. Therapeutic, II.
Read moreCase of late hematoma after breast augmentation
We present a case report of a patient who experienced a late, spontaneous breast hematoma 26 years after primary breast augmentation. Late hematomas are a rare complication of breast augmentation with uncertain etiology. In this case, there was no trauma, calcifications, or implant rupture. We believe the patient’s hematoma was secondary to erosion of a capsular vessel due to capsular contracture.
Read moreEfficacy of Botulinum Toxin A for Scar Prevention After Breast Augmentation: A Randomized Double-Blind Intraindividual Controlled Trial.
Botulinum toxin A benefits postsurgical scar prevention by reducing wound edge tension and inhibiting in vitro scar tissue fibrosis. To investigate the efficacy of botulinum toxin Type A (BTX) in improving inframammary scar appearance after primary breast augmentation. A prospective, double-blinded, randomized controlled trial was performed with 27 participants receiving primary augmentation mammoplasty with inframammary incisions. After skin closure, intradermal injections of BTX were administered to 1 (treated) side of the inframammary incision. The contralateral side was the control. Scars were evaluated at 3 months, 6 months, and 9 months using the Patient and Observer Scar Assessment Scale and multispectral imaging analysis. Overall, 22 patients completed the study. There were no significant subjective differences between the treated and control sides except the patient's treated side had significantly higher scores than the control side at 9 months. The treated side showed significantly smaller scar widths at 6 months and 9 months (p < .001) and better scar surface textures at 9 months (p = .003) than the control side. Subjectively, intradermal BTX injection immediately after breast augmentation skin closure caused no significant differences. Objectively, scar width and texture significantly improved at 6 months and 9 months.
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