Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) is a very rare type of T-cell lymphoma that is uniquely caused by a single environmental stimulus. Here, we present a comprehensive ...genetic analysis of a relatively large series of BIA-ALCL (n = 29), for which genome-wide chromosomal copy number aberrations (CNAs) and mutational profiles for a subset (n = 7) were determined. For comparison, CNAs for anaplastic lymphoma kinase (ALK)− nodal anaplastic large cell lymphomas (ALCLs; n = 24) were obtained. CNAs were detected in 94% of BIA-ALCLs, with losses at chromosome 20q13.13 in 66% of the samples. Loss of 20q13.13 is characteristic of BIA-ALCL compared with other classes of ALCL, such as primary cutaneous ALCL and systemic type ALK+ and ALK− ALCL. Mutational patterns confirm that the interleukin-6–JAK1–STAT3 pathway is deregulated. Although this is commonly observed across various types of T-cell lymphomas, the extent of deregulation is significantly higher in BIA-ALCL, as indicated by phosphorylated STAT3 immunohistochemistry. The characteristic loss of chromosome 20 in BIA-ALCL provides further justification to recognize BIA-ALCL as a separate disease entity. Moreover, CNA analysis may serve as a parameter for future diagnostic assays for women with breast implants to distinguish seroma caused by BIA-ALCL from other causes of seroma accumulation, such as infection or trauma.
•Frequent losses at chromosome 20q13.13 provide genetic justification to recognize BIA-ALCL as a separate disease entity.•Omnipresent chromosomal aberrations in BIA-ALCL may be a basis for a sensitive screening assay for women with breast implant–related seroma.
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Background
Hyaluronic acid (HA) dermal fillers are widely used in aesthetic medicine. While generally safe, potential complications can arise.
Objective
This systematic review aims to identify and ...classify potential complications linked to the use of HA dermal fillers, as informed by high-quality, low-risk-of-bias studies.
Methods
This review follows the Cochrane review standards for clinical systematic reviews. This systematic review analyzed 48 high level of evidence studies on the use of hyaluronic acid (HA) dermal fillers in non-surgical facial aesthetics and the adverse events that occurred.The inclusion criteria were randomized control studies on HA dermal fillers and their complications. Excluded were case reports, case series, observational studies, and other non-randomized research due to their inability to provide generalized conclusions and their inherent publication bias.
Results
Adverse events were classified into three categories: expected reactions, product or technique-related adverse events, and severe adverse events. Most adverse events were short-lived injection site reactions, which resolved spontaneously. Specific HA fillers and injection techniques influenced the occurrence of adverse events, which generally resolved within weeks without treatment. Severe adverse events were rare, persisting for months and requiring active medical intervention.
Discussion
This classification system can enhance understanding, prevention, and treatment of HA filler complications, and support patient education. The common complications were injection site reactions, with persistent symptoms treated with topical steroids, NSAIDs, or hyaluronidase. Severe complications included severe edema, angioedema and others, often necessitating specific treatments.
Conclusion
HA dermal fillers are generally safe and effective, with most adverse events being transient and mild to moderate in severity. Severe adverse events, although rare, do occur and are generally non-treatment related. Informed consent, patient education, and professional training are crucial for safe and successful outcomes.
Level of Evidence II
This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors
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Abstract
Background
Recurrent scandals involving breast implants have revealed that scientific evidence on the performance of these devices is lacking, and passive monitoring systems are not capable ...of detecting problems at an early stage. The German health authorities therefore decided to implement a prospective, mandatory registry.
Objectives
The aim of this article was to provide information about the advantages of implementing a mandatory registry, the potential hurdles involved, and to establish structural requirements that future registries can use.
Methods
Since 2018, the authors have assisted the German Ministry of Health in refining the Implant Law and its implementation. They adapted an internationally consented dataset, promoted international data amplification and conducted monthly trial inputs for over 2 years. By identifying several key issues they were able to assist in developing solutions.
Results
The cooperation with the authorities was characterized by appreciation of the authors’ expertise and previous international work. Challenges included data privacy issues, federal competence, longitudinal follow-up, and contact data; as well as associated costs and technical solutions for data inclusion and the use of information technology to communicate with stakeholders. Addressing these challenges required considerable interference with personal rights and complementary measures for all stakeholders. Extensive structural precautions were taken to safeguard personal data privacy as far as possible.
Conclusions
The authors’ experience and lessons learned can guide registries seeking to engage in high levels of evidence data. The authors describe their approach, the obstacles they encountered, and the strategies employed to overcome the setbacks of other registries.
Breast implants are among the most commonly used medical devices. Since 2008, the number of women with breast implants diagnosed with anaplastic large-cell lymphoma in the breast (breast-ALCL) has ...increased, and several reports have suggested an association between breast implants and risk of breast-ALCL. However, relative and absolute risks of breast-ALCL in women with implants are still unknown, precluding evidence-based counseling about implants.
To determine relative and absolute risks of breast-ALCL in women with breast implants.
Through the population-based nationwide Dutch pathology registry we identified all patients diagnosed with primary non-Hodgkin lymphoma in the breast between 1990 and 2016 and retrieved clinical data, including breast implant status, from the treating physicians. We estimated the odds ratio (OR) of ALCL associated with breast implants in a case-control design, comparing implant prevalence between women with breast-ALCL and women with other types of breast lymphoma. Cumulative risk of breast-ALCL was derived from the age-specific prevalence of breast implants in Dutch women, estimated from an examination of 3000 chest x-rays and time trends from implant sales.
Relative and absolute risks of breast-ALCL in women with breast implants.
Among 43 patients with breast-ALCL (median age, 59 years), 32 had ipsilateral breast implants, compared with 1 among 146 women with other primary breast lymphomas (OR, 421.8; 95% CI, 52.6-3385.2). Implants among breast-ALCL cases were more often macrotextured (23 macrotextured of 28 total implants of known type, 82%) than expected (49 193 sold macrotextured implants of total sold 109 449 between 2010 and 2015, 45%) based on sales data (P < .001). The estimated prevalence of breast implants in women aged 20 to 70 years was 3.3%. Cumulative risks of breast-ALCL in women with implants were 29 per million at 50 years and 82 per million at 70 years. The number of women with implants needed to cause 1 breast-ALCL case before age 75 years was 6920.
Breast implants are associated with increased risk of breast-ALCL, but the absolute risk remains small. Our results emphasize the need for increased awareness among the public, medical professionals, and regulatory bodies, promotion of alternative cosmetic procedures, and alertness to signs and symptoms of breast-ALCL in women with implants.
The impact of clinical prediction models within Artificial Intelligence (AI) and machine learning (ML) is significant. With its ability to analyze vast amounts of data and identify complex patterns, ...machine learning has the potential to improve and implement evidence-based plastic, reconstructive, and hand surgery. Among others, it is capable of predicting the diagnosis, prognosis, and outcomes of individual patients. This modeling aids daily clinical decision making, most commonly at the moment, as decision-support.Therefore, the purpose of this paper is to provide a practice guideline to plastic surgeons implementing AI in clinical decision-making or setting up AI research to develop clinical prediction models using the 7-step approach and the ABCD validation steps of Steyerberg et al. Secondly, we describe two important protocols which are in the development stage for AI research: 1) the Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) checklist, and 2) The PROBAST checklist to access potential biases.
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a very rare type of T-cell lymphoma that is uniquely caused by a single environmental stimulus. Here, we present a comprehensive ...genetic analysis of a relatively large series of BIA-ALCL (n = 29), for which genome-wide chromosomal copy number aberrations (CNAs) and mutational profiles for a subset (n = 7) were determined. For comparison, CNAs for anaplastic lymphoma kinase (ALK)- nodal anaplastic large cell lymphomas (ALCLs; n = 24) were obtained. CNAs were detected in 94% of BIA-ALCLs, with losses at chromosome 20q13.13 in 66% of the samples. Loss of 20q13.13 is characteristic of BIA-ALCL compared with other classes of ALCL, such as primary cutaneous ALCL and systemic type ALK+ and ALK- ALCL. Mutational patterns confirm that the interleukin-6-JAK1-STAT3 pathway is deregulated. Although this is commonly observed across various types of T-cell lymphomas, the extent of deregulation is significantly higher in BIA-ALCL, as indicated by phosphorylated STAT3 immunohistochemistry. The characteristic loss of chromosome 20 in BIA-ALCL provides further justification to recognize BIA-ALCL as a separate disease entity. Moreover, CNA analysis may serve as a parameter for future diagnostic assays for women with breast implants to distinguish seroma caused by BIA-ALCL from other causes of seroma accumulation, such as infection or trauma.
Background
Oncological safety of different types and timings of PMBR after breast cancer remains controversial. Lack of stratified risk assessment in literature makes current clinical and shared ...decision‐making complex. This is the first systematic review and meta‐analysis to evaluate differences in oncological outcomes after immediate versus delayed postmastectomy breast reconstruction (PMBR) for autologous and implant‐based PMBR separately.
Methods
A systematic literature search was performed in MEDLINE, Cochrane Library, and Embase. The Cochrane Collaboration Handbook and Meta‐analysis Of Observational Studies in Epidemiology checklist were followed for data ion. Variability in point estimates attributable to heterogeneity was assessed using I2‐statistic. (Loco)regional breast cancer recurrence rates, distant metastasis rates, and overall breast cancer recurrence rates were pooled in generalized linear mixed models using random effects.
Results
Fifty‐five studies, evaluating 14,217 patients, were included. When comparing immediate versus delayed autologous PMBR, weighted average proportions were: 0.03 (95% confidence interval CI, 0.02–0.03) versus 0.02 (95% CI, 0.01–0.04), respectively, for local recurrences, 0.02 (95% CI, 0.01–0.03) versus 0.02 (95% CI, 0.01–0.03) for regional recurrences, and 0.04 (95% CI, 0.03–0.06) versus 0.01 (95% CI, 0.00–0.03) for locoregional recurrences. No statistically significant differences in weighted average proportions for local, regional and locoregional recurrence rates were observed between immediate and delayed autologous PMBR. Data did not allow comparing weighted average proportions of distant metastases and total breast cancer recurrences after autologous PMBR, and of all outcome measures after implant‐based PMBR.
Conclusions
Delayed autologous PMBR leads to similar (loco)regional breast cancer recurrence rates compared to immediate autologous PMBR. This study highlights the paucity of strong evidence on breast cancer recurrence after specific types and timings of PMBR.
Lay summery
Oncologic safety of different types and timings of postmastectomy breast reconstruction (PMBR) remains controversial.
Lack of stratified risk assessment in literature makes clinical and shared decision‐making complex.
This meta‐analysis showed that delayed autologous PMBR leads to similar (loco)regional recurrence rates as immediate autologous PMBR. Data did not allow comparing weighted average proportions of distant metastases and total breast cancer recurrence after autologous PMBR, and of all outcome measures after implant‐based PMBR.
Based on current evidence, oncological concerns do not seem a valid reason to withhold patients from certain reconstructive timings or techniques, and patients should equally be offered all reconstructive options they technically qualify for.
Oncologic safety of different types and timings of postmastectomy breast reconstruction (PMBR) remains controversial. This meta‐analysis showed that delayed autologous PMBR leads to similar (loco)regional breast cancer recurrence rates compared to immediate autologous PMBR.
The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) was requested by the European Commission (EC) to provide a scientific opinion on the safety of breast implants in ...relation to anaplastic large cell lymphoma (ALCL). There are several types of textured breast implants; surface textures of breast implants are not all manufactured in the same way, and breast implants with diverse surface textures may also present different benefits. The magnitude of the risk per type of textured implant is difficult to establish due to the low incidence of the breast implants associated anaplastic large cell lymphoma (BIA-ALCL). Therefore, risk assessments per implant type are needed.
Overall SCHEER considers that there is a moderate weight of evidence for a causal relationship between textured breast implants and BIA-ALCL, particularly in relation to implants with an intermediate to high surface roughness.The pathogenic mechanisms are not fully elucidated; current hypotheses include genetic drivers, chronic inflammation resulting either from bacterial contamination, shell shedding of particulates, or shell surface characteristics leading to friction, or by implant associated reactive compounds. Reporting of new BIA-ALCL cases by the national clinical registries is critically important to obtain a better estimate of the risk of BIA-ALCL for patients with a breast implant.
•SCHEER considers there is a moderate weight of evidence for a causal relationship between textured breast implants and ALCL.•This causal relationship applies particularly to implants with an intermediate to high surface roughness.•Several types of textured breast implants exist of which the surface textures are not all manufactured in the same way.•SCHEER recognises that implants with diverse surface textures may also present different benefits.•There is a need for further research to better understand the aetiology and pathogenesis of BIA-ALCL.•Reporting new BIA-ALCL cases by relevant registries is of major importance to better estimate BIA-ALCL risk for patients.
Abstract An estimated 1-3% of all women in the Netherlands carry breast implants. Since the introduction five decades ago, problems with a variety of breast implants have emerged with direct ...consequences for the patients’ health. Plastic surgeons worldwide reacted through campaigning for auditing on long-term implant quality surgeon performance and institutional outcomes in implant registries. Especially the PIP implant scandal of 2010 demonstrated the paucity of epidemiological data and uncovered a weakness in our ability to even ‘track and trace’ patients. In addition, a recent report of the Dutch Institute of National Health showed a lack of compliance of 100% of breast implant producers to CE requirements. These arguments stress the need for an independent implant registry. Insufficient capture rates or dependence from the implant producers made the variety of national and international patient registries unreliable. The Dutch Breast Implant Registry is unique because it is an opt-out registry without the need for informed consent and thus a high capture rate. Furthermore, an estimated 95% of breast implants are implanted by board-certified plastic surgeons. Funding was achieved from a non-governmental organisation to increase the quality of health care in the Netherlands and maintenance is gathered by 25 euros per implant inserted. This article describes the way the Dutch have set up their system, with special attention to the well known hurdles of starting a patient registry. Examples include; funding, medical ethical issues, opt out system, benchmarking, quality assurance as well as governance and collaboration. The Dutch consider their experience and data shareware for others to be used globally to the benefit of patient safety and quality improvement.
In immediate implant-based breast reconstruction (IBBR), large variation is observed in current practices between a direct-to-implant and a two-stage approach (insertion of a breast implant after a ...tissue expander). This population-based study aimed to compare unplanned short- and long-term revision incidence between direct-to-implant and two-stage IBBR in The Netherlands.
All patients who underwent immediate IBBR following a mastectomy between 2015 and 2019 were selected from the nationwide Dutch Breast Implant Registry. Short- and long-term unplanned revision incidences were studied per immediate IBBR, including revision indications and the total number of additional operations. Confounding by indication was limited using propensity score matching.
A total of 4512 breast implants (3948 women) were included, of which 2100 (47%) were for direct-to-implant IBBR and 2412 (53%) were for two-stage IBBR. Median (IQR) follow-up was 29 months (range, 16 to 45 months) and 33 months (range, 21 to 47 months), respectively. Short-term revision incidence was 4.0% and 11.7%, respectively (conditional OR, 0.31; 95% CI, 0.23 to 0.42%). Long-term revision incidence was 10.6% (95% CI, 9.2 to 12.1%) and 16.4% (95% CI, 14.8 to 17.9%), respectively. In the propensity score-matched cohort, similar results were found. In the direct-to-implant group, more breasts were reconstructed within the planned number of operations than in the two-stage group.
Unplanned revision surgery occurred less often after direct-to-implant IBBR, and more breasts were reconstructed within the planned number of operations compared to two-stage IBBR. These results, based on real-world data, are important for improving patient counseling and shared decision-making.
Risk, II.
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