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Introduction: Soft tissue fillers are used for cosmetic and reconstructive purposes, and soft tissue filler procedures are among the most common nonsurgical procedures in the USA. Although soft tissue filler procedures are relatively quick and safe, adverse events such as late inflammatory reactions have been reported with every filler product. Infections and vaccinations have been proposed as potential triggers for late inflammatory reactions (LIRs), and it is therefore not surprising that these adverse events have been reported after SARS-CoV-2 infection and vaccination. Therefore, this review aims to give a detailed overview of these cases. Materials and methods: A literature search was undertaken on LIRs in patients with a history of soft tissue filler use after SARS-CoV-2 infection or vaccination. This systematic review was reported according to the PRISMA guidelines. We searched the electronic database PubMed from January 2020 to August 2021. Data on patient characteristics, filler characteristics, clinical findings, and treatment options were included. Results: This review included 7 articles with a total of 19 patients with LIRs after SARS-CoV-2 infection or vaccination. Three patients with postinfection LIRs and 16 patients with postvaccination LIRs were reported. These LIRS mainly occurred in females who had HA injections for cosmetic purposes. Three patients with postinfection LIRs had symptoms of facial swelling and/or lip angioedema in a matter of weeks. Sixteen patients reported reactions after SARS-CoV-2 vaccination (13 following Moderna vaccination and 3 after Pfizer vaccination, after both the first and second doses) from 13 hours up to three weeks. These patients presented with similar clinical symptoms as patients with postinfection LIRs. All patients were treated in a conservative manner. Discussion: This review shows a relationship between LIRs and SARS-CoV-2 infection and vaccination. In the case of vaccination, these adverse events have been reported only after Moderna and Pfizer vaccinations. The reported adverse events are generally minor and self-limiting, and we encourage patients with soft tissue fillers to participate in vaccination programs.

Capsular contracture is the leading complication after surgery with breast implants. A lot of progress has been made investigating this complication over the years, and knowledge has been gained on this complication. Currently, the exact cause for capsular contracture is still unclear. It has been hypothesized that immunobiological factors (i.e., immunological and bacterial factors) and several risk factors play a central role in its development. In this paper, we give an overview of the known immunological factors that have been investigated in contracted and non-contracted capsules, as well as the role of bacterial formation around breast implants. We also report on risk factors that might increase the risk of capsular development. Lastly, it provides the latest research on this matter and discusses future perspectives as follow-up research is needed to unravel the pathogenic process leading to capsular contracture. This knowledge is of interest to establish medical therapies in order to prevent such side effects. Overall, capsular contracture seems to be a multifactorial condition consisting of several risk factors. Level of Evidence V: 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.

ObjectiveAn unknown portion of women with silicone breast implants (SBI) report development of systemic symptoms, recently named as ‘breast implant illness (BII)’. We aim to describe the symptoms and characteristics of women with SBI reporting these systemic symptoms and compare the clinical course of women who chose to keep their implants, to women who had their implants removed.DesignObservational cohort study.SettingSpecialised BII out-patient clinic at Amsterdam UMC, the Netherlands, from 2011 to 2020.ParticipantsAll women presenting to the BII clinic with SBI and systemic symptoms.Results467 women were included for baseline analyses and 398 women for follow-up. Most frequently reported systemic symptoms at baseline included fatigue (88%), arthralgia (71%), morning stiffness (59%), myalgia (48%), cognitive impairment (33%), peripheral neurological symptoms (30%) and lymphadenopathy (22%). Furthermore, 56% reported pre-existing allergies at baseline and positive antinuclear antibodies were observed in 23%. At follow-up with a median of 3.3 years (IQR 2–4), 152 women had their implants removed on clinical grounds. Symptoms improved significantly in 65 women (43%), improved moderately in 37 women (24%), did not change in 37 women (24%) and deteriorated in 13 women (9%). Women who underwent explantation showed more improvement of their systemic symptoms compared with women who did not (OR 2.9, 95% CI 1.3 to 6.2). Additionally, women who underwent explantation within 10 years after implantation improved significantly better than women who got the implants removed after 10 years (p=0.007). Lastly, local symptoms decreased from 75% to 34% after implant removal (pConclusionMost women with SBI who developed systemic symptoms experienced improvement after explantation, especially when removed within 10 years after implantation. Early recognition of the pattern of systemic symptoms in women with SBI is important and implant removal should be considered.

Background: To date, it is unknown why some individuals develop late-onset inflammatory adverse events after treatment with fillers. These events may result from various factors, including an immunological response of the adaptive immune system. Objective: In a pilot study, we looked for evidence that is there a relation between late-onset inflammatory adverse events and the presence of immune cells surrounding the injected filler. Methods and Materials: We included 47 patients, of whom 20 experienced late-onset inflammatory adverse events to different fillers (inflammatory group) and 27 who did not (reference group). A biopsy was taken from the area of the adverse event. Hematoxylin–eosin staining and immunohistochemistry analysis with CD3 (T-cells) and CD68 (macrophages) on paraffin tissue sections was used to assess the biopsies. Results: Immune cells were found in biopsies obtained from 18 of 47 patients: Nine biopsies from the inflammation group and nine from the reference group. All these 18 cases showed CD68-positive immune cells. Virtually no CD3-positive immune cells were found. Conclusion: Our results indicate that there is no T-cell activity in biopsies from areas with late-onset adverse events after filler injections. The macrophages found in the biopsies are probably not responsible for the inflammatory response.

Background Late inflammatory reactions (LIRs) are the most challenging complications after filler use. The immune system plays a prominent role in its etiology, albeit to an unknown extent. Bacterial contamination in situ has been hypothesized to be causative for LIRs. How this relates to the immunological processes involved is unknown. This article aims to provide an overview of immunological and bacterial factors involved in development of LIRs. Methods We undertook a systematic literature review focused on immunological factors and microbiota in relation to LIRs after filler use. This systematic review was performed in accordance with the PRISMA guidelines. PubMed, EMBASE and the Cochrane databases were searched from inception up to August 2019. Included studies were assessed for the following variables: subject characteristics, number of patients, primary indication for filler injection, implant type/amount and injection site, type of complication, follow-up or injection duration, study methods, type of antibiotics or medical therapies and outcomes related to microbiota and immunological factors. Results Data on immunological factors and bacterial contamination were retrieved from 21 included studies. Notably, the presence of histocytes, giant cells and Staphylococcus epidermidis within biopsies were often associated with LIRs. Conclusion This review provides a clear overview of the immunological factors associated with LIRs and provides a hypothetical immunological model for development of the disease. Furthermore, an overview of bacterial contamination and associations with LIRs has been provided. Follow-up research may result in clinical recommendations to prevent LIRs. Level of Evidence III This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors-www.springer.com/00266..

Background: The aetiology of capsular contracture around breast implants remains unclear. The leading theory is that a subclinical infection around the implant plays a role in the development of capsular contractions. Several studies found associations between the presence of bacteria and the occurrence of capsular contraction. However, it is unclear whether detected bacteria originate from the breast capsule, breast glandular tissue or skin contamination. Moreover, this has never been investigated with molecular techniques. The aim of this study was to assess the bacterial microbiota on breast capsules, glandular tissue and skin using a highly sensitive PCR assay. Materials and Methods: Fifty breast capsules were collected during implant removal or replacement. Ten specimens of glandular breast tissue and breast skin were collected in females who were undergoing reduction mammoplasty. A sample specimen (4 mm) was sterilely obtained from all tissues. All specimens were analysed by IS-pro, a 16S–23S interspace region-based PCR assay. Results: Low numbers of Staphylococcus spp. (four species in four capsules) were found on breast capsules. There was no difference in bacterial presence between normal and contracted capsules. The skin of the breast-harboured Streptococcus spp. and Staphylococcus spp. while the glandular tissue was sterile. Conclusion: The low numbers of bacteria found on the capsules are most likely caused by contamination during capsule removal. More and larger studies are needed to investigate the bacterial presence on breast capsules using a PCR assay. This is the first study in which breast capsules have been studied using a highly sensitive PCR assay. 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.

Introduction: The etiology of capsular contracture after surgical implantation of breast implants remains unclear, but an important role is seen for the immune system. Toll-like receptors are immune receptors recognizing both pathogen-associated molecular patterns and damage-associated molecular patterns. The former are present on bacteria such as Staphylococcus epidermidis (bacteria earlier associated with capsular contracture), and the latter are released after (mechanical) stress. The aim of this study was to investigate the expression of TLRs 1–10 in relation to capsular contracture. Materials and Methods: Fifty consecutive breast capsules were collected during implant removal or replacement. The extent of capsular contracture was scored according to the Baker score. A sample specimen (0.5 cm3) was obtained from all tissues. cDNA was synthesized from isolated mRNA from the collected specimens. PCR analyses were conducted to test for cDNA presence and to quantify concentration. TLR1–10 expression was measured for each of the Baker scores separately and compared to all Baker scores. Results: Expression of all TLRs in all Baker scores was seen. TLR2 and TLR6 were more often present in contracted samples (Baker 3 or 4) compared to uncontracted samples (Baker 1 or 2) [Baker 2 vs. 3 (p = 0.034) and Baker 2 vs. 3 (p = 0.003), respectively]. None of the TLRs displayed a significantly higher expression in contracted capsules compared to uncontracted capsules. Conclusion: This study shows that TLR2 and TLR6 are more often expressed in contracted capsules compared to non-contracted capsules however not in higher concentrations. Level of Evidence III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Even though manufacturers claim that the dermal fillers are nontoxic and nonimmunogenic, adverse events may occur. Clinically and histologically, most of the late onset adverse events present as an inflammatory response. To assess whether HLA polymorphisms are associated with late-onset inflammatory adverse events related to dermal fillers. A total of 211 patients were included, of whom 129 experienced late-onset inflammatory adverse events to different fillers (Inflammation group) and 82 who did not (Reference group). Patients completed a standardized questionnaire and provided a blood sample or oral swap for HLA testing. The study population consisted of 188 (89%) women and 23 (11%) men. The two study groups were similar in the distributions of filler type, location of injecting, allergy, autoimmune disease, gender, age, ethnicity, and smoking status. Of the 211 patients in the sample, 25 had the combination of HLA subtype-B*08 and HLA subtype-DRB1*03. This was 16.3% of the inflammatory group and 4.9% of the reference group. This combination of HLA subtypes was associated with an almost 4-fold increase in the odds of developing immune mediated adverse events (odds ratio = 3.79, 95% CI 1.25-11.48). Genetic polymorphisms such as HLA combinations may identify patients at risk of developing late onset immune mediated adverse events to dermal fillers.

Background The Poly Implant Prothèse (PIP) implants were withdrawn from the market in 2010 due to the use of low-grade silicone, causing a high risk for implant rupture. The aim of this study was to investigate the implant dynamics of PIP breast implants, as well as to determine the rate and predictors of implant gel bleeding, rupture, and capsular contracture in PIP implants. Methods Eighty women with a total of 152 PIP implants who underwent a reoperation in 2012 were enrolled in this study. Physical investigation included assessing the Baker score and demographics were retrospectively traced in medical records. The pre- and post-operative volumes of the implants were calculated and their state was determined intraoperatively by the surgeon. Results The implants were removed after a mean implant duration of 11 ± 2.1 years. Gel bleed and implant rupture occurred in respectively 42 and 25% of the implants. Intact implants had post-operative volume increase as well as decrease. There was a correlation between gel bleeding and more post-operative implant volume increase (P ≤ 0.05). Capsular contracture had a protective effect against post-operative implant volume increase (P ≤ 0.05), while a post-operative implant volume increase provided a protective influence in developing capsular contracture (P ≤ 0.05). Additionally, implant rupture led to a higher risk of capsular contracture (P ≤ 0.05). Conclusions We managed to illustrate that PIP implant shells were too permeable and that there is a correlation between gel bleeding and the increase of the post-operative implant volume. Implant rupture led to a higher risk for developing capsular contracture. Level of evidence: Level III, risk / prognostic study. Electronic supplementary material The online version of this article (10.1007/s00238-018-1427-y) contains supplementary material, which is available to authorized users.

Summary Background Capsular contracture is the most frequent complication after breast augmentation or reconstruction with breast implants. The immune system plays a prominent role in capsular contracture formation, albeit to an unknown extent. Bacterial contamination in situ has been hypothesized to be causative for capsular contracture. How this relates to the immunological processes involved is unknown. This article aims to provide an overview of immunological and bacterial factors involved in development of capsular contracture. Materials and methods We undertook a systematic literature review focused on immunological factors and microbiota in relation to capsular contraction around implants. This systematic review was performed in accordance with the PRISMA guidelines. PubMed, EMBASE, and the Cochrane databases were searched from inception up to October 2016. Included studies were assessed for the following variables: subject characteristics, number of capsules, primary indication for surgery, surgical procedure, follow-up or implant duration, study methods, type of antibiotics or medical therapies and outcomes related to microbiota and immunological factors. Results Data on immunological factors and bacterial contamination were retrieved from 64 included studies. Notably the presence of macrophages and Staphylococcus epidermidis within capsules was often associated with capsular contracture. Conclusion This review provides a clear overview of the immunological factors associated with capsular contracture and provides a hypothetical immunological model for development of the disease. Furthermore, an overview of bacterial contamination and associations with capsular contracture has been provided. Follow-up research may result in clinical recommendations to prevent capsular contracture.

The authors note that an incorrect version of their article was published. Please see below updated text for the section ‘‘Recommendations for Injection Techniques and Treatment Options’’ and correct Fig. 4. Based on this review we propose the following treatment algorithm for LIRs (Fig. 4). As stated above, culture proven infections are common after filler injection. Therefore, when clinical features of inflammation such as oedema, heat, erythema, tenderness or pain are present, the first choice should be conservative treatment with oral antibiotics. We recommend the use of tetracyclines (such as doxycycline or minocycline (100–200 mg daily) or clarithromycin because of their dual action as antimicrobial and immune modulatory medication. In some cases, non-steroidal anti-inflammatory drugs (NSAIDs) or oral corticosteroids can be added. When conservative treatment fails, it may be necessary to remove any residual filler material. Treatment option may be hyaluronidase (enzymes that are able to degrade hyaluronic acid) or intralesional laser treatment (ILT; removing the material in a microinvasive manner). When the aforementioned treatment options fail, or are not applicable, surgical treatment may be required. (Figure presented.).

Background: Distal pole resection of the scaphoid is one of the surgical techniques applied for the treatment of painful scaphotrapeziotrapezoid osteoarthritis (STT-OA). Methods: In this retrospective study, we evaluated midterm outcomes in a consecutive series of patients who underwent distal pole resection of the scaphoid: 13 patients (15 wrists) with a mean follow-up of 4.1 years. We examined objective functional and patient-reported outcome measures. In addition, we assessed the degree of dorsal intercalated segment instability (DISI) and postoperative complications. Results: All patients scored within a normal range on objective functional and patient-reported outcome measures. We observed a mild postoperative DISI deformity with an average lunocapitate angle of 22° (range, 0°-44°), which did not correlate with pain scores. In the opposite wrists, with and without STT-OA, the average lunocapitate angle was 6° (range, 0°-20°). Conclusions: According to this study, midterm results for distal pole resection of the scaphoid are satisfactory.

Background:. Poly Implant Prothèse (PIP) silicone breast implants were removed from the market between 2010 and 2012 because of the use of nonmedical grade silicone filler. The chemical and physico-chemical properties of PIP implants have been analyzed by several groups. In addition, our previous study illustrated that PIP implant shells were more permeable. Therefore, we analyzed the chemical composition of the envelope and gel of PIP silicone breast explants. Also, the composition of absorbed material into the implant was analyzed. Methods:. This study was conducted on 3 PIP implants explanted from 2 patients. The envelope was analyzed using Raman microscopy, whereas the gel was analyzed using near-infrared spectra, nuclear magnetic resonance spectroscopy, and gas chromatography coupled to mass spectrometry. Absorbed material was investigated with Fourier-transform infrared spectroscopy and sodium dodecyl sulfate polyacrylamide gel electrophoresis. Results:. The 3 implants appeared to be Rofil implants, and all implants displayed a yellow color. None of the envelope showed a barrier layer. Amounts of D4, D5, and D6 were found to be below 100 ppm. Water was found in all 3 implants and also proteins were absorbed into the implants. Conclusions:. The current study shows that the analyzed implants originate from the manufacturer Rofil but have PIP1 hallmarks. Apparently, these are own brand labeling implants. The presence of water and proteins in the explants indicate exchange of small and large molecules into the explants, even in the implant with a visually intact envelope. Because of the PIP1 hallmarks of the Rofil implants, patients with such implants are advised to be counseled by their physicians.

Background:. Silicone breast implants have been used for decades for cosmetic breast augmentation or reconstruction after mastectomy. In selected cases, postmastectomy adjuvant radiotherapy is given with the breast implants in situ. Previous clinical studies have shown that radiotherapy may lead to complications such as capsular contracture and infection and that removal of the implant may be required. Yet, the effect of radiotherapy on silicone breast implants themselves is unknown. The aim of this study was to investigate if irradiation of breast implants influences their mechanical properties. Methods:. This was an ex vivo study on 32 ready-to-use silicone breast implants (Mentor and Silimed). Half of the implants of each brand were irradiated with 1 × 60 Gy, the other half were not irradiated. Tensile, mechanical hysteresis, and rheology tests were performed. Differences in mechanical properties between the irradiated and nonirradiated implants were determined. Results:. No significant differences were found in tensile strength, mechanical hysteresis, and rheological properties between irradiated and nonirradiated implants. Conclusions:. Breast implants’ mechanical properties for these 2 brands were not significantly affected after single-dose irradiation in an ex vivo setting.

Summary Background Capsular contracture is the most frequent complication in breast augmentation or reconstruction with breast implants. The exact mechanism for this complication is not completely understood. Yet, it is most likely to be a multifactorial condition. Several patient-, surgery-, and implant-specific risk factors have been related to cause capsular contracture. This review aims to provide a clear overview of all risk factors for capsular contracture. Methods A systematic literature review was performed focusing on patient-, surgery-, and/or implant-related factors related to capsular contracture in breast implants. PubMed, Embase, and Wiley/Cochrane Library databases were searched for relevant articles published from inception up to October 20, 2016. The included studies were assessed for the following main variables: study characteristics, patient characteristics, indication for surgery, type of surgery, implant characteristics, and other characteristics. Results Data on the risk factors for the development of capsular contracture were retrieved from 40 studies. A presumptive increased risk in the development of capsular contracture is shown for the following variables: longer duration of follow-up, breast reconstructive surgery in patients with a history of breast cancer, subglandular implant placement, postoperative hematoma, and a textured implant surface. There is little, weak, or no evidence for the association of other factors with capsular contracture. This review also shows a large heterogeneity between studies and within the definition of capsular contracture. Conclusion This review provides an overview of the relationship between patient-, surgery-, and implant-specific risk factors in the development of capsular contracture.

INTRODUCTION: It is essential to have a reliable assessment method in order to compare the results of cleft lip and palate surgery. In this study the computer-based program SymNose, a method for quantitative assessment of the nose and lip, will be assessed on usability and reliability.METHODS: The symmetry of the nose and lip was measured twice in 50 six-year-old complete and incomplete unilateral cleft lip and palate patients by four observers. For the frontal view the asymmetry level of the nose and upper lip were evaluated and for the basal view the asymmetry level of the nose and nostrils were evaluated.RESULTS: A mean inter-observer reliability when tracing each image once or twice was 0.70 and 0.75, respectively. Tracing the photographs with 2 observers and 4 observers gave a mean inter-observer score of 0.86 and 0.92, respectively. The mean intra-observer reliability varied between 0.80 and 0.84.CONCLUSIONS: SymNose is a practical and reliable tool for the retrospective assessment of large caseloads of 2D photographs of cleft patients for research purposes. Moderate to high single inter-observer reliability was found. For future research with SymNose reliable outcomes can be achieved by using the average outcomes of single tracings of two observers.

Purpose: Resection of the distal pole of the scaphoid is one of the surgical techniques applied for the treatment of painful scaphotrapeziotrapezoid osteoarthritis (STT-OA) and nonunion of fractures in the distal part of the scaphoid. Very few studies report on the outcome of this technique. The purpose of this study is to evaluate the midterm outcomes in a consecutive series of patients. Methods: This is a retrospective study in which we evaluated 13 patients (15 wrists) with a mean follow-up of 4.1 years. The indication for surgery was in all cases a STT-OA. We evaluated objective functional outcome measures (range of motion and grip strength) and patient-reported outcome measures (visual analogue scale for pain, Michigan Hand Questionnaire [MHQ], and Quick Disabilities of the Arm, Shoulder and Hand [QuickDASH]). The degree of dorsal intercalated segmental instability (DISI) and the postoperative complications were also assessed. Results: Extension and flexion averaged 61.6° and 74.3°, while radial and ulnar deviation averaged 16.7° and 27.8°, respectively. Grip strength at position 1 to 5, respectively, averaged 16.0, 23.6, 21.5, 18.3, and 15.6 kg. Reported pain averaged 2.1/10, MHQ 76.4/100, and QuickDASH 25.2/100. A mild postoperative DISI deformity was observed in 13 wrists with an average lunocapitate angle of 22.1° (range, 0°-44°) on radiographic evaluation without a correlation with reported pain scores. None of the opposite wrists, whether with or without STT-OA, displayed DISI deformity. The only observed complication was a complex regional pain syndrome in 1 case. Discussion: The midterm results for distal pole resection of the scaphoid in the treatment of STT-OA and scaphoid nonunion are satisfactory. Almost all patients develop a mild degree of DISI deformity, but this does not affect the outcome.