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Tatjana Pavicic,1 Welf Prager,2 Markus Klöppel,3 Simon Ravichandran,4 Olivier Galatoire5 1Private Practice, Munich, Germany; 2Dr. Prager & Partner, Derma-Hamburg, Hamburg, Germany; 3Private Practice Clinic of Esthetic Surgery, MediCenter Munich-Solln, Munich, Germany; 4Clinetix Rejuvenation, Glasgow, Scotland, UK; 5Department of Ophthalmology, Adolphe Rothschild Ophthalmological Foundation, Paris, France Purpose: To characterize utilization patterns and treatment satisfaction with incobotulinumtoxinA for aesthetic indications and assess adherence to the Summary of Product Characteristics. Patients and methods: Data were collected retrospectively from physicians in Germany, France, and the UK regarding patients (n=638) treated with incobotulinumtoxinA for aesthetic indications. Data on indication, treatment interval, dose injected, physician and patient satisfaction, and adverse drug reactions were recorded according to routine daily practice. Results: Most patients (76.0%) received incobotulinumtoxinA for glabellar frown lines (GFL) and were given doses of ≤20 U. The majority of treatment intervals were 5 months or longer. Overall, 64.1% of patients were treated for off-label indications, sometimes in combination with treatment for GFL. The most frequently treated off-label indications were horizontal forehead lines (38.6%) and/or crow's feet (CF; 31.7%); for CF, >95% of injected doses were ≤24 U. In Germany, a smaller proportion of patients were given incobotulinumtoxinA treatment for CF (27.6%), compared with France (40.4%) and the UK (33.2%), although country-specific differences were less prominent when treatment cycle data for CF were examined. Treatment satisfaction among physicians and patients (overall, and for GFL specifically) was very high, with excellent tolerability and only one mild adverse drug reaction reported. Conclusion: In daily practice, incobotulinumtoxinA is mainly used for GFL; however, its use for CF and horizontal forehead lines (often in combination with GFL) is relatively common. Treatment satisfaction across aesthetic indications is high, and incobotulinumtoxinA is well tolerated, with time intervals of 5 months or longer between injections in the majority of cases. When considering factors such as dose and treatment interval, adherence to the Summary of Product Characteristics when treating GFL in daily practice is good. These results support previous reports that incobotulinumtoxinA is an effective treatment for GFL, with an excellent safety profile. Furthermore, incobotulinumtoxinA may display efficacy and tolerability in other indications. Keywords: incobotulinumtoxinA, Xeomin®/Xeomeen®/Bocouture®/XEOMIN Cosmetic™, NT 201; free from complexing proteins, retrospective, daily practice, glabellar frown lines, crow's feet

Background: The authors' previous research suggested the hypothesis that aesthetic surgery in general has a positive impact on quality of life (QoL). This prospective study aimed to investigate the indication-specific effect on QoL in patients undergoing transaxillary endoscopic breast augmentation., Methods: Seventy-seven patients underwent aesthetic breast augmentation. Fifty patients met the inclusion criteria. All of them answered one set of the questionnaires preoperatively, and the follow-up set at 6 months postoperatively. The testing instruments included a self-developed indication-specific questionnaire and five standardised and validated questionnaires with German norm data available: Questions on Life Satisfaction, Modules (FLZ M , German version), the Freiburg Personality Inventory-Revised (FPI-R), the Rosenberg Self-Esteem Scale (SRES), the Patient Health Questionnaire (PHQ-4) and the Breast-Q | Augmentation., Results: Our self-developed indication-specific questionnaire shows high satisfaction with the postoperative results. The FLZ M demonstrated significant improvements in the module life in general (p < 0.001), 'hobbies' (p < 0.001), 'health' (p = 0.04), 'family life' (p = 0.03) and 'partner relationship/sexuality' (p < 0.001). Moreover, the FPI-R revealed a significant improvement in emotional stability (p < 0.001). Moreover, the PHQ-4 showed a significant reduction in overall psychological distress (p < 0.001). Further, Breast-Q indicated a significant increase in psychological (p < 0.001) and sexual well-being (p < 0.001)., Conclusion: Transaxillary endoscopic breast augmentation has a significant impact on QoL and sexuality. The surgery leads to a higher satisfaction not only with the result of intervention and the outer appearance specifically, but also with life and the state of health generally. It improves emotional stability. Therefore, the authors' hypothesis in a previous research was confirmed for this specific indication prospectively., (Copyright © 2024. Published by Elsevier Ltd.)

Background: The study examines, for the first time, the impact on quality of life after liposuction for lipoedema. The influence of aesthetic plastic interventions and their effects on treatment outcomes has been a major focus of our research group over the past 20 years., Methods: A total of 35 patients were invited to participate in our prospective study, with 30 responding to both the pre- and postoperative questionnaires. The patients received the questionnaires pre-operatively, and 6 months after the liposuction. Our questionnaire set included a self-developed, indication-specific part, along with standardised and validated questionnaires such as the Questions on Life Satisfaction (FLZ M ), Patient Health Questionnaire (PHQ-4), Rosenberg Self-Esteem Scale (RSES) and the Freiburg personality inventory-revised (FPI-R)., Results: Our self-developed questionnaire showed that our patients feel more balanced, more attractive and more self-confident after the treatment. The FLZ M showed significant improvements in all three modules: the general satisfaction with life, the state of health and the outer appearance (body image). Using the PHQ-4, a significant improvement in the two subscales of anxiety and depression could be determined, as well as a reduction in overall mental stress. In addition, the RSES showed a significant improvement in self-esteem post-operatively. Furthermore, the FPI-R indicated a significant improvement in emotional stability., Conclusions: Liposuction improves the quality of life in lipoedema patients. Post-operatively, our patients reported less pain and were more satisfied with their bodies and appearance. The hypothesis that liposuction in lipoedema improves the quality of life as a multidimensional construct could be confirmed., Competing Interests: Declaration of Competing Interest None., (Copyright © 2024 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Background: Our previous retrospective study indicates that esthetic surgery in general results in a significant improvement in Quality of life (QoL). This is the first indication-specific prospective evaluation of QoL after blepharoplasty using standardized and validated questionnaires., Objectives: To report changes in QoL after blepharoplasty prospectively with a 6-month follow-up., Methods: The same surgical team performed an esthetic blepharoplasty on 50 patients. Participants answered 1 set of questionnaires preoperatively and 6 months postoperatively. The instrument consisted of a self-developed indication-specific part specially designed for blepharoplasty and 4 validated and standardized testing instruments (FLZ, FPI-R, RSES, and PHQ-4) with norm data for German-speaking countries available., Results: This study reveals a high rate of satisfaction after blepharoplasty. 96% felt better about themselves and 94% would undergo the procedure again. Statistically significant increased values were found postoperatively in the items "income" ( P =0.016), "family life" ( P =0.028), "partner relationship" ( P =0.039), "ability to relax" ( P <0.001), "energy" ( P <0.001), "hobbies" ( P <0.001), and with their outer appearance in general ( P =0.018). Blepharoplasty showed a statistically significant improvement in emotional stability ( P =0.017) and a reduction in depressive symptoms ( P <0.001). Our patients had statistically significantly higher self-esteem before ( P <0.001) and after ( P <0.001) the intervention., Conclusion: Our prospective study shows that blepharoplasty increases most aspects of QoL significantly, has a positive effect on emotional and physical well-being, and reduces the incidence of depressive symptoms and anxiety., Competing Interests: The authors report no conflicts of interest., (Copyright © 2022 by Mutaz B. Habal, MD.)

Background: During transaxillary endoscopic subpectoral breast augmentation, the innervation of the abdominal part of the pectoralis major muscle can be injured. The question has been raised whether this could even be of value, as for a better result, the caudal fibers of the pectoralis major muscle have to be detached from their origin. The authors' aim was to identify the exact position and the intramuscular course and target of these nerve branches., Methods: Fifty pectoralis major muscles and their supplying nerve branches from 27 formalin-fixed anatomical specimens were studied using macroscopic dissection and anthropometry. Furthermore, eight muscles underwent the modified Sihler procedure to determine the intramuscular course and target of the supplying nerve branches., Results: The branches for the abdominal part of the pectoralis major muscle pierced the pectoralis minor muscle or coursed around its lower border 3.2 to 8.4 cm from the tip of the coracoid process. Within the muscle, at least one small nerve branch, innervating the abdominal part, ascended into the lowermost portion of the sternocostal head, and anastomosed with the lowest small branch of its supplying nerve branches., Conclusions: Because of the variable position of the nerve branches, they may often cross the operative field during transaxillary endoscopic breast augmentation. However, their interruption can be of value, because weakening of the lower part of the pectoralis major muscle is desired to keep the implant in place, and to avoid animation deformity., (Copyright © 2022 by the American Society of Plastic Surgeons.)

It is known that co-administration of CYP3A inducers may decrease the effectiveness of oral contraceptives containing progestins as mono-preparations or combined with ethinylestradiol. In a randomized clinical drug-drug interaction study, we investigated the effects of CYP3A induction on the pharmacokinetics of commonly used progestins and ethinylestradiol. Rifampicin was used to induce CYP3A. The progestins chosen as victim drugs were levonorgestrel, norethindrone, desogestrel, and dienogest as mono-products, and drospirenone combined with ethinylestradiol. Postmenopausal women (n = 12-14 per treatment group) received, in fixed sequence, a single dose of the victim drug plus midazolam without rifampicin, with rifampicin 10 mg/day (weak induction), and with rifampicin 600 mg/day (strong induction). The effects on progestin exposure were compared with the effects on midazolam exposure (as a benchmark). Unbound concentrations were evaluated for drugs binding to sex hormone binding globulin. Weak CYP3A induction, as confirmed by a mean decrease in midazolam exposure by 46%, resulted in minor changes in progestin exposure (mean decreases: 15-37%). Strong CYP3A induction, in contrast, resulted in mean decreases by 57-90% (mean decrease in midazolam exposure: 86%). Namely, the magnitude of the observed induction effects varied from weak to strong. Our data might provide an impetus to revisit the currently applied clinical recommendations for oral contraceptives, especially for levonorgestrel and norethindrone-containing products, and they might give an indication as to which progestin could be used, if requested, by women taking weak CYP3A inducers-although it is acknowledged that the exact exposure-response relationship for contraceptive efficacy is currently unclear for most progestins., (© 2020 Bayer AG. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Background: The authors' previous research suggested the hypothesis that aesthetic surgery in general has a positive impact on quality of life (QoL). This prospective study aimed to investigate the indication-specific effect on QoL in patients undergoing aesthetic liposuction. To our knowledge, no other prospective study has been conducted using standardised and validated questionnaires with a comparable return rate and sample size., Methods: Sixty-four patients underwent aesthetic liposuction. Forty-two patients met the inclusion criteria, and 38 of them answered one set of questionnaires preoperatively and the follow-up set at six months post-operatively. The testing instrument included a self-developed, indication-specific questionnaire and four standardised and validated questionnaires with German norm data available: Questions on Life Satisfaction, Modules (FLZ M , German version), the Freiburg Personality Inventory-Revised (FPI-R), the Rosenberg Self-Esteem Scale (RSES) and the Patient Health Questionnaire (PHQ-4)., Results: Our self-developed indication-specific questionnaire showed high satisfaction with the postoperative results. The FLZ M demonstrated significant improvements for all modules, concerning life in general (p = 0.02), health (p = 0.04) and body image (p = 0.02). Moreover, the FPI-R revealed a significant improvement in emotional stability (p < 0.01). Moreover, the PHQ-4 showed a significant reduction in overall psychological distress (p = 0.03) and anxiety (p = 0.01)., Conclusion: Liposuction had significant impact on QoL. The surgery led to a higher satisfaction not only with the result of intervention and the outer appearance specifically but also with life and the state of health generally. It improved emotional stability and reduced anxiety. Therefore, the authors' hypothesis in a previous research was confirmed for this specific indication prospectively., (Copyright © 2019 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Background: In our previous retrospective study, we detected an increased quality of life after aesthetic abdominoplasty. In this survey, we analyzed quality of life, self-esteem, emotional stability, and mental health before and after aesthetic abdominoplasty prospectively., Methods: Twenty-two female patients were surveyed before and six months after their surgeries. The testing instrument consisted of a self-developed indication-specific questionnaire and four standardized tests (Questions on Life Satisfaction plus a specified part body image, Rosenberg Self-Esteem Scale, Freiburg Personality Inventory, and Patient Health Questionnaire-4)., Results: Significantly increased values were found concerning feeling comfortable in swimwear in front of the mirror or the sexual partner and at social or professional activities (each p=0.000). Women had less problems doing sports (p=0.029) and felt more feminine (p=0.012). Sum scores of general life satisfaction (p=0.016) and scores of the items leisure activity (p=0.003), relaxing abilities (p=0.002), and sexuality (p=0.046) showed significant improvements. The body image improved in general (p=0.010) and in particular in the items abdomen, hips, and waist (each p=0.000). Emotional stability increased significantly (p=0.029). We detected a mild mental depression in 27% and a moderate depression in 32% of our patients before surgery. Depressive disorders were significantly reduced (p=0.004) down to mild depression in 18% and moderate depression in 9% of the patients., Conclusion: Positive results for quality of life shown in the retrospective study were confirmed. Abdominoplasty improves general life satisfaction and satisfaction with health and outer appearance and increases emotional stability. Depressive patients showed a significant improvement after aesthetic abdominoplasty., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

One major objective of all types of breast reduction procedures is to achieve a long-lasting, stable and aesthetically pleasing three-dimensional (3-D) breast shape, but current surgical outcome evaluation is limited. This study compares the extent of soft-tissue oedema and breast tissue migration related to 3-D breast morphology changes after inverted T-scar and vertical-scar breast reduction over 12 months. 3-D breast surface scans of patients undergoing inverted T-scar (n=52 breasts) and vertical-scar (n=44 breasts) reduction mammaplasty were obtained preoperatively and 2-3 days, 1 week, 1 month, 3 months, 6 months, 9 months and 12 months postoperatively. 3-D images were analysed at each time point comparing distances, 3-D breast contour deviations (%), breast surface (cm2) and volume (cc) measurements including volumetric distribution between the upper portion (UP) and the lower portion (LP) of the breast (%). Total postoperative breast volume decreased by 11.7% (T-scar) and by 7.8% (vertical-scar) during the first 3 months (both p<0.001) without relevant changes in the following months, indicating that soft-tissue oedema is resolved after 3 months. The T-scar (vertical-scar) group showed a preoperative UP to LP volumetric distribution of 43:57% (45:55%) versus 86:14% (91:9%) immediately after surgery. Breast tissue significantly redistributes (both p=0.001) from the UP to the LP during the first postoperative year by 16.5% (T-scar) and 21% (vertical-scar), resulting in a final UP to LP ratio of 70:30% for both techniques, without further breast contour deviations (both p>0.05) after 6 months (T-scar) and 9 months (vertical-scar). Breast morphological changes after reduction mammaplasty are completed after a period of 3-6 months in the T-scar group and 6-9 months in the vertical-scar group., (Copyright © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Background: Currently, postoperative outcome analysis in breast augmentation is essentially subjective, and objective evaluation of treatment efficacy is lacking. This study evaluates the influence of anatomic and round implant parameters on breast contour changes after subpectoral breast augmentation using three-dimensional (3D) surface imaging., Methods: 3D surface breast scans of 17 patients (34 breasts) undergoing subpectoral breast augmentation with round implants and of ten patients (20 breasts) receiving anatomic implants via an axillary approach under endoscopic assistance or a submammary fold incision were obtained before and 6 months postoperatively. 3D linear distance, breast volume, and surface measurement were correlated with the implanted round and anatomic implant parameters, and the resulting breast shape changes were evaluated., Results: Total breast volume changed in correlation with the implant size (2.4% difference; r=0.894; p<0.001). Implant volume and type influence the nipple-to-inframammary fold distance (N-IMF). Every inserted 100 ml implant volume enlarges the N-IMF distance by 0.8 cm (anatomic>round; p=0.01). Postoperatively, the IMF dropped by an average of 1.3 cm for round implants and by 1.1 cm for anatomic implants, without relevant differences between the applied surgical incision and the selected implants (p>0.05). Breast projection increased significantly more with anatomic implants (2.4 cm) than with round implants (1.7 cm) (p=0.01). The breast projection increase was 22% less than expected for round implants and 25% less than expected for anatomic implants based on the manufacturer implant parameters (p<0.01), without essential differences regarding the surgical incision., Conclusions: 3D breast shape changes induced by round and anatomic implants after subpectoral augmentation mammaplasty are objectively documented including breast projection, volume, and N-IMF distance changes. 3D surface imaging may have a potential clinical contribution to objective surgical outcome research., 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 at www.springer.com/00266.

This study develops an objective breast symmetry evaluation using 3-D surface imaging (Konica-Minolta V910(®) scanner) by superimposing the mirrored left breast over the right and objectively determining the mean 3-D contour difference between the 2 breast surfaces. 3 observers analyzed the evaluation protocol precision using 2 dummy models (n = 60), 10 test subjects (n = 300), clinically tested it on 30 patients (n = 900) and compared it to established 2-D measurements on 23 breast reconstructive patients using the BCCT.core software (n = 690). Mean 3-D evaluation precision, expressed as the coefficient of variation (VC), was 3.54 ± 0.18 for all human subjects without significant intra- and inter-observer differences (p > 0.05). The 3-D breast symmetry evaluation is observer independent, significantly more precise (p < 0.001) than the BCCT.core software (VC = 6.92 ± 0.88) and may play a part in an objective surgical outcome analysis after incorporation into clinical practice., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Since 2008, blood stability testing has gained considerable attention in the European Bioanalysis Forum (EBF) with discussions aiming to align processes, timing and reporting of analyte stability testing in blood as part of method development and validation. In this recommendation, EBF summarizes the conclusions reached to date and aims to provide recommendation for the experimental conduct of such assays as well as the inclusion of stability testing into the scope of method development and validation. Besides considering a step-wise approach for blood stability testing, recommendation is made to analyze the blood fraction using a qualified assay in order to circumvent important experimental hurdles. This article will provide an increased understanding of the impact of blood stability testing but furthermore invites scientists to share their views in order to refine the thinking to reach a global harmonized view.

This is a summary report of the workshop on the EMA Draft Guideline on Validation of Bioanalytical Methods held April 15-16th 2010 in Brussels (Belgium) and jointly organised by the European Bioanalysis Forum (EBF) and the European Federation for Pharmaceutical Sciences (EUFEPS). Aim of the workshop was to discuss the current scientific knowledge in the area of bioanalysis, the regulatory requirements with special focus on the new Draft Guideline and their subsequent implementation to the work in bioanalytical laboratories. Comments on the Draft Guideline were presented and discussed with representatives from regulatory authorities in Europe. The workshop started with discussions on the scope of the Guideline and the need for implementation of GLP. A special focus was set on method validation of chromatographic procedures and subsequent study sample analysis. In addition, requirements for ligand-binding assays were briefly addressed. Intention of this Conference Report is to summarise important aspects of the discussions in order to draw certain conclusions, and to identify points which remain open and may require clarification at a later stage., (Copyright © 2011 Elsevier B.V. All rights reserved.)

In the study presented, the long-term outcome and satisfaction of 34 patients who underwent simultaneous bilateral breast reconstruction with a free transverse rectus abdominis muscle (TRAM) flap between 1988 and 2001 were assessed. Flap complications affected 13 of 68 flaps (19.1%). Anastomosis revision was needed in 6 cases (8.8%), the salvage rate being 50%. The rates of total and partial flap loss were 4.4% and 1.5%, respectively. Bilateral flap loss did not occur. Four patients developed donor site complications (11.7%), with wound healing problems being the most common (5.8%). Most patients were satisfied with their decision to have had breast reconstruction with free TRAM, 91% would choose the same operation again, and 91% would recommend this procedure to other patients. Of the operated patients, 20.8% felt an improvement in their sexual life; more patients, however, reported an improvement concerning their social life (37.5%) and life in general (50%).

The principle of prefabricated flaps is based on the transformation of a formerly random-pattern vascularized flap, through implantation of a vascular pedicle, into a newly neovascularized axial flap, which can be transferred after a period of neovascularisation from the prepared donor site to the recipient site by using microvascular techniques. In 30 Chinchilla Bastard rabbits weighing from 3700 to 4200 g, a skeletonized arteriovenous pedicle with distal ligation harvested from the femoral and saphena magna artery and vein was implanted beneath an 8 x 15 cm abdominal skin flap to investigate the neovascularisation process in the flap over the course of time. In order to prevent neovascularisation occurring from the underlying vascular bed into the flap, a silicon sheet measuring 8 x 15 cm x 0.25 mm was placed and fixed on the abdominal wall. Flap vitality and neovascularisation process in prefabricated flaps were evaluated by macroscopic observation, blood analysis, selective microangiography, histology and scintigraphy at the various time intervals of 4, 8, 12, 16 and 20 days. The study results showed that newly formed vessels sprouting from the implanted pedicle were seen four days after pedicle implantation. With the retention time of pedicle in the flaps, they continued to grow, became meander and more dense. Respective connections between newly formed vessels and the originally available vasculature of the abdominal flap were markedly observed in the 12- and 16-day groups. Twenty days after prefabrication, the abdominal flap was completely perfused by the blood flow supplied from the newly implanted arteriovenous pedicle through newly formed vessels arising from the implanted pedicle and their rich vascular communications. The neovascularisation in the prefabricated flap consisted of the implanted pedicle, newly formed vessels, the originally available vasculature and their vascular connections. In comparison to the control group (the quantification was determined of 100 %), the vessel quantity in the prefabricated flap of the 20-day group had increased to 98.7 %. As a pre-clinical test, prefabricated flaps through arteriovenous pedicle implantation with special advantages can be a new useful method in plastic and reconstructive surgery.