Sensitivity after Clitoral Reconstruction in Patients with Female Genital Mutilation.

Background: In the past decades, reconstructive choices after female genital mutilation extended beyond de-infibulation and scar release. The current trend to expand techniques addressing sexual and aesthetic aspects by reconstructing the clitoris and prepuce, and dissecting the clitoral nerves raises concern, as there is a paucity of evidence on the functional outcomes and suspected iatrogenic lacerations. Methods: A total of 128 female genital mutilation patients were included in the study. To evaluate clitoral sensitivity after elevation, the Semmes-Weinstein-monofilament test was performed before and after genital reconstruction. Results: Preoperatively, patients with a visually intact clitoris showed significantly better sensitivity compared with patients with a mutilated clitoris or infibulation (P < 0.0001). Surgery was performed in 84 patients. After clitoral reconstruction (CR), 70 of 73 patients were able to perceive 2.83 monofilaments (95.9%), whereas three perceived 3.61. Patients with a visually intact clitoris served as control, and 95.0% perceived 2.83 monofilaments. We showed a significant improvement of clitoral sensitivity (P = 0.0020) in the subgroup consisting of patients with a mutilated clitoris in whom the test was performed before and after reconstruction. Conclusions: Clitoral sensitivity improves significantly after CR. Seventy of 73 patients attained the same sensitivity as unharmed women. No patient showed a decreased sensitivity compared with their preoperative findings. Therefore, our study supports the argument that CR offers sufficient improvement of objective clitoral sensitivity without additionally addressing clitoral nerves.

The phyllodes menace-Variation in course, therapy, and appearance of phyllodes tumors in a case series of three patients.

Key Clinical Message: Early and complete surgical resection is the most important therapeutic and diagnostic measure. Adjuvant radiation is suggested for malign phyllode tumors, phyllode tumors larger than 10 cm or those with a low distance to the resection margins. Abstract: Phyllodes tumors are rare fibroepithelial tumors of the breast. Histologically, they are usually classified as benign, borderline or malignant, though these classifications do not necessarily reflect the clinical course of the disease. These tumors may stay undetected for years, or show sudden and rapid progression. There is currently no consistent therapy recommendation based upon histological findings, the localization of the tumor and/or whether it is recurrent. Using the examples of three patients, we show how courses and therapy may differ widely, and discuss this in the context of the current state of the literature.

Breast Implant-Associated Tumors.

In addition to anaplastic large T-cell lymphomas (BIA-ALCL), other implant-related tumors have been described for some years. Squamous cell carcinoma (SSC) and B-cell lymphomas occurred in very rare cases. The unexplained pathogenesis as well as the unclear individual risk profile is an ongoing source of uncertainty for patients and physicians. The pathogenesis of the tumors is still largely not understood. While BIA-ALCL occurs more frequently with textured breast implants, other tumors were also observed with smooth implants and at other implant sites. Multiple potential mechanisms are discussed. It is suspected that the etiology of a chronic inflammatory response and subsequently immunostimulation is multifactorial and appears to play a key role in the malignant transformation. Since there are currently no sufficiently valid data for a specific risk assessment, this must be done with caution. This article presents the incidence, pathogenesis, as well as the level of evidence according to the current state of knowledge, and evaluates and discusses the current literature.

The Mandatory German Breast Implant Registry Law: A Model for Sustainable Implant Registries.

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.

Reconstructive and Aesthetic Surgeries on the Female Genitalia. Guideline of the DGGG, DGPRÄC, OEGGG and SGGG (S2k-Level, AWMF Registry No. 009/019, May 2022).

Aim This official guideline was coordinated and published by the German Society for Gynaecology and Obstetrics (DGGG), the German Society for Plastic, Reconstructive and Aesthetic Surgery (DGPRÄC), the Austrian Society for Gynaecology and Obstetrics (OEGGG), and the Swiss Society for Gynaecology and Obstetrics (SGGG). The guideline aims to provide a consensus-based overview of reconstructive and aesthetic surgeries on female genitalia based on an evaluation of the relevant literature. Methods This S2k-guideline was developed by representative members from different medical professions on behalf of the guidelines commission of the DGGG, DGPRÄC, OEGGG and SGGG using a structured consensus process. Recommendations Statements and recommendations on the epidemiology, aetiology, classification, symptoms, diagnosis, and treatment of acquired changes of the external genitalia are presented and special situations are discussed.

Postoperative Course of Reconstructive Procedures in FGM Type III-Proposal for a Modified Classification of Type III Female Genital Mutilation.

BACKGROUND: Reconstruction after female genital mutilation (FGM) has developed from being merely a therapy for complications to addressing body perception and sexuality. However, evidence regarding a direct correlation between FGM and sexual dysfunction is scarce. The present WHO classification provides an imprecise grading system, which makes it difficult to compare present studies with treatment outcomes. The aim of this study was to develop a new grading system based on a retrospective study of Type III FGM, evaluating operative time and postoperative results. METHODS: The extent of clitoral involvement, operative time of prepuce reconstruction and lack of prepuce reconstruction, and postoperative complications of 85 patients with FGM-Type III were retrospectively analyzed at the Desert Flower Center (Waldfriede Hospital, Berlin). RESULTS: Even though universally graded by the WHO, large differences in the degree of damage were found after deinfibulation. In only 42% of patients, a partly resected clitoral glans was found after deinfibulation. There was no significant difference in operative time when comparing patients who required prepuce reconstruction and patients who did not (p = 0.1693). However, we found significantly longer operative time in patients who presented with a completely or partly resected clitoral glans when compared to patients with an intact clitoral glans underneath the infibulating scar (p < 0.0001). Two of the 34 patients (5.9%) who had a partly resected clitoris required revision surgery, while none of the patients in whom an intact clitoris was discovered under the infibulation required revision. However, these differences in the complication rates between patients with and without a partly resected clitoris were not statistically significant (p = 0.1571). CONCLUSIONS: A significantly longer operative time was found in patients who presented with a completely or partly resected clitoral glans when compared with patients with an intact clitoral glans underneath the infibulating scar. Furthermore, we found a higher, though not significantly significant, complication rate in patients with a mutilated clitoral glans. In contrast to Type I and II mutilations, the presence of an intact or mutilated clitoral glans underneath the infibulation scar is not addressed in the present WHO classification. We have developed a more precise classification, which may serve as a useful tool when conducting and comparing research studies.

Comparing 200,000 Breast Implants and 85,000 Patients over Four National Breast Implant Registries.

BACKGROUND: Growing awareness about breast implant-related adverse events has stimulated the demand for large, independent data resources. For this, data from breast implant registries could be combined. However, that has never been achieved yet. METHODS: Real-world data from four currently active national breast implant registries were used. All permanent breast implants from the Australian, Dutch, Swedish, and American registries were included. A subpopulation present across all registries between 2015 and 2018 was subsequently selected, including only permanent breast implants inserted during primary surgery for breast reconstruction or augmentation in patients without previous breast device surgery. Nationwide coverage, patient and implant characteristics, infection control measures, and revision incidences were analyzed. RESULTS: A total of 207,189 breast implants were registered. Nationwide coverage varied between 3% and 98%. The subpopulation included 111,590 implants (7% reconstruction, 93% augmentation). Across the registries, mean patient age varied between 41 and 49 years ( P < 0.001) for reconstruction and 31 and 36 years ( P < 0.001) for augmentation. Variation was observed in implant preferences across the countries and over the years. Infection control measures were most frequently registered in Australia. Cumulative revision incidence at 2 years ranged from 6% to 16% after reconstruction and from 1% to 4% after augmentation. CONCLUSIONS: For the first time, independent, national, registry-based data from four breast implant registries were combined. This is a powerful step forward in optimizing international breast implant monitoring, evidence-based decision-making, and patient safety.

Current trends in postmastectomy breast reconstruction.

PURPOSE OF REVIEW: Breast reconstruction is established as integral part of the treatment. New materials, indications and surgical techniques are subject to rapid modification to further improve safety, quality and longevity. RECENT FINDINGS: Skin-sparing-mastectomy is accepted as an appropriate alternative in risk-reducing and many breast cancer patients, further reducing conventional mastectomy patterns.Radiation in combination with reconstruction is still challenging with no clear advances reducing skin-toxicity.Autologous reconstructions, not only in radiation settings, are turning to a first line approach. A trend driven by improved techniques to minimize morbidity and flap-variations.Breast implant surfaces associated with a high risk of Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) are now withdrawn. The residual risk for the remaining implant styles is not known, but can be expected considerably lower than estimations published presently.In order to reduce local complications, supplemental material often in combination with prepectoral implant placement is advertised. The present evidence on long-term outcome is limited.Super-microsurgery treating lymphedema is evolving rapidly. Refinements of various techniques and their differential indication are under evaluation to standardize the procedures. SUMMARY: Breast reconstruction evolved to a complex, specialized field with a multitude of options. A multidisciplinary team is required to fully utilize todays potential and offer optimal individual treatments.

Cognitive-Emotional Aspects of Post-Traumatic Stress Disorder in the Context of Female Genital Mutilation.

Around 200 million women and girls worldwide are affected by female genital mutilation/cutting (FGM/C). FGM/C is a procedure that harms or alters the external female genitals for non-medical reasons, and is usually performed on children. Often, this procedure leads to severe consequences for the women's physical and mental health. In a cross-sectional sample of 112 women seeking medical counseling, physical and mental health characteristics associated with FGM/C were examined and possible predictors for the development of post-traumatic stress disorder (PTSD) in women affected by FGM/C were identified. A total of 55.4% (n = 66) of the women reported symptom levels of probable PTSD. Predictors for higher PTSD symptomology were an older age at the time of the FGM/C procedure, feelings of guilt and the centrality of the event in the woman's life. Thus, cognitive-emotional processing was found to play an important role in the emergence of PTSD in women suffering from FGM/C. However, interventions taking into consideration these characteristics are mostly lacking and need to be investigated further in the context of FGM/C.

Comparison of venous couplers versus hand-sewn technique in 4577 cases of DIEP-flap breast reconstructions - A multicenter study.

INTRODUCTION: Venous anastomosis remains to be a challenging step in microsurgical tissue transfer and venous complications constitute to a common reason for free flap failure. While several studies have compared mechanical vs. hand-sewn venous anastomoses, there is no large-series study comparing the type of anastomosis exclusively in DIEP flap breast reconstructions. PATIENTS AND METHODS: Between 2011 and 2019, 3926 female patients underwent 4577 free DIEP-flap breast reconstructions in 22 different breast cancer centers. Patient data was collected via an online database, files were screened and cases were divided into a hand- (HA) and a coupler-anastomosis (CA) group. Complications were accounted for and the two groups were then compared. RESULTS: Mean ischemia time was significantly shorter in the CA group (46.88 ± 26.17 vs. 55.48 ± 24.70 min; p < .001), whereas mean operative time was comparable (316 ± 134.01 vs. 320.77 ± 120.29 minutes; p = .294). We found no significant difference between both groups regarding the rate of partial (CA: 1.0% vs. HA: 1.3%) and total flap loss (CA: 2.2% vs. HA: 1.8%). However, revision rates were significantly higher in the CA group (CA: 10.5% vs. HA: 7.9%; p = .003), with higher numbers of arterial (2.3 vs. 0.9%; p < .001) and venous thromboses (3.4 vs. 1.8%; p = .001) accounting for this finding. CONCLUSIONS: All taken into account, our findings do support the feasibility of venous coupler anastomoses in principle, however the inflationary use of coupler devices should be evaluated critically.

Overall Complication Rates of DIEP Flap Breast Reconstructions in Germany-A Multi-Center Analysis Based on the DGPRÄC Prospective National Online Registry for Microsurgical Breast Reconstructions.

While autologous breast reconstruction has gained momentum over recent years, there is limited data on the structure and quality of care of microsurgical breast reconstruction in Germany. Using the breast reconstruction database established by the German Society of Plastic, Reconstructive and Aesthetic Surgeons (DGPRÄC), the presented study investigated the overall outcomes of deep inferior epigastric perforator (DIEP) flap reconstructions in Germany. Data of 3926 patients and 4577 DIEP flaps performed by 22 centers were included in this study. Demographics, patient characteristics, perioperative details and postoperative outcomes were accounted for. Centers performing < Ø 40 (low-volume (LV)) vs. ≥ Ø 40 (high-volume (HV)) annual DIEP flaps were analyzed separately. Overall, total and partial flap loss rates were as low as 2.0% and 1.1% respectively, and emergent vascular revision surgery was performed in 4.3% of cases. Revision surgery due to wound complications was conducted in 8.3% of all cases. Mean operative time and length of hospital stay was significantly shorter in the HV group (LV: 385.82 min vs. HV: 287.14 min; LV: 9.04 (18.87) days vs. HV: 8.21 (5.04) days; both p < 0.05). The outcome and complication rates deduced from the national registry underline the high standard of microsurgical breast reconstruction on a national level in Germany.

[Psychological Strain due to Female Genital Mutilation: An Explorative Analysis in the Context of Medical Counselling]. / Psychische Belastung durch weibliche Genitalverstümmelung: Eine explorative Untersuchung im Rahmen einer medizinischen Sprechstunde.

Female genital mutilation (FGM) is a procedure that injures or removes parts of the external female genitals for nonmedical reasons and without the consent of the affected girls. Often this procedure leads to severe consequences for the women's physical and mental health. Reconstructive surgery can reduce these symptoms. In an exploratory study of 97 women seeking medical counselling, characteristics of the sample were analysed descriptively, reasons for reconstructive surgery were examined and agreement between the women's knowledge with the results of the medical examination was assessed. 56.7% (n=55) of the women examined were suspected to suffer from PTSD. Relief of pain was the reason most frequently mentioned for reconstructive surgery (45.4%; n=44). Accordance between women's knowledge of anatomic structures and the degree of mutilation with the results of the medical examination was low (κ=0.09). In addition to surgical measures, women suffering from FGM should be offered psychotherapeutic assistance. To improve the understanding on the effect of psychotherapy after FGM, sound longitudinal studies are indispensable.

Effect of Radiation Therapy on Microsurgical Deep Inferior Epigastric Perforator Flap Breast Reconstructions: A Matched Cohort Analysis of 4577 Cases.

INTRODUCTION: Breast reconstruction with autologous tissue is a state-of-the art procedure. Several patient-related factors have been identified with regard to the safety and efficacy of these reconstructions. The presented study investigates the impact of prereconstruction radiation on outcomes of deep inferior epigastric perforator (DIEP) free-flap breast reconstructions using largest database available in Europe. MATERIALS AND METHODS: Between 2011 and 2019, 3926 female patients underwent 4577 DIEP flap breast reconstructions in 22 different German breast cancer centers. The cases were divided into a no-radiation (NR) and a radiation (R) group, according to radiation status before reconstruction. Groups were compared with regard to surgical complications and free-flap outcome. RESULTS: Overall, there was no significant difference between the groups regarding the rate of total flap loss [1.9% (NR) vs 2.1% (R), P = 0.743], partial flap loss [0.9% (NR) vs 1.5 (R), P = 0.069], and revision surgery [vascular revision: 4.4% (NR) vs 4.1% (R), P = 0.686; wound revision: 7.6% (NR) vs 9.4% (R), P = 0.122]. However, the patients had a significantly higher risk of developing wound healing disturbances at the recipient site [1.2% (NR) vs 2.1% (R), P = 0.035] and showed significantly longer hospitalization {8 [SD, 8.4 (NR)] vs 9 [SD, 15.4 {R}] days, P = 0.006} after prereconstruction radiation. CONCLUSIONS: Our findings suggest that DIEP flap reconstruction after radiation therapy is feasible. Women with a history of radiation therapy should, however, be informed in detail about the higher risk for wound healing disturbances at the recipient site.

Toward International Harmonization of Breast Implant Registries: International Collaboration of Breast Registry Activities Global Common Data Set.

BACKGROUND: The Poly Implant Prothèse incident and breast implant-associated anaplastic large cell lymphoma have pointed to the need for uniform registries for breast implants as key features to monitoring the outcomes of breast implant surgeries internationally. The purpose of this study was to identify and harmonize common data elements collected by breast implant registries across the International Collaboration of Breast Registry Activities (ICOBRA) global consortium. METHODS: The authors convened an international group of surgeons, consumers, nurses, registry experts, and regulators to review the data points. A modified Delphi approach was applied, to rate the importance of each point on a six-point Likert scale. RESULTS: Data points from six national breast implant registries were divided into categories: clinical, implant-related, patient-reported findings; operation details and implanting technique details; patient characteristics; unique device identifiers; unique patient identifiers; and clinical demographics. A total of 52 data points collected by over 33 percent of national registries were identified. After five rounds, 34 data points formed the final set with agreed definitions. The group recognized the critical importance of additional elements that are currently not uniformly collected (e.g., patient-reported outcomes and long-term data) and set out the process for the dynamic global set updates driven by evidence gaps. CONCLUSIONS: The authors defined internationally agreed on common data elements and definitions used in breast implant registries. This collaboration will allow data sets to be combined, enabling an effective global early warning system of implant-related problems and further work on data sets.

Autologous Lipotransfer - Daily Therapeutic Practice in Breast Cancer: An Intergroup Analysis Encompassing NOGGO, WSG, GBG, AWO Gyn and DGPRÄC.

BACKGROUND: Autologous fat transfer in breast reconstruction has become increasingly important in breast reconstructive surgery. Although the indication to obtain fat, the various operative procedures, and the risks for the patient have been addressed in a large number of studies, detailed information on the everyday use of autologous lipotransfer in breast units in Germany is still lacking. METHODS: The objective of the study was to obtain primary data on the use of autologous lipotransfer to treat breast cancer patients in Germany and to determine measures for quality assurance in the daily practice. An online questionnaire concerning breast cancer and lipofilling was sent to specialists in gynecology and plastic surgery. RESULTS: Two-thirds of the specialists who responded to the questionnaire use autologous lipotransfer for breast reconstruction and did not report an increase of local recurrence following lipotransfer. There were only small differences between gynecologists and plastic surgeons regarding the procedure and indication for lipotransfer. The method is highly accepted by patients and physicians, and both gynecologists and plastic surgeons rated the improvement achieved through lipofilling as 'high'. CONCLUSIONS: The lack of randomized controlled data, especially in high-risk patients, demonstrates the necessity for a registry study on this topic. Our survey describes, in detail, the indications for lipofilling as well as its appropriate application in breast cancer patients in Germany and may thereby reduce the present therapeutic uncertainties.

Regenerative potential of adipocytes in hypertrophic scars is mediated by myofibroblast reprogramming.

Abnormal scarring is a major challenge in modern medicine. The central role of myofibroblasts and TGF-ß signaling in scarring is widely accepted, but effective treatment options are missing. Autologous fat grafting is a novel approach that has led to significant improvements in the functionality and appearance of scar tissue. While the underlying mechanism is unknown, the potential role of paracrine effects of adipocytes has been discussed. Hence, with the aim of unraveling the regenerative potential of adipocytes, their effects on in vitro differentiated myofibroblasts and on fibroblasts from hypertrophic scars were investigated. Exposure to adipocyte-conditioned medium significantly decreased the expression of the myofibroblast marker α-SMA and ECM components, indicating the occurrence of myofibroblast reprogramming. Further analysis demonstrated that myofibroblast reprogramming was triggered by BMP-4 and activation of PPARγ signaling initiating tissue remodeling. These findings may pave the way for novel therapeutic strategies for the prevention or treatment of hypertrophic scars. KEY MESSAGES: Adipocytes induce distinct regenerative effects in hypertrophic scar tissue. Adipocytes secrete several proteins which are involved in wound healing and regeneration. Adipocytes secrete BMP-4 which activates myofibroblast reprogramming. Mediators secreted by adipocytes directly and indirectly activate PPARγ which exerts distinct anti-fibrotic effects. These findings may pave the way for novel therapeutic strategies for the prevention or treatment of hypertrophic scars.

[Breast reconstruction with the free TRAM or DIEP flap ­ What is the current standard? Consensus Statement of the German Speaking Working Group for Microsurgery of the Peripheral Nerves and Vessels]. / Brustrekonstruktion mit freien TRAM oder DIEP Lappen ­ Was ist zeitgemäßer Standard?

The most common donor-site for autologous breast reconstruction is the abdomen. Over the past several decades technical advances have resulted in the development of flaps that have been associated with a progressive decrease in abdominal wall morbidity. However, controversy exists related to the differences between muscle-sparing (MS)-TRAM and deep inferior epigastric perforator (DIEP) flaps. Hence, the question which approach should be considered standard of care remains unanswered. To address this question the current literature and published evidence was critically reviewed and discussed by an expert panel at the 39th Annual Meeting of the German-speaking Society for Micro surgery of the Peripheral Nerves and Vessels (DAM). Based on this discussion a consensus statement was developed that incorporates contemporary data regarding postoperative complication rate, donor site morbidity, as well as expert opinion regarding technical details in autologous breast reconstruction with free TRAM and DIEP flaps.

Early risk prognosis of free-flap transplant failure by quantitation of the macrophage colony-stimulating factor in patient plasma using 2-dimensional liquid-chromatography multiple reaction monitoring-mass spectrometry.

Although great success of microvascular free-flap transplantation surgery has been achieved in recent years, between 1.5% and 15% of flaps are still lost due to vascular occlusion. The clinical challenge remains to salvage a transplant in the case of vascular complications. Since flap loss is devastating for the patient, it is of utmost importance to detect signs of complications or of conspicuities as soon as possible. Rescue success rates highly depend on early revision. In this study, we collected blood samples during transplantation surgery from either the contributory artery or the effluent vein of the flap and applied a targeted mass spectrometry-based approach to quantify 24 acute phase proteins, cytokines, and growth factors in 63 plasma samples from 21 hospitalized patients, generating a dataset with 9450 protein concentration values. Biostatistical analyses of the targeted plasma protein concentrations in all 63 plasma samples showed that venous concentrations of macrophage colony-stimulating factor (M-CSF) provided the highest accuracy for discriminating patients with either clinical conspicuities or complications from control individuals. Using 21.33 ng/mL of M-CSF as the diagnostic threshold when analyzing venous blood plasma samples, the assay obtained a sensitivity of 0.93 and a specificity of 0.85 with an area under the curve value of 0.902 in the receiver operating characteristic analysis. Overall, our results indicate that M-CSF is a potential molecular marker for early risk prognosis of free-flap transplant failure.

Mass spectrometric characterization of limited proteolysis activity in human plasma samples under mild acidic conditions.

We developed a limited proteolysis assay for estimating dynamics in plasma-borne protease activities using MALDI ToF MS analysis as readout. A highly specific limited proteolysis activity was elicited in human plasma by shifting the pH to 6. Mass spectrometry showed that two singly charged ion signals at m/z 2753.44 and m/z 2937.56 significantly increased in abundance under mild acidic conditions as a function of incubation time. For proving that a provoked proteolytic activity in mild acidic solution caused the appearance of the observed peptides, control measurements were performed (i) with pepstatin as protease inhibitor, (ii) with heat-denatured samples, (iii) at pH 1.7, and (iv) at pH 7.5. Mass spectrometric fragmentation analysis showed that the observed peptides encompass the amino acid sequences 1-24 and 1-26 from the N-terminus of human serum albumin. Investigations on peptidase specificities suggest that the two best candidates for the observed serum albumin cleavages are cathepsin D and E. Reproducibility, robustness, and sensitivity prove the potential of the developed limited proteolysis assay to become of clinical importance for estimating dynamics of plasma-borne proteases with respect to associated pathophysiological tissue conditions.