Soft-Tissue Augmentation With Hyaluronic Acid Filler for Labia Majora and Mons Pubis

Hexsel, Dóris; DalʼForno, Taciana; Caspary, Patricia; Hexsel, Camile L.

doi:10.1097/dss.0000000000000733

Cited by 19 publications

(7 citation statements)

References 4 publications

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“…Palpable nodule formation is a complication encountered due to the formation of capsule form around the injected material. In this case, the use of intra-nodular corticosteroid or hyaluronidase is required [14]. In our study, we did not encounter post-surgical nodule, granuloma or lipoma formation since we used fat products that were micronized with Adinizer Ò and reduced to 400 microns.…”

Section: Discussionmentioning

confidence: 92%

“…A total of 2-6 ml of HA was applied to deep tissues either subcutaneously per se or to the deep tissue below Dartos fascia together with subcutaneous injection. Minor complications such as ecchymosis, edema, redness and nodule formation have been reported after these applications [13,14]. Palpable nodule formation is a complication encountered due to the formation of capsule form around the injected material.…”

Section: Discussionmentioning

confidence: 99%

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360 Genital Fat Transfer

Cihantimur¹,

Aglamis²,

Özsular³

2021

Aesth Plast Surg

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Background This study was designed to evaluate utility of transferring autologous adipose-derived mesenchymal stem cells with high regenerative capacity and adipose tissue derived-stromal vascular fraction, so-called 360 Vaginal Beautification technique, in labia majora augmentation and vaginal tightening operation. Methods A total of 97 female patients who underwent labia majora augmentation and vaginal tightening operation with 360 Vaginal Beautification technique were included. Post-discharge early (3rd and 7th postoperative day) and late (1 st and 3rd postoperative month) surgical complications were assessed , while the Female Genital Self-Image Scale (FGSIS) was applied before surgery and also during postoperative 6-12 months. Results All complications noted on postoperative 3rd day (ecchymosis of labia majus, ecchymosis of clitoral hood, tenderness in the pubic area and pain at the vaginal entrance points) regressed on postoperative 7th day with no infection, edema, lipoma or granuloma formation in any patient. Total mean FGSIS score was 17.7 ± 1.6 in the preoperative period, and increased significantly to 20.9 ± 1.4 and 22.2 ± 1.8 in the postoperative 6th month (p \ 0.001) and 12th month (p = 0.013), respectively.Conclusions The use of autologous fat, called 360 vaginal beautification, in the labia majora augmentation and vaginal tightening appears to be a safe technique due to use of autologous tissue transfer and to be associated with high satisfaction rate and an advantage of being more minimally invasive than surgical labia majora augmentation and vaginal tightening.

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Section: Discussionmentioning

confidence: 92%

Section: Discussionmentioning

confidence: 99%

360 Genital Fat Transfer

Cihantimur¹,

Aglamis²,

Özsular³

2021

Aesth Plast Surg

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“…Hyaluronic acid filling: Variable volumes of hyaluronic acid are injected into the subcutaneous tissue 52,65 …”

Section: Methodsmentioning

confidence: 99%

“…[62][63][64] (2) Hyaluronic acid filling: Variable volumes of hyaluronic acid are injected into the subcutaneous tissue. 52,65 Labia majora augmentation-surgical:…”

Section: Labia Majora Augmentation Proceduresmentioning

confidence: 99%

Joint Report on Terminology for Cosmetic Gynecology

2022

Female Pelvic Med Reconstr Surg

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Introduction and hypothesis:The current terminology used to describe cosmetic gynecologic procedures includes many nondescriptive, trademarked, or informal names, which contributes to substantial ambiguity about their aims and specific techniques. The development of clear, uniform descriptive terminology for cosmetic gynecology is needed for patients, researchers, and practitioners across multiple specialties.Methods: This document was developed from a collaboration of selected members from the International Urogynecological Association (IUGA) and the American Urogynecologic Society (AUGS). Wide-ranging literature reviews were performed to identify the breadth of currently used terms and tools for measuring efficacy and safety. After extensive internal review the adoption of each definition was ratified by group consensus.Results: A terminology report for elective cosmetic gynecology procedures, anatomical classification, outcome metrics, and reporting of complications has been developed. This document seeks to provide clear descriptive guidance for patients, researchers, and practitioners across multiple specialties. This document will be subject to internal review by IUGA and AUGS to incorporate and adopt evidence-based changes in the field.Conclusions: A consensus-based document establishing clear terminology for cosmetic gynecology procedures has been created. Use of these terms should be encouraged to provide clarity to patients seeking these procedures and to facilitate future research to establish the safety and efficacy of these procedures.

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“…45,46 This is analogous to the FDA approval of STFs for hand rejuvenation. Practitioners will likely continue to find new innovative uses for STFs; a recent publication 47 reports the use of STFs for labia majora and mons pubis augmentation. Off-label use of devices and drugs remains a significant component of medicine.…”

Section: Key Pointsmentioning

confidence: 99%

Device Safety Implications of the Clinical Data Leading to US Food and Drug Administration Approval of Soft-Tissue Fillers

Lohman

Ghobadi

2017

JAMA Facial Plast Surg

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oft-tissue filler (STF) injections are the second most common nonsurgical cosmetic procedure in the United States, preceded only by botulinum toxin injections. In 2015, the number of STF procedures increased more than 27% for hyaluronic acid, 15% for calcium hydroxylapatite (Radiesse), and 4% for poly-L-lactic acid (Sculptra) injections from the prior year. 1 Absorbable STFs are approved for correction of facial wrinkles and skin folds, such as the nasolabial folds. A permanent STF is indicated for nasolabial folds and acne scars, whereas the indications for other permanent STFs are limited to correction of lipoatrophy in individuals with human immunodeficiency virus (HIV). 2 However, off-label use of STFs for upper, middle, and lower facial treatments is common in women and increasing in men. [3][4][5][6] Soft-tissue fillers are regulated as a class III medical device, the highest risk designation given by the FDA. Most class III devices require a premarket approval (PMA) application detailing the device's safety and efficacy. 7 In May 2015, the FDA issued a safety communication that highlighted reported complications of STFs, including vision impairment, blindness, stroke, and death of skin and facial structures. 8 In aesthetic medicine, there has been ongoing concern about the safety of STFs and the risk of irreversible adverse events (AEs). Because of the popularity of STFs, recent safety concerns, and legislative changes to medical device regulation, including the recent passage of the 21st Century Cures Act, [9][10][11] there is an impetus for clinicians to understand the quality of evidence that led to approval of STFs and the implications for future device safety. MethodsThe FDA's publicly available database of original PMAs was assessed for all STFs using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The FDA publishes a summary of safety and effectiveness data (SSED) for approved devices that details the preclinical, pivotal, and supplemental trials from the PMA process. This document is the primary source of PMA data provided by the FDA. The manufacturer typically prepares the SSED with guidelines provided by the FDA. Of 14 original IMPORTANCE The US Food and Drug Administration (FDA) recently issued a safety warning regarding soft-tissue fillers (STFs) based on the risk of blindness and facial necrosis.OBJECTIVE To examine the quality of evidence leading to FDA approval of STFs.EVIDENCE REVIEW All original approvals for STFs were mined using the publicly available FDA database. The Cochrane Collaboration's risk of bias assessment tool was applied to all randomized clinical trials (RCTs).FINDINGS A total of 14 STF approvals were identified. Of those, 10 pivotal studies (71%) were RCTs and 9 (60%) were masked. The median number of patients per trial was 144 (range, 30-439). Eleven of 12 studies (92%) met their primary end point. Ten of 14 trials (71%) involved injections solely of the nasolabial folds or cheeks; only 4 trials involved treatment of other facial r...

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Soft-Tissue Augmentation With Hyaluronic Acid Filler for Labia Majora and Mons Pubis

Cited by 19 publications

References 4 publications

360 Genital Fat Transfer

360 Genital Fat Transfer

Joint Report on Terminology for Cosmetic Gynecology

Device Safety Implications of the Clinical Data Leading to US Food and Drug Administration Approval of Soft-Tissue Fillers

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