McIndoe Operation without Skin Graft: A New Neovaginal Prosthesis of Polylactic Acid (PLA)

Acién, Pedro; Acién, Maribel; Oliva-Meyer, Miguel-Angel; Sanchez-Lozano, Miguel; Martínez-Garcia, Javier

doi:10.9734/bjmmr/2016/29512

Cited by 5 publications

(9 citation statements)

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“…All these have an impact on their family members too. To overcome these issues it is necessary that the patient as well as their family undergo psychological counseling, to educate and motivate them about the treatment before commencement of the procedure [6].…”

Section: Discussionmentioning

confidence: 99%

“…is a technique frequently used in Europe which is a mixture of surgical and non surgical procedures. Other procedures for the creation of the neovagina include the Davydou technique, Creatsas vaginoplasty, and Wharton-Sheares-George neovaginoplasty [6].…”

Section: Discussionmentioning

confidence: 99%

“…The various materials used for fabrication of neovaginal prosthesis/ vaginal dilator as mentioned in the literature are: Silicon, foam rubber, wood, plastic, glass, teflon, dexon, vacuum expandable condom, simple syringe, polyethylene bag, heat polymerizing acrylic, autopolymerizing acrylic and PLA. PLA or Poly Lactic acid is a biodegradable polymer derived from lactic acid, designed by 3D technology (a material which is highly biocompatible and has the property to stimulate epithelial regeneration [6].…”

Section: Materials Used For Fabrication Of Neovaginal Prosthesismentioning

confidence: 99%

See 2 more Smart Citations

Neovaginal Prosthesis - Hallmark in the Management of Patients with MRKH Syndrome – A Case Report

E¹,

A²,

Sreelal³

et al. 2020

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Materials Used For Fabrication Of Neovaginal Prosthesismentioning

confidence: 99%

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Neovaginal Prosthesis - Hallmark in the Management of Patients with MRKH Syndrome – A Case Report

E¹,

A²,

Sreelal³

et al. 2020

SJODR

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“…The PACIENA prosthesis ® has been introduced as a new prototype of neovaginal prosthesis adapted to the vagina of normal women and has been patented (utility model U201630650, international pub. WO/2017/203076) [11–13]. The basic and novel features of this new prototype of prosthesis for neovaginas were described in [12].…”

Section: Methodsmentioning

confidence: 99%

“…Good results have been achieved by simply covering the prosthesis with Interceed® [8], and other authors [9, 10] have also obtained good results without using skin grafts, with evidence of squamous epithelization of the neovaginal vault. Acién et al [11–13] suggested that by using a prosthesis made of poly-lactic acid (PLA, a biodegradable polymer derived from lactic acid often used as a scaffold in tissue engineering and regenerative medicine [14, 15] and whose contribution to epithelization has been studied by different authors [16, 17]) and designed and manufactured with 3-dimensional (3D) printing technology as a vaginal mould, skin grafting could be avoided, and vaginoplasty would be simpler, with good anatomical and functional results. We do not know of any other neovaginal prostheses for humans with the design, printing and characteristics of our PLA prosthesis.…”

Section: Introductionmentioning

confidence: 99%

Clinical pilot study to evaluate the neovaginal PACIENA prosthesis® for vaginoplasty without skin grafts in women with vaginal agenesis

et al. 2019

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BackgroundTo evaluate the feasibility and clinical outcomes of vaginoplasties using a neovaginal polylactic acid prosthesis made with 3-dimensional (3D) printing technology as an intraneovaginal mould.MethodsThis was an interventionist, prospective, and multicentre clinical pilot investigation of a sanitary product (PACIENA prosthesis®) aiming to recruit and operate on 8 patients over 6 months with a follow-up period of 6 months. Only six patients with Rokitansky syndrome and one patient with Morris syndrome (7 patients in total) were operated on in two university hospitals: “La Fe”, Valencia (H1) and “Arrixaca”, Murcia (H2). Interventions: Extensive surgical dissection of a defined space between the urethra and bladder in the front and of the rectum in the back as well as insertion of the PACIENA prosthesis® covered with Interceed® were performed. After 12 days, the prosthesis was changed to the silicone-covered version for daily application.ResultsIn the 6 patients with Rokitansky syndrome (86%), the primary endpoint (satisfactory vaginal outcome in terms of appearance, function, and sensation without relevant additional morbidity) was achieved, although only 2 patients (28%) were sexually active at the end of 6 months of follow-up. The patient with Morris syndrome withdrew from the study after 1 month. Patients without bacterial colonization showed positive Schiller tests at 1 month, and subsequent biopsies showed adequate keratinization and epidermization. Epithelization and iodopositivity were delayed in the patients who developed inflammatory granulomas.ConclusionsGood anatomical and functional results can be achieved with the PACIENA prosthesis® for vaginoplasties without skin grafts. However, adequate patient selection and education, good surgical techniques and haemostasis, postoperative support, and prevention of bacterial colonization are important.Trial registrationThis clinical study was approved by the Ethical Clinical Investigation Committee of San Juan University Hospital on September 27, 2016, to be conducted in the participating centres; it was authorized by the Spanish Agency of Medicines and Health Products (AEMPS) on April 24, 2017 (exp. no. 585/16/EC), to be carried out in that hospitals.

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Vaginoplasty: modified McIndoe using xenograft and a tailored 3D-printer mold

2021

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McIndoe Operation without Skin Graft: A New Neovaginal Prosthesis of Polylactic Acid (PLA)

Cited by 5 publications

References 0 publications

Neovaginal Prosthesis - Hallmark in the Management of Patients with MRKH Syndrome – A Case Report

Neovaginal Prosthesis - Hallmark in the Management of Patients with MRKH Syndrome – A Case Report

Clinical pilot study to evaluate the neovaginal PACIENA prosthesis® for vaginoplasty without skin grafts in women with vaginal agenesis

Vaginoplasty: modified McIndoe using xenograft and a tailored 3D-printer mold

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