Background: After approval of Sientra silicone gel breast implants in March of 2012, the U.S. Food and Drug Administration required completion of a 10-year U.
View Article and Find Full Text PDFBackground: Skin preconditioning prior to and following procedures, has previously been demonstrated to hasten and optimize healing, and decrease the symptoms and signs associated with invasive surgery. These trials involved the use of multiple topical products. In an effort to control costs and to increase patient compliance, a single surgical product was developed, with actives aimed at decreasing swelling, bruising, induration, and internal fibrous banding.
View Article and Find Full Text PDFBackground: XPAND II was a prospective, multicenter, single-arm, open-label, continued-access study designed to confirm the results from the XPAND study, a multicenter, prospective, randomized study for breast reconstruction. The AeroForm device received clearance from the U.S.
View Article and Find Full Text PDFPlast Reconstr Surg
April 2018
Background: The AlloX2 Breast Tissue Expander (Sientra, Santa Barbara, Calif.) is a unique device that contains a second port to allow for transdermal communication with the pocket around the implant. The injection dome of this expander contains two ports; one is used for traditional saline injection, and a new second port facilitates fluid drainage from the periprosthetic space through an integral drain.
View Article and Find Full Text PDFBackground: In March 2012, the United States Food and Drug Administration approved Sientra's application for premarket approval of its portfolio of round and shaped silicone gel breast implants based on data from the largest silicone gel breast implant study to date. This article presents the results of Sientra's Core Study at the conclusion of 10 years.
Methods: The Sientra Core Study was a 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra's breast implants in augmentation and reconstruction.
In this review, the authors provide a 20-year review and comparison of implant options and describe the evolution of breast implant surface textures; compare available implant surfaces; present long-term safety data from the 10-year US-based Core clinical studies; list the key benefits and risks associated with smooth and textured implants; and provide perspectives on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The authors explore the key benefits and risks associated with all available devices so that optimal and safe patient outcomes can be achieved.
View Article and Find Full Text PDFBackground: AeroForm is a new type of remote-controlled, needle-free, carbon dioxide-based expander involving a potentially faster method of tissue expansion. Results are presented here from the AirXpanders Patient Activated Controlled Tissue Expander pivotal trial comparing AeroForm to saline tissue expanders.
Methods: Women undergoing two-stage breast reconstruction were randomized at 17 U.
Background: Since approval in March 2012, data on Sientra's (Santa Barbara, CA) silicone gel implants have been updated and published regularly to provide immediate visibility to the continued safety and performance of these devices. The 9 year follow-up data support the previously published data confirming the ongoing safety and efficacy of Sientra silicone gel breast implants.
Objectives: The authors provide updated 9 year study data for Sientra's round and shaped silicone gel breast implants.
Background: Implant-based breast reconstruction is the most common reconstructive technique in the United States. Despite its popularity, saline-based tissue expansion still has its limitations, including lengthy expansion times, large uncomfortable bolus dosing, and frequent percutaneous injections/expansion visits. Ideally, a novel technology would eliminate frequent, percutaneous saline injections and allow patients to perform expansion at home, reducing the disruptive experience of current tissue expansion.
View Article and Find Full Text PDFBackground: On March 9, 2012, the Food and Drug Administration (FDA) approved Sientra's premarket approval application for its portfolio of silicone gel breast implants based on their review of Sientra's 3-year study data from the largest pivotal silicone gel breast implant study to date. This included the first approval of shaped breast implants in the United States.
Objectives: The authors provide an update to the 8-year safety and effectiveness of the Sientra High-Strength silicone gel breast implants.
Background: Intraoperative bleeding during rhinoplasty makes it difficult to sculpt cartilages. Residual blood from a wet field can lead to induration, fibrosis, and definition loss. Recent studies with desmopressin (1-deamino-8-D-arginine vasopressin) to reduce blood loss in a variety of operations and minimize postoperative bleeding problems suggest using that drug routinely for elective rhinoplasty and not just for patients with coagulation issues.
View Article and Find Full Text PDFBackground: Prosthetic reconstruction of the breast, as a 2-staged procedure using tissue expanders followed by placement of permanent implants, offers favorable aesthetic results with minimal additional surgical intervention. However, the current outpatient process to fill saline expanders can be lengthy and onerous, involving months of office visits and discomfort from the bolus saline expansions. We present a new technology (AeroForm Tissue Expansion System), which has the potential to improve the process of breast tissue expansion by providing a method for low-volume incremental filling, eliminating the need for injections and directly involving the patient by allowing her some control over the expansion process.
View Article and Find Full Text PDFBreast reconstruction improves quality-of-life of breast cancer patients. Different reconstructive options exist, yet commentary in the plastic surgery literature suggests that financial constraints are limiting access to autologous reconstruction (AR). This study follows national trends in breast reconstruction and identifies factors associated with reconstructive choices.
View Article and Find Full Text PDFThe transverse tensor fascia lata (TTFL) flap is an important alternative flap for autologous breast reconstruction. It is a horizontal variant of the tensor fascia lata myocutaneous flap and contains fat from the prominence of the upper lateral thigh (saddle bag). We present the surgical management of a woman with trochanteric lipodystrophy, who underwent staged bilateral mastectomy and autologous breast reconstruction with TTFL flaps.
View Article and Find Full Text PDFThe Accreditation Council of Graduate Medical Education has defined 6 core competencies that residents must master before completing their training. Objective structured clinical examinations (OSCEs) using standardized patients are effective educational tools to assess and teach core competencies. We developed an OSCE specific for microsurgical head and neck reconstruction.
View Article and Find Full Text PDFIntroduction: During microvascular breast reconstruction, exposure of internal mammary vessels (IMVs) is facilitated by the removal of a portion of the rib resulting in occasional chest contour deformity (CCD). The use of rib plating may reduce CCD and reduce postoperative pain.
Methods: All patients underwent microvascular breast reconstruction using IMVs.
White light spectroscopy non-invasively measures hemoglobin saturation at the capillary level rendering an end-organ measurement of perfusion. We hypothesized this technology could be used after microvascular surgery to allow for early detection of ischemia and thrombosis. The Spectros T-Stat monitoring device, which utilizes white light spectroscopy, was compared with traditional flap monitoring techniques including pencil Doppler and clinical exam.
View Article and Find Full Text PDFObjectives: To assess the efficacy of using concurrent partial mastectomy and reduction mammoplasty for resection of a wide range of tumor sizes and compare oncologic outcomes and postoperative complications on the basis of tumor size.
Background: Although tumor size greater than 4 cm has been considered an indication for undergoing a mastectomy, this dictum may not apply in women with breast hypertrophy, where the ratio of tumor size to breast size may still permit breast conservation. We wished to evaluate whether an approach combining partial mastectomy with reduction mammoplasty could provide a safe oncologic procedure with immediate breast reconstruction that could technically be applied even for large (>4 cm) lesions.
Introduction: Plastic surgery training has traditionally been modeled as an "apprenticeship," where faculty teach surgical skills to residents on live patients. Although this is a well-established process, the demand by the public and healthcare agencies for improved patient care, outcomes, and patient safety has led to the development of adjunct methods of teaching. The goal of this project is to assess the effectiveness of a web-based microsurgical curriculum.
View Article and Find Full Text PDFIn the elderly population with significant medical comorbidities, the safety of general anesthesia is often in question. In the head and neck, where regional and extradural anesthesia are not options, reconstruction of defects requiring free tissue transfer becomes a particular challenge for patients in whom general anesthesia is contraindicated. We present a case of a scalp reconstruction utilizing a latissimus dorsi free flap in a 91-year-old man performed entirely under local and regional anesthesia.
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