A Multicenter, Randomized, Double-Blind, Split-Body Clinical Trial Evaluating the Efficacy and Outcomes of a Topical Product Pre and Post Aesthetic Surgical Body Procedures.

Background: 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. Objectives: This multi-center trial was designed to measure the efficacy of this single product in these mentioned parameters. Methods: A double-blind, randomized, split body, clinical study was undertaken in 29 patients involving 38 surgical procedures. Assessments included photography, biopsies, ultrasound imaging, and blinded investigator and participant assessments. Results: Differentiated results between test comparator sides became apparent at postop day 10-14 (as previously observed). Thus, blinded investigator and participant assessment scores demonstrated statistical significance exclusive to the test product side at postop day 10-14 for ecchymoses and then extending to skin discoloration, edema, induration and subcutaneous fibrous banding, at weeks 3, 4, 6, and 12. Ultrasound evaluation confirmed the earlier dissolution of fibrous banding on the test side in the subcutaneous tissue at the 3-6-week postop period. In addition, biopsies assessing the pre-conditioned period prior to surgery confirmed that the topical test product stimulated a remodeled extracellular matrix without comparative changes on the opposite side. Conclusions: A single peri-surgical product designed for the use with invasive surgery produced significant differences in ecchymosis, skin discoloration, edema, induration and ongoing resolution of fibrous banding over many weeks. This study validation provides an additional adjunct to surgical procedures.

Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel.

BACKGROUND: 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. A total of 1,788 patients (3,506 implants) were enrolled, including 1,116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction. RESULTS: Across all cohorts, the rate of rupture by patient was 8.6%, the rate of Baker grade III/IV capsular contracture was 13.5%, and the rate of reoperation was 31.5%. The rate of capsular contracture was statistically significantly lower for textured devices [9.0%; 95% confidence interval (CI), 7.0-11.5%] compared with smooth devices (17.5%; 95% CI, 14.9-20.4%). There were no cases of breast implant-associated anaplastic large cell lymphoma. Primary reasons for reoperations included capsular contracture (18.8%), and style/size change (19.3%), with over 50% of the reoperations due to cosmetic reasons. CONCLUSION: The 10-year results of Sientra's Core Study support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped breast implants.

Sientra AlloX2 Short-Term Case Study, Surgical Pearls, and Roundtable Discussion.

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. The AlloX2 allows for the treatment of seromas and diagnostic fluid sampling to identify bacteria and hone antibiotic treatment in the setting of periprosthetic infection. This device has a significant advantage over traditional expanders, given that seromas and infections are the most common complications in implant-based breast reconstruction, with or without the use of soft-tissue support matrix. METHODS: This article provides short-term case studies and surgical pearls from 3 surgeons who utilize the AlloX2 in primary breast reconstruction patients. Three surgeons implanted 40 primary reconstruction patients with AlloX2. Follow-up was approximately 6 months, per the standard of care. All patients implanted with AlloX2 underwent immediate reconstruction, with the exception of 1 delayed reconstruction. RESULTS: The most common complications the patients experienced were seromas. In most cases, the surgeons successfully used the second port to drain periprosthetic fluid. CONCLUSIONS: The AlloX2 has been successful in treating seromas and should be considered a tool for noninvasive treatment of common complications of implant-based breast reconstruction. Three surgeons with varied backgrounds and techniques provide their surgical and postoperative management experiences and recommendations.

Long-Term Safety of Textured and Smooth Breast Implants.

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.

Nine-Year Core Study Data for Sientra's FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel.

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. METHODS: The Core Study is an ongoing 10 year study that enrolled 1788 patients with 3506 Sientra implants across four indications (primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction). For the safety analysis, Kaplan-Meier risk rates were calculated to evaluate postoperative complications, including all breast implant-related adverse effects. For the effectiveness analyses, results were presented through 8 years as patient satisfaction scores were assessed at even years. RESULTS: Through 9 years, the overall risk of capsular contracture was 12.6%. Smooth devices (16.6%, 95% CI, 14.2%, 19.5%) had a statistically significantly higher rate of capsular contracture compared to textured devices (8.0%, 95% CI, 6.2%, 10.4%). Out of the 610 reoperations in 477 patients, over half of all reoperations were due to cosmetic reasons (n = 315; 51.6%). Patient satisfaction remains high through 8 years, with 90% of primary augmentation patients indicating their breast implants look natural and feel soft. CONCLUSIONS: The 9-year follow-up data from the ongoing Core Study of the Sientra portfolio of HSC and HSC+ silicone gel breast implants reaffirm the very strong safety profile as well as continued patient satisfaction. LEVEL OF EVIDENCE: 2 Therapeutic.

Carbon Dioxide versus Saline Tissue Expanders: Does It Matter?

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. METHODS: Within the past 6 years, the AeroForm tissue expander system has used remotely activated carbon dioxide release as the fill medium instead of saline, eliminating many limitations of traditional tissue expanders. In this article, the authors first review the relevant literature concerning carbon dioxide-based tissue expansion in animal and human models. The authors then analyze the similarities and differences between two groundbreaking human trials (i.e., Patient Activated Controlled Expansion and AirXpanders Patient Activated Controlled Tissue Expander) with carbon dioxide-based expanders and discuss the risks and benefits associated with this new technology. RESULTS: At their site, the authors have enrolled 34 patients using 36 experimental devices in total, and have found significantly shorter expansion and overall reconstruction times in the patient-controlled tissue expander group. CONCLUSIONS: The authors believe that carbon dioxide-based devices may play a significant role in the future of implant-based breast reconstruction, and may be widely applicable to other areas of plastic surgery that also involve tissue expansion.

Desmopressin as a hemostatic agent to provide a dry intraoperative field in rhinoplasty.

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. METHOD: Seventy-three consecutive rhinoplasty patients received desmopressin for the purpose of obtaining a dry operative field. The initial dose was 0.1 µg/kg. If the field was not as dry as desired, a second dose was given; if necessary, a third dose to a maximum of 0.3 µg/kg was given. All cases exhibited a satisfactorily dry field. There were no adverse effects. A retrospective comparison was made to 300 consecutive cases not receiving desmopressin. RESULTS: Thirty of the 73 patients received a starting dose of 0.1 µg/kg and nothing more. Fourteen received a second dose of 0.1 µg/kg because the field was not as dry as desired and 29 received a third dose of 0.1 µg/kg because the field was not as dry as desired. All 73 patients exhibited a satisfactorily dry field, in contrast to 9 percent in the group not receiving desmopressin. CONCLUSIONS: This study confirms the hemostatic effectiveness of desmopressin at lower than normally used doses in rhinoplasty. It also confirms its safety. It suggests its use in other procedures. A larger, carefully controlled study is indicated. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

AeroForm patient controlled tissue expansion and saline tissue expansion for breast reconstruction: a randomized controlled trial.

BACKGROUND: 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. METHODS: The described study is a 2:1 randomized controlled trial of the investigational CO2 expansion system and saline expanders. Of the 82 women receiving expanders, 58 (39 bilateral and 19 unilateral; bilateral rate, 67%) were implanted with CO2 tissue expanders and 24 subjects (15 bilateral and 9 unilateral; bilateral rate, 63%) were implanted with saline expanders. RESULTS: Preliminary validated expansion results were available for 55 women. Available mean time for active expansion in the CO2 group was 18.2 (9.2) days (median, 14.0; range, 5-39; number of expanders, 53), which was less than the mean time for active expansion in the saline group: 57.4 (33.6) days (median, 55; range, 5-137; number of expanders, 33). Available mean time from implant placement to exchange for a permanent prosthesis in the CO2 group was shorter [106.3 (42.9) days; median, 99; range, 42-237; number of expanders, 53] than for the women in the control group [151.7 (62.6) days; median, 140; range, 69-433; number of expanders, 33]. After 2 events--underexpansion (n=1) and erosion (n=1)--in the CO2 group, the internal membrane was redesigned and the expander bulk was decreased to minimize the risk of underexpansion and erosion in subsequent patients. CONCLUSIONS: Preliminary evidence indicates that the CO2-based tissue expansion system performs the same function as saline expansion devices without significantly altering the risk to the patient and that the device has the potential to make the expansion process faster and more convenient for both the patient and the physician.

The Matrix Rib Plating System: improving aesthetic outcomes in microvascular breast reconstruction.

INTRODUCTION: 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. In the retrospective arm, photographs were assessed by a blinded reviewer for CCDs. In the prospective cohort, patients were randomized to rib plating with the Synthes Matrix Rib Plating System or no rib plating. Postoperatively, patients were assessed for CCD and pain. RESULTS: In the retrospective arm, 11 of 98 (11.2%) patients representing 12 of 130 (9.2%) breast reconstructions had a noticeable contour deformity. The average body mass index (BMI) of patients with CCDs was 26.6 kg/m. In the prospective arm, there was 16% (3 of 19) rate of visible and palpable CCDs among controls, compared to 0% rate of palpable and visible contour deformity in the rib plating group. Pain was decreased in the rib plating group on all postoperative days. The pain reduction was statistically significant at rest by postoperative day 30. CONCLUSION: The majority of patients (9 of 11) with compromised aesthetic outcomes had a BMI less than 30 kg/m, suggesting a paucity of overlying soft tissue contributed to visibility of these bony defects. Rib plating prevented chest contour deformity, reduced postoperative pain, and added limited additional morbidity. We believe that rib plating is a safe, useful adjunct to microvascular breast reconstruction using IMVs, as it may improve aesthetic outcomes and reduce postoperative pain.

Teaching core competencies of reconstructive microsurgery with the use of standardized patients.

The 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. Fifteen plastic surgery residents participated in the OSCE simulating a typical new patient consultation, which involved a patient with oral cancer. Residents were scored in all 6 core competencies by the standardized patients and faculty experts. Analysis of participant performance showed that although residents performed well overall, many lacked proficiency in systems-based practice. Junior residents were also more likely to omit critical elements of the physical examination compared to senior residents. We have modified our educational curriculum to specifically address these deficiencies. Our study demonstrates that the OSCE is an effective assessment tool for teaching and assessing all core competencies in microsurgery.

Transverse tensor fascia lata myocutaneous flap for microvascular breast reconstruction: case report and review of the literature.

The 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. We discuss technical points in TTFL flap design and harvest. Breast reconstruction was successful and the thigh donor sites had excellent aesthetic contour. There were no complications at either recipient or donor sites. The TTFL flap is an important alternative flap for autologous breast reconstruction when other options are less optimal, and has a secondary benefit of thigh donor site closure with lateral thigh lift techniques. The TTFL flap should be presented as an option for autologous breast reconstruction in women with prominent trochanteric lipodystrophy of the upper lateral thighs.

Evaluating the feasibility of extended partial mastectomy and immediate reduction mammoplasty reconstruction as an alternative to mastectomy.

OBJECTIVES: 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. METHODS: A retrospective review of all patients undergoing partial mastectomy and concurrent reduction mammoplasty performed at our institution from 2000 to 2009. Clinical characteristics at presentation, pathologic data, and follow-up data were collected and analyzed. RESULTS: Eighty-five consecutive simultaneous partial mastectomy/reduction mammoplasty procedures were performed in 79 patients. Average tumor size was 2.8 cm for ductal carcinoma in situ (0.05-17.0 cm), 2.4 cm for invasive ductal carcinoma (IDC) (0.2-8.9 cm), 3.5 cm for lobular carcinoma (1.6-8.0 cm), and 5.7 cm for phyllodes tumors (3.7-7.6 cm). Twenty-five of 85 tumors (29.4%) were larger than 4 cm. Distribution for stage 0, I, II, III, and IV disease was 15, 12, 35, 19, and 2 tumors respectively, with an additional 2 phyllodes tumors. Median follow-up was 39 months (10-130 months). Seventy-five patients (94.9%) achieved successful breast conservation, whereas 4 patients (5.1%) went on to completion mastectomy. Thirteen patients (16.4%) required 1 reexcision to achieve clear margins, and 2 (2.5%) required multiple reexcisions. Two patients had a local recurrence during the follow-up period, one of whom underwent reexcision and the other underwent mastectomy. The overall complication rate was 14.1%, which included 4 major complications (4.7%) requiring an unplanned return to the operating room and need for hospital readmission, and 8 minor wound-related complications (9.4%). Neither recurrence nor complication rates were increased in patients with tumors greater than 4 cm when compared with tumors less than or equal to 4 cm. CONCLUSIONS: A partial mastectomy with concurrent reduction mammoplasty technique is a viable option for breast conservation even for larger tumors, combining a safe oncologic procedure with excellent cosmesis. A combined effort between breast surgeons and reconstructive surgeons has a high probability of success with low recurrence rates. In carefully selected patients, this approach may be preferable to mastecomy and breast reconstruction, particularly when postmastectomy radiation therapy is anticipated.