Safety and Efficacy of Smooth Surface Tissue Expander Breast Reconstruction

Fairchild, Berry; Ellsworth, Warren A.; Selber, Jesse C.; Bogue, David P.; Zavlin, Dmitry; Nemir, Stephanie; Checka, Cristina M.; Clemens, Mark W.

doi:10.1093/asj/sjy199

Cited by 33 publications

(47 citation statements)

References 44 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Particularly considering the association of textured devices with BIA-ALCL, 18 it is prudent that studies investigate the safety and efficacy of surface texture on complication profiles and reconstructive outcomes. Recently, two studies described complication profiles of TEs specifically, although they did not compare the rate of malpositioning or evaluate time to final reconstruction 19,20 . Both studies reported overall smooth TE complication rates to be lower at 15.6% than textured TE (26.1% and 19.1%) and comparable to rates reported in this study.…”

Section: Discussionsupporting

confidence: 54%

Smooth Versus Textured Tissue Expander Breast Reconstruction: Complications and Efficacy

et al. 2022

View full text Add to dashboard Cite

Introduction Ongoing recognition of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) and its link with textured devices has brought a paradigm shift in prosthetic-based breast reconstruction. Many institutions no longer offer textured expansion devices for staged reconstruction. However, there is a paucity of data regarding the efficacy of smooth tissue expanders (TE). We hypothesized that the time to final reconstruction and complication profile between smooth and textured TEs would be similar in breast reconstruction patients. Methods A retrospective chart review was performed of all patients who underwent TE breast reconstruction during a 6-year period at the Penn State Hershey Medical Center. Rates of complications treated nonoperatively and those requiring reoperation were assessed. Mechanical complications, including expander malposition and rupture, were evaluated. Time to final breast reconstruction was quantified. Mixed-effects logistic regression and linear regression models, as appropriate, were used to compare textured to smooth TEs. Patient characteristics and anatomic plane placement were adjusted for in all analyses of outcomes. Results Data were collected on 389 patients, encompassing 140 smooth and 604 textured TEs. Textured devices had an increased incidence of complications treated nonsurgically (16.7% vs 10.7%; P = 0.14). However, smooth TEs had an increased incidence of reoperation (12.1% vs 7.6%; P = 0.06). Most noteworthy was that although smooth TEs had a 40-fold increase in malposition (13.6% vs 0.3%; P < 0.001), no reoperation for this complication was warranted. Further, the time to final reconstruction was comparable between the 2 devices (textured expanders: 221 days and smooth expanders: 234 days; P = 0.15). Conclusions Staged, implant-based reconstruction is the most common surgical approach to recreate the breast mound following mastectomy. Textured TEs were the cornerstone to this approach. Unfortunately, the association between textured devices and BIA-ALCL now mandates an alternative. We postulated that smooth expanders would compare favorably for breast reconstruction. Although our study suggests that smooth TEs suffer more malposition, this has a negligible impact on the reconstructive timeline. Thus, smooth TEs may prove beneficial when considering the risk of BIA-ALCL associated with textured devices.

show abstract

Section: Discussionsupporting

confidence: 54%

Smooth Versus Textured Tissue Expander Breast Reconstruction: Complications and Efficacy

et al. 2022

View full text Add to dashboard Cite

show abstract

“…The ability to drain periprosthetic fluid with ease not only permits treatment of postoperative seroma, but also allows aspirated fluid to be sent for culture. While the ability to use the integrated drain of the AlloX2 TE for periprosthetic washouts, and thus, successfully treating select patients with periprosthetic infections without surgical intervention have been previously reported, 7 , 18 , 19 the value of having knowledge of the microbiological makeup of the periprosthetic fluid in an asymptomatic patient became evident in a patient who went on to develop surgical site infection. Having knowledge of the presence of Actinomyces neuii permitted initiation of targeted antibiotic therapy without delay, thus, avoiding a trial with broad-spectrum antibiotics and permitting salvage of the device without surgical intervention.…”

Section: Discussionmentioning

confidence: 99%

“…The advantage of being able to identify the pathogen was also commented on by Fairchild et al, who following early detection and treatment of methicillin-resistant Staphylococcus aureus via intravenous and periprosthetic washout with vancomycin were able to salvage the TE without surgical intervention. 19 …”

Section: Discussionmentioning

confidence: 99%

Advances in Tissue Expander Technology Enable Early Targeted Intervention in Prepectoral Breast Reconstruction

Liu

Henn

Shrefren

et al. 2021

Plastic and Reconstructive Surgery - Global Open

View full text Add to dashboard Cite

Background: Seroma and infection are among the most common complications after staged prepectoral implant-based reconstruction. Advances in tissue expander technology permit seroma aspiration via an integrated drain port, thus, holding promise for improving clinical outcomes. Methods: A prospectively maintained database of patients who had undergone immediate prepectoral breast reconstruction using the Sientra AlloX2 tissue expander was used to determine the rate of postoperative seroma formation, its volume and microbiological spectrum, as well as postoperative complications. Results: 49 patients (mean age: 49 years, mean body mass index: 24.5 kg/m 2 ) underwent 79 prepectoral breast reconstructions. Seroma was clinically suspected in 26 reconstructions (32.9%) and was easily aspirated in all cases via the integrated drain port. Importantly, periprosthetic fluid was successfully aspirated in 45 reconstructions (57%) without any clinical evidence for seroma, with aspirated cumulative fluid volumes exceeding 10 cm 3 in 12 reconstructions. Bacterial cultures from aspirated fluid were positive in six patients (12.2%), of whom two developed clinical signs of infection, at which point targeted antibiotic treatment was initiated. Conclusions: Our study demonstrates that routine office-based aspiration of periprosthetic fluid via the integrated drain port of the AlloX2 tissue expander not only permits successful aspiration of periprosthetic fluid but also allows aspirated fluid to be sent for culture, thus, providing a lead-time advantage for initiation of targeted antibiotic therapy in cases of postoperative surgical site infection. Furthermore, our observations indicate that positive bacterial cultures in the absence of clinical signs of infection do not mandate antibiotic therapy.

show abstract

“…Additional studies are needed to analyze complications related to devices that incorporate novel tissue expansion technology (eg, smooth tissue expanders), 16 optimization of lower pole expansion, patient-directed tissue expansion, dual port expanders, or other technologies that have demonstrated benefits compared with the technology used in the present analysis. 3 However, these results demonstrate that the use of CPX4 Breast Tissue Expanders are a safe and efficacious option for women undergoing 2-stage, expander-to-implant based primary breast reconstruction.…”

Section: Discussionmentioning

confidence: 99%

Safety of CPX4 Breast Tissue Expanders in Primary Reconstruction Patients

Maxwell¹,

Estes

Walcott

et al. 2021

Plastic and Reconstructive Surgery - Global Open

View full text Add to dashboard Cite

Background: In the United States, 2-stage expander-to-implant–based breast reconstruction accounts for more than half of all breast reconstruction procedures. Tissue expansion technology has undergone significant advancements in the past few decades. Previous reports suggest that the most common perioperative complications associated with breast tissue expanders are infection and skin flap necrosis. However, little clinical data are available for CPX4 Breast Tissue Expanders. The aim of the study was to measure real-world outcomes related to safety and effectiveness of the tissue expansion process, in patients who underwent primary breast reconstruction following the use of CPX4 Breast Tissue Expanders. Methods: This was a single-arm retrospective cohort design looking at patients who underwent 2-stage, expander-to-implant–based primary breast reconstruction at a single site between April 2013 and December 2016 and who had a minimum of 2 years follow-up. Descriptive statistics were used to summarize baseline characteristics and safety outcomes. Results: A total of 123 patients were followed for an average of 3.73 ± 0.94 years. At least 1 complication during the time of tissue expansion, before the permanent implant, was reported in 39/123 (31.7%) patients [51/220 implants (23.2%)]. The most frequently reported complications were delayed wound healing (13.8%) and cellulitis/infection (9.7%). Conclusion: Analyses of real-world data from a single site provide further support for the safety and effectiveness of the CPX4 Breast Tissue Expander for women undergoing 2-stage expander-to-implant primary breast reconstruction.

show abstract

Safety and Efficacy of Smooth Surface Tissue Expander Breast Reconstruction

Cited by 33 publications

References 44 publications

Smooth Versus Textured Tissue Expander Breast Reconstruction: Complications and Efficacy

Smooth Versus Textured Tissue Expander Breast Reconstruction: Complications and Efficacy

Advances in Tissue Expander Technology Enable Early Targeted Intervention in Prepectoral Breast Reconstruction

Safety of CPX4 Breast Tissue Expanders in Primary Reconstruction Patients

Contact Info

Product

Resources

About