Breast Implants for Mammaplasty: An Umbrella Review of Meta-analyses of Multiple Complications

Bi, Siwei; Liu, Ruiqi; Wu, Beiyi; Shen, Yinzhi; Jia, Kaiyu; Sun, Kaibo; Gu, Jun

doi:10.1007/s00266-020-01866-0

Cited by 10 publications

(10 citation statements)

References 51 publications

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“…Historical reports suggested higher infection and seroma rates associated with ADM use. 9 , 11 , 12 These reports have been countered by studies showing similar complication profiles between ADM and nonADM cohorts. 4 , 18 , 19 18 Although some reports have suggested that the use of ADM may curb the complication of capsular contracture, limited population sizes and study durations decrease the strength of the data from such studies.…”

Section: Discussionmentioning

confidence: 98%

Acellular Dermal Matrices in Breast Reconstruction: CARE Trial 5-Year Outcomes Data for More Than 9500 Patients

Ellsworth

Hammer

et al. 2022

Plastic and Reconstructive Surgery - Global Open

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Background: Few studies have assessed long-term complications in women undergoing implant-based breast reconstruction with use of an acellular dermal matrix (ADM). This study compared outcomes over 5 years in women undergoing breast reconstruction procedures with and without ADM. Methods: Complications data in patients enrolled in the prospective Continued Access Reconstruction/Revision Expansion trial were segregated by use of ADM versus no ADM in patients undergoing primary breast reconstruction or revision-reconstruction. Continued Access Reconstruction/Revision Expansion trial evaluated long-term safety and effectiveness of shaped, textured, silicone implants. Results: Of the 9502 women, 257 had primary (n = 160) or revision-reconstruction ( n = 97) with ADMs; 9245 had primary (n = 6977) or revision-reconstruction ( n = 2268) without ADMs. Capsular contracture rates in primary reconstruction were lower with ADM than without at year 5 (3.2% versus 7.4%); rates were similar at year 1 (≤2.4%). Capsular contracture rates in revision-reconstruction were lower with ADM than without at year 5 (1.4% versus 8.9%); rates were similar at year 1 (≤2.5%). Seroma rates were low and sustained for all cohorts throughout the 5 years (≤2.9%). Reoperation rates increased over time in all cohorts, with similar rates between groups (2.4%–47.3% from week 4 to year 5 across cohorts). Other trends over time included lower rates for asymmetry and implant malposition with ADM than without. Conclusion: These long-term data suggest that the use of ADM in breast reconstruction procedures may provide a benefit in reducing complications, such as capsular contracture, and may sustain low rates of seroma.

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Section: Discussionmentioning

confidence: 98%

Acellular Dermal Matrices in Breast Reconstruction: CARE Trial 5-Year Outcomes Data for More Than 9500 Patients

Ellsworth

Hammer

et al. 2022

Plastic and Reconstructive Surgery - Global Open

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“…This supports previous literature findings that type of acellular dermal matrix does not affect patient-reported outcomes. [12][13][14] Age significantly influenced several satisfaction scores in the postmastectomy questionnaire, with older patients reporting higher levels of satisfaction. Specifically, older patients reported more satisfaction with overall choice of undergoing breast reconstruction, which type of breast reconstruction they chose, and in confidence of recommending the same type of reconstruction to a friend.…”

Section: Discussionmentioning

confidence: 99%

The BREASTrial Stage III: Acellular Dermal Matrix Breast Reconstruction Outcomes from Three Months to Two Years Postoperative

Mendenhall

Moss

Graham

et al. 2022

Plastic &Amp; Reconstructive Surgery

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Background:The Breast Reconstruction Evaluation of Acellular Dermal Matrix as a Sling Trial (BREASTrial) is a blinded, randomized trial comparing the outcomes of tissue expander breast reconstruction using AlloDerm or DermaMatrix. In this final stage of the trial, outcomes 3 months to 2 years after definitive reconstruction are reported along with patient satisfaction data. Methods: A randomized trial was conducted to compare complication rates between groups of patients who underwent reconstruction with AlloDerm and DermaMatrix. Regression models were used to analyze the impact of matrix type, age, chemotherapy, radiation therapy, and reconstructive type on complication rates. Premastectomy and postmastectomy questionnaires were used to assess patient satisfaction and were also analyzed using regression models. Results: Of the 128 patients (199 breasts) who were randomized in the trial, 108 patients (167 breasts) were available for analysis in stage III. There was no difference in the overall complication rates between the AlloDerm and DermaMatrix groups (6% versus 13.2%; P = 0.3) or the severity of those complications (P = 0.7). Obesity was a positive predictor for complications, regardless of reconstruction group (P = 0.02). Patient satisfaction was positive overall and did not grossly vary between AlloDerm and DermaMatrix groups. Conclusions: Findings from the BREASTrial conclude that AlloDerm and DermaMatrix exhibit similar histologic and clinical outcomes. Patient satisfaction is also similar between matrices. Obesity is a predictor of complications, and acellular dermal matrices should be used with caution in these patients. As the largest head-to-head trial comparing two acellular dermal matrices, the BREASTrial contributes to the fund of knowledge regarding acellular dermal matrix supplementation in breast reconstruction.

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“…2 15 Both had a smaller sample size of ADM-assisted breast reconstruction cases that may have been underpowered to detect any differences in complications ( n = 1,717–3,301). 2 3 15 Most meta-analyses looking at complications have consistently found higher risks of flap necrosis, 16 17 18 infection, 16 17 18 seroma, 16 17 18 19 reconstructive failure, 16 17 18 and total complications. 16 17 Furthermore, a randomized controlled trial of implant-based breast reconstruction with and without ADM found higher risks of wound healing problems.…”

Section: Discussionmentioning

confidence: 99%

“…2 3 15 Most meta-analyses looking at complications have consistently found higher risks of flap necrosis, 16 17 18 infection, 16 17 18 seroma, 16 17 18 19 reconstructive failure, 16 17 18 and total complications. 16 17 Furthermore, a randomized controlled trial of implant-based breast reconstruction with and without ADM found higher risks of wound healing problems. 20 However, complications of hematoma, 18 implant explanation, 17 reoperation, 17 and cellulitis 18 were inconclusive or did not see an increase.…”

Section: Discussionmentioning

confidence: 99%

“… 24 25 This can be concerning since higher infection rates are seen in ADM-assisted breast reconstruction in both our study and meta-analyses. 16 17 18 Contrarily, Hidalgo and Weinstein demonstrated superior success in treating capsular contracture in breast augmentation patients with ADM over the conventional treatment of capsulectomies. 26 Perhaps clearer indications and better patient selection should be considered in terms of the application of ADM in breast reconstructions.…”

Section: Discussionmentioning

confidence: 99%

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A Nationwide Analysis Evaluating the Safety of Using Acellular Dermal Matrix with Tissue Expander-Based Breast Reconstruction

et al. 2022

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Background In March 2021, the United States Food and Drug Administration (FDA) safety communication cautioned against the use of acellular dermal matrix (ADM) products in breast reconstruction and reiterated that the FDA does not approve ADM use in breast surgery. This study aims to assess the safety of ADM use in breast reconstruction. Methods Women who underwent ADM and non-ADM assisted tissue expander (TE)-based breast reconstruction were identified using the National Surgical Quality Improvement Program database (2012–2019). Trends of ADM use over time, and 30-day outcomes of surgical site infection (SSI), dehiscence, and unplanned reoperation were assessed. Results Of the 49,049 TE-based breast reconstructive cases, 42.4% were ADM assisted and 57.6% non-ADM assisted. From 2012 to 2019, the use of ADM increased from 26.1 to 55.6% (relative risk [RR] =1.10; p < 0.01). Higher rates of SSI (3.9 vs. 3.4%; p = 0.003) and reoperation (7.4 vs. 6.0%; p < 0.001) were seen in the ADM cohort. There was no significant difference seen in dehiscence rates (0.7 vs. 0.7%; p = 0.73). The most common reoperation within 30 days for the ADM group (17.6%) was removal of TE without insertion of implant (current procedural terminology: 11,971). ADM-assisted breast reconstruction was associated with increased relative risk of SSI by 10% (RR = 1.10, confidence interval [CI]: 1.01–1.21; p = 0.03) and reoperation by 15% (RR = 1.15, CI: 1.08–1.23; p < 0.001). Conclusions ADM-assisted breast reconstruction more than doubled from 2012 to 2019. There are statistically higher complication rates of SSI (0.5%) and reoperation (1.4%) with ADM use in TE-based breast reconstruction, suggesting that reconstruction without ADM is safe when comparing immediate postoperative outcomes.

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Breast Implants for Mammaplasty: An Umbrella Review of Meta-analyses of Multiple Complications

Cited by 10 publications

References 51 publications

Acellular Dermal Matrices in Breast Reconstruction: CARE Trial 5-Year Outcomes Data for More Than 9500 Patients

Acellular Dermal Matrices in Breast Reconstruction: CARE Trial 5-Year Outcomes Data for More Than 9500 Patients

The BREASTrial Stage III: Acellular Dermal Matrix Breast Reconstruction Outcomes from Three Months to Two Years Postoperative

A Nationwide Analysis Evaluating the Safety of Using Acellular Dermal Matrix with Tissue Expander-Based Breast Reconstruction

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