Dataset Information

Pregnancy following Unilateral Immediate Breast Reconstruction with Titanized Polypropylene Mesh (TiLOOP(R) Bra) without Compromising the Result.

ABSTRACT: Immediate breast reconstruction after mastectomy due to cancer or as a prophylactic treatment is widely preferred to avoid psychosocial distress, poor body image, and diminished sexual well-being. An increasing number of women undergoing breast reconstruction are in childbearing age; however, only limited data are available on the cosmetic outcome of patients undergoing implant-based breast reconstruction with a surgical mesh and subsequent pregnancy. This is a case report of a female patient who underwent unilateral implant-based breast reconstruction with a titanized surgical mesh implant (TiLOOP Bra). Twenty-two months after reconstruction, the woman delivered a healthy child. No adverse events occurred. The patient breastfed with the contralateral breast. The cosmetic result and patient-reported outcome was excellent. Pregnancy after breast reconstruction with a synthetic surgical mesh is not contradictory to an excellent cosmetic outcome.

SUBMITTER: Nolte E

PROVIDER: S-EPMC6191232 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Pregnancy following Unilateral Immediate Breast Reconstruction with Titanized Polypropylene Mesh (TiLOOP(R) Bra) without Compromising the Result.

Nolte Elke E Klein Evelyn E Paepke Stefan S

Plastic and reconstructive surgery. Global open 20180914 9

Immediate breast reconstruction after mastectomy due to cancer or as a prophylactic treatment is widely preferred to avoid psychosocial distress, poor body image, and diminished sexual well-being. An increasing number of women undergoing breast reconstruction are in childbearing age; however, only limited data are available on the cosmetic outcome of patients undergoing implant-based breast reconstruction with a surgical mesh and subsequent pregnancy. This is a case report of a female patient wh ...[more]

PMID: 30349788

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Project description:BackgroundUse of biological or synthetic mesh might improve outcomes of immediate implant-based breast reconstruction-breast reconstruction with implants or expanders at the time of mastectomy-but there is a lack of high-quality evidence to support the safety or effectiveness of the technique. We aimed to establish the short-term safety of immediate implant-based breast reconstruction performed with and without mesh, to inform the feasibility of undertaking a future randomised clinical trial comparing different breast reconstruction techniques.MethodsIn this prospective, multicentre cohort study, we consecutively recruited women aged 16 years or older who had any type of immediate implant-based breast reconstruction for malignancy or risk reduction, with any technique, at 81 participating breast and plastic surgical units in the UK. Data about patient demographics and operative, oncological, and complication details were collected before and after surgery. Outcomes of interest were implant loss (defined as unplanned removal of the expander or implant), infection requiring treatment with antibiotics or surgery, unplanned return to theatre, and unplanned re-admission to hospital for complications of reconstructive surgery, up to 3 months after reconstruction and assessed by clinical review or patient self-report. Follow-up is complete. The study is registered with the ISRCTN Registry, number ISRCTN37664281.FindingsBetween Feb 1, 2014, and June 30, 2016, 2108 patients had 2655 mastectomies with immediate implant-based breast reconstruction at 81 units across the UK. 1650 (78%) patients had planned single-stage reconstructions (including 12 patients who had a different technique per breast). 1376 (65%) patients had reconstruction with biological (1133 [54%]) or synthetic (243 [12%]) mesh, 181 (9%) had non-mesh submuscular or subfascial implants, 440 (21%) had dermal sling implants, 42 (2%) had pre-pectoral implants, and 79 (4%) had other or a combination of implants. 3-month outcome data were available for 2081 (99%) patients. Of these patients, 182 (9%, 95% CI 8-10) experienced implant loss, 372 (18%, 16-20) required re-admission to hospital, and 370 (18%, 16-20) required return to theatre for complications within 3 months of their initial surgery. 522 (25%, 95% CI 23-27) patients required treatment for an infection. The rates of all of these complications are higher than those in the National Quality Standards (<5% for re-operation, re-admission, and implant loss, and <10% for infection).InterpretationComplications after immediate implant-based breast reconstruction are higher than recommended by national standards. A randomised clinical trial is needed to establish the optimal approach to immediate implant-based breast reconstruction.FundingNational Institute for Health Research, Association of Breast Surgery, and British Association of Plastic, Reconstructive and Aesthetic Surgeons.

Project description:BackgroundImplant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure following mastectomy. IBBR techniques are evolving rapidly, with mesh-assisted subpectoral reconstruction becoming the standard of care and more recently, prepectoral techniques being introduced. These muscle-sparing techniques may reduce postoperative pain, avoid implant animation and improve cosmetic outcomes and have been widely adopted into practice. Although small observational studies have failed to demonstrate any differences in the clinical or patient-reported outcomes of prepectoral or subpectoral reconstruction, high-quality comparative evidence of clinical or cost-effectiveness is lacking. A well-designed, adequately powered randomised controlled trial (RCT) is needed to compare the techniques, but breast reconstruction RCTs are challenging. We, therefore, aim to undertake an external pilot RCT (Best-BRA) with an embedded QuinteT Recruitment Intervention (QRI) to determine the feasibility of undertaking a trial comparing prepectoral and subpectoral techniques.Methods and analysisBest-BRA is a pragmatic, two-arm, external pilot RCT with an embedded QRI and economic scoping for resource use. Women who require a mastectomy for either breast cancer or risk reduction, elect to have an IBBR and are considered suitable for both prepectoral and subpectoral reconstruction will be recruited and randomised 1:1 between the techniques.The QRI will be implemented in two phases: phase 1, in which sources of recruitment difficulties are rapidly investigated to inform the delivery in phase 2 of tailored interventions to optimise recruitment of patients.Primary outcomes will be (1) recruitment of patients, (2) adherence to trial allocation and (3) outcome completion rates. Outcomes will be reviewed at 12 months to determine the feasibility of a definitive trial.Ethics and disseminationThe study has been approved by the National Health Service (NHS) Wales REC 6 (20/WA/0338). Findings will be presented at conferences and in peer-reviewed journals.Trial registration numberISRCTN10081873.

Project description:(1) Introduction: In response to patient concerns about breast cancer recurrence, increased use of breast magnetic resonance imaging and genetic testing, and advancements in breast reconstruction techniques, mastectomy rates have been observed to rise over the last decade. The aim of the study is to compare the outcomes of prepectoral and subpectoral implants and long-term, dual-stage resorbable mesh-based breast reconstructions in mutation carriers (prophylactic surgery) and breast cancer patients. (2) Patients and methods: This retrospective, two-center study included 170 consecutive patients after 232 procedures: Prepectoral surgery was performed in 156 cases and subpectoral was performed in 76. (3) Results: Preoperative chemotherapy was associated with more frequent minor late complications (p < 0.001), but not major ones (p = 0.101), while postoperative chemotherapy was related to more frequent serious (p = 0.005) postoperative complications. Postoperative radiotherapy was associated with a higher rate of minor complications (31.03%) than no-radiotherapy (12.21%; p < 0.001). Multivariate logistic regression found complications to be significantly associated with an expander (OR = 4.43), skin-reducing mastectomy (OR = 9.97), therapeutic mastectomy vs. risk-reducing mastectomy (OR = 4.08), and postoperative chemotherapy (OR = 12.89). Patients in whom prepectoral surgeries were performed demonstrated significantly shorter median hospitalization time (p < 0.001) and lower minor complication rates (5.77% vs. 26.32% p < 0.001), but similar major late complication rates (p = 0.915). (4) Conclusions: Implant-based breast reconstruction with the use of long-term, dual-stage resorbable, synthetic mesh is a safe and effective method of breast restoration, associated with low morbidity and good cosmesis. Nevertheless, prospective, multicenter, and long-term outcome data studies are needed to further evaluate the benefits of such treatments.

Dataset Information

Pregnancy following Unilateral Immediate Breast Reconstruction with Titanized Polypropylene Mesh (TiLOOP(R) Bra) without Compromising the Result.

Publications

Pregnancy following Unilateral Immediate Breast Reconstruction with Titanized Polypropylene Mesh (TiLOOP(R) Bra) without Compromising the Result.

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