Implant Breast Reconstruction Research Articles

Discussion: Replacement of Shaped Textured Implants with Round Smooth Implants in Breast Reconstruction: Long-Term Outcomes.

Discussion: Replacement of Shaped Textured Implants with Round Smooth Implants in Breast Reconstruction: Long-Term Outcomes.

Discussion: Replacement of Shaped Textured Implants with Round Smooth Implants in Breast Reconstruction: Long-Term Outcomes.

Discussion: Replacement of Shaped Textured Implants with Round Smooth Implants in Breast Reconstruction: Long-Term Outcomes.

Young Women with Early-Stage Breast Cancer Treated with Upfront Surgery: Overview of Oncological Outcomes.

Background: Breast cancer in young women aged < 40 years is rare and often aggressive with less favorable survival rates. The lack of systematic screening, later stage at diagnosis, and a more aggressive disease biology may all contribute to their poor prognosis. Data on the best management remain conflicting, especially those regarding surgical management, either breast-conserving or mastectomy. To our knowledge, there are limited studies surrounding the treatment of young women with early breast cancer, and this analysis evaluated the oncological outcomes for those patients who underwent surgery upfront. Methods: We conducted a retrospective study including 130 young women with early breast cancer from a total of 373 consecutive patients treated with upfront surgery between January 2016 and December 2021 at our institution. Local recurrence-free survival (LR-FS), distant metastasis-free survival (DMFS), disease-free survival (DFS), and overall survival (OS) were evaluated. Results: The median follow-up was 61.1 months (range, 25-95). A total of 92 (70.8%) patients underwent breast-conserving surgery, while 38 (29.2%) patients underwent conservative mastectomy with immediate implant breast reconstruction. In total, 8 of 130 patients (6.2%) developed a local recurrence in the treated breast, an7 (5.4%) patients presented distant metastasis. Overall, two (1.6%) patients died due to breast cancer recurrence. Conclusions: The results of our study interestingly support breast-conserving surgery in young patients with early-stage breast cancer. While appropriate breast-conserving surgery can achieve favorable oncological outcomes and can always be considered a valid alternative to conservative mastectomy in upfront surgery, a younger age at diagnosis should never be used alone to choose the type of surgery.

A Comparative Study on Aesthetic and Pain Outcomes in Flap Versus Implant Breast Reconstruction After Mastectomy.

Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death among women worldwide. Surgical treatments, including mastectomy and subsequent breast reconstruction, are critical components of breast cancer management. This systematic review compares the outcomes of flap versus implant reconstruction post-mastectomy, focusing on aesthetic differences, pain, recovery, and psychological adaptation. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA) 2020 guidelines, we conducted a comprehensive literature search across PubMed, Cochrane, and ScienceDirect databases. Inclusion criteria targeted studies comparing aesthetic outcomes, pain, recovery costs, duration, and psychological adaptation between flap and implant breast reconstructions. We excluded non-English and non-Spanish studies, case reports, and those without full-text availability. The risk of bias was assessed using the Newcastle-Ottawa Scale (NOS). From an initial pool of 25,881 articles, 16 high-quality studies involving 14,196 participants were selected for synthesis. Flap reconstruction was associated with higher patient satisfaction regarding aesthetic outcomes and psychological well-being but also had higher complication rates, including infections and wound dehiscence. Implant reconstruction showed fewer complications but did not achieve the same level of patient satisfaction. Flap reconstruction, despite its higher complication rates, tends to provide superior aesthetic and psychological outcomes compared to implant reconstruction. These findings highlight the importance of personalized treatment plans considering individual patient needs and preferences. Future research should focus on long-term randomized controlled trials (RCTs) and standardized outcome measures to further delineate the comparative effectiveness of these reconstruction techniques. Personalized care and ongoing research are essential to improving the quality of life for breast cancer survivors undergoing reconstruction.

From 0 to 100: Delayed Direct to Implant Breast Reconstruction, an Alternative to Tissue Expansion

From 0 to 100: Delayed Direct to Implant Breast Reconstruction, an Alternative to Tissue Expansion

Autologous fat transplantation prior to permanent expander implant breast reconstruction enhances the outcome after two years: a randomized controlled trial.

Radiotherapy is important in breast cancer treatment. A side effect of the treatment is fibrosis that decreases the possibility for a successful breast reconstruction with expanders and with high patient satisfaction with the result. The most common option for mastectomized, irradiated women wishing for a breast reconstruction is autologous tissue transplantation. However, some patients are not suitable for flap surgery. Fifty mastectomized and irradiated women were included in a randomized controlled trial. They underwent breast reconstruction with expanders and were allocated 1:1 to either receive pre-treatment with autologous fat transplantation (AFT) or not. Primary outcomes were frequency of reoperations and complications. Secondary outcomes were number of days in hospital, number of outpatient visits to surgeon or nurse and patient reported outcome as reported with Breast Q. Follow-up time was 2 years. Fifty-two per cent of the intervention group and 68% of the controls underwent reoperations (p = 0.611). Thirty-two per cent of the intervention group and 52% of the controls had complications (p = 0.347). The median number of consultations with the nurse was four in the intervention group and six in the control group (p = 0.002). The AFT patients were significantly more satisfied with their breasts and psychosocial well-being after 2 years. They also had higher increase in satisfaction with breasts, psychosocial well-being, and sexual well-being when comparing baseline with 2 years postoperatively. This randomized controlled trial indicates benefits of AFT prior to breast reconstruction with expanders, especially on patient reported outcome even if the study sample is small.

The Usage of Mesh and Relevant Prognosis in Implant Breast Reconstruction Surgery: A Meta-analysis.

Although mesh-based implant breast reconstruction surgery is emerging as the primary surgical procedure for breast reconstruction, mesh use remains controversial in implant breast reconstruction surgery, especially in terms of how to select the ideal mesh. Our aim is to elaborate relevant prognosis in the mesh-based implant breast reconstruction surgery. Relevant studies were identified from PubMed, Web of Science, EMBASE, and Cochrane library searches. Extracted data included study type, basic characteristics, mesh information, complications, etc. We analyzed the included cohort studies and randomized controlled trials that reported mesh-related implant breast reconstruction complications and breast quality scale scores. A total of 32 studies including 7475 subjects were included. The results showed that the overall complication rate was 2.07 times higher in the biological mesh group than in the synthetic mesh group (risk ratio [RR]: 2.07, 95% CI 1.14-3.78). The risk of seroma was 4.50 times higher in the biological mesh group than in the synthetic mesh group (RR: 4.50, 95% CI 2.27-8.95). In terms of comparing breast quality scale scores, the mesh group had scores that were 1.49 (95% CI 0.19-2.78) higher than the non-mesh group for "physical well-being" and 2.05 (95% CI 0.08-4.02) higher for "sexual well-being." Our study found that the risk of total complications was higher with biological mesh than with synthetic mesh in implant breast reconstruction surgery. Based on short-term cost, healthcare burden, and healthcare benefits, synthetic meshes are superior to biological meshes. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Effect of Perioperative Prophylactic Intravenous Antibiotic Use in Immediate Implant-Based Breast Reconstruction: A Retrospective Matched Cohort Study.

Background Among breast reconstruction methods, implant-based breast reconstruction has become the mainstream. However, periprosthetic infection is still an unresolved problem. Although published articles have revealed that limited use of antibiotics is sufficient to reduce infection rates, the number of surgeons still preferring elongated usage of antibiotics is not less. The aim of our study is to validate the appropriate duration of antibiotic use to reduce infection rate after implant-based breast reconstruction. Methods A retrospective study reviewed medical record of 235 patients (274 implants for reconstruction) who underwent prepectoral direct to implant breast reconstruction using acellular dermal matrix wrapping technique. Infection rates were analyzed for the patients administered postoperative prophylactic antibiotics until drain removal and those who received only perioperative prophylactic antibiotics for 24 hours. Results Of the 274 implants, 98 who were administered prophylactic antibiotics until drain removal had an infection rate of 3.06% (three implants) and 176 who received prophylactic antibiotics no longer than 24 hours postoperatively had an infection rate of 4.49% (eight implants). A total of 11 patients diagnosed with postoperative infection clinically, 8 were salvaged by antibiotic treatment, and 3 had implant removal and replacement with autologous flap. Postoperative antibiotic prophylaxis duration had no statistically significant effects in the risk of infection ( p = 0.549). Conclusion The duration of prophylactic antibiotics after surgery was not related to infection risk. Further study with a large number of patients, randomized control study, and route of antibiotics is needed.

Breast Reconstruction: Focus on Implant-Based Reconstruction

Autologous tissue-based reconstruction and prosthetic implant-based reconstruction are the two main categories of breast reconstruction. The natural feel, size, and form of the breast can be restored by breast reconstruction with breast implants. Following a nipple- and skin-sparing mastectomy and a modified radical mastectomy, implant-based breast reconstruction is most readily executed. The most popular technique for immediate and delayed postmastectomy breast reconstruction is implant breast reconstruction, which makes use of silicone tissue expanders, which were initially utilized for breast reconstruction by Radovan in 1978 and Austad in 1979. As a sign of femininity, breasts might be lost, which can cause a woman great psychological discomfort and negatively impact her sexual life and self-image. Women are given the choice of breast reconstruction following a breast cancer removal treatment, which can enhance their quality of life. However, implant-based reconstruction ought not to be seen as an adjuvant treatment. Procedures like skin-sparing mastectomy and nipple-areola-sparing mastectomy, which enable conservative surgery with an instant implant breast reconstruction, can only be carried out with an early diagnosis.

Evaluating the Quality of Online Patient Information for Prepectoral Breast Reconstruction Using Polyurethane-Coated Breast Implants

An increasing number of patients are using online information regarding medical issues; however, the Internet is not subject to content ratings or filters. Unreliable information found on the web can heavily influence patients to the extent that it can lead to wrong decisions in the choice of treatment. In our daily experience we meet more informed patients and given the increasing use of polyurethane-coated implants in breast reconstruction in Europe, we wondered about the level of information available online. Our study aims to assess the quality of information available online on breast reconstruction with polyurethane-coated implants. Assuming that the most used search engines are Google and Yahoo, we used a search strategy to identify online information regarding prepectoral breast reconstruction with polyurethane-coated implants. The selected websites were divided into 5 groups (practitioners, hospitals, healthcare portals, professional societies, and encyclopedias), and the quality of information was assessed by using an expanded version of the Ensuring Quality Information for Patients (EQIP) tool, which is a checklist applicable to all existing types of information. Fifty-six websites were selected and were categorized into 5 groups: 17 practitioners, 9 hospitals, 13 healthcare portals, 7 professional societies, 10 encyclopedias. The average score was 17 points (range: 12 - 25). We found 13 reliable websites with a score higher than 20 using the expanded version of the EQIP tool, whereas 43 were deemed unreliable, as they scored lower. Proper communication between surgeon and patient is crucial in the therapeutic choice, as the available online information presently is scarce and can lead to wrong decisions if not properly verified.

When to Consider Prepectoral Implant Conversion After Subpectoral Implant Breast Reconstruction and How to Plan It.

Many deformities occur after subpectoral implant-based breast reconstruction. Today, immediate prepectoral reconstruction with implants shows a significant increase in popularity as it has many advantages over subpectoral positioning: absence of muscle deficit, breast animation, reduced implant dislocation, less postoperative pain and easy recovery. As such, implant pocket conversion from the submuscular to prepectoral plane has become our preferred strategy for solving most problems related to the submuscular implant position. The authors performed a retrospective review (from June 2018 to December 2022) of patients who underwent prepectoral implant conversion for the correction of animation deformity, dysfunctional chronic pain, and to ameliorate poor cosmetic results. The use of acellular dermal matrix (ADM) was done in the first 7 cases, in the remaining 56 were used polyurethane-covered implants. Resolution of animation deformity, chronic pain was evaluated in addition to cosmetic results and the onset of postoperative complications. Sixty-three patients (87 breasts) underwent prepectoral implant conversion with complete resolution of animation deformity, chronic pain and improved cosmetic results. Preventive lipofilling was done in 18 patients. Complication rate included 3 periprosthetic seroma in ADMs group. All were solved after US-guided aspiration. Rippling was noted in 3 patients and edge visibility was documented in 1 patient. There are no incidences of grade III and IV capsular contracture. The prepectoral implant conversion improves functional and aesthetic results, reaching excellent outcomes. The preparation for this surgery with fat graft is considered a complementary procedure that increases the indications for prepectoral implant conversion.

Effect of Post-Mastectomy Autologous versus Implant Reconstruction on Body Image and Quality of Life among Egyptian Women

Abstract Purpose The ultimate goal is to evaluate patient satisfaction with autologous versus implant breast reconstruction, as well as the influence of these surgeries on the quality of life and body image of women who have had a mastectomy for breast cancer. Method A multicenter, retrospective, cross-sectional study included 117 patients who underwent mastectomy and subsequent breast reconstruction surgery at El Demerdash University Hospital and Alexandria Main University Hospital between January 2017 and March 2021. A BREAST-Q 2-0 Reconstruction module questionnaire was given to each patient. Result 117 patients were divided into two groups: autologous breast reconstruction ABR (n = 77) and implant-based breast reconstruction IBR (n = 40). The ABR group was operated on using Transverse Rectus Abdominis Myocutaneous (TRAM) or latissimus Doris (LD) flaps. The average age of the participants in the study was 44.51 ± 6.88. Patients with silicone implants were younger on average than those with LD or TRAM flaps. The patient's quality of life in the two areas evaluated (psychosocial and physical well-being) was excellent in implant repair but poor in TRAM flap, according to our findings. In TRAM flap, we also discovered that overall satisfaction with the breast was low. Conculsion TRAM flap produces a low quality of life and overall satisfaction with the breast, whereas implant reconstruction provides a high quality of life.

A New Ultrasound-assisted Protocol to Avoid Seroma-related Complications in Prepectoral Breast Reconstruction with Acellular Dermal Matrix

Summary: Seroma, with its secondary complications, represents one of the major unsolved problems in direct to implant breast reconstruction with acellular dermal matrix. The seroma formation not only represents a complication, but causes other secondary complications such as major infections, surgical dehiscence, and implant loss. These lead to the failure of the reconstruction. The authors have developed a new ultrasound protocol for early diagnosis and management of seroma, with the aim of detecting and treating early seroma through a series of ultrasound-guided suctions. In this way, we want to avoid the onset of seroma-related complications. After 12.5 months of mean follow-up time, we performed 22 fluid aspirations, and no seroma recurrence was reported, as well as no secondary complications. The authors believe that the introduction of this novel ultrasound protocol allows the plastic surgeon to actively and promptly manage seroma.

Lightweight implants in breast reconstruction.

Since the first use of silicone implants by Cronin in 1962, there have been several attempts to introduce alternative filling materials for breast implants on the market. A promising new development are lightweight implants, whose filler material is one third lighter than conventional silicone gel. While these implants have been used primarily for aesthetic augmentation, a benefit could be expected particularly in post-mastectomy reconstruction. Since 2019, 92 operations using lightweight implants have been performed at our clinic, 61 of them for breast reconstruction after mastectomy. These have been compared to 92 breast reconstructions using conventional silicone implants. The average volume of the lightweight implants was 30% higher than of the conventional implants (452 ml resp. 347 ml), whereas the implant weight was comparable in both groups (317 g resp. 347 g). Grade 3-4 capsular fibrosis was seen in 6 cases in both groups; revision was required 9 times (lightweight implants) and 7 times (conventional silicone implants) during the follow-up period. To our knowledge, this is the first study to investigate the use of lightweight implants in breast reconstruction. With exception of the filler material, the implants used in the two groups were comparable in shape and surface. The inserted lightweight implants had a greater volume but nearly the same weight as the conventional implants and were used in patients with a higher body mass index. Thus, lightweight implants were preferred in patients whose reconstruction required a larger implant volume. Lightweight implants are a new alternative for breast reconstruction especially in case that larger implant volume is demanded. The increased complication rate has to be verified in further studies.

How Postoperative Infection Affects Reoperations after Implant-based Breast Reconstruction: A National Claims Analysis of Abandonment of Reconstruction.

We conducted a retrospective cohort study using Optum's de-identifed Clinformatics Data Mart Database to analyze women undergoing implant breast reconstruction from 2003 to 2019. Unplanned reoperations were identified via Current Procedural Terminology (CPT) codes. Outcomes were analyzed via multivariate linear regression with Poisson distribution to determine statistical significance at P < 0.00625 (Bonferroni correction). In our national claims-based dataset, post-IBR infection rate was 8.53%. Subsequently, 31.2% patients had an implant removed, 6.9% had an implant replaced, 3.6% underwent autologous salvage, and 20.7% discontinued further reconstruction. Patients with a postoperative infection were significantly associated with increased incidence rate of total reoperations (IRR, 3.11; 95% CI, 2.92-3.31; P < 0.001) and total hospital length of stay (IRR, 1.55; 95% CI, 1.48-1.63; P < 0.001). Postoperative infections were associated with significantly increased odds of abandoning reconstruction (OR, 2.92; 95% CI, 0.081-0.11; P < 0.001). Unplanned reoperations impact patients and healthcare systems. This national, claims-level study shows that post-IBR infection was associated with a 3.11× and 1.55× increase in the incidence rate of unplanned reoperations and length of stay. Post-IBR infection was associated with 2.92× increased odds of abandoning further reconstruction after implant removal.

Choosing the Best Design in Surgical Research.

Choosing the Best Design in Surgical Research.

D91. Effect of Pre-pectoral Versus Sub-pectoral Implant Placement in Breast Reconstruction on the Delivery of Post-mastectomy Radiation

PURPOSE: The placement of breast implants in a pre-pectoral compared to sub-pectoral plane has become increasingly popular in breast reconstruction, though data are limited on how this affects radiation delivery for locoregional disease control in women with breast cancer. This study aims to assess the dosimetric implications of implant location in women undergoing post-mastectomy radiation therapy (PMRT) after immediate breast reconstruction. METHODS: Patients with breast cancer treated with mastectomy, implant breast reconstruction, and PMRT between 2014-2022 at a single center were included. All patients received either intensity-modulated or 3-D conformal radiation therapy over an average of 5 weeks. Demographic, clinical and treatment data were collected through chart review. Patients were matched 1:1 on cancer sidedness, use of boost, fractionation and extent of radiation fields. Groups were compared using Mann-Whitney U or t-tests for continuous variables, and chi-square or Fisher’s Exact tests for categorical variables, as appropriate. RESULTS: Twenty-seven patients with pre-pectoral and 26 patients with sub-pectoral implants were included. Patients with pre-pectoral reconstruction had lower average implant volumes (452cc vs 503cc) prior to radiation. There was no difference in chest wall coverage (p=0.107), internal mammary node coverage (p=0.215), heart dose (p=0.627) or lung V20Gy (p=0.774). CONCLUSION: In this assessment of radiotherapeutic dosimetry in patients undergoing immediate breast reconstruction, we found no significant difference in target coverage or normal tissue dose based on pre- versus sub-pectoral implant location. This suggests that implant placement can be selected to optimize reconstructive outcomes, without concern for compromise to the oncologic quality of PMRT.

The Effect of Postoperative Infection after Implant Breast Reconstruction on Additional Revision Procedures

Francis, Shannon MSc; Shah, Jennifer K.; Thawanyarat, Kometh BA; Rowley, Mallory BS; Kim, Trudy; Sheckter, Clifford MD; Nazerali, Rahim MD, FACS Author Information

Abstract P2-15-07: Current status of latissimus dorsi flaps with or without implants for breast reconstruction in patients with breast tumor: A single-center retrospective study

Abstract Background: Asian women have relatively small breast sizes compared to European American women, so the latissimus dorsi flap (LDF) is the most commonly used autologous flap for breast reconstruction in Chinese patients with breast tumor. To explore the current status of LDF with or without implants (IMP) breast reconstruction in China, we conducted this study. Methods: This study was a single-center retrospective study that included breast tumor patients who underwent LDF breast reconstruction in Fudan University Shanghai Cancer Center (FUSCC) from 2000 to 2019. The basic clinicopathological information, the timing and type of reconstruction, postoperative hospitalization time and serious complications requiring surgical intervention were analyzed. Continuous variables were expressed as mean values or median values, while categorical variables were expressed as frequencies. Data were analyzed by using Chi-square and Kruskal-Wallis tests. All P values reported were two-sided and were calculated at a significance level of 0.05. Results: A total of 2868 patients who underwent breast reconstruction for breast tumor were analyzed in this study, 785 (27.4%) patients used LDF for breast reconstruction, and 397 (13.8%) patients underwent autologous breast reconstruction utilizing abdominal flap. The number of breast reconstruction patients and the diversity of reconstruction procedures were increasing year by year. Breast reconstructions utilizing LDF have decreased as a percentage of breast reconstructions, but have increased in number in the past few years. Among patients with LDF breast reconstruction, the majority (97.3%) underwent immediate reconstruction, 11 patients underwent delay reconstruction, and 10 patients underwent immediate-delay reconstruction. 448 patients underwent expanded LDF breast reconstruction, and 337 (42.9%) patients underwent LDF combined with IMP breast reconstruction. 13 patients underwent restoration of reconstructed breast with LDF, 12 of which were changed to LDF±IMP reconstruction due to unsatisfactory outcome of expander reconstruction or failed implant reconstruction, and one patient was changed to LDF reconstruction from failed abdominal flap reconstruction. In terms of pathological type, 629 (80.1%) patients had invasive carcinoma, 129 (16.4%) had carcinoma in situ, 18 (2.3%) patients had phyllodes tumor and 9 (1.1%) patients had other malignancies. The median reconstruction age of the patients was 37 years old, the mean BMI was 21.76kg/cm2, and the mean postoperative length of stay was 11.13 days. There were no significant differences in postoperative hospitalization time, reconstruction age, BMI, pT, ER, PR, HER2, Ki67, and radiotherapy between patients with expanded LDF and LDF combined with IMP breast reconstruction. Patients with neoadjuvant therapy (P=0.045), phyllodes tumors or other malignant tumors (P=0.023), and those with more metastatic lymph nodes (P=0.031) were tent to expanded latissimus dorsi flap reconstruction. Serious complications requiring surgical intervention occurred in 13 patients (1.65%), including 7 patients who underwent surgical debridement or scar repair due to wound infection and poor healing, and 3 patients who removed the implant due to implant infection. The reconstructed latissimus dorsi flaps necrosis occurred in 3 patients, and the reconstructed breasts were removed in these patients. There was no significant difference in the incidence of serious complications requiring surgical intervention between patients with expanded LDF and those with LDF combined with implant reconstruction, P=0.79. Conclusions: LDF±IMP breast reconstruction is a mature breast reconstruction procedure in our center with high safety. Whether combined with implant reconstruction did not affect the postoperative hospitalization time and the incidence of serious complications. Citation Format: Shuyue Zheng, Jiajian Chen, Shuang Hao, Benlong Yang, Xiaoyan Huang, Guangyu Liu, Jiong Wu. Current status of latissimus dorsi flaps with or without implants for breast reconstruction in patients with breast tumor: A single-center retrospective study [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-15-07.

Abstract OT1-13-01: BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices with Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction. ClinicalTrials.gov Identifier: NCT05449691

Abstract Research question: Is it feasible to conduct a multicentre randomised controlled trial (RCT) to test the long-term efficacy and safety of biological matrices compared with synthetic meshes in women undergoing one-stage mesh and implant breast reconstruction as standard care. Background: The use of biological and synthetic meshes in implant-based breast reconstruction has become standard care and is the most widely used procedure in the UK. However, there is limited evidence on patient outcomes and how safe each type of mesh is in the long-term to guide patient choices and surgeon decision-making. Aims: To assess patient and clinician acceptance, recruitment rate, and compliance with randomly allocated intervention. We will evaluate completeness of data on proposed future main study outcomes. The standard deviation (SD) of patient reported ‘satisfaction with breasts’ score on Breast Q will inform sample size calculations for the main study. To inform economic evaluation of main study, we will evaluate completeness of EQ-5D-5L and recommendation of an alternative preference-based QoL measure to be used in a definitive trial. Methods: Design: Pragmatic, feasibility, randomised controlled trial. Target population: Women undergoing mastectomy for breast cancer or risk reduction and immediate one-stage breast reconstruction using implant and mesh as standard care. Randomisation: Women will be randomised to biological matrix or synthetic mesh in a 1:1 ratio. Measurement of outcomes Complications: such as infection, wound breakdown, readmission, reoperation, unplanned surgery, skin flap necrosis, implant loss, seroma, pain, capsular contracture and haematoma will be recorded at 3- and 6-months post-surgery. Patient reported outcomes: Women will complete Breast Q and EQ-5D-5L questionnaires at randomisation, 3- and 6-months post-surgery. Sample size: By recruiting 60 (out of 120) we will be able to estimate a participation rate of 50% of women offered the trial to within a 95% confidence interval of +/-9% and a completion rate of 90% (54 of 60) within a 95% confidence interval of (80%, 95%). Additionally, 60 participants will be enough to estimate the SD for sample size calculation for the main study. Timelines for delivery: Recruitment start date: 01 September 2022. Anticipated Impact and Dissemination: The BIOSYM research question has been identified as a key research gap by Association of Breast Surgery (UK). If we can demonstrate feasibility, the definitive trial will provide high quality long-term data on patient outcomes and safety of each type of mesh. Results will be published in peer-reviewed high impact journals and, with PPI partners we will produce patient-facing summaries for a lay audience. The results will inform specialist and NICE guidelines. Citation Format: Amit Goyal, Emanuele Garreffa, Robert Newcombe, Helena Harder, Janice Rose, Valerie Jenkins. BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices with Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction. ClinicalTrials.gov Identifier: NCT05449691 [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT1-13-01.