Shifting Practice Patterns in Implant-based Breast Reconstruction in China: Insights From a 13-year Large-scale Retrospective Cohort.

INTRODUCTION
Breast cancer (BC) is the most common malignancy among women worldwide, accounting for 31% of all new cancers in women in 2023, and remains the leading cancer among Chinese women, with more than 400,000 new cases and 120,000 deaths annually.1,2 As surgery remains the cornerstone of BC treatment, increasing attention has been directed toward postmastectomy breast reconstruction, which improves aesthetics, psychosocial well-being, and quality of life.3–7
Over the past decade, implant-based breast reconstruction (IBBR) has become the predominant technique globally, including in China, driven by advances in surgical techniques and expanding reconstructive options.8–11 Among these, the choice between direct-to-implant (DTI) and 2-stage tissue expander (TE) reconstruction remains one of the most critical and debated decisions.12–14 Recent BREAST-Q studies in China indicate that DTI reconstruction is associated with fewer major complications and implant losses than TE reconstruction, reflecting international trends toward 1-stage reconstruction.15,16 The selection of reconstructive strategy is influenced by multiple clinical variables, including nipple-sparing mastectomy (NSM),17 implant placement plane (prepectoral versus subpectoral),18 use of mesh materials,19,20 postmastectomy radiotherapy (PMRT),21,22 and body mass index (BMI). However, large-scale, population-specific data on IBBR trends and outcomes in China remain scarce.
This study analyzed a decade of data from Fudan University Shanghai Cancer Center (FUSCC), one of China’s largest breast reconstruction centers, to elucidate patterns and outcomes of IBBR. We particularly examined how NSM, implant plane, TiLOOP Bra mesh use, PMRT, and BMI influence the adoption of DTI versus TE. These findings aim to inform individualized, evidence-based reconstruction strategies for the Chinese population.

METHODS

Patient Cohort
A retrospective review of all patients who underwent surgical treatment for BC at FUSCC between January 2010 and December 2023 was conducted. A total of 6088 patients with BC underwent reconstructive surgery at FUSCC. Of these, 5911 unilateral breast reconstruction procedures were included in the study. Male patients and those with stage IV disease undergoing palliative surgery were excluded. Bilateral reconstructions were omitted to minimize heterogeneity, as their clinical indications and patient motivations differ substantially from unilateral cases. The study was approved by the FUSCC Ethics Committee.

Breast Reconstruction Procedures
Patients underwent skin-sparing mastectomy (SSM), including nipple-sparing (NSM) and SSM approaches. Implant placement was classified as prepectoral or subpectoral, and reconstruction timing as DTI or 2-stage TE. Additional variables included the use of TiLOOP Bra mesh and PMRT.
Throughout the study period, MENTOR (Johnson & Johnson) silicone gel implants were primarily used. The shell type was generally microtextured silicone elastomer, which has been progressively replaced by smooth or nanotextured shells in recent years following international safety updates and evolving regulatory guidance. The implant fill consisted of cohesive silicone gel (MemoryGel), providing a natural feel and stable shape retention. Implant volumes for DTI reconstruction typically ranged from 200 to 350 mL, depending on breast size, mastectomy specimen weight, and desired postoperative symmetry.
Unplanned reoperations were defined as secondary procedures for complications such as infection, wound dehiscence, or implant exposure requiring debridement or implant removal, as well as revision procedures performed for unsatisfactory aesthetic outcomes.

Statistical Analysis
Continuous variables were compared using independent t tests or analysis of variance. Categorical variables were analyzed with χ2 tests, with Bonferroni correction for multiple comparisons. Temporal trends were evaluated using linear regression. Statistical analyses were performed with IBM SPSS Statistics 25.0 (IBM Corp., Armonk, NY), and a P value less than 0.05 was considered statistically significant.

RESULTS

Rising Trends in Breast Reconstruction at FUSCC From 2010 to 2023
From 2010 to 2023, 6088 patients with BC underwent reconstructive surgery at FUSCC. During this period, the number of mastectomies increased nearly 5-fold (from 1443 to 7213), whereas reconstruction procedures rose about 16-fold (from 77 to 1207) (Fig. 1A). The reconstruction rate increased from 5.3% in 2010 to more than 15% by 2021, with 2 plateau phases (2010–2015 and 2021–2023) indicating stabilization of reconstruction uptake in routine practice (Table 1).
Among all patients who underwent reconstruction, 5911 (97.1%) underwent unilateral and 177 (2.9%), bilateral reconstruction. (See figure, Supplemental Digital Content 1, which displays the proportion of unilateral and bilateral reconstructions, reconstruction timing [immediate, immediate-delay, and delay], and different reconstruction types [autologous, implant-based, and combined methods], https://links.lww.com/PRSGO/E750.) For unilateral cases, patient age ranged from 15–77 years (median 40 y); height, 145–183 cm (mean 161.3 cm); weight, 36–99 kg (mean 57.6 kg); and BMI, 15.1–37.3 kg/m2 (median 22.1 kg/m2), suggesting that most were middle-aged with a normal BMI.
Regarding reconstruction timing, 5646 (95.5%) underwent immediate reconstruction, 85 (1.4%) underwent immediate-delayed, and 180 (3.0%) underwent delayed procedures (Supplemental Digital Content 1, https://links.lww.com/PRSGO/E750).

Dominance of IBBR Since 2016
Among patients who underwent unilateral breast reconstruction, 4046 (68.5%) received implant-based reconstruction, 1460 (24.7%) underwent autologous reconstruction, and 408 (6.9%) had combined procedures (mainly latissimus dorsi flap with implant) (Supplemental Digital Content 1, https://links.lww.com/PRSGO/E750).
Across the 14-year study period, reconstruction preferences shifted markedly. Although all techniques showed growth in absolute volume, the expansion of IBBR was most pronounced (Fig. 1B). Before 2013, autologous and combination reconstructions predominated; however, since then, the proportion of IBBR has increased steadily, stabilizing between 70% and 80% from 2016 onward (Table 2). This transition coincided with the sharp rise in overall reconstruction rates beginning in 2016, reflecting the widespread adoption of IBBR in clinical practice. In contrast, autologous-only reconstruction remained relatively stable at around 20%, whereas combination procedures peaked at nearly 40% in 2008 but declined progressively, remaining less than 10% after 2015 (Fig. 1C).

DTI Has Reemerged as the Preferred Approach for IBBR
Among 4046 patients who underwent unilateral IBBR, 1964 (48.5%) received DTI reconstruction, and 2082 (51.5%) underwent 2-stage TE reconstruction. (See figure, Supplemental Digital Content 2, which displays the overall proportion of DTI and TE reconstructions among IBBR, https://links.lww.com/PRSGO/E751.) However, their relative proportions changed substantially over time.
From 2010 to 2013, likely due to the limited availability of expanders and the small scale of IBBR overall, most procedures were DTI. Between 2014 and 2017, as the total volume of implant-based reconstruction surged, TE reconstruction became the dominant approach, accounting for more than 95% of cases. However, this proportion declined markedly from 2018 to 2022, falling to only 26.61% by 2023. In contrast, DTI reconstruction remained stable at approximately 50% during 2018–2022, then increased sharply to 73.37% in 2023—reemerging as the predominant implant-based technique after a decade-long transition (Fig. 2, Table 3).

Distributions and Trends of IBBR Characteristics
The gradual transition from TE to DTI reflects the combined influence of evolving surgical techniques, expanding technological options, and an increasing focus on individualized patient care. To better characterize this evolution, key clinical and procedural variables were analyzed.
Overall, 60.9% of patients underwent NSM and 39.1% received SSM. TiLOOP Bra mesh was applied in 30.7% of cases, whereas 69.3% were reconstructed without mesh support. The majority of implants were placed subpectorally (81.4%), whereas 18.6% of cases used a prepectoral approach. PMRT was administered in 13.4% of cases. (See figure, Supplemental Digital Content 3, which displays the overall distribution of NSM versus SSM, use of mesh, implant placement plane [prepectoral versus subpectoral], and radiotherapy status, https://links.lww.com/PRSGO/E752.)
Temporal analyses demonstrated parallel increases in both NSM and SSM volumes, with a pronounced rise in NSM use since 2017. By 2023, NSM accounted for more than 50% of reconstructions, surpassing SSM for the first time. Similarly, TiLOOP Bra use increased sharply after 2018, reaching 87.7% of implant-based procedures by 2023, underscoring its widespread clinical adoption. A gradual shift toward prepectoral placement was also observed, although the subpectoral plane remains predominant. The proportion of patients receiving PMRT remained stable and consistently lower than that of nonirradiated cases (Fig. 3).

Determinants Associated With the Choice Between DTI and TE
We next identified clinical factors influencing the selection of DTI versus 2-stage TE reconstruction among unilateral IBBR cases.
NSM was strongly associated with DTI in both univariate (odds ratio [OR] = 1.79, 95% confidence interval [CI] 1.57–2.04, P < 0.001) and multivariate analyses (OR = 1.43, 95% CI 1.24–1.65, P < 0.001). Reconstruction incorporating TiLOOP Bra mesh showed the most robust association with DTI reconstruction (univariate OR = 7.20, 95% CI 6.10–8.49; multivariate OR = 6.43, 95% CI 5.44–7.63; P < 0.001 for both).
Regarding implant positioning, DTI procedures were performed using both prepectoral and postpectoral approaches (prepectoral 553, 28.2%; postpectoral 1411, 71.8%). In contrast, TE reconstruction was predominantly subpectoral (prepectoral 200, 9.6%; postpectoral 1882, 90.4%). Thus, although both planes were used, the vast majority of TE reconstructions were performed in the postpectoral position. Consistently, prepectoral implant placement significantly favored the DTI approach (univariate OR = 3.56, 95% CI 2.98–4.27; multivariate OR = 2.96, 95% CI 2.45–3.60; P < 0.001).
In contrast, higher BMI was only weakly associated with TE use in univariate analysis (OR = 1.04, 95% CI 1.01–1.06, P = 0.004) and became nonsignificant after adjustment (OR = 1.00, 95% CI 0.98–1.03, P = 0.90). PMRT similarly showed no significant effect on reconstructive choice (OR = 0.97, 95% CI 0.79–1.19, P = 0.79) (Table 4).

Unplanned Reoperations
From 2010 to 2023, 113 unplanned reoperations were recorded (median time to event: 189 d), representing 2.79% of all IBBR cases. Among them, 37 (1.88%) occurred after DTI and 76 (3.65%) after TE reconstruction.
Reoperation rates fluctuated over time. Between 2011 and 2013, rates were relatively high for both techniques. Since 2014, the rate for TE reconstruction has remained mostly less than 5%, except for a transient rise in 2018 (5.32%). Early DTI cases (2011–2013 and 2015) showed higher variability, largely reflecting limited TiLOOP Bra use and small sample sizes (eg, n = 4 in 2015). In recent years, reoperation rates have declined markedly for both methods, reaching 0.34% overall in 2023 (DTI: 0.31%; TE: 0.43%), although this may partly reflect shorter follow-up. Despite annual variation, TE reconstruction consistently exhibited higher reoperation rates than DTI, except in isolated years (eg, 2017–2018) (Table 5).
The main indications for unplanned reoperations were hematoma evacuation (10 cases, 0.24% of all IBBR procedures), debridement for mastectomy skin or flap necrosis (5 cases, 0.12%), surgical washout for infection (11 cases, 0.27%), and implant removal due to exposure or loss (87 cases, 2.15%). Notably, the annual rate of implant removal demonstrated a steady decline—from 37.5% in 2012 and 9.9% in 2015 to less than 1% after 2022—reflecting significant improvements in surgical techniques, perioperative care, and complication management during the study period (Table 6).
In logistic regression, TiLOOP Bra use was associated with reduced reoperation risk (univariate OR = 0.52, 95% CI 0.36–0.76, P < 0.001; multivariate OR = 0.63, 95% CI 0.42–0.96, P = 0.030). Conversely, TE reconstruction increased the likelihood of reoperation compared with DTI (univariate OR = 1.90, 95% CI 1.28–2.83, P = 0.002; multivariate OR = 1.58, 95% CI 1.02–2.45, P = 0.039). Other variables—including BMI, mastectomy type, implant plane, and PMRT—showed no significant association (Table 7).

DISCUSSION
Over the past decade, China has experienced a steady rise in breast reconstruction following mastectomy. At our center, both mastectomy and breast-conserving surgery volumes have grown proportionally over time, resulting in a relatively stable proportion of mastectomy (~40%–50%) between 2010 and 2023. Historically, reconstruction rates were exceedingly low but have increased with growing patient awareness, improved healthcare access, and advances in oncoplastic techniques. National data indicate that reconstruction rates rose from 4.5% in 2012 to 10.7% in 2018, paralleling global trends toward integrated BC care.8,23 At our institution, the reconstruction rate increased from approximately 5% in 2010 to more than 15% since 2021, although remaining less than 20% by 2023. This upward trend parallels the overall growth in BC diagnoses and surgical volume at FUSCC, which has evolved into one of China’s largest national referral centers during this period. The number of newly diagnosed BC cases has risen steadily due to increased public awareness, improved screening programs, and broader referral coverage. This progress demonstrates encouraging institutional and national development but still reveals a persistent gap compared with Western countries, where more than 40% of mastectomy patients in the United States and more than 50% in South Korea underwent reconstruction following broader insurance coverage.24,25 These disparities highlight structural, cultural, and socioeconomic barriers that continue to limit reconstruction access in China, including the lack of universal insurance reimbursement and regional variations in surgical expertise.
Interestingly, although bilateral cases were excluded, we observed that their proportion was only 2.9%, markedly lower than in Western countries, reflecting a more conservative clinical practice in China. This likely results from limited indications for prophylactic mastectomy, lower uptake of genetic testing, and cultural preferences favoring breast preservation.26,27 Given that the survival benefit of prophylactic procedures remains under ongoing evaluation, Chinese clinicians generally adopt a more cautious and individualized approach.
Consistent with global trends, IBBR has become the predominant technique in China.28 In our series, implant-based procedures accounted for nearly 70% of all reconstructions after 2016. Notably, the choice of reconstructive method has shifted dramatically from 2-stage TE to 1-stage DTI reconstruction. TE dominated until 2015, but since 2018, DTI and TE have been performed at nearly equal proportions, with DTI further rising to 73.4% by 2023. At our center, the number of surgeons qualified for implant-based reconstruction has steadily increased. This evolution reflects accumulated surgical experience, wider access to supporting devices such as meshes, and greater emphasis on immediate reconstruction and patient satisfaction.
Several interrelated factors have driven this transition. First, the increasing adoption of NSM has expanded the candidacy for immediate 1-stage reconstruction. NSM provides superior aesthetic outcomes and oncological safety in properly selected patients.29,30 By preserving the nipple–areolar complex and skin envelope, it offers an optimal setting for immediate permanent implant placement.31,32 In our cohort, NSM constituted more than 50% of IBBR procedures by 2023, with complication and reoperation rates comparable to those of non-NSM cases, underscoring its safety and feasibility.
Second, the introduction of mesh-assisted reconstruction—particularly TiLOOP Bra—has been a pivotal milestone.4,33–36 When used in the lower pole, the mesh reinforces the inframammary fold, provides inferolateral support, and stabilizes the implant pocket. TiLOOP Bra, a titanium-coated lightweight polypropylene mesh, remains the only synthetic material explicitly approved by the National Medical Products Administration for breast reconstruction in China. Compared with acellular dermal matrices, biosynthetic meshes have demonstrated excellent safety profiles, significant cost advantages, and potentially lower rates of short-term complications.37–42 In our study, TiLOOP Bra was used in only 30.7% of reconstructions overall but reached 87.7% of implant-based cases in 2023, reflecting rapid nationwide adoption.
Third, a progressive shift toward prepectoral implant placement has accompanied the increased use of meshes. Subpectoral placement was historically preferred, but mesh coverage has enabled prepectoral reconstruction by improving soft-tissue support.18 A large meta-analysis reported comparable complication rates and a lower incidence of capsular contracture compared with submuscular techniques.43 Our data mirror this trend: although only 18.6% of reconstructions were prepectoral overall, the proportion rose to 35.2% by 2023, without increased reoperation risk. Together, these advances demonstrate how technical refinements have facilitated safe expansion of 1-stage reconstruction.
Previous studies linked PMRT to higher complication rates in IBBR.44 In our analysis, PMRT showed a nonsignificant trend toward increased reoperation risk. Moreover, in our center, no significant association was found between reconstruction type (DTI versus TE) and receipt of PMRT. Notably, approximately one-third (30.7%) of patients who underwent DTI reconstruction and received PMRT had prepectoral implant placement in our center. Given prior studies suggesting that prepectoral placement may reduce the risk of radiation-associated capsular contracture,45–47 this may partly explain the absence of a statistically significant increase in reoperation rates in our cohort. Thus, prepectoral DTI reconstruction may remain a favorable option for selected patients undergoing PMRT.48,49
Obesity has been identified as a risk factor for infection, wound dehiscence, and implant loss.15,50 A large US cohort study also reported that DTI patients typically had lower BMI and fewer comorbidities than TE patients, although complication rates were similar after adjustment.16 However, in our cohort, BMI was not significantly associated with reconstruction type or reoperation risk, likely reflecting the generally lower BMI of Chinese women compared with Western populations. Previous anthropometric analyses have consistently shown that Asian women, particularly Chinese patients, have smaller breast volumes (average 320–350 mL)51,52 compared with Western women (typically 500–600 mL).53,54 These anatomical characteristics contribute to the technical feasibility and favorable aesthetic outcomes of NSM and DTI reconstruction in Chinese women. These results further emphasize the importance of population-specific data when interpreting global reconstruction outcomes.
In our cohort, the unplanned reoperation rate was 2.79%, which is within or below rates reported internationally (~2.7%–16.7% across recent series).55–57 Notably, the annual rate of implant removal demonstrated a steady decline. Historically, concerns have existed about higher complication risks with DTI compared with 2-stage reconstruction, due to larger implant volume and flap tension.58,59 However, recent studies have significantly shifted this perception, demonstrating that DTI is a feasible and safe option for postmastectomy reconstruction, with no significant increase in reconstruction failure or major complications compared with the 2-stage approach.60–62 Alongside our center’s experience, these findings suggest that with improved surgical techniques and careful patient selection, DTI reconstruction can achieve outcomes comparable to, or even better than, those of traditional TE-based reconstruction. At our institution, DTI did not lead to higher complication rates; in fact, unplanned reoperations declined over time. By 2023, 1-stage reconstruction had become a safe, routine option in well-selected patients. TiLOOP Bra use was a protective factor, whereas BMI, mastectomy type, implant plane, and radiotherapy were not independently associated with reoperation risk. Notably, the use of mesh was strongly associated with the choice of DTI, and both factors were significantly correlated with lower rates of unplanned reoperation. These findings support the synergistic role of mesh and DTI techniques in optimizing surgical outcomes in implant-based reconstruction.
This shift toward 1-stage IBBR reflects a major step forward in aligning Chinese practice with global trends. However, our study has several limitations. It is retrospective in nature, based on data from a single center, and does not incorporate patient-reported outcome measures. Nonetheless, we are actively addressing these gaps. As one of the leading BC centers in China, FUSCC plays a nationally representative role in BC management and reconstruction practices. The present analysis is part of a broader retrospective overview, and 2 prospective randomized controlled trials are currently underway at our institution—the COSTA study, comparing the safety of immediate 1-stage IBBR with expander-implant 2-stage IBBR augmented with TiLoop Bra (NCT03589924),63 and another trial evaluating prepectoral versus subpectoral reconstruction (NCT04688697).
National health insurance typically reimburses mastectomy but not reconstruction or imported devices. Consequently, out-of-pocket costs remain a major barrier, particularly for meshes and implants. With rising socioeconomic levels and greater emphasis on quality of life, improved reimbursement for reconstructive procedures and devices—such as TiLOOP Bra—could substantially enhance access to high-quality care. To further improve outcomes, we recommend multidisciplinary case planning; expanded training in oncoplastic and reconstructive techniques; and enhanced insurance coverage, including reimbursement for TiLOOP Bra or other mesh materials, to ensure broader access to high-quality breast reconstruction across China.

CONCLUSIONS
Over the past decade, IBBR in China has experienced a transformative evolution. We observed a clear increase in reconstruction volume accompanied by a paradigm shift from traditional TE procedures to 1-stage DTI reconstructions. This transition has been driven by the widespread adoption of NSM, the introduction and increasing availability of TiLOOP Bra, and advancements in surgical techniques, including the shift toward prepectoral implant placement. Notably, both DTI and TiLOOP Bra use were associated with lower reoperation rates. Over time, Chinese surgeons have demonstrated improved clinical outcomes and reduced complication rates, marking a significant advancement in reconstructive breast surgery.

DISCLOSURES
The authors have no financial interest to declare in relation to the content of this article. This work was supported by grants from the National Natural Science Foundation of China (No. 82272865).

ETHICAL APPROVAL
The authors are accountable for all aspects of the work, ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). Ethical approval was obtained from the ethical review community of FUSCC (050432-4-2108*), and all patients provided written informed consent in accordance with institutional guidelines.

Supplementary Material