Breast implant-associated late hematoma: a narrative review of case reports and case series

Introduction

Breast implants are widely used in augmentation mammoplasty for aesthetic purposes and in post-mastectomy breast reconstruction following breast cancer surgery (1). Driven by increasing public acceptance of body aesthetics and continuous advancements in breast reconstruction and implant technology, the number of patients undergoing prosthetic breast augmentation and reconstructive surgery has grown significantly (2).

Breast cancer has become the leading disease threatening women’s health worldwide (3). Currently, the treatment paradigm for breast cancer is centered on surgery as part of a comprehensive systemic therapy. For patients with early-stage breast cancer who are not suitable for breast-conserving surgery, those with positive axillary lymph nodes, or those clinically evaluated as candidates for R0 resection, modified radical mastectomy has become the treatment of choice. However, mastectomy can negatively impact women’s body image and sexual life, not only increasing their psychological burden but also potentially intensifying social pressures. Breast reconstruction surgery plays a significant role in restoring feminine physical aesthetics and holds considerable importance for patients’ mental health and social adaptation (4).

Concurrently, with growing societal awareness and understanding of gender identity, there has been a significant rise in the demand for transgender healthcare. Among such interventions, breast augmentation surgery has become one of the most common gender-affirming procedures for transgender women (5). Globally, the number of breast-augmentation surgeries among transgender women has been rising steadily. A long-term follow-up study of 527 transgender women showed a significant increase in surgical volume over the past 30 years, with the median implant size growing from 275 cc in the 1990s to 375 cc in the 2010s (6). This procedure is not only a crucial step in achieving a feminine chest appearance, but also an essential intervention to help alleviate gender dysphoria and improve quality of life (7). Similar to cisgender women, transgender women may also experience a variety of complications following breast augmentation surgery (6).

According to statistics from the International Society of Aesthetic Plastic Surgery, a total of 1,892,777 breast augmentation procedures were performed worldwide in 2023, with implant-based augmentations accounting for 93.7%. Among these implant surgeries, silicone implants comprised 90.6%, while saline implants made up 3.1% (8). Silicone implants have become the material of choice thanks to their more natural feel and superior shape stability, making them especially important in both aesthetic augmentation and post-mastectomy breast reconstruction (9). Although the success rate and safety of implant-based breast augmentation have improved markedly with advancing techniques, postoperative complications remain a key concern for both surgeons and patients (10). Complications after implant-based breast augmentation mainly include pain, infection, hematoma, seroma, implant displacement, capsular contracture, systemic symptoms attributed to breast implants, and breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) (11,12). These complications not only compromise surgical outcomes but also have long-term effects on patients’ health and quality of life (13).

Hematoma is one of the most severe complications following implant-based breast augmentation and typically develops within the first postoperative week. Potential contributing factors include: (I) rough surgical manipulation with inadequate hemostasis; (II) absence of surgical drainage, or drain kinking and occlusion; (III) pre-existing coagulation disorders; (IV) strenuous early postoperative breast movement or external breast trauma.

In contrast, late hematoma occurring months or even decades after surgery is extremely rare. Late hematoma commonly presents with progressive breast swelling, periprosthetic fluid accumulation, or a sudden increase in breast volume and may therefore be mistaken for BIA-ALCL, late seroma, infection, or tumor recurrence. Therefore, despite the extremely low incidence of this complication, its diagnosis and management are of great clinical significance.

To date, studies on late hematoma after breast implant surgery have been published almost exclusively in the form of case reports or small case series, lacking systematic integration and discussion at the mechanism level. This article systematically reviews the existing literature, comprehensively analyzes the clinical characteristics, pathophysiological mechanisms and management protocols of late hematoma, and aims to provide a qualitative synthesis of reported clinical presentations, hypothesized pathophysiological mechanisms, diagnostic approaches, and management strategies described in the available literature. By sorting out the relevant risk factors, diagnostic methods and treatment options, it aims to help clinicians better recognize, evaluate and manage this challenging complication, and ultimately improve patient outcomes.

Clinically, late hematoma is particularly challenging because progressive breast swelling or periprosthetic fluid accumulation is indistinguishable from BIA-ALCL, late seroma, infection, implant rupture, or tumor recurrence based on presentation alone. This creates substantial diagnostic uncertainty: clinicians must decide when to perform image-guided aspiration, what fluid studies are required to exclude malignancy, whether capsulectomy is mandatory, and whether the implant can be retained or replaced. What is agreed upon is that systematic imaging and histopathological assessment are essential; what remains controversial is the optimal sequence of diagnostic steps and the threshold for surgical intervention in frail or high-risk patients.

This narrative review evaluates the clinical features, pathogenesis, differential diagnosis, and management of breast implant-associated late hematoma. We present this article in accordance with the Narrative Review reporting checklist (available at https://gs.amegroups.com/article/view/10.21037/gs-2026-0194/rc).

Methods

Search strategy

A comprehensive systematic literature search was performed across three electronic databases: PubMed, Web of Science, and Cochrane Library (from database inception to December 31, 2025). The search combined MeSH terms and free-text keywords related to “breast implant”, “late hematoma”, and their variants (Table 1). The complete search strategies for all databases are provided in Appendix 1.

Supplementary searches: manual screening of reference lists of included articles and relevant reviews; citation tracking of key publications using Google Scholar; contact with corresponding authors for unpublished data or clarifications (when essential data were missing).

Inclusion and exclusion criteria

Definition of late hematoma

Late hematoma was defined as a hematoma occurring ≥4 months postoperatively (14), characterized by accumulation of blood and its breakdown products within the periprosthetic capsule or potential spaces surrounding the implant, and distinguished from early hematoma by its chronic pathophysiological mechanisms (capsular microfractures, chronic inflammation, external trauma) rather than acute surgical factors (inadequate hemostasis, early postoperative trauma).

Inclusion criteria

The inclusion criteria were as follows: (I) study design: retrospective studies, prospective cohort studies, case reports, or case series; (II) population: patients with breast implants (aesthetic augmentation or post-mastectomy reconstruction); (III) outcome: documented late hematoma (≥4 months post-implantation) with clear clinical description; (IV) language: English-language publications; (V) data availability: sufficient clinical details for meaningful extraction (patient demographics, implant characteristics, time to onset, presenting symptoms, management, and outcomes).

Exclusion criteria

The exclusion criteria were as follows: (I) study design: commentary articles, editorials, systematic reviews, meta-analyses, conference abstracts without full text, letters without original data, and animal studies; (II) population: early hematoma, hematoma without breast implants, or non-implant breast hematoma; (III) outcome: studies focusing solely on seroma without hemorrhagic component, or studies where hematoma could not be distinguished from other fluid collections; (IV) language: non-English publications; (V) data quality: insufficient clinical details for meaningful extraction, duplicate publications of the same case, or inability to verify data accuracy.

Study selection

Two independent reviewers (J.L. and T.Z.) screened titles and abstracts for initial eligibility. Full-text articles were retrieved for potentially eligible studies and independently assessed against inclusion criteria. Disagreements were resolved through discussion or consultation with a third reviewer (T.Y.).

The study selection process was illustrated using a flow diagram adapted from the PRISMA 2020 statement (15), detailing the number of records identified, screened, assessed for eligibility, and included in the final analysis, with reasons for exclusion at each stage.

Data extraction

A standardized data extraction form was developed acknowledging the inherent limitations of case report literature. Two independent reviewers extracted all available data; the extracted variables are summarized in Table 2. Variables not reported in original publications were recorded as “not reported” rather than imputed.

Data synthesis and analysis

We conducted a qualitative descriptive synthesis structured around: (I) epidemiological characteristics; (II) pathophysiological mechanisms; (III) clinical presentation and diagnosis; (IV) therapeutic strategies; and (V) differential diagnosis.

Simple descriptive aggregation of reported demographic and clinical data was performed to characterize the case literature. Descriptive statistics (frequencies, medians, and means) were calculated to summarize the reported clinical data. These values represent simple aggregation of published case descriptions and should not be interpreted as epidemiological estimates.

Results

A total of 1,045 clinical research literatures were retrieved. Through reading the titles and abstracts of the literatures, 1,008 relevant literatures were initially screened out; after reading the full texts, under the constraints of the inclusion and exclusion criteria, 37 literatures with a good correlation with the research purpose and reliable evaluation were finally selected for narrative review (Figure 1).

Figure 1 Flow diagram of study selection process.

A total of 37 literatures were included in this study, covering 47 cases of late hematoma after breast implant placement from 12 countries, among which the number of studies published in the United States was the largest (Figure 2). Information extraction and statistics were performed on the included 37 literatures (Table 3). The basic information, medical history of patients and types of breast augmentation implants are shown in Table 2. Most literatures reported the implantation time of the implant, the occurrence time of hematoma, the type of implant and the treatment methods.

Figure 2 Geographic distribution of reported cases of late hematoma after breast implantation. The United States accounted for the largest proportion of reported cases (38.3%, 18 cases). Canada and South Korea each contributed 10.6% (5 cases), followed by Italy and China (8.5%, 4 cases each). Japan, Australia, the Netherlands, and the United Kingdom each reported 2 cases (4.3%), while Germany, Turkey, and Brazil each reported 1 case (2.1%).

Quality and limitations of the included case reports

The included case reports exhibited substantial heterogeneity and methodological limitations that affect the interpretation of all findings presented below. Clinical histories were frequently incomplete: implant surface characteristics were unreported in nearly half of cases, hematoma volume was documented in fewer than half, and follow-up duration was often absent or limited to the immediate postoperative period. Diagnostic work-ups varied widely; none of the included reports documented systematic preoperative exclusion of BIA-ALCL using current standard protocols (ultrasound-guided aspiration with cytology, flow cytometry, and CD30 immunohistochemistry). When lymphoma exclusion was mentioned, it relied solely on postoperative pathological examination of excised tissue. Terminology was also inconsistent, with “late hematoma”, “delayed hematoma”, and “capsular hematoma” used interchangeably without standardized definitions. Because severe, unusual, or dramatic presentations are more likely to be published, the case literature probably overrepresents complex cases and underrepresents mild or self-resolving events. These limitations mean that the frequencies, mechanisms, and outcomes described in the following sections should be interpreted as illustrative rather than epidemiological, and proposed etiologies should be distinguished from directly observed findings.

Epidemiology

Unlike early hematoma (with an incidence rate of approximately 2%) (51,52), late hematoma after breast implant placement is a rare complication, and precise epidemiological incidence data are currently lacking. This inaccuracy in incidence rate is mainly due to the length of follow-up time; short-term follow-up may fail to capture late hematoma that occurs months or even years after surgery. A retrospective study involving 579 patients (1,158 breasts) showed that the incidence rate of late hematoma was 0.2% during a 2-year postoperative follow-up period (53). This indicates that late hematoma is a rare complication during a relatively short follow-up period. However, its actual incidence rate may increase with the extension of follow-up time, because the occurrence of hematoma can be delayed to several years or even decades after surgery. Based on the fact that only a limited number of cases have been reported worldwide over decades, its incidence rate is clinically recognized to be much lower than that of early hematoma, possibly at or below the order of magnitude of other known rare implant-related complications (such as BIA-ALCL). When evaluating late periprosthetic fluid accumulation, it must be included in the differential diagnosis, but its probability is much lower than that of BIA-ALCL, which needs to be considered.

Clinical manifestations

Main symptoms and signs

The clinical manifestations of late hematoma after breast implant placement are diverse and non-specific, and patients usually develop symptoms months or even years after implantation. However, almost all patients have experienced sudden or progressive enlargement of one (or both) breasts, with the affected breast being significantly larger than the contralateral one. The affected breast has a hard texture and high tension, and a mass can be palpated. Most patients are also accompanied by obvious pain and discomfort. Some patients have purplish-red or bluish-purple ecchymosis on the skin (19), and even rupture and bleeding (20). However, it is worth noting that not all patients with late hematoma will have acute pain symptoms. Some cases may be asymptomatic or have mild symptoms, only showing progressive changes in breast contour or asymmetry, which increases the complexity of diagnosis.

Signs of associated complications

Some patients also develop capsular contracture, which is often Baker grade III/IV, and the breasts may become hard and deformed; if it is a silicone implant rupture combined with hematoma, rupture signs can be seen; distant silicone migration (such as masses in the axilla and upper extremities) may also occur simultaneously.

Therefore, when clinicians are faced with patients with a history of breast implantation who have any abnormal changes in breast size, shape or sensation, whether accompanied by pain or not, late hematoma should be included in the differential diagnosis considerations.

Pathogenesis

The etiology and pathophysiology of late hematoma after breast implant placement remain unclear. Although some case reports and clinical studies have explored the pathogenesis of this complication, the specific pathogenesis has not been fully clarified, mainly including the following mechanisms (Figure 3).

Figure 3 Pathogenic mechanisms of breast implant-associated late hematoma. The figure is created via BioRender with credit.

Mechanical

• Capsular microfractures: operative and histopathological findings in several cases directly suggested capsular microfractures as a mechanism: long-term chronic inflammation leads to thickening, hyalinization, stiffness and loss of elasticity of the fibrous capsule; daily minor shear forces can cause “microfractures” of the capsule, tearing the new blood vessels within it. Due to the inability of the stiff capsule wall to effectively retract and compress to stop bleeding, blood continuously accumulates in the potential space within the capsule, eventually forming a delayed intracapsular hematoma (19,22-24).
• Textured implant-capsule friction: textured implant-capsule friction is hypothesized to contribute to bleeding based on operative findings in reported cases: continuous minor friction and shear forces are generated by daily activities between the rough surface of the textured implant and the granulation tissue rich in new blood vessels on the inner wall of the capsule. This mechanical stimulation can directly damage fragile capillaries and cause bleeding; at the same time, it induces chronic inflammation, making blood vessels more prone to rupture and less likely to contract to stop bleeding. If friction leads to partial separation between the implant and the capsule, a double-layer capsule structure may form, and blood accumulates between the layers, eventually developing into a delayed and progressive intracapsular hematoma (14,31,42,48). Histological studies of macro-textured implants have demonstrated that the inner capsule layer adjacent to the implant undergoes synovial metaplasia and neovascularization, creating a pathological interface between the two capsule layers. Daily micro-movements of the implant generate shearing forces across this interface, tearing fragile capillaries and predisposing to chronic bleeding and delayed hematoma formation (54).

External forces

External forces were identified as temporally associated precipitating factors in several reports (e.g., strenuous exercise, mammographic compression, trauma, occupational activities, forceful compression during sexual activity), but uncontrolled case descriptions cannot establish causality: these forces may directly cause tearing of the fibrous capsule, lacerate the abundant new blood vessels on its inner wall, and induce acute bleeding (23,26,29,37,39,43,46).

Chronic hematoma theory

The chronic expanding hematoma theory is biologically plausible and consistent with pathophysiology described in other anatomical sites, but direct serial imaging or histopathological confirmation in breast implant cases is limited: the blood accumulates in the capsule (such as subdural). The blood accumulated in the capsule and its decomposition products themselves become a persistent inflammatory stimulus, thereby forming a self-sustaining “bleeding-irritation-rebleeding” cycle, leading to slow and progressive enlargement of the hematoma (16,30).

Chronic inflammation

Chronic inflammation is hypothesized to contribute to late hematoma based on biological plausibility: as a persistent foreign body, breast implants can induce chronic inflammation of the capsule. This chronic inflammatory environment stimulates the release of mediators such as vascular endothelial growth factor (VEGF), promoting the formation of a large number of newly formed capillaries with fragile structure and high permeability in the capsule. These fragile blood vessels are prone to rupture and bleed under mild mechanical stimulation (or without clear incentives) (17,38).

Iatrogenic

• Hormones: the high dose of hormone (40 mg triamcinolone acetonide) contained in the implanted prosthesis exerts a strong local anti-inflammatory and healing-inhibiting effect. Under long-term action, it leads to atrophy, dissolution and weakening of the capsule and surrounding soft tissues (including blood vessel walls). A medium-sized intracapsular artery is thus eroded and ruptured, causing delayed bleeding (21).
• Use of anticoagulant drugs: for patients with breast implants, the initiation of anticoagulant/antiplatelet therapy is an important risk factor, which significantly increases the risk of delayed and spontaneous intracapsular hematoma (25,55).
• Chemotherapy: severe thrombocytopenia secondary to chemotherapy can also lead to late hematoma in patients after breast implant placement (40).
• Medical procedures: any chest wall puncture performed on patients who have undergone breast implant placement carries the risk of rupturing the breast prosthesis and causing hematoma (35).
• Prostheses with polyurethane coating: polyurethane-coated implants were originally developed to reduce the risk of capsular contracture. However, it induces a stronger, more persistent, and more vascular-rich chronic foreign body inflammatory response than smooth silicone prostheses, leading to fragile capsular tissue and increased vascular permeability. Under long-term mechanical friction or mild stress, these fragile blood vessels are prone to spontaneous rupture or erosion, causing bleeding and accumulation to form hematomas (28,32,44).

Others

The patient had performed 10 minutes of bilateral upper arm myoelectrostimulation the day before the hemorrhage occurred (36).

Imaging examinations

In the diagnosis of late hematoma after prosthetic breast reconstruction, imaging examinations play a crucial role.

X-ray

The fibrous capsule present in the breasts of patients after breast implant placement is considered a source of difficulty and interference in mammography, and some patients have difficulty undergoing X-ray examination due to swollen and painful breasts.

Ultrasound

Due to its convenience, radiation-free nature and high sensitivity, ultrasound examination is often used as the preferred screening method. Ultrasound can clearly display the anechoic areas around breast implants or within breast tissue, evaluate the scope and nature of effusion, and has important value in distinguishing hematoma, seroma or infectious effusion (56). Ultrasound-guided puncture aspiration can not only obtain diagnostic samples but also play a certain therapeutic role (33). Moreover, recent studies have shown that ultrasound is also an effective tool for diagnosing breast implant rupture (57).

Computed tomography (CT)

CT can be used as an auxiliary examination method in complex cases, especially having unique advantages in evaluating the relationship between hematoma and surrounding tissues. CT can quickly obtain high-resolution three-dimensional images, clearly showing the scope, density of the hematoma and its spatial relationship with the chest wall, muscles and prosthesis. At the same time, for hematomas located in areas difficult to detect by ultrasound, such as behind the prosthesis, CT can provide clear images and is an ideal choice for evaluating such complex cases (58). However, the limitations of CT lie in its radiation exposure and low soft tissue contrast, so it is usually only considered when magnetic resonance imaging (MRI) is contraindicated or the diagnosis is unclear.

MRI

MRI, due to its excellent soft tissue resolution, has become an indispensable imaging method for evaluating such complications (59). MRI is more reliable than ultrasound in diagnosing prosthesis rupture and evaluating hematoma (30-32). On MRI, the signal intensity of hematoma changes with its formation time: in the acute phase, it shows isointense or slightly hypointense signals on T1 weighted imaging (T1WI) and significantly hypointense signals on T2 weighted imaging (T2WI); in the early subacute phase, it presents a peripheral hyperintense ring on T1WI and still hypointense signals on T2WI; in the middle and late subacute phase, it shows hyperintense signals on both T1WI and T2WI; in the chronic/organized phase, the hematoma characteristically presents a mixed signal shadow with a central hyperintense signal and a surrounding hypointense ring on T2WI (60).

In summary, the imaging evaluation of late hematoma after prosthetic breast reconstruction should follow the principle of individualization. As the preferred examination method, MRI can comprehensively evaluate the status of hematoma and prosthesis; ultrasound is suitable for initial screening and guiding interventional procedures; while CT plays an auxiliary role in complex anatomical evaluation. Clinicians should select the most appropriate examination method according to the patient’s specific conditions and imaging characteristics to optimize diagnosis and treatment decisions.

Treatment strategies

The treatment of breast implant-associated late hematoma follows the principle of “individualized treatment based on clinical condition, with surgical treatment as the gold standard (30) and minimally invasive/interventional treatment as alternatives”. The primary treatment goals are to evacuate the hematoma, control bleeding, prevent complications (e.g., skin necrosis), and exclude malignant diseases such as BIA-ALCL. Treatment selection is based on factors including hematoma size, presence of active bleeding, implant integrity, patient’s surgical tolerance, and underlying diseases (Figure 4).

Figure 4 Proposed diagnostic and treatment algorithm for breast implant-associated late hematoma. (This framework synthesizes current reported case experience; it is not a prospectively validated, evidence-based protocol). BIA-ALCL, breast implant-associated anaplastic large-cell lymphoma; MRI, magnetic resonance imaging; PE, physical examination; US, ultrasound.

The surgical method is usually incision and exploration, with specific steps including: incising the hematoma cavity, thoroughly removing old blood and blood clots to reduce any factors that stimulate capsule formation, carefully exploring the capsule and managing active bleeding points to achieve complete hemostasis (31); capsulotomy can be performed simultaneously, as failure to remove the capsule may result in long-term persistent bleeding of the intracapsular blood vessels (16). It is necessary to perform diagnostic capsulotomy to obtain a pathological biopsy. If reimplantation of a new prosthesis is planned subsequently, this biopsy should be completed before surgery (48). The prosthesis should be carefully inspected during the operation; if prosthesis damage is found, prosthesis replacement should be considered. In addition, the capsule cavity should not be left empty, and the original prosthesis should be replaced with a smooth-surface prosthesis as much as possible (40). Postoperatively, it is recommended to place a drainage tube and conduct close monitoring to detect signs of rebleeding early.

However, in specific cases, non-surgical or minimally invasive intervention can be used as an effective option. For cases with an intact prosthesis, hematoma mainly in liquid form, no definite active bleeding, and stable patient condition, ultrasound-guided percutaneous aspiration can be used as an exploratory treatment (33). For elderly and debilitated patients who cannot tolerate surgery (such as those with severe dementia or long-term bed rest), if imaging confirms the presence of a definite responsible bleeding vessel, transcatheter arterial embolization can be used as a palliative treatment to control acute bleeding and stabilize the patient’s condition, especially when the surgical risk is extremely high (20).

Differential diagnosis

Late hematoma occurring after breast implant placement may be clinically similar to a variety of other complications or diseases, so accurate differential diagnosis is crucial.

Late seroma after breast implantation

Late seroma is also a rare complication that occurs late in the periprosthetic space after breast implant placement, usually developing several months to more than 10 years after breast augmentation. Its main manifestation is breast swelling, and patients generally do not have infectious symptoms such as elevated body temperature or abnormal white blood cell count; during surgery, pale yellow serous sterile fluid around the prosthesis can be found. If no other clear etiology is identified, late seroma can be considered a complication caused by textured prostheses (61). Van Slyke et al. counted 539 patients after breast augmentation and found that late seromas basically occurred in patients with textured prostheses (62). Robinson believed that this complication only occurs after breast augmentation with textured silicone gel prostheses and is rare in those with smooth prostheses (63). To date, the etiology and pathogenesis of late seroma have not been determined; possible etiologies include increased vascular permeability, chronic infection, synovial metaplasia of the capsule, hormonal and endocrine disorders, allergic reactions, and prosthesis rupture (64). Large seromas are often accompanied by significant asymmetry of the breasts; diagnosis is centered on ultrasound-guided puncture, and effusion analysis (cytology, culture, biochemistry) is used to rule out infection, hematoma, and malignant tumors (especially anaplastic large cell lymphoma). For treatment, if antibiotics are ineffective or effusion recurs, total capsulectomy with prosthesis removal (with possible simultaneous replacement) is recommended. It should be noted that complete resection of the capsule is the key to preventing seroma recurrence, and tumorous lesions should be vigilant under multidisciplinary collaboration (65).

Malignant tumors and breast implant-associated anaplastic cell lymphoma

Current National Comprehensive Cancer Network (NCCN) guidance recommends ultrasound-guided aspiration with CD30 immunohistochemistry for all late periprosthetic effusions to exclude BIA-ALCL; this standard work-up is distinct from the variable approaches described in the case reports reviewed herein.

Whether breast silicone implants increase the risk of breast cancer has been a sensitive issue of concern and intense discussion among scholars since the advent of implants. To date, epidemiological studies have found no evidence that women undergoing breast augmentation have an increased risk of breast cancer (66).

BIA-ALCL is also a rare disease associated with breast implants. BIA-ALCL is a type of non-Hodgkin T-cell lymphoma; the first case of this disease was reported in 1997, occurring 35 years after prosthesis placement (67). Subsequently, more patients were continuously identified; in 2016, the World Health Organization (WHO) classified it as a new type of ALCL independently (68). Large-scale clinical observation trials have found that the incidence rate of ALCL is approximately 1/30,000 to 1/3,800 (69). This disease is closely related to the use of textured implants (70), and usually occurs around 8 to 10 years after the placement of textured breast implants (71).

The most common clinical manifestation of BIA-ALCL is periprosthetic effusion or solid mass that persists for more than 1 year after prosthesis placement. Other symptoms include capsular contracture, axillary lymphadenopathy, and B symptoms (fever, lymphadenopathy, night sweats, fatigue) (72-76).

Currently, color Doppler ultrasound, MRI and other imaging examinations are the preferred methods for diagnosing BIA-ALCL. After clarifying the location of the effusion, fine-needle aspiration or lymph node biopsy is performed, and the specimens are assisted in diagnosis by immunohistochemistry, microbiology and cytology examinations (77,78). At the same time, deletion of the 20q13.13 locus can be found in most patients with BIA-ALCL (79), so genomic sequencing can be performed to determine chromosomal copy number aberrations to assist in differential diagnosis. It should be emphasized that the above represents current NCCN and multidisciplinary guidance for evaluating delayed periprosthetic fluid. In contrast, the case reports reviewed herein described variable diagnostic work-ups, and BIA-ALCL exclusion was not always complete (71).

It must be emphasized that none of the case reports reviewed herein documented complete preoperative BIA-ALCL work-up according to current NCCN and multidisciplinary guidance (ultrasound-guided aspiration with cytology, flow cytometry, and CD30 immunohistochemistry). BIA-ALCL exclusion, when reported, was based on postoperative pathological examination of excised tissue rather than preoperative fluid analysis. This represents a major limitation: these historical cases cannot be considered equivalent to modern cases with systematic lymphoma exclusion, and the true incidence of unrecognized BIA-ALCL in this literature is unknown.

In addition, there have been recent reports of a rarer squamous cell carcinoma in the capsule surrounding the implant (BIA-SCC). Although its incidence rate is extremely low, it further emphasizes the importance of accurate differential diagnosis for late masses around the prosthesis (12).

In summary, the core of improving the accuracy of late hematoma diagnosis lies in combining detailed clinical manifestations and conducting multidisciplinary consultations. When clinicians are faced with late masses or effusions after prosthetic breast reconstruction, they should maintain a high degree of vigilance, perform systematic imaging evaluations (such as ultrasound and MRI), and ultimately rely on surgical exploration and histopathological examination, the gold standard, to confirm the diagnosis. Through this rigorous differential diagnosis process, late hematoma can be effectively distinguished from late seroma, BIA-ALCL, tumor recurrence, or other serious complications, thereby formulating the safest and most appropriate treatment strategy for patients.

Discussion

Clinical practice considerations

Given the rarity of breast implant-associated late hematoma and the fact that current evidence is derived solely from case reports and small case series, the following considerations are proposed based on a systematic synthesis of published cases, clinical reasoning, and multi-disciplinary expert consensus. They are intended to serve as a practical framework for clinicians managing this rare complication, rather than as mandatory standards of care. All clinical decisions should be individualized based on patient-specific factors and resource availability.

Patterns across the reports and persistent uncertainties

Several recurring patterns emerge from the 47 published cases. First, the dominant presentation was acute, painful, unilateral breast swelling occurring months to years after implantation. Second, the temporal window was wide (median 72 months, range from 4 months to several decades), underscoring the need for long-term vigilance. Third, surgical evacuation with capsulectomy was the most frequently reported intervention and was associated with resolution when follow-up was documented. Fourth, textured and polyurethane-coated implants appeared overrepresented among reported cases; however, this may reflect publication patterns or heightened surveillance rather than true risk, and the absence of denominator data precludes any conclusion.

Despite these patterns, fundamental questions remain unresolved because the evidence derives exclusively from uncontrolled case reports. Incidence cannot be calculated without denominator data (total implant recipients at risk). Independent risk factors cannot be identified without a control group of implant recipients who did not develop late hematoma. Prognosis is unknown because follow-up was short or absent in most reports, and recurrence may be underreported. Optimal management cannot be defined because no comparative studies exist: the relative efficacy of surgical evacuation versus aspiration, the necessity of total versus partial capsulectomy, and the safety of immediate implant replacement remain unstudied. The sections that follow present a pragmatic clinical framework synthesized from current guidance and these low-level observations, but they do not constitute a validated, evidence-based protocol.

Screening and long-term follow-up considerations

Routine follow-up for all implant recipients

Given the wide temporal window of late hematoma onset reported in case literature, it is prudent to offer long-term routine follow-up to all patients undergoing breast implant surgery. A reasonable approach includes physical examinations at 1, 3, 6, and 12 months postoperatively, and annually thereafter, to monitor breast morphology, capsular status, and implant integrity.

Enhanced awareness for high-risk populations

Pooled analysis of case data suggests a higher proportion of late hematoma reports among specific groups, including transgender women, elderly patients (aged 60 years and older), those with textured or polyurethane-coated implants, long-term anticoagulant/antiplatelet users, patients with a history of capsular contracture (Baker grade III/IV), and those with a history of breast trauma. Therefore, a lower threshold for clinical investigation is suggested for these populations. A prudent approach may include considering annual ultrasound screening in addition to physical examination to potentially enable earlier detection of periprosthetic fluid, although the cost-effectiveness of this strategy remains unproven.

Patient education

All implant recipients should be informed of the potential signs and symptoms of late hematoma (unexplained breast swelling, pain, asymmetry) and advised to seek medical attention promptly if such symptoms occur. For high-risk patients, it may be reasonable to advise avoidance of strenuous breast trauma and contact sports.

Diagnostic algorithm for suspected late hematoma

For patients with a history of breast implantation presenting with unexplained breast swelling, hardening, or pain, a rigorous diagnostic algorithm is paramount. The following algorithm represents a synthesis of current reported case experience; it is not a prospectively validated, evidence-based protocol and should be adapted to individual circumstances.

Initial evaluation

We suggest obtaining a detailed clinical history and performing a physical examination, followed by ultrasound screening to evaluate periprosthetic fluid accumulation, implant integrity, and to exclude obvious solid masses.

Definitive diagnosis

If ultrasound suggests hematoma, we suggest performing MRI to confirm the diagnosis, clarify hematoma staging and scope, and accurately assess implant integrity.

Differential diagnosis

We strongly encourage performing ultrasound-guided percutaneous puncture aspiration to obtain fluid samples for cytological examination, biochemical analysis, and microbiological culture to rule out infection, BIA-ALCL, and tumor recurrence. For cases with suspected solid components, core needle biopsy for pathological examination is suggested.

Multi-disciplinary consultation

For uncertain cases (e.g., suspected BIA-ALCL), we suggest conducting a multi-disciplinary consultation involving breast surgery, radiology, and pathology departments to confirm the diagnosis.

Individualized treatment selection

After a definitive diagnosis of late hematoma is established.

Assessment of surgical indications

We suggest evaluating for active bleeding, implant rupture, hematoma size (e.g., 300 mL or greater as reported in some cases), risk of skin ischemia, and surgical tolerance.

Surgical treatment as the primary definitive approach

In the majority of published cases where intervention was performed, surgical exploration with hematoma evacuation and total capsulectomy was associated with successful resolution and provided tissue for histopathological exclusion of malignancy. Therefore, for patients with surgical indications, this approach is suggested as the preferred treatment. Removal of ruptured implants and replacement with smooth-surface silicone implants may be considered, and pathological examination of the capsule is recommended to exclude malignant diseases.

Minimally invasive/interventional alternatives

For patients without clear surgical indications: (I) ultrasound-guided percutaneous aspiration may be considered for those with intact implants, predominantly liquid hematoma, and stable clinical condition; (II) transcatheter arterial embolization may be considered for elderly, debilitated patients with a confirmed bleeding vessel and poor surgical tolerance.

Post-treatment follow-up

We suggest short-term (1 to 3 months) physical examination and ultrasound to monitor for rebleeding and fluid resolution, and integration of long-term annual follow-up into routine implant care.

Multi-disciplinary collaboration

Multi-disciplinary collaboration is strongly encouraged for the management of late hematoma, especially for differential diagnosis and complex cases. Breast surgeons are responsible for clinical evaluation and treatment decision-making; radiologists provide accurate imaging diagnosis and hematoma staging; pathologists confirm the diagnosis and exclude malignant diseases such as BIA-ALCL; interventional radiologists may perform percutaneous aspiration or arterial embolization for select patients. For transgender women and other special populations, collaboration with gender medicine specialists is recommended to optimize treatment and follow-up strategies. Hematologists should be consulted for perioperative management of anticoagulation and coagulopathy, particularly in patients on antiplatelet or anticoagulant therapy. Oncologists should participate when malignancy is suspected or confirmed, and when the differential diagnosis includes BIA-ALCL or breast cancer recurrence.

Study limitations and future research directions

Strengths of the review

To our knowledge, this is the first narrative review to systematically synthesize the available evidence on breast implant-associated late hematoma. Key strengths include: (I) a comprehensive literature search across multiple databases with explicit inclusion/exclusion criteria; (II) a detailed analysis of pathogenic mechanisms integrated into a unified conceptual framework (Figure 3); (III) a practical diagnostic and treatment algorithm (Figure 4) to guide clinical decision-making; (IV) specific attention to high-risk populations such as transgender women and elderly patients; and (V) a clear differentiation from BIA-ALCL and late seroma, which is critical for avoiding misdiagnosis. Despite the low level of evidence (case reports and case series), this review provides a structured foundation for clinical practice and future research.

Study limitations

This review is based exclusively on case reports and small case series. Consequently, it cannot estimate incidence or comparative risk, establish causal relationships, or define optimal management, and it is especially vulnerable to publication and reporting bias.

Publication bias

Case reports are prone to publication bias, with severe, atypical, or rare cases more likely to be reported, potentially leading to an overestimation of the severity and incidence of late hematoma.

Language restriction

We restricted the search to English-language publications due to resource constraints. Because late hematoma is rare and every well-documented case may contribute to understanding, this restriction may have omitted relevant reports from non-English-speaking countries where breast implant surgery is commonly performed (e.g., parts of Latin America, Asia, and Eastern Europe). If non-English case series describe different implant types, patient populations, or management approaches, our synthesis may not fully represent global clinical experience. This should be considered when interpreting the generalizability of the findings.

Incomplete data

A significant portion of case reports lack detailed clinical data (e.g., nearly half of cases have unreported implant surface characteristics, and only a small fraction of studies report hematoma volume), limiting comprehensive quantitative analysis and risk factor identification.

No control group

The lack of a control group (e.g., implant recipients without late hematoma) makes it impossible to accurately assess the risk factors and true incidence of late hematoma.

Heterogeneity

The included cases are heterogeneous in terms of implant type, surgical purpose, patient population, and treatment methods, making it difficult to compare the efficacy of different treatment strategies.

Unclear incidence

The absence of denominator data (total number of implant recipients) precludes calculation of the precise incidence of late hematoma.

Proposed mechanisms

Including capsular microfractures, textured surface friction, chronic inflammation, and iatrogenic triggers were inferred from isolated case descriptions rather than confirmed through controlled studies.

Future research directions

To address the limitations identified above, future research should prioritize the following:

• Adopt consistent definitions: a standardized definition of late hematoma (e.g., hematoma occurring ≥4 months post-implantation, with clear distinction from early surgical bleeding and from seroma) is needed to enable meaningful comparison across reports.
• Standardize reporting: future case reports and series should use standardized templates documenting implant characteristics (surface, fill, manufacturer, size), precipitating factors, diagnostic work-up (imaging, aspiration studies, BIA-ALCL exclusion methods), operative findings, pathology, treatment, and follow-up duration.
• Establish prospective registries and multicenter studies: international or national multicenter registries are needed to capture denominator data, clarify true incidence, and enable prospective cohort or nested case-control designs that can distinguish true risk factors from coincidental findings.
• Ensure longer follow-up: future studies should incorporate standardized, longer-term follow-up to assess recurrence, delayed complications, and implant longevity after late hematoma management.
• Additional directions: beyond these priorities, molecular biomarker research to differentiate late hematoma from BIA-ALCL, comparative studies of surgical versus aspiration management, dedicated research on special populations (e.g., transgender women), and biomechanical studies of implant-capsule interaction may further advance understanding.

Conclusions

Breast implant-associated late hematoma is a rare, multifactorial complication with an onset window of months to decades postoperatively, driven by capsular microfractures, mechanical friction, chronic inflammation, external trauma, and iatrogenic factors. Its non-specific clinical manifestations—predominantly unilateral breast swelling and pain—make it easily misdiagnosed with BIA-ALCL, late seroma, and tumor recurrence, posing significant clinical challenges. The diagnosis of late hematoma follows a standardized process of ultrasound screening, MRI confirmation, and percutaneous puncture aspiration for differential diagnosis, with multi-disciplinary collaboration critical for avoiding misdiagnosis. Surgical exploration with hematoma evacuation and capsulectomy remains the gold standard treatment, with ultrasound-guided percutaneous aspiration and transcatheter arterial embolization as effective alternatives for select patients.

With the increasing global volume of breast implant surgery—including aesthetic augmentation, post-mastectomy reconstruction, and gender-affirming care for transgender women—clinicians must maintain a high degree of clinical vigilance for late hematoma. Enhanced long-term follow-up is recommended for high-risk populations, and early identification and individualized treatment are key to improving patient outcomes. Finally, with portable ultrasound increasingly available, we encourage surgeons to incorporate point-of-care ultrasound into routine follow-up, enabling rapid bedside differentiation between late hematoma and late seroma, facilitating immediate aspiration for diagnosis, and accelerating BIA-ALCL exclusion—particularly with textured implants—thereby reducing diagnostic delay and optimizing intervention. Future research should focus on establishing multicenter registries, identifying diagnostic biomarkers, and optimizing follow-up and preventive strategies to address the current gaps in evidence and improve the clinical management of this rare complication.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the Narrative Review reporting checklist. Available at https://gs.amegroups.com/article/view/10.21037/gs-2026-0194/rc

Peer Review File: Available at https://gs.amegroups.com/article/view/10.21037/gs-2026-0194/prf

Funding: This study was supported by the Joint Science Foundation of Gansu Province (No. 25JRRA1242). The funder had no role in the study design, data collection, analysis and interpretation, writing of the manuscript, or the decision to submit the article for publication.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://gs.amegroups.com/article/view/10.21037/gs-2026-0194/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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