Use Of Textured Implants Research Articles

Dynamic insights into infection risk over time in two-stage implant-based breast reconstruction: a retrospective cohort study.

Infections following postmastectomy implant-based breast reconstruction (IBR) can compromise surgical outcomes and lead to significant morbidity. This study aimed to discern the timing of infections in two-stage IBR and associated risk factors. A review of electronic health records was conducted on 1,096 breasts in 1,058 patients undergoing two-stage IBR at ** National University Hospital (2015-2020). Infections following the first-stage tissue expander (TE) insertion and second-stage TE exchange were analyzed separately, considering associated risk factors. Over a median follow-up of 53.5 months, infections occurred in 2.9% (32/1096) after the first stage and 4.1% (44/1070) after the second stage. Infections following the first-stage procedure exhibited a bimodal distribution across time, while those after the second-stage procedure showed a unimodal pattern. When analyzing risk factors for infection after the first-stage procedure, axillary lymph node dissection (ALND) was associated with early (≤7 weeks) infection, while both ALND and obesity were independent predictors of late (>7 weeks) infection. For infections following the second-stage procedure, obesity, postmastectomy radiotherapy, a history of expander infection, ALND, and the use of textured implants were identified as independent risk factors. Postmastectomy radiotherapy was related to non-salvaged outcomes after infection following both stages. Infections following first and second-stage IBR exhibit distinct timelines reflecting different pathophysiology. Understanding these timelines and associated risk factors will inform patient selection for IBR and aid in tailored postoperative surveillance planning. These findings contribute to refining patient suitability for IBR and optimizing personalized postoperative care strategies.

The Influence of BIA-ALCL on the Use of Textured Breast Implant and its Placement: A Survey of Dutch Plastic Surgeons.

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) and its association with macrotextured breast implants may have induced plastic surgeons to change their breast augmentation and breast reconstruction practice. The aim of this study was to survey Dutch plastic surgeons about the effects of BIA-ALCL on their choice of breast implant texture and placement technique. An online questionnaire was distributed to all members of the Dutch Association of Plastic Surgeons. Descriptive data were presented as frequencies and percentages. Technique alterations were analyzed by the marginal homogeneity test for paired nominal data. A total of 63 plastic surgeons completed the questionnaire. The majority of respondents altered their use of textured implants due to BIA-ALCL concerns for both breast augmentation and reconstruction (75.4% and 69.8%, respectively; both being statistically significant, P < .001). Microtextured and smooth/nanotextured breast implants are now most frequently used. BIA-ALCL did not influence the placement technique in breast augmentation and reconstruction (87.7% and 94.3%, respectively). Dual-plane breast implant placement is still the most favored technique for breast augmentation, and submuscular placement is still most favored for breast reconstruction. BIA-ALCL has had a significant impact on the use of macrotextured breast implants by Dutch plastic surgeons in both aesthetic and reconstructive breast surgery. Breast implant placement technique has not been affected.

Breast Implant Illness: Surgical, Autoimmune, and Breast Reconstruction Associations

Breast implant illness refers to a combination of different symptoms related to breast implant surgery, including fatigue, brain fog, and arthralgias. This malaise occurs after cosmetic and reconstructive breast surgeries, although it has not been proven to be a disease. Even recent studies have reported concluding statements of the etiology, diagnosis, and treatment as unclear and widely unknown. Therefore, this review aimed to determine the associations between the manifestations of breast implant illness in surgery and breast reconstruction, as well as the autoimmune responses involved. Complications associated with breast implants include breast pain, capsular contracture, infections, as well as other manifestations specific to breast reconstruction. Moreover, patients with implants may present with new-onset systemic sclerosis, Sjögren’s syndrome, and connective tissue diseases. However, the incidence of capsular contracture has steadily decreased with each generation of implants, particularly since the development of textured implants, as well as with the use of antibiotics and antiseptic pocket irrigation. However, the incidence of anaplastic large cell lymphoma has increased with the use of textured implants. Remarkably, the autoimmune response to these implants remains unclear. Therefore, close follow-up, careful observation of any symptom presentation, and evidence-based treatment decisions are necessary for patients with breast implants.

Use of flow cytometry and cytology to differentiate breast implant-associated anaplastic large cell lymphoma from reactive seromas in Brazilian patients.

The combination of cytology and multiparametric flow cytometry (MFC) may be useful in the diagnosis of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and may be a practical way to differentiate lymphoma from benign and reactive seromas. Although the Brazilian breast implant market is the second largest in the world, with several manufacturers and the almost exclusive use of textured implants, the occurrence of BIA-ALCL in Brazil is underreported. One hundred seventeen sequential collections of suspicious periprosthetic fluid (PF) from 105 Brazilian patients registered between March/2018 and March/2021 were evaluated by routine cytomorphology and flow cytometry. The combination of CD30, HLA-DR, and CD25 was used together with T and B lymphocyte and monocyte evaluation. The PF samples were divided into positive, acute reactive (neutrophilic exudate), or chronic reactive (macrophage or lymphocyte rich), and unavailable samples. Nine BIA-ALCL positive cases (7.7%) were identified, with typical morphology and increased FSC/SSC dispersion, bright expression of CD30, CD25 and HLA-DR, and absence or weakness of T-cell antigens (CD3, CD8, CD4, CD5, and CD7). Reactive samples were acute (n= 18, 15.4%) and chronic (n= 70, 59.8%). Twenty samples were excluded. The mean age of BIA-ALCL patients was 50 years (31-57 years) and 35 years in reactive patients (20-69 years). Use of MFC with a comprehensive antibody panel consisting of CD30 in conjunction with CD25 and HLA-DR can discriminate anaplastic cells of BIA-ALCL from lymphoid or neutrophilic reactive cells and should be considered in the initial evaluation of seroma.

Epidemiological Profile in Portugal of Breast Implant-Associated Anaplastic Large Cell Lymphoma: A Cross-Sectional Study.

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare T-cell neoplasm that is predominantly associated with the use of textured implants. Recently, several countries have tried to clarify their epidemiological profile of BIA-ALCL. This study aims to estimate the number of cases of BIA-ALCL in Portugal and to describe the pattern of use of breast implants at a national level. This is a cross-sectional study including 57 healthcare institutions - 29 public hospitals and 28 private institutions. Each department of Plastic, Reconstructive and Aesthetic Surgery was asked to provide information concerning the main manufacturer(s) and respective device texture of the breast implants used, and to report the number of registered cases of BIA-ALCL. In our study sample, the response rate was 58%. In our sample, most hospitals reported using textured breast implants from Mentor (45.45%), Allergan (42.42%) and Polytech (39.39%). Only one private institution referred using smooth-coated implants from Mentor and Motiva. Despite several hospitals reporting late-onset seromas, there was only one confirmed case of BIA-ALCL after proper investigation with immunohistochemistry and histological procedures. BIA-ALCL may represent a shift for surgeons regarding selection of implant type. Smooth-coated implants or autologous tissue represent adequate alternatives that could surpass the risks associated with textured devices. In the future, the creation of a national patient registry and proper recognition of BIA-ALCL by plastic surgeons could be useful tools to clarify the impact of the disease nationally and to mitigate potential risk factors.

Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in axillary lymph nodes – a case report and review of 29 other cases from world literature

Introduction. Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALC) is a new disease established by the WHO in 2016. BIA-ALCL is one of the most severe adverse effects of breast augmentation or breast reconstruction with the use of silicone implants. Material and methods. In our report we present a case of a 46-year-old patient diagnosed with BIA-ALCL in the General and Oncological Surgery Clinic of the Pomeranian Medical University in Szczecin. This is one of the first described cases of this disease in Poland. Especially interesting is the fact that the lymphoma developed two years after the removal of the implants and the pathology occurred in the axillary lymph nodes. In order to compare the published case of BIA-ALCL we reviewed 29 cases from literature. Results. We described the most clinically relevant factors. The age range of females analysed with diagnosed BIA-ALCL is between 27 to 87 years. The time from implant insertion to the appearance of the first symptoms varies. The use of textured implants seems to be one of the most important risk factors of novel lymphoma. Conclusions. The patients with breast implants should be informed about the risk of BIA-ALCL and related symptoms. The number of articles about BIA-ALCL is minimal, therefore knowledge about the disease remains limited. There is a need to broaden knowledge about the pathological process, clinical manifestations, risk factors and medical tests crucial to achieve an accurate diagnosis.

Are Textured Implants After Mastectomy Associated with Breast Cancer Recurrence

The association between the use of textured implants for breast reconstruction and the development of anaplastic large cell lymphoma is well known,

Association of the Implant Surface Texture Used in Reconstruction With Breast Cancer Recurrence

The potential association between breast implant-related anaplastic large cell lymphoma (BIA-ALCL) and implant texture has raised concerns about the additional unexpected adverse effects of textured implants, including potentially adverse outcomes for other cancers. In addition to the risk of developing BIA-ALCL, breast cancer survivors may worry about whether the type of implant inserted is associated with recurrence of their original cancer-an issue for which little evidence currently exists. To evaluate the oncologic outcomes of breast cancer according to the surface type of implants used for reconstruction and to identify the independent factors associated with breast cancer recurrence and survival, including implant surface type. This cohort study was conducted at Samsung Medical Center, a single tertiary referral center in Seoul, South Korea. Patients with breast cancer who underwent total mastectomy and immediate 2-stage tissue expander/implant reconstruction between January 1, 2011, and December 31, 2016, were identified from a prospectively maintained database. Patients were categorized into 2 groups according to the surface type of implant used for their reconstruction (smooth or textured implant). These patients were followed up for at least 2 years after insertion of the implant. Data analysis was performed from February 15, 2020, to March 5, 2020. Use of smooth implants vs textured implants at the second-stage operation. The main outcomes of interest were local and regional recurrence-free survival (LRRFS) and disease-free survival (DFS) rates. Cumulative incidence of oncologic events in the smooth implant and textured implant groups and their respective hazard ratios (HRs) were collected and updated regularly. In total, 650 patients (all women, with a mean [SD] age of 43.5 [7.4] years), representing 687 cases, met the inclusion criteria and were followed up for a median (range) duration of 52 (31-106) months. Of the 687 cases, 274 (39.9%) received a smooth implant and 413 (60.1%) received a textured implant. Patients in these 2 surface texture groups had similar characteristics, including tumor staging (stage I: 102 [37.2%] vs 173 [41.9%]; stage II: 93 [33.9%] vs 119 [28.8%]; stage III: 14 [5.1%] vs 20 [4.8%]; P = .50) and rates of adjuvant radiotherapy (42 [15.3%] vs 49 [11.9%]; P = .19) and chemotherapy (113 [41.2%] vs 171 [41.4%]; P = .97). The 5-year LRRFS was 96.7%, and the 5-year DFS was 95.2%. Compared with the use of a smooth implant, textured implant use was statistically significantly associated with lower DFS, and this difference remained significant after adjusting for estrogen receptor (ER) status and tumor stage (HR, 3.054; 95% CI, 1.158-8.051; P = .02). Similar statistically significant associations were observed on multivariable analysis of patients with ER-positive cancer (HR, 3.130; 95% CI, 1.053-9.307; P = .04) and those with invasive cancer (HR, 3.044; 95% CI, 1.152-8.039; P = .03). The association of textured implant use with recurrence (lower DFS) was more prominent in cases with late-stage (stage II or III) tumor (HR, 8.874; 95% CI, 1.146-68.748; P = .04). The LRRFS did not differ statistically significantly according to implant surface texture. This cohort study found that use of textured implants in reconstruction appears to be associated with recurrence of breast cancer. Further investigation is required to verify these results.

EUSOMA position regarding breast implant associated anaplastic large cell lymphoma (BIA-ALCL) and the use of textured implants

During the last two decades the number of breast implants used in aesthetic, oncologic and risk reducing surgery has increased substantially mainly due to the improvement and confirmed safety of these devices. Since identification of the first case of anaplastic large cell lymphoma associated with a breast implant (BIA-ALCL) 20 years ago, there has been an increase in the number of reports of this very rare disease, demonstrating a clear association with breast implants. Whilst the majority of cases are localised and cured by implant removal and full capsulectomy, a small percentage require chemotherapy and the mortality rate is very low. The evidence linking BIA-ALCL to implant surface texturing, as the majority of cases were diagnosed in patients with textured implants, has raised concerns about the long term safety of these devices resulting in patient and regulatory authority concerns globally. We hereby present the current published knowledge about the link between BIA-ALCL and implant surface texture and a review of current regulatory and professional body advice across Europe, which may enable a better understanding of this rare disease, how to manage and ultimately prevent it. We conclude by giving EUSOMA recommendation, towards the unnecessary change in attitudes towards implant based surgery, according to the most recent available published evidence as long as patients are properly informed about the risk of BIA-ALCL.

Evolving Trends in Textured Implant Use for Cosmetic Augmentation in the United States.

Breast implants have evolved for decades. In 2011, the U.S. Food and Drug Administration identified an association between textured breast implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The purpose of this study was to identify the trends of textured implant use since that time. Maintenance of Certification tracer data were queried between 2011 and 2015 for cosmetic breast augmentation cases submitted by American Board of Plastic Surgery diplomates. A nested random effects logistic regression analysis was used to identify associations between variables. Eleven thousand seven hundred sixteen breast augmentations were performed by 880 unique surgeons. The overall proportion of cases using textured implants increased steadily from 2.3 percent in 2011 to 13.0 percent in 2015 (p < 0.001). The proportion of surgeons whose cases included both textured and smooth implants increased (from 6.2 percent to 24.3 percent), as did those using only textured implants (from 0.4 percent to 4.4 percent) (p < 0.001). Significance remained after controlling for form-stable implants, suggesting an alternative motivation for use of textured implants. Subglandular cases (20.5 percent) were more likely to use a textured implant than submuscular (8.4 percent) or dual-plane (7.8 percent) (p < 0.001) cases. Maintenance of Certification tracer data represent a random sampling of American Board of Plastic Surgery-certified plastic surgeons spanning the gamut of practice settings. Despite ongoing education regarding the association of BIA-ALCL with textured implants, American Board of Plastic Surgery diplomates have trended toward increased use of textured implants for cosmetic breast augmentation since 2011. This finding does not appear to be driven by the introduction of anatomical implants during the study period.

Capsular Contracture after Breast Augmentation: An Update for Clinical Practice.

Capsular contracture is the most common complication following implant based breast surgery and is one of the most common reasons for reoperation. Therefore, it is important to try and understand why this happens, and what can be done to reduce its incidence. A literature search using the MEDLINE database was conducted including search terms 'capsular contracture breast augmentation', 'capsular contracture pathogenesis', 'capsular contracture incidence', and 'capsular contracture management', which yielded 82 results which met inclusion criteria. Capsular contracture is caused by an excessive fibrotic reaction to a foreign body (the implant) and has an overall incidence of 10.6%. Risk factors that were identified included the use of smooth (vs. textured) implants, a subglandular (vs. submuscular) placement, use of a silicone (vs. saline) filled implant and previous radiotherapy to the breast. The standard management of capsular contracture is surgical via a capsulectomy or capsulotomy. Medical treatment using the off-label leukotriene receptor antagonist Zafirlukast has been reported to reduce severity and help prevent capsular contracture from forming, as has the use of acellular dermal matrices, botox and neopocket formation. However, nearly all therapeutic approaches are associated with a significant rate of recurrence. Capsular contracture is a multifactorial fibrotic process the precise cause of which is still unknown. The incidence of contracture developing is lower with the use of textured implants, submuscular placement and the use of polyurethane coated implants. Symptomatic capsular contracture is usually managed surgically, however recent research has focussed on preventing capsular contracture from occurring, or treating it with autologous fat transfer.

Comparison of the postoperative incidence rate of capsular contracture among different breast implants: a cumulative meta-analysis.

BackgroundA large number of clinical studies have reported that the different materials used in breast implants were a possible cause of the different incidence rates of capsular contracture observed in patients after implantation. However, this theory lacks comprehensive support from evidence-based medicine, and considerable controversy remains.ObjectivesIn this study, a cumulative systematic review examined breast augmentation that used implants with textured or smooth surfaces to analyze the effects of these two types of implants on the occurrence of postoperative capsular contracture.MethodsWe conducted a comprehensive search of literature databases, including PubMed and EMBASE, for clinical reports on the incidence of capsular contracture after the implantation of breast prostheses. We performed a cumulative meta-analysis on the incidence of capsular contracture in order from small to large sample sizes and conducted subgroup analyses according to the prosthetic material used, the implant pocket placement, the incision type and the duration of follow-up. Relative risks (RR) and 95% confidence intervals (CI) were used as the final pooled statistics.ResultsThis meta-analysis included 16 randomized controlled trials (RCTs) and two retrospective studies. The cumulative comparison of textured and smooth breast implants showed statistical significance at 2.13 (95% CI, 1.18-3.86) when the fourth study was entered into the analysis. With the inclusion of more reports, the final results indicated that smooth breast implants were more likely to be associated with capsular contracture, with statistical significance at 3.10 (95% CI, 2.23-4.33). In the subgroup analyses, the subgroups based on implant materials included the silicone implant group and the saline implant group, with significant pooled statistical levels of 4.05 (95% CI, 1.97-8.31) and 3.12 (95% CI, 2.19-4.42), respectively. According to implant pocket placement, a subglandular group and a submuscular group were included in the analyses, and only the subglandular group had a statistically significant pooled result of 3.59 (95% CI, 2.43-5.30). Four subgroups were included in the analyses according to incision type: the inframammary incision group, the periareolar incision group, the transaxillary incision group and the mastectomy incision group. Among these groups, only the pooled results of the inframammary and mastectomy incision groups were statistically significant, at 2.82 (95% CI, 1.30-6.11) and 2.30 (95% CI, 1.17-4.50), respectively. Three follow-up duration subgroups were included in the analyses: the one-year group, the two- to three-year group and the ≥five-year group. These subgroups had statistically significant results of 4.67 (95% CI, 2.35-9.28), 3.42 (95% CI, 2.26-5.16) and 2.71 (95% CI, 1.64-4.49), respectively.ConclusionIn mammaplasty, the use of textured implants reduces the incidence of postoperative capsular contracture. Differences in implant pocket placement and incision type are also likely to affect the incidence of capsular contracture; however, this conclusion awaits further study.

Capsular Contracture in Subglandular Breast Augmentation with Textured versus Smooth Breast Implants: A Systematic Review

There are conflicting recommendations in the literature regarding the use of textured implants to reduce capsular contracture in subglandular breast augmentation. The authors reviewed the literature to evaluate the effectiveness of surface texturization in reducing capsular contracture. The electronic databases MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were searched for randomized controlled trials comparing textured with smooth implants for subglandular breast augmentation. Study quality was evaluated, and data were extracted from the relevant studies by two reviewers. Outcome measures were reduction in capsular contracture as defined by Baker grade, applanation tonometry, and patient self-assessment. Overall, the treatment effects were expressed as relative risk for dichotomous data and as weighted mean differences for continuous data. Six randomized controlled trials were identified with a total of 235 patients (470 breasts). Textured implants were associated with less capsular contracture as evaluated by Baker grade at 1 year (relative risk, 4.16; 95% CI, 1.58 to 10.96), 3 years (relative risk, 7.25; 95% CI, 2.42 to 21.69), and 7 years (relative risk, 2.98; 95% CI, 0.86 to 10.37) of follow-up. Applanation tonometry used as an objective measure of firmness, however, was not sensitive enough to detect any significant difference in contractures in the two groups (weighted mean differences, -1.54; 95% CI, -6.83 to -3.75). Interestingly, the self-assessment questionnaire revealed that capsular contracture or firmness is one (albeit a very important factor) of many facets in patient overall satisfaction. This systematic review suggests that implant texturization reduces the incidence of early capsular contracture in subglandular breast augmentation. However, further studies are needed to evaluate the long-term effect of texturization and confirm the long-term benefits noted in this study.

Textured Surface Breast Implants in the Prevention of Capsular Contracture among Breast Augmentation Patients: A Meta-Analysis of Randomized Controlled Trials

Capsular contracture is a common complication associated with the use of breast implants. Numerous randomized controlled trials addressing the efficacy of textured surface breast implants in reducing capsular contracture have yielded nonuniform results. This meta-analysis addresses the use of textured breast implants in the prevention of capsular contracture. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases were searched to identify all randomized controlled trials involving the use of textured versus smooth breast implants. The results of these trials were meta-analyzed to obtain a pooled odds ratio of the effect of textured surfacing on capsular contracture rates. In addition, subgroup analyses were performed based on implant type (saline or silicone gel), type of surface texturing (Siltex or Biocell), placement (subglandular or submuscular), and length of follow-up. Eleven trials were reviewed. Four were excluded because they failed to meet a priori inclusion criteria. The remaining seven trials were meta-analyzed. Only three of these studies found significantly lower rates of capsular contracture with the use of textured implants. However, when all seven studies were pooled, the odds ratio was found to be 0.19 (95 percent confidence interval, 0.07 to 0.52), indicating a protective effect for surface texturing on the rate of capsular contracture. Submuscular placement was the only subgroup in which significance was not achieved. However, this subgroup consisted of a single study, which was dramatically underpowered. The results of this meta-analysis demonstrate the superiority of textured over smooth breast implants in decreasing the rate of capsular contracture.