Association Of Breast Implants Research Articles

Systematic review of breast implant associated squamous cell carcinoma.

e12508 Background: Breast augmentation is a cosmetic procedure with low rates of complication like bleeding, infection, implant rupture, and capsular contracture. However, rare cases of breast implant-associated (BIA) malignancies, including anaplastic large cell lymphoma (ALCL) and squamous cell carcinoma (SCC), have been reported. BIA-SCC is rarer than ALCL and current literature is limited to case reports. In 2022, the American Society of Plastic Surgeons (ASPS) issued a BIA-SCC summary statement based on 16 reported cases in response to an FDA safety communication. The aim of this study is to review published cases of BIA-SCC and present clinical and outcome data systematically. Methods: We conducted a literature search in English to identify studies reporting BIA-SCC from inception to October 2022. Patient characteristics and relevant outcomes were gathered from the studies. The mortality rates at 6 and 12 months were calculated as the inverse of the Kaplan-Meier survival estimate and presented with a 95% confidence interval (CI). Results: 14 articles and 18 cases of BIA-SCC were identified through a literature search. A rising trend in case reporting was observed, with 4 cases in the 1990s and 14 cases since 2010. The mean patient age was 56 years (range 40-81), and the mean time from breast augmentation to symptom appearance was 21 years (range 10-35). Most patients (13/18, 72%) underwent the procedure for cosmetic reasons. Out of 17 cases with available implant information, 11 cases had silicone based implants and 6 cases saline implants. Implant surface information was available in 5 cases, 4 smooth and 1 textured. 16 patients had swelling of the breast and 15 patients had breast pain at presentation of BIA-SCC. All patients had their implants removed and 10 underwent mastectomy after a diagnosis of SCC. Of the 12 cases with available treatment information, 7 received adjuvant chemotherapy and/or radiotherapy, 2 received neoadjuvant chemotherapy, and 3 did not receive perioperative chemotherapy or radiotherapy. Follow-up data was available for 10 cases. The 6-month and 12-month mortality rates were 11.1% (95% CI: 0.5% to 40.6%) and 23.8% (95% CI: 2.8% to 56.1%). Conclusions: The estimated 6-month mortality rate of 11% (95% CI: 0.5%-40.6%) should be interpreted cautiously due to the small sample size. It is lower than the rate reported by ASPS (44%), but the reason for this difference cannot be accurately explained as the methodology for determining then mortality rate is not provided in the ASPS statement. This study provides a valuable systematic review of a rare and poorly understood condition with a poor prognosis. Monitoring and sharing information is crucial to improve detection and management of BIA-SCC. [Table: see text]

Breast implant associated EBV-positive Diffuse Large B-cell lymphoma: an underrecognized entity?

Breast-implant associated (BIA) lymphoma is an infrequent type of cancer occurring in the fluid and fibrous capsule around a textured breast implant. Recently, both the 2022 WHO 5th edition classification of Haematological tumours (WHO HAEM5) and 2022 International Consensus Classification of Mature Lymphoid Neoplasms (22ICC), recognized breast implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) as a definitive entity, defined as a mature CD30-positive T-cell lymphoma, confined by a fibrous capsule, in a breast implant setting. Only few B-cell lymphomas have been reported in the literature to be associated with breast implants. Here we report two EBV-positive Diffuse Large B-cell lymphomas (EBV + DLBCL) in relation to a breast implant, both expressing CD30 as well as EBV latency type 3. Both lesions were considered as DLBCL associated with chronic inflammation (CI-DLBCL), but one presented as a 7 cm solid mass, while the other presented as a fibrin-associated DLBCL (FA-DLBCL) in an HIV patient. Clinically, both are in complete remission 6 months or longer after capsulectomy and graft removal, without additional chemotherapy.Such cases, characterized by large CD30-positive cells, can easily be misdiagnosed as BIA-ALCL if the cell of origin is not further established. Therefore, a diagnostic panel including lineage-specific B-and T-cell markers and EBER in situ hybridization is essential to recognize this rare entity, to understand lymphomagenesis, to predict outcome and to define clinical approach.

Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE): Updated Report 2012-2020.

In January of 2011, the U.S. Food and Drug Administration released a safety communication regarding the potential association between breast implants and anaplastic large-cell lymphoma (ALCL). In 2012, the American Society of Plastic Surgeons, The Plastic Surgery Foundation, and the Food and Drug Administration signed a cooperative research and development agreement to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large-Cell Lymphoma Etiology and Epidemiology (PROFILE) patient registry. This is an updated report of registry findings. From August of 2012 to August of 2020, 330 unique, suspected, or confirmed cases of breast implant-associated (BIA) ALCL in the United States were reported to PROFILE, including 144 cases newly reported since the 2018 publication. Median time from implantation of any device to BIA-ALCL diagnosis was 11 years (range, 2 to 44 years). At the time of presentation, 91% of cases had local symptoms and 9% had concurrent systemic symptoms. The most common local symptom was seroma, seen in 79% of patients. All patients had a history of a textured device; there were no patients who had a confirmed smooth-only device history. Approximately 11% of the reported cases were diagnosed with stage 1A disease (tumor-node-metastasis staging classification). The PROFILE registry continues to be an essential tool in unifying the collection of granular-level data pertaining to BIA-ALCL. These data emphasize the critical importance of detailed tracking of BIA-ALCL cases, and will contribute significantly to our understanding of the relationship between breast implants and ALCL.

Augmenting Breast Implant Research: Accessible Methods for Fabricating Miniature Smooth and Textured Breast Implants in a Laboratory Setting.

Because of the association of textured breast implants with breast implant-associated anaplastic large cell lymphoma, anatomically shaped breast implants, which rely on a textured surface to maintain rotational stability, have been recalled from the market. The dearth of anatomically shaped implants on the market reflects a need for novel breast implant technology, which has been traditionally developed by commercial breast implant manufacturers due to the complexities of implant manufacturing. To increase the accessibility of preclinical breast implant research, miniature breast implants made from polydimethylsiloxane were designed and fabricated for high throughput and low-cost prototyping and in vivo testing of both smooth and textured implants in a laboratory setting. Two-piece negative molds measuring 2 × 1 cm were constructed in Fusion360 and 3D printed in Polysmooth filament. Textured molds were painted with a mixture of an epoxy and fine sugar or granular salt to create textured surfaces, while molds for smooth implants were smoothed using ethanol spray. Molds were injected with polydimethylsiloxane and cured for 12 hours at 37°C. The surface topography of laboratory-made implants and commercial textured and smooth implant shells was analyzed using scanning electron microscopy and implants were evaluated in vivo in an immunocompetent rodent model. Implants retained the original dome shape of the 3D-printed molds. Qualitative assessment of scanning electron microscopy images demonstrated similar surface topography between laboratory-made and commercial smooth and textured implants. There was no statistical difference in the diameter or density of the surface indentations of the Allergan's textured implant compared with laboratory-made textured implants (P > 0.05). Finally, the surface topography and thickness of laboratory-made implant capsules were similar to previously published data using industry made miniature silicone devices implanted in rats. This study demonstrates a low-cost, highly customizable approach to fabricate miniature smooth and textured breast implant prototypes for in vivo studies. The accessibility of this implant fabrication strategy allows nonindustry investigators to develop novel implant designs more rapidly for preclinical investigation.

Anaplastic Large-cell Lymphoma Involving Gastrointestinal Tract: A Clinicopathologic Study of 25 Cases of a Rare Tumor at a Rare Site.

Background. Anaplastic large-cell lymphoma (ALCL) is an uncommon lymphoma divided into anaplastic lymphoma kinase (ALK) positive, ALK negative, and breast implant-associated (BIA) ALCL. Gastrointestinal tract involvement is very rare and may be difficult to diagnose. Its recognition is crucial as prognostic ramifications are different. Objectives. To describe clinicopathological features of ALCL involving the gastrointestinal tract. Materials and Methods. Slides were reviewed. Diagnosis was confirmed. Histological and immunohistochemical features were described. Results.Twenty-five tumors were diagnosed during the study period. Ages ranged from 14 to 65 years (mean 41 years). Mean age for ALK-negative and ALK-positive patients were 49 and 17 years, respectively. Twenty-one were males and 4 were females. Eighteen involved small intestine. Mean tumor size was 4.2 cm. All showed diffuse sheets of large anaplastic cells with pleomorphic nuclei, abundant pink cytoplasm, and strong positivity for CD30. Epithelial membrane antigen was positive in 17 tumors and keratin was negative in all. Eighteen tumors were ALK negative. Out of 14 patients with follow-up, 12 died within a few months of diagnosis. Seven had stage IE, 5 had stage IIE, and 2 had stage IV disease. Two patients were alive at 35 and 60 months. Twelve received chemotherapy. Conclusion. A marked male predominance was noted. Small intestine was the commonest site of involvement. Majority were ALK negative. ALK-negative tumors occurred in older patients and ALK positive in younger patients. Prognosis was poor. ALCL should be included in the differential diagnosis of anaplastic epithelioid cell neoplasms in the gastrointestinal tract.

A nonrandom association of breast implants and the formation of desmoid tumors.

Studies suggest that surgical breast augmentation with implants is a risk factor for breast desmoid tumors. The statistical strength of this correlation is unknown, as evidence is limited to anecdotal reports. Patients with breast desmoid tumors and a history of breast implants seen at a single center between 2000 and 2021 were identified via radiology, breast, and sarcoma databases. The standardized incidence ratio (SIR) was calculated to assess the correlation between breast desmoid tumors and breast implants. The cases were pooled with published cases for analyses. Progression-free survival curves and hazard ratios were estimated using the Kaplan-Meier method and Cox proportional-hazards modeling. Fourteen patients from one institution and 66 cases in the literature were identified. All patients were female, and the mean age was 38years old (range 20-66). 63 patients (82%) underwent resection, 9 (12%) received chemotherapy, 3 (4%) received sorafenib, 11 (14%) received hormonal therapy, and 3 (4%) underwent active surveillance. After resection, the 2-year recurrence-free survival rate was 77% (95% CI 65%-89%). The recurrence risk was lower for resection with no residual tumor (R0) compared to microscopic (R1) or macroscopic (R2) residual tumor (HR: 0.15; 95% CI 0.02-0.8; p<0.05). The SIR was 482 (95% CI 259-775) to 823 (95% CI 442-1322), suggesting a 482-823 times higher risk of developing a breast desmoid tumor after breast augmentation than the general population. We present a nonrandom association between breast implants and desmoid tumors. Whether the tumors arise from the surgical trauma or the implant's biomaterial is unknown. When surgery is indicated, negative margins reduce the risk of recurrence.

Association of Breast Implants with Nonspecific Symptoms, Connective Tissue Diseases, and Allergic Reactions: A Retrospective Cohort Analysis.

Given the rising media attention regarding various adverse conditions attributed to breast implants, the authors examined the association between breast implantation and the risk of being diagnosed with connective tissue diseases, allergic reactions, and nonspecific constitutional complaints in a cohort study with longitudinal follow-up. Women enrolled in a regional military health care system between 2003 and 2012 were evaluated in this retrospective cohort study. A propensity score was generated to match women who underwent breast implantation with women who did not undergo breast implantation. The propensity score included age, social history, health care use, comorbidities, and medication use. Outcomes assessed included International Classification of Diseases, Ninth Revision, diagnoses codes for (1) nonspecific constitutional symptoms, (2) nonspecific cardiac conditions, (3) rheumatoid arthritis and systemic lupus erythematosus, (4) other connective tissue diseases, and (5) allergic reactions. Of 22,063 women included in the study (513 breast implants and 21,550 controls), we propensity score-matched 452 breast implant recipients with 452 nonrecipients. Odds ratios and 95 percent confidence intervals in breast implant recipients compared to nonrecipients were similar, including nonspecific constitutional symptoms (OR, 0.77; 95 percent CI, 0.53 to 1.13), nonspecific cardiac conditions (OR, 0.97; 95 percent CI, 0.69 to 1.37), rheumatoid arthritis and systemic lupus erythematosus (OR, 0.66; 95 percent CI, 0.33 to 1.31), other connective tissue diseases (OR, 1.02; 95 percent CI, 0.78 to 1.32), and allergic reactions (OR, 1.18; 95 percent CI, 0.84 to 1.66). Women with breast implants did not have an increased likelihood of being diagnosed with nonspecific constitutional symptoms, connective tissue disorders, and/or allergic reaction conditions. Therapeutic, III.

Breast Implant-associated Anaplastic Large Cell Lymphoma – a Systematic Review with Pooled Analysis

The association of breast implants and anaplastic large cell lymphoma (BIA-ALCL) was first described in 1997. Such an association has aroused public health concerns on breast implant safety. A systematic review was carried out with a pooled analysis of data. In total, 674 non-duplicate articles were retrieved; 77 articles were included for data extraction; 395 patients were identified for analysis. The median age at the time of diagnosis was 52 years. Implant texture was described in 201 (50.9%) patients; all 201 patients had a textured implant. The median time from the last implant insertion to diagnosis was 7.5 years. Most patients presented with seroma (67.1%, n = 265), 20.5% of patients presented with breast mass (n = 81). Patients with a breast mass at presentation, lymphadenopathy and those without seroma had more disseminated disease (P < 0.001). 73.2% of patients (n = 289) opted for primary surgery, among which 68.6% (n = 271) received removal of the implant, 61% (n = 241) received capsulectomy and 2% (n = 8) received mastectomy. Of note, 5.3% (n = 21) had reinsertion of an implant after primary surgery. Non-surgical modalities included chemotherapy, radiotherapy and haematopoietic stem cell transplant. The median follow-up interval was 2 years (range 0–14.5 years). Seventeen patients (4.3%) had recurrence of BIA-ALCL and 195 patients (49.4%) did not. The median duration to first recurrence was 1 year (range 1–3 years). Long-term clinical outcome was not reported in 183 patients. BIA-ALCL is an indolent disease that presents with seroma after implant insertion. A high index of suspicion is needed for early diagnosis and treatment.

Breast Implants for Mammaplasty: An Umbrella Review of Meta-analyses of Multiple Complications.

The association of breast implants and complications after mammaplasty has been extensively researched. The aim of this study isto summarize all available results in meta-analysis investigating the association between implants and the incidence of various complications. An umbrella review for breast implants and associated complications was performed by searching related reviews from electronic databases including Pubmed, Ovid and CINAHL. We collected and reviewed evidence across meta-analyses of observational and interventional studies of implants and any health outcome. The quality of the reviews was assessed using the AMSTAR tool (A measurement tool to assess systematic reviews). The research included 92 meta-analyses of 609 studies concerning various areas. Capsular contracture was the most investigated outcome. Radiotherapy, human acellular dermal matrix application, direct-to-implant reconstruction, smooth implant, silicone-filled implant and periareolar incision were significantly associated with higher rates of some of the complications. This umbrella review provides surgeons with summarized evidence of the association between the complications and implant-related factors in mammaplasty surgery to help surgeons make informed choices in the future. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Death by Implants: Critical Analysis of the FDA-MAUDE Database on Breast Implant-related Mortality.

Introduction:Since the 1992 moratorium by the Food and Drug Administration (FDA), the debate on the association of breast implants with systemic illnesses has been ongoing. Breast implant-associated anaplastic large cell lymphoma has also raised significant safety concerns in recent years.Methods:A systematic search of the Manufacturer and User Facility Device Experience (MAUDE) database was performed to identify all cases of breast implant-associated deaths reported to the FDA.Results:The search identified 50 reported cases of apparent implant-related mortality; breast implant-associated anaplastic large cell lymphoma comprised the majority of fatal outcomes (n = 21, 42%), followed by lymphoma (n = 4, 8%), breast cancer (n = 3, 6%), pancreatic cancer (n = 2, 4%), implant rupture (n = 2, 4%), and postoperative infections (n = 2, 4%). Single cases (n = 1, 2% each) of leukemia, small bowel cancer, lung disease, pneumonia, autoimmune and joint disease, amyotrophic lateral sclerosis, liver failure, and sudden death, and 2 cases (4%) of newborn deaths, to mothers with breast implants, were also identified. A literature review demonstrated that 54% of alleged implant-related deaths were not truly associated with breast implant use: the majority of these reports (82%) originated from the public and third-party sources, rather than evidence-based reports by health-care professionals and journal articles.Conclusions:Although there exists a need for more comprehensive reporting in federal databases, the information available should be considered for a more complete understanding of implant-associated adverse outcomes. With only 46% of FDA-reported implant-related deaths demonstrated to be truly associated with breast implant use, there exists a need for public awareness and education on breast implant safety.

The Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand Confirms the Highest Risk for Grade 4 Surface Breast Implants.

The epidemiology and implant-specific risk for breast implant-associated (BIA) anaplastic large cell lymphoma (ALCL) has been previously reported for Australia and New Zealand. The authors now present updated data and risk assessment since their last report. New cases in Australia and New Zealand were identified and analyzed. Updated sales data from three leading breast implant manufacturers (i.e., Mentor, Allergan, and Silimed) were secured to estimate implant-specific risk. A total of 26 new cases of BIA-ALCL were diagnosed between January of 2017 and April of 2018, increasing the total number of confirmed cases in Australia and New Zealand to 81. This represents a 47 percent increase in the number of reported cases over this period. The mean age and time to development remain unchanged. The implant-specific risk has increased for Silimed polyurethane (23.4 times higher) compared with Biocell, which has remained relatively static (16.5 times higher) compared with Siltex implants. The number of confirmed cases of BIA-ALCL in Australia and New Zealand continues to rise. The implant-specific risk has now changed to reflect a strong link to implant surface area/roughness as a major association with this cancer.

Breast Implant-Associated Lymphoma.

There has been increasing evidence in recent years that breast implants can, in rare cases, be associated with the development of an anaplastic large-cell lymphoma (ALCL). This review is based on relevant publications retrieved by a selective search in PubMed for articles that appeared from the time of the initial description of breast-implant-associated ALCL onward (1997 to January 2018), and by a further search in German nationwide databases. 516 pathologically confirmed cases of breast-implant-associated (BIA) ALCL were documented around the world until February 2018; seven of these arose in Germany and were reported to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). In approximately 80% of the affected women, the BIA-ALCL manifested itself as a late-developing seroma at the implant site; in the rest, as a solid tumor with or without an accompanying seroma. The mean implant exposure time ranged from 7 to 13 years on average. 16 fatalities have been reported worldwide. Among the 7 cases reported in Germany, four women had undergone breast reconstruction with implants after breast cancer surgery, and two had undergone breast augmentation surgery. In all patients, the entire capsule-and-implant unit was resected. One patient underwent chemotherapy and one further patient underwent chemotherapy and adjuvant radiotherapy. The risk that a woman with breast implants will develop a primary anaplastic large-cell lymphoma is estimated at 0.35 to 1 case per million persons per year. The incidence of implant-associated ALCL is thus very low, yet nevertheless markedly higher than that of other primary lymphomas of the breast. Because of the low case numbers, recommendations for the diagnostic evaluation and treatment of this entity have not been adequately evaluated. Treatment with primary curative intent for BIA-ALCL confers a much better prognosis than when performed for a systemic ALCL. Whenever a patient with a breast implant presents with a late-developing seroma, BIA-ALCL should be included in the differential diagnosis. This diagnosis is reportable.

The Dutch Breast Implant Registry: Registration of Breast Implant–Associated Anaplastic Large Cell Lymphoma—A Proof of Concept

The Dutch Breast Implant Registry (DBIR) was established in April of 2015 and currently contains information on 38,000 implants in 18,000 women. As a clinical registry, it evaluates the quality of breast implant surgery, including adverse events such as breast implant-associated (BIA) anaplastic large cell lymphoma (ALCL). To examine the efficacy of the DBIR, the capture rate of BIA-ALCL was compared to the registration of BIA-ALCL in the Dutch Nationwide Network and Registry of Histo- and Cytopathology (PALGA) as a gold standard, in combination with matching these databases to obtain complementary information. All BIA-ALCL patients diagnosed and registered in The Netherlands in 2016 and 2017 were identified separately in the PALGA and DBIR databases. In addition, both databases were matched using indirect key identifiers. Pathologic information from the PALGA and clinical and device characteristics from the DBIR were obtained for all patients. Matching of both databases gave a capture rate of BIA-ALCL in the DBIR of 100 percent (n = 6) in 2016 and 70 percent (n = 7) in 2017. In total, 17 patients were identified in the PALGA, of which 14 patients were also identified in the DBIR; three patients were not registered; and 10 patients were registered false-positive. Of all confirmed patients, symptoms, staging results, treatment, and implant information were registered. Currently, the DBIR contains 2 full registration years and captures most of the BIA-ALCL patients despite overestimation. Therefore, pathology confirmation remains essential. By matching these databases, complementary clinical and implant information could be retrieved, establishing the DBIR as an essential postmarketing surveillance system for health risk assessments.

The current UK perspective of breast surgeons on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare type of T cell lymphoma associated with breast implants. Five hundred and twenty-one cases have been reported worldwide to date. The clinical presentation has two distinct subtypes: late seroma and, rarely, a distinct mass lesion. We wanted to determine the implications of this emerging disease on the current practice of breast surgeons in the United Kingdom (UK) and Ireland and whether they have changed their practice following growing reports of associations with BIA-ALCL in the literature. An 11-question survey was sent to four associations in the UK and Ireland: Association of Breast Surgery (ABS); British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS); British Association of Aesthetic Plastic Surgeons (BAAPS); and the Irish Association of Plastic Surgeons (IAPS). It was advertised in newsletters and also emailed to a list of consultant members of BAPRAS. Seventy-two responses were from consultant surgeons throughout both the UK and Ireland. Ninety-seven percent of consultants discussed the risks and associations of breast implants and BIA-ALCL with their patients. Seventeen percent had a patient who was diagnosed with ALCL in their practice. Seventeen percent of consultants have already changed their practice, including a transition to using smooth implants or using micro- or nano-textured implants. A further 11% will consider changing their practice in the future depending on more information and recommendations from higher departments. BIA-ALCL is likely to be caused by a complex interplay of factors, allowing for the variation in clinical presentation and disease progression. Our survey has already shown a growing knowledge amongst breast surgeons in the UK and Ireland as well as a switch in practice in less than a third of consultants already. Level of Evidence: not ratable

How to Diagnose and Treat Breast Implant-Associated Anaplastic Large Cell Lymphoma.

After reading this article, the participant should be able to: 1. Describe the diagnostic criteria for breast implant-associated (BIA) anaplastic large cell lymphoma (ALCL). 2. Appropriately evaluate a patient with suspected BIA-ALCL, including appropriate imaging, laboratory tests, and pathologic evaluation. 3. Understand the operative treatment of BIA-ALCL, and indications for systemic chemotherapy and/or radiation therapy in advanced disease. 4. Understand treatment outcomes and prognosis based on stage of disease. The goal of this continuing medical education module is to present the assessment of a patient with suspected breast implant-associated anaplastic large cell lymphoma, the evaluation and diagnosis, the preoperative oncologic workup, the formation and execution of a surgical treatment plan, and the inclusion of adjunct treatments when indicated. In addition, staging and disease progression for treatment of breast implant-associated anaplastic large cell lymphoma are discussed.

Association of Breast Implants With Anaplastic Large-Cell Lymphoma

Association of Breast Implants With Anaplastic Large-Cell Lymphoma

Is reimplant after breast implant-associated anaplastic large cell lymphoma a safe procedure? Yes, no, or may be?

Breast implant-associated (BIA) anaplastic large cell lymphoma (ALCL) is a rare clinical-pathologic entity recently recognized in the 2016 WHO classification of lymphoid neoplasms. Being a very rare lymphoma sub-type, it is difficult to be certain about the absolute risk of developing this disease and the issues about pathogenesis and etiology are still controversial and matter of debate. Current treatment strategies indicate that the capsulectomy and removal of breast implants are required. An excellent prognosis is reached after surgical removal. Thanks to the excellent prognosis, an increasing number of women who underwent breast implant for aesthetical reasons express the desire of a new reimplant, if safe. Here we present the case of a 48 years old woman diagnosed with a BIA-ALCL developed 8 years after breast implants for aesthetic reasons, in absence of any breast disease, with no evidence of disease 6 months after implant removal. She worried about her physical aspect after bilateral removal of breast implants and asked how safe a breast reimplant would be. After a careful analysis of pros and cons we concluded that smooth implants could be re-inserted after at least 1 year of follow-up, once the absence of any recurrence was confirmed. Given the relevance of the question proposed by our patient, we believe that more information on safety of breast reimplant is urgently needed.

Breast implant-associated anaplastic large-cell lymphoma and the role of brentuximab vedotin (SGN-35) therapy: A case report and review of the literature.

Breast implant-associated (BIA) anaplastic large-cell lymphoma (ALCL) is a rare disease, comprising a small percentage of all non-Hodgkin lymphomas (NHLs), reportedly 2-3%. There is currently no established standard approach to the treatment of BIA ALCL. The first case on the development of ALCL in the presence of a breast implant was reported in 1997 and the association was first identified by the Food and Drug Administration in 2011. We herein describe a case of BIA ALCL in a patient with a previous history of breast cancer and breast reconstruction who presented with hardening of her breast implant. The patient underwent capsulectomy and the findings of the pathological examination were consistent with ALCL. The patient completed three cycles of combination chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP regimen) followed by radiation consolidation therapy, and has maintained a complete remission ever since. The aim of the present study was to review the treatment options for BIA ALCL and suggest an investigation of the CD30-directed antibody-drug conjugate, brentuximab vedotin, as a potential treatment option for BIA ALCL.

Prospective cohort study of breast implants and the risk of connective-tissue diseases

A 2000 meta-analysis indicated no overall association between breast implants and risk of connective-tissue diseases (CTDs). However, a large retrospective cohort study we previously conducted suggested, instead, a small increased risk of CTDs. Because of limitations inherent to the retrospective cohort study design, we sought clarification by conducting a prospective cohort study of the association of breast implants with CTD risk. Participants were 23 847 US women (mean age 56.6 years), 3950 of whom had breast implants and 19 897 did not. Women reported their breast implant status at baseline in 2001 and were followed for a median of 3.63 years. During follow-up, women reported incident CTD, confirmed using a CTD screening questionnaire (CSQ) and medical records. In multivariate analyses, the rate ratios for self-reported CTD (113 vs 377 cases in the implanted and non-implanted group, respectively) were 1.60 [95% confidence interval (CI) 1.28-2.00], for CSQ-confirmed CTD (77 vs 226 cases), 1.80 (1.37-2.38) and for medical record confirmed CTD (21 vs 74 cases), 1.39 (0.82-2.35). Although this prospective cohort study represented a stronger design than the retrospective cohort study, the present data should still be viewed cautiously because of remaining methodological limitations, including the potential for differential self-reporting of CTD and CTD symptoms among women with and without breast implants, the difficulty of obtaining medical records for women reporting CTD and the low and possibly differential confirmation of self-reported disease against medical records. A reasonable conclusion is the lack of a large increase in CTD risk (e.g. ≥2-fold) associated with breast implants.

Breast Implants and Lymphoma Risk: A Review of the Epidemiologic Evidence through 2008

In the past, concerns about lymphoma among women with breast implants have been raised by anecdotal observations. A recent report of a case-control study from The Netherlands reported an association of breast implants with anaplastic large T-cell lymphoma, but limitations inherent in the study design and the restriction of the association to saline implants preclude any causal evaluation. To determine whether lymphoma risk is in fact elevated in women with breast implants, the authors have reviewed the evidence from five long-term follow-up studies comprising over 43,000 women with cosmetic breast implants followed for up to 37 years, which reported results specifically regarding the incidence of non-Hodgkin's lymphoma, among other cancers. Overall, there were 48 observed incident cases of non-Hodgkin's lymphoma compared with 53.9 cases expected, yielding a summary standardized incidence ratio of 0.89 (95 percent confidence interval, 0.67 to 1.18). None of the epidemiologic cohort studies reported a primary lymphoma originating in the breast. To date, there is no credible evidence of an increase of non-Hodgkin's lymphoma regardless of site or specifically originating in the breast among women with cosmetic breast implants.