Textured Breast Implants Research Articles

Final opinion on the safety of breast implants in relation to anaplastic large cell lymphoma: Report of the scientific committee on health, emerging and environmental risks (SCHEER)

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) was requested by the European Commission (EC) to provide a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (ALCL). There are several types of textured breast implants; surface textures of breast implants are not all manufactured in the same way, and breast implants with diverse surface textures may also present different benefits. The magnitude of the risk per type of textured implant is difficult to establish due to the low incidence of the breast implants associated anaplastic large cell lymphoma (BIA-ALCL). Therefore, risk assessments per implant type are needed.Overall SCHEER considers that there is a moderate weight of evidence for a causal relationship between textured breast implants and BIA-ALCL, particularly in relation to implants with an intermediate to high surface roughness.The pathogenic mechanisms are not fully elucidated; current hypotheses include genetic drivers, chronic inflammation resulting either from bacterial contamination, shell shedding of particulates, or shell surface characteristics leading to friction, or by implant associated reactive compounds. Reporting of new BIA-ALCL cases by the national clinical registries is critically important to obtain a better estimate of the risk of BIA-ALCL for patients with a breast implant.

The surface topography of silicone breast implants mediates the foreign body response in mice, rabbits and humans.

Silicone is widely used in chronic implants and is generally perceived to be safe. However, textured breast implants have been associated with immune-related complications, including malignancies. Here, by examining for up to one year the foreign body response and capsular fibrosis triggered by miniaturized or full-scale clinically approved breast implants with different surface topography (average roughness, 0-90 μm) placed in the mammary fat pads of mice or rabbits, respectively, we show that surface topography mediates immune responses to the implants. We also show that the surface surrounding human breast implants collected during revision surgeries also differentially alters the individual's immune responses to the implant. Moreover, miniaturized implants with an average roughness of 4 μm can largely suppress the foreign body response and fibrosis (but not in T-cell-deficient mice), and that tissue surrounding these implants displayed higher levels of immunosuppressive FOXP3+ regulatory T cells. Our findings suggest that, amongst the topographies investigated, implants with an average roughness of 4 μm provoke the least amount of inflammation and foreign body response.

Applying Principles of Breast Revision to Managing Aesthetic Patients with Textured Implants.

Textured breast implants have garnered increased attention recently because of their risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), an uncommon and treatable type of T-cell lymphoma. Treatment involves bilateral en bloc capsulectomy, which is curative in the majority of cases. At present, there is no defined management approach for aesthetic patients asymptomatic for BIA-ALCL requesting the removal of their textured implants, particularly as it relates to the management of the capsule. It is unclear if en bloc capsulectomy is necessary in these patients as it is in patients with BIA-ALCL. In the absence of clear guidance on the management of the capsule in asymptomatic patients, the basic principles of breast revision surgery can be applied to these patients.

Linfoma T anaplásico de células grandes asociado a prótesis mamarias con afectación sistémica

Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is a rare type of T-cell lymphoma (cancer of the immune system) with an expression of the CD30 receptor. After the first case was described in 1997, more than 600 cases have been identified worldwide and. The published estimated lifetime risk of BIA-ALCL in international series ranges from 1:1000 to 1:10,000 women with textured breast implants. Many of these epidemiologic data are approximated, and it is a common opinion that the risk might be higher, especially for macrotextured high-surface implants. Mortality is very low because the lymphoma is mainly diagnosed in early stages.We hereby report one case of BIA-ALCL in a 78-year-old female who received a silicone breast implant. She showed a sudden breast volume increase and erythema that was diagnosed and treated as a mastitis that did not get better after antibiotics treatment. Some biopsies was taken and pathologic examination inform about a breast implant associated anaplastic large cell lymphoma. There were lymphadenopathies positive so a chemotherapy treatment was started. Patient had an excellent evolution and illness regression.

BIA-ALCL and Textured Breast Implants: A Systematic Review of Evidence Supporting Surgical Risk Management Strategies.

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a significant public health concern for women with breast implants. The increase in incidence rates underscores the need for improved methods for risk reduction and risk management. The purpose of this study was to perform a systematic review to assess surgical risk reduction techniques and analyze communication/informed consent practices in patients with textured implants. A systematic review of the literature was conducted in PubMed (legacy), Embase (Embase.com), and Scopus with four search strategies including key terms centered around breast reconstruction and BIA-ALCL. A total of 571 articles were identified, of which 276 were included in the final review after duplicates were removed. After review, no articles were determined to fit the inclusion criteria of demonstrating data-driven evidence of BIA-ALCL risk reduction through surgical measures, demonstrating a significant lack of data on risk reduction for BIA-ALCL. Risk management for BIA-ALCL is an evolving area requiring additional investigation. Although removal of textured devices in asymptomatic patients is not currently recommended by the Food and Drug Administration, variability in estimates of risk has led many patients to electively replace these implants in an effort to decrease their risk of developing BIA-ALCL. To date, however, there is no evidence supporting the concept that replacing textured implants with smooth implants reduces risk for this disease. This information should be used to aid in the informed consent process for patients presenting to discuss management of textured breast implants.

Elective Implant Removal and Replacement in Asymptomatic Aesthetic Patients with Textured Devices.

The management of patients with breast implants requires secondary procedures through the life of the implant, sometimes in the early postoperative period and more commonly many years after the initial surgery. In performing revisional procedures, removal and replacement of the implants is often required for a variety of reasons. With growing concerns of implant safety, implant exchange or removal with or without a capsulectomy has been increasingly requested by patients. In particular, textured breast implants have been under increased scrutiny secondary to their association with breast implant-associated anaplastic large cell lymphoma. Unfortunately, to date, there are no data and very little guidance as to the appropriate management of patients currently with textured implants as well as patients with a history of having had textured implants placed in the past. The surgeon must not only consider the appropriate management of patients with uncomplicated, asymptomatic textured devices but also consider the appropriate management when faced with another indication for revisional surgery and the need determine the appropriate course of action. An algorithm for the management of the explantation patient in general will be introduced in this review with a focus on the rationale, planning, and management of patients with an uncomplicated, asymptomatic textured implants.

Is Breast Implant Associated-Anaplastic Large Cell Lymphoma linked to textured implants?

Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) is a distinctive type of T-cell lymphoma arising around breast implants. We performed a review of the existing literature with the aim of providing an evidence-based overview of the available data on BIA-ALCL with a standardized evaluation of the quality of the studies and investigating the potential association between textured breast implants and BIA-ALCL.We analyzed the literature reporting estimates of relative or absolute risks of BIA-ALCL in case-control, cohort studies and case series studies. The total number of BIA-ALCL cases reported in literature is very low. Furthermore, most of the reported cases have been reported in case-control studies or case series. This means that our knowledge is based on a low level of evidence. Moreover, low-medium quality scores were observed in the included case series studies. In relation to the rarity of the event, better information could only derived by international cooperation to pool together data deriving from all over the world, with the clear need of better reporting patients and implant characteristics in case series and when adding data to public registries. LEVEL OF EVIDENCE IV: 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 .

Treating breast implant-associated anaplastic large cell lymphoma.

Each year, hundreds of thousands of women undergo aesthetic or reconstructive breast implant surgery. Clinicians and patients must be aware of the benefits and risks of this surgery. Recently, the FDA suggested a recall of certain textured breast implants because of a link between these implants and a rare form of lymphoma, now referred to as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This malignancy has an indolent course and an excellent prognosis when detected and treated early. This article reviews BIA-ALCL, addresses public safety advisories, and emphasizes protocol that all clinicians should follow when encountering a patient with textured breast implants.

AB006. SOH21AS117. The role of brentuximab vedotin in BIA ALCL: a review of the literature and recommendations for refinement of the NCCN guidelines

Background: Breast implant-associated anaplastic large-cell lymphoma (BIA ALCL) is a newly legitimised disease associated with textured breast implants. Presenting with periprosthetic swelling 7–10 years post-implantation, the clinical course is usually indolent. More rarely, BIA ALCL may present at a later stage. Surgical excision is the gold standard. The National Comprehensive Cancer Network (NCCN) have formulated guidelines for BIA ALCL, however clarity is lacking for stages II–IV. Brentuximab vedotin is a monoclonal antibody targeting CD30 which is effective in treating BIA ALCL. Current guidelines indicate brentuximab combined with chemotherapy for stages II–IV. We propose stage-specific refinement of the NCCN guidelines, with a view to reducing unnecessary toxicity.

Commentary on: Management of Asymptomatic Patients With Textured Breast Implants: A Survey Analysis of Members of The Aesthetic Society.

Commentary on: Management of Asymptomatic Patients With Textured Breast Implants: A Survey Analysis of Members of The Aesthetic Society.

Management of Asymptomatic Patients With Textured Breast Implants: A Survey Analysis of Members of The Aesthetic Society.

The management of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has been well established. However, there is minimal data and significant variability in the management of asymptomatic textured implant (ATI) patients. The purpose of this study was to survey members of The Aesthetic Society on management of ATI patients in order to understand trends in practice patterns. Members of The Aesthetic Society were queried via an electronic survey regarding management of ATI patients. Anonymous responses were collected by QualtricsXM (SAP, Walldorf, Germany) survey software. Descriptive statistics were used to examine the data, reported as frequencies. All analyses were performed with IBM SPSS Statistics 26. The survey was sent to 2149 active and candidate members of The Aesthetic Society with a total of 470 responses (21.87% response rate). For ATI patients presenting with concerns regarding BIA-ALCL risk, 88.8% of respondents educate the patient with clinical follow-up and/or imaging. The other 11.2% of surgeons recommend implant removal with variability in capsulectomy technique. For ATI patients requesting surgery, 42.5% of respondents educate the patient with clinical follow-up and/or imaging. The majority of surgeons (57.6%) recommend removal of the implant, with 30% recommending total capsulectomies. There is considerable variability in how members of The Aesthetic Society manage ATI patients who request surgery. Future regulatory agency and professional society collaborative efforts should continue to aim for generation of high-level scientific data to aid in the counseling and management of ATI patients.

Current risk of breast implant-associated anaplastic large cell lymphoma: a systematic review of epidemiological studies.

Recent epidemiological studies have attempted to accurately determine the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). However, comparisons of previously published works are difficult due to widespread variations in reporting. We systematically review the epidemiology in order to better define the current risk of BIA-ALCL. Herein, we report the global epidemiology with an emphasis on the U.S. breast implant population while simultaneously assessing the oncologic safety of smooth-surface devices. In the current manuscript, a systematic review of PubMed and other scientific databases, as well as the grey literature, was conducted for epidemiologic studies on BIA-ALCL. Using analytical and descriptive epidemiology, we estimated the cumulative incidence and incidence rate of BIA-ALCL using a standardized approach. Cumulative incidence was reported at implant and patient-specific levels. The patient-specific cumulative risk within the U.S. market ranges from 1.79 per 1,000 (1:559) to 2.82 per 1,000 (1:355) patients with a textured implant. The implant-specific risk of Allergan textured devices ranges from 1:602–871 to 1:8,500, while the risk of commercially available Mentor Siltex implants is 1:50,000. No epidemiological study or regulatory agency reported a case of BIA-ALCL occurring exclusively with a smooth device. As such, with the removal of Allergan textured breast devices, this study demonstrates substantial gaps in the epidemiological knowledge of BIA-ALCL, including the current risk of commercially available textured breast implants in the U.S. market. Although the risk of BIA-ALCL is low, surgeons should exercise extreme caution when considering the use of a textured breast device for cosmetic or reconstructive purposes.

Breast Implant-Associated Anaplastic Large Cell lymphoma: Brief overview of current data and imaging findings.

In 2016, the World Health Organization added Breast Implant-Associated Anaplastic Large Cell lymphoma as a provisionally recognized lymphoma to the family of existing Anaplastic Large Cell lymphomas. Current estimates of the lifetime risk of the disease in women with textured breast implants range from 1:1,000 to 1:30,000. The mean interval from implant placement to diagnosis is 10.7 ± 4.6 years and the most common clinical symptom at presentation is breast swelling. A high level of clinical suspicion is recommended in patients presenting with breast symptoms and/or peri-implant fluid collection occurring more than 1 year after breast implant placement. Ultrasound is the imaging modality of choice, with a high sensitivity for peri-implant fluid and a high specificity for peri-implant mass. When ultrasound is inconclusive, breast MRI is indicated. As of today, all confirmed cases have tested positive for CD30 immunohistochemistry and the disease has shown to have an excellent prognosis when it is diagnosed earlier (localized disease), and when complete surgery, consisting of explantation, capsulectomy, and removal of any associated capsule mass, is performed. This overview summarizes the available epidemiological and clinical data of Breast Implant-Associated Anaplastic Large Cell lymphoma, with an emphasis on imaging features.

Breast erythema and nodular skin metastasis as the first manifestation of breast implant-associated anaplastic large cell lymphoma.

Anaplastic large cell lymphoma (BIA-ALCL) associated with rough textured breast implants was first reported in 1997. It is a non-Hodgkin’s lymphoma originating from a T lymphocyte which occurs on average 10.9 years after placement of the breast implant. BIA-ALCL mainly manifests as a periprosthetic seroma or a mass adjacent to the implant. To our knowledge, we describe the first case of BIA-ALCL with initial presentation by indurate erythematous plates located in both breasts and the progressive appearance of several asymptomatic metastatic nodular lesions that have been appearing on the right arm some weeks later.

Analysis of the Molecular Signature of Breast Implant-Associated Anaplastic Large Cell Lymphoma in an Asian Patient

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)—a new category of anaplastic large cell lymphoma associated with textured breast implants—has a distinct variation in incidence and is especially rare in Asia. We report the first case of BIA-ALCL in Korea and present its histological and genetic characteristics. A 44-year-old female patient presented with a typical clinical course and symptoms, including breast augmentation with textured breast implants, late-onset peri-implant effusion, and CD30+ALK− histology, followed by bilateral implant removal and total capsulectomy. For histological analysis, we performed immunohistochemistry of the bilateral breast capsules. For transcriptome analysis, we identified highly upregulated gene sets employing RNA-sequencing and characterized the lymphoma immune cell components. In the lymphoma-associated capsule, CD30+ cells infiltrated not only the lymphoma lesion but also the peritumoral lesion. The morphologies of the myofibroblasts and vessels in the peritumoral lesion were similar to those in the tumoral lesion. We observed strong activation of the JAK/STAT3 pathway and expression of programmed death ligand-1 in the lymphoma. Unlike the molecular profiles of BIA-ALCL samples from Caucasian patients—all of which contained activated CD4+ T cells—the Asian patient’s profile was characterized by more abundant CD8+ T cells. This study contributes to a better understanding of the pathogenesis and molecular mechanisms of BIA-ALCL in Asian patients that will ultimately facilitate the development of clinical therapies.Level of Evidence: 5

Breast Implant-Associated Anaplastic Large Cell Lymphoma: A Clinical Update.

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a recently recognized malignancy of T-lymphocytes that is linked to certain types of textured breast implants. Although rare, the increasing awareness of the disease is resulting in more case reports and heightened anxiety in patients with textured breast implants. This review aims to summarize the available BIA-ALCL data, including the existing theories of etiopathogenesis, the diagnostic work-up for BIA-ALCL patients, BIA-ALCL treatment recommendations, the epidemiologic challenges, and the current opinions surrounding the use of textured breast implants.

Clinical Characteristics and Follow-up Post-Surgery of Women with Bia-ALCL Operated at a Single Institution

Clinical Characteristics and Follow-up Post-Surgery of Women with Bia-ALCL Operated at a Single Institution

\u201cTopographic Shift\u201d: a new digital approach to evaluating topographic changes of the female breast

PurposeTo assess precise topographic changes of the breast, objective documentation and evaluation of pre- and postoperative results are crucial. New technologies for mapping the body using digital, three-dimensional surface measurements have offered novel ways to numerically assess the female breast. Due to the lack of clear demarcation points of the breast contour, the selection of landmarks on the breast is highly dependent on the examiner, and, therefore, is prone to error when conducting before-after comparisons of the same breast. This study describes an alternative to volumetric measurements, focusing on topographic changes of the female breast, based on three-dimensional scans.MethodThe study was designed as an interventional prospective study of 10 female volunteers who had planned on having aesthetic breast augmentation with anatomical, textured implants. Three dimensional scans of the breasts were performed intraoperatively, first without and then with breast implants. The topographic change was determined as the mean distance between two three-dimensional layers before and after augmentation. This mean distance is defined as the Topographic Shift.ResultsThe mean implant volume was 283 cc (SD = 68.6 cc, range = 210–395 cc). The mean Topographic Shift was 7.4 mm (SD = 1.9 mm, range = 4.8–10.7 mm). The mean Topographic Shifts per quadrant were: I: 8.0 mm (SD = 3.3 mm); II: 9.2 mm (SD = 3.1 mm); III: 6.9 mm (SD = 3.5 mm); IV: 1.9 mm (SD = 4.3 mm).ConclusionThe Topographic Shift, describing the mean distance between two three-dimensional layers (for example before and after a volume changing therapy), is a new approach that can be used for assessing topographic changes of a body area. It was found that anatomical, textured breast implants cause a topographic change, particularly on the upper breast, in quadrant II, the décolleté.

Is It Time to Abandon Textured Breast Implants for Breast Cancer Reconstruction?

Is It Time to Abandon Textured Breast Implants for Breast Cancer Reconstruction?

Navigating Women's BIA-ALCL Information Needs: Group Seminars May Offer an Opportunity to Empower the Patient-Surgeon Team.

Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a T-cell non-Hodgkin's lymphoma that has been linked to textured breast implants, and is an emerging concern within the plastic and reconstructive surgery community. Many surgeons are struggling with how best to inform their patients and manage BIA-ALCL care without overwhelming their standard clinical practice. Five educational group seminars were held for 53 patients. A thematic analysis of the field notes taken at each seminar was conducted to identify recurring patient and surgeon behaviors. The thematic analysis identified 5 key themes: seeking, amplifying, framing, trusting, and empowering. Seeking describes the knowledge sought by patients and their varying engagement in their care. Amplifying underlines how the emotionally charged topic of BIA-ALCL impacted patient and surgeon behaviors. Framing presents surgeon efforts to help patients understand the risk level of BIA-ALCL. Trusting addresses the ways BIA-ALCL has impacted patient trust in the medical community and the mechanisms to rebuild this trust. Empowering outlines surgeon efforts to engage patients in shared decision-making. Herein is presented a possible framework for efficient BIA-ALCL patient education that can be adapted to different surgical practices. Lessons learned are: (1) patients want information on BIA-ALCL's clinical features and prophylactic implant removal; (2) BIA-ALCL discussions are emotionally charged and surgeons must remain cognizant of group dynamics and that the physician-patient power differential may impact patient decision-making; (3) patient trust has been strained but can be restored; and (4) patient responses to BIA-ALCL are variable and subjective; thus, surgeons should emphasize patient-centered care.