MedicalResearch.com Interview with:
On behalf of the Netherlands BIA-ALCL Consortium: Daphne de Jong (Hematopathologist, VU university medical Center, Amsterdam, the Netherlands), Hinne Rakhorst (Plastic Surgeon, MST/ZGT, Enschede, the Netherlands) René van der Hulst (Plastic surgeon, MUMC+ Maastricht, the Netherlands) Flora van Leeuwen (Epidemiologist, Netherlands Cancer Institute, Amsterdam, the Netherlands), Jan Paul de Boer (Hemato-oncologist, Netherlands Cancer Institute, Amsterdam, the Netherlands) Lucy Overbeek (Database expert PALGA, Houten, the Netherlands),
MedicalResearch.com: What is the background for this study?
Response: Breast implants are one of the most commonly used medical devices worldwide. Associations with breast cancer, connective tissue diseases and auto-immune diseases have never been unequivocally supported. For lymphoma risk, this is different and several reports have suggested an association between breast implants and risk of anaplastic large cell lymphoma in the breast (breast-ALCL).
Over the past few years, the number of women with breast implants reported with breast-ALCL has strongly increased. This has resulted in significant attention amongst medical professionals and women alike with publications in medical journals and lay press. In part due to the rarity of the disease and due to the lack of breast implant prevalence data in the population, the absolute risks of breast-ALCL are largely unknown, precluding evidence-based counseling about implants. In the Netherlands, we are in the unique position to be able to retrieve all diagnosed breastALCL since 1990 as well as appropriate population-based control groups from the Nationwide Network and Registry of Histo- and Cytopathology in the Netherlands (PALGA). This has allowed a formal epidemiological risk assessment study based on sufficient numbers. Moreover, using combined and complementary sources of information, we have been able to determine age- and calendar year-specific implant prevalence rates to determine reliable absolute risks.
This study could be successfully performed thanks to a multidisciplinary taskforce consisting of plastic surgeons, hematopathologists, epidemiologists, hemato-oncologists and radiologists from the several large institutions in the Netherlands
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In 2008, we reported the first epidemiological study showing an increased risk of breast-anaplastic large cell lymphoma in the breast in association with breast implants of 18,2, based on five exposed cases only diagnosed between 1990 and 2006. In the present study, we identified 43 patients with breast-ALCL, diagnosed between 1990 and 2016, of whom 32 carried breast implants. With only 1 breast-implant carrier of 146 patients in the control group, this resulted in a 421 times greater relative risk of developing breast-ALCL in women with implants. The interval between placement of the first implant and diagnosis of breast-ALCL varied widely from a few months to more than 20 years with a mean of 13 years. Next, we could determine the implant prevalence in Dutch women at 3.3%, corresponding to approximately 200.000 women. Thereby, we could calculate that the risk to be diagnosed with breast-ALCL before age 50 is 1:35.000, increasing to 1:7000 by the time women reach the age of 75. Significantly more cases were diagnosed in the context of macrotextured breast implants, but also cases associated with microtextured implants were noted. Since the market share in the Netherlands of macrotextured breast implants is largest, but has fluctuated widely over time, no strong conclusions can be made on risks or associations with specific products or brands.
MedicalResearch.com: What should readers take away from your report?
Response: For the first time, we now have reliable data on the absolute risk for women with breast implants to be diagnosed with breast-anaplastic large cell lymphoma in the breast. Albeit that the relative risk is highly elevated, the absolute risk remains low. Women who consider breast implants should be well-informed of this risk and of alternative breast augmentation and reconstruction methods and discuss these with their plastic surgeon. There is no support for the notion that women who currently carry breast implants should have these removed in the absence of symptoms or complaints suggestive of breast-ALCL. Women should be aware of these symptoms and complaints and consult their general practitioner or plastic surgeon in case of (late) seroma or a mass. Currently, international regulatory bodies are reconsidering their advice on the use of breast implants and results are awaited.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Once we have more insight in the oncogenesis of breast-implant associated ALCL, we may better prevent and treat this disease. Aspects of specific breast implant characteristics such as texture, the possible immunological role of an adherent bacterial biofilm on the implant surface and predisposing patient characteristics as well as in depth characterization of the molecular landscape of breast-ALCL merit further studies. Since breast-ALCL seems to be an increasing problem over the past few years, registration programs supported by national governmental and regulatory bodies for breast implant usage and complications are needed to identify breast-ALCL patients, to serve as postmarketing monitoring systems and enable risk-benefit evaluations. It is our opinion close collaboration between international research groups, registries and governmental organizations is essential to further enhance our understanding of this rare disease. Any disclosures Response: This study was performed in an independent fashion, without any financial support of breast implant vendors or breast implant manufacturers. The authors have no disclosures to report.
de Boer M, van Leeuwen FE, Hauptmann M, Overbeek LIH, de Boer JP, Hijmering NJ, Sernee A, Klazen CAH, Lobbes MBI, van der Hulst RRWJ, Rakhorst HA, de Jong D. Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in the Breast. JAMA Oncol. Published online January 04, 2018. doi:10.1001/jamaoncol.2017.4510
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