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Breast implants are widely considered among the most intensely studied and regulated devices in the medical industry. For nearly four decades, Mentor, along with Health Canada and other regulatory bodies, have closely tracked and monitored patient satisfaction and complications associated with breast implants through clinical studies, registries, and real-world complaint data to better understand the breast implant benefits and safety.
In 2011, regulatory agencies identified an association between breast implants and the development of Anaplastic Large Cell Lymphoma (ALCL). Today it is believed that women with breast implants have a very small, but increased risk of developing Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL). More recently some women with breast implants have reported a range of systemic symptoms that they refer to as “breast implant illness.” To date, the overall body of scientific evidence does not support claims that breast implants cause systemic illness, however further research is underway to better understand any possible connection.
Breast Implant Associated Anaplastic Large Cell-Lymphoma (BIA-ALCL)
Women with breast implants are at a small but increased risk of developing Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma that is highly curable if detected early.17,18 BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma (cancer of the immune system), that affects lymphocytes (immune cells), typically taking between 8-10 years to develop.19 In most cases (>85%), BIA-ALCL is found in the implant effusion (fluid surrounding the implant), which current data suggest may be cured by removal of the implant and capsule.20
Many factors may contribute to the development of BIA-ALCL, including bacterial contamination, genetic predisposition and the surface texture of the implant. Current literature, and real world evidence, concludes that the risk of developing BIA-ALCL differs between different textured devices and has been shown to be rare with MENTOR® Breast Implants21,22,23,24,25,26,27,28,29
While MENTOR® Breast Implants have a low rate of BIA-ALCL, it remains a concern we take seriously. We closely monitor the clinical performance of our breast implants through clinical studies, registries and post market surveillance activities and continue to work with industry groups, physicians, scientists and health authorities to better understand the associated risks and causes of this type of lymphoma.
In March 2018, Mentor began contributing to an industry-funded BIA-ALCL Patient Assistance Fund for uninsured patients diagnosed with ALCL. Patients with MENTOR® Breast Implants diagnosed with BIA-ALCL as of January 1, 2019 are covered even if their implant surgery was prior to that date (based on diagnosis date, not original implant date).
Breast Implant Illness
Some patients with breast implants have reported a range of systemic symptoms which they refer to as breast implant illness. Some reported symptoms include fatigue, chronic pain, rash, anxiety, muscle pain, recurring infections and swollen lymph nodes. While the current body of scientific evidence does not support claims that breast implants cause systemic illness, FDA, in partnership with industry, medical and plastic surgery societies, and researchers are taking steps to better characterize the set of conditions and its risk factors and researchers are working to understand the origins of the symptoms.
We support these efforts and have been partnering with the regulatory authorities around the world and diligently reviewing our long-term implant safety and real-word complaint data seeking to better understand any possible connection.
Following your breast surgery, it’s important that you have regular follow up exams and follow your doctor’s instructions to monitor your breast implants. If you notice any changes to your breast implants or experience any unusual signs or symptoms of health issues, contact your health care provider promptly to schedule an appointment.
It is important for you to have a discussion about these risks with your doctor and/or surgeon so that you have a full understanding of both benefits and risks before undergoing surgery for breast implants.
17 Clemens MW, Medeiros LJ, Butler CE, Hunt KK, Fanale MA, Horwitz S, et al. Complete Surgical Excision Is Essential for the Management of Patients With Breast Implant-Associated Anaplastic Large-Cell Lymphoma. J Clin Oncol. 2016;34(2):160-8. Epub 2015/12/03.doi: 10.1200/jco.2015.63.3412. PubMed PMID: 26628470; PubMed Central PMCID: PMCPMC4872006 online at http://www.jco.org. Author contributions are found at the end of this article.
18 Clemens MW, Horwitz SM. NCCN Consensus Guidelines for the Diagnosis and Management of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Aesthetic surgery journal. 2017. Epub 2017/02/12. doi: 10.1093/asj/sjw259. PubMed PMID: 28184418.
19 Clemens, M.W., et al., How to Diagnose and Treat Breast Implant–Associated Anaplastic Large Cell Lymphoma. Plastic and Reconstructive Surgery, 2018. 141(4): p. 586e-599e.
20 Deva, A.K. Breast Implant Associated Large Cell Lymphoma (BIA-ALCL) – Key Update. Plastic Surgery Hub. https://www.plasticsurgeryhub.com.au/breast-implantassociated-anaplastic-large-cell-lymphoma-bia-alcl-key-update/. June 8, 2018, accessed Aug 7, 2018.
21 de Boer, M., et al., Breast implants and the risk of anaplastic large-cell lymphoma in the breast. JAMA Oncology, 2018. 4(3): p. 335-341
22 Brody, G.S., et al., Anaplastic Large Cell Lymphoma Occurring in Women with Breast Implants: Analysis of 173 Cases. Plastic and Reconstructive Surgery, 2015. 135(3): p. 695-705.
23 Gidengil, C.A., et al., Breast Implant–Associated Anaplastic Large Cell Lymphoma: A Systematic Review. Plastic and Reconstructive Surgery, 2015. 135(3): p. 713-720.
24 Loch-Wilkinson, A., et al., Breast implant associated Anaplastic Large Cell Lymphoma in Australia and New Zealand - high surface area textured implants are associated with increased risk. Plastic and Reconstructive Surgery, 2017. 140(4): p. 645-654.
25 Doren, E.L., et al., U.S. Epidemiology of Breast Implant–Associated Anaplastic Large Cell Lymphoma. Plastic and Reconstructive Surgery, 2017. 139(5): p. 1042-1050.
26 Srinivasa, D.R., et al., Global Adverse Event Reports of Breast Implant-Associated ALCL: An International Review of 40 Government Authority Databases. Plast Reconstr Surg, 2017. 139(5): p. 1029-1039.
27 Johnson, L., et al., Breast implant associated anaplastic large cell lymphoma: The UK experience. Recommendations on its management and implications for informed consent. Eur J Surg Oncol, 2017. 43(8): p. 1393-1401.
28 Deva, A.K. “BIA-ALCL: Translating Science Into Practice.” The Aesthetic Meeting of ASAPS, April 29, 2018, Javits Center, New York, NY. Lecture in Panel: Hot Topics in Breast Surgery—ALCL, Texture, Biofilms
29 Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). US Food & Drug Administration. March 2018 [accessed 12DEC2018].