Breast Implant Illness FAQ

What is Breast implant illness?

Breast implant illness (BII) is a term used to describe a collection of symptoms that women with breast implants have experienced and believe are associated with their breast implant devices (1).  Women who have experienced these collective symptoms believe that removing their breast implants will cure the symptoms experienced. Some women have continued to experience these symptoms after removing their breast implants, while other women claim removing their implants made them feel better.

What are the symptoms associated with BII?

There are over 50 different symptoms associated with BII, and they vary from women to women. Although there is currently little evidence linking the exact symptoms of BII to breast implants, the reported symptoms are common and seen in many other medical and emotional conditions and can also occur as a result of aging (1).

If I get breast implants, what is the chance of me getting BII?

Unlike other associated breast implant complications that have been heavily researched, due to the scarcity of clinical data linking the common symptoms to breast implant devices and the variability of broad range symptoms experienced, it is difficult to estimate the risk of BII. We do know that many women get breast implants and go on to have an enjoyable and positive experience, while a small percentage of women may develop systemic symptoms for which no cause may be found. The majority of women give breast implant surgery high satisfaction rates.  With that said, however small the percentage of unsatisfied women, the relationship between a woman and her breast implants should be respected. Should a woman find that the relationship with her breast implants is compromised due to uncertainties around safety or potential health issues, not only should she have the freedom to choose to explant her breast implants but her decision to do so should be respected.

Is BII a new illness?

Although the term BII is a newly recognized concept, most of the symptoms reported have been linked to breast implants in the past (2). However, following a series of studies conducted which found no conclusive evidence directly linking the symptoms reported to breast implants, the claims were dismissed. Nonetheless, today, following recent reports of the same nature, the combination of these symptoms is now referred to as BII.

If I experience symptoms associated with BII, should I get my breast implants removed?

Unfortunately, it is not that simple; there have been cases in which women have been misled into believing that removing their breast implants will suddenly make them healthy. While in other instances, women who wanted to remove their breast implants were advised to keep them. Women have as much right to have their implants removed as they did to have them placed in the first place. What we don’t know is if the removal of the implants will improve the symptoms. Some studies show in the absence of abnormal laboratory analysis or a defined autoimmune disease diagnosis; many patients will achieve at least a temporary improvement in their symptoms.

Another significant risk lies when women remove their devices under the assumption that they will be cured, fundamentally, delaying receiving a diagnosis and an appropriate treatment at the right time and potentially causing further damage.

As a women’s health company, we advocate freedom of choice. We understand that women do not need breast implants; they elect to have them based on aesthetic and lifestyle considerations and should be free of criticism or harassment for choosing to have them or remove them.

Should I get breast implants just to enhance the look of my breasts?

The decision to enhance the look of your breasts should be your own well thought, personal choice, after having researched the risks and benefits, and with the expert advice of a plastic surgeon. Today, breast implant surgery has greatly evolved; with a combination of newly advanced surgical techniques and the next generation breast implants, women now have many options around safely enhancing their breasts.

What is it that makes Establishment Labs different?

Our founders worked with plastic surgeons for many years, and based on that experience, had the insight that breast aesthetics needed a true commitment to women’s health. To act on the insight required a combination of great engineering, science, and a patient-centric approach to product design. To deliver options that not only provide safety but also meet the individual needs of the women in the 21st century. We recognize that breast implants are not just a medical device. In fact, behind every breast procedure is a unique woman with an individual story, in which her breast implants are a part of her journey. As an industry, we should acknowledge these individual journeys – and promote a culture of diversity and self-expression, empowering women to embrace their individual journey freely, safely, and without prejudice. For that reason, we did not just create a breast implant, but rather a comprehensive portfolio of innovative products and services crafted around each woman and their journey. 

How does Establishment Labs commit to their values and ensure the commitment to women’s health?

Since founding Establishment Labs, we have gone against the grain of the industry to defend women’s health. Staying true to our substantive beliefs that as an industry, we can do better for women. However – this meant disrupting the industry and rebelling against the models and beliefs that no longer apply. For instance, when we decided not to bring a macro-textured device to the market, we made this subjective decision based on the needs of women, not the beliefs of the industry or even some well-known plastic surgeons. This brought controversy. However, we understood that women deserved better and to commit to women’s health; it involved a two-pronged approach. To evolve with the modern woman, we needed to listen to her concerns and desires and then instigate practice development to safely meet her individual needs. The world itself is in a constant state of evolving, health is evolving, technology is evolving, and society is evolving, but most importantly, women and their needs are evolving, and that requires continuous revaluation and innovation. 

There is much discussion on social media surrounding BII, how are Establishment Labs dealing with BII?

Despite the lack of scientific evidence to link these symptoms directly to breast implants, it is important to note that these stories are real. Women are experiencing these symptoms; they are real and are affecting their day to day lives. We do not understand the causes of BII, just as in some cases, we do not understand why some women develop allergies, food intolerances, hypersensitivities to chemicals, and so on. But with that said, what we do know is that some women who have breast implants experience these symptoms and others do not. Many surgical procedures hold contraindications to some candidates, and it could well be the case that women with previous autoimmune disease or hypersensitivity to materials could be a risk factor for breast implants. Without substantial evidence, it is hard to say. However, what is certain is that as an industry, we need to acknowledge these symptoms, then work collaboratively to combat the uncertainty around these symptoms. This includes identifying risk factors to provide women with clarity and transparent and reliable information to make safe, healthy choices about their body and health. 

What are the general recommendations to women who are considering breast implants, and hold concerns surrounding BII?

The advice given to women who are considering or already have breast implants would be very similar to the advice given to women without breast implants. That is to make your health a priority, particularly breast health. Globally, breast cancer represents one in four of all cancers in women in which a large percentage of breast cancers are found through self-breast examination. Commitment to regular check-ups and monthly self-breast examinations can help detect early signs of the disease. For those women who are considering breast implants, in addition to routine checks, we would also recommend maintaining regular MRI scans, as breast implants are not lifetime devices (3). Eventually, you may need to replace the device, particularly if you have had your breast implants for several years, as it is likely that there is an improved, safer breast implant device available for you.

Why is it that you refer to yourself as a women’s health company when you are manufacturing breast implants? 

We believe breast implants are not just medical devices. In fact, we recognize that behind every breast implant is a unique woman with her own individual story. For instance, a recent study showed that over 70% of women are unhappy with their breasts for a variety of reasons, for roughly half of them, they thought of their breasts as being too small and indicated a reduced breast awareness associated with a lower breast self-examination frequency (4). Women with positive breast awareness are associated with improved self-examination and increased efficient breast cancer detection, fundamentally contributing to their health. Therefore, whether it be the woman who decides she wants to feel comfortable again with her own body or the mastectomy patient who has felt loss after her surgery and is given an opportunity to feel whole again, the journey of breast implant surgery can have a positive impact in their lives. We founded the company not to manufacture medical devices but to transform the industry, to add value to women’s health and enable women to have the freedom to make healthy choices about their bodies.

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Women today hear and read a lot about implants and breast cancer; what is Establishment Labs position on that?

As a women’s health company, you want to reach out to women diagnosed with breast cancer and in need of surgical treatment; women need to have access to insured medical care for breast reconstruction with and without implants. There is also increasing awareness for prophylactic procedures for women with a genetic mutation; these women are exposed to higher cancer risk, not just breast cancer but also ovarian cancer (5). These procedures have a huge emotional and social impact, not only for women but on their whole family and need a holistic approach.

Depending on ethnic background and geography, there seems to be a fear for screening, both the component and the outcome, which leads to no screening at all. This cannot be the way forward.

Self-examination and screening don’t prevent cancer, but with early detection, we can be so much more effective in treating and lower the morbidity of cancer.

[9] ** The information presented here is not intended or implied to be a substitute for professional medical advice, diagnosis, or treatment. All content, and information, contained on or available through this website is for general information purposes only. ESTA makes no representation and assumes no responsibility for the accuracy of the information contained here, and such information is subject to change without notice. You are encouraged to confirm any information obtained from or through this content with other sources and review all information regarding any medical condition or treatment with your physician. 

Sources

Food and Drug Administration (2020)  Medical Device Reports Systemic Symptoms in Women with Breast Implants. [Online] available at:https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-systemic-symptoms-women-breast-implants. Accessed 14 Octobe

Breast Cancer Org (2020) Breast Implant Illness: Special report Breast Implant Illness and Bia-alcl [online] available at:  https://www.breastcancer.org/treatment/surgery/reconstruction/types/implants/special-report/breast-implant-illness. Accessed 24 September 2020.

Food and Drug Administration (2020) Breast Implants – Certain Labeling recommendations to Improve patient communication. 2020. p. 6.

Swami, V., Tran, U. S., Barron, D., Afhami, R., Aimé, A., Almenara, C. A., Alp Dal, N., Amaral, A., Andrianto, S., Anjum, G., Argyrides, M., Atari, M., Aziz, M., Banai, B., Borowiec, J., Brewis, A., Cakir Kocak, Y., Campos, J., Carmona, C., Chaleeraktrako. The Breast Size Satisfaction Survey (BSSS): Breast size dissatisfaction and its antecedents and outcomes in women from 40 nations. 2020, Body Image, Vol. 32, pp. 199–217.

American Cancer Society (2020) Breast Cancer Risk and Prevention . American Cancer Society.  [Online] available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8578.00.pdf .Accessed August 2020.