Author Insights: The Breast Implant Illness Debate

Dr Christopher Homsy and Natalie Kuhn describe the debate surrounding breast implant illness, how and why it has evolved in recent years, and the future directions for research and patient care.

Natalie Kuhn: Hi, I'm Natalie Kuhn. I am a fourth year medical student at Tufts University School of Medicine and I recently matched into the Integrated Residency Program for Plastic Surgery at the Lahey Clinic.

Dr Christopher Homsy: This is Dr. Christopher Homsy. I am a plastic and reconstructive surgeon at Tufts Medical Center in Boston. I specialize in general reconstructive surgery, microsurgery, cosmetic surgery and gender affirmation surgery, as well as breast implant reconstruction for breast cancer.

Prompt 1: Why is breast implant illness a topic of debate? How has that debate evolved over the years?

Dr Christopher Homsy: Very, very interesting question and I actually was there to witness the debate and controversy back in 2019, if I'm not mistaken, and at the ASPS meeting in San Diego. And that was maybe one of the only times where I've seen people get heated a little bit when it comes to a topic of conversation and what is supposed to be a scientific meeting, and it was actually for breast implant illness. And I think it's a very polarizing topic because breast implants are actually used by every plastic surgeon on the planet and they have stood the test of time. We know that they are safe and we use them for either cosmetic or reconstructive purposes.

But recently there has been this, I would call it movement, that was facilitated by the fact that everyone is on social media now, and everybody can share their opinions or their experiences with the world. So what actually happened is this breast implant illness terminology was actually coined by patients and women rather than the scientific community or plastic surgeons. And it all started with women sharing pretty much an umbrella of symptoms that we call them extramammary so they're not really related to their breasts or their breast implants. They're related to other other things, can be a headache, can be a rash, could be joint pain, could be muscle pain, could be hair loss, could be what they refer to as brain fog, loss of appetite, unable to lose weight, et cetera. So not very vague, but maybe very general symptoms if I may say.

And what these women had in common is that they had breast implants. So automatically the attention got shifted that, "Oh, perhaps it's because we have breast implants that we have these symptoms." And what interestingly happened too is that a lot of these women when they had their breast implants removed, their symptoms subsided at least by 50 to 60%. So they had a market improvement in their symptoms and that started a big domino effect. And a lot of plastic surgeons basically became believers and automatically there were non-believers and plastic surgeon who are saying, "This is not related to breast implant. We know breast implants are safe. It could be just a chronic illness, could be an autoimmune disease."

And the confounder per se is breast implant because there's a lot of people who have breast implants and that's a big confounding factor from a statistical analysis. So I really think this breast implant illness topic will continue to be a topic of debate until we have level one or at least level two scientific evidence where people can read the literature and agree that, "Okay, fine. This is something real or there is some sort of association."

Natalie Kuhn: Yeah. I would be happy to give more background about how the debate has evolved and what the research has shown over the years. The debate of the existence around breast implant illness kind of started in the nineties with just anecdotal symptoms from patients. And this was around the same time that silicone implants were taken off the market given safety concerns for a lymphoma. And studies between then and more recently were not suggestive of the existence of breast implant, unless although many of them were not super high level evidence, so they weren't able to just demonstrate a significant association, but the evidence wasn't really superb.

And in 2006, the FDA actually said there was no association between breast implants and connective tissue disease or breast implant illness. But in more recent years, there have been some papers that have suggested the evidence of breast implant illness does exist. Although, like I said, the evidence hasn't been great and there's been a large growing number of patients online and through the media that have brought this issue to the forefront and patients have become more aware of it in bringing this issue up to their doctors. And interestingly in fall of 2020, the FDA changed their standards and did advise that breast implant illness and these general collection of symptoms is something that physicians should be talking to their patients about while consenting them for breast augmentation. So there does seem to be a shift in how people are thinking about breast breast implant illness and the validity in existence of this disease.

Dr Christopher Homsy: I agree with Natalie. It's been an interesting, almost like a deja vu in terms of how things have been. In the early 2000s, no one wanted to use silicone implants because they were taken off the market so everybody switched to saline implants. And I think a lot of what I'm going to say now is based on my personal studies that I've done, which actually I found that at least in the cohorts that I saw, that those symptoms of breast implant illness are not necessarily related to silicone implants, per se. They're related to breast implants and maybe saline implants.

And I think based on what I saw in the data and what I'm seeing now every day in my practice is my theory at least, and I hope one day I can prove that with high level evidence, is that these patients who are complaining of this huge variety or this large wide gamut of symptoms from headache, to joint pain, to muscle aches, to hair loss, if you try to put together maybe a theme of what is common to these, or what's the common denominator for these symptoms, these are symptoms that we see in autoimmune disease and chronic kind of illnesses.

Now, if you think from a pathophysiology standpoint, why people with chronic illnesses like Crohn's Disease or autoimmune thyroiditis, et cetera? Why do they have these fatigue or hair loss or symptoms that are kind similar to what these patients with breast implant illness are describing? I think it's just because your body is mounting a large chronic immune response that is causing this chronic steady inflammatory state that is not necessarily an acute inflammation. When someone has an appendicitis, they have a fever and they have to go to the emergency room. It's more like a slow, almost subclinical inflammation that is causing these patients to experience something similar to the connective tissue disease symptoms that we see.

And the common denominator, again, becomes if you remove the implant with the shell or the capsule around them, theoretically you are removing what has been causing this chronic inflammatory state and the patients are feeling much better afterwards. I don't think it's the silicone per se or the shell per se. I think there is some sort of inflammation or some sort of subclinical infection or colonization with bacteria, which we alluded to in an hour case report, that is driving, I think, the body to mount this kind of unusual response. And once you take care of it or perform some sort of source control, the patients are feeling much better. The tricky thing is some patients still say that they have some symptoms that are not completely resolved. But for the most part, a lot of these symptoms the patient really feel much, much better.

Prompt 2: What should be the future directions for research in breast implant illness?

Natalie Kuhn: I think that as we've talked about, there's a lot of need for future research on this topic as there's a lot of confusion and contradictory evidence up to this point. But it's going to be important to kind of better characterize the disease and which symptoms are actually related to breast implant illness, if that is what is causing these symptoms, as well as risk factors and incidents to kind of better counsel patients and create guidelines of how we can best support our patients, and decide who is and who might not be a good candidate for breast augmentation or breast reconstruction with implants. And kind of in addition to that, we also will need to have better basic science research to figure out the exact pathophysiology of what is going on with these implants that might be causing these systemic systems. So I think we'll both need better clinical research and basic science research to elucidate the cause of these symptoms and how to better help our patients navigate their decision making.

Dr Christopher Homsy: I think I agree with Natalie when it comes to the research we need. I think if I had to choose maybe one or two things we can do better in research, number one, making sure we have good patient stratification and good patient selection when we're studying breast implant illness. Because it's one thing that you look at a cohort of patient that had breast implant illness symptoms, and then you look at their past medical histories and they are on 10 different medication for what we call fibromyalgia, or they are on medication for rheumatoid arthritis. So they have a baseline of symptoms that could be worsening, and now the patient is maybe associating this with breast implant. But then the question becomes did they develop these symptoms because were they labeled as patients with rheumatoid arthritis because of these symptoms, but these are actually symptoms of like breast implant illness?

So basically it's who came first, the chicken or the egg? But I think patient stratification is important. We cannot just study all commerce and say, "Okay, you have a breast implant and then you have these symptoms. This is breast implant illness." I think we need to be very careful how we choose our patient population when we study these patients. And I think number two, in terms of what's important in breast implant illness, I think the focus should be shifted away from the silicone and more towards an implant in general. Just like I said, we have to have basically an open mind that the theory or the explanation could be an underlying infection or infective process driving this entire inflammatory process rather than, "Oh, it's the actual silicone molecule or the cynical particle that is driving that."

And we need to be honest with our patients. Like I tell my patients all the time, you can get better, you can get worse, or you can just wake up and not feel anything change. So I never guarantee my patients that the results going to be positive because I say we need more research. So I think this is very important for everybody listening to this interview and they're interested in BII. You have to be honest with yourself before you're honest with the patient. It's not a marketing tool that we're doing just because we can remove implants and add another code to our surgeries or build the patients just to have more business. We need to stay ethical as plastic surgeons because we are doctors at the end of the day, and we need to be careful how we counsel these patients. And I think that's why the FDA has added this black box warning to basically remind us that you need to tell the patient that there are symptoms associated with that, but be also honest that it could be something else.

Prompt 3: What should patients and doctors know about breast implant illness?

Dr Christopher Homsy: If someone who's listening to this interview is a patient with breast implant and they think they might have breast implant illness. I highly recommend they talk to a board certified plastic surgeon that can guide them into making the appropriate informed decision rather than just going blindly and saying, "I'm having problems. This is from my breast implant. I want my implants out." So I really think this is extremely, extremely important for patients and doctors to understand that it's an open discussion. It's kind of intriguing and exciting at the same time because it's an evolving topic that hopefully in five years I might be wrong what I said today. Everything that I might say might not be valid anymore. But hopefully I'm right, at least in one thing, that always it needs to be a discussion and the plastic surgeon should be able to guide their patients with the decision rather than just drive them into a decision blindly.

Natalie Kuhn: I second what Dr. Homsy said. I think it's a really interesting and exciting topic that definitely needs more research to be done on it. And kind of going through this case report and learning more about breast implant illness has been a really important reminder of the importance of having really in depth, thorough discussions with your patients about risks and benefits of every procedure, in addition to the importance of evidence based research and medicine. So it's been a really interesting topic to learn more about and do research in.