Breast Implant Illness: What Do We Know Right Now?
Frank DellaCroce, M.D., FACS
August 2, 2019

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Dr. Frank DellaCroce, or "Dr. D" as he has come to be known, is a founding partner of the Center for Restorative Breast Surgery and St. Charles Surgical Hospital in New Orleans. Board-certified in plastic surgery, Dr. D has performed thousands of reconstructive procedures, both for women diagnosed with breast cancer and women at high risk of the disease who choose to have prophylactic breast removal. He is a Fellow of the American College of Surgeons and a member of numerous professional societies, including the American Society of Plastic and Reconstructive Surgery, the American Society for Reconstructive Microsurgery, and the World Society for Reconstructive Microsurgery. He also has been named one of the “Best Doctors in America.”

In this podcast, Dr. DellaCroce discusses illness linked to breast implants, the Allergan textured implant recall, as well as how he is counseling his patients.

Listen to the podcast to hear Dr. DellaCroce discuss:

  • the differences between textured and smooth implants, as well as the differences between silicone-filled and saline-filled implants and the theories as to why textured and silicone implants are linked to disease
  • what breast implant-associated anaplastic large-cell lymphoma is and how it is treated
  • what to do if you have an implant and are concerned

Running time: 44:29

Thank you for listening to the Breastcancer.org podcast. Please subscribe on iTunes, StitcherSpotifyTuneIn, or wherever you listen to podcasts. To share your thoughts about this or any episode, leave feedback on the podcast episode landing page on our website.

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Show Full Transcript

Jamie DePolo: Welcome to the Breastcancer.org podcast! I’m Jamie DePolo, senior editor at Breastcancer.org. Our guest is Dr. Frank DellaCroce, or Dr. D., as he has come to be known. He is a founding partner of the Center for Restorative Breast Surgery and St. Charles Surgical Hospital in New Orleans.

Board-certified in plastic surgery, Dr. D. has performed thousands of reconstructive procedures, both for women diagnosed with breast cancer and women at high risk of the disease who choose to have prophylactic breast removal. He is a fellow of the American College of Surgeons and a member of numerous professional societies, including the American Society of Plastic and Reconstructive Surgery, the American Society for Reconstructive Microsurgery, and the World Society for Reconstructive Microsurgery. He also has been named one of the Best Doctors in America.

Today, he joins us to talk about the risk of illness linked to breast implants, including the recent recall of Allergan textured implants, as well as alternatives to implants. Dr. D., welcome to the podcast!

Dr. DellaCroce: Thank you, Jamie! Always happy to be with you.

Jamie DePolo: So, this is a very timely and a little bit scary topic that we’re going to go into today. Breast implants were approved by the U.S. Food and Drug Administration in the 1960s, is my understanding. Now, since that time, a number of women who had implants placed have reported health problems such as chronic fatigue, flu-like symptoms, and hair loss. And then more recently, a rare type of cancer called anaplastic large-cell lymphoma, which a lot of people abbreviate as ALCL, has been linked to textured breast implants.

So, we have a lot to unpack because there’s a lot going on there. So, I guess my thought was, for a start, what’s the difference between a textured implant and a smooth implant, and why would someone choose one over the other?

Dr. DellaCroce: Perfect, yes, good starting point. So, to help frame the discussion, I’ll get to the answer in just a second.

For the listeners, they need to know that this really is kind of coming together all at once. For the physicians, for the FDA, for the manufacturers, and so forth, most of these questions gained significant momentum in January, when the first report of the data that was due to be collected by the implant manufacturers starting in 2006 when the silicone implants were re-released onto the market, came out with a lot of moving parts in it that suggested again there may be some associations with these illnesses — rheumatic, autoimmune, and other.

Then in the same very few months leading up to today, increasing reports of this lymphoma occurrence also began to hit the media. In February, the FDA sent out a letter to practitioners to advise them of these concerns, and then, you know, going into March, they had hearings in Washington about all this stuff and so forth.

And so there are two primary questions on the disease-occurrence side. One is the risk of developing this rare form of lymphoma, again, that’s the textured association question. And the other are these other illnesses — these autoimmune, connective tissue diseases — that are also in question.

So, two disease fronts, and then two questions related to the type of implant. One: textured versus smooth, as you mentioned in your question, and the other, silicone versus not, and whether that alone carries any relation to any of these concerns. So those are the moving parts.

So, let’s dive in again to your question about textured versus smooth. That’s the issue related to whether or not lymphoma is something that is related to implant placement. The difference between a textured implant and a smooth implant is sort of intuitive. The textured implant has a coating on the outside that’s like sandpaper. It’s just rough. A smooth implant, as it sounds, it’s smooth on the outside.

Why do they make textured implants? What’s the difference? Textured implants were brought onto the market in the 1980s, and various forms of texturing have been played with over the decades since then. What the manufacturers were looking for was a solution to something called capsular contracture, which is the most common problem with implants of all varieties. That is the forming of a scar layer around the breast implant that shrinks, becomes tight, makes the breast hard, and can become painful.

So texturing was placed onto the implants in an effort to stop or slow this capsule formation. The idea was that the rough surface would disorganize the bundles of collagen that were forming the tight scar layer, and so it would be less inclined to form. And it seemed to help with that to some degree, although it wasn’t a complete solution.

And so, when and why, then, do we use textured versus smooth? We usually default to smooth in cosmetic surgery because the outer layer is a bit more pliable. They don’t tend to wrinkle as much. And if a patient develops recalcitrant, or recurrent, capsular contracture, then we would consider switching from a smooth to a textured implant to prevent that capsule formation.

In breast reconstruction, textured implants are more often selected because it helps them stay put. It helps them not rotate, particularly when we have a shaped, or anatomic, implant, so that if it were to move, it would create an odd shape in the breast. And also, because breast reconstruction tends to have a higher incidence of capsular contracture by default. And so that’s why textured implants were often more popular in breast reconstruction relative to breast augmentation, and that’s the reason that manufacturers put them into the marketplace and the kinds of patients that would be selected for their placement.

A lot of popularity actually caught on when breast reconstruction surgeons started to entertain prepectoral, or breast reconstruction with implants in front of the muscle. Then the textured implants became very, very popular again because they were selecting a shaped implant, because it was covered with a less thick layer of tissue, being in front of the muscle, and because it was shaped it needed to stay put. It needed to not move. So that’s kind of a summary of the whole texturing thing.

Jamie DePolo: Now, you also mentioned silicone versus saline — well you didn’t say saline, but other. So could you kind of go through the same differences with those two because I know some people think that the silicone is possibly — I have not seen any studies — but possibly linked to more of the autoimmune issues that are being seen with some implants.

Dr. DellaCroce: Right. So, the first implants ever on the market in 1962 were silicone filled, and they were placed in Houston by a doctor named Tom Cronin in a young lady who was a mother of six who volunteered to be the first patient. And since then all implants, for the great majority of cosmetic work that followed — it ballooned. The market received them quite well, as you may imagine. All the implants were silicone filled.

Then in 1982, a report came out of three patients who had the question of whether or not they had developed rheumatoid arthritis, Sjogren’s syndrome, Raynaud’s disease, and a mixed connective tissue disease associated with their silicone implant placement. All three of these patients had silicone implants, and all three of them developed these diseases and maladies within 2 or 3 years after they were placed.

So that report was put into the literature by one of the rheumatic journals as a, “Hey, here’s something we see. We don’t know if it’s real or related to silicone or not, but maybe there’s an association. It’s probably worth studying more.” From there, increasing reports began to come out and then, as you know, lawsuits followed, Dow Corning pulled the implants from the market, and then they were held from the market for 14 years, from 1992 to 2006.

In that interim, the silicone implants were studied to some degree, and they were rereleased onto the market. The reason that they were popular, have always been popular, and are once again very popular is because texturally, they feel more like tissue than does an implant that is filled with saltwater, or saline.

So, the saline implants were all we had during that 14-year moratorium. When the silicone implants were rereleased onto the market, they once again became the implant of choice because they’re softer, they feel more like tissue, they wrinkle less, and so the gravitation towards them is for those various reasons.

The question of whether silicone implants are associated with the breast implant illnesses is still in flux, as it has been since 1982. The difficulty in 1992 when the Dow Corning lawsuits came about was that we didn’t have the data. We didn’t have the information to say that, “No, no, silicone implants are perfectly safe. Here’s the data that shows it.” We didn’t have that data, and so the lawsuits followed and they were indefensible.

As a condition of rereleasing the implants onto the market, in 2006, the FDA required the manufacturers to agree to study these devices with improved scrutiny. They were to put together a 10-year study with a minimum of 40,000 patients and then report to the medical industry and the FDA and to the public what they were seeing.

We didn’t get a look at any of that information to any significant degree until January of this year, as I mentioned, where a study came out that put all of what we have of that data together, and it once again showed some question of association to these connective tissue diseases.

And so, now it’s back again. It’s sort of Groundhog Day again. Your surgeons, your medical personnel all had reassurance in 2006 that the FDA had approved these devices, the manufacturers had vouched for their safety. They were going to do these studies, enroll patients in these various registries, and we would have increased clarity once all that was reported. The disappointing news is that despite the study in January showing, again, some question of association of a rare degree with these connective tissue and other illnesses, the data isn’t well compiled. A lot of it was self-reported. A lot of the patients dropped out at between 2 and 7 years. So, it’s not the data collection that we were hoping for because it still leaves a lot of questions.

Jamie DePolo: Does it matter at all — I’m not sure if this was in the data released — if the implants leak? Does that seem to be a factor in any of the diseases?

Dr. DellaCroce: The initial lawsuits back in the 1990s were framed around that question, that women with leaking implants were developing these diseases. The data then that followed that I just mentioned put together didn’t give us clarity there. It did show that implants still leak to a significant degree. The manufacturers report in their little inserts that a great percentage of implants by 7 to 10 years have leaked — between 10-30+% of them.

We know that if implants leak, it can create the question of an inflammatory response, meaning that one of the classic signs of a silicone implant leak is if someone suddenly develops capsular contracture that they didn’t have before. We know that capsular contracture is related to inflammation, so if the silicone leaks and causes capsular contracture then it may be causing some inflammation.

All of these various questions and all of these various diseases seem to have a common thread of that — that inflammation of one source or another may be the causative agent.

Most of what we have in terms of theories — these are theories — with respect to what’s causing this chronic inflammation is that either the implants had a low-grade bacterial contamination at the time of placement, or maybe they get seeded later from a root canal or a bug bite, where they develop something called a biofilm, which is a mucous layer that little bacteria live in on the surface of an implant. It’s not enough of an infection to give you fever or make you sick, but it’s enough contamination to activate your immune system.

So, it may be that biofilms are the causative agent, or it may be some inherent reactivity of the silicone material. If it leaks — perhaps even if it doesn’t, because we do know that silicone does bleed through intact implant shells. What does that mean? It means that silicone filler material inside an intact outer shell tends to slowly sweat through the shell over time with or without an actual hole in the shell.

So again, going back to the theory or question of inflammation being a source of problems, if we know that people with various inflammatory diseases are at a greater risk for lymphoma, the idea is that the inflammation activates something called a T cell, and we found higher numbers of T cells in women with biofilms.

Jamie DePolo: And a T cell, I’m sorry to interrupt. I just want to explain to everybody, that’s an immune system cell that goes out and kills invaders, or bacteria, or something that’s attacking the body, right?

Dr. DellaCroce: That’s right. The T cell is the source cell that forms breast implant-associated lymphoma — BIA-ALCL. A lot of letters. Breast implant-associated anaplastic large-cell lymphoma is a T-cell lymphoma.

And so, the question then is, if the immune system is chronically activated by low-grade inflammation of one source or another, then the number of T cells continues to be stimulated, or propagated, into the area where the implant is. And eventually, one of those T cells, because of the chronic stimulation, becomes mutated, and the mutation forms the lymphoma. So those are theories. None of that is proven yet, and so that’s where the open questions remain. There’s more study to be done, but the inflammatory issue has some commonality with the women who may experience these other issues — joint pain, muscle aches, skin rashes, overt rheumatoid arthritis, lupus, fibromyalgias — those are all inflammatory immune diseases. So again, you see that these things probably are intertwined together in a complicated fashion. And it may also require that someone have a genetic susceptibility to these issues. Because there are 10-plus million women with implants around the world. And for an example, with the lymphoma, we only have a few hundred cases ever reported, the other gazillion women are doing fine.

The same thing with the breast implant-associated stuff. Again, that’s been a question for 37 years. There’s a little bit of smoke there. Maybe there’s fire, but we don’t have clarity. What we do know is there’s this inflammatory thing that can happen, with biofilms in particular, and perhaps with those who may have an elevated sensitivity to silicone material, but the jury, again, is still out.

Jamie DePolo: And is anybody collecting data or doing studies on, say, the number of women who started with some sort of autoimmune disorder like fibromyalgia or something like that, perhaps because they have implants or with an implant, that were then diagnosed with anaplastic large-cell lymphoma? Is anybody looking at that, or do we know if there are cases like that?

Dr. DellaCroce: We don’t have enough well-put-together data to make that connection yet, but we do know, for example, that Sjogren’s syndrome, which is an autoimmune disease of the salivary glands and the tear glands, you get dry eyes and dry mouth and things of that sort. Sjogren’s syndrome is 800% more common in women with silicone implants versus those with not. We also know that those with Sjogren’s syndrome are up to 19 times more likely to develop lymphoma in their lifetimes.

So, we have some dots that sort of beg to be connected, but the science hasn’t been produced yet that allows us to make categorical, causative, clear statements about any of this. It’s a bit murky, very murky, actually.

Jamie DePolo: Right, which is scary. So I kind of want to move on to the Allergan recall…

Dr. DellaCroce: Sorry to interrupt you, but you did ask about saline implants, and I didn’t say anything about that. The question of saline implants — how do they fit into this whole mix? I mentioned that during the moratorium from 1992 until 2006, all we had was saline implants.

Within the context of all of these discussions, smooth-walled saline implants have never been implicated in any of this. It’s only been silicone implants that had the question mark over them, and now, the textured implants that have the big question mark over them.

Smooth-walled saline implants have never been associated with these things in the epidemiologic literature, and that includes the report from January of this year. So an interesting fact to let your audience be aware of.

Jamie DePolo: That’s good to know. Now, I do want to ask, to move on to the Allergan recalls. Allergan recently issued a recall of its Biocell textured implants, as well as tissue expanders, which is frightening for anyone who perhaps has one of the recalled implants in.

So, what are you telling your patients about this if they call and ask, and also I do want to ask — I did not know that tissue expanders could be textured or smooth. And, you know, throughout this whole conversation it’s really been the implants, but obviously a tissue expander is put — in most cases as far as I know — it’s put in place first but then it’s removed. Has a tissue expander been implicated in any of this? I guess I’m curious why those were recalled as well.

Dr. DellaCroce: This issue is not whether it’s an expander, an implant, whether it’s gel-filled or saline-filled as related to this texturing question. It’s purely a matter of whether it has a rough surface on the outside or not. Whether it’s an expander, implant, saline, silicone. This is the lymphoma issue, again, framing it back for your audience. Lymphoma issue related to the texturing. Doesn’t matter whether it’s a shaped implant, a round one, expander, saline-filled, silicone-filled… If it has a rough texture on it and it was made by Allergan, then the FDA requested that they pull them from the market.

That had already been done in Europe, as you know. Canada pulled theirs in May of this year. The other two manufacturers who do make textured implants, Mentor and Sientra, they still have the authority to sell their textured implants in the U.S. It’s only the single manufacturer. Why is that? Because the reports of the number of cases with development of this lymphoma have been mostly associated with implants manufactured by Allergan. Well, maybe that’s a red herring because they sell the most implants, so you’d expect the most cases to probably be related. So, the implant manufacturers started pointing fingers at each other.

The question of what the texture problem is relates to some of the things I told you a few minutes ago, about biofilm and inflammation. Why would textured implants have an association with any of this as opposed to a smooth implant? The theory is that the rough surface has a greater opportunity in its nooks and crannies to trap bacteria. And the trapped bacteria then have the opportunity to create a biofilm, and the biofilm creates inflammation, activates the T cells, T cells mutate, lymphoma forms. So, that’s why textured implants are implicated.

Only one form of Allergan’s textured implants was pulled from the market last week, and it’s the roughest of the varieties they make, the ones with the most nooks and crannies. The one called Microcell, which has a smoother texture, is still on the market and yet to be pulled from the market. It’s still available, and it isn’t as associated. I don’t think as many of those implants were put into the marketplace, or patients, and if this biofilm theory holds true, then the intuitive logic would be, “Well, it has fewer nooks and crannies. Fewer bacterium have the opportunity to make a home there.” But again, all that remains to be sorted out.

Jamie DePolo: So, if someone called you because she was concerned that she had one of the recalled implants placed, what is your advice to someone who has those? I mean, I know the FDA is saying, if you’re not having a problem you don’t need to have it removed. You should monitor it carefully. If you notice any pain, tightness, immediately talk to your doctor.

Dr. DellaCroce: Right. So, it brings up the question, what now? I saw this thing on the news last week. I checked my card. It says I have the textured implants. What now?

First is be aware that this is still a super rare disease relative to what we have, data in hand, at present. The number of cases continues to increase. We had 457 in March, and now we have some 573. We had nine reported deaths in March, and now we have around 30.

So again, as the news comes in we get a little more information relative to the level of concern someone should have. But among the hundreds of thousands of women with textured implants, the 10 million plus with implants globally, we only have a few hundred cases, so don’t forget to breathe. It’s very, very rare.

That being said, you need to be aware of the symptoms of a problem if you have the textured implants — and really, even if you don’t — which includes some of what you mentioned. The sudden swelling of the breast. Fluid around the implant that wasn’t there before. The occurrence of a mass or a lump in the breast that wasn’t there before — always something that’s concerning and should be followed. The development of a rash in the skin that seems unrelated to anything that someone may have been exposed to. Those are all triggers to visit your doctor sort of in a timely fashion, AKA now.

If you’re not having any symptoms, then the present recommendation is not to remove implants that aren’t causing a problem. But you should be aware of the information that we have and that it’s all coming in sort of all at once, and we didn’t have all this information months and certainly years ago, so you should call your doctor if you have any of those symptoms. You should be aware that the information continues to come in, that you don’t have to have them removed. If you want them removed, you certainly can have them removed. And then you should be aware of what can be done, then, if you have them removed. What are my options from there in terms of a solution?

Jamie DePolo: I’m curious. If a woman is having autoimmune disease symptoms, say… I’m trying to think of a good example. You know, fatigue or pain in the joints. And I’m thinking that most general practitioners may not connect those kinds of symptoms with implants. So if a woman has implants and starts developing something like that, should she then go to her breast surgeon and talk about that?

Dr. DellaCroce: Yes. The short answer is yes. With the data we have in hand from 2006 and beyond, there was a lot of dismissal of these complaints and these diseases and the questions of them and whether they were associated with silicone implants. The core studies that we had that were done to allow them to be rereleased didn’t show any significant associations. But they were funded by the implant industry, so we don’t know.

We can’t be dismissive of these things, and you should seek out a qualified expert that has experience with all of this sort of thing. Your plastic surgeon certainly is aware of all the evolving data. They’re aware of the study from January. They’re certainly aware of the hearings that happened in March, and clearly, they’re aware of the recall last week. So, it’s best to seek out the advice of a qualified, experienced, board-certified plastic surgeon to get clarity and to get proper information.

Jamie DePolo: It seems to me that there are two questions that we don’t really have good answers for yet. So, if a woman has implants on both sides, and, say, one side has developed breast implant-associated anaplastic large-cell lymphoma, she’s had that implant removed. Does it make sense to leave the other implant in place is one question. I mean, is she more likely to develop it on that side, or is it two sort of independent things? And I guess, the other question to me is, if a woman has had an implant removed because of anaplastic large-cell lymphoma, is it safe to put another implant in there?

Dr. DellaCroce: We don’t know.

Jamie DePolo: We don’t know. Okay.

Dr. DellaCroce: First question: if you have this lymphoma on the, say, left breast, you have the implant removed, the capsule removed, which is the operation of choice to treat the disease. You have a textured implant in the other breast unless they put in a smooth on one side and a textured on the other, which would be uncommon. Yes, you probably should have the opposing implant exchanged to something different or removed completely.

As I mentioned, it may not all be a direct correlation to the textures, the biofilm, the silicone exposure, whatever, and all these other things. There may be necessarily some genetic susceptibility. We don’t have all that ironed out yet. But if someone develops the disease, we think, “Wow, we have all the moving parts in place for this patient to be at risk for it occurring on the other side.” So then, horse-sense logic would tell you yes, we should deal with the other breast as well.

Relative to — we didn’t get to this yet, but it’s probably good to discuss a little bit of it — the question of breast implant-associated lymphoma: How is it treated? What are my odds of doing okay? What does it mean for me in terms of my health and well-being?

If you do develop this lymphoma, the good news is it’s almost always curable. It’s generally curable with removal of the implant and that scar layer around it where the lymphoma’s kind of living. On very rare occasions, it can spread to other areas in the body. If that happens, then you need chemotherapy as well as the surgery.

Ninety-three percent of women at 3 years following treatment for this disease are disease free, and 10-year survival is 98+%. So, the good news, again: it’s rare, generally curable, it may require chemotherapy. I did mention, though, that some 30 women globally have succumbed to the disease, so it’s serious.

So that would be the treatment protocol or the regimen for someone who were to develop this.

Jamie DePolo: If someone did have an implant removed because of lymphoma, is it safe to put another implant in there, or is it better to do something like autologous reconstruction using tissue from another part of the body?

Dr. DellaCroce: That remains to be sorted out because, as I mentioned, the smooth-walled implants have been largely left out of this conversation. So the question would be, if I have a textured implant can I get a smooth one back in? Sure. The answer is yes.

We don’t have it all worked out in terms of timing. You have the implant removed. You have the capsule removed. Should you wait a period of time before considering another implant placement? As a general rule, I think most doctors who’ve treated these very few hundred cases are removing the implant and leaving it out until the treatment is completed and the patient has been rendered disease-free.

And then, what would we do next in terms of autologous, or natural tissue, reconstruction or replacing the implant? If we were to go back with an implant on a patient like that, we would likely choose a smooth-walled implant, of course. I mentioned that smooth-walled implants have largely been left out of the conversation; however, there are some 28ish cases reported globally that seem to be associated or seem to have occurred in women with smooth-walled implants. The question of that data purity is there still. Those cases aren’t completely confirmed, but smooth-walled implants may, in very rare occasions, be subject to cause development of this as well or be associated with it.

Using your own natural tissue, you know, would sort of be the ultimate way to steer around all of this, not to have the smooth or textured or silicone or any of it. So yeah, autologous, natural tissue, or the flaps as we call them — living implants, I guess we could even call them — are certainly an option for someone who has a breast implant removed for development of lymphoma, or for the fact that they don’t want implants at all anymore, or they want the silicone out.

But recall again, as I mentioned, that smooth-walled saline implants, of what we have now, data in hand, since 1962, smooth-walled, saline-filled implants are the safest implants we have in terms of associations and literature reports related to these various diseases.

Are we going to start using more of them in the coming months? I would guess probably so. Are we going to have an increasing demand for natural tissue as opposed to implant reconstruction in breast cancer? I would say certainly. I think that that is probably long overdue, because I am fairly certain that implants are overutilized with respect to breast reconstruction, as is evidenced by the American Society of Plastic Surgeons procedural statistics, which showed last year that 82% of all breast reconstruction done in the United States is done with implants. And 95% of those are silicone filled. Only 18% of women have a natural tissue reconstruction.

Of the patients I see in my clinic, I am absolutely certain that 80+% of them are not best suited for an implant reconstruction, and that more of them would choose natural tissue or flap reconstruction if they weren’t scared away from it, if they had proper information, if they were informed of what it can do, and they knew where to go if it’s not available in their local area.

Jamie DePolo: Well that kind of raises another question for me. So the statistics I’ve seen show that when we’re strictly talking about implants, more women — and it’s a significant number more women — have implants placed for breast augmentation versus breast reconstruction after breast cancer. And I don’t know if this matters at all. Is anybody looking at the statistics as far as does it matter, are more women with augmentation versus reconstruction developing any of these diseases, or does it just not matter?

Dr. DellaCroce: With respect to the disease and the numbers… So last year, 300,000 and some odd women had breast augmentation or cosmetic surgery related to implants, and about 100,000 or so had reconstructive surgery with implants. With respect to development of these diseases in the cosmetic augmentation patients versus the reconstructive patients, no. We don’t see any difference in the data reported in January relative to the occurrence. It wasn’t well-stratified.

What we do know is this: that women who undergo breast reconstruction with implants have a much higher rate of local complications than do women who have augmentation with implants, meaning that something doesn’t heal well, or the implant leaks, or they have capsular contracture. The data that we have in hand says, in a nutshell basically, this: Greater than 50% of women who have breast reconstruction with a breast implant have a complication of some sort by 7 years. About a third of women who have a primary augmentation with implants have a complication of some sort by 7 years.

So, women who have breast reconstruction have a greater risk of something not performing well. Again, it’s sort of intuitive. Sometimes they’re placed in an irradiated field. Sometimes the tissue coverage is grossly inadequate. Sometimes the implant, for whatever reason, isn’t handled well. Breast reconstruction carries the need of drains. Breast augmentation does not. We’re using another layer of material in breast reconstruction, the dermal matrix. We’re throwing in something else that has the opportunity to bring a bacterium along for the ride. The drains are sort of a highway to carry in a bacterium, which can produce a biofilm.

So, women who have breast reconstruction, yeah, they do have higher rates of these kinds of problems, but the data in hand relative to the breast implant illnesses and the lymphoma doesn’t seem to affect women undergoing breast reconstruction more than those undergoing cosmetic surgery. Those issues seem to be fairly well distributed across that spectrum.

Jamie DePolo: And then I guess, unless you have anything else you would like to add on this topic — I’m sure we could talk for a much longer time — but to sort of wrap up, what would you tell a woman… so she has implants, she’s not having health issues, but she’s worried. What should she do?

Dr. DellaCroce: Well, we talked about some of the symptoms to be aware of, so awareness and knowledge first. Your routine self-exams. If something changes or doesn’t seem right, go visit your doctor. If you are worried about the occurrence of any of these things, walk away knowing that what we have in hand datawise shows us they’re relatively rare.

If you’re not having health issues, as I mentioned earlier, there’s no call with respect to the textured implants to have them removed, but that doesn’t mean that you can’t have them removed. Be aware of what can be done for you if you do choose to have them removed or need to have them removed, whether it’s the textured issues you’re concerned about, silicone issues you’re concerned about, be aware of the fact, as I mentioned, so far, smooth-walled saline implants seem to be the safest thing we have on hand. Natural tissue reconstruction seems to be the ultimate solution. Be aware of what kinds of operations can be done for that. Be aware it requires specialized expertise. Know that, at the end of the day, this is all an evolving story. The surgeons and the practitioners are much like pilots, and the implant manufacturers are sort of like Boeing. We rely on the manufacturers and the governmental agencies to put safe devices in our hands and to provide us with the information so that we can properly counsel our patients. And so we rely and we count on them to continue to do what needs to be done relative to proper reporting, data dissemination, advisories, and improvements of their devices. There’s no compelling reason that implants should be leaking between 10 and 30% of the time. You would think that since 1962 they might have figured that out yet. They haven’t.

So, increased attention to their own technology, proper reporting, open dialogues where patients can be empowered and not be afraid so that they can know what they should look for, if they have something what they should do about it, who should they see, what kinds of tests might be ordered, and what are my options for a solution if they need to be out.

You know, one solution is to have them out and just have them out, to accept the deformity or the deflation or whatever, and there’s no crime in that. But there are options to exchange the questionable devices that can help you sort of have your cake and eat it, too. And that may be the choice for living fat transplantation, or it may be a different style of implant.

So awareness, keep your ears open. This is going to continue to evolve as the months and weeks and years go by. And that’s about all we have in terms of counseling patients at this point relative to these issues.

Jamie DePolo: Alright. Dr. DellaCroce, thank you so much. This has been really informative and helpful.

Dr. DellaCroce: My pleasure, as always.

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