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 talks about why numbness happens after mastectomy or breast reconstruction and factors that can affect how much sensation returns.
Listen to the podcast to hear him explain:
- the differences between immediate and delayed reconstruction and how each procedure can affect the potential for sensation to return
- the difference between implant reconstruction and autologous reconstruction and how each procedure can affect the potential for sensation to return
- how the type of mastectomy can affect the potential for sensation to return
- why we need more research on using nerve grafts to possibly help sensation return
Running time: 42:43
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Show Full Transcript
Jamie DePolo: Dr. Frank DellaCroce, or Dr. D as he has come to be known, is the 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 at 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 numbness after breast reconstruction and the resensation procedure that claims to repair nerves during reconstruction. Dr. D, welcome to the podcast.
Dr. Frank DellaCroce: Thank you, Jamie. It’s a pleasure to be with you today.
Jamie DePolo: Yeah, it’s good to talk to you again. Now, I know that most women have some areas of numbness after breast reconstruction. So can you help us understand why this happens?
Dr. Frank DellaCroce: Sure. As you mentioned, the central topic of our conversation is about numbness and regaining or losing a sensation after mastectomy and how that relates to reconstruction. In some ways what’s old is new again, and we’ve seen a lot of activity on the internet and different things, Facebook pages and so forth, so this is an area where there’s a lot of activity. So I think it’s a great opportunity to open the dialogue.
So there’s some of the foundational points of that, as you asked, are why do women have numbness after mastectomy or within and around the timeframe of having reconstruction? And it has to do with the fact that the sensory nerves to the breast skin and nipple and areola run through the breast tissue. And so when the breast tissue is removed, many of the nerves that supply the overlying skin and nipple are cut or removed as well. And so it’s a byproduct of our innate anatomy and the impact of mastectomy on those nerve fibers in the periphery of the breast.
Jamie DePolo: Okay, now I know there are two main types of reconstruction. There’s reconstruction with an implant and reconstruction using a woman’s own tissue. So could you talk about both of those and how the different types of reconstruction may affect numbness, maybe... I’m not sure if either type affects how long numbness lasts or where numbness is? If you could kind of explain that for us.
Dr. Frank DellaCroce: Right. So going back to what we’re focusing on, that being feeling in the breast after mastectomy. And there’s been some question of what we mean when we say that. Today we’re not talking about the way the breast feels texturally with the reconstruction, whether it’s soft or hard or somewhere in between. What we’re talking about now is feeling, meaning touch and touch sensation, pressure, temperature, erotic sensation, pain.
The first thing to get your arms around when you’re trying to discriminate the types of reconstruction and related to this topic are how does mastectomy affect it? We touched a little bit on the fact that the nerves are often transected, but we have to do a little bit of housekeeping for our listeners relative to terminology before we move into the reconstruction side of it itself. And those are the fundamental terms related to mastectomy, because a big part of the punchline of this whole discussion is dependent on your audience having a handle on that difference. And what I’m talking about are immediate and delayed reconstruction and how that impacts the style of mastectomy and what is removed and what’s not during the mastectomy.
So, immediate and delayed reconstruction are very different. Immediate reconstruction means we make a new breast with an implant or your own natural tissue on the day that the mastectomy happens, and delayed means we do it down the line at some point. And each of those choices affects our next set of words, which are skin-sparing and nipple-sparing mastectomies. The reason for that difference is because immediate reconstruction usually means you get to keep your own breast skin, a la skin-sparing mastectomy, and often, nowadays, to keep your whole outer breast skin envelope including the nipple, and that’s called nipple-sparing mastectomy.
Doing reconstruction down the line, a la delayed reconstruction, usually means cutting off most or all of your own breast skin and the nipple along with it and rebuilding the whole thing later, including adding a new large patch of skin when we’re doing natural tissue reconstruction to replace that that was cut away. So the fundamental differences of immediate versus delayed reconstruction impact whether or not we’re preserving the natural outer skin layer. That, in turn, affects our sensation potential.
So the differences sort of become obvious and intuitive right away when you think about it. If we keep your own skin and the surgeon doing the mastectomy handles it gently and works to preserve most of the nerves along the outer edges, sensation will likely return to some or even, in some cases, a great degree without doing anything else. If the skin is thinned aggressively, the nerves remaining under the skin can be obliterated, and despite preserving that outer shell or pillowcase envelope of skin, we’d expect that patient to have a harder time regaining sensation.
If we take all the breast skin off on day one and come back to do a delayed reconstruction, then we’ll be replacing all of that skin that’s brought in with the new tissue or stretching it with an expander if we’re doing a delayed expander reconstruction. In either case, we’re at a disadvantage from the loss of that original skin envelope and its remaining nerves. I’ll talk a little bit about how nerves travel through breast tissue, but there are also branches that travel in the fat just underneath the skin that can migrate through the skin as the recovery continues and in some cases even give back nipple sensation to women who’ve had nipple-sparing mastectomies.
Jamie DePolo: It sounds like whether you have delayed or immediate reconstruction makes, as you said, a pretty big difference in the possibility of sensation coming back in the breast area. If it’s not too far off the topic, if you could talk a little bit about why someone might not be a good candidate for immediate reconstruction, like what are the big reasons for choosing one or the other?
Dr. Frank DellaCroce: Sure. Excellent question. So why would someone have delayed reconstruction when there may be an opportunity for immediate reconstruction? Well, if there’s not an opportunity for immediate reconstruction because of significantly advanced disease or the recommendation of your oncology team to avoid that, whether it might be because radiation is required or some other impediment to preserving the outer envelope, perhaps cancers involving a large portion of the skin or otherwise, then someone might not be a great candidate for immediate reconstruction.
The good news is that that’s relatively rare in our era of early detection. And so most women by default are candidates for immediate reconstruction. Now, there are those that are unsure or may not be ready to commit to reconstruction right away, and that’s totally fair as well, as long as they understand the implications that go along with that. In someone who doesn’t choose immediate reconstruction, then they would be navigating through the same pathway as described with delayed reconstruction, and you lose some opportunity for look and some sensory recovery, but we can still do a nice job with flaps and things of that sort as we discussed before.
Jamie DePolo: Okay. Okay, great. Thank you. So if you want to continue on now, it sounds like, as you said, with immediate reconstruction there is more opportunity for sensation to return, and that’s because more of the skin and nerves are preserved. But are there any other reasons for that?
Dr. Frank DellaCroce: Well, with immediate reconstruction, particularly — and we’ll get into this as we discuss the different kinds of reconstruction, the two main types. With immediate reconstruction, particularly when we are applying natural living tissue to that envelope, that can also be a source of stimulation of nerve regrowth in a completely spontaneous way, because we know that fat and natural tissue brought in carries, obviously, increased oxygen and all the good things that go with that and the nutrients and so forth. But there are also other neurotrophic elements like adipose derived stem cells and neuroendocrine elements that come with the fat, and that’s where a lot of the interest was started relative to stem cells and their own independent potential, which is a completely separate topic.
But immediate reconstruction not only gives the opportunity to preserve a neural structure of your own skin envelope, but if we’re doing immediate reconstruction it gives us the opportunity to boost that with a flap tissue, whether or whether not we’re doing what we’ll talk about later relative to reconstructing nerves. So there are some benefits on both sides of the coin.
Jamie DePolo: Okay. So I guess now, then, let’s talk about the two main types of reconstruction, whether it’s going to be implant or with a person’s own tissue and how that plays into everything. Because it sounds like to me — and please correct me if I’m wrong — that even if you had immediate reconstruction with an implant, immediate reconstruction with your own tissue may offer more advantages for sensation return. Is that correct or no?
Dr. Frank DellaCroce: The short answer is yes.
Jamie DePolo: Okay.
Dr. Frank DellaCroce: So, the next foundational building block for your audience — and I encourage them to rewind this as many times as it takes to get their arms around it — the next foundational set of concepts are those differences between natural tissue reconstruction and implant reconstruction and what that brings to the party.
Natural tissue reconstruction, be it the DIEP flap, a GAP flap, any kind of tissue transplant, those patients have been shown repeatedly in the literature to regain more sensation than do those who have implant reconstruction. There are at least six different publications over the last 25 years that show that, and it remains true today.
Interestingly, it happens spontaneously in these studies that have looked at it, and over time, because nerves grow very slowly as they heal, the usual number quoted is a millimeter a day. So that happens on its own and often to a large and sometimes surprising degree, even in women with big skin patches having a delayed reconstruction, which goes against all of what you think would happen. This process has been shown to start in the first year and progresses for more than 3 years, as demonstrated by Shaw and his colleagues in 1995 and others after that.
Implants perform less well with respect to leaving the breast numb because they’re plastic and they don’t bring nourishment and they don’t have their own internal nerves like flaps do, so the chance of nerve regrowth and spontaneous return of sensation is lesser. In delayed implant reconstruction it’s probably the worst case, because the skin has to be stretched and expanded, putting pressure and stress on all the surrounding tissues as well. This all seems, in those cases, to hinder the kind, quality, and extent of sensory return that we see in flap-based reconstructions.
Jamie DePolo: Okay, I am curious. Is one particular flap, has it been shown to perhaps offer better return of sensation than another, or is it that pretty much all types of flap reconstructions are better than implants?
Dr. Frank DellaCroce: It’s mostly been studied in the abdominal-based flaps. There is one report that includes GAP flaps, and in that very small series it actually showed that the GAP flap had a little bit better spontaneous return. But we have to frame everything we’re going to talk about today relative to what we have in the literature, and most of the studies were small and most of them were controlled in sort of not-uniform ways. So there’s a lot of science out there, but super high-quality science we really don’t have a lot of, most of it is anecdotal and small series.
Jamie DePolo: Okay. Okay, thank you. So I guess moving forward, I know you said the flaps bring more nourishment and they have their own blood supply and things like that, but even in some women who have flap procedures, while they may be more likely to return sensation, it seems like the time that sensation returns is different for every woman and can vary widely. And do we know why that is?
Dr. Frank DellaCroce: We don’t have a very clear handle on it. It’s likely related to how the mastectomy was done — again, whether the tissues were very, very thin, whether the field of dissection extended out widely beyond what we call the intercostal nerves, which surround the perimeter of the breast. It probably relates to the quality of the reconstruction and how much of their own skin was preserved and how much was removed. And then there may be some elements with their own individual makeup that affect it, whether they have comorbidities like smoking or diabetes or other things that impair healing and nerve function particularly relative to diabetes. And we know that radiation can impact the quality of sensory return. I know we’ll talk about that a little bit more later.
So there are multiple factors, but we can’t single out one single thing that gives us a great chance or a lesser chance, other than we know that preserving your own breast skin envelope and using a natural tissue reconstruction — those two things combined together — give us our best opportunity as has been shown in all these previous studies over the many, many years.
Jamie DePolo: Okay. Thank you. Now, I know you have mentioned a couple times that radiation can increase the risk for loss of sensation or for sensation taking longer to come back after mastectomy and reconstruction. Are there other things that increase that risk, like for example chemotherapy, does that do anything, or are there other treatments that may affect it?
Dr. Frank DellaCroce: We know that chemotherapy, certain drugs in the chemotherapeutic arsenal, have a very significant effect on nerve function. People can develop numbness in their hands and fingers and things of that sort, as you well know. That issue has not been studied to any significant degree in our reconstructive literature. So we don’t know that someone who had cisplatin then goes on to have a 25% chance of increased sensation, or some other therapeutic modality in that regard.
Short answer there is that we don’t know, but intuition would say that the drugs that have been known to have neural side effects, in all likelihood that would parlay into a regenerating nerve in a surgical field as well, in the breast in this case.
Jamie DePolo: Okay. Okay, so let’s kind of talk about the other side. Are there things that a woman can do to help reconstruction return faster? I know you mentioned smoking, so obviously stopping smoking would be one thing. But I want to use that to segue into this resensation technique that says it can restore sensation after mastectomy. So I’m wondering if there are things a person can do, and then if you could kind of talk about this technique and what it actually is?
Dr. Frank DellaCroce: The primary thing that one can do in the early period is basically what we talked about earlier, and that is have a very clear handle on what type of mastectomy is being contemplated for them and why. A very nice article out of Johns Hopkins did some elegant work on the return of sensation in the breast after a nipple-sparing mastectomy, and in some of their patients they even had erogenous sensation return. So early choices are the most impactful. There’s no vitamin regimen, there’s no exercise, there’s no massage or anything like that, no hyperbaric chamber treatment or anything of that sort after surgery that would enhance the recovery. It’s mostly based on the steps that are taken during the surgical journey, if you will.
Jamie DePolo: Okay, and I know regarding the resensation procedure, I know you have some concerns about it because you’ve done quite a bit of research on this topic. So if you could talk a little bit about that, explain what it is and talk about your concern.
Dr. Frank DellaCroce: Sure. So we’ll get into the substance of the conversation relative to that. We’re a little bit behind, because the whole thing now has been branded and packaged up and big marketing budgets have been put behind it and so forth.
The Resensation product is basically a nerve graft collected from cadavers, from dead donors, and processed to render it free of cellular material so that your body doesn’t generate an immune response to it and reject it. It’s been widely available and on the market since 2007, mostly used in hand and arm surgeries where a lot of neural repair is done. With respect to breast care, it’s only picked up traction really over the last 3 years or so. The material, once it’s harvested, packaged, processed, and collected, it’s been sold to hospitals for use in the operating room. Unpackaged, it looks like a wet noodle, and it comes in different lengths. And so that’s the summation of what it is.
Now what is it for, how does that play into breast reconstruction? Well, in the field of mastectomy, there are often nerves that you can plug into, and in this case I’ll get into some of the technical issues there where an existing nerve is cut down and a graft is attached to it to reach the recipient nerve that lies underneath the flap itself. So the nerve graft is basically an extension cord to reconnect a couple of sensory nerves.
So, my concerns about the way that it is migrating through the internet and the literature and websites and even promotional efforts, is that we don’t have a high-quality scientific platform from which we can say this is doing anything. And I’ll give you some reasons for that in a moment. My bigger concerns relate to the fact that there’s probably little awareness that this isn’t for women having reconstruction with implants, period.
Jamie DePolo: That was going to be my question, because you said somebody who had delayed reconstruction with an implant probably had the highest risk of sensation loss, so would this be a good candidate for them? But clearly it’s not, because you just said you can’t use it with an implant.
Dr. Frank DellaCroce: Right, because only those with flap reconstructions are candidates for it, because the nerves that are connected are nerves that are running into the flap tissue itself. A sensory nerve that comes with the transplanted fat is connected to a nerve in the breast pocket, and the extension cord to do it is the Resensation Avance Nerve Graft made by Axogen. So there’s nothing to plug a nerve into in an implant reconstruction, because an implant is an implant, right?
Jamie DePolo: Okay. Got it.
Dr. Frank DellaCroce: There’s nothing to feed the nerve into to allow it to migrate and grow through the composite of material.
As you are aware, in the United States among the 101,000 or 106,000 year-to-year variation of women that have breast reconstruction, 82% were done with implants. And this procedure is generally only offered to women having DIEP flaps. So that means that only a tiny subset of women are actually eligible to even consider choosing this, whether it works or not.
We know that 9,500 DIEP flaps were done last year of the 101,000+ reconstructions. Two-thirds of those or so were bilateral, so the number of women who might have been able to choose this is around 6,400 or so of the 325,000 women diagnosed with invasive or preinvasive cancer on an annual basis.
Jamie DePolo: Yeah, that’s a very small percentage that might be eligible.
Dr. Frank DellaCroce: My next layer of concern is more on the scientific side, the anatomic side and the physiologic side. So we have to kind of do a little “Bill Nye the Science Guy” moment and talk a little bit about nerves, how they heal, what we do and we don’t know about their repair, and how that applies to this whole idea, why it might or might not work and whether any or some of the claims being made or implied, probably more importantly, are real or not.
We talked earlier about the impact of delayed versus immediate reconstruction, preserving your skin, the skin envelope, and even the nipple with nipple-sparing mastectomy and what those things mean for the set-up. Those concepts are important for how this idea fits into the bigger picture.
As I mentioned earlier, in immediate reconstruction we preserve the envelope. To do the Resensation nerve connection, most surgeons are cutting down what’s called the third intercostal nerve, which is a nerve that supplies the skin over the area extending from the sternum and across the middle and the top of the breast, and sometimes maybe even part of the nipple. That’s the nerve that’s being cut so that the graft can be connected to it, and then the graft would be connected to the nerve in the flap.
Interestingly, that nerve is often partly still intact to that preserved breast skin, so if we cut it down, we may be taking sensation away from outer breast skin and rerouting it under the flap with a graft, which again, you can think of as an extension cord, because the third intercostal nerve and the flap nerve are usually too far apart just put together by themselves. You then connect all that together with this, what I described as kind of a wet noodle, this graft, it’s 4 or 5 centimeters in length, and then we wait. Because as I mentioned, nerves regrow at about 1 millimeter a day. And since the distance from the cut nerve, that third intercostal, the added graft, and the distance that the flap nerve has to regenerate through its own substance may be 12 centimeters or so, so we would expect zero, zilch for 120 days as this process continues. The only thing we might experience is numbness where the third intercostal was cut down.
But in the meantime in this 120 days, all the internal layers in the new breast that healed internally scarred together. We know that grafts, when we repair nerves, perform less well than when we connect two nerves back together directly. This is, again, because of that added distance that I mentioned and the fact that nerves grow slowly, and it’s because we have two suture lines in the nerve repair, one at each end of the graft rather than a single nerve put back together.
Neuroscience tells us that across every suture line, we can expect about 50% of the little axons to fail to make it through, because they’re sort of like little tiny wires growing in different directions and they don’t always make it to the other side of the repair.
Jamie DePolo: And the axon is like a little nerve hair, is that right? It’s like a fiber in the nerve cable, to use an analogy?
Dr. Frank DellaCroce: Yes. It’s the regenerating wiring of our nervous system. And I always describe it to patients, think about a fence in your backyard and you cut a piece of ivy or whatever you have back there, and then that ivy migrates down the fence and somehow it sort of finds its way down the fence. It’s a lot like what an axon, or a nerve fiber, does as it’s trying to heal, it tends to migrate through different tissues, in this case the suture line. So if 50% are impeded on the first line, we’d expect another 50%, so maybe 25% would make it through.
We also know in graft surgery — this comes from the upper extremity literature that I mentioned earlier, hands and arms — that grafts longer than 2 or 3 centimeters often do very little to nothing to improve function, because the little Schwann cells — just some more medical terminology, these are the little cells in our nervous system that help guide those fibers. After about 2 centimeters they sort of peter out through a graft, they lose their way. It’s called a Büngner band for anybody who’s a sort of a technical junkie in the audience. But we know that from all of the work that’s been done. The more of a graft you put, the less you can expect from it.
We’re going to go into the 400 level of my “Bill Nye the Science Guy” talk now, but it’s important for your audience to have these ideas in their mind because it’ll make it easier for them to understand. Let’s say that all of that nerve repair science doesn’t hold true, and if the connection worked like a charm from the intercostal through the graft into the fat, and finally makes these little regenerating fibers reach the surface of the flap.
Well, now we have two problems, actually at that point. One of them was elegantly described by what’s regarded as the godfather of nerve surgery, Dr.. Lee Dellon, who said in his relative ease of reinnervation hypothesis, that reinnervation, or nerve growth, or in this case what we’re calling resensation as it’s been branded, depends on the regenerating nerve reaching what’s called a sensory organ in the skin.
The body is a remarkable and miraculous thing, and in our skin we have what are called touch organs, which are tiny little structures that allow us to sense vibrations, temperature, light touch, two-point discrimination, and they’re in the layers of the skin itself. And the one that we’re interested in talking about in this case is the Meissner's corpuscle, as it’s concerned mostly with light touch. There are other ones called Pacinian, Merkel, and so forth, and lastly and most importantly there are also free nerve endings, and those are pain fibers, those pick up pain stimulus. They don’t touch a sensory organ, they go right into the dermis, and when they’re activated it hurts.
So when we put a flap in under your own skin in a nipple-sparing or skin-sparing mastectomy, we shave away that flap skin. And so we shave away these little corpuscles, or these little sensory organs, along with that flap skin and you throw it away, so that we can close your own natural skin over the flap. That then leaves, if all of this worked miraculously well, this new little regenerating nerve reaching the surface of the flap internally, likely without a receptor to connect to, and so then it becomes a free nerve ending...
Jamie DePolo: Meaning it’s only going to feel pain, is that right?
Dr. Frank DellaCroce: Right, it’s a pain fiber. It’s the same set of things that causes postmastectomy pain syndrome and neuromas, trigger points as they’re sometimes called. So, for that free nerve ending to then jump across the surface of the flap through the overlying scar tissue, the fat under your preserved skin, and then migrate into the under surface of your preserved breast skin, into its surface or even more unlikely into the preserved nipple... Anatomy and nerve physiology tell us that everything weighs heavily against it, because it’s like putting on a glove and telling you that by restoring sensation to your fingertip I’m also going to give the glove itself touch sensation. It ain’t going to happen.
Anyone who’s sat through a neuroanatomy course, knows everything I’m telling, could say, “Well, okay, that makes sense, so why don’t we just cut away some of the breast skin and bring that internal flap skin to the outside so that if there’s some regeneration we then might have a chance to feel it.” My opinion is that we should not cut away the nipple or a patch of skin to bring the flap to the outside because as we mentioned earlier, we already know there are a lot of remaining nerves in that breast skin that are going to wake up and regenerate spontaneously. And if we’ve done a high-quality mastectomy, we can expect that there will be some spontaneous return. To throw that away for the opportunity for this long, winding graft to do something confounding wouldn’t make much sense. Not to mention the fact that cutting away the breast skin or replacing the flap skin kind of uglies things up.
I by no means want to have the substance of our conversation be one where I’m a Debbie Downer or I’m against research in this area, which is absolutely not true, and I’ll tell you later about how I believe this should be further studied and I believe it is terribly important to bring this topic up. As I’ve mentioned before, in a New York Times article a couple years ago I was quoted as calling it the Holy Grail of breast reconstruction, and I do believe that.
You know, we’ve come a long way with all that we do. We can produce beautiful aesthetic results, but if there’s a way that we can improve sensation as a component of that we ought to be thinking about it. A lot of that has to do now with how mastectomies are done. So we touched a lot on that. What we don’t know relative to this resensation issue is whether we may be actually doing harm in some cases, and the fact that we decided to sell it before studying it adequately leaves it unclear.
But one thing we didn’t talk about is whether this has some opportunity to do some good in delayed reconstructions, where we’re bringing a big, new skin patch in. Most of what we talked about was related to immediate reconstruction. For delayed reconstruction patients, there may be some differences. These women have lost all of their breast skin, and although we know natural tissue can do a lot to help sensation return spontaneously in those women, they still often suffer with significant numbness in the transplanted flap skin.
I do believe as I mentioned, the nerve graft has an incredibly low chance of doing much for all the reasons we just went over, but if it does have the opportunity to improve flap sensation, then this would be the place where we should look at it first. I would love to see something show improvement there because I think there’s real opportunity for material benefit in those cases.
Jamie DePolo: So my understanding is that using a nerve graft like this increases the cost of the reconstruction. Do we know, is that covered by insurance?
Dr. Frank DellaCroce: The great majority of insurers do not cover it, and if they do it’s probably a whoops, it probably slipped through their system because it’s regarded as experimental, and as you probably well know, insurers often aren’t inclined to support someone else’s experiment. It’s kind of not their job, as mentioned earlier. And so there are impediments to access that result from that.
The other things that are impediment to its use and its access and research and so forth is that it’s not approved by the FDA.
Jamie DePolo: Interesting. Do you know what? That didn’t even occur to me, I guess I just assumed that it was because it was being marketed. That’s my bad, I should have looked that up.
Dr. Frank DellaCroce: Well, this became an issue of great concern when we had our hearings in Washington last March 2019 on the breast implants, remember?
Jamie DePolo: Right. Breast implant illness, yeah.
Dr. Frank DellaCroce: There were some early concerns because implants weren’t approved by the FDA until they were on the market some 20 years.
But during that course of hearings, dermal matrix was also brought up because — and that’s the collagen sheet that we use to do immediate implant reconstruction — it was brought up in those hearings because it had what’s called HCT/P categorization, human connective tissue are the abbreviations, and a homologous designation, which meant that it fit under the FDA’s 21 [Code of Federal Regulations] Part 1271 regulation requirement. What did all that mean?
It meant that they had the special ability to use it if it was deemed homologous, which means like repairing like, so that they could sell and promote it. But the FDA said this is not a homologous use, this dermal matrix, when we use it in the breast. So you’re not allowed to promote it, to make sales calls on breast surgeons, to create pamphlets, or do anything else that markets this as a component of breast reconstruction surgeries until you do what are and were called “prerelease studies” on it.
So now these dermal matrix companies are having to go back and do premarket approval studies to regain their opportunity to market it for use in breast reconstruction. In the meantime, surgeons are still using it in the breast, however it’s considered an off-label use. This Avance nerve graft may well fall into the same issue that the dermal matrix companies did because it also is sold under the HCT/P categorization and regulated with the FDA’s 21 CFR blah blah blah, the thing that I mentioned earlier.
Jamie DePolo: So we talked about a lot of things, a lot of it was technical, and I guess the bottom line in my viewpoint is, we know that loss of sensation is an issue for women who have mastectomy and breast reconstruction. In many cases, sensation does come back, but it can take awhile where it’s not clear whether this nerve graft may help, it doesn’t seem like the research is there yet. So to my mind the bottom line is, we kind of have to wait and see. What would your bottom line be?
Dr. Frank DellaCroce: I agree. I think that to wrap up some takeaways for our listeners, what should we be doing at this point, what should we not be doing, what can we expect in the future? I mean, absolutely we should be studying this issue. I think all of this being brought into the forefront is great because it opens the dialogue and it stimulates thinking minds to contemplate solutions.
So I think the study of it is important with the technology in hand. That means, I think, looking at it principally for those who can’t have immediate reconstruction, then going from there. Again, it may have a place in delayed flap reconstructions as we mentioned. The expense is tremendous. It would be great if the company would find a way to make it more affordable. It shouldn’t be an opportunity just for those with significant means. I mean, right now Medicare patients are priced completely out. We have to consider that.
Maybe the graft and the nerve repairs have some role in all of that at some point, but it’s not ready for prime time yet.
Jamie DePolo: Okay. That is a very good summary. I want to thank you so much for explaining all of this and talking about the need for research and making it understandable. We all really appreciate your insights. Thank you.
Dr. Frank DellaCroce: You’re very welcome. Thank you, Jamie.
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