Episode 47: Friday December 3
Drs. Sam Jejurikar @samjejurikar, Salvatore Pacella @sandiegoplasticsurgeon, and Sam Rhee @bergencosmetic discuss the new FDA safety requirements and the updated study results for breast implants. Recently the U.S. Food and Drug Administration announced a "black box" warning for breast implants. What does that scary-sounding term mean for patients? We break it down and discuss how this can lead to better informed patients and improved communication between patients and their surgeons.
#plasticsurgery #plasticsurgeon #cosmeticsurgery #surgery #beauty #boardcertified #beforeafter #aesthetic #boardcertifiedplasticsurgeon #implants #breastimplants #breastaugmentation #breastaug #natrelle #boobjob #gummybearimplants #3plasticsurgeonsandamicrophone #bestplasticsurgeon
S02E47 New FDA Guidelines for Breast Implants
[00:00:00] Dr. Sam Rhee: All right. Welcome to another episode of three plastic surgeons and a microphone with my two favorite plastic surgeons. Dr. Sam Jejurikar of Dallas, Texas, and Dr. Sal Pacella out of San Diego, California. And today we are talking about something that just came down the pike with the FDA a couple of weeks ago.
New breast implant safety requirements and updates which Sal we'll be talking about in just a second and bringing us up to speed. But before that, let me just go ahead and give our disclaimer. This show is not a substitute for professional medical advice, diagnosis or treatment. This show is for informational purposes, only treatment and results may vary based on the circumstances, situation and medical judgment after appropriate decision.
All we seek the advice of your surgeon or other qualified health provider with any questions you may have regarding medical care and never disregard professional advice or delay seeking medical advice because of something in this show and with that cell I'll have you bring us up to speed about what's going on?
[00:01:02] Dr. Salvatore Pacella: Hi, Jen, how are y'all doing today? Doing great. Good. Good. Good. So this is a topic. It's a little bit of a dry topic, but I think equally important to discuss and all of us utilize breast implant surgery in our practices, all of us wholeheartedly believe in the safety of breast implants, both for cosmetic reasons and reconstructive purposes.
But that goes without saying. Breast implants do have their downsides. And I think arguably no other device in surgery or human medicine has been studied more than the silicone breast implant for obvious reasons of the the silicone scare in the 1990s. And we're recently seeing kind of a push from patients and the FDA.
For better information, a better disclosure over the risks associated with breast implants. And so most recently the FDA has come out with some recommendations for both implant companies and surgeons placing implants. There's also several informational pieces that I want to go over that are going to be important for patients to, to understand during their consent process.
So I'm going to share my screen. Okay. For a second okay. How about that? Yep. So it's a PDF document. I'm scrolling. So if you'd like a copy of this is actually posted on the fda.gov website. All you need to really search is. Black box warning, breast implants at fda.gov and this document will pop up.
So essentially this is a non-binding document that the FDA has created giving us some future guidance on implant companies and surgeons. And so what's a little bit of the background on this. So we all know that over the last couple of years, there's been some information regarding breast implants.
Causing a specific problems and most notably an issue related to a breast implant associated lymphoma. And what is that? It's a type of non-Hodgkin's lymphoma that's found in patients along the shell or the capsule of the breast implant. It's most notably been associated with. Texture devices with a specific type of texturing and the type of texturing is a more aggressive texture.
And what the biology of this is, is that there's some sort of interaction between the salt of the texture of the implant and your body's reaction to it that causes a chronic inflammatory. Type of reaction and that chronic inflammatory reaction can lead to this rare type of lymphoma. Now this type of lymphoma, it's exceptionally even much more rare to have any systemic complication from this.
A few patients have died from this type of. But in general, if you have a patient with this type of lymphoma, it's it's easily treatable by doing what we call it complete capsulectomy or removal of the breast implant, shell gents, have any of you had any patients with a breast implant associated lymphoma?
[00:04:04] Dr. Sam Jejurikar: I've had two that I've taken care of?
[00:04:07] Dr. Sam Rhee: I haven't had any.
[00:04:10] Dr. Sam Jejurikar: Yeah. Sorry. So I'll just out of curiosity before we get to that, what's the incidence, like how many cases of breast implant associated with lymphoma can have been seen worldwide. And how would you compare and contrast that to just traditional breast cancer that women are apt to getting?
Is it as common as that? Because I think patients will ask us these questions oftentimes, and they're shocked by the actual incidents of the two.
[00:04:32] Dr. Salvatore Pacella: Yeah, absolutely exceptionally rare. Okay. So if you look at all comers, all patients, all. With breast cancer, traditional breast cancer, the risk of developing breast cancer in someone's lifetime is about one and eight.
So an exceptionally high number. Okay. The risk of developing breast implant associated lymphoma with textured implants in place is at the highest risk for one particular company. One in two. I believe the last numbers I saw was one in 2300. So that's a small, small risk. And in fact, if you take all breast implants, that's even much less, I've heard numbers as low as one in a 200,000.
So this is a very, very rare phenomenon, but a real phenomenon when you have a patient. And again, if you're the patient with breasts, Lymphoma. It doesn't matter what all the other patients are doing. You're the one that has it right.
[00:05:25] Dr. Sam Rhee: And sell. Can you clarify to me, are these textured implants still on the market at this point?
[00:05:31] Dr. Salvatore Pacella: No. They, many of them have been recalled from specific companies. I don't want to get into really which companies or are, which, because some of that's a little bit controversial, but the. The implant texture that has been most implicated, where there was actual recall of this implant has been removed from the market, both in Europe and the United States.
Now that doesn't mean that you can S you, you cannot still get texture devices. You can get textured devices, but just not one specific type of CA texturing that has been implicated in, in this type of. Right.
[00:06:08] Dr. Sam Jejurikar: So going back to your question. Yeah. Yeah. That did for sure. The two patients that I have seen both presented years after their surgery both.
Breast augmentation patients, not breast reconstruction after cancer, but breast augmentation patients that had had textured devices that have been put by the manufacturer that sells actually referring to they both presented with one sided swelling that was asymmetric. And there's not a lot of things that cause asymmetric, swelling years after breast augmentation, there's a there's.
Phenomenon that we refer to as a double capsule where sometimes someone will get fluid. So the bottom line is both patients got sent for cytology, where they went to see a radiologist, they got fluid, withdrew, withdrawn, they showed this particular type of non-Hodgkin's lymphoma. So the treatment in that situation was to do a what's called an unblocked.
Capsulectomy where you basically take out the implant and the entire capsule in one piece Then they were turned over to a medical oncologist. They got better and bottom line was the surgical treatment in both of those cases. And this is true for the majority of patients that have this diagnosis is really what you need to do.
And and most of the time that's all right, people
[00:07:14] Dr. Salvatore Pacella: will need, but not all the time. And I would say, our worlds are slightly different here with the patients that we've experienced with breast implant associated lymphoma. I, I take care of a large majority of breast reconstructive patients after breast cancer surgery.
So imagine a scenario where you've had breast cancer one time before, and you have a thin flap of skin over your implant, and you've been radiated from. Lymph nodes. And so that's a much different problem than someone that comes in for cosmetic reasons that has breast implant associated lymphoma.
The recommendation for treatment is to remove the capsule, but if we're in a situation where. The capsule is adherent, right to the underlying skin. It just can present a huge, huge problem. So this is important stuff that we need to really disclose with patients and do a better job quite frankly.
Now let's move on with these recommendations here. So, we talked about the history of breast implants and the important thing with this advisory from the FDA is it, it's not that they didn't create this box warning just simply because of breast implant associated lymphoma.
They've created it for other reasons, too. We have a sort of a controversial. Disease and plastic surgery called breast implant associated illness. There are a subset of women that can that oftentimes have issues related to subs, systemic systems symptoms related to their breast implants. We don't unfortunately have a lot of good data on that.
It's also because I think in general, we, as plastic surgeons probably don't do the best job of disclosing part of the issues related to long-term use of breast implants. So for example, if you're a smoker and you have complications or. Having breast implants for 10, 20, 15 years. Women may not really anticipate this or understand the complications of having an implant long-term.
And so, so this black box warning is really designed to get a visual look and a visual checklist for patients so that they can understand the complications. I will say, in full disclosure, I do a very comprehensive informed consent process. So implementing this specifically into a practice such as mine is not very difficult at all.
In fact, we do pretty much all of this already. So Jen, maybe you want to comment a little.
[00:09:34] Dr. Sam Jejurikar: I think this has been coming down the pipeline for a while. We've heard a lot about breast implant illness over the past three to five years. A few months ago, we had John Burns on who literally has an aunt for a practice, which is. It takes care of hundreds, even thousands of patients with breast implant illness, where he has mastered the unblocked capsulectomy and fat grafting procedure.
So it's a real thing that's out there. I think the FDA black box warning has just brought more awareness of something that I think most patients have already had an awareness of. And not only do I do, I think your practice does a great job of informing patients, even the American society of plastic surgeons and their standard consent forms that I use in my practice.
And you guys may as well. Cover this and exhaustive detail. Most of my patients that come in know about breast implant illness, most of my patients that come in know about breast implant associated to lymphoma as well. And so we certainly talk about it, but most patients already seem to be very well-educated when they've already come in the door.
[00:10:31] Dr. Sam Rhee: Yeah, I agree. I feel that the, this is a good step for the FDA just to standardize what I think. Plastic surgeons who are responsible, do they inform the patients about, the potential risks that are associated with breast implants? They specify some of the things about breast implant illness, which we're still learning a lot about, I see studies every month as to maybe why breast implant illnesses , occurs and what factors are involved. And then there are a number of different things in the checklist that the FDA is asking plastic surgeons, or I'm sorry, all surgeons to use to make sure that the patient understands that these are not lifetime devices, that these are, synthetic devices made by human beings.
And all of those things are really important for patients to make their informed. I do know that most of the plastic surgeons I know already incorporate, as Sal said something very similar in their educational process with patients. I know I do. And this is just going to be helpful for everyone to better informed.
This does not mean that somehow breast implants are more unsafe today than they were last month or two months ago. It sounds scary when you put a black box warning on something, but when patients ask me, how do you feel about breast implants? I say I would never offer something that I wouldn't have my family do.
My wife, sister. If any of them wanted breast implants, I would be completely fine with it. And I would have absolutely no trouble doing that. And I would never wreck recommend something to my patient that I wouldn't have one of my family members have. And that's how I feel about breast implants. Are they perfect devices by no means?
Are they perfect devices, but with the correct amount of information and knowledge, I think patients can make great choices about what they want.
[00:12:25] Dr. Salvatore Pacella: Excellent point, excellent point. So I just want to point out a couple of sentences here on the FDA document. FDA believes it's important for patients considering breast implants to have the information that they need for a balanced discussion with their physicians regarding the benefits and risks of breast implants.
To help ensure that patients have this information, a box warning, a patient decision checklist, and a patient information booklet brochure specific to the breast implants should be provided by manufacturers and given to patients prior to implement implementation. Now, again, I want to say we. In my practice have been doing this ever since I started practice in 2008.
So this is not anything new. It's just now on the radar of the FDA. And all three of us on this podcast are board certified plastic surgeons. We have a set of professional standards based on the American board of plastic surgery. In addition, All three of us are members of one of at least two or three societies across the world and the United States that ensure the highest level of safety.
And that is the gold standard for our practices. Breast implants are placed by not just plastic surgeons. They can be placed by so-called cosmetic surgeons who have very little training in breast implants. They can be placed by general surgeons. They can be placed by gynecologists and I, I'm not commenting on their surgical skill, but they are not held to the same standard as the rest of us are that are board certified and members of a professional society specifically for breast or for specifically for plastics.
So let's look at these label components here. So issue number one or recommendation number one is that each breast implant box will have a list on it. Okay. And the interesting thing about this, which doesn't make a ton of sense to me is patients really never see the box that their implant comes in.
Okay. So it doesn't make, it doesn't mean it doesn't make a ton of sense. Because those boxes, so when we talk about the sizes of implants, they're placed in the office, we decide on the office and we don't have. The actual box that we're going to give to the patient on their implant in the office, that's in the operating room.
By the time that's opened, the patients are asleep. So I imagine this will come with some sort of checklist that will be given to the patient. That's not exactly on the box, so to speak. Okay. So breast implants are not considered lifetime device. So there may be a chance in your lifetime that these may need to be replaced.
The chance of developing complications increases over time. And that is something that has been documented study after study in the literature. In fact, the longer you have implants in the more issues that can potentially be it infection, malposition, capsular, contracture, rupture. Some complications will require more surgery, absolutely critical.
And in fact, that's something I teach every single patient that comes into the office. That's considering breast implants. Breast implants have been associated with the development of cancer of the immune system called breast implant associated anaplastic, large cell lymphoma, BIA ALCL we've. We just discussed that, which occurs more commonly in patients with textured implants than smooth implants and deaths have occurred.
And this last comment hints at the breast implant associated illness issue that we discussed breast implants have been associated with systemic simple. Okay. So John's any comments on that?
[00:15:55] Dr. Sam Jejurikar: I think that's a great overview. I, the one thing I would echo is what Sam said. We have not just recently discovered something new or problematic about breast implants.
These are the same things that have been swirling in the, in the news for the last several years. I think this is a nice, comprehensive review. By the FDA, but I can't imagine a scenario in which any reputable plastic surgeon and one I've already had had these discussions with patients ahead of time or any informed patient will not know any of this stuff ahead of time as well.
I think that like Sal said I guess we could send the box home with the patient after. But it'd be pretty hard for them to return their implant at that point. So I'm not sure they've entirely thought this through. I also think that, when you think about other things that have block black box warnings on them like cigarettes, I think equating breast implants as being in the same category is somewhat misleading.
I would feel very comfortable with any member of my family getting breast implants. Some of them do. And and I've operated on many friends and they're not perfect. They're man-made devices with imperfections. They have risks associated with them. So it's great to highlight them. I think it's important that we take this in proper perspective.
[00:17:03] Dr. Salvatore Pacella: And I think, one of the, one of the important things here too, is the FDA is recommending that all patients go home or leave the procedure with a unique identifying card that gives a serial number and identification number of their implants. Should they have any issues? And this, again, we have been doing this.
Close to 30 years. Right. And so it's not anything new. And in fact, every single patient that leaves the operating room gets a little card and whether or not they keep it is problematic. But I think it's important really to understand that this information needs to be kept secure in a secure place.
It's like your vaccination card. You never know when you're gonna need it until you. And until you have it. So this card will have the devices, serial number, the style and size, the manufacturer, the unique device, identifying number and web linked to this specific box warning. So let's just go through a few more things here.
So we appendix say, we talked about this box warning, and then what I really want to spend some time on here is. Is this sort of checklist example that patients will have to go through in the office. And again, this is nothing dramatic and nothing new that we don't already talk about. If you are a plastic surgery board, certified provider, it, this is really the standard of care to discuss any of this ahead of time.
So again, it's not that the FDA is coming up with something new. It's just more. So patients will have to check a little consent form that says, I understand that I am not a candidate for breast implants. If I have any of the following situations, I have an active infection anywhere in my body and that.
Pretty intuitive. If you have an infection in a tooth somewhere or your dentist sorta nailed another tooth next to you and you have an infection Dr Jejurikar house.
You don't wanna have a breast him. You don't want to have a breast implant, obviously that can seed the body with infection and can cause more problems. Number two, I have an existing cancer or precancer of my breasts that has not been adequately treated. And so they're not saying that. If you have cancer, you can have breast implants.
It just needs to be fully treated. And of course, if I'm pregnant or nursing, not a good idea to proceed. Section number two here. I understand that if I have any of the following conditions, I may be at a higher risk for poor surgical outcome. Number one medical condition that affects my body and ability to heal such as diabetes or connective tissue disorder.
You're an active smoker or former smoker. You're taking medications that can weaken the immune system, such as chemotherapy, drugs, prednisone et cetera. You have a history of chemotherapy. So this is. Our breasts our breast patients that are breast cancer patients, or if you have a history of radiation therapy, and again, this goes without saying, this is a discussion we always have about the effects of radiation and chemotherapy on our breast cancer patients or other issues related to blood clotting that can lead to bleeding or hematoma during, or after the surgery, or any issues related to the blood supply of the.
And then of course some other issues related to breast implants, auto immune disease. If you have been diagnosed with a mental health disorder that can affect your body image, obviously, and that can affect your health in general. And then specifically the consent we'll go through and talk about various numbers of specific.
Related complications in breast implants. And I think this is a little bit more this is a bit more new and a little bit more precise than I think the consents we have in currently. And th this sort of goes through all of the potential complications based on existing evidence-based medicine and what each specific complications are accordingly.
So Jen's.
[00:20:39] Dr. Sam Jejurikar: Well, it doesn't look as though that list they're actually mentioned capsular contracture, which has interesting potential risks which is probably the risk I spend the most time talking to people about when we talk about breast implants. So that, that's interesting. I also think that the checklist is great.
If things that patients have to go. It seems like very little of it actually has to do with the actual black box warning. But it is something that is very helpful. And I think most of us are already flushed out as part of our routine history and physical with the patient ahead of time. I have no objection to patients going through this extra list.
That'll just ensure that we know more about them and they're better informed. I do think this is an interesting list of complications that could happen because it's far from comprehend. Yeah. Yeah. It looks very precise. So it almost gives the impression of being comprehensive. Right.
[00:21:25] Dr. Salvatore Pacella: I agree.
Very good. Yeah. And then finally, there's a segment on long-term risks associated with breast implants. So I think
[00:21:33] Dr. Sam Jejurikar: oh, that's where it is. I say, okay, you sent me up. Okay. 51, 51 0.7% of patients. Wow. Okay. Yeah. That's a high cap.
[00:21:42] Dr. Salvatore Pacella: So I think let me just stop sharing my screen. So in general I think, although this has made a substantial news, it it really is not changing much.
Our existing recommendation for breast implants or how we go about choosing who who is a candidate for breast implants. I think, we're all consider ourselves very comprehensive surgeons and informed consent is certainly at the top of our list. None of us work in these sort of so-called cosmetic chop shops, where we don't meet patients ahead of time.
And that's, that's unfortunately a a problem with. In our discipline where patients may not get the appropriate consent that they need ahead of time and the time to adjust some of that consent to, it's one thing if this assigned right before five seconds before surgery starts, but it's a whole nother thing.
If this has given a weeks ahead of time to patients, so they can do their own research
[00:22:31] Dr. Sam Jejurikar: here, here. Very good.
[00:22:32] Dr. Salvatore Pacella: All right, gents. Perfect. Well,
I think that's a time to sign off
[00:22:38] Dr. Sam Jejurikar: very much. So that was a, that was a great review of where we're at with breast implants these days. So thank you very much.
[00:22:44] Dr. Salvatore Pacella: Very good. Thank you guys. All right. We'll take care.
