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    Dallas Texas Surgeon Podcast: New FDA Guidelines for Breast Implants

    Dr. Sam Rhee: Alright, welcome to another episode of 3 Plastic Surgeons and a Microphone with my two favorite plastic surgeons, Dr. Sam Jejurikar out 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 will 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 discussion, always seek the advice of your surgeon or another 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, Sal, I’ll have you bring us up to speed about what’s going on.

    Dr. Salvatore Pacella:  Hi, gents. How are you all doing today?

    Dr. Sam Rhee: Doing great!

    Dr. Sam Jejurikar: I’m awesome! How are you?

    The Black Box Warning Explained

    Dr. Salvatore Pacella:  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. 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 silicone scare in the 1990s.

    And we’re recently seeing kind of a push from patients and the FDA for better information and 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 are also several informational pieces that I want to go over that are going to be important for patients to understand during their consent process. So I’m going to share my screen here for a second. How about that? Yes. So it’s a PDF document I’m scrolling.

    So if you’d like, a copy of this is actually posted on the website. All you need to really search is a black box warning breast implants at, 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 specific problems, most notably an issue related to 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 textured 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 lymphoma. But in general, if you have a patient with this type of lymphoma, it’s easily treatable by doing what we call complete capsulectomy or removal of the breast implant shell. Gents, have any of you had any patients with breast implant-associated lymphoma?

    Dr. Sam Jejurikar: I’ve had two that I’ve taken care of.

    Dr. Sam Rhee: I haven’t had any.

    Dr. Sam Jejurikar: Sorry, Sal, just out of curiosity before we get to that, what’s the incidence, like, how many cases of breast implant-associated lymphoma have been seen worldwide? And how would you compare and contrast that to just traditional breast cancer that women are after getting? Is it as common as that? Because I think patients will ask us these questions oftentimes, and they’re shocked by the actual incidence of the two.

    Dr. Salvatore Pacella: Yeah, absolutely. Exceptionally rare. Okay, so if you look at all comers, all patients, all women with breast cancer, traditional breast cancer, the risk of developing breast cancer in someone’s lifetime is about one in eight. So an exceptionally high number. The risk of developing breast implant-associated lymphoma with textured implants in place is at the highest risk for one particular company 1:2. I believe the last number I saw was 1 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 1 in 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 breast implant and lymphoma, it doesn’t matter what all the other patients are doing, and you’re the one that has it.

    Dr. Sam Rhee: And Sal, can you clarify to me, are these textured implants still on the market at this point?

    Dr. Salvatore Pacella: No, many of them have been recalled from specific companies. I don’t want to get into really which companies or which, because some of that’s a little bit controversial, but the type, the implant texture that has been most implicated, where there was an 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 cannot still get textured devices. You can get textured devices, but just not one specific type of texturing that has been implicated in this type of problem.

    Dr. Sam Jejurikar: So going back to your question, yeah, that did for sure. The two patients that I have seen both presented years after their surgery. Both had been 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 Sal is actually referring to.

    They both presented with one-sided swelling that was asymmetric. And there are not a lot of things that cause asymmetric swelling years after breast augmentation. There’s a phenomenon that we refer to as a double capsule where sometimes someone will get the flu. So the bottom line is both patients got sent for cytology, where they went to see a radiologist, and they got fluid withdrawn. They showed this particular type of non-Hodgkin lymphoma.

    So the treatment in that situation was to do what’s called an on-block 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. The 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 most of the time, that’s all you need.

    Dr. Salvatore Pacella: People will need it, 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 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 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 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 that they didn’t create this boxed warning just simply because of breast implant-associated lymphoma. They’ve created it for other reasons too. We have a sort of controversial disease in plastic surgery called breast implant-associated illness. There is a subset of women that oftentimes have issues related to systemic systems symptoms related to their breast implants.

    We don’t, unfortunately, have a lot of good data on that, but 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 the 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, or 15 years, women may not really anticipate this or understand the complications of having an implant long term.

    And 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 jets, maybe you want to comment a little bit.

    Patient Checklist for Informed Consent

    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 intent for a practice that takes care of hundreds, even thousands of patients with breast implant illness, where he has mastered the on-block 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 think your practice does a great job of informing patients, but even the American Society of Plastic Surgeons and their standard consent also forms that I use in my practice, and you guys may as well cover this in 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 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.

    Dr. Sam Rhee: Yeah, I agree. I feel that this is a good step for the FDA just to standardize what I think most 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 illness 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 they are 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 be 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, mother, 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 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 to do.

    Dr. Salvatore Pacella: Excellent point. So I just want to point out a couple of sentences here in the FDA documents. 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 boxed 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 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.

    Now, 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’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 breasts or specifically for plastic. 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? It doesn’t make a ton of sense because of 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. So breast implants are not considered lifetime devices, 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, the more issues there can potentially be. It infection, malposition, capsuler, contracture, rupture, etc.

    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 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 symptoms. So Jej, any comments on that?

    Evaluating the Pros and Cons of Breast Implants

    Dr. Sam Jejurikar: I think that’s a great overview. 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 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 will have already 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, as Sal said, I guess we could send the box home with the patient after surgery, 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 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 I’ve operated on many friends, and they’re not perfect. Their manmade devices have been perfections. 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, though.

    Dr. Salvatore Pacella: And I think 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. Again, we have been doing this for 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 going to need it until you have it. So this card will have the device’s serial number, the style and size, the manufacturer, the unique device identifying number, and a web link to this specific boxed warning. So let’s just go through a few more things here. So, in Appendix A, we talked about this box warning, and then what I really want to spend some time on here 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, 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 visible. 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’s pretty intuitive.

    If you have an infection in a tooth somewhere, or your dentist sort of nailed another tooth next to you, and you have an infection. Dr. Jejurikar, you don’t want to have a breast implant. 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 pre-cancer of my breast 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 perceive.

    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 outcomes. Number one, medical condition that affects my body and ability to heal, such as diabetes or conductive 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, etc. You have a history of chemotherapy. So this is 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, 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 them. And then, of course, some other issues related to breast implants, autoimmune 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, then specifically, the consent will go through and talk about various numbers of specifically related complications in breast implants. And I think this is a bit newer and a little bit more precise than I think the consents we have currently and this sort of goes through all the potential complications based on existing evidence-based medicine and what each specific complications are accordingly. So Jej comments on that.

    Long-term Risks and Capsular Contracture

    Dr. Sam Jejurikar: Well, it doesn’t look as though that list there actually mentions capsular contractors, which is interesting, of potential risks, which is probably the risk I spend the most time talking to people about when we talk about breast implants. So that’s interesting. I also think that the checklist is great for things that patients have to go through. 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 already flush 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. It’ll just ensure that we know more about them and that they are better informed. I do think this is an interesting list of complications that could happen because it’s far from comprehensive, yet it looks very precise, so it almost gives the impression of being comprehensive.

    Dr. Salvatore Pacella: Right.

    Dr. Sam Rhee:  Agree. Very good!

    Dr. Salvatore Pacella: And then, finally, there’s a segment on long-term risks associated with breast implants.

    Dr. Sam Jejurikar: Oh, that’s where it is. I see. Okay. Yeah, you set me up. Okay. 51.7% of patients. Wow.

    Dr. Salvatore Pacella: Yeah!

    Dr. Sam Jejurikar: Yeah, that’s a high capital.

    Dr. Salvatore Pacella: Let me stop sharing my screen. So, in general, I think, although this has made substantial news, it really is not changing much of our existing recommendation for breast implants or how we go about choosing who is a candidate for breast implants. I think we all consider ourselves very comprehensive surgeons and informed consent is certainly at the top of our list.

    None of us work in these sorts of so-called cosmetic chop shops where we don’t meet patients ahead of time. And that’s, unfortunately, a problem in our discipline where patients may not get the appropriate consent that they need ahead of time and the time to digest some of that consent, too. It’s one thing if this is signed right 5 seconds before surgery starts, but it’s a whole other thing if this is given weeks ahead of time to patients so they can do their own research.

    Dr. Sam Jejurikar: Perfect!

    Dr. Sam Rhee:  Very good!

    Dr. Salvatore Pacella: Alright, gents. Well, I think that’s a time to sign off.

    Dr. Sam Rhee: Very much, Sal!

    Dr. Sam Jejurikar: That was a great review of where we’re at with breast implants these days. So thank you very much!

    Dr. Sam Rhee: Very good. Thank you very much, guys!

    Dr. Salvatore Pacella: Alright, take care. Bye!



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