Breaking Down the Breast Implant Black Box Warning

Announcer (00:07):
You're listening to The La Jolla Cosmetic Podcast.

Monique Ramsey (00:14):
Welcome everyone to The La Jolla Cosmetic Podcast. I'm your hostess, Monique Ramsey. And today we're welcoming Dr. Hector Salazar back to the podcast. We're going to be talking about breast implant safety. And Dr. Salazar is a bit of a safety superhero from what I understand. He graduated from the program where the silicone implant was invented, and he's part of the public education committee at ASPS, which is the Society of Plastic Surgeons and his role at the ASAPS, which is the Aesthetic Society, is on the patient safety committee. So welcome Dr. Salazar.

Dr. Hector Salazar (00:53):
Thank you so much. I'm really, really happy to talk to you as usual. And you know how excited I am about this podcast. I mean, it's a way of maintaining that close contact with our patients and with potential patients that are interested in procedures.

Monique Ramsey (1:06):
So tell us about this program. So when you were in the program that you trained in, you said the silicone implant was invented there. And so tell us about that.

Dr. Hector Salaza (1:17):
You're right. You're right. I trained in Houston at the program of the Methodist Hospital and St. Joseph Hospital. So it turns out that back in the 1960s, 1961 to be precise, Dr. Frank Gerow and Dr. Thomas Cronin were pioneers in creating the first breast implant. So they had this idea, and it was being done before their time was actually having different types of material injected into breasts, but just like not as an implant or what we now know as an implant. Apparently, they were taking call together one night at the hospital and it was a slow night. And then they're talking about this. And then all of a sudden they look at an IV sailing bag.

Monique Ramsey (02:06):
Oh.

Dr. Hector Salazar (02:07):
And it was actually Thomas Cronin who feels it and he says, "Well, this could be the answer." And they started being in Houston where there's a lot of oil industry and chemical industry and petrochemical industry. They started working and trying to find what was the ideal material to put in. And they came up with silicone finally. So that happened through 1960, 1961.

Dr. Hector Salazar (02:32):
And then what happened is that they created the breast implant. So now the problem was, "Who are we going to be using this first breast implant and who's going to be volunteering to undergo breast augmentation?" And when they were actually having that discussion, a nice young lady actually from Galveston, I mean her name is public, so it's Timmie Jean Lindsey, she walks into the office and she was asking to have one of her tattoos removed. She was coming to a plastic surgeon to talk about tattoo removal. And they said, "Well, we can remove the tattoo for free. Would you be interested in having or undergoing the breast augmentation with this new material called silicone and it's on a shell?" And she said, yes, but only if I can also get my ears pinned back, an otoplasty. So in exchange for that-

Monique Ramsey (03:24):
It's wheeling and dealing, I love it.

Dr. Hector Salazar (03:35):
Oh my God. In exchange for that. So it was a tattoo removal and an otoplasty and in exchange for allowing them to do a breast augmentation. As you know, now we have all these different protocols and the FDA and everything, all these different regulations. Back then, I mean, they could really reach an agreement with the patient directly and they did that first breast documentation. She was the mother of six kids. She had really, really deflated breasts. I mean, she was fascinated with the result. And then after that, the rest is history, right? Then it started becoming more and more popular. That's the first generation of breast implants. In The 1970s, the second generation. Then in the '90s, the third generation. And now we are in the fourth generation of breasts implants.

Monique Ramsey (04:11):
And your role in the patient safety committee at the Aesthetic Society is what? What do you do?

Dr. Hector Salazar (04:20):
So what we do, and pretty much as you were mentioning it on the Aesthetic Society, I'm part of the safety committee in the ASPS, the Society of Plastic Surgeons. I'm part of the public education committee. Those are, within our organizations, are plastic surgeons that are part of the organization that take a particular interest in a certain topic. And I would say that those two topics are of my prime interest. We meet several times a year and we discuss different safety issues, or how can we achieve or create material to educate the public opinion or future patients in a better way. So that's how I participate in those two groups.

Monique Ramsey (04:59):
So today's topic with breast implant safety, the reason we were inspired to bring this topic to the podcast is because Sientra, and they're a breast implant manufacturer, they recently released their annual consumer research. For the first time ever, the top concern for women who are considering breast implants for the first time was safety, instead of cost. So every other year they've been thinking about cost is kind of their main driver. Now they're starting to talk about safety. So why, Dr. Salazar, do you think that their top concerns shifted?

Dr. Hector Salazar (05:34):
The world that we are living in now is a world that is packed, is full of information and information that you can gain pretty easy access to. It's a matter of doing... It's not always going to be accurate, but it's very easy to access a lot of information, either you do a Google search, either you are on social media, either you belong to different groups of special interest. And all this information now, including cost, including safety, including potential complications or issues are available to the public. And what happens is, since I would say, for instance, pricing is something that's very, very transparent now... I mean, it's not a mystery of how much a breast documentation's going to be. You can click on the place where you want to go and get it and you're going to see how much is it. I feel that now patients are more and more getting involved more in the process off breast augmentation.

Dr. Hector Salazar (06:30):
Recently in 2019, there was this release of the FDA saying, "Well, we're going to put some black box warning in the implants." And again, even though they were always there, those risks have always existed, but now that the FDA says, "Why don't we make it more visible?", of course, that attracts the attention of everybody, including press and including social media. And then that's the reason why I feel that people are now paying more attention to those.

Monique Ramsey (06:59):
Why do you think the FDA was compelled to issue this warning?

Dr. Hector Salazar (07:05):
Well, I think the FDA, groups of patients, and including both societies, the Aesthetic Society of Plastic Surgeons, meaning plastic surgeons, the people that do the augmentations, and the industry have been working very, very close. All four entities. And that decision was a joint decision. Everything that we can do in favor of more and more educated decisions being made by patients is beneficial. So it was not a unilateral decision. It was something that was actually, that everybody participated in a one way or the other. And us as plastic surgeon, as part of the society, we're investing actually money into studies to better understand some of the topics that we're going to be talking about today.

Monique Ramsey (07:52):
So I keep hearing it called a black box warning. Is there actually a scary black box around the package? Or is that just a term?

Dr. Hector Salazar (07:59):
No, no, there's a black box. It is not all black. I mean, it's a black frame box. But yeah, it says warning. And then they basically talk, or it's motivated, by two basic entities or two main things that are happening in two hot topics and plastic surgery. And it's related to ALCL and what the so-called BII or breast implant illness. So I'm pretty sure you're going to want to know more about this. So I'll let you lead in that sense. But that's basically what motivated this black box.

Monique Ramsey (08:34):
So the actual FDA order says that they issued these orders to help ensure that patients who are considering having breast implants are provided with adequate risk information, so they can make a fully informed decision. This is something that's near and dear to us at La Jolla Cosmetic, making informed decisions is that's what informed consent is. So I feel like that's something that we've always done with our patients. When somebody comes to you for a breast augmentation consult, you're going through a lot of the risks, what could happen, like different checklist of things that you're going to talk about whether there was an FDA warning or not, right?

Dr. Hector Salazar (09:18):
Correct. It's something that we were doing on a routine basis. And as you know, Monique, at La Jolla cosmetic, there's also some story behind pioneering informed consent and doing it in an electronic way. And it's something that we've always done as you're correctly saying, but in reality, the FDA and the societies really, really wanted to emphasize that for doctors and patients, try to stimulate somehow for everybody to be talking about all those different points that patients need to make an informed decision.

Monique Ramsey (09:51):
Mm-hmm. And I found that along with that warning, the FDA requires some other things, like one is a patient decision checklist. They're very elegant. They're very clear, easy to understand so that you can then be thinking on your own, like, "Here are the things that I want to make sure I understand before proceeding." And good talking points for your doctor. And so does that conversation usually happen at the consult or at the pre-op? Or when does informed consent happen?

Dr. Hector Salazar (10:19):
Both, during the consultation and during the pre-operative visit. And again, as you know, when we see our patients at the morning of surgery even, we spend a good amount of time with them of about like 20, 25 minutes still doing and placing those markings and answering kind of last minute questions. And again, that's another opportunity. The more opportunities we can have of touching base with our patients before surgery, or even during a second consultation sometimes, the better.

Dr. Hector Salazar (10:44):
Yeah. As you're saying, this is number one. And one thing that I want to be very clear here is that breast implants are safe. As doctors, we wouldn't be implanting devices on patients that have not been proving, that are not approved by the FDA, that are experimental. I mean, again, we're not back in the 1960s like those pioneers that, yeah, they developed this, but at that point it was more of an experimental procedure. So they are safe. There are potential risks and potential complications. I mean, would you say, is flying an aircraft, is that safe? Right? I mean, yeah, it's safe. I mean, can accidents happen? Yes, but overall, it's a very safe procedure. I want to be clear on that. And then from there, start talking about this rare events or rare potential complications.

Monique Ramsey (11:32):
First, what I'd like to do is unpack the actual warning message first that is on the "box". It's short and there's just three bullet points, and I'll read them. The first one says, "Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications. Some of which will require more surgery." So do you find that most patients are already... oh, I mean, it seems sort of obvious. It's not going to last forever. But when patients come in, what do they think about that implant?

Dr. Hector Salazar (12:06):
This is a great question because implants are man made objects, right? Everything that we do in this world that it's not created by nature, it's something that it's a man made device. Can it rupture? Can it fail? Will it last forever? So the absolute answer to those questions is no, it's not going to last forever. Yes, it can rupture. Yes, it can fail. Right? Because that's what we do. It's imperfection. But for some reason, patients have this idea that if you get breast implants, they're going to stay with you forever. That they're going to be permanent devices. So it's something that I would say there's a little bit of that misconception. I always tell them that they're manmade objects.

Dr. Hector Salazar (12:50):
And just think about something that it's a man-made object. Sometimes even I talk about a refrigerator. You purchase a refrigerator, it's a big device, it's a manmade object. And that refrigerator it's going to be with you for a long time, but it's not forever, right? At some point, you're going to need to change that. It comes with a 10 year warranty. If it's year 11 or 12, do you have to change it? Well, it's probably not going to be working the same way that it was working before.

Dr. Hector Salazar (13:19):
We don't think about breast implants as an iPhone, right?

Dr. Hector Salazar (13:22):
I mean, you purchase one iPhone, you purchase a pair of implants. Is that going to be the last iPhone you're going to purchase? No. The breast implants, is that going to be the last pair you're going to purchase? Most likely not, especially if you're getting an augmentation when you're young, when you're 24. So no, they're not forever. The FDA recommends that after 10 years of you having those breast implants, that you go and get them exchanged. At the same time, I tell patients, "Can you imagine that at year 10 and one day the implants are going to start magically dissolving inside of you?" So the absolute answer to that is no. So it's not that, "Oh my God, I have a trip planned but I going to cancel it because it's now 10 years and two days, and I'm going to run. So no, absolutely not. But that's what the FDA recommends. And you'll see. I tell patients, you'll see that most likely around year 10, 15, changes happen in life and then you probably want to get them exchange because you want to have something else done to your breasts.

Monique Ramsey (14:22):
Since they mentioned that you could be having complications, what kind of complications might they be referring to?

Dr. Hector Salazar (14:29):
Let's start with the obvious, such as a ruptured implant.

Monique Ramsey (14:32):
Okay.

Dr. Hector Salazar(14:33):
Or an implant malposition, so the implant is not sitting where it used to be sitting. Or another potential complication it's that the implant flips. It can flip from, the front part of the implant can go to the back and vice versa. Another potential complication is that the implant gets encapsulated, gets surrounded by tissue that the body creates to "defend you" from the implant. And then that tissue that gets in the encapsulation starts squeezing the implant and makes it hard. So those could be some complications or some things that patient can be experiencing with implants that can happen. And if that's happening and you're operating for that, then it's a good time to change those implants.

Monique Ramsey (15:14):
Now, how common are complications? Like, you're a first time breast aug patient? Is it able to be expressed in a percentage like maybe about 10%?

Dr. Hector Salazar (15:27):
That's a good question because they're breast implant studies, they're multiple, and then there's a big range of numbers. But as you're correctly saying, I mean, more or less, you're talking about anywhere from 10 to 20% of patients that can experience in the first 10, 15 years some complications.

Monique Ramsey (15:43):
And do most people, if they were to experience let's say a capsular contracture, does it happen right away? Or does this happen much later?

Dr. Hector Salazar (15:50):
Well, I would say that it can happen at any point, but the longer the time, like for instance the longer that the implant has been in, the higher chances of developing this or that, or either a rupture or a failure or a malposition or a capsular contracture.

Monique Ramsey (16:08):
Now, if somebody was thinking, "Well, gosh, I have implants. I might be having a complication," I'm assuming the first person they go to is their surgeon. And what do you do in that case?

Dr. Hector Salazar (16:19):
Right, as you're saying the ideal world to come back to their surgeon. For instance, in my particular case and in our center, patients know that they have the doors open to come back. That's something that's important because what I normally do is I see my patients, well, the day after surgery, one week after, three weeks, six weeks, three months, six months in a year. And then after that, I invite them every single year to come for a follow up appointment. And of course that follow up appointment, it's a courtesy follow up appointment. We not only say hi and make sure that they know exactly what's going in our professional life and how is it going in their personal life because we become very close with them, but of course we are going to be focusing on different FDA recommendations. What are the updates? What are the different things that we have to be looking for and even how to monitor their implants. And we can talk about that as well.

Monique Ramsey (17:16):
Correct me if I'm wrong, but I think we have a special machine, a special ultrasound machine that's specifically for looking at breast implants in-

Dr. Hector Salazar (17:26):
That's right.

Monique Ramsey (17:27):
And so tell us about that.

Dr. Hector Salazar (17:29):
Yeah. So the FDA recommends an MRI and/or a high definition ultrasound now. So the recommendations have changed lately. In the past, the FDA would recommend an MRI after three years that you had your implants placed in. So now the recommendation is either an MRI or a high definition ultrasound. And now the recommendation moved from three years to five years, okay? And then after that, every other year, you still come and get that study to just make sure that the shell of the implant is intact. Now what happens is that the MRI, if it's for just pure monitoring and surveillance of the implant, no insurance company would cover for that MRI.

Monique Ramsey (18:25):
Oh, because it's the cosmetic implant they chose to have.

Dr. Hector Salazar (18:):
Exactly, it's not that-

Monique Ramsey (18:32):
And you're like, "Hey, how's it doing?"

Dr. Hector Salazar (18:33):
Nature did not develop those beautiful breasts. And that's what happened. So what they say is like, "No, no, this is not going to be covered." So then patients would have to pay out of pocket for that. And the cost is significantly high. We're talking in the range of $2,500, $3,000 for an out of pocket MRI. And that makes it a little bit prohibitive for certain patients. Because if you think about it after two or three of those MRIs, you already have a new pair of implants, right? I mean...

Monique Ramsey (19:02):
Right. True.

Dr. Hector Salazar (19:03):
So what happens is that as an alternative, the high definition ultrasound is a good technology. It's a technology that allows to monitor that implant shell. We perform those studies on our patients in our clinic. And then it takes like 25 minutes away from their life, but gives them good reassurance if we see integrity there.

Monique Ramsey (19:23):
Yeah. And then is there any way that you might suggest a patient plans ahead for replacement? Or is it more when you think you might need it and you go to your doctor? Or should they be thinking, "Well, in 12 year I should be saving 500 bucks every year for the next X amount of years." How do you recommend patients deal with that?

Dr. Hector Salazar (19:44):
No, we're pretty serious about the FDA recommendations and we tell them, right? We tell them upfront, the FDA recommends after 10 years to have it exchanged. And that's actually official recommendation.

Monique Ramsey (19:56):
Well, I would think that let's say you're 22 years old and you get your breast implants, and now you're 37 years old. You've had a couple kids. It's been 10 years or more. And now you might be thinking, "Okay, I want them smaller, bigger or lifted." There's kind of that mommy makeover is sort of a next step. So it's sort of like, you might be changing them anyway for your own reasons, not just because it's been more than 10 years.

Dr. Hector Salazar (20:22):
That's absolutely right.

Monique Ramsey (20:25):
So the second bullet from the FDA sounds a little more concerning. So here we go. Here's what it says. "Breast implants have been associated with the development of a cancer in the immune system called breast implant associated anaplastic large cell lymphoma, which is also BIA-ALCL, which is a lot easier. This cancer occurs more commonly in patients with textured breast implants than smooth implants. Although rates are not well defined, some patients have died from BIA-ALCL." So my first question is how do they know that the implant caused the cancer?

Dr. Hector Salazar (21:04):
Hmm. Your questions are very, very sharp always and I like it. Because yeah, they were seeing this type of very rare, extremely rare type of lymphoma. And by the way, it's a non aggressive type of lymphoma, right? But it can be related to death. Yeah, there have been like a total of 36 deaths since they started placing the implants. And you're talking about millions and millions of implants, right? But how can they associated that? We knew about that entity ACL, anaplastic large cell lymphoma. But until 2011, it was not directly related to the implants. So starting in 2011, that relationship was established. And we're talking about a total number of 733 cases in the world. In the world. Half of which are around 330 something in the United States. And the reason is, "Oh, we take 50% of the entire implant placement?" No, the thing is that we're better at monitoring and diagnosing and reporting than other countries. And that's the reason why we have that data a little fresher or our number might seem to be like a little higher in relationship to the rest of the world.

Dr. Hector Salazar (22:29):
But you're talking about something that it's a very, very rare event, because again, we're talking since 1960s, a 733 cases.

Monique Ramsey (22:41):
Right. Right. So when you say very rare, you really mean very, very rare.

Dr. Hector Salazar (22:46):
It's something that, do we have to mention? Do we have to talk about it? Absolutely. Absolutely. But comparing it to the airline industry, right? I mean, if you compare the number of flights that take place every day and how many days we have no incidents and how many days we have no accidents, I mean, it's a really, really low number compared to a very high number of surgeries of augmentations.

Monique Ramsey (23:10):
So first of all, what kind of implants do we use? And it said here that it occurs more commonly in patients with textured implants than smooth. Do you use textured implants?

Dr. Hector Salazar (23:21):
I don't. So I don't use textured implants. But almost all cases are related to textured implants. Some of the cases where they couldn't establish a relationship to textured implants, the patients had either there was no information. So they couldn't know if it was a texture or a smooth because there was no information documented. Some cases in which they found it with smooth implants, they said like, "Oh, ALCL with a smooth implant. Here you go. There was an a... Oh, give me a second. The patient had textured implants in the past."

Monique Ramsey (24:02):
Oh.

Dr. Hector Salazar (24:03):
So even though we cannot rule out this from smooth implants, but most of the time has been associated with textured implants. As they say in shark tank, "And for that reason, I'm out." No. So textured implants are safe devices as well. Again, we're sticking to the FDA recommendations here. There was a specific type of textured implant that was coming from a specific company that was removed from the market. There was a call back on that and the company responded pretty well and said, "Take it out and we'll give you a fresh pair of implants." Smooth, of course. There are surgeons that use texture implants and there's nothing wrong with that. But in my particular case, I'll rather not have to do with texture implants, even though it's extremely rare as we are talking about.

Monique Ramsey (24:56):
Right. And what's the difference or why is textured indicated or why might it be indicated in some cases versus smooth? Does it keep it where it is more because it's sticky?

Dr. Hector Salazar (25:10):
Right.

Monique Ramsey ):
Or what's the...

Dr. Hector Salazar (25:11):
Yeah. So smooth implant... I mean, if you closed your eyes, I mean, Monique, you have seen implants, but our audience, probably not everybody. When they come to the office, they get to see them. And not only see them, touch them and also compare and be able to see, "Oh, this is what texture looks like. This is what smooth looks like." Imagine that the implant was sprinkled with some sugar powder or something like that around the implant. And actually it's a little rough. And what that roughness creates, it creates two things. One, a little bit of friction, and two, causes the tissue of the patient to a little bit embrace the implant, to in grow into the outer surface of the implant. So it holds it in place. So it doesn't move down or it doesn't move to the side. And that's the "advantage" of textured implants. That's why textured implants exist because they allow you to hold the implant against the body like a Velcro patch. So that's kind of how that works.

Monique Ramsey (26:05):
Now how would if something was happening to you? Like again, 300 people out of... Let's call it even 400 people out of 60 years. But if somebody was worried and they have implants in now and they were worried that something's going on, would a mammogram catch it? Or how would they know if there was any visible, I guess, indication?

Dr. Hector Salazar (26:32):
For ALCL for that rare type of lymphoma, let's talk about the classic case presentation. So it's a patient that had, let's say breast augmentation with textured implants, and it happened a long time ago. It tends to be like 10 or 15 years or 20 years ago. The patient was very happy with her implants. No pain. Nothing. Everything was fine. And then after that period of time, then all of a sudden she starts noticing that one breast is bigger than the other, but significantly bigger. And then over the course of the next weeks, it keeps kind of growing. And then the first thing, as you were saying, first thing what's going to happen is she's going to go to either her primary care doctor or ideally to the plan back to the plastic surgeon right away or her gynecologist. And then the next step would be to do an image study on that breast.

Dr. Hector Salazar (27:24):
So to clarify, this ALCL weird lymphoma, we are not talking about breast cancer, which is like adenocarcinoma of the breast. It has nothing to do with breast cancer, what we know or think as breast cancer. So the ideal study to start studying this cancer, this lymphoma, is to do an ultrasound. And then what you're going to find, the reason why one breast is bigger than the other is because there're going to be some fluid, some liquid around the implant that your body kind of created. So you get a sample of that fluid. They introduce a little needle, the interventional radiologist, and then they study that fluid. And then boom, voila, you find that ALCL.

Dr. Hector Salazar (28:09):
But the most common is a little bit discomfort, a little bit of pain, but the main reason is because of the presence of that water that you have around the implant. And what's swimming in that water are those rare lymphoma cells. What's the treatment for that? So the treatment for that is to go ahead, remove the capsule, remove the implant. And then plus/minus, of course when you have a case like this, you want to have a general surgeon involved. You want to have an oncologist involved because it might require maybe it's only removing the capsule, removing the implant, or it could be removing the capsule, removing the implant, and maybe some other therapies like chemotherapy or some radiation that would be determined by the oncology team.

Monique Ramsey (28:55):
So the third bullet from the FDA says, "Patients receiving breast implants have reported a variety of systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement." So what's going on here? What does that mean? And have you seen it yourself?

Dr. Hector Salazar (29:26):
Yeah, no, absolutely. I've seen patients with those complaints. So right now in social media and the internet, Google, et cetera, you're going to find this entity called BII or breast implant illness or generalized illness or unexplained systemic symptoms associated to implants. When doctors talk about certain disease, such as we were talking about breast cancer, or we were talking about ALCL, or you talk about flu, or you talk about chickenpox, So when you talk about diagnoses, those diagnoses are well established, are well described. And actually, the World Health Organization actually approves them and they say, "This is an entity. This is a disease."

Dr. Hector Salazar (30:14):
But breast implant illness, it is not a disease. It is not a well-established diagnosis. I'm not saying that patients don't have symptoms, but what I'm saying is that you cannot place or document the diagnosis of breast implant illness on a patient because that diagnosis has not been coined and doesn't exist as it is. And the reason for that is because two things. In order for you to be able to describe a disease, you have to find a cost and a bunch of symptoms that are specific to that disease, right? I mean, if I tell you chickenpox, you can close your eyes and you can tell me, "Oh, let me tell you what happens in chicken pox, right?"

Monique Ramsey (30:54):
Uh-huh.

Dr. Hector Salazar (30:55):
But if you talk about breast implant illness, you get more than 45, 50 different symptoms that can go anywhere from, "I feel sick," to "I have low libido," to "I have acid reflux," to "I have migraine," to "I have gain weight." So it's really difficult to get those symptoms, bunched them up and then associate them directly to the breast implant. And right now the Society of Plastic Surgeons and the Aesthetic Society, we're actually paying attention to all these symptoms, listening to all these patients because we want to make sure that we don't miss anything.

Dr. Hector Salazar (31:35):
So if a patient is telling me about all these different symptoms and if she's sitting in front of me in the office, she's taking time out of her life, it's not in her imagination. She's feeling all these things and she's sitting in front of me. And the classic thing that has happened before they're sitting in front of you is that they have been to their primary care doctor or they have been to their internal medicine doctor and sometimes they have been referred to a specialist and they've been looking for an answer they can't find a real cost for that or something that they could say like, "Oh, I'm sorry, but I got all the tests that I normally do for joint pain and I don't see any other thing." So it's important for us to listen to what they have to say, to dedicate a time and then to talk about that potential removal of the implant and what it implies.

Dr. Hector Salazar (32:24):
One thing, Monique, and let me go over the top six symptoms that were reported and are "associated" to this BII. So number one is fatigue. Number two is brain fog. Number three is joint pain in different areas. The next one is anxiety. Another one is hair loss. And then number six is depression. And just for you to see enormous variety of symptoms and some of the complaints such as like for instance, brain fog, let's say we've all experienced that, right? But again, brain fog is also not a medical diagnosis or anything, but we've all had it. So that's why I'm telling you, we never dismissed these patients. We always listen to their complaints. And if they want to have their implants removed because they truly feel that they're causing the symptoms, we can. We cannot assure them that the symptoms are going to resolve, but we are here to assist them.

Monique Ramsey (33:27):
So the last requirements outside of the boxed warning were these things, "A patient decision checklist, updated screening recommendations for silicone gel implants, a list of specific materials in the implant and the device card." So what is that patient decision checklist? Have you seen that?

Dr. Hector Salazar (33:47):
Oh, no, absolutely. We've seen it and we have it in the office. That breast implant patient decision checklist, it's a document that it's important that patients review. I mean, they review it with their surgeon. And basically what that list goes through is pretty much what we've been talking about right now. And then you go ahead and you sign it. And also the surgeon signs that together with the patient. Oh, you were mentioning a breast implant card.

Monique Ramsey (34:15):
Uh-huh. The device card. What's the-

Dr. Hector Salazar (34:16):
The device card.

Monique Ramsey (34:18):
So what's the purpose of that?

Dr. Hector Salazar (34:19):
So that card is really, really important for the patient to know exactly what device they have. Because it has a serial number. It has a product number. And it's important for them, again, not to have them in their wallet of course, but to keep them next to their, I don't know, social security card, right? I mean, you never carry that one around, but you have it. The other thing is now there's something that's called a National Breast Implant Registry. And that's also something that American Society of Plastic Surgeons is promoting a ton and that we do participate on that. What that is literally what its name says. It's a national registry of all patient and the implant that the patient has.

Monique Ramsey (35:00):
Okay. Well, that makes sense. So if you're listening and want to explore all the resources that we've mentioned here, check the show notes for links because we'll have everything there. The patient safety checklists are PDFs, which are meant for patients considering breast implants. Those are linked in the show notes for you as well for Sientra and Natrelle, which are the implants we primarily use at La Jolla Cosmetic. And you can also find the FDA announcement and any data mentioned on this episode.

Monique Ramsey (35:28):
So Dr. Salazar, final question. Get ready. We've covered a lot of ground here, and I want to simply ask your opinion as if I were a patient considering breast augmentation for the first time. Are breast implants safe?

Dr. Hector Salazar (35:41):
Yes. The absolute answer is yes, 100% they're safe. But as in any other thing, I mean in life, remember, I mean, after I finished the podcast, I'm going to hop in my car and I'm going to be driving home. So, I mean, I said safe. Yes, it's absolutely safe. Can there be some problems, some issues with any device with any activity that you do in life? Yes. As long as I understand them and as long as I know what I can expect, then you have made an educated decision and then it's the right thing to do. So absolutely. Yes, they're safe devices.

Monique Ramsey (36:16):
This has been so enlightening. Really good time exploring this subject in depth. And I hope that for you, the audience, anybody who's been thinking about maybe a breast augmentation or even if you have breast implants, you're thinking about, "Do I need to switch them?" It's important that we address all this very transparently, because like you say, the Internet's full of all kinds of information. Some of it good, some of it less good. And so we really want to bring you the best information from experts who know and who are going to be honest. And so I think it's wonderful that you are able to spend some time with us today, Dr. Salazar. And we look forward to having you again on the next podcast.

Dr. Hector Salazar (37:01):
Very good. Thanks so much, Monique. And thanks La Jolla Cosmetic for inviting me again.

Speaker 1(37:10):
Take a screenshot of this podcast episode with your phone and show it at your consultation or appointment, or mention the promo code PODCAST to receive $25 off any service or product of $50 or more at La Jolla Cosmetic. La Jolla Cosmetic is located just off the I-5 San Diego Freeway in the Ximed building on the Scripps Memorial Hospital campus. To learn more, go to ljcsc.com or follow the team on Instagram at LJCSC. The La Jolla Cosmetic Podcast is a production of The Axis, the axis.io.