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Interviewer: In spring of 2022, there were some headlines going around almost every news outlet saying that the FDA had finally approved a new weight loss drug, one that would promised 10% to 25% weight loss with little more than just a weekly injection. The drug is called tirzepatide, or a brand name Mounjaro.

Now, it seems a little too good to be true. So, today, we're going to be looking at what exactly is the drug and what can it actually do for weight management.

Joining us today is Juliana Simonetti. She is the medical co-director of the Comprehensive Weight Management Program at U of U Health. So she knows a thing or two about weight management.

Dr. Simonetti, thank you so much for joining us.

Dr. Simonetti: Yes. Thank you so much for having me here today. I'm very excited to be talking about this new drug.

Interviewer: So why don't we start there? What is tirzepatide and what does it do to the body?

Dr. Simonetti: I'll start by just telling a short story. I was at an endocrine meeting in California two weeks ago when this drug got approved by the FDA for the treatment of diabetes. And we were doing a lecture, and all of a sudden, everyone started clapping and announced that this drug had been approved by the FDA for the treatment of the diabetes. So that's the kind of excitement we're getting with this drug.

It is a new class of medication for the treatment . . . Currently, it's only approved for the treatment of diabetes. However, we have seen really significant amounts of weight loss with the medication, and they are doing clinical trials at this point, and they have the results of the clinical trial for the treatment of obesity with this drug as well.

Tirzepatide is unique in the sense that is a dual incretin medication. It attaches to two different receptors. So we have a class of medication that has been in the market now for about 15 years called GLP-1 receptor agonist. And some of the drugs I think are well known at this point, both for diabetes and for weight loss. All those drugs were initially developed for the treatment of diabetes, and then they found that they led to significant amounts of weight loss.

So some of the drugs currently on the market that are GLP-1 receptor agonists are Victoza, Ozempic, Trulicity, and those drugs really have revolutionized the treatment of diabetes in the sense that they bind to receptors in our body that stimulates our own pancreas to produce insulin. And at the same time, they cross the receptors in our brain and tell us that we're full.

Therefore, when you start eating, you feel fuller sooner. It leads to induced satiety, so therefore people eat less, and it promotes the release of our own insulin so you have better glucose control, better sugar control for the treatment of diabetes. And we have this induced satiety that leads to people eating less, feeling fuller, and therefore losing significant amounts of weight.

Interviewer: So tirzepatide has been approved by the FDA to help manage and treat types of diabetes. But there's a lot of evidence in their, I guess, Phase 3 trials that are showing real potential to help with weight loss. What are they finding?

Dr. Simonetti: That's right. So their clinical trials for diabetes show . . . for those participants that had diabetes, it led to a significant amount of weight loss. And so they also then did clinical trials for this medication for those without diabetes for the treatment of obesity.

And what they found is that they highest dose of the medication, which is 15 milligrams, can reduce body weight on average by 28.4 pounds, which is nearly about 14% of the total body weight. So, for someone that weighs about 200 pounds, they will lose on average of about 28 pounds on this medication, which is really, really significant.

Interviewer: Wow. That sounds like a lot of weight loss for people without diabetes, but what does it do for people who do have type 2 diabetes? What kind of results have they been seeing with them?

Dr. Simonetti: Yeah, the results, it's really interesting because the results for those with type 2 diabetes, on the highest dose, show that those participants lost almost 21% of their total amount of weight, which is really, really impressive. This is more than anything else, any other medication we currently have in the market.

Interviewer: So if I get this correct, there are other . . . I've seen other drugs out there that fill your stomach up, the Plenity or whatever it's called, or they claim to impact your metabolic system, etc., but this drug actually impacts your pancreas in a way to help with glucose levels and help suppress hunger.

Dr. Simonetti: Yes. So the class of medication I was talking about is the GLP-1 receptor agonists that already exist that have been in the market now for about 15 years. The newer ones, one of them being semaglutide, or the other name is Ozempic, has been the latest.

They also got approved for the treatment of obesity and leads to very significant amounts of weight loss and improvement in the sugars in our blood because it stimulates the pancreas to release insulin and tells our brain . . . So it works on the appetite centers of the brain.

The difference between some of these drugs and what you're talking about, Plenity . . . So Plenity is considered a device because it's three capsules that kind of inflate in your stomach and therefore makes you feel fuller, so you have the physical sensation of fullness. However, the GLP-1 receptor agonists work in your brain and in the appetite centers of the brain. It works in the brain to tell you that you're full, so you don't have those cravings and then sensation that you wanted to keep on eating. It really leads to the feeling of feeling fuller.

With tirzepatide, why this is so exciting and different is that this not only works with the GLP-1 receptors, but also works in another receptor called GIP, which is a glucose-dependent insulinotropic peptide. It's a mouthful, but it's really another hormone in our body that is usually . . .

Both of those hormones are released in response to us eating food. So when I eat carbs or sugar, it goes in my stomach and then reaches my stomach and my intestines, my gut. My body says, "Whoa, we got nutrients here." We release the GLP-1 and this other one called GIP hormones that then say, "We got food, we got carbs, we got sugar. Let's tell our pancreas to release insulin," because we just got some food in our body. We got some sugar in our body. And then it crosses the brain and tells the appetite centers in my brain that, "I just got nutrients. We should stop eating." It should make me feel a little fuller.

The issue with our natural hormones in our body is that they get taken down, they get broken down very quickly. They only last a few seconds. And these new drugs bind now to those two different kinds of hormones and lead to this really much heightened sensation of fullness and to a much more significant response lasting much longer than what our own body would produce.

Therefore, that's why they're so effective. And therefore, that's why they are also given once a week, which is really kind of neat for a lot of those medications. So you don't have to take a medication every day. It's a small injection once a week.

Interviewer: Wow. So I guess when I first came into this interview, I'm used to doing stories about how some new drug that came out is not actually going to help you with weight loss when you really look at the research. But with your professional opinion, as a doctor who works with patients suffering from obesity or helping them live healthier with their weight management, why is this drug so exciting like you keep saying?

Dr. Simonetti: It is so exciting because the amount of weight loss we are seeing with the clinical trials from this drug is much more significant than what we had seen previously.

So as a measure for FDA approval for a drug for weight loss is usually about 5%. And with the latest drug, which is semaglutide with the other name of Wegovy, we saw a significant more amount of weight loss, around 14%, 15% with the higher doses. And with tirzepatide, we are seeing weight loss of around 20% with the higher dose of the medication, which 20% is a lot of weight, right? So it's a really significant amount of weight loss that we are seeing with these new classes of medication.

And as we know, weight loss is extremely difficult, right? This idea that if we just diet and exercise, we should just be able to lose weight. And it's not true. Eighty-five percent of those that diet and exercise actually, unfortunately, end up gaining the weight back and this weight loss is not sustainable.

And there are a lot of reasons for that, right? There is genetics. So 60% to 70% of the way we are, we know that it's related to genetics or the way we accumulate fat.

There's also our environment, and then there is this regulation in a lot of the hormones. There are these regulation appetite hormones. There is this regulation with insulin. The more weight that we gain, the more insulin-resistant we become. Therefore, there is this combination of insulin resistance.

So 90% of those that have diabetes also have excess weight. And some of the older medications that we had for diabetes, like the glipizide, glimepiride, and even insulin would lead to more weight gain, which then meant more insulin resistance and then making the condition just worse.

And with these new drugs, we see significant improvement in weight. Therefore, you also see significant improvement in decreasing in insulin resistance and also improvement in the glucose control and the sugar control in the blood because it works in conjunction. You have the stimulation of the pancreas and decrease in appetite.

Reading through the clinical trials again, and I just had done a quick review before we sat down for this interview, really it's quite impressive. One of their trials, they compare this drug for participants that have diabetes that were taking insulin and they gave them the tirzepatide. And those that took the tirzepatide lost weight versus those that were taking insulin actually by itself gained weight. So this is, again, quite significant in the amount of weight loss as well as in the amount of glucose control that we get with this medication.

Interviewer: So for all of the people who are thinking, "Oh, hey, this is the drug that's going to make me lose all my weight, finally," it's not ready for them, right? Is that what I'm understanding correctly?

Dr. Simonetti: That's right. So this medication is not yet approved for weight loss. I believe it will be, hopefully, within the next year or two. They are just finishing the Phase 3 clinical trials for weight loss.

Currently, this medication is approved for those with diabetes, and I think it'll be a wonderful tool for those that have diabetes and excess weight, overweight or obesity. This would be just a wonderful medication because it leads to a significant amount of weight loss and improvement of their diabetes.

This is great, and I think this is going to really improve the care that we can provide. However, we need to remember that obesity is such a complex disease, right? There's a multitude of issues that go with it. So this is addressing maybe some of our physiology, but we still need to do lifestyle modifications with modifications in our diet, increasing physical activity.

Behavioral health is a really important piece. Oftentimes, we eat in response to feeling sad, depressed, because when we eat in particular foods that are sweet or high caloric foods, it releases dopamine and serotonin in our brain. So it actually makes us physically feel better at the moment. And therefore, we go back and eat more because then I need another hit and then I feel better. And it becomes that very vicious cycle that once you start eating certain things . . . know for me, it's a piece of chocolate, right? I'm having a bad day at work, I eat a little piece of chocolate and my life is better at that moment. However, that doesn't help me because then my sugars crash and it makes me want to crave it more.

So really trying to address as many things as possible, and that's why in our program, we have this multidisciplinary team approach. We have the registered dieticians. We have an exercise physiologist. We have two Ph.D. psychologists. We also have other options such as surgery. So we work with the bariatric surgeons.

So again, it's wonderful to have one more tool, a very effective tool in our toolbox, but this is a tool. We are able to use it, and the more tools that we have, I think the better offer we're going to be, but we have to address all these other pieces as well.

Interviewer: So, obesity, it is not as simple to treat as just getting a new injection, even with some of these great new drugs. So I guess we'll just keep a look on the headlines, see if this is approved for obesity treatment in the next couple years, and maybe we'll have you back on and we can talk about how you guys can utilize it in your toolbox to battle obesity.

Thank you so much for joining us, Dr. Simonetti. I really appreciate you taking some time to talk to us about this new drug.

If you are considering having breast implants, for whatever reason, how do the new FDA guidelines on breast implants affect you and your decision?

Breast augmentation is near the top of the most cosmetic surgical procedures. Although the number of women who had breast implants fell by one-third in 2020, probably related to COVID-19 pandemic, still 200,000 people had breast implants in the U.S. in 2020, down from the usual 300,000 implants per year. About 75% of the implants are for cosmetic reasons, and the rest are part of reconstruction after breast cancer surgery.

Recently, the FDA took some new steps to improve and strengthen the information guidelines about implants and short- and long-term consequences.

It's hard to know how women want to receive information about the risks of breast implants. They believe that they know the benefits, at least for the persons they believe themselves to be right now. They can't really assess the benefits to the woman they will be at, let's say, 60. However, the assessment of benefits is a completely personal process and will be different from woman to woman. And this includes trans women making the decision to have breast implants.

The risks are harder to communicate. Language is often very medical, numbers are hard to process, and some people don't even want to know the risks.

There are data from a randomized trial of information giving that women who received more information were happier with their decision, were less likely to experience preoperative anxiety, and were less likely to experience postoperative regret. So in the information era, I think more is better.

So what are the new components of these new FDA guidelines? First of all, they aren't exactly new. They've been worked on for several years now, and they went out for public comment and were published back in 2020. However, they became more official in the fall of 2021.

Firstly, the boxed warning, the ominous black box that comes on some package inserts of medications and devices that actually nobody really reads unless you stick it on their nose.

I'm going to quote here the example from the FDA with my own asides put in. "Warning," and this is in a big black box, "breast implants are not considered lifetime devices. The longer people have them, the greater the chances are they will develop complications, some of which will require more surgery.

"Breast implants have been associated with the development of a cancer of the immune system called breast-implant-associated anaplastic large cell lymphoma. This cancer occurs more commonly in patients with textured breast implants than smooth implants. Although the rates are not well defined, some patients have died from this." Okay, that's number two.

Three, "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 patients' risk for developing the symptoms has not been well-established. Some patients report complete resolution of the symptoms when the implants are removed without replacement." Okay, that's the black box.

Well, I would want to know more about the phrase that the implants are not considered lifetime devices. There are no recommendations that breast implants be removed after some certain years, not like IUDs that have a finite effectiveness with recommendations for removal at a certain time.

Eighty percent of women who've had an implant placed still have it at 10 years. Of course, the woman that you are at 25 will not be the woman that you are at 55, and neither are your breasts, as all of us know.

"The chance of complication increases over time." What does that mean? Your surgeon should explain those complications, what they are, how often they happen, and what can be done about them.

The common ones are hard fibrous walls around the implant that can be unnatural-looking and feeling, or rupture of the implant capsule.

The uncommon one is the cancer that's associated with the certain kind of implant with a textured, not a smooth, outer covering. That cancer, which is mentioned in the black box, is called breast-implant-associated anaplastic large cell lymphoma. This is a mouthful, but is lymph cancer that arises over time, rarely.

The incidence in women who have these textured implants is 1 in 3,000 to 1 in 30,000. So it's not common. We have a great interview with Dr. Jay Agarwal on this kind of cancer and breast implants. You can find this interview at The Scope if you want to know more.

"Breast implants have been associated with these systemic symptoms." What does that mean? Some women have experienced symptoms such as pain, autoimmune symptoms, chronic fatigue. In the past, this has been somewhat ignored. But there are some women who've had fewer symptoms after their breast implants are removed. This isn't very well understood, but here it is in the black box.

To help understand the black box warning about breast implants, the FDA has created a model patient decision checklist. I think this is really great if it's given to the woman well in advance so she has time to read it or have someone read it to her and explain it to her. This isn't something to be handed out in the pre-op visit just to sign, the way you sign your permissions to your software like Google or your phone. This should actually be read word for word.

The FDA created this checklist to add to that surgeon's counseling. It is meant to be a springboard for discussion, and the patient will read and check off that they've read it and understood it.

It is long, multiple pages, with places for the patients to sign at the bottom of each topic. It includes who shouldn't have implants, at least at the moment: women who have an infection, women who are pregnant or breastfeeding, women who are having chemotherapy or have a suppressed immune system. It includes more information about the rare lymph cancer and about long-term systemic symptoms.

Actually, the example in the FDA guidelines is a really, really good one. If you're an information junkie like me and you read at, at least, the 12th-grade level, it's great.

The long-term risks of complications are spelled out. The frequency at which these things happen are attached, such as painful scar tissue around the implant reported in 51% of patients, rupture or leaking of the implant 30%, need for reoperation 60%. But those are just the biggies.

It's a really great document. It's what your surgeon should have been telling you anyway, but in the heat of the moment in the office, they might not take the 30 minutes to talk to you about this. And you might not remember. This is a great chance to take it home and read it carefully and bring it back with your questions.

And with the FDA guidelines, there's an updated suggestion about management of breast implant rupture or leakage, that 30% of the time it happens.

And last but not least, there's a card for the patient to keep forever in her wallet or personal records about what kind of implant she has, what it's made from, and when it was placed.

Now, you think you'll remember all this stuff, but you won't. And maybe you'll have them still at 80 and your memory is fading. Your surgeon may have retired or gone on to surgeon heaven. Your medical records may be lost. But at least you have a document about what is existing in your body.

If I had implants, I would laminate mine and put it next to my driver's license or my organ donation card.

I think these are really good steps in the right direction in patient information and decision-making. I know you just want what you want and you wanted it yesterday, but it's a long-term decision with long-term consequences, some good, some not so good. You should take your time and try to get it as right as you can.

Thanks for joining us on the "7 Domains of Women's Health" at The Scope.

Announcer: Health information from experts supported by research. From University of Utah Health, this is thescoperadio.com.

Interviewer: Botox and fillers, common question, what is the difference and how can they help you? Dr. Eric Cerrati is the Director of Facial Plastic Surgery at University of Utah Health. So, first of all, are Botox and fillers the same? I would say probably not, but that's why you're here. I want to find out.

Dr. Cerrati: So they're very different. Botox is a neurotoxin. And Botox, it just happens to be the trade name that everyone knows of. But actually, there's three others now that are FDA-approved, and they affect the muscles, whereas fillers are volumizing agents.

Interviewer: Okay. And how are they used differently then?

Dr. Cerrati: So, in general, Botox is used for the upper third of the face. FDA approved for three different areas, which are the horizontal forehead lines, the vertical 11s that you have between your eyes, and the smile lines outside. Obviously, there are some other off-label uses that we tend to use them for. And then, fillers are the lower two-thirds of the face. You know, I'm not a huge fan of using Botox and, you know, around the mouth or other areas, because obviously the lower two-thirds of the face is very mobile and you want to maintain that mobility.

Interviewer: So kind of give us a general rundown, what are the different types of Botox and fillers? When would you use them? What do they do?

Dr. Cerrati: So Botox, in general, so it's a neurotoxin that's injected into muscles. It takes about two to three days to take effect. I usually tell patients to give it a full seven till you kind of go to the mirror and see what it does. And on average, it lasts about three to four months. After three to four months, you're right back where you started. No better, no worse.

Interviewer: Okay.

Dr. Cerrati: Fillers, on the other hand, you know, there's a whole variety of fillers that are out there. There are permanent ones, and there are, you know, hyaluronic acid ones that are dissolvable. I tend to use the dissolvable ones just for safety because, you know, it's not a benign procedure that should be taken lightly. And the different fillers, they come in different thicknesses, you know. Some are placed deeper. Some are placed more superficial. Some last a year. Some last two years.

Interviewer: And when you say safety, what do you mean exactly?

Dr. Cerrati: With any filler injection, there's a risk of bruising and swelling. All hyaluronic acid fillers attract water to a certain degree, so that's how you get the swelling. They pick up red blood cells, and doing so, that's how you end up with the bruise. I don't consider those risks. I consider them known side effects. And there are certain things you can do to try to limit those side effects. Kind of the scary risk that people see and hear about online is more if the filler is injected in or around a blood vessel. That's why it's very important to go to someone who's very knowledgeable about the facial anatomy and where the filler is going and what we're trying to accomplish.

Interviewer: The dissolvable versus non-dissolvable, so let's just take, for example, maybe under the eye. That would be a place where you might use a filler. Is the dissolvable . . . does that mean that the results don't last as long much like the Botox and the dissolvable would last longer?

Dr. Cerrati: So the filler that I tend to use around the eye will last about a year. Again, after about a year, your body dissolves it or metabolizes it, and you're back to where you started. Under the eye tends to be an area where people will swell and bruise pretty significantly. I tend to use a cannula to try to limit that, you know. And it's also a high-risk area. Given the risk associated with the under the eye fillers, I tend to favor the dissolvable fillers.

Interviewer: Yeah. It sounds like it's a little bit more complicated than just an injection of Botox here, some fillers there.

Dr. Cerrati: Exactly. And, you know, I do all of my injections myself in the office. I just think that I can give a little bit more high-quality product to the patients if I do it that way.

Interviewer: And during either type of treatment, whether it's Botox or fillers, where does this happen? It happens in your office?

Dr. Cerrati: It happens in the office. Actually usually a pretty quick procedure, probably it takes anywhere from 5 to 15 minutes. And a lot of times, we can couple them together to accomplish, you know, full facial rejuvenation. That's where you start to get into things called liquid facelifts. You know, you can use Botox in the neckline to tighten the jaw line. There's a lot of different, you know, kind of off-label uses that you can really accomplish quite a bit with these two modalities.

Interviewer: And it sounds like the advantage of having someone like yourself do the procedure. I mean, you're a surgeon. On the surface, it might seem like it's a little overkill. But a lot of factors involved as to what to use and safety concerns, and it's a balance of outcome versus safety. I think I'm starting to understand why I would come to someone such as yourself.

Dr. Cerrati: So I tend to believe that surgeons are going to have a more thorough knowledge of the anatomy of the face and can place the fillers in the safest way possible to give the longest-lasting result. I think when you're seeing a surgeon for a complication, it's probably not the best setting.

Interviewer: We've talked before about being comfortable with the person that is doing the procedure in the terms of when it's like a facelift, when it's a surgical procedure. These non-surgical procedures with fillers and Botox, does the same thing apply? You should be comfortable with that person?

Dr. Cerrati: Absolutely. So this is very customizable for each patient. And you can think of the surgeon as, you know, someone who's trying to sculpt or mold an image that they have in their face, of how to rejuvenate a patient's face. And so the combination of Botox and fillers and what they can accomplish is very specific to what the surgeon sees and what that patient desires. And so having that conversation before doing any of the injections is very important.

Interviewer: And there are some great surgeons to choose from here.

Dr. Cerrati: Absolutely. So we have a team of surgeons here that offer this. And obviously, Botox and fillers are widely used all across the country and all over the world. But it's very important to go to someone who's well qualified and knowledgeable.

Announcer: Have a question about a medical procedure? Want to learn more about a health condition? With over 2,000 interviews with out physicians and specialists, there's a pretty good chance you'll find what you want to know. Check it out at thescoperadio.com.

Dr. Jones: Do women with breast implants have a higher risk of cancer? What cancer? What's the risk and what should we know?

Announcer: Covering all aspects of women's health, this is The Seven Domains of Women's Health with Dr. Kirtly Jones on The Scope.

Dr. Jones: There are about 300,000 breast implant surgeries performed every year in the U.S. Now, there are a number of reasons for breast implant surgery, but all people requesting breast implant surgery have concerns about risks and side effects. There's a new concern about a very rare cancer that might be more common in women with breast implants.

And today in The Scope studio, we're talking with Dr. Jay Agarwal, who is chief of Plastic Surgery at the University of Utah. He's a plastic surgeon at the Huntsman Cancer Institute, who specializes in breast reconstructive surgery, and he's going to help us think about this risk.

Welcome back to The Scope, Dr. Agarwal.

Dr. Agarwal: Thank you. Thank you for having me.

Dr. Jones: So what did the FDA identify as a possible association between breast implants and a rare non-breast cancer?

Dr. Agarwal: Over the past decade and a half, the FDA, the medical societies, and doctors in general have been paying very close attention to the outcomes of their patients that have had breast implants placed. And so, over the past number of years, we found that there is a very small but significant incidence of a rare lymphoma, and it appears that it's associated with a specific type of breast implant, whether they're placed for reconstructive purposes or cosmetic reasons. And that's ALCL, an anaplastic large cell lymphoma.

Dr. Jones: That's a new one to me.

Dr. Agarwal: Yeah. Most people haven't heard it.

Dr. Jones: Right. Very rare.

Dr. Agarwal: And it's not a breast cancer as we think of breast cancers. It is a lymphoma. It's typically found in the capsule, the scar tissue that surrounds a breast implant. But again, I want to emphasize that it's exceedingly rare.

Dr. Jones: If there's an increased risk, what kind of numbers are we talking about?

Dr. Agarwal: We're talking about really low risk. It appears that patients with breast implants have about a one in 3,800 to one in 30,000 risk of developing this type of lymphoma. To put that in a broader context, you can think that the average woman in the United States, one in eight women will develop breast cancer.

Dr. Jones: In their lifetime, yeah.

Dr. Agarwal: In their lifetime. So this is orders of magnitude lower than that risk.

Dr. Jones: So it's very small or . . . this is where I put it in the teensy when I . . . this is my teensy risk.

Dr. Agarwal: That's correct.

Dr. Jones: However, it's a scary thing because many women who are having implants are maybe not doing it for cosmetic purposes but for reconstructive purposes, and they already have cancer on their brain and their heart. What kinds of breast implants are the most likely?

Dr. Agarwal: So what we've seen, first of all, there have been about 400 to 500 cases of this ALCL reported to the FDA. And after looking back at those patients and the types of implant they've had, it appears that the highest association is with textured breast implants.

Dr. Jones: So tell me about that. I don't get textured. Is textured meaning its outside is kind of rough, or what do you mean by textured?

Dr. Agarwal: That's correct. So breast implants come in a variety of styles. The first you may know is saline-filled implants or silicone-filled implants. And then another characteristic can be whether they have a smooth outer surface or a textured outer surface.

We started using textured implants because there was a thought that maybe it decreased the amount of scar tissue that formed around the implant or what we call capsular contracture. Sometimes we use implants that are slightly shaped, and the texturing helps prevent the implant from turning. But the association with the ALCL is the highest with the ones that have a texture on the outer surface.

Dr. Jones: Well, that has some biological possibility. I mean, it could cause a different kind of reaction than a smooth, slippery one.

Dr. Agarwal: It could. It's possible that the texturing creates more inflammation or an area for bacteria to reside and cause an inflammatory response.

Dr. Jones: You mentioned that it's in the capsule or the area around the breast implant. How does this present? Because quite frankly, when we think about lymph cancer, I think about lymph nodes, I think about armpits, neck nodes. I wouldn't think of looking at the breast itself. So how might it present if I were an OB/GYN or a clinician? What am I looking at?

Dr. Agarwal: Right. So patients who've had breast implants can present to their physician, OB/GYN, general family physician, or their plastic surgeon with a variety of different complaints. The breast is swollen, it's become more painful, or they feel a mass. The most common presentation is fluid around the implant. And about 86 percent to 90 percent of patients who've had this ALCL presented with what we call an effusion or a seroma around the implant.

Dr. Jones: Was it years after their implant or . . . it must have been years because cancer doesn't happen in a day.

Dr. Agarwal: Right. So the average time to presentation of the 400 to 500 patients that have had this has been 8 to 10 years after the breast implant has gone in.

Dr. Jones: Right. So if it's 400 in the U.S., that means the vast majority of plastic surgeons, OB/GYNs, primary care docs, nurse practitioners have never seen this, have never heard of it. But if a patient comes with a new complaint some years after the breast implant should be pretty stable, they should know enough to say, "That's not normal."

Dr. Agarwal: That's correct. Again, to put it in a little bit of context, as you mentioned in your opening, there are about 300,000 to 500,000 breast implants that are placed annually in the United States. It's believed that worldwide there are about 35 million women who have textured implants, and it's believed worldwide about 1.5 million implants are placed annually.

So, again, small numbers, but any OB/GYN, family physician, plastic surgeon should be made aware of this, because as we're learning more about it and as we're observing our patients more closely after they've had implants placed, we're identifying more cases of this. And while the number is small, we don't know where it will end up at.

Dr. Jones: Right. Well, when we're talking about breast cancer, even a very rare one, people think about this being lethal. So, when this presents, is this usually a cancer that's spread already? Do most people die from this cancer? What happens when people find this cancer?

Dr. Agarwal: Most of the time with ALCL that's associated with breast implants, the cancer resides locally in the tissues around the implant. And for most of the cases, removal of the implant and removal of the capsule, the scar tissue around the implant can cure the patient of the lymphoma. In rare instances, the lymphoma can spread to the lymph nodes or elsewhere, but the most common presentation is a local one.

Dr. Jones: Well, that's actually great news for a rare cancer, for it to be actually mostly curable with the surgery, just remove the implant and capsule. To me, as a provider and as a woman, that's very reassuring to me.

Dr. Agarwal: Yes. Nobody wants to have an increased risk of anything if they're having a medical device placed. The good news is (a) it's very rare, and if caught within an early period of time, it can be cured by removing the implant and the capsule. If there's something good about it, I'd say.

Dr. Jones: That's right. I think that's good news about bad news.

Dr. Agarwal: Right. I will say that at the University of Utah and Huntsman Cancer Hospital, we have placed a moratorium on textured breast implants. We no longer place any textured implant until the medical community and the FDA learn more about this ALCL, and until we feel confident or have some better understanding of what the true association, if there's really a cause and effect association.

I think you want to ask all the right questions as a patient. What type of implant am I having placed? What are the risks of the surgery? What are the risks of the implant?

From the physician side, it's important to do a full physical exam when your patient comes in for their annual visit. That includes a full breast exam, particularly in patients who have had breast implants. If a patient notices anything suspicious or a change in the shape, size, or feel of their breast, they should bring it to the attention of their physician. And if an OB/GYN or a family practice doc has concerns, they should then have the plastic surgeon involved.

The FDA at this point recommends that either an ultrasound or an MRI can be done as a screening tool. Anyone who has symptoms should go directly to MRI. Anyone who has an implant placed, particularly a textured implant, should have a screening MRI after five or six years after the implant was placed.

Dr. Jones: Well, for many women who are making the choice about breast implants, only they will be able to balance the risks and benefits in their own bodies. But we try to give them the best information that we have and help support them with their decision. Thanks, Dr. Agarwal, and thanks for joining us on The Scope.

Announcer: Have a question about a medical procedure? Want to learn more about a health condition? With over 2,000 interviews with our physicians and specialists, there's a pretty good chance you'll find what you want to know. Check it out at thescoperadio.com.

Recently the Food and Drug Administration (FDA) has identified a possible association between textured breast implants and development of a rare form of cancer called anaplastic large cell lymphoma (ALCL).

The majority of the data suggests the cancer risk is associated with breast implants that have textured surfaces rather than those with smooth surfaces. The risk is low and thus far only a small percentage of patients with textured implants have been found to have ALC in the United States. Nevertheless, out of an abundance of caution the FDA has recalled a specific brand of textured implants.

The Division of Plastic Surgery at U of U Health has stopped using all brands of textured implants in light of the recent concern of developing ALCL. Please note that the recall of these implants does not mean that the implants need to be removed. If you have concerns or questions regarding the recall please refer to the FDA website or speak with your doctor.

For More Information About the FDA’s Ongoing Status on Breast Implants and ALCL

Dr. Jones: Well, you just happen to be at your computer and your sex life was on your mind and you Googled women's low libido. An amazing number of natural products came up with rather naughty names. Well, what about this? This is Dr. Kirtly Jones from Obstetrics and Gynecology at University of Utah Health, and this is the scope of supplements on The Scope.

Announcer: Covering all aspects of women's' health. This is the Seven Domains of Women's Health with Dr. Kirtly Jones on The Scope.

Dr. Jones: Recently the FDA announced a recall of two supplements marketed to increase women's sex drive called Libido-Max and Zrect. These supplements have a prescription chemical called flibanserin in them that was not disclosed. Flibanserin is a drug in the prescription medicine called Addyi for low libido in pre-menopausal women, which has some significant side effects including dizziness and passing out.

This is the first time the FDA has recalled a product contaminated with this drug, but it's just the latest in the recall of a number of supposedly natural supplements for men and women's libido which have been found to have drugs in them. In the case of some men's drugs for libido, they included drugs for animals not approved for humans. Some of the drugs for men that were recalled were Uproar and Monkey Business and Rectalis and some other names I really don't want to say out loud in The Scope studio.

So the supplement business is a multi-billion dollar a year industry. With many of my patients who have come with a bag of their medicines with questions for me, and this bag might have many bottles of supplements that claimed the contents would be used for one problem or another. At the bottom of the bottles was the statement required by the FDA, "These statements have not been evaluated by the Food and Drug Administration. This product is not indicated to diagnose, treat, cure, or prevent any disease."

My patients would ask if these supplements were good for them and I could only answer that I don't know what's in them and that there's no standards for the herbs or supplements in them except for ordinary vitamins and minerals. Now the FDA's mandate is to evaluate the safety of food and the safety and efficacy of drugs it has no mandate and does not evaluate any supplements. Nobody does, except some independent researchers.

Over the past several years studies have found that over 25% of supplements for athletic performance are contaminated with steroids, stimulants, and banned substances. And in 2008 two products were pulled off the market because they were found to contain about 200 times more Selenium, an element that some believe can help prevent cancer, than their labels said and people got sick. According to the FDA about 50,000 adverse reactions to dietary supplements occur every year.

So what should you do? First of all, if natural supplements really worked, without the pharmaceuticals contaminating them, we would all be taking them. And if herbal supplements really worked better than placebo the company wouldn't need to add those drugs to the mix. So number one, eat a balanced diet and if you cannot or have a particular issue like pregnancy make sure your vitamins and minerals are tested.

Two, dietary supplements are complex products. The FDA has established good manufacturing practices, GMPs for dietary supplements to help insure their identity, purity, strength and composition. These GMPs are designed to help prevent the inclusion of wrong ingredient, the addition of too much or too little, and the possibility of contamination, and proper packaging and labeling. But the FDA doesn't really monitor these, they may actually inspect facilities periodically, but what does periodically mean?

Three, in addition, several independent organizations offer quality testing and allow products that pass these tests, to display their seals of approval. Some of these organizations that do testing include the US Pharmacopeia, the Consumer Lab, and NSF International.

And lastly, if the supplement has the statement "proprietary blend" on it, then all bets are off as to what's in it and how much is in it. We all want to feel well and function at our best. The supplement business survives on that hope. For our Scope listeners, just be careful and skeptical and thanks for joining us on The Scope.

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Interviewer: The University of Utah is home to the only Ryan White-sponsored HIV clinic in Utah, treating up to 90% of Utahan HIV patients. We're joined today by two doctors from the clinic to speak on what that clinic offers.

Announcer: Health tips, medical news, research, and more for a happier, healthier life. From University of Utah Health Sciences, this is The Scope.

Interviewer: We're sitting down with Dr. Claudia Goulston. She is an Associate Professor in Infectious Diseases, and Dr. Rosado, who is the Medical Program Director for the Ryan White Program. When it comes to HIV and AIDS treatment and diagnosis, and things like that, where does the Ryan White Program fit within the Salt Lake community?

Dr. Rosado: So the Ryan White Program, basically, the purpose of this program is to treat people who are HIV infected and are unable to pay for HIV therapy, because the HIV therapy is very expensive even in this country. We also have funding to do HIV testing mainly for partners of our patient, spouses, and anybody who wants to have an HIV test, we can do that using Ryan White funding.

Interviewer: So, Dr. Rosado, how many people do you see here in Salt Lake?

Dr. Rosado: In the clinic, we had about 1,600, 1,700. It depends. Patients that come to our clinic, not all of them are Ryan White patients because we see people who are Medicare, Medicaid, or they have primary insurance. That's the total of the 1,600 patients. But people who quality for Ryan White is about 500 patients that receive Ryan White funding.

Interviewer: And Dr. Goulston, why is a program like this important for a population like this?

Dr. Goulston: Well, many people are uninsured or underinsured, as the case may be, and so it kind of dovetails with that. And we have all sorts of providers within the clinic that work as a medical home to help get patients care. So we have case managers that can help treat patients and get them into care. We have counselors, psychiatrists, OB-GYN, neurology in our clinic as well and we work with all these different subspecialties to try and give them the best care possible.

Interviewer: So that sounds like a pretty comprehensive care. So that's at Clinic 1A? Is that important for the treatment? It's not just medication, it's everything else?

Dr. Rosado: Well, again, we offer a comprehensive HIV care to our patients and we try, as Dr. Goulston mentioned, to have a medical home model so the patient can come to that clinic and they can see the HIV provider. If they need to see psychiatric care, mental health, neurology, or OB-GYN, we have all those services in the clinic.

Interviewer: I mean, programs like Ryan White where you can get these new treatments and things, it . . . I mean, treatment is not like it was 20, 30 years ago, right?

Dr. Goulston: Not at all.

Interviewer: How has it changed?

Dr. Goulston: Well, now, we have many regimens that are single-drug or single-tablet regimens once a day. We have much lower side effects and very effective, and it is much more tolerable for patients to take and to remember. We used to have treatments that could be up to five times a day with miserable side effects, and those days are gone.

Interviewer: So it's not a death sentence anymore either, right?

Dr. Goulston: If you take your meds and can afford them and can carry through, then people can live.

Interviewer: So Clinic 1A . . . So it's treatment. Do they offer services for prevention?

Dr. Rosado: We do. In Clinic 1A, we do offer clinic services for prevention. But we need to emphasize here that the Ryan White Program doesn't pay for TRUVADA for prevention or HIV PrEP, because the funding for Ryan White is for people who are HIV infected. But we do see patients that are taking PrEP, TRUVADA, to prevent HIV. Usually, these people have their own insurance. And the company that makes TRUVADA, Gilead, they do have a patient assistant program. If a patient is unable to pay for the medication, they can offer the medication for free as long as the patient qualifies.

Interviewer: So say a listener who might be HIV-positive, underinsured, or not even have insurance, where they can go get more information for the Ryan White Program?

Dr. Rosado: Now, these people can go online and Google "Ryan White" and they will get all the information they need. In Utah, they can call the University Hospital Clinic 1A and we can offer them more information about Ryan White. We see anybody who wants to come to the clinic, and I need to mention, including people who are undocumented. As long as they are a Utah resident, they qualify for the Ryan White. And the reason I say this is Ryan White is present in every single state. The only qualification will be that you have HIV and you reside in that specific state, and you are unable to pay for your medication. The Ryan White, definitely, will cover your HIV therapy.

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Interviewer: New FDA approved oral medication that has been shown to prevent transmission of HIV, we're talking about PrEP today on The Scope.

Announcer: Health tips, medical news, research, and more for a happier, healthier life. From University of Utah Health Sciences, this is The Scope.

Interviewer: We're here with Dr. Claudia Goulston. She is the associate professor in infectious diseases, and she is a HIV specialist. When it comes to HIV, prevention is huge, right?

Dr. Goulston: Correct.

Interviewer: Because I've been hearing that it's what, 40,000 new cases in America each year?

Dr. Goulston: That's the ones that are known.

Interviewer: Why did you specify that? Are there tons that aren't known?

Dr. Goulston: Potentially, there's a lot more than that. They actually estimate around 50,000 at least.

Interviewer: And that number doesn't seem to be changing. Why is that?

Dr. Goulston: No. Because even though we prevent cases, some people are not on medications and some people also don't know that they're HIV positive, and so their risk is high and spreading it to other people.

Interviewer: When it comes to prevention, what is the tried and true best way to prevent infection?

Dr. Goulston: Condoms, first.

Interviewer: Is it that simple?

Dr. Goulston: It's that simple. But there's also PrEP, which is pre-exposure prophylaxis, which is with a medication that they can take called TRUVADA, and that helps prevent cases in people who engage in higher risk behaviors.

Interviewer: I've seen down at the Pride Center and stuff, there's posters and stuff about PrEP. What is PrEP exactly? How does it prevent? It sounds like it's a full blown vaccine, but . . .

Dr. Goulston: No. It's a medication that you have to take every day and it prevents you from getting HIV if you engage in sex or exchange blood with someone who has HIV.

Interviewer: Now, is it expensive?

Dr. Goulston: It's extremely expensive. It's about $1,700 a month.

Interviewer: Wow, and is that just because it's new? Is that because . . .

Dr. Goulston: No. That's the cost. It's not new.

Interviewer: So it might be a little easier to just . . .

Dr. Goulston: It's part of the cocktail that we give patients when they have HIV.

Interviewer: It's the same cocktail that you give after the infection, but it helps prevent it?

Dr. Goulston: Correct.

Interviewer: What are some of the side effects of PrEP?

Dr. Goulston: First, you have to have to not be HIV positive to begin with. We screen patients for that. It can also treat hepatitis B, which is one of the good things about it. But as far as side effects, it can cause renal toxicity which is kidneys, and it can also cause osteoporosis or thinning of the bones.

Interviewer: Are those side effects pretty common? Are those . . .

Dr. Goulston: The thinning of the bones takes a while and the kidney dysfunction can occur in not the majority, but in some patients it can occur.

Interviewer: This isn't necessarily . . . It's not 100% prevention?

Dr. Goulston: No.

Interviewer: What are the rates of prevention?

Dr. Goulston: It's supposed to be helpful in up to 90% if you take it. But if you don't take it, it doesn't work, number one. Then if you have someone who has a more resistant virus and they are the person who's infecting you, there has been one case of transmission in someone who is taking PrEP and was documented to actually be taking it at the time that they were infected, but they got it from someone who had a resistant virus.

Interviewer: What kind of patient is PrEP good for?

Dr. Goulston: Anyone who has multiple partners. It would be a good person or someone who is monogamous with a partner who is HIV infected, that would be a good one, or someone who is in a partnership and they want to get pregnant, and one of the couple is positive and the other one is negative.

Interviewer: After talking about prevention and PrEP, if there is someone who is wondering about it or might be engaging in some of these behaviors that might expose them to HIV, what is the one take-away message you would have for them?

Dr. Goulston: That PrEP is effective and it can reduce the risk for HIV by at least 90%, and that they should come in if they're so interested, and we can help them.

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