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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.

Dr. Jones: Disfigured, mutilated. These are words that are the way some women feel after mastectomy, the extensive surgery for breast cancer. What can we offer women who have had this surgery, to help them recover their self-image?

Dr. Jones: About a quarter of a million women will be diagnosed with invasive breast cancer in the US this year. Some will choose a smaller operation, a lumpectomy, but many will choose a larger surgery in their hope for a cure. And the percent of women choosing mastectomy is increasing. Although we're grateful for the treatments that can cure breast cancer, mastectomy can leave a woman and her body image profoundly changed. The Scope's Seven Domains of Women's Health team is in the office. I've Dr. Agarwal, a breast reconstructive surgeon at the Huntsman Cancer Institute, and we're going to talk about breast reconstructive surgery. So, Dr. Agarwal, tell us a little about your training. How is it different from a breast cancer surgeon, the person who did the mastectomy?

Dr. Agarwal: Well, I'm a plastic and reconstructive surgeon so my role is to try and rebuild. After a patient undergoes a mastectomy by the breast cancer surgeon, I work with the patient to try and then rebuild the breast. And this can be really any part of the body. As a reconstructive surgeon, our goal is to try and restore form and function for a patient.

Dr. Jones: Can you do the reconstruction at the time of the mastectomy, or are there advantages of doing it immediately versus delayed?

Dr. Agarwal: You can do the reconstruction at the time. We often, in fact, start the reconstructive process on the same time, in the same operative setting as the mastectomy surgery. Sometimes, it's a staged operation in which the first stage is started at the time of mastectomy and then the subsequent stages occur in the future. And sometimes, you can complete the entire reconstruction all in one setting.

There are advantages and disadvantages to doing it all at once. Some patients like the idea of just having one operation or, at least, having one operation where the majority of the surgery is done. Some patients like waking up from the operating room with the start of a creation of a breast, rather than waking up with a flat chest. The downsides are it does add surgery time and does add recovery time to the operation, but, in general, we're starting to see an increase in the number of patients that are having reconstruction that is initiated at the time of mastectomy.

Dr. Jones: Right. So women actually use to think of reconstruction as something that came to them six months or a year later when they felt like they were cured of their cancer and they were really ready to go on with the next step of their life. But now I think women are expecting to walk out knowing that they're going to feel a little bit more like themselves.

Dr. Agarwal: I think that's true. I think, in the past, reconstructive surgery was often considered something that was not part of the cancer care process of a patient. And today, reconstructive surgery and the role of a reconstructive surgeon are really integral into the entire comprehensive care of a cancer patient.

Dr. Jones: Right. So what's changed with our new tissues, new materials?

Dr. Agarwal: The types of surgeries we do and the technologies that we have have improved. We don't quite have the 3D printing of a breast down yet, although we may get there in the near future. But the quality, the implants, the implant material, and the ability to use tissues from different parts of the body has really improved dramatically over the past 15 years.

Dr. Jones: So we're using some of the woman's own tissues for some of the breast, and some implants, or combinations?

Dr. Agarwal: Both scenarios. So patients can have implants only, their tissue only, or a combination of implant and their own tissue. And that sort of depends on their body, their choices, and what may be the best option. And that often requires a discussion with their surgeon.

Dr. Jones: Well, honestly, Dr. Agarwal, as a woman, my personal fear about mastectomy, with or without reconstructive surgery, would be that I would be asymmetrical, that I'd have one normal breast and one plastic breast, and I just wouldn't be balanced. And I feel that breast had betrayed me already, and I wouldn't want to have breast cancer in the other breast. So I might ask you as if I were your patient to just do them both, so make them, when we're done, they can both look the same and be the same. Are you getting more requests? Does this sound crazy?

Dr. Agarwal: This isn't crazy. In fact, we're getting an increasing number of requests for bilateral mastectomy and reconstructions. And it's a very personal choice, it's not a choice that every woman makes, and it's not an easy choice. I think there are a lot of factors that go into it. Fear is, by far, the biggest factor. Patients exactly like you said, patients are worried that they might develop cancer in their other breast, or they're always going to be nervous and can't sleep at night and so they want to be free of that fear. And that's a real consideration when we consider doing a bilateral mastectomy.

I will say, though, just like any surgery, you have to be prepared that the more surgery you do, the more recovery, the more potential for a problem. So think carefully, talk to your surgeon, talk to your family before you make these decisions.

Dr. Jones: Fears of cancer and fears of disfigurement may lead women to avoid mammograms or seeking medical help if a lump is noticed. There are many more options for women as they face the challenges of breast cancer, and challenging, and living after a breast cancer treatment. Dr. Agarwal, thanks for helping us and think about our options, and thank you for joining us on The Scope.

updated: June 17, 2021
originally published: October 22, 2015

Dr. Jones: When women have had breast cancer surgery, the major surgery such as a mastectomy, they are often looking forward to living their lives and getting their body back. What are the new steps and what are the things that we have here at the Huntsman that will really help them make this difficult decision? How do we make the decision, and who is the team involved?

We are in the office of Dr. Agarwal here at the Huntsman Hospital with a beautiful view out the back door of people living their lives. I want to talk about how women who have had mastectomies make the decision to live their lives going forward as they make the transition from a cancer victim to a cancer survivor. We're talking about breast reconstruction here with Dr. Agarwal, plastic surgeon and reconstructive surgeon here at the Huntsman Hospital.

Let's talk a little bit about women who request the bilateral mastectomy. Of course, there are women with BRCA mutations, mutations that increase their risk of cancer. They don't have cancer yet, but both of their breasts are going to be involved so that's pretty easy to understand. How about if a woman has breast cancer on one side and wants the other one done? Does insurance pay for that?

Dr. Agarwal: Not always. We're seeing an increased demand, if you will, in patients who want to have the contralateral breast removed. A lot of times, this is driven by fear of developing cancer in the other breast. Oftentimes, it's driven by the desire to have symmetry and it's not a guarantee that your insurance will pay for this. More and more, we're seeing that insurance wants to really focus on the breast that has cancer and may not always pay for removal and reconstruction of the other breast.

But any time a patient has these concerns or desires to have both breasts removed, it requires a good discussion with their doctors, their oncologists, their surgeons because while things like symmetry may be improved in some cases, there are also potential consequences to having your other breast removed. You lose sensation of an otherwise normal and healthy breast. Just like with any other surgeries, there is the risk of potential complications by adding more surgery time or more operations.

Dr. Jones: And if women are young enough that they might want to consider having children if they get past their diagnosis and are cured, then they couldn't breastfeed if they have bilateral reconstruction and that has to be discussed. There is so much on the Internet about the pros and cons, but are there other women that someone can talk to? Do you have support groups of women who have made decisions and how they worked through their decisions? How do women go about finding out more information?

Dr. Agarwal: There are definitely support groups here at the Huntsman Cancer Hospital. There are teams of patients who have offered their services to other patients because they've gone through this process in the past and they give the whole picture, the good and the bad of going through this process. Throughout the Salt Lake community, there are organizations that provide a lot of information to patients, including Susan Komen's Foundation. So there are definitely support groups. I think that it is a very personal decision in the end and I think that a frank conversation with your medical team and your family is important when finally making these types of decisions.

Dr. Jones: Let's talk briefly about nipple reconstruction. I've heard that you have an amazing tattoo artist here at the Huntsman who might be able to even tattoo a nipple or are you using other tissues for nipple reconstruction?

Dr. Agarwal: First of all, we do have a great tattoo artist here at the University of Utah and Huntsman Cancer Hospital, but there are different ways of reconstructing a nipple. We can actually use some of a patient's own tissue to create the nipple itself and then tattoo the areola around it. And another option is to purely use tattooing. Some of the tattoo artists can create 3D tattoos of a nipple, which looks amazing. They look like real nipples that have projection even though they're flat on the surface of the skin.

Dr. Jones: That must be very gratifying to have the ability to give a woman that gift, not only as a reconstructive surgeon to give the gift of having symmetry and a self-image that will carry her forward as she works through her recovery but even having the ancillary staff that can help her through that like the tattoos and the counselors and therapists and all of the people, a whole team that can take care of people.

Dr. Agarwal: It's absolutely gratifying to see a patient go through this process and come out feeling whole again and feeling like they can get past or move beyond their initial diagnosis of cancer, and that's really the goal is to help them move forward in life.

updated: June 8, 2021
originally published: October 22, 2015

Gretchen: A breast cancer diagnosis can feel like a body blow to anyone. Kimberly Myers, PhD, from the Penn State College of Medicine is here to tell us why one of her first responses to her own diagnosis was to meet with a professional photographer to document her body. That's coming up on The Scope.

Announcer: Medical news and research from the University of Utah physicians and specialists you can use for a happier and healthier life. You're listening to The Scope.

Gretchen: Hi, I'm Gretchen Case from the Division of Medical Ethics and Humanities at the University of Utah School of Medicine, and I'm here with Kimberly Myers. So my first question for you is why did you want to meet with a photographer? Why was that one of your first thoughts?

Dr. Myers: I think when one gets diagnosed with breast cancer one's mind goes just goes blank in many ways. But one of the things I did know was having had no photographs of my breasts, I wanted to know what I would look like after surgery. I knew that I had a very short window of time in which to get photographs, if I were going to do that. A friend of mine suggested Wendy Palmer, a professional photographer.

Gretchen: So you wanted to be able to remember with photographs what your body had looked liked before you moved on.

Dr. Myers: Yes, because I was convinced that I wanted bilateral mastectomy.

Gretchen: So when you met with Wendy, what was that experience like?

Dr. Myers: It was a bizarre experience. Wendy and I had never met in person and I was going to her studio for the photo shoot. She had said, "Bring scarves and jewelry and bring music. I'd like for you to dance. We won't pose this." And so it was three hours of, first of all, meeting someone completely new and then going through various stages of undress to the point of being completely nude and having oneself photographed. It's something I would never have expected that I would do and she got some amazing photographs.

Gretchen: And then you had an idea about where this might go further. Can you talk about that?

Dr. Myers: Right. So I had a partial mastectomy and then went to chemotherapy. I had decided that one of the things I wanted to do with Wendy's photographs is to go through them and select one to have made into a portrait. Wendy and I, again, after I was into and almost through with chemotherapy, we got together and we looked through the 440 photographs that she had taken that afternoon, and I was struck with the range of emotions that she had captured. She's a phenomenal artist and I thought, I mentioned to her that so many of these feelings and moods were things that perhaps other people could relate to in their breast cancer experience.

We began a conversation about what we might want to do and that's when we decided that she would at least come and photograph subsequent stages of the process so that we would have the primary material if we wanted to do anything with it.

Gretchen: So what you ended up with is a series of photographs that goes from just days after your diagnosis all the way through your surgeries, your treatments, and your reconstruction.

Dr. Myers: Right.

Gretchen: Can you tell us how you went from taking these pictures for yourself to creating an exhibit that has gone around the country and is likely to go around the world?

Dr. Myers: It's strange when you put something out in the universe what happens sometimes. I think many, many people who go through breast cancer have this commitment to do absolutely whatever they can to help other women. Education has always been my passion and so my great desire going through this experience was to do whatever I could to help educate and encourage women about this.

We selected photographs that captured different moods and different dimensions, different parts of the process of reconstruction. It's a 30 piece exhibit and it's paired with verbal reflections that are very, very brief, like verbal snapshots that complement the visual images and those were added when I was looking back at the images. So it was well after the fact, months after the fact, when I was looking at the images and remembering what I would have been feeling like in those particular shots.

Gretchen: And what do you hope for someone to see or to take away from this exhibit? What do you want people to take away?

Dr. Myers: The main thing I want people to take away is a feeling that a diagnosis of breast cancer is not a death sentence necessarily, and it's certainly not something that will make a person into a monstrosity. I think many women are very concerned about losing a vital part of their femininity and aren't really aware that the cosmetic result can be really wonderful. That said, I also would never want to imply that my experience or the results I was fortunate enough to have would be the same experience and results that other women would go through. I think it's very individual.

Announcer: Interesting, informative, and all in the name of better health. This is The Scope Health Sciences Radio.