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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.

Breast Implants and Anaplastic Large Cell Lymphoma

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.

Types of Implants and Likelihood for ALCL

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?

Helping Your OB/GYN Identify ALCL

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.

ALCL's Severity and Ability to Spread

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.

Preventative Measures before Breast Surgery

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.

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Breast Implants and the Risk of ALCL

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.