Breast Implants and Risk for Anaplastic Large Cell Lymphoma

Pippa Wysong; Phillip C. Haeck, MD

Disclosures

February 16, 2011

Editor's Note:

Recently, media attention has focused on a possible link between breast implants and risk for anaplastic large cell lymphoma (ALCL), a rare but benign form of non-Hodgkin lymphoma that may develop in the scar capsule surrounding an implant. In response to concerns, the US Food and Drug Administration (FDA), in conjunction with the American Society of Plastic Surgeons (ASPS) conducted a review of published case studies and epidemiologic studies,[1] and is now in the process of creating an ALCL registry. Medscape's Pippa Wysong spoke to Phillip C. Haeck, MD, President of the ASPS, about ALCL and the registry. Dr. Haeck is a board certified plastic surgeon and has a cosmetic surgery practice in Seattle, Washington.

Medscape: Let's start with walking through what ALCL is.

Dr. Haeck: ALCL is a rare cancer occurring in an estimated 1 out of 500,000 women in the United States annually. The good news is that it is a benign growth, but it can get quite painful if it's not removed. Pathologists have determined that ALCL has the characteristics, under the microscope, of lymphoma, but it has an extremely unusual clinical course in that it doesn't metastasize, and it's cured with simple excision.

Medscape: How and where do these tumors form?

Dr. Haeck: Every implant stimulates formation of a thin filmy layer of scar tissue called a "capsule." In 100% of known cases, the tumor presented within that scar tissue. As that scar tissue thickens and the lymphoma forms, the breast changes both in terms of softness (it gets harder) and firmness – patients can actually feel the thickening of the scar tissue. Most cases are accompanied by seroma (ie, a fluid buildup within that scar pocket around the implant). Seromas can occur anywhere in the body post-surgically.

Medscape: How common is ALCL and who is at risk?

Dr. Haeck: The FDA, in a recent literature review, identified 34 cases worldwide – those are confirmed cases. However, there is some confusion because there is a second number of 60 cases that represents a mix of both confirmed and potential cases. The potential cases are cases that haven't been confirmed as ALCL, and some might be duplicate cases reported in different studies in the literature. The number 60 is the number that was picked up on by much of the media. Whether it's 34 or 60 cases, this is out of about 10 million implants worldwide. Both numbers are extremely small. You have a higher chance of being hit by lightning than you do of developing this disease.

Medscape: Is the risk higher with silicone implants or with saline implants?

Dr. Haeck: The ratio is skewed a little bit towards silicone implants. There is also an issue of whether the affected implants are textured. That's a question we need answered, because most cases involved textured implants.

Medscape: Are there any theories about why textured implants might be associated with a slightly increased risk for this growth?

Dr. Haeck: There is speculation but no theories. There is a real need to get data into the registry and answer that question.

Medscape: Are other types of implants (other than breast) associated with this type of growth?

Dr. Haeck: In the literature, we can't find ALCL associated with hip implants, dental implants, or any other type of implant. It appears there's something about the breast implants that stimulates this condition.

Medscape: Something about breast implants or the breast itself?

Dr. Haeck: Yes. That's what we need the registry for. The other interesting issue is that ALCL has occurred with both breast augmentation and breast reconstruction. That's another question that we need answered. It appears to be related to the implant, not to the reason for getting an implant.

Medscape: Let's talk about the registry. Did the FDA initiate this by themselves? What drove them to do this project?

Dr. Haeck: The FDA sees ALCL as a safety signal in their ongoing approval of breast implants. After all, they're charged with monitoring all medical devices. As they started to look at these cases, they felt they had to let both plastic surgeons and patients know about it, but they also felt that it was an opportunity to start this registry so we could get more information about it. They're very proactive about assembling the data from these cases and any new cases that may arise.

Medscape: Was the ASPS involved in doing the review?

Dr. Haeck: Yes. We've worked with them for many months getting this ready.

Medscape: So, it's really a joint project?

Dr. Haeck: Yes. It's the first time ASPS has done a joint project with the FDA, and we're very excited about this. We also look forward to possibly doing other joint efforts with them.

Medscape: What form will the ALCL registry take?

Dr. Haeck: The registry will have an investigator and a scientific committee. Scientists will be invited to use the data in their own studies. Registries are basically a repository of information for researchers to use to test their hypotheses and form conclusions. We will have a chief epidemiologist on the registry, but he or she won't be the only one with access to the data; other epidemiologists and pathologists will be able to use the data, too.

Medscape: How will the information be collected?

Dr. Haeck: The biggest step is to start with the 34 cases the FDA identified and go back to obtain more data, such as the pathology slides. When tissue is taken out of the body, it's put into paraffin and then very carefully sectioned off to go into the slide. In some of these cases, we were unable to get that paraffin block, and in other cases, the paraffin block still exists. So the very first thing is to get those pieces of data from these cases for further analysis. Then we need to obtain answers to some basic questions about the patients, such as "How long has she had the implant? What type of implant was it? Where was it put in?" Right now, much of that information is incomplete, which is why we have to go back and try to get it.

Medscape: What about new cases? How will those be included?

Dr. Haeck: They'll be identified by plastic surgeons who have done the surgical excision of the tissue and then contacted us at ASPS. The registry is needed because, beforehand, there were scattered reports in the literature but no way to really put it all together to get the big picture. There are differences of opinion among researchers as to what kind of lymphoma this is, and some people have even questioned whether it's lymphoma at all, because of its extremely benign course. When the FDA came to the ASPS and talked to us about doing a registry with them, we were very excited.

There is also talk that at a later stage, when the World Health Organization reviews lymphoma classifications, which they do every 3 years, of asking them if we can have the experts actually look at ALCL. It behaves more like a lymphoma of the skin, which can be cured with surgical excision.

Medscape: Can a registry give you clearer details than a literature review?

Dr. Haeck: Yes. Plus, an advantage of getting all these cases into a registry is that it eliminates having to deal with HIPPA (Health Insurance Portability and Protection Act) issues as much – not that there will be identifying patient details available. It's just that some of the privacy laws we have to deal with hinder our ability to capture, for instance, the pathology slides from cases 5-10 years ago. Having the FDA involved means it will be easier to get the needed data. We'll get information a lot faster on some of these older cases.

Going forward, virtually everything that's available will be turned over to the registry. Then, the information in the registry will be open to review by epidemiologists and pathologists. We'll get to the critical questions that people want answered a lot faster this way. But I'll repeat, identifying details about patients won't be accessible.

Medscape: What should the plastic surgeon tell patients about ALCL and breast implants?

Dr. Haeck: The plastic surgeon should tell patients to monitor their health, do their breast self examinations, and not change their routines. There is nothing subtle about this condition when it occurs. When a woman suspects she has changes to her breast, she needs to see a board certified plastic surgeon. If she can't find her original surgeon, she can go to the ASPS Website where we have a "Find a surgeon" search tool.

Medscape: What sort of changes should patients look for?

Dr. Haeck: Swelling and pain. Those are the hallmark presentations.

Medscape: What should surgeons tell patients who are considering getting breast implants?

Dr. Haeck: The FDA still considers breast implants to be safe and effective, and no changes in their recommendations have been made since this has come to light. When women with implants do self examinations, this condition is easy to detect. ALCL is rare and does not pose any threat to a patient's overall health. The benefits of getting a breast implant are not outweighed by the extremely low risk for this condition.

Medscape: Is there any idea how long these growths might happen after an implant is put in?

Dr. Haeck: Of the 34 confirmed cases, the average appears to be about 8 years. One occurred 23 years after getting the implant. In 1 case report the ALCL developed in just 1 year; we want to study that case.

Medscape: Would you like to add anything else?

Dr. Haeck: Yes. The FDA continues to believe that implants are safe and effective. That has not changed as a result of this. The FDA continues to tell people "this is not breast cancer," and "implants do not cause breast cancer."

Medscape: Thank you for explaining all this to Medscape readers.

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