Stunning Comments on the Risk of Breast Implants, and Cancer

The FDA recently identified a link between breast implants and a rare form of lymphoma. From today’s report in the New York Times:

When talking to patients about a rare type of cancer linked to breast implants, plastic surgeons should call it “a condition” and avoid using the words cancer, tumor, disease or malignancy, the president of the American Society of Plastic Surgeons advised members during an online seminar on Feb. 3.

This is how doctors spoke to patients 50 and 100 years ago, and in some cultures still do, by not mentioning scary words – especially to women, and not calling a cancer what it is.

Cosmetic verbage?

Most cancers aren’t lethal* is one message for 2011: the “big  C” turns out to be a spectrum of hundreds of diseases, each with distinct subtypes, and patients shouldn’t panic when they hear the word. Some are benign in behavior although technically malignant; others behave live chronic illnesses; some, unfortunately, grow fast and can kill.

Oncologists can have a hard time persuading patients that a slow-growing tumor doesn’t need much treatment. It would help if other doctors don’t shy away from the term – keeping it taboo and, ultimately, promoting fear.

shhhhh

*NCI – cancer incidence and mortality summary data, accessed 2/18/11

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An Oncologist Considers Rare Lymphomas in Women With Breast Implants

I have to admit that when I first read about the FDA’s report tying rare cases of anaplastic large cell lymphoma to breast implants, my mind raced with a strange blend of excitement, intense interest and concern. My thoughts shifted from “wow, that’s really interesting” to “exactly what did the FDA find” to “should I be worried?”

So I’ve decided to write this morning’s post from my perspective as an oncologist who spent roughly 15 years of her life studying the causes of lymphomas and related blood malignancies. Some readers of this blog, who fortunately at this point in ML’s slow-but-steady growth are mainly strangers, may be unaware that understanding rare lymphomas was what I lived for in my research work, which occupied the bulk of my time and thought, which I loved very much (as strange as that may seem to some) and which I miss intensely, still, today.

The reality, as very-carefully documented by the FDA in its excellent analysis (which, in my opinion, far surpasses that of most case series reported in the medical literature; I’d give the agency an A+ for detail, thoroughness, clarity and openness about the limitations of the findings thus far), is that these cases of ALCL are few and far between: a total of 60 cases, worldwide, as I reviewed in yesterday’s post. Sometimes just a few cases are indicative of a problem, and I think that is exactly what’s going on with these rare lymphomas.

The pathology is interesting: Essentially all of the ALCL cases are T-cell derived and express CD30. Anaplastic lymphoma kinase (ALK) was negative in each of 26 cases examined for that receptor. The findings are plausible in the context of an aberrant immune response – which can occasionally become malignant – to a foreign body or particular antigen associated with the implants. These oddly uniform characteristics among these rare lymphoma cases support that the FDA’s findings are not random.

Most of the ALCL tumors were limited to the area of the implant capsules, and could – as best I can tell from the few reports – be treated by removal of the implants and affected, adjacent breast tissue. These don’t appear to be aggressive lymphomas, as are some ALCL’s. I would go as far as to speculate that these might indeed be antigen-driven tumors; in this light, it would make sense in principle and in practice to treat these by removal of the implants, at least as a first-line approach.

So if I had a patient with this condition, I’d tell her that these lymphomas are very rare and, when they do arise, can usually be treated by removal of the implant. But I wouldn’t down-play the risk, which is tiny but real.

As an oncologist, I found most of the coverage of the FDA’s alert disappointing, the discussion dominated by plastic surgeons’ reassurances and device makers’ dismissals. Statements like “a woman is more likely to be struck by lightning than get this condition” – proffered by an Allergan spokeswoman as quoted and emphasized in the WSJ Health Blog, Bloomberg News, LA Times and elsewhere – are not helpful to women with implants who are genuinely concerned about their health.

Because I understand that once a woman has had one form of cancer, her risk of developing another tumor is elevated – from whatever genetic, environmental or other disposition she has for malignancy, and from treatment toxicity. Most of the women I’ve seen with implants after mastectomies have some problems considered minor – like thickening of the capsule and dimpling in peri-implant tissue. But these are the exact sort of abnormalities as described in the FDA’s alert, for which there is now a recommendation: evaluate and report cases to the FDA.

Ultimately this is an issue about informed consent – and I don’t mean by this the paperwork, but the reality of women with choosing, or not, to get breast implants. Doctors need more information about these rare lymphomas: how often these arise, why they occur, and how they should be managed so as to cause the least harm when and if treatment is necessary.

The FDA provides a helpful list of sources, from which I’ve selected those that seem most relevant (see reference page). Of historic interest, also, is a NEJM perspective from 15 years ago on the debate about rheumatologic illness, the public’s perception and risks associated with breast implants.

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FDA Reports on Association of Breast Implants and a Rare Form of Lymphoma

Yesterday the FDA issued an alert about a possible link between breast implants – saline or silicone – and a rare form of lymphoma called anaplastic large cell lymphoma (ALCL). These lymphoma cases are exceedingly rare, but the association appears to be significant.

The FDA identified a total of approximately 60 ALCL cases in association with implants, worldwide. Of these, 34 were identified by review of published medical literature from 1997 to May, 2010; the others were reported by implant manufacturers and other sources. The agency estimates the number of women worldwide with breast implants is between 5 and 10 million. These numbers translate to between 6 and 12 ALCL cases in the breast, per million women with breast implants, assessed over 13 years or so.

In women who don’t have implants, ALCL is an infrequent tumor, affecting approximately 1 in 500,000 women is the U.S. per year. This form of lymphoma – a malignancy of lymphocytes, a kind of white blood cell – can arise almost anywhere in the body. But ALCL cases arising in the breast are unusual. The FDA reports that roughly 3 in 100,000,000 women are diagnosed with ALCL in the breast per year in the U.S.

These are very small numbers. Still, the finding of ALCL tumors by the implant capsules is highly suggestive. Almost all of the implant-associated ALCL cases were T-cell type, whereas most breast lymphomas are of B-cell type. The lymphomas arose in women with both silicone and saline-type implants, and in women with implants placed for purposes or augmentation and for reconstruction after mastectomy.

The clinical features varied among the reported cases. From the FDA’s review:

… the median time from breast implant placement to ALCL diagnosis was 8 years, with a range from 1 year to 23 years. Most patients were diagnosed when they sought medical treatment for implant-related symptoms such as persistent seromas, capsular contractures, or peri-implant masses warranting breast implant revision operations. In each case, lymphoma cells were found in the effusion fluid (seroma) surrounding the implant, in the fibrous capsule, or within a peri-implant mass. Typically, there was no invasion beyond the fibrous capsule into the breast parenchyma.

Figure 1 illustrates the location of the reports of ALCL adjacent to the breast implant.

This illustration shows the breast implant placed under the skin and breast tissue. The implant is separated from the breast tissue by a fibrous scar capsule. ALCL lymphoma cells are shown in the effusion fluid between the breast implant and the capsule and attached to the capsule itself.

Figure 1. Presence of ALCL cells in close proximity to a breast implant. In most cases, the ALCL cells were found in the effusion fluid (seroma) surrounding the implant or contained within the fibrous capsule. ALCL is lymphoma, a type of cancer involving cells of the immune system. It is not cancer of the breast tissue, and typically, invasion of the lymphoma beyond the fibrous capsule into the breast parenchyma was not observed. Modified from Thompson et al, (2010).

With such a small number of cases worldwide, it’s hard to draw evidence-based conclusions regarding the appropriate treatment of these rare lymphomas. More from the FDA:

Treatment was reported for 20 patients. Most had the implants removed, and some went on to receive treatment with radiation and/or chemotherapy. Overall, the outcomes appeared to be more favorable than would typically be expected for systemic ALCL. Outcomes were reported for 19 cases. Of these, 14 patients had no evidence of disease at last follow-up. However, most cases were diagnosed with early stage disease, and follow-up on many cases was limited.

At this time, the FDA is advising health care providers to be aware of the possible diagnosis, to carefully evaluate breast implant patients with suspected ALCL, and to report all confirmed cases to the agency.

As for patients, the situation is troubling. The incidence of these tumors is quite low, almost immeasurable, and the prognosis – based on the few treatment reports – seems good. But many women do have some fluid, contractures, thickening and other complications around the implant capsules. Most of those physical aberrations surrounding the implants are not lymphoma.

It’s a Pandora’s box, but one that needs be opened. The problem is that if we biopsy every abnormality – such as a minor thickening or fluid accumulation adjacent to a breast implant – we’ll hike up the costs and, more importantly, the complications associated: With every needle stick there’s a risk of infection, additional scar formation and more. On the other hand, you wouldn’t want to overlook a treatable, early-stage lymphoma. Women need to know of the risks of implants, which can only be determined if doctors thoroughly investigate these sorts of complications.

The LA Times quotes Dr. Phil Haeck, president of the American Society of Plastic Surgeons: “I think there’s reason to be concerned about this, but there shouldn’t be reason for panic,” he said. According to that article: “Signs of ALCL associated with implants ‘are pretty dramatic. There’s a lot of swelling and pain. They won’t miss it,’ Haeck said.”

I’m not so sure. Lymphoma, including ALCL in my experience as an oncologist, can be very subtle.

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Stem Cells, Breast Reconstruction and a Magazine Cover

The cover of the November print edition of Wired features large, unnatural-appearing cleavage. Inside and toward the back of the issue, a curious article ties together stem cells and the future of breast reconstruction. It got my attention.

Wired, November 2010 issue

The detailed and admittedly interesting piece, by Sharon Begley, describes what’s science or science fiction: first humans, such as some plastic surgeons, remove adipose tissue, a.k.a. fat, by a well-established cosmetic surgery procedure called liposuction, from a body part where there’s a fat surplus – such as the belly or backside; next, laboratory workers purify and grow what are said to be stem cells from that that fat; finally, they use a nifty, calibrated and expensive device to inject those fatty stem cells where women want, such as in a hole or dimpled breast where a tumor’s been removed.

The story starts, unfortunately and distractingly, with a portrait of a male, enterprising and PowerPoint presentation-giving CEO of a biotech company, Cytori Therapeutics. Toward the end of the article, the author provides stats to support the potential business. Ultimately, improved breast cancer survival means that greater numbers of women will live more years after a lumpectomy or mastectomy, she explains. The reconstruction market may expand further, still, because some women opt for prophylactic mastectomies upon positive genetic testing for a BRCA mutation. Others, without cancer or high risk, might simply want to use these adipose-derived stem cells for cosmetic breast augmentation. What’s clear, if nothing else, is that women’s breasts are perceived as a commodity.

In between the money elements of the discussion, there’s some cool science about adipose-derived stem cells, which according to the cited scientists are quite prevalent in fatty tissue and relatively easy to grow if you give them some blood to feed on in the lab. A putative advantage of the cells is that they draw blood vessels to the area of engraftment, which is a concern to this oncologist (me) and, evidently, to an FDA panel that has not yet approved of this innovative method of breast reconstruction in women who’ve had breast tumors.

I’m not convinced, at least from what’s reported in this Wired article, that the cells used in this process are true stem cells, based on the high numbers the scientists describe finding so readily, and in rich proportions, in human fat tissues. It could be, for example, that what they’re isolating are really primitive adipose cells that can, indeed blend into the breast tissue and even recruit blood vessels as described, but aren’t true, pluripotent stem cells – the kind that can form any kind of blood cell or heart cell or neuron. Perhaps stem cells just sound sexy, at least to investors.

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New NY State Law on Information for Women Undergoing Mastectomy

A few days ago, NY State Governor Paterson quietly signed a new public health law* on information and access to breast reconstructive surgery. From the details provided on my state’s Open Legislation website, it seems this took place on August 13.

The purpose of the new law is to assure that all women undergoing mastectomy in NY are told about reconstructive surgery options and that insurance will cover those additional procedures.

What’s curious are two things – first, why so little coverage of this event? It is end-of-summer, I suppose.

But maybe editors and people like me who are educated in medicine and read newspapers are out-of-touch with the fact that many women who have breast cancer – over 200,000 each year in the U.S. – still don’t really know about breast reconstruction during or after cancer treatment. In my community, people read books and ask multiple doctors in second and third opinion before deciding whether to undergo a trans-flap or have implants inserted and then, once electing for implants, attempt a careful review the not-so-current literature on silicone vs. saline…

The reality is that many women, particularly poor women without newspapers or internet access in their homes, don’t know about any of this. They don’t know their insurance covers pretty much all of these options, by law. Now they will, or should as of Jan 1, 2011. Good.

The other curiosity is that a Montefiore Medical Center-affiliated plastic and reconstructive surgeon is said to have authored this bill, which was sponsored by State Senator Ruth Hassell-Thompson. The doctor’s intentions were surely good; he advocated its passage based on the sad case of a single mom who, after undergoing mastectomy and seeing several physicians, still wasn’t aware that she might undergo breast reconstruction. Nonetheless, it’s not surprising that a plastic surgeon in the Bronx cares about this legislation.

There is a dark side to this, unfortunately. Even among the women with good insurance and purportedly top docs, the results of reconstructive breast surgery are sometimes devastating to the women who undergo these procedures. These are no boob-jobs, and there’s widespread misconception about that. So I hope the law, also, might eventually protect women from botched attempts at reconstruction, an under-reported problem that might also be newsworthy.

*addendum – first link above adjusted because the previous url, http://www.cnbc.com/id/38743477 is no longer available, ES 2/14/11

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