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FDA Reports On Association Of Breast Implants And A Rare Form Of Cancer

The FDA [has] 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 five and 10 million. These numbers translate to between six 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 one 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 three 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. In my expe­rience as an oncol­ogist, lymphoma — including ALCL — can be very subtle.

*This blog post was originally published at Medical Lessons*

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One Response to “FDA Reports On Association Of Breast Implants And A Rare Form Of Cancer”

  1. DrJohnDiSaia says:

    I have seen such a case and the diagnosis was not straightforward. Still the number of women involved is tiny relative to those affected by more common breast cancers. It will likely be more commonly associated with silicone gel implants if they ever get enough cases to do meaningful statistics. I am not a big fan of gel implants.

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