Monday, January 31, 2011

ALCL and Breast Implants

Last week, the U.S. Food and Drug Administration requested health care professionals to report confirmed cases of anaplastic large cell lymphoma (ALCL) in women with breast implants.

The FDA made this request as they continue to investigate a possible association between breast implants, both saline and silicone gel-filled, and ALCL.

The definition given of ALCL by the National Cancer Institute calls ALCL an aggressive type of non-Hodgkin lymphoma, but oncologist Elaine Schattner, M.D. concludes after studying the FDA’s assessment (bold emphasis is mine)

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.

 

The FDA cites the Surveillance, Epidemiology, and End Results (SEER) Program of the NCI when noting ALCL is diagnosed in the United States in  approximately 1 in 500,000 women each year. ALCL in the breast is even more rare; approximately 3 in 100 million women per year in the United States are diagnosed with ALCL in the breast (Altekruse et al., 2010).

The FDA press release mentions an awareness of about 60 cases of ALCL in women with breast implants worldwide.   The same press release later notes “a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants.”

There are an estimated 5 million to 10 million women worldwide who have breast implants.

Among the 34 unique cases, the median age was 51 (28-87, with no age given in 8 cases); implant type (24 silicone, 7 saline, 3 unknown); implant texture (4 textured, 0 smooth, 30 unknown); median time from implant to diagnosis was 8 years (1-23, but not known in 11 cases); reason for implantation (11 reconstructive, 19 augmentation, 4 unknown).

The FDA notes (bold emphasis is mine):

ALCL is a very rare condition; when it occurs, it has been most often identified in patients undergoing implant revision operations for late onset, persistent seroma. Because it is so rare and most often identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, it is unlikely that increased screening of asymptomatic patients would change their clinical outcomes. The FDA does not recommend prophylactic breast implant removal in patients without symptoms or other abnormality.

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The FDA is requesting health care professionals report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

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Women with implants should remember ALCL is extremely rare.  There is no need to change your routine medical care and follow-up.  For more information from the FDA:
Breast Implant Consumer Information

ALCL and Breast Implants Consumer Article

 

Other blog posts on topic:

An Oncologist Considers Rare Lymphomas in Women With Breast Implants; Medical Lessons Blog (January 28, 2011)

Breast implants and anaplastic large cell lymphoma (ALCL): Is there a link?; Science-Based Medicine Blog (January 31, 2011)

 

REFERENCES

FDA Review Indicates Possible Association Between Breast Implants and a Rare Cancer; January 26, 2011

Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses; FDA

Breast Implants and Lymphoma Risk: A Review of the Epidemiologic Evidence through 2008; Plastic & Reconstructive Surgery. 123(3):790-793, March 2009; Lipworth, Loren Sc.D.; Tarone, Robert E. Ph.D.; McLaughlin, Joseph K. Ph.D.

Anaplastic large-cell lymphoma in women with breast implants; JAMA. 2008;300:2030-2035; De Jong D, Vasmel WLE, de Boer JP, et al.

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