Wednesday, March 9, 2011

ALCL and Breast Implants – an article review

In light of the recent new regarding the FDA safety alert on the possible association of acute large cell lymphoma (ALCL) with breast implants, the authors of the recently Plastic and Reconstructive Surgery Journal article (full reference below, published online ahead of print) conducted a systematic literature search on the topic.

The search included the literature of PubMed, Embase, and Web of Science (Science Journals & Proceedings) databases.  Dates searched included references from 1966 for PubMed and Embase ; from 1980 for Web of Science; and from 1990 for Web of Science Proceedings, through July 2010 for all of them.

Research (categorized as epidemiologic studies or scientific papers) and non-research (case reports or case series) articles from peer-reviewed journals, conference abstracts, and unpublished manuscripts were retrieved from the literature search.

Only human-based topics and articles written in English were considered. Of the initial 884 titles, 83 articles discussed ALCL and breast implants. Fourteen additional articles were provided by 2 expert plastic surgeons (V.L.Y. and K.C.C.).

Their conclusions:

A form of ALCL, which clinically behaves more like the less-aggressive cutaneous form of ALK-negative ALCL rather than the more-aggressive systemic form, may be associated with breast implants. Future research on the epidemiology and biology of this rare disease is clearly needed to better understand its nature.

What is conclusive:

  • ALCL is a rare disease, comprising 2% of all newly-diagnosed non-Hodgkin’s lymphomas (NHLs) worldwide2 and 0.9% of the estimated 65,540 cases of NHL diagnosed in the U.S. in 2010.
  • Lymphomas of the breast are extremely rare, comprising 0.04-
    0.5% of all breast cancers and approximately 1-2% of all extranodal lymphomas.
  • Despite the rarity of both ALCL and primary breast lymphomas, multiple cases of ALCL developing adjacent to breast implants have been reported, including by Brody et al., who have recently presented but not yet published a series of 34 cases.
  • In 2009 alone, a reported 289,328 breast augmentation, 86,424 reconstruction, and 87,386 lift procedures were performed in the U.S.; unfortunately, the exact number of women who received implants is not known because only some breast reconstructions and lift procedures utilized implants.

The literature review noted the case presentation characteristics (bold emphasis is mine):

Fourteen (48%) of 29 ALCL cases were noted to have presented with a seroma, 1 (3%) ALCL case did not present as a seroma and data was not reported in the remaining 14 (48%) ALCL cases.

Seven (24%) of the 29 ALCL cases reported data indicating that the patient had a palpable breast mass on presentation, 5 (17%) reported absence of a mass and information was missing for the remaining 17 (59%) ALCL cases.

Less frequently cited symptoms among ALCL cases were pain [6/29 (21%], redness [4/29 (14%)], and capsule contracture [2/29
(7%)].

Other symptoms (e.g., skin lesions, fever) were reported in only 2 (7%) of 29 ALCL cases but in 5 (71%) of 7 patients with other NHLs [not reported in 27/29 (93%) ALCL and 2/7 (29%) non-
ALCL cases].

Duration of symptoms was rarely noted. In the 7 cases where it was, mean duration in years for ALCL cases was 0.8 (range 0.2-1.7). Mean symptom duration among 5 non-ALCL cases for which it was reported was 5.4 years (range 0.5-17).

…..

Remember the FDA report noted (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.

…..

Of interest is this post from Maggie Mahr:  The FDA “Has a Chat” With Plastic Surgeons 

………….It is probably not a coincidence that ASPSS and ASAPS repeated the cancer-denial line first promulgated by Allergan: Both organizations have received funding from the company. ASPSS has also received funding from Allergan’s main competitor, J&J, which makes the Mentor implant line. (Mentor’s reaction to the FDA warning was more muted than Allergan’s but its statement also avoided mentioning the C-word.)

Both Allergan and J&J fund provide funds for ASPSS, as noted on its web site.

At ASAPS, Allergan’s funding is more indirect. It has supplied research grants through ASAPS’ research arm, the Aesthetic Surgery Education and Research Foundation. You can see those grant award announcements by searching for “Allergan” here.

The two groups ought to be ashamed of themselves. It is one thing to take funding from drug and device companies . .  . . But the groups ought to represent the medical expertise of the healthcare providers who are their members, not the PR agendas of two companies who are afraid they may lose money from too much blunt but accurate talk about breast cancer.

 

 

 

Previous related posts:

ALCL and Breast Implants (January 31, 2011)

Breast Implants and Lymphoma Risk (June 29, 2009)

 

 

REFERENCE

Anaplastic Large Cell Lymphoma and Breast Implants: A Systematic Review; Kim, Benjamin; Roth, Carol; Chung, Kevin C.; Young, V. Leroy; van Busum, Kristin; Schnyer, Christopher; Mattke, Soeren; Plastic & Reconstr Surgery., POST ACCEPTANCE, 25 February 2011; doi: 10.1097/PRS.0b013e3182172418

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