What is conclusive: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.
- 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.
…..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)