Is Rare Breast Implant Risk Cancer, or 'Condition?'

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Several doctors interviewed about the findings countered that just because the patients were aggressively treated doesn't mean the powerful treatments were necessary, noting that several of the cases arose in breast cancer survivors previously treated with types of chemotherapy known for their potential to produce cancers of the lymph system years later.

Still, the very presence of this apparent disease in these women worries some doctors. Dr. Kristi M. Funk, the Beverly Hills breast surgeon who diagnosed singer Sheryl Crow's breast cancer in 2006, said she'd never seen a case of ALCL, but that any pain, swelling or change in the breast "has to be evaluated. If it's present, it requires treatment of some sort. That in and of itself makes it more than benign. Whether it turns out to be ALCL is inconsequential."

Funk termed it "inappropriate to try to pretend it's not a tumor or a disease or not a malignancy. Calling it some kind of implant capsule reaction that's benign is misleading." She said that in the general population, only 3 out of 100 million women without implants get ALCL in the breast area, compared with a reported 34 of 10 million women with breast implants. "That does raise eyebrows. That's a very significant increase between women with implants and women without implants."

Because the case reports involve both silicone and saline implants, the FDA has refrained from saying one type is more responsible than another. Funk however, noted that of 34 reported cases, seven were saline, 24 were silicone. She hypothesized that there could be something "a little bit more immune-stimulating in the silicone group." Combined with her observations of intact silicone gel implants "sweating to the lymphatic system" where she can sometimes see silicone in the lymph nodes of the armpit, she said that it's possible that in some genetically predisposed people, implants may cause "their body to create these immune responses prematurely."

FDA Needs More Data; Asks Doctors to Report All Confirmed Cases

The FDA, which on Jan. 26 released preliminary findings and analyses of published case reports of ALCL among women with breast implants, issued a statement Thursday acknowledging receipt of Public Citizen's letter and saying it would respond "directly to the group."

The agency has said "additional data are needed to fully understand the possible relationship between ALCL and breast implants" and has asked doctors to report all confirmed cases. In addition, the FDA called for establishment of a registry of cases, while maintaining its official position that "FDA-approved breast implants are safe and effective when used as labeled."

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