DALLAS – Jan. 26, 2011 – Today the Food and Drug Administration (FDA) announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL). The FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant.
“It is unfortunate that women who have battled breast cancer and have moved on to survivorship have to consider this possible association with ALCL, even in rare circumstances,” said
Elizabeth Thompson, president of Susan G. Komen for the Cure®.
ALCL is extremely rare, diagnosed in only 3 of 100 million women in the United States without breast implants. The FDA is aware of about 60 cases of ALCL worldwide in women with breast implants, which is small compared to the estimated 5 to 10 million women who have implants worldwide. The FDA is asking health care providers to be vigilant in considering ALCL and reporting confirmed cases to the FDA for further study. The FDA does not recommend that women without symptoms consider removal of their implants, nor do they suggest any change in routine medical care or follow-up.
Susan G. Komen for the Cure encourages all women to know their bodies and know what is normal for them after reconstructive surgery. Women should report any changes – such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed – to their breast oncologist or plastic surgeon, preferably a physician with specialized training in breast surgery. Women who are considering breast implants as part of their reconstructive surgery should talk to their surgeon about the risks and benefits.
