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FDA Advises Women with Breast Implants about ALCL

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Uploaded on Jun 15, 2011

[vpmedicaldevices] FDA Advises Women with Breast Implants about ALCL

If you or someone you know has breast implants, or if you're thinking about getting them, you may have heard of Anaplastic Large Cell Lymphoma or ALCL. FDA recently announced that women who have breast implants may have a very small but increased risk of developing ALCL in the scar tissue surrounding the implant.

Like other lymphomas, ALCL is a cancer of the immune system. It's not a cancer of the breast tissue.

FDA is aware of about 60 reports of ALCL worldwide in women with breast implants, which is a very small number compared to the estimated 5 to 10 million women who have breast implants. In most cases, these women went to their health care providers after noticing changes in the look or feel of the area around their implants --- changes like swelling, pain, lumps or asymmetry --- where one breast becomes different in size or shape than the other. These changes usually occurred years after first getting the implants.

When these women were diagnosed with ALCL, most of the them were treated by removing their implants and the surrounding scar tissue. Some of these women also received chemotherapy or radiation therapy or both. Some researchers think that ALCL in women with breast implants may be less aggressive than the more common form of the disease but at this time, there isn't enough information to say for sure.

Because there are so few cases of ALCL in women with breast implants, we also can't confirm that breast implants cause ALCL, or know if certain kinds of implants increase the risk more than others. FDA is gathering additional data so we can learn more about ALCL in women with breast implants.

So if you have breast implants, what should you do?

If you don't have symptoms, FDA does not recommend getting your implants removed only because you're concerned about developing ALCL. Just continue your routine medical care, including your regular breast screening evaluations. If you do notice changes in the area around your implant, have it evaluated by your healthcare provider.

You can get the most current information about ALCL and breast implants at www.fda.gov/breastimplants.

Links:
www.fda.gov/MedWatch

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