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FDA Advises Health Care Providers about Breast Implants and ALCL

FDA Advises Health Care Providers on Breast Implants and ALCL

FDA is notifying healthcare providers that women with breast implants may have a very small but increased risk of developing Anaplastic Large Cell Lymphoma in the area immediately surrounding the implant. Anaplastic Large Cell Lymphoma, or ALCL, is a rare type of non-Hodgkin's lymphoma.

FDA is aware of about 60 reports of ALCL diagnosed in women with breast implants, so this is a rare finding given that an estimated 5 to 10 million women have received breast implants worldwide.

FDA conducted a detailed review of 34 cases reported in the scientific literature. These cases occurred in women with saline and silicone-gel filled breast implants. The women sought treatment for implant-related problems that usually occurred years after getting the implant --- problems such as pain, lumps, swelling, or asymmetry. You can find FDA's analysis of these cases on www.fda.gov/breastimplants.

Here are FDA's current recommendations for healthcare providers who care for breast implant patients:

- Continue to provide routine care to your patients--keeping in mind that ALCL has been diagnosed in the peri-implant region of some women.

- If you suspect ALCL, refer the patient to an appropriate specialist for evaluation.

- To test for ALCL, obtain fresh peri-implant seroma fluid and representative portions of the fibrous capsule for pathology evaluation.

- If your patient is diagnosed with peri-implant ALCL, individualize her treatment plan using a multidisciplinary team approach. There is no uniform or standard treatment for peri-implant ALCL. Most patients have been treated with surgery and some patients also received radiation therapy, chemotherapy or both.

- For asymptomatic patients, FDA does not recommend prophylactic breast implant removal solely due to concerns related to the development of ALCL.

We don't know if breast implants cause ALCL or if certain kinds of implants increase the risk more than others. To better characterize this disease, FDA is
asking clinicians to report all confirmed cases of ALCL in women with breast implants to MedWatch, FDA's safety and adverse event reporting program. You can report online at www.fda.gov/MedWatch or by calling 1-800-332-1088.

Links:
www.fda.gov/breastimplants

www.fda.gov/MedWatch

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