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Brett Emison
Brett Emison
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Breast Implants Linked To Rare Cancer, Says FDA

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The FDA announced yesterday that there is a potential link between breast implants and a rare form of cancer, Anaplastic Large Cell Lymphoma, (ALCL). According to this FDA report approximately 1 in 500,000 women are diagnosed with this disease in the U.S. each year. It is even rarer for the cancer to occur in the breast with about 3 in 100,000,000 U.S. cases annually.

The FDA has said it found 60 cases of ALCL and has verified 34 instances of the disease in breast implant recipients since 1997.

[FDA illustration showing location of ALCL in patients with implants]

It is important to note that ALCL is not breast cancer, even when found in the breast area. Rather than cancerous breast tissue, ALCL is actually a form of lymphoma, which is a cancer of the cells of the immune system which can occur almost anywhere in the body including in lymph nodes, bones, skin and other organs. In cases where the woman has breast implants, it is most often found in the area around the implant, within the “fibrous scar capsule”.

The FDA has advised women with breast implants that if you are not experiencing any symptoms, there is no need to contact your doctor. However, if you have observed a change in the look or feel of the area surrounding the implant or experienced persistent swelling or pain, you should consult with your physician to rule out ALCL.

Questions and Answers from the FDA:

Q. What does FDA want women to know about breast implants and ALCL?

A. Although the risk is quite small, we want women to be aware that there have been reports of ALCL occurring around saline and silicone gel-filled breast implants. In the cases reported, ALCL was typically diagnosed years after the implant surgery. In most of these cases, the women were diagnosed after they observed changes in the look or feel of the area surrounding the implant.

Q. What advice is FDA giving to women?

A. If a woman with breast implants has no symptoms, FDA does not recommend doing anything additional. Women should continue monitoring their implants and obtaining regular breast screening evaluations. FDA does not recommend removing the implants.

Q. How long will it be until FDA has more information?

Women who see changes in the way the area around the implant looks or feels—including swelling or pain around the implant—should see a physician for evaluation.

Women considering breast implants should be aware of the very small, but increased risk of developing ALCL and discuss it with a physician.

Q. How long will it be until FDA has more information?

A. Depending upon the number of reports the registry receives, we may have information that we can share soon. If we receive only a few reports, it may take some time to get the information we’re looking for—such as whether this is a new type of ALCL and if the type of implant has an impact on ALCL development

Because the risk of developing ALCL is very small, the existing data support the continued marketing and use of breast implants. FDA will provide updates as new information becomes available.

In the United States, breast implants are sold by Allergan, Inc. and Johnson & Johnson subsidiary, Mentor.

According to a report by The Wall Street Journal, health officials have advised patients not to panic or have their implants removed if they do not have symptoms. However, breast implant patients should have routine checks with their doctors because of the increased risk.

Additional resources and information:

(c) Copyright 2011 Brett A. Emison