FDA Has New Health Advice for Women with Breast Implants

New information today from the U.S. Food and Drug Administration (FDA) of special interest to women with breast implants, and the family who love them.

The FDA announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. ACLC is not a form of breast cancer–it is lymphoma, a type of cancer involving cells of the immune system. Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.

This illustration shows the typical location of the ALCL that was diagnosed in patients with breast implants. ALCL is lymphoma, a type of cancer involving cells of the immune system. It is not cancer of the breast tissue. (From the FDA)

In an effort to gather more information, FDA and the American Society of Plastic Surgeons are establishing a registry of ALCL patients who have breast implants. FDA scientists hope the registry yields enough information to better understand what the risks for developing ALCL are for women with breast implants.

The message from Binita Ashar, M.D., a physician and FDA scientist evaluating ALCL cases is this:

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.

What does this mean for women who have or are considering breast implants? The FDA has some specific information:

  • 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.
  • 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.

The risk of anyone developing ALCL is very small–each year, only about 1 of every 500,000 women in the United States is diagnosed with this particular cancer. However, this new information suggests that women with implants have a higher risk than women without implants. This means that women who are highly cautious may choose not to receive implants…and that women with implants need to be more aware of breast changes, and to seek medical advice if changes are noticed.

In particular, women should watch for pain, swelling, lumps, or asymmetry. In addition, talk with your doctor if you have any of the more general symptoms of swollen lymph nodes…a lump in your armpit, neck, or groin…extreme fatigue…night sweats…chronic fever…unusual, unexplained weight loss.

In an effort to ensure that patients receiving breast implants are informed of the possible link between ALCL and breast implants, the FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and providers.

To read more about this issue from the FDA, click here:  FDA Advises Women with Breast Implants

We’ll continue posting information about this issue as it becomes available. If you have been diagnosed with ALCL and would like to talk with someone about your legal options, please don’t hesitate to call the attorneys of HensonFuerst at 1-800-4LAW-MED. If you have questions, HensonFuerst has answers.

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