FDA Recommendations re: Lymphoma &Breast Implants

FDA Recommendations re: Lymphoma &Breast Implants

On January 26, 2011 the American Health Authorities have released a safety signal on Anaplastic Large Cell Lymphoma (ALCL) in women with breast implants.
Although the number of patients who developed the disease is extremely small (34 identified cases out of an estimated number of 5 to 10 million women with breast implants), patients should be informed and follow the recommendations of the FDA closely.

FDA Advice to Patients:

If you have breast implants, there is no need to change your routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants. Although not specific to ALCL, you should follow standard medical recommendations including:

  • Monitoring your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment. For more information on self breast exams, visit Medline Plus: Breast Self Exam.
  • Getting routine mammography screening.
  • If you have silicone gel-filled breast implants, getting periodic magnetic resonance imaging (MRI) to detect ruptures as recommended by your health care provider. The FDA-approved product labeling for silicone gel-filled breast implants states that the first MRI should occur three years after implant surgery and every two years thereafter.

If you do not currently have breast implants but are considering breast implant surgery, discuss the risks and benefits with your health care provider. You may also visit FDA‘s Breast Implants website for additional information.

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