Sunday, January 30, 2011


■FDA issues safety signal on ALCL and breast implants

The FDA on Wednesday warned that women with breast implants might be at a "small increased risk" of an immune system cancer called anaplastic large cell lymphoma after data revealed a total of 60 ALCL cases among those with saline and silicone implants. The FDA is seeking more data on ALCL cases and advises women with implants to consult their doctors if they experience implant-related symptoms, including pain, lumps or swelling.

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.
It is estimated that the incidence of ALCL in patients with breast implants is about 1:500,000, whereas, the risk of a woman developing breast cancer over their life-time is about 1 in 9.  To put things in prespective, one is much more likely to be stuck by a lighting bolt or an asteroid than developing ALCL of the breast.  The type of ALCL we are talking about is a rare condition that occurs within the capsule (scar tissue) surrounding the implant.  It is a T-Cell Lymphoma that is ALK negative. It is different than ALCL that starts elsewhere and spreads to the breast.  The ALCL condition that occurs in the capsule around the breast implant seems to be much more indolent than other types of ALCL.  It is usually cured by removing the capsule.  Whether radiation therapy and chemotherapy are necessary is still uncertain, although some physicians studying this condition feel that radiation and chemotherapy are not needed. It is usually a condition that occurs on just one side. There is no blood test available to diagnose this condition.  The most frequent presentation is a late seroma (fluid collecting around the implant) which causes swelling in the breast and pain.  A palpable lump may be another presentation. In other words, the patient knows something has changed within the breast so this is not a condition that occurs without symptoms or signs. This condition usually occurs years after having implants - the mean time is about 8-10 years.

Although not specific to ALCL, you should follow standard medical recommendations including:

· Monitoring your breast implants. If you notice any changes, contact me 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 me. 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 me. You may also visit FDA’s Breast Implants website for additional information.  The FDA has established a registery ( implants) to accumulate more information on this condition, and as more information becomes available, I will share it with you.