Most Patients with either saline- or silicone gel�filled breast implants may have a very minute but significant risk for a rare cancer called anaplastic large-cell lymphoma (ALCL), a cancer of the immune system, contiguous to the implant. This is currently under investigation and its existence should be considered if there is a make up or collection around the implant (seroma) years after the original surgery. Because the risk is very small the current policy is one of data collection only and no changes have been suggested for the use of breast implants or the frequency of follow up after breast implant surgery. The FDA continues to state that breast implants are "safe and effective when used as labeled."
The ALCL can occur anywhere in the body in the absence of breast implants. Recently it is diagnosed in 1 of every 500,000 women per year in the United States. ALCL in the breast is rarer still, diagnosed yearly in roughly 3 of every 100 million women without implants. In women with breast implants, it is usually inside the fibrous scar tissue � called a capsule � surrounding the implant. It is not a cancer of the breast per se.
ALCL associated with breast implants is restricted to the fluid within the capsule and the inner wall of the capsule. It can occur whether the breast implants were placed for cosmetic (breast augmentation) or reconstructive purposes (reconstruction after breast cancer surgery).
Options for Treatment of ALCL are chemotherapy, radiation, and surgery. The ALCL found related to breast implants is less aggressive and is sometimes treatable by simply removing the implant, the capsule, and the collected fluid resulting in a cure. Those patients who have had new implants placed at the time of lymphoma and prior implant removal have not had a recurrence of the lymphoma to date. The problem is in most capsulectomies with implant exchange the back wall of the capsule is repeatedly left at least partially intact. In cases with ALCL it is imperative that no capsule be left behind. An FDA review of scientific literature published from January 1997 through May 2010 uncovered 31 unique cases of ALCL in women with breast implants throughout the world. As of this writing the FDA is aware of 60 cases in all, some of them recognized through other channels. The FDA does not know how many of the 60 may be duplicates of cases found in the literature. An estimated 5 million to 10 million women worldwide have acknowledged breast implants, according to the FDA.
Since the small number of cases worldwide the immense majority of plastic surgeons will not see a single case in a lifetime of practice and the current recommendations for women with breast implants are:
Do not change your routine medical care and follow-up because ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants Monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment.
Find routine mammography screening.
If any of you have silicone gel-filled breast implants, get 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.
Risk for breast cancer is 1 in 9 and the risk for ALCL is 1 in 500,000.
The American Society of Plastic Surgeons is collaborating with the FDA to develop a centralized registry to gather more information on existing case reports and any new cases that may be identified going forward. Only patients with confirmed ALCL will be entered into the registry. It is estimated that only 2 or 3 patients will be entered into the registry per year.
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