FDA Reports on Extremely Rare Finding of ALCL In A Few Women With Breast Implants

The FDA just announced that there may be an extremely small risk of the development of a rare type of cancer in women who have either saline or silicone breast implants. This release was in response to some reported cases of anaplastic large-cell lymphoma (ALCL) found in the scar tissue surrounding breast implants and associated with the presence of fluid. No definitive association has been established and more studies will need to be performed to determine if there is any relationship.

ALCL is quite rare, being diagnosed in 1 out of every 500,000 women in this country annually. Its annual incidence with the primary location being the breast is an infinitesimal 3 in 100 million. The total number of women with breast implants reported to have this disease is somewhere between 34 and 60 worldwide out of an estimated 10 million or more women who do have breast implants.

To put this into perspective, the average yearly risk of primary breast cancer in American women is 123 per 100,000 which translates into 123,000 per 100 million women or 41,000 times more common than ALCL. In other words, this is nothing to lose sleep over.

The particular form of ALCL that has been found in women who have breast implants is fairly “benign” and not very difficult to diagnose once suspicion is raised. Those who have been diagnosed with this disease presented with the onset of pain, a palpable mass in the breast and a sudden enlargement in size secondary to a fluid accumulation known as a seroma. The average time of occurrence following implant placement has been around 8 years.

Treatment has been found to be straightforward and completely curative. This “simply” involves the removal of the capsule which forms around the implant and which is the location of this tumor. Although several of these women had new implants reinserted, studies will need to be performed to determine the advisability of this. There have been no reported deaths in any of the women who have been diagnosed with ALCL and there is no indication for chemotherapy or radiation therapy.

In summary, though anaplastic large-cell lymphoma (ALCL) has been found in a few women who have breast implants, no definite association has been established. The disease is extremely rare and seemingly “benign” in course, easily diagnosed by symptoms, completely curable and not associated with any deaths. For more information, you can check out the FDA’s report on this as well the American Society of Plastic Surgeons website.

If you have any questions regarding this news or any other questions regarding cosmetic or reconstructive breast surgery or any other plastic surgery procedure that I perform or to schedule a complimentary consultation, please feel free to call my office at 480-451-3000.

Steven H. Turkeltaub, M.D. P.C.
Scottsdale and Phoenix, Arizona

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