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FDA Issues Report on Extremely Rare Occurrence of ALCL In A Few Women With Breast Implants

The Federal Drug Administration (FDA) just issued a press release regarding the appearance of a very rare type of cancer that has been found in some women who have either saline or silicone breast implants. In these women, anaplastic large-cell lymphoma (ALCL) has been identified in the capsule (scar tissue) that forms around breast implants along with the accumulation of fluid known as a seroma. Despite these few cases, there is no evidence that there is any direct cause and effect and so more studies will need to be conducted to determine whether or not there is any relationship.

ALCL is extremely rare in general with an annual incidence in this country of 1 out of every 500,000 women. The rate of occurrence with the primary location in the breast is an infinitesimally microscopic 3 in 100,000,000 women per year. Worldwide, there have been somewhere between 34 and 60 cases of this disease out of an estimated total of 10 million or more women who have had breast implants.

How insignificant is this? The average annual risk of developing primary breast cancer in American women is 123 per 100,000 which is equivalent to 123,000 cases per 100 million women. This translates to a risk that is 41,000 times more common than ALCL.

The form of ALCL that has been identified in women who also have breast implants is a relatively “benign” disease that presents with a consistent constellation of symptoms that can facilitate the diagnosis once a level of suspicion is raised. These findings include the onset of pain in the affected breast associated with a mass and a rapid increase in size as a consequence of the accumulation of fluid. The median time of occurrence of ALCL following the placement of breast implants is 8 years.

Once the diagnosis is made, treatment is straightforward and curative with no need for chemotherapy or radiation therapy. The cure is simply the removal of the scar tissue (capsule) that surrounds the implant which is the location of the disease. Some of the affected women actually had new implants reinserted without untoward consequence though studies will need to be performed to determine the advisability of this. Importantly, there have never been any report of death associated with ALCL.

To sum up the findings of anaplastic large-cell lymphoma (ALCL) with regards to breast implants:

  1. no association has been firmly established between the disease and either saline or silicone breast implants
  2. the constellation of presenting symptoms can make the diagnosis of this relatively easy with a level of suspicion
  3. the disease is quite benign and completely cured with surgical removal of the capsule surrounding the breast implant
  4. there is no need for chemotherapy or radiation therapy
  5. no deaths have been reported

For more information on ALCL, you can read the FDA’s report.

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

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