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Due to very careful surveillance, monitoring and reporting of breast implant related issues by the plastic surgery community and professional organizations, a relatively “new” and very rare entity has been identified. This pathological occurrence has been categorized as Breast Implant Associated-Squamous Cell Carcinoma (BIA-SCC). Its existence has just been recently publicized by a Food and Drug Administration (FDA) safety communication).

Though it may be confused with the very rare disease Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL), the two disease processes are completely unrelated though they both involve the capsule that forms around breast implants. BIA-ALCL is a type of lymphoma whereas BIA-SCC is an epithelial cell based one – different cell lines and far different prognoses. For more information on BIA-ALCL, you can refer to Important Information About Allergan’s Textured Surfaced Breast Implant Recall.

What is BIA-SCC?

This is an extremely rare but generally aggressive tumor that seems to originate in the implant capsule that forms around breast implants. It can grow and invade the local surrounding tissues as well as spread to lymph nodes and other tissues of the body like muscle and bone.

This is not a breast cancer.

How Rare is BIA-SCC?

There have been between 16 and 18 reported cases in total worldwide. For perspective, though it is impossible to precisely determine the total number of patients who have had placement of the modern day breast implants (since 1962), for either cosmetic or reconstructive reasons, this number may very well be in excess of 12 million worldwide. Mathematically, 16 cases out of 12,000,000 translates to an incidence of around 0.00013%. In fact, this is so incredibly rare that, for comparison, more people have orbited the moon from all countries, 24, than have so far been diagnosed with this disease.

Are There Any Known Etiological Factors Causing BIA-SCC?

Because BIA-SCC is so incredibly rare, not very much is known about etiological factors. However, it has been identified in association with both smooth and textured breast implants as well as with both saline and silicone implants. It has also been seen in both cosmetic and reconstructive patients.

Those individuals who have developed this disease, generally have had their implants in place for many years. The average duration has been 22.74 years, ranging from 11 to 40 years.

How Does BIA-SCC Present in Patients?

The very limited number of patients who have been diagnosed with BIA-SCC often have unilateral breast swelling that has been associated with pain and even redness. Firmness around the implant, known as capsular contracture, is often present.

All these are very non-specific findings and can be present with many other issues. BIA-SCC is at the bottom of that list for suspicion and probability.

How is BIA-SCC Diagnosed?

In light of the presenting factors, the diagnosis can be made with a few tests. An ultrasound is performed to both evaluate for the presence of fluid around the implant and to perform an aspiration of the detected fluid. This fluid is then assessed for certain markers and cells that are diagnostic for this tumor. An MRI is done to evaluate the capsule around the implant and to determine if there are any masses present.

What is the Treatment for BIA-SCC?

Based on the very limited number of cases of BIA-SCC, the present official recommendation is for the surgical removal of the implant along with a complete capsulectomy. Anything less than that can lead to an early and possible aggressive recurrence.

Adjuvant chemotherapy and radiation therapy do not appear to have any positive therapeutic impact whatsoever.

Clinical Considerations

If you have breast implants, whether for cosmetic or reconstructive reasons, and have noticed one or even both sides inexplicably increasing in size, possibly associated with pain and hardness around the implants, should you panic and worry about BIA-SCC?

Of course not!

This could represent manifestations of many far less severe processes including a ruptured implant.

What you should do is contact either your Plastic Surgeon or a reputable, board certified Plastic Surgeon and have your situation thoroughly assessed.


To schedule your consultation with me, you can either call us at (480) 451-3000 or contact us by email.

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


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