[The following information is current as of October, 2017]

What is BIA-ALCL?

Anaplastic Large Cell Lymphoma is a malignant cancer that has been discovered to rarely occur with some textured breast implants, hence “Breast Implant Associated” ALCL.  Although associated with the breast in these cases, it is not a typical breast cancer.  It is easily cured with surgical removal of the implant, breast capsule, and tumor when discovered early.  However, if not discovered early, it can be fatal.  Although treatment with chemotherapy may be necessary for more advanced cases, this is not needed for early cases, and in fact deaths have occurred from complications of therapy in a couple patients where disease was treated too aggressively.  Early intervention with surgery alone would have likely been curative in these cases.

 

Is it associated with all breast implants?

No.  It has never been seen with smooth implants, only textured implants.  But it is also mostly seen with Allergan textured implants or polyurethane textured implants (not available in US), with just about one third of all cases associated with other implant brands, including a handful of Mentor cases and one Sientra.

 

How rare is it?

There have been just over 400 cases identified worldwide.  It’s prevalence seems to vary with location, which might indicate a genetic or environmental factor in its predisposition.  In the United States, the rate is about 1 in 30,000 textured implants, while in Australia the rate is estimated to be between 1 in 10,000 to as high as 1 in 1000.  It seems less common in Asian countries.

 

What causes it?

This is still under investigation.  There are a few things that seem to contribute to BIA-ALCL.  An unusual bacteria has been found inside the breast capsule and around the implant that seems to be supported by implant texture, particularly Allergan’s proprietary texturing.  Some individuals, with an as yet unknown genetic susceptibility, react to this microbiome with what on a cellular/cytokine level seems similar to an allergic reaction, triggering overproduction of certain T-lymphocytes.

 

How is it diagnosed?

BIA-ALCL typically presents as a fluid accumulation (seroma) around a breast implant, usually several years later (2-28, average 5.8 years).  Of these “delayed seromas” in patients with textured implants, about 10% will have ALCL.  A fine needle aspirate is done to remove the fluid and a screening test for CD30 is done.  If this is positive, more specific testing is done for ALCL.  Imaging studies will help stage the tumor and plan for treatment.

 

What is the treatment?

85% of BIA-ALCL is cured with surgery alone.  In more advanced cases, the chemotherapeutic agent Brentuximab seems effective and safe.  More traditional chemotherapeutic regimens such as CHOP don’t fare as well, and aggressive stem cell transfer therapy seems unnecessary and dangerous.

 

What is being done to learn more?

A collaborative database has been established to collect data on BIA-ALCL patients and help patients find proper treatment.  Many surgeons, pathologists, and oncologists are unaware of this tumor and benefit from guidance being formulated by leaders in this research including the M.D. Anderson Cancer Research Center in Houston.  Some investigators are studying specific issues, such as the implant biofilm and its associated bacteria and ways to target it. Research is investigating characteristics of texture, microbiome, and the body’s immunological response that may lead to BIA-ALCL

 

Should Allergan textured implants be removed or replaced?

Prophylactic removal or replacement of textured implants is not recommended at this time.  Certainly any delayed seroma around an implant should be aspirated and analyzed as noted above.  

 

What can be done to prevent BIA-ALCL?

Minimizing contamination and bathing the implants with antibiotic solution at the time of surgery is standard practice.  Using smooth implants, or textured implants that have extremely low rates of BIA-ALCL should minimize its occurrence.

 

Where can more information be found?

These links have more information, and additional resources and links:

FDA webpage on BIA-ALCL

American Society of Plastic Surgeons

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