What My Patients Should Know About BIA-ALCL

If you have breast implants or have been thinking about breast implants, you may have heard some chatter regarding something called Breast implant-associated anaplastic large cell lymphoma, otherwise known as BIA-ALCL, or simply ALCL. With a name like this, it sounds pretty scary and may well raise some questions about whether this is something that affects you. The short answer is most likely “probably not,” and if you are a patient of mine, you’ll be relieved to know that the smooth, round implants I use are not associated with ALCL. So, what’s the scoop on all this? Allow me to elaborate.

ALCL overview

ALCL is a rare lymphoproliferative disorder, like a lymphoma that can occur in the capsule, which is the tissue that surrounds a breast implant.  The first report of this was in 1997. In the subsequent ten years, a few cases popped up here and there. In 2011, the FDA identified a possible link between ALCL and breast implants. Since that time, a lot has been learned about ALCL, although we do not know the specific reason it occurs.  Thus far, about 575 cases of this have been reported worldwide.

We now know that BIA- ALCL only occurs in patients with textured or rough-surfaced breast implants. And, the rougher or coarser the texturing, the higher the risk. It is for this reason that the Allergan textured devices have been withdrawn from the market in this country as well as in other countries. It makes no difference if the implant is a saline or silicone implant. What matters is whether the surface of the implant is textured or smooth. If you have smooth implants, you should have nothing to worry about (and you can stop reading if you want to).

It’s all about the texture.

Textured implants were introduced around 25 to 30 years ago. Initially, it was thought that the texturing could lead to softer results. I was skeptical. Recently, with the increased use of anatomically shaped implants, textured implants have been more prevalent. The texturing is required so the implants will adhere to the surrounding tissues and stay in the proper orientation. This is not needed with round implants, which are the ones I use.

Only about 10 % of the implants used in this county are textured. However, in Europe, they are a lot more popular. While this may make ALCL in this country a bit less common, it remains something we need to be aware of. Again, if your implants are smooth (and if you have only had smooth implants), your risk is zero, or close to it.

If your implants are textured…

Generally, this condition will develop many years after the placement of textured breast implants. The affected side will develop considerable swelling due to fluid that collects around the implant. Usually, the diagnosis can be made from specialized testing of this fluid. Treatment involves the removal of the implant and the surrounding capsule. In most cases, this is all that needs to be done. However, there have been some cases where the disease had progressed due to delays in diagnosis and treatment, and further treatment may be needed.

Most plastic surgeons believe that ALCL is the result of inflammation that occurs over a long time at the interface of the surface of the textured implant and the capsule around the implant. The fact that ALCL occurs more frequently in the rougher textured implants supports this possible cause as these implants would have greater friction with the overlying tissue and thus more significant inflammation.

Since the inflammation is a continuous process, it makes sense that it would take time for this disease to develop, which is why it does not present until many years following the original placement of the implants. Other possible causes may include a low-grade infection or genetic mutation of the lymphocytes of a patient’s body. But these have not been proven.

This June, the FDA found that 84% of the cases of ALCL where the manufacturer of the implant was known (in only 7% of cases was the manufacturer not known), the implants were made by Allergan. They have a rougher texture than the other implants available from Mentor, Sientra, and Silmed. However, ALCL cases have been found in association with all the manufacturers of textured implants. It was due to the increased incidence of ALCL with Allergan implants that these textured products were withdrawn from the market.

Is an exchange in your future?

If you have textured implants, you might, quite naturally, ask what if anything needs to be done about them. Presently, the FDA and the implant manufacturers are not recommending removal of textured implants, or exchange of the implants with smooth implants, in asymptomatic patients. However, for the next year, Allergan will give smooth replacement implants to any women with Allergan textured implants if they wish to have them exchanged.

My recommendation is to speak with your board-certified or board-eligible plastic surgeon if you have textured breast implants. Most of us will probably recommend no action other than observation if you are having no issues and are happy with your breasts. However, if you develop swelling in one breast, you should be evaluated expeditiously. If, on the other hand, you have textured implants and you are not happy with them, or if you were contemplating a revision, it would be a great time to replace your implants with smooth ones.

The more pressing concern

The risk of developing ALCL if you have textured implants has been estimated to be somewhere between 1 in 2,832 and 1 in 30,000. To put this in perspective, the risk of developing breast cancer in all women is 1 in 9. So, the risk exists, but it’s a small one.

As we are approaching October, which is breast cancer awareness month, we are reminded of the importance to women of monthly breast self-examination, and appropriate screening mammography. This will probably have a more significant impact on your health than anything else.

All the best,

 

 

David B. Reath, MD