The Blog

The New York Times had an article this weekend about (BIA-ALCL) with the headline:

A Shocking Diagnosis: Breast Implants ‘Gave Me Cancer’ Link to article here

This was an important topic at the American Society of Aesthetic Plastic Surgeons conference that I just attended April 27-May 2, 2017 and I would like to summarize the latest findings from the world experts who have just presented at our national conference that took place in San Diego.

BIA-ALCL was first described in 1985, so it is not a new topic.

Although it is a rare cancer, it is associated with a common procedure, the use of breast implants in augmentation or reconstruction.

I’m pleased to say that the American Society of Plastic Surgeons, the American Society of Aesthetic Plastic Surgeons (both of which are am a longstanding member) and the International Society of Aesthetic Plastic Surgeons have taken this very seriously and funded research and studies.

There are now 457 confirmed cases of BIA-ALCL around the world including the 359 cases reported to our FDA according to Dr. Anand Deva, a plastic surgeon and professor from Australia who has been a leading researcher on biofilm and now BIA-ALCL ( more about the connection in a minute) who spoke at a special presentation at our meeting over the Internet.

The Micromort Perspective

The Micromort perspective is one way to understand risk. A”micromort” is a unit of risk defined as a one in a million chance of death. This concept can help us to compare high risk and everyday activities like skydiving / mountaineering / riding a bike 10 miles/ smoking a pack of cigarettes

Activities that increase your risk of dying by 1:million:

• Drinking 0.5 liter wine ( 16.92 ounces which is equivalent to just over 3 typical 5 ounce glasses of wine)
• Eating 40 tbsp peanut butter
• Walking 17 miles
• Driving by car 250 miles
• Flying by jet 1000 miles

A patient that develops ALCL  (not associated with breast implants) has a risk of 1.24 micromorts year/46 in a lifetime

To compare this to other diseases:

• Basal cell carcinoma has 6.17 micromorts/ year (228 Micromorts lifetime)
• Colon cancer 152 mm/year/ 5624 lifetime

So what is the risk of BIA-ALCL for a woman with breast implants:

• The lifetime risk of a woman with bilateral breast implants dying from BIA-ALCL is 0.34 micromorts.
• Skiing one day in USA has twice  the risk or 0.77 micromorts
• Traveling in a car 230 mikes or drinking 1/2 liter of wine carries a 3x(1.0 micromort) risk compared to BIA-ALCL.

So a woman who has bilateral breast implants has a lifetime risk of contracting and dying from BIA-ALCL that is 1/2 the risk is of skiing for one day in the USA and 1/3 the risk of drinking 3 glasses of wine, walking 17 miles or riding in a car 250 miles just  one time,

Genetics/Texture/Bacteria and Time

The best current theory of how BIA-ALCL happens is the malignant transformation of immune cells responding to biofilm.

It is thought that the normal white blood cells that respond to infection are transformed into cancer cells after years of chronic stimulation by biofilm.  BIofilm is where bacteria can wall themselves off by secreting a kind of shell, so that the body can’t fight them. The tartar that dentists scrape off our teeth is a biofilm. Biofilm has been linked to capsular contracture ( a condition where scar tissue tightens around the implant and they become hard) and so we have been focused on ways to avoid biofilm to avoid capsular contracture ( link to the capsular contracture video). It turns out that this may also be one it the main keys to avoid BIA-ALCL.

To summarize, Bacteria contamination leads to chronic inflammation which over years can lead to BIA-ALCL.

Bacteria are bad. And more bacteria are worse.

Textured implants are associated with BIA-ALCL. In fact, there have been no cases where only smooth implants have been used. In the few cases where BIA-ALCL developed with smooth implants the patients had had textured tissue expanders in before.  Why is texture thought to be a problem?  Texture has more surface area for the bacteria to attach to. And the majority of the cases have been with the texture found on Allergan implants. This is a more aggressive texture using a “salt loss method ” where salt is used to develop the texture and then dissolved at the end of the manufacturing process. This texture has significantly more surface area than the Mentor texture  for  example, which is simply stamped into the implant. And the stamped texture has less “nooks and crannies ” for bacteria to attach to- less surface area.  Dr. Anand Deva stated that Australia has 90% texture usage vs 12.7% in the USA. He was able to do a study in Australia that shows that the Allergan Biocell surface has 14 times the risk of the Mentor Siltex surface of developing BIA-ALCL.   So there are no reported cases with smooth implants alone and the majority of cases have been with the aggressive texture.

Do we need to stop using textured breast implants. The various speakers said no. Texture can prevent the rotation of shaped implants and may decrease the shifting of smooth implants. But it makes sense to be more  selective in its use and if needed use the less aggressively textured devices.

What to do if you develop sudden swelling of your breast more than 12 months after surgery:

See a plastic surgeon. He or she will send you to interventional radiology where under ultrasound guidance the fluid collection around your implant will be removed with a small needle and sent for testing. The fluid will be tested for a ” cell marker ” called CD30.

If this is positive then you will get a PET scan to look for solid tumors and see an oncologist. Don’t panic. In the rare case that you do have BIA-ALCL Dr. Mark Clemens, a plastic surgeon from MD Anderson reported that it has been successfully treated in all cases with removal of the implant and the “capsule” of tissue around the implant. This procedure is done by a plastic surgeon and is called a ” total capsulectomy”

There have been 12 deaths reported worldwide from BIA-ALCL But all deaths resulted from cases with  incomplete surgical treatment – a total capsulectomy was not performed. Because this is a rare condition, early cases were not always recognized and treatment guidelines had not been developed yet due to the small numbers.  MD Anderson has now treated 38 cases and the treatment has been so successful with total capsulectomy that they are now allowing the women to have smooth breast implants replaced at the same time.

And Dr. Clemens also reported that Brentuximab, A chemotherapy agent that targets CD30 and is also used in Hodgkins Lymphoma, has led to complete remissions in those rare cases that were not treated early with total capsulectomy and had developed metastasis.

So the risk of developing BIA-ALCL for a woman with breast implants is still thankfully quite low, and the risk of death is even less-there have been no reported deaths when the current treatment guidelines have been followed. Using the “micromort” analysis a woman who has bilateral breast implants has a lifetime risk of contracting and dying from BIA-ALCL that is 1/2 the risk is of skiing for one day in the USA and 1/3 the risk of drinking 3 glasses of wine, walking 17 miles or riding in a car 250 miles just  one time,

So what to do if you are thinking about breast implant implants for the first time?  Find a board certified plastic surgeon who helps guide you through the decision process in understanding the various tradeoffs of breast augmentation. If texture is worth the tradeoffs in your case, understand the differences with the different textures.  When the use of texture is indicated, I prefer the less aggressively textured implants. And understand what your surgeon is doing to decrease the risk of biofilm. It is now thought that you need biofilm over a period of time to develop BIA-ALCL and it is also important to avoid biofilm to decrease your risk of capsular contracture.

Learn more about how you can avoid capsular contracture in my ‘Thoughtful Patients’ Guide’ entry —  (link to video here)

Dr. Hall

Link to ASAPS-ASPS Joint Statement