Breast Implant Recall

  • Posted on: Jul 26 2019
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It’s been all over the news.  You’ve probably heard about it, read about it, or seen it on TV.    Allergan, one of the companies that makes breast implants sold in the U.S., has issued a recall of some of it’s breast implants.  But what does this recall mean, and why did the FDA request it?

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Anaplastic large cell lymphoma (ALCL) is a rare kind of cancer of the blood system.  White blood cells called lymphocytes are cells in the blood that typically fight infection.  A person who has lymphoma has lymphocytes that are growing out of control.  In typical cases of ALCL, these abnormal lymphocytes build up in lymph nodes or the skin or even the lungs.  Over the last few years some women who have breast implants have developed an even more rare type of ALCL.  In these cases the disease begins in the scar tissue immediately around a breast implant.  This breast implant-associated ALCL is not breast cancer, but rather lymphoma that is somehow associated with the implant.

How common is BIA-ALCL?

Breast augmentation is the most common cosmetic surgical procedure in the United States.  In 2017 about 300,000 women underwent cosmetic breast augmentation in the U.S.  Another 100,000 underwent breast reconstruction with breast implants.   It is estimated that between 10 and 20 million women worldwide have had breast implants.  BIA-ALCL to date is known to have happened in 573 women.  Of these 573 women, 320 were reported from the United States.

Textured Breast implants

Every case of BIA-ALCL has been found in women who have textured surface breast implants.  To date, no cases have been found in women who have only had smooth surface implants.  So what is texturing?  Texturing is a process that makes the surface of a breast implant rough.  Not really rough, though.  Think of a peach; kind of like that.  Not all implants have textured surfaces.  Texturing was created to try to stabilize an implant in a breast pocket, allowing breast tissue to grow into the rough surface and “attach” to it.  Textured surface breast implants have been found to reduce the rate of capsular contracture (hardening of tissue) around a breast implant.  So, textured surfaces may be useful on breast implants.

The different companies all created their own process for creating textured surfaces.  Allergan calls their textured surface Biocell.  Compared to Mentor and Sientra textured breast implants, the Biocell texturing may be considered to be a little more rough.  The Food and Drug Administration (FDA) asked Allergan to recall their Biocell textured implants because of the 573 known cases of BIA-ALCL, 481 had Biocell implants.

Allergan Breast implant recall

The FDA requested Allergan to recall any of the textured surface breast implants that have been distributed but not used.  Any Allergan textured implants that are in boxes on shelves somewhere should be sent back to Allergan.  That is very different than saying women who have Biocell textured implants should have them removed.  The FDA has not said that.  The media makes this kind of confusing, though.  When the headlines scream “Breast Implant Recall” (like the title of this blog!) it draws your attention.  That’s good, in a way.  But it’s important to know that the FDA is not suggesting that women who have these types of implants should have them removed.  The numbers of cases are very small in relation to the number of women who have these types of implants.

It has been estimated that the risk of a woman who has an Allergan Biocell implant developing BIA-ALCL is about 1 in 3500.  Said another way, the chance of a woman who has Allergan Biocell textured implants developing BIA-ALCL is 0.0003%.  It’s actually a small number, but it’s a scary situation.  Allergan textured implants account for only about 5% of implants used in the United States.  Textured surface implants are actually used much more commonly in Europe and countries outside the U.S. than in the United States.

which Allergan implants are being recalled?

Allergan currently sells breast implants through its Natrelle brand.  Not all Allergan Natrelle implants are being recalled.  Only implants with textured surfaces are being recalled.  When a woman undergoes breast augmentation or breast reconstruction she typically receives a card that has her implant information on it.  Here is a link to the FDA site that tells more about the recall and which implants are specifically affected: FDA Safety Communication

What are the symptoms and signs of BIA-ALCL?

The most common symptom is swelling of one breast.  This typically occurs several years after the implants were placed, about 8 years on average.  An affected breast could become hard and painful.  If you have breast implants and this has happened, you should go get your breasts checked.

What causes bIA-ALCL?

A lot of research is going into this.  Contributing factors may include reactions to implant particles, long-term allergies, genetic factors, or reactions to bacteria that grow on the implant’s surface.  For instance, this process almost never affects Asian women.  That suggests a genetic component.  One study suggested that a common contaminant of drinking water could be involved.  It seems that something about the textured surface stimulates the immune system.  In cases where BIA-ALCL develops, the immune system shifts into overdrive.

Treatment of BIA-ALCL

When caught early, treatment consists of removing the breast implant and the entire scar tissue capsule around it.  That’s it.  That’s why it’s so important to monitor your breasts if you have breast implants.  Any unusual swelling, particularly years after the implants were placed, needs to be evaluated as soon as it is noticed.  There would be additional testing involved, and a referral to a medical oncologist if BIA-ALCL were to be found.  More advanced cases could require other types of care, including chemotherapy and possibly even radiation or stem cell transplantation.

I have textured implants; what should I do?

First, take a deep breath.  Second, monitor your breasts.  BIA-ALCL is a real thing, but it also happens to very small numbers of women who have textured surface implants.  The FDA advises women who have textured implants but no symptoms to monitor their breasts.  The FDA is not suggesting women without symptoms should have their implants removed.  If you have textured surface implants, call the surgeon who placed them.  You might even want to visit with the surgeon.  Websites and media tend to create excitement but often don’t provide context or scientific detail.  Your surgeon can fill in the blanks.  I encourage any of my patients to contact us.  I am happy to see any of my patients to talk about this.

If you have breast implants and one of your breasts is swollen, you should contact your surgeon or a plastic surgeon near you who knows about breast implants.   It’s worth finding out about what the specific problem is.

 

 

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Posted in: Aesthetics, Breast, Breast Implants, news, Safety



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