Worried About BIA-ALCL? Here is What You Need to Know About the Condition & Allergan Recall

person holding textured breast implant

The conversation around breast augmentation has undergone something of a paradigm shift in the last year. As the link between textured implants and BIA-ALCL emerged, followed by the recall of Allergan’s Biocell implants, the question that many prospective breast augmentation patients now ask first isn’t which implants are best, but “are breast implants safe?”

As a physician and cosmetic surgeon, my patients’ safety and health are the most important factors, period. I believe it’s essential to be transparent about the risks associated with any procedure as well as the benefits so that you can make a fully informed decision about cosmetic surgery.

So I’ll start by clarifying that yes, textured breast implants have been shown to raise the risk of a type of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. This risk is very small, the disease is very rare and treatable, and only certain textured implants (Allergan Biocell) have been recalled due to a greater association with the disease.

That’s the concise version of what is going on; now I’d like to help you understand the key issues on a deeper level. Continue reading for more facts about BIA-ALCL, followed by what you need to know about the Allergan recall.

While BIA-ALCL is a risk you should be aware of, it is extremely rare and should not deter you from undergoing breast augmentation if you would like to—or keeping breast implants you are currently happy with.

What is BIA-ALCL and how common is it?

If you are concerned about BIA-ALCL, I encourage you to read this article from the American Board of Cosmetic Surgery. It explains in depth what we know about BIA-ALCL, including the risk statistics, why certain textured implants increase the risk, symptoms and treatment options, and what to do if you are concerned. Here are some of the key points to help you put it all in perspective:

  • BIA-ALCL is not breast cancer. It is an immune cell cancer that, under certain conditions, can develop in the scar tissue capsule surrounding a breast implant.
  • The lifetime risk of developing BIA-ALCL is 1 in 30,000 (0.003%) if you have ever had textured implants. The risk is significantly lower, approaching zero, if you have only ever had smooth implants.
  • Since 2010, there have been 573 cases confirmed worldwide, including 33 deaths. It’s estimated that over 10 million women have breast implants worldwide.
  • In its early stages, BIA-ALCL is completely contained within the capsule; this makes it possible to remove all cancerous cells from the body as long as a diagnosis is made soon after symptoms appear.
  • BIA-ALCL symptoms include swelling/fluid accumulation and/or pain in one or both breasts more than 6 months after initial implant placement. If you experience these symptoms, see your cosmetic surgeon and/or primary care doctor ASAP. These symptoms do not automatically mean you have BIA-ALCL, but should be checked.
  • If you are not experiencing symptoms, it is not recommended that you have your implants removed. The overall risk of BIA-ALCL is so very low, even with textured implants, that it’s likely that the risks of undergoing a second surgery are greater than the likelihood of ever developing BIA-ALCL.

In summary: while BIA-ALCL is an issue that both patients and cosmetic surgeons need to take seriously, the disease is extremely rare. Most patients who fully understand how small the risks are can still feel confident with choosing breast augmentation, or keeping their implants if they already have them.

If you are considering breast augmentation for the first time, I recommend choosing smooth-shelled implants as they have the lowest BIA-ALCL risk. I also prefer the aesthetic outcomes of smooth, round gel implants—they simply look and feel more natural.

Why were Allergan implants recalled?

On July 24, 2019, the implant manufacturer Allergan announced a voluntary worldwide recall of its Biocell textured breast implants and tissue expanders. For the full story about the Allergan recall, this resource from the American Board of Cosmetic Surgery will tell you everything you need to know. But again, here are the important highlights.

If you have Biocell implants and you are not experiencing any symptoms, you do not need to have your implants removed. Just continue with recommended follow-up care and alert your cosmetic surgeon if any symptoms arise.

These implants were made using a unique texturing method that resulted in a shell with a relatively high surface area. This high surface area provided more space for bacteria to accumulate and build a “biofilm” around the implant. In certain patients, this leads to the development of BIA-ALCL.

Studies have shown the incidence of BIA-ALCL to be between 6 and 14 times higher with Biocell implants than with other types of textured implants, hence the recall.

The recall means that Allergan Biocell textured implants may no longer be sold or used. It does not mean that patients who have these implants need to have them removed. 

If you have Biocell textured implants, such as Natrelle 410s, but you are not experiencing any symptoms, you do not need to do anything. Simply continue with recommended follow-up care and stay tuned to your body. If at any point you do see or experience something that concerns you, see your cosmetic surgeon.

All that said, if you have Biocell implants and just would feel better not having them, Allergan is offering a special Biocell replacement warranty in light of the recall. They will cover the cost of a new pair of Allergan smooth implants if you choose to have your implants replaced. This warranty covers the cost of the implant devices only; it does not cover any surgery fees. For more complete warranty info, and how coverage expands if you do contract BIA-ALCL, please refer to the aforementioned ABCS article.

Finally, please contact me if you have any questions or concerns

The last thing I want is for you to worry needlessly. I understand that learning of any new risk associated with something you have or are thinking about can be a cause for concern, and I am here to help.

While I do not use Allergan textured implants for my Bellevue breast augmentation patients, and have not for quite some time, I welcome you to contact us should you have any questions or concerns. My staff and I will listen and address your questions to the best of our ability. You can reach us at 425-453-9060.

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