What You Need to Know About Breast Implant-Associated Anaplastic Large Cell Lymphoma

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What You Need to Know About Breast Implant-Associated Anaplastic Large Cell Lymphoma

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“Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is an oncological entity with the first diagnosed case dating back to 1997.

Currently, it’s a topic that generates misinformation and fear among patients with implants or those considering surgery, as the limited available information often comes from non-specialized sources, which may be imprecise.

In this blog entry, we aim to clarify the key aspects of this disease.

Annually, over 1.5 million women undergo breast surgery with implants worldwide. Since the first diagnosed case in 1997, more than 35 million patients have undergone surgery, with approximately 1100 cases diagnosed until 2022. Thus, the current risk would be 1 in every 30,000 women.

On average, it has been observed to appear around 7.5 years after implant placement.

It is currently considered a multifactorial entity, meaning it doesn’t have a single cause and requires a combination of factors for its development. Potential causes identified for this condition include:

  • Textured implants (with higher risk in implants using salt imprint in their manufacturing process).
  • Smooth implants: fewer cases, but some are associated.
  • Genetic predisposition.
  • Biofilm: Bacterial contamination around the implant, more common in centers with questionable aseptic measures and surgical techniques.
  • Surgeon’s experience. More cases have been diagnosed in uncertified or inexperienced surgeons.
  • Micro-traumas.
  • Surgical technique. There are specific measures that, if correctly employed, can reduce the theoretical risk of the disease’s occurrence.

As you can see, it’s challenging to state that simply having a textured implant will lead to the disease, as several causes need to combine. Moreover, implants posing higher risks have been removed from the market in most countries, including Spain.

Regarding the severity of the disease, early detection and surgical treatment involving implant and surrounding capsule removal have shown excellent prognosis, often not requiring additional complementary treatments.

In most cases (over 87.5%), diagnosis is early, as surgeons now provide detailed information to patients and conduct close follow-ups throughout life. Therefore, a well-informed patient, aware of potential symptoms and signs, maintaining long-term follow-up, and wisely choosing both surgeon and hospital, significantly minimizes the risk or late diagnosis of the lymphoma, thereby reducing its severity.

Signs that should alert and prompt contacting your surgeon include:

  • Sudden increase in volume in one or both breasts.
  • Ultrasound detecting a significant amount of fluid around the implant (seroma).
  • Imaging revealing a mass in the capsule surrounding the implant.
  • Palpable hardened area around the implant or in the breast.

In such cases, a sample of the fluid/mass is taken via a guided ultrasound puncture for examination, ruling out the presence of the disease. Previously, due to lack of knowledge, when seroma was detected, only bacterial analysis was performed, and if negative, surgery was conducted without urgency or therapeutic intent, solely for aesthetic correction.

With today’s understanding of the disease, prompt diagnosis and action have notably reduced the severity of the lymphoma.

Moreover, micro-textured breast implants that do not use salt imprint in manufacturing are currently safe medical devices (there is no recommendation against their use by the American FDA or the AEMPS), presenting a minor risk, less than 0.05%, according to recent scientific studies. No causality has been proven in studies, they haven’t been banned in any country, and scientific research has demonstrated several significant advantages:

  • Lower risk of capsular contracture compared to smooth implants.
  • Less micro-trauma as they don’t move within the capsule.
  • Lower risk of displacement or asymmetry compared to smooth implants.

All of this translates to a decreased likelihood of future surgical intervention. Therefore, ongoing research and increased knowledge about the disease suggest there’s no scientific justification to claim that “only smooth implants are safe”.

In conclusion, after evaluating the current scientific literature, BIA-ALCL is an oncological entity with a good prognosis when diagnosed early. Its causes are multifactorial, and currently, there’s insufficient scientific evidence to suggest that the use of micro-textured implants alone causes its occurrence. However, there are scientific studies supporting their advantages. Surgery with implants remains safe when all necessary measures are taken and patients are closely monitored.”


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