ALCL (anaplastic large cell lymphoma) is a very rare subtype of Non-Hodgkin Lymphoma which recently received a lot of media attention for a possible association with breast implants.

ALCL is NOT breast cancer.

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Essential facts:

What is BIA-ALCL?
BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma) is a rare spectrum of disorders that can range from a benign collection of fluids around the breast implant (seroma) to a rare lymphoma. BIA-ALCL is not a cancer of the breast tissue itself. When caught early, it is readily curable. If the disease is advanced, chemotherapy or radiation may be required.

What are the symptoms of BIA-ALCL?
The first symptom of BIA-ALCL is usually a swelling of the breast between 2 to 28 years after the insertion of breast implants, with an average of about 8 years after implantation. The swelling is due to a collection of fluid surrounding the implant. This fluid can cause the breast to enlarge significantly over a period of days or weeks. It can also present as a lump in the breast or armpit, firmness of the breast, or pain. It is usually easily and completely treated if patients see their doctor at the first symptom.

What is the risk of developing BIA-ALCL?
Based on current data, the risk can be explained by the texture grade of the implants as follows:

  • Grade 1 (Smooth only) – The current lifetime risk is zero.
  • Grade 2 (e.g. Microtexture, Siltex and similar) – 1:82,000
  • Grade 3 (e.g. Macrotexture, Biocell and similar) – 1:3,200
  • Grade 4 (e.g. Polyurethane) – 1:2,800*

Have there been any deaths due to BIA-ALCL?
There have been 16 confirmed deaths, (globally), attributed to BIA-ALCL since the disease was first reported nearly 20 years ago. However, when detected early before it becomes a lymphoma, BIA-ALCL is readily cured with removal of the implant and surrounding scar pocket or capsule.

Is it a problem with Saline or Silicone implants?
Of the 414 reported cases of BIA-ALCL, 312 reports included information on the types of implants used. Of those,234 reported implants with silicone gel and 119 reported implants filled with saline.
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastI
It appears to purely be related to the surface of the implant and not to what the implant is filled with.

How does this impact those with breast implants?
The most important issue for women with breast implants is to screen for breast cancer with self-exam, a regular physician exam, and mammography/ultrasound/MRI as recommended by their physician. All women should see their plastic surgeon immediately if they note a change to the size, feel, or shape of their breasts.

Why would a surgeon recommend textured implants?
There are two primary reasons a surgeon may have recommend textured surface breast implants. First is that some data has shown a lower rate of capsular contracture (firm scar tissue formation around the implant). Second, all teardrop or anatomic shaped implants have a textured surface to help hold them in place. Some surgeons believe these implants can offer an enhanced shape for certain patients, perhaps with a reduced risk of rippling.

How is BIA-ALCL treated and what is the prognosis?
Current recommendations for the treatment of BIA-ALCL call for bilateral capsulectomy (removing all the scar tissue) and removal of the old breast implants. This is a very common procedure performed by plastic surgeons, identical to what is done when an implant has ruptured or capsular contracture has developed. Smooth implants can be put back in or the patient can choose not to have implants. In all but a few cases, the disease has been fully resolved by this surgery alone. The majority of patients require no additional treatment. However, if the disease has spread to lymph nodes or adjacent tissues, chemotherapy or radiation may be necessary. This has only been necessary in a small percentage of patients.

Should patients have their implants removed because of a risk of BIA-ALCL?
Since BIA-ALCL has only been found with textured breast implants, smooth implant patients do not need to be concerned. For textured implant patients, neither the FDA nor any plastic surgery society currently recommends that women should preventatively remove textured breast implants to prevent BIA-ALCL. However there are women who have been concerned enough about BIA-ALCL and have chosen to have their implants removed. There are some women who were already considering a breast implant revision, and the BIA-ALCL issue gave them one more reason to decide to proceed.

Should women with breast implants be screened for BIA-ALCL?
There is no blood test to specifically screen for BIA-ALCL. The expert opinion is that asymptomatic women without breast changes do not require more than routine mammograms and breast exams. But if a patient experiences a change in her breasts – especially if there is swelling or a lump – she should undergo immediate examination, imaging, and consultation with a plastic surgeon. If there is fluid around the implant the fluid should be aspirated under ultrasound guidance and sent for analysis.

What causes BIA-ALCL?
ASAPS, ASERF, the FDA, and the implant manufacturers are intensely studying BIA-ALCL. To date, no specific causal factors have been identified. Implant texturing, bacteriologic contamination, and genetic factors have been implicated and are undergoing further study. The best theory today is that a combination of four factors are required for the development of

  1. BIA- ALCL:
  2. Highly textured implant
  3. Chronic bacterial-inflammation
  4. Genetic pre-disposition
  5. Time

The source of the chronic inflammation is thought to be bacteria that have been identified around the implants in affected breasts. Evidence is accumulating that a long-term inflammatory response to the presence of these bacteria is one of the factors that may cause BIA-ALCL. Research is ongoing and cases are being monitored.

Genetic factors may play a role. Some geographic areas have reported very few cases. Ongoing data collection worldwide will help to determine whether or not there are any genetic propensities for this disease.

Is the use of textured implants restricted now?
The available data does not support discontinuance of textured implants. The best practice is always for the physician to discuss with each patient the known risks and potential complications associated with any procedure. It is important for the patient and her doctor to frankly discuss all options available, and the risks involved.

Every plastic surgeon offers patients options regarding breast implants in terms of sizing, shape, and surface. Depending on a particular patient's needs, a textured implant may be preferable. The plastic surgeon must provide a frank and transparent discussion regarding the benefits and risks of implants, both smooth and textured. The patient must then make an informed decision, based upon her own assessment of her needs and the risks involved.

Why is there a suspected link between ALCL and Breast Implants?

Although the total number of ALCL cases in women with breast implants is extremely low, it is higher than would be normally expected. These cases ALCL seem to follow fairly consistent patterns, including the close proximity of the tumor to the breast implants and the type of tumor pathology. Because of this, the FDA believes that ALCL which develops in the scar capsule adjacent to the implant may be related to the implant presence.

When ALCL does occur, it has been identified most frequently in patients undergoing implant revision operations for late onset (mean time 8 years), persistent seroma. The FDA does not recommend prophylactic (preventative) breast implant removal in patients without symptoms or other abnormalities.

Should women avoid getting breast implants?

Because the risk of ALCL appears very small, FDA believes that the overall evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and women can continue to undergo breast augmentations with FDA-approved breast implants.

Breast Augmentation

Breast augmentation is one of the most common cosmetic surgery procedures, and it is the most commonly performed procedure by Dr. Jugenburg (Dr6ix). Check out our page on this topic, and browse several related articles found in our “Guide to Breast Augmentation” found on the left side of the Breast Augmentation page.