What is BIA-ALCL?
BIA-ALCL (breast implant-associated anaplastic large cell lymphoma) is a rare spectrum of disease that can range from an indolent accumulation of fluids around the breast (seroma) to a potentially metastatic lymphoma especially when there are delays in diagnosis. It is a disease that ranges from indolent to full-blown metastatic disease when not caught early. BIA-ALCL is not a cancer of the breast tissue itself. When diagnosed early, it is readily curable. If the disease is advanced, chemotherapy or radiation may be required. BIA-ALCL is currently classified as a lymphoma. Many experts believe that it behaves clinically as a lymphoproliferative disorder (LPD) that encompasses the spectrum of disease from benign CD30+ seromas to CD30+ malignant seromas to invasive capsular disease, and finally metastatic disease. Current research is underway to further understand the proper classification of this disorder. Similar to other lymphomas, BIA-ALCL is a highly treatable disease with high cure rates.
Have there been any deaths due to BIA-ALCL?
There have been 36 confirmed deaths globally (11 in the United States) attributed to BIA-ALCL since the disease was first reported nearly 20 years ago.
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 eight 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?
In August of 2020, the FDA issued a BIA-ALCL update. The BIA-ALCL update cites a total of 733 unique cases of BIA-ALCL and 36 patient deaths globally, representing an increase of 160 new cases (64 from the United States) and three deaths since the July 2019 update. The FDA reports of an overall risk of 1:30,000 in their latest statement. These risk assessments are changing on an ongoing basis, but this is the most accurate information currently available (August 2020). Based on current data, the risk can be further explained by the texture grade of the implants as follows:
- Grade 1 (smooth only): The data is conflicting as to the possibility of smooth implants causing any risk. As stated below, the cases of smooth implants are not clear.
- Grade 2 (e.g., microtexture, Siltex®, and similar): 1:82,000
- Grade 3 (e.g. Macrotexture, Biocell and similar): 1:3,200
- Grade 3 (e.g., macrotexture, Biocell®, and similar): 1:3,200
- Grade 4 (e.g., Polyurethane): 1:2,800
Of the 733 total unique cases of BIA-ALCL reported to the FDA, 496 cases were reported to have textured implants, and 209 cases did not specify the implant surface. The FDA notes that 28 cases have presented with a smooth implant at the time of BIA-ALCL diagnosis. Of those cases, eight have a history of at least one textured implant, nine have a history of prior implants with unknown texture, one has a history of one smooth implant and no known textured implant, and 10 have unknown prior history of implants. Given the uncertainty of the cases and the lack of direct evidence, the plastic surgery community and literature support the overriding conclusion that BIA-ALCL is completely related to textured implants.
If a breast implant patient comes to see us when she develops a first symptom, will she be cured?
That answer is not known, and is a very important piece of information for patients and plastic surgeons. Most of the time, patients see their plastic surgeon right away when they develop significant swelling of the breast. In these cases, the disease is almost always caught early and cured with a straightforward operation. Some women developed advanced disease after ignoring earlier symptoms, or saw a doctor who did not properly diagnose them. There are also a few patients who presented with advanced disease who said that they never had earlier symptoms.
What are the differences in implant texture, and what role does that factor play in the research?
Although it’s rare, BIA-ALCL appears to currently develop exclusively in women with textured implants. There are several theories which attempt to explain the higher rate for textured implant patients. Many believe that the increased surface area of textured implants allows a higher number of bacteria around the implant, which forms a biofilm in some patients and can result in chronic inflammation — ultimately leading to a proliferation of lymphocytes. Less accepted theories are that textured implants create greater inflammation because of chronic mechanical irritation, and that microscopic shedding of silicone from the textured wall induces inflammation.
Is it a problem with saline or silicone implants?
Of the 733 unique cases of BIA-ALCL (FDA, August 2020), implants are both silicone and saline. It appears to purely be related to the surface of the implant — not to what the implant is filled with.
How does this impact those with breast implants?
Patients considering textured breast implants should discuss this issue with their plastic surgeon. As of this publication, there are no true contraindications of having textured implants. There are patients who are candidates for shaped textured implants. In them, science must precede fear.
What about those considering breast implants?
Patients considering textured breast implants should discuss this issue with their plastic surgeon. As of this publication, there are no true contraindications of having textured implants. There are patients who are good candidates for shaped textured implants. In them, science must precede fear.
Do we recommend textured implants to a patient?
The choice of implant type is ultimately a decision between an educated patient and her board-certified plastic surgeon. There may be certain circumstances where a textured implant is recommended for particular patients. All patients should have a detailed conversation with their surgeon about the risks associated with textured implants, beyond what is published online or in pamphlets. Ultimately, there are instances where textured implants are the best choice for them.
How is BIA-ALCL diagnosed?
If a woman develops swelling in an augmented breast, she should undergo an ultrasound scan. If fluid is detected, it should be drained and tested for:
CD30 immunohistochemistry is not diagnostic for BIA-ALCL; however, it is a marker for activated T cells. If a patient’s seroma is CD30 positive and the cytology is negative, this likely represents a precursor to BIA-ALCL and should be treated with total capsulectomy. If the seroma test is CD30 negative with negative cytology, then it should be treated as a benign seroma using the individual surgeon’s protocol. The majority of seromas seen clinically are benign seromas, and not BIA-ALCL. Management of all seromas should be by a board-certified plastic surgeon. Mammograms are not useful in diagnosing BIA-ALCL. In confirmed cases, PET or MRI/CT scans may be used to help stage the disease. If a patient wants to have their textured implants removed and replaced, the options are to exchange to smooth implants, or to exchange to smooth implants with a capsulectomy
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 and is identical to what is done when an implant has ruptured or when capsular contracture has developed. Smooth implants can be put back in, or the patient may choose not to have implants. In all early-stage 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 grown into the adjacent tissues, chemotherapy and radiation may be necessary. These are very serious treatments with significant side effects.
Are some patients at greater risk than others?
The rates of BIA-ALCL seem different throughout the world. This may be due to different reporting and registries, but there may also be a genetic predisposition that is not yet fully understood. For instance, as of this time, there are very few cases in Asian patients. The risk is only with textured implants and not smooth implants, the rate is no different between silicone and saline, and it occurs in both cosmetic and reconstructive patients. There is no test to determine whether one textured implant patient is at any more risk of developing this disorder than any other patients.
Should patients have their implants removed because of BIA-ALCL?
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 that they 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. Breast implant patients should have ongoing follow-up. Current FDA recommendations and ASAPS recommendations indicate that patients with textured implants with no issues should not do anything, and implant removal is not recommended.
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?
Major plastic surgery societies and research wings such as ASAPS, ASERF, and the FDA, along with 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 BIA-ALCL:
- Textured implants (surface area to sequester bacteria)
- Chronic bacterial-inflammation
- Genetic predisposition
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 also 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.
Do we recommend against the use of textured implants?
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. Every plastic surgeon needs to help each individual patient make her own decision about which implant she prefers in a fully transparent manner. This involves weighing any possible increased risks against the advantages offered by a particular type of implant. It is critical that the patient makes a fully informed decision following a full discussion of the risks and benefits.
What is the recommended clinical response to a patient presenting with symptoms that could be attributable to ALCL?
Detailed information can be found on the ASAPS website at http://www.surgery.org/professionals.
Where can I find more information on BIA-ALCL?
Additional information and resources on BIA-ALCL are available online at https://www.surgery.org/media/resources.
What research is being conducted?
ASERF is currently funding two BIA-ALCL studies: Pathogenesis of BIA-ALCL and Genomic Profiling to Understand the Pathogenesis of BIA-ALCL. ASERF is sponsoring leading, cutting-edge research on BIA-ALCL to better define the disease and improve diagnosis and outcome. More information can be found on the ASERF website at www.aserf.org.