Current Updates on BIA-ALCLFor Patients with Breast Implants, or Who Are Considering Getting Breast Implants
You may have seen recent news reports about an association between a textured breast implant and rare development of lymphoma in the scar tissue (capsule) surrounding the implants.
The following is from a FAQ about BIA-ALCL from the American Society of Aesthetic Plastic Surgeons sent to physicians in February 2019.
Because research is ongoing and data continues to be analyzed, future updates are likely. Please check back regularly to stay up-to-date with the latest information.
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 (seroma) around the breast 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 it behaves clinically as a lymphoproliferative disorder (LPD) that encompasses the spectrum of disease from benign CD30+ (a tumor marker) seromas, to CD30+ malignant seromas, to invasive capsular disease, and finally metastatic disease. Current ASERF (Aesthetic Surgery Education and Research Foundation) research is underway to further understand the proper classification of this disorder. Similar to LPDs, BIA-ALCL is a highly treatable disease with high cure rates.
Have there been any deaths due to BIA-ALCL?
There have been 17 confirmed deaths globally, (9 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 two and 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?
The FDA reports it is 1:3,817 to 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.
Based on current data, the risk can be further explained by the texture grade of the implants as follows:
- Grade 1 (smooth only) – In global databases, there has not been a confirmed case of smooth only. In the February 2019 FDA statement, it was reported that “there have been reports of BIA-ALCL in patients with smooth-surfaced implants and many reports do not include the surface texture of the implant at the time of diagnosis.” At the time of this publication it is known that a single case of smooth only BIA-ALCL was originally reported to the FDA; however, it was later determined this was not accurate, and the case was a mixed implant case. The report to the FDA was amended.
- 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*
* Based on data from an Australian study – however this was 100% Silimed polyurethane implants that had a manufacturing defect and have since been taken off the market.
Loch-Wilkinson, A., et al. (2017). “Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia with Increased Risk.” Plastic and Reconstructive Surgery 140(4): 645-654
If a breast implant patient sees a plastic surgeon 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 with advanced disease ignored earlier symptoms or saw a doctor who did not properly diagnose them. There are a few patients who presented with advanced disease who said they never had earlier symptoms.
Can you explain the differences in implant texture and what role that factor plays in the research?
Although it is rare, BIA-ALCL appears to currently develop exclusively in women with textured implants. To date there has not been a case of BIA-ALCL in a patient with only smooth implants. There are several theories which attempt to explain the higher rate for textured implant patients: many believe 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 textured implants create greater inflammation because of chronic mechanical irritation, and another postulates microscopic shedding of silicone from the textured wall induces inflammation.
Is it a problem with saline or silicone implants?
Of the 457 unique cases of BIA-ALCL (FDA 2-2019) implants are both silicone and saline. 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?
ASAPS (American Society of Aesthetic and Plastic Surgeons) and ASERF emphasize 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. Regardless of BIA-ALCL, all women should see their plastic surgeon immediately if they note a change to the size, feel, or shape of their breasts.
What about those considering breast implants?
Patients considering textured breast implants should discuss this issue with their plastic surgeon. Since our knowledge of this condition is continuing to evolve, thanks in large part to ASERF-sponsored research, patients should check www.surgery.org and the FDA website for any updates.
What if a doctor is recommending 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 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 their textured implants removed and replaced, the options are:
- Exchange to smooth implants
- 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, 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 early stage cases, the disease has been fully resolved by this surgery alone. The majority of patient 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 to have difference rates throughout the world. This may be due to different reporting and registries, but there is likely to 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; 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 women should preventatively remove textured breast implant 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 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 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 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 board-certified 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, not 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 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.
Have More Questions?
If you have any concerns whatsoever about your implants, or are considering getting breast implants and want to speak with one of the most experienced, trusted cosmetic surgeons in the Dallas Fort Worth area about your best options, feel free to contact Dr. Elizabeth Kerner’s office at (972) 981-7144 for an appointment to discuss your questions and have a breast implant checkup.
Our West Plano office is conveniently located on the 1st floor of Texas Health Presbyterian Hospital Plano in Medical Office Building 1.
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