Breast Implant-Related Lymphoma – “BIA-
ALCL”


“BIA-ALCL” is a cancer of the lymphatic system. It can be treated when found early but can be fatal if not discovered or treated in a timely fashion.

Recently this cancer  has been associated with breast implants. But it is only associated with textured surface implants. There no cases related to smooth surface implants.
The cases known so far can occur if the implant was used for cosmetic or reconstruction for breast cancer.

 

“BIA-ALCL” is uncommon cancer. The estimates range from 1 to 3 cases per million women with breast implants per year. In other words of one million women with breast implants, three will develop BIA-ALCL each year.

The most recent estimate of lifetime risk of BIA-ALCL is not known accurately yet but thought to be over your lifetime at 1:4000 – 1:30,000 women with textured
implants.

These rates are difficult to calculate accurately as it is unknown how many women in the United States have breast implants. Manufacturer and physician data are not comprehensive. Similarly, in the rest of the free world, it is also unknown the number of women with breast implants. Best estimates show about 1-2 million women in the US have breast implants in place. Many other developed countries have populations with women with breast implants as well. Dr. Jacobsen surmises there are  ikely 10,000,000 women in the world with implants of the years.

Also, there may have been other BIA-ALCL cases that have not been reported or were undiagnosed.

So, 700 women with BIA_ALCL over 10,000,000 women with implants results in about 1 case in 15,000 women with implants overall since implants have been used for the last 40 years.

 

Roughly 700 cases are known in the world and about 300 of them in the United States. The records and data on many of these patients are flawed or duplicative.

The 5-year survival for patients with this cancer is thought to be 95% if treated properly and diagnosed early.

If BIA-ALCL is diagnosed early treatment is usually surgical and can be curative, utilizing ‘in-toto‘ complete removal of the capsule and implant.

“BIA-ALCL” now has been associated with breast implants but only certain kinds of breast implants. Specifically, only so far is only associated with textured implants. Textured implants are not often used in the United States. Dr. Jacobsen does not use them at all. Normally implants are smooth on their surfaces. The mooth implants have no association with “BIA-ALCL”. Textured implants were originally developed as an alternative surface of the breast implant that was thought to prevent capsular contracture of the breast after breast implant placement. These textured implants are generally thicker and as a result, reduce the softness of the reast feel after placement. Roughly 20 years later we now know that these implants do not have a reduced rate of capsular contracture. There is no need, in Dr. Jacobsen’s, opinion to exist as the smooth surfaced implants are better in feel, safe and not associated with “BIA-ALCL” .

“BIA-ALCL” tends to remain to be limited to around the breast implant. Most patients have a good prognosis when they receive cancer treatment. “BIA-ALCL” does not tend to show up in other parts of your body … only to the capsule around the implant, in the capsule tissue. Often there is fluid accumulation around the implant that normal women would not normally have around their implants. This apparently is a common finding in patients with “BIA-ALCL”. Sometimes the breast can be reddened on the skin for no reason.

But many women now have textured implants and wish removal of the implants. Dr. Jacobsen does recommend removal of the textured implants and replacement with a smooth implant.

At the same time as removal of the textured implants, you should undergo complete removal of the capsule around the implant. This is called a capsulectomy.

If you do not know whether you have a textured implant you can find out. Either call your previous plastic surgeon or refer to your implant card given to you at the time of your original implant surgery. If you know the implant manufacturer of your implant you can call the Mentor Corporation or the Allergan Corporation who should have a record of your implant placement with style shape and surface either smooth or textured.It is by no means an emergency to remove your textured implants removed but you should promptly see your plastic surgeon if you think you have textured implants.

There presently no test to find out if you have textured implants. Sometimes surgery is the only way to find out if you have textured implants or not. It is not known if the silicone implant material causes this cancer or the arrangement of the rough surface of a textured implant. Some scientists speculate that there may be a type a bacterial that can harbor within the rough surface of the textured implant and ultimately cause “BIA-ALCL”. It unknown exactly what causes “BIA-ALCL” at this time.

Dr. Jacobsen feels it IS NOT the silicone material itself as this same material, silicone is used in most implanted medical devices including the knee joint, heart valves, pacemakers, brain shunts IV catheters and implants of the nose and other parts of the body. None of these other silicone devices have been implicated in either breast implant-related diseases or “BIA-ALCL”. It appears to be the arrangement of the implant surface that stimulates the immune system in a chronic abnormal fashion. Much study is needed to determine this cancer’s cause.

Dr. Jacobsen performs a complete “in-toto” capsulectomy when a capsulectomy is needed. Dr. Jacobsen always sends this tissue and fluid to the pathology laboratory after surgery to check for this cancer so you can be properly screened for this cancer. Be careful reading blogs regarding this “BIA-ALCL”. Advice from non-surgeons can be emotionally based and not science based.

But if you think you have any of these factors you should consider seeing a plastic surgeon for treatment:
1. Fluid around your implant
2. A thickened capsule around your implant
3. A textured implant

Note also that testing of the fluid preoperatively might be helpful but it is better to simply have the implant capsule, fluid and implant removed entirely, in toto, to ensure you do not have this cancer rather than just testing the fluid if you implant is textured.

 

Dr. Jacobsen has removed hundreds of breast capsules, in-toto, and has never seen this cancer in any patient and also has never had a colleague who has had a patient with this cancer. Should, however, this cancer arise in one of his patients he has extensive experience in surgically managing many kinds of soft tissue cancers and will manage this one for you as well as unlikely as it may be. Some doctors will claim to be experts in this kind of cancer, but this is likely not accurate as there are very few doctors in the country that have ever managed more than one. So, choose a doctor skilled in the basic tenants of cancer surgery and works closely with medical oncologists. Not all cosmetic surgeons are familiar with soft tissue cancer management.

Be cautious and remember that because you have a capsular contracture does not mean you have a “BIA-ALCL” cancer.

Be cautious and remember that because you have fluid around your implant does not mean you have a “BIA-ALCL” cancer.

Be cautious and remember that because you have a textured implant does not mean you have a “BIA-ALCL” cancer.

 

Publications / Resources Scientific Links to Information on BIA-ALCL:

PROFILE Registry Frequently Asked Questions

How to Add a Case to PROFILE

A Patient Death Attributable to Implant-Related Primary Anaplastic Large Cell Lymphoma of the Breast

Biomarkers Provide Clues to Early Events in the Pathogenesis of Breast Implant-Associated Anaplastic Large Cell Lymphoma

Commentary on: Lymphomas Associated with Breast Implants: A Review of the Literature

Breast Implant-Associated Anaplastic Large Cell Lymphoma: Two Distinct Clinicopathological Variants with Different Outcomes

Breast Implant-Associated Anaplastic Large Cell Lymphoma: Sensitivity, Specificity, and Findings of Imaging Studies in 44 Patients

Anaplastic Large Cell Lymphoma Occurring in Women with Breast Implants: Analysis of 173 Cases

Implant-Associated Primary Anaplastic Large-Cell Lymphoma with Simultaneous Involvement of Bilateral Breast Capsules

Breast Implant Informed Consent Should Include the Risk of Anaplastic Large Cell Lymphoma

Chronic Biofilm Infection in Breast Implants is Associated with an Increased T-Cell Lymphocytic Infiltrate: Implications for Breast ImplantAssociated Lymphoma

Complete Surgical Excision is Essential for the Management of Patients with Breast Implant-Associated Anaplastic Large-Cell Lymphoma

Coming of Age Breast Implant-Associated Anaplastic Large Cell Lymphoma After 18 Years of Investigation

Anaplastic Large-Cell Lymphoma in Women with Breast Implants

Breast Implant-Associated Anaplastic Large-Cell Lymphoma: Long-Term Follow-Up of 60 Patients

Managing Late Periprosthetic Fluid Collections (Seroma) in Patients with Breast Implants: A Consensus Panel Recommendation and Review of the Literature

Breast Implant-Associated ALCL: A Unique Entity in the Spectrum of CD30 Lymphoproliferative Disorders

The 2016 Revision of the World Health Organization Classification of Lymphoid Neoplasms

Breast Implant-Associated Anaplastic Large Cell Lymphoma: A Systematic Review of the Literature and Mini-Meta Analysis

MBN 2016 Aesthetic Breast Meeting BIA-ALCL Consensus Conference Report

22 Cases of Breast Implant–Associated ALCL: Awareness and Outcome Tracking from the Italian Ministry of Health

Breast Implant–Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Are Associated with Increased Risk

Discussion: Breast Implant–Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand High-Surface-Area Textured Implants Are Associated with Increased Risk

Discussion: Breast Implant–Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand High-Surface-Area Textured Implants Are Associated with Increased Risk Myckatyn, Terence M.; Parikh, Rajiv P. Plastic and Reconstructive Surgery. 140(4):655-658, October 2017.

Reply: Risk Factor Analysis for Capsular Contracture, Malposition, and Late Seroma in Subjects Receiving Natrelle 410 Form-Stable Silicone Breast Implants

U.S. Epidemiology of Breast Implant–Associated Anaplastic Large Cell Lymphoma

Global Adverse Event Reports of Breast Implant–Associated ALCL: An International Review of 40 Government Authority Databases

Bacterial Biofilm Infection Detected in Breast Implant–Associated Anaplastic Large-Cell Lymphoma

Breast Implant–Associated Anaplastic Large Cell Lymphoma: A Systematic Review

The Case against Biofilm as the Primary Initiator of Breast Implant– Associated Anaplastic Large Cell Lymphoma Brody, Garry S.

Anaplastic Large T-Cell Lymphoma and Breast Implants: A Review of the Literature

Anaplastic Large Cell Lymphoma and Breast Implants: A Systematic Review

How to diagnose and treat breast implant associated anaplastic large cell lymphoma

Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in the Breast

BIA-ALCL in a transgender woman

Whole exome sequencing reveals activating JAK1 and STAT3 mutations in breast implant-associated anaplastic large cell lymphoma anaplastic large cell lymphoma.

Consensus Guidelines for the Diagnosis and Management of Breast ImplantAssociated Anaplastic Large Cell Lymphoma.

The 2016 revision of the World Health Organization classification of lymphoid neoplasms.

Clinicopathologic Features and Prognostic Impact of Lymph Node Involvement in Patients With Breast Implant-associated Anaplastic Large Cell Lymphoma.

Implant–Associated Anaplastic Large Cell Lymphoma A Systematic Review.

 

The Food and Drug Administration (FDA) issued a Safety Communication Wednesday, July 24, requesting that Allergan recall its BIOCELL textured breast implants and tissue expanders to protect patients from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) associated with the implants. The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan agreed and is removing these products from the global market.

In line with its mission of safeguarding the care of all surgical patients, the American College of Surgeons (ACS) urges its members to immediately stop using the breast implants and discuss this recall with their patients. Following are some specific recommendations for our members:

Immediately stop using (implanting) the breast implants and tissue expanders listed in the July 24, 2019, FDA Safety Communication and work with your facility to return existing inventory.

Inform your patients who have the implants and tissue expanders listed in the July 24, 2019, FDA Safety Communication about the symptoms associated with BIA-ALCL, such as pain, lumps, swelling, fluid collections, or unexpected changes in breast shape, including asymmetry; the FDA does not recommend implant removal in patients with no symptoms because of the low risk of developing BIA-ALCL.

Consider the possibility of BIA-ALCL when treating a patient with late onset, peri-implant changes, including the development of a seroma, mass, or hardening adjacent to the breast implant. If you have a patient with suspected BIA-ALCL, refer the patient’s case to an expert familiar with the diagnosis and treatment of BIA-ALCL, ideally a board-certified plastic surgeon.

Report all cases of BIA-ALCL in individuals with breast implants to the BIA-ALCL registry called PROFILE and MedWatch, the FDA Safety Information and Adverse Event Reporting program.

For more detailed recommendations from the FDA, read the Safety Communication.

To learn more about BIA-ALCL, go to the American Society of Plastic Surgeons BIA-ALCL Physician Resources web page.

To find a board-certified plastic surgeon, go to the American Society of Plastic Surgeons website.

Thank you for putting your patients first as the FDA and the surgical community work to address these concerns about BIOCELL textured breast implants.

 

 

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