ALCL and Breast Implant Illness

BIA-ALCL Textured Implants | Mark EpsteinBreast augmentation surgery is an important personal decision that many women make. We consider it an honor to serve patients who wish to enhance their confidence and satisfaction with their shape. We consider it a duty to prioritize the safety and well-being of each patient who entrusts us with her body and her health. Recent reports in the media have raised concerns about the potential for breast implants to cause a rare form of lymphoma.

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an important topic of discussion among plastic surgeons and between doctors and their patients. Here, we answer many of the question’s patients are asking about this condition and what it means for them.

What is breast implant-associated anaplastic large cell lymphoma?

Breast implant-associated anaplastic large cell lymphoma, referred to as BIA-ALCL, is a rare form of Non-Hodgkin’s lymphoma that can develop around breast implants. The term “lymphoma” describes a type of cancer that originates in the infection-fighting cells called lymphocytes. This is not “breast cancer”.

What are the symptoms of BIA-ALCL?

Because BIA-ALCL involves the accumulation of fluid around a breast implant, the most common indication of this condition is significant swelling in the affected breast. At this stage, ALCL should be entirely curable. Symptoms may occur within a year of breast augmentation or a few decades later. The average time for developing ALCL is about 8 years. Additional, less common signs of a potential breast implant problem include breast hardening, a lump in the breast or the armpit, or a persistent rash on the skin of the breast.

How do I know if I have BIA-ALCL?

Your initial clue that you may have BIA-ALCL is that one breast appears significantly larger than the other. The swelling that develops around the breast implant is usually not subtle. This or other breast implant symptoms should be evaluated by a plastic surgeon right away. Further information is obtained through an ultrasound-guided aspiration of the breast. Aspiration means that fluid is removed from the area around the breast implant. The fluid that is collected is analyzed in a clinical laboratory, where a formal diagnosis can be made.

How is ALCL associated with breast implants?

Research is ongoing to better understand the factors that may contribute to BIA-ALCL. Current data suggests that the texture on the outer shell of an implant leaves space in which bacteria may accumulate. In response to bacterial infiltration, the tissue around the implant becomes inflamed. This is the immune system’s way of isolating bacteria so white blood cells can destroy them. In the case of bacteria around a breast implant, long-term inflammation results in such rapid reproduction of white blood cells that some become malignant.

Textured Implants Long Island | Mark Epstein

How serious is BIA-ALCL?

At this time, less than 400 cases have been confirmed in the United States. Globally, approximately 600 cases have been reported. Since reporting began, 17 deaths have been confirmed. It is important to understand that cases of mortality occurred well before BIA-ALCL was understood. Neither the patients involved nor their doctors had the capacity to know what condition was presenting or how to treat it. Most of the deaths occurred when there was a delay in diagnosis and treatment.

Today, 85% of diagnosed BIA-ALCL cases take a fairly benign course. This is because women are obtaining care at an earlier state of inflammation. In such cases, the removal of the implant and scar tissue achieves successful, long-term results. Usually, no further treatment is necessary. In advanced cases, chemotherapy and radiation might be necessary, but again, this is only for advanced cases that were not treated when symptoms presented and there was a significant delay in treatment. As awareness increases about BIA-ALCL, we expect mortality rates to approach zero.

Is the risk the same with saline and silicone gel implants?

The type of filling material inside the implant is irrelevant. ALCL is only connected to textured implants which refers to the outer surface of the implant. The risk of developing ALCL is the same in saline and silicone gel implants.

Does ALCL develop only in women with textured implants?

There are no known cases of ALCL developing in a woman who has only had round implants. There are fewer than ten instances where ALCL has been reported in women with smooth implants who have also previously had textured implants. If the capsule was removed along with the textured implants prior to receiving the smooth implants, then the fact that these women had textured implants in the past was no longer a risk for developing ALCL. In the few cases of women that had textured implants in the past, and did not undergo removal of the capsules at the time of removal of the textured implants and replacement with smooth implants, and developed ALCL, it is surmised that the capsular tissue was already abnormal at the time the textured implants were removed.

As previously stated, there is currently NO reason to remove textured implants in an asymptomatic patient. This said, there is certainly no reason to remove smooth implants in a patient who had textured implants in the past.
Should you have smooth implants, or for that matter have no implants, and you develop an abnormality with your breasts, you need to have your breasts evaluated by a physician right away.

Why would my surgeon choose a textured implant?

Textured implants have several advantages over smooth implants. All teardrop implants are textured to prevent them from rotating inside your breast, which would cause your breast to continually change shape. Therefore, all teardrop implants are textured. In the United States, until a few years ago, the very most cohesive/gummy bear-filled implants were teardrop, and so if you have that filler you might have a textured implant. Only checking with your doctor (or reviewing your implant card) will confirm the exact type of breast implant that you have. There is evidence that texturing might reduce capsular contracture and movement of the implant out of its ideal position. For decades textured implants were the most favorably used implants worldwide.

What is the risk of developing ALCL?

The risk for developing ALCL if you have a Biocell™ (Allergan’s texturing) implant may be as high as 1:2000 women. The rate is much lower with Silimed/Sientra and Mentor implant. Mentor’s is said to be about 1:86,000 women.

The difference in risk is related to the increase of surface area by the particular type of texture. The risk is highest with Biocell™ texturing, which is currently made by Allergan, but originally by McGhan and later by Inamed. (This is the texturing that is used on the Style 410 anatomic/teardrop implant.) Cases have been reported with Silimed/Sientra and Mentor textured implants, but less frequently. In November of 2018 Biocell™ implants were removed from the market by European regulatory bodies. Currently, the FDA has taken the position that the benefits of textured devices are substantial enough that they should be left as a choice for patients and surgeons.

Are some races more likely to develop ALCL?

As of this writing, there is only one Asian patient located in Thailand. Of the cases located in the United States, as of this writing, there is no known Asian patient with ALCL. The really interesting fact is that in southeast Asia, textured implants represent the majority of breast implants used!

Are there any transgender women with ALCL?

As of this writing, there are three reported cases in Europe, none in the United States.

Will a mammogram or ultrasound detect ALCL?

A mammogram evaluates the breast tissue only, so it is not an adequate test to screen for or diagnose ALCL. Mammograms are a kind of x-ray that shows masses and calcifications in breast tissue. This screening will not pick up indications of ALCL.
An ultrasound is ordered only for further evaluation for a suspicious mammogram, or to evaluate a mass or enlargement of the breast, so this test too would not be used to screen for ALCL. Should you notice an enlargement of your breast, then an ultrasound would be used to determine if there is an abnormal fluid collection in the breast.

Will insurance cover diagnostic testing for ALCL?

Diagnostic testing for ALCL may be covered by insurance and may also be covered under the breast implant warranty. If signs of BIA-ALCL develop, patients are advised to consult with their plastic surgeon right away regardless of their insurance situation.

How can I get screened for ALCL?

There are no screening tests for ALCL. That said, should you develop a mass, swelling in your breast, an unexplained rash or hardening of your breast, then see your doctor right away. With early diagnosis, ALCL should be easily curable.

Are textured breast implants still available?

As of this writing, some textured implants are no longer available in about 35 countries. The United States and Canada have not posed such a restriction on textured implants. It is not known at this time whether this will change in the future. Again, even in the countries that have banned textured implants, there is also no recommendation for the removal of textured implants in asymptomatic women.

If I have textured implants, should I have them removed? Can other implants be placed?

There is currently no recommendation for women with textured breast implants to undergo removal for preventative purposes alone. The risk of BIA-ALCL is very low. If you so desire, smooth round silicone gel implants can be placed at the very same operation.

What if I am doing well but I just want my implants out anyway?

Despite understanding that there is no medical reason to remove your textured implants, should you still feel uncomfortable with your textured implants and desire to have them removed, that is also perfectly acceptable.
As long as there is no concern for ALCL and you want your implants removed, then only the implants themselves need to be removed. There is no medical indication to remove the capsules in addition. Should you so desire to remove the capsules regardless, this can be performed as well, upon discussion with your surgeon. The surgery will be somewhat longer and more involved, but a “total capsulectomy” or “en-bloc removal” can be easily performed. You can also choose to have smooth implants placed during the very same surgery.

Furthermore, it is understandable that some patients may already be considering undergoing breast implant revision. Possibly you have been considering revision of your implants anyway – maybe going larger or smaller, choosing a softer implant, or getting a lift or some other tweak, but were unsure of when you want to do this. Just as it is a very personal decision to have breast augmentation surgery, revision is a choice that needs to be made with a great deal of consideration. This may represent a good time to undergo that revision and remove/exchange your implants for a smooth surface device. If your textured implants are removed, new smooth surface implants can be placed at the same time!

How is anaplastic large cell lymphoma treated?

Most often, BIA-ALCL is limited to the tissue directly around the breast implant. In this situation, the disease can be successfully treated by removing the breast implant and the entire capsule of tissue around it. This is called a capsulectomy. If the disease has spread, additional treatment such as radiation or chemotherapy may also be needed.

Where can I find additional information on ALCL?

American Society for Plastic Surgery 
American Society for Aesthetic Plastic Surgery
FDA Website

  • Patient letter – textured implants

Over the past several months, textured breast implants have been in the news. On July 24, 2019 the FDA requested that the Allergan company voluntarily recall its Biocell textured implants: https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan. You may receive information directly from Allergan. I am writing to provide additional information and to discuss what action, if any, is appropriate.

What is BIA-ALCL? “Breast Implant Associated Anaplastic Large Cell Lymphoma”, (BIA-ALCL), is a rare form of lymphoma. It is not a cancer that develops in the breast. There are many types of lymphomas. This type of lymphoma develops within the capsule that forms naturally around the implant.

Why Just the Allergan BioCell Textured Implants? Some breast implants have a textured surface. The texturing of the Biocell implants is different from the texturing of other implants and has been associated with the highest risk of BIA-ALCL. It is important to know that there have been NO confirmed cases of BIA-ALCL associated with smooth implants.

Is Allergan’s Recall like an Automotive Safety Recall? No. There are several different types of FDA recalls. Unlike an automotive recall that seeks to replace the “recalled” part, this type of recall is simply a withdrawal of Biocell implants from future use. The term is a little confusing, but it is the term that the FDA chooses to use. The “recall”, in other words, is directed at Allergan, not at you, the patient, or at your implants.

Is Allergan Or The FDA Asking Me To Have My Implants Removed? No, just the opposite. The FDA specifically stated that it does not recommend removal or replacement of Allergan BioCell textured implants in patients who have no symptoms.

Why Did Allergan Withdraw Its BioCell Textured Implants? Although there are manufacturers of textured implants other than Allergan, the FDA analysis found that the risk of a BIA-ALCL diagnosis with Allergan products is approximately six times higher than that of other types of texture. 84% of the 573 reported cases have been linked to Allergan BioCell textured products. The diagnosis of BIA-ALCL is rare; the best estimate is thought to be approximately 1:3,000, although some centers have reported higher incidences.

How Serious Is BIA-ALCL? When BIA-ALCL is detected and treated early it is usually curable. Of the 573 cases in the world, there have been 33 deaths. Deaths associated with BIA-ALCL are thought to have resulted from delayed diagnosis or inappropriate treatment. The single most important intervention to prevent advanced BIA-ALCL is regular monitoring and early detection.

What Symptoms Should I Be Looking For? Unlike breast cancer, BIA-ALCL most commonly presents with swelling of one breast. Other less common symptoms include hardening of the breast, an unusually persistent rash or a palpable mass in the breast or armpit – all easily identified by you. If you have any of these symptoms, please call to schedule an appointment for an examination and if needed, further tests. An ultrasound can detect the presence of fluid, and if present, a small amount can be aspirated with a needle and tested. Should this be positive for tests called CD30 and ALK, a diagnosis of BIA-ALCL will be considered. If the tests are negative, the fluid collection is considered benign. Benign fluid collections, known as seromas, are not uncommon around breast implants so it is important to differentiate them from those associated with ALCL.

What If The Tests Confirm BIA-ALCL? In most patients, BIA-ALCL is curable with surgery alone – removing the textured implants and the capsule. Consultations with other medical specialists may be recommended but in most cases there is no need for radiation or chemotherapy.

What If I Do Not Have Any Symptoms? The FDA recommends that you do not remove your BioCell textured breast implants at this time. Should you develop any of the signs or symptoms mentioned above, you should make an appointment for evaluation. You are the patient, however, and you do have the option of removing your BioCell implants, with or without replacement with smooth implants.

What Will Surgery Cost? You will be responsible for all operating room, anesthesia and surgeon fees for having your BioCell textured implants removed and for any additional surgery you may select, such as a breast lift or fat transfer. In some cases, Allergan will provide the smooth implants without charge if you desire to have the implants exchanged. This warranty at this time is limited to surgeries performed in the next two years or until July 24, 2021.

Where Can I Find More To Read? Additional information on ALCL and Allergan’s recall can be found here:

• FDA letter 5/3/2019 Summarizing recent FDA committee findings and recommendations: https://www.fda.gov/news-events/press-announcements/statement-fda-principal-deputy-commissioner-amy-abernethy-md-phd-and-jeff-shuren-md-jd-director-fdas
• FDA Reports of Breast Implant Associated Anaplastic Large Cell Lymphoma https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma
• FDA Safety Communication to Patients 7/24/2019 https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue
• Allergan’s Letter to Consumers 8/9/2019 – attached to this website

What are my options?

  1. Keep your implants, and should you develop any of the signs or symptoms that have been associated with ALCL, you can make an appointment for evaluation.
  2. You can have your implants removed, with or without replacement with round smooth implants. If you do not replace with round smooth implants, then there would be expected to be some deformity due to the loss of significant volume from your breasts. Additional surgery such as a breast lift or fat transfer may be required to mitigate the deformities caused by removing your breast implants.

If you choose the second option, I will remove your implants, with or without replacement with round smooth implants as you desire. As for the capsule, if at surgery I do not find a seroma (abnormal collection of fluid surrounding the implant) or nodules in the capsule, there is no problem with leaving the capsule in place. If, however, I find a seroma, or abnormalities in the capsule, I will send a sample of the fluid for diagnostic testing, as well as remove in total all the capsular tissue from both breasts, so that it can be tested.
There is some good news here. In some cases, and limited to the next two years, Allergan will provide without charge to the patient smooth surface saline or silicone implants to asymptomatic women who desire removal of their textured implants and replacement with smooth surface implants. Costs for facility (operating room), anesthesia and surgeons fees are not paid for by Allergan.

What should I do?
This is a personal choice. Let’s make two cases, either one is acceptable:

  1. The case to do nothing:
    1. If you are asymptomatic, happy with your breasts, and your implants have been placed within the last 8 – 10 years, and you are comfortable with the idea of just surveillance for now – that is, you will watch for any of the previously discussed signs and symptoms of ALCL, then I would recommend not removing your breast implants for now.
    2. Please understand that implants do NOT need to be removed after ten years if all is going well. Previous studies on silicone gel implants demonstrated that at ten years 90.6% of the implants are still intact.
    3. Lastly, silicone gel textured (style 410) implants were approved in 2013, so all my patients with these implants do not need to be thinking about the age of their implants at this time.
  2. The case to replace your implants:
    1. Age of implants: As for the saline textured (styles 168 & 468) implants that I placed, many of these are well over ten years and at this time may be on “borrowed time,” so you may want to consider replacing them with round smooth silicone gel implants before your saline implants have the opportunity to deflate.
    2. Change in weight – maybe you have gained weight and your breasts are now too large and you do not need your implants anymore, or, your breasts have not kept up in size with the rest of you and you need a larger implant so that your breasts match the rest of your body.
    3. If breasts are drooping and you need a lift, this may represent a convenient time for your implants to be exchanged at the same time as undergoing a breast lift.
    4. You want to have softer breasts – Maybe you have saline implants which are considerably firmer and ripple far more than silicone gel implants. You desire to have softer, more natural feeling breasts. This may also be a good opportunity to switch your implants to round smooth silicone gel? If you have saline or silicone gel implants and your breasts feel too firm because you have a capsule contracture, this may also be a good opportunity to have the capsules removed (due to the thick scar tissue, not due to concerns about ALCL) and place round smooth implants.
    5. Do you want to be larger or smaller? A size change may give you the size you would really like at this time in your life.
    6. You have no symptoms of ALCL, are otherwise happy with your breasts, but you are just uncomfortable with having textured implants inside you and having to worry about developing ALCL? This is also an equally good reason to switch out your textured implants to round smooth implants. This is the case with the majority of my patients who present for textured-to-smooth implant exchange.

If you have any further concerns and would like to meet with me, please contact my office for an appointment at 631-689-1100.

Questions on BIA-ALCL?

If you have any questions or concerns, we encourage you to contact our office at (631)689-1100. Our office proudly serves Hauppauge, LI, and surrounding areas.

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Epstein Plastic Surgery Long Island NY

NEW PATIENT CONSULTATIONS, INJECTABLES,
NON-SURGICAL PROCEDURES AND POST-OP CARE
Mark D. Epstein, M.D., F.A.C.S.
200 Motor Parkway, B12
Hauppauge, NY 11788