BIA-ALCL Implant related lymphoma

JameeCook

Breast Implant Associated Anaplastic Large Cell Lymphoma BIA-ALCL was first recognized by the FDA in 2011 as a possible lymphoma linked to breast implants. In 2016, the World Health Organization recognized it as a distinct entity. In March of 2017, the FDA agreed with the World Health Organization. As of last year, there were approximately 359 cases worldwide. There are now around 460+. The FDA lists 28 cases with smooth implants but the ASPS actually clarifies to say that all of these cases had previous sets of implants, either textured or unknown surface. This has resulted in a movement to say that this lymphoma is only linked to textured breast implants (and possibly expanders). The current theory is that contributing factors are bacterial contamination, chronic inflammation, and genetic predisposition. Doctors have joined globally to create and implement a 14-point plan that will hopefully reduce the risk for bacterial contamination. Unfortunately, not all patients have had a common bacteria present. It also does nothing for genetic predisposition. The common denominator is the textured surface. The most implicated has been implants with macro texturing (larger, rougher). The highest number of cases has been with Allergan. When first announced in 2011, the US risk was around 1:500,000. This year, the ASPS puts the risk around 1:30,000. That's still rare, but a huge jump. Australia puts their risk at 1:1,000 - 1:10,000. The US numbers are rising as more public awareness is made and more symptomatic women are pushing for testing. A study done in the US specifically on Allergan 410 put the risk between 1:3,000 and 1:4,000. This is still a rare disease but there are a lot of unknowns. Whatever implant you choose, the most important thing is to be educated on the risks and know what to watch for. The most common symptom is a unilateral swelling/seroma. The cells begin in a fluid that develops between the implant and the scar capsule. Other symptoms have been a breast mass, capsular contracture, skin lesions, and general lymphoma symptoms like lymphadenopathy, weight loss, and night sweats. An educated patient can play a huge role in the diagnosis and treatment of this disease because the knowledge base is just not there yet. The National Comprehensive Cancer Network (NCCN) put out algorithms for diagnosis and treatment in late 2016. These should be the guidelines that any oncologist or plastic surgeon follows. DISCLAIMER: I am not a doctor. If you have questions or are symptomatic, please seek advice from your surgeon or oncologist I have been studying BIA-ALCL for a couple of years as an advocate and run a support group for women diagnosed and those struggling to get tested. We also work on public awareness aimed at clinicians and trying to create a better bridge of communication between patients and clinicians in regards to this cancer. The past year has been a whirlwind of changes and we expect to see many more. Best of luck with your decisions on reconstruction. I do not have breast cancer so I can't help too much with that. I just want to try and offer more assistance on questions related to BIA-ALCL. I may not know all answers but have access to clinicians that can help.

XXXGGGYYY

Thanks Jamee. I'm in the middle of this decision right now. I have exchange surgery in January. The textured tear drop would work best with my anatomy. The odds for getting BIA-ALCL seem so very tiny, that I am inclined to choose the textured tear drop implant. I hope I am not being naïve.

TrmTab

Jamee - thanks for posting. I had my exchange in September. Expected to received SRX Inspira, woke to find I had TCX's. A long story that had me immediately wanting them out of me! I was persuaded that my personal risk of ALCL was minute relativel to my personal risk of another surgery...so I have not YET had a revision...put am still keeping it on the table. Thanks for your help. TT

JameeCook

@xxxgggyyy You are not being naive. This is an individual decision that only you can make. My only guidance to you would be to understand that the warnings for BIA-ALCL should be on all implant packaging inserts now. The warning is there with no guarantees on a method for prevention. The reason I say this is because patients who implant now and then develop this may not have any legal recourse for failure to warn or any other reason against the manufacturer or surgeon. I can try to attach a publication about the incidence showing which brands are most and least implicated. The brands with macro-texturing have a higher occurrence.Only you can look at the risks and make an educated decision. I do wish you the best in whatever you decide. I'm sure it isn't easy.

TrmTab

how do you get the package inserts?

I had TCX800 Inspira...is that macro textured

JameeCook

@trmtab The site won't allow me to add links. You can google the following - Allergan Natrelle Patient Labeling. The first google link should be for Allergan Labeling. Click that. Choose "Natrelle Breast Aesthetics USA". Then look under the pamphlets listed for "Silicone-Filled Breast Implants". There are several different ones. There is a section above that for the Allergan 410 highly cohesive, too. These pamphlets should be readily available to all patients who receive the devices. I have found that they aren't easily searchable online. I only know because we are in the process of getting the FDA to update their website with the most recent brochures. 

JameeCook

A good publication to read is called "U.S. Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma". The site won't allow me to add a link but the publication is searchable. You might have to join the journal site to read. 

JustAJennifer

I have a textured silicone cohesive gel implant and understand the risk to be elevated. I am eager to reduce risk however possible and hope to have it swapped for a smooth silicone implant. Does anyone have information on whether this type of exchange surgeryis being covered by insurance yet? I know the recommended action is still do nothing and watch and wait at this point.

JustAJennifer

I am scheduled for exchange surgery on Jan 22, going from textured to smooth silicone. No word on insurance yet. I saw yesterday that lawyers in Canada have begun moving toward a class action lawsuit against 5 implant manufacturers.

https://www.google.com/amp/s/edmontonsun.com/news/local-news/montreal-law-firms-seek-class-action-against-breast-implant-makers/wcm/94ddf2f1-af79-4f3e-9736-cc486343ff7c/amp

Rah2464

Mine are textured but I don't recall the manufacturer. I do remember signing a form about risk prior to the surgery. Not truly in a state of mind to process it all when you are just wanting the cancer out.

JennieKeaton

I'm doing my exchange late February, and my PS is wanting to do textured. She says it's the only way to get the look I want. I was against at first, but now considering. I'm petite and really, really want the teardrop look. I understand there is an increased risk, but also understand I make choices every day that increase my cancer risk. I used oral contraceptives for 30 years for hormonal migraines and other issues. I use artificial sweeteners. I color my hair (when I have it). I eat foods that may not always be the healthiest (but I do well most of the time). I sit around fire pits and sometimes inhale the smoke. Etc. I just need to wrap my head around this and make the best choice for me. Which my include getting textured implants. I do appreciate that I would be going in with my eyes open and could take them out if there's a problem. The hardest part is finding good statistics - which there may not be yet. I had been so against it, that it's hard to wrap my head around a change. But this may be the best choice to get the look I want - and I don't want to be unhappy with the look after all of this!

My PS said if she were getting implants, she would do textured.

JameeCook

Hi ladies, I would highly recommend that you do a capsulectomy if undergoing exchange. I know the risk is still very rare, however, we have seen women develop BIA-ALCL in retained capsule. This most likely means that the patient was positive at time of removal or exchange and just didn’t know.

Allergan textured implants and expanders in Europe (any textured under the CE mark) were just removed from the market citing a lack of requested information by the manufacturer. Australia is also in the process of deciding whether or not to keep textured implants and expanders on the market. Just something to take into consideration as you make your decisions.

The latest count of BIA-ALCL cases by the ASPS is 656 - up from the 414 documented on the FDA website. There are also now 16 deaths as opposed to the previous 9.

TrmTab

I had an MRI in September 1 year after the TCX implant was wrongly put into me...previous storyline.

The MRI showed fluid in the capsule, which again is one of the issues that can lead to the ALCL. This made be finally move forward with the exchange as the TCX was way too big and hard for me AND was textured!

I agree with the capsulectomy...I did finally get an exchange from TCX to SRX700 on Dec 17...I am currently 3.5 weeks post-op. I had the direct capsule tissue removed (capsulectomy) and it went to pathology...no findings, clear...go on with your life!

My body is reacting much better to this implant...I was swollen and brusined for months with the textured 800.

Irony

Jamee, Thank you for the information. I have a very annoying, fear mongering, co-worker that knows I have textured implants and keeps posting these brief, no information blurbs on Facebook about how people are dying from this.

My reconstruction was March 13, 2007. Almost immediately after surgery, I saw the first article linking these implants to lymphoma.

My surgeon chose textured Allergan Natrelle 410s for me because I have a pectoral deformity. She thought they would stay in better. That didn't actually work. My right implant is lower than my left. I was getting surgical clearance to have it fixed, when I had to cancel the surgery because I needed open heart surgery to replace my aortic valve and replace an aneurysmal section of my aorta. It was a big surgery and everything else was put on the back-burner.

When I saw my breast surgeon and oncologist neither were that concerned with the increased lymphoma risk. They said my surgical risk due to blood thinning meds was riskier than just keeping the implants. My cardiologist says I can get the exchange surgery whenever I want. He isnt concerned with my being on thinners, I just run a greater risk for hematoma. Im so confused.

I consulted another plastic surgeon, he said he would take them out and that he is not putting textured into any of his patients. I can't face another surgery right now, but I think, down the road, i will replace them.

Does anyone know if insurance will cover this?

Thanks

NotVeryBrave

I have textured implants, anatomical shape. I had to sign a document stating the risks and that I was aware of them. But my PS still recommended them because I wanted to have a skin and nipple sparing, direct to implant surgery. They are also prepectoral.

Every time this topic is in the news I cringe a little. My family and friends ask if my implants are textured. My understanding is that the association is much greater with textured, but is also a factor with smooth.

Early on after surgery I had considered having more surgery to fix some things - one implant rotated, they are a bit wide for my frame, there are some ripples and a dent. But as time goes on and I recover from treatment (and menopause and aging) - I really don't want more surgery unless it's necessary.

So I've decided that everything is staying "as is" unless there is a recommendation for something else. And I hope for the best.

JameeCook

@TrmTab That's great to hear.

JameeCook

@irony As a reconstructive patient and with potential displacement, I believe your insurance would cover the exchange. I'm so sorry that you had the other health issues arise. It sounds like you've been through a lot. Again, I would be sure to ask if a total capsulectomy could be done at time of exchange. This is not to scare - but inform. The Allergan textured implants have the highest incidence of BIA-ALCL. The CE mark (similar to our PreMarket Approval) was denied in Europe recently. A meeting in France this past week discussed these issues with the ANSM. The resulting decision was that the Allergan textured devices should stay off the market because of their higher incidence for BIA-ALCL. They are NOT currently recommending removal for patients who have these textured implants but encouraging women to be aware and to watch any changes in breasts or symptoms.

@NotVeryBrave The current recommendations do not urge for removal. This has to be a personal decision. I'm sure that the news has, at the very least, made women more aware and I'm sure you will pay close attention to any new changes.

JameeCook

Statement from Binita Ashar, M.D., of the FDA's Center for Devices and Radiological Health on agency's continuing efforts to educate patients on known risk of lymphoma from breast implants

BIA-ALCL Update from the FDA. They will be sending out a "Letter to Healthcare Providers" about this lymphoma. We urged the FDA to do this in our last meeting with them in September of 2018. We believe it is important to educate on a multidisciplinary level as many symptomatic women do not present to their plastic surgeon. In addition, the FDA will be holding an Advisory Committee Panel Meeting on breast implants in March to discuss multiple concerns.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630895.htm

Sharon2010

Hi, It's been a VERY long time since I've been on this site, but with the new concerns with textured implants, I came back to get educated. I had a bilateral mastectomy and reconstruction with the Mentor 410, anatomically shaped, textured implants. One breast had been radiated, and the capsular contracture on that side has gotten so bad, it's like a bowling ball on my chest. My doctor wants to remove them. He no longer uses the 410s at all, because of the risk for cancer.

What I'm not understanding based on all the statistics posted, is the true risk. If textured implants only account for only 13% of the US market of ALL breast implants, shouldn't the risk data be dialed down to what percentage of women with textured implants are at risk for BIA-ALCL? Some statistics are saying 1:30,000 women will get it, others say 1:3,000. Apparently in Australia, they are saying 1:1,000. This is a huge difference. I want to know what these stats are based on. Is it based on data from the millions of breast implants done/year, worldwide, including ALL types of implants? Because if the highest risk (almost exclusively) is with textured implants, and textured implants only account for 13% of the market, then BIA-ALCL risk shouldn't be lumped in with the vast majority of implants, which are smooth. Of course the risk will appear low if looking at ALL implants overall. I want to know specifically, the risk factor ONLY for women who have textured implants. I wonder if the huge chasm between 1:30,000 and 1:1,000 is differing because the 1:30,000 is based on ALL implants, both smooth and textured, and the 1:1,000 is just based on textured implants. I also want to know if the pool they're drawing data is from just US procedures, or internationally as well? If it was just pulled from the US data, then it's not including risk and findings that other countries are recognizing. Mine are being removed, and swapped out for smooth and round, not anatomically shaped. So I guess knowing statistics shouldn't really matter to me because they're being removed anyway, but it does matter. I think they should look at the risk only for textured, and if they did that, they might see they need to do a recall. If anyone has more information that can better describe how these statistics were formulated, please post here.

Thank you,

Sharon

Sharon2010

Thank you for all your information and research! Can you post a link to the study you referenced... "A study done in the US specifically on Allergan 410 put the risk between 1:3,000 and 1:4,000."

OneFoot

I have mentor round cohesive 1 textured implants and it appears that I may have BIA-ALCL. I have only had my implants for 2 years. I have all the standard symptoms and my doctors are currently pooing themselves. I am still undertaking testing at the moment but my surgeon has stated that regardless of the test results (type of bc) my implants and the capsules are coming out.

I will be replacing with smooth at some point but when is yet to be determined.

As I get info from my doctor re: current stats etc I will update here

Moderators

Hi there, OneFoot! We're so sorry to hear that, we know how frustrating it can be. Please do keep us updated as you learn more!

The Mods

rmgrmg

Did your physician recommend the implant and capsule out or just implants?

rmgrmg

Sharon so sorry that your one breast that had been radiated has a capsular contractureon that has gotten so bad, it's like a bowling ball on your chest! Good luck with the implant removals and capsulectomy! Prayers and keep us posted.

JameeCook

@sharon2010 This is the older publication I was referring to. The incidence is now actually higher. I help run a support group for diagnosed women. We also work with researchers. I think what I will try to do is start adding some of the important documents in this thread for your review. I believe that they might help.

https://journals.lww.com/plasreconsurg/Fulltext/2017/09000/Reply___Risk_Factor_Analysis_for_Capsular.48.aspx?fbclid=IwAR1PLvIoY2fwycY4Dkri2s7VnjlfnPKeE2i50gwSOdMC_Z7rz3IFu7WjwOE

JameeCook

@OneFoot I am sorry to hear of your complications. Please make sure that your surgeon is following protocol for testing. It is very important that any fluid be tested prior to removal. If positive, the next step would be PET/CT for staging prior to explantation. Dr. Anand Deva is the leading expert in Australia. You might want to reach out and contact him. anand.deva@mq.edu.au

Sharon2010

Thank you! I will read that study. I will see my doc for a pre-op apt tomorrow, and run the protocol for biopsing the capsule. I think he likely does it that way, as he’s on a list of docs who specialize in Implant Illness capsulectomies, and was a principal investigator for the 410 trial. But can’t be too sure

JameeCook

Just a quick note. The FDA lists several smooth cases. The researchers (world experts) all say that they have never seen a case of BIA-ALCL with purely smooth implants. These patients had a history of textured surface implants or expanders - or had implants or expanders with unknown surface. Please remember that most expanders are textured and, therefore, still increase the risk. It's not just the actual implants. The most recent FDA publication did note that it can occur in both smooth and textured. In our patient group with over 150 diagnosed, we have not seen a purely smooth case.

I will start posting some links that I think you ladies might find helpful in your research on BIA-ALCL.

JameeCook

Breast implant-associated anaplastic large cell lymphoma: a review

https://lookaside.fbsbx.com/file/Modern Pathology.pdf?token=AWx9v_tapvteoHlV4HQrM1ECbZzN04Ne8oi7b8nAa9FmZ5qh345Yh_VY1NkEffc_vTN7dE4pod5dqa69jYuw4K2Vwv5MTA-n4TYMc-tMzp0oYcEAf3yPqaZyrV0mffskFTU1hSQDfFZIZ1BHXu3LrTex

JameeCook

The most important is the NCCN Guidelines. Diagnostic algorithms can be found here under T Cell Lymphomas. You must register or login to view but it is free.

Look under T Cell Lymphomas

https://www.nccn.org/professionals/physician_gls/default.aspx?fbclid=IwAR18BMJvDL9wvi90P9FaShhMt-ugIv5cCeFDWn073zXhpL-Z0pTgQSR8xzM

JameeCook

Pages 6, 7, and 8 of this publication from Aesthetic Society News

https://drive.google.com/file/d/1j5_y_uyqCxf-5uuBNirYrLz3ulVXzSKy/view?fbclid=IwAR3pExjt5rgI4tBiQfU1EDPPbvx53zBlAudJvaxsw471CJ23OtuQvyTlWLo