Health concerns of Allergan Textured implants
Comments
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Beesie
You missed my basic point but I don't see the need to rehash the issue. Not everyone..not even all doctors agree about this issue. I have a right to my opinion and if I am healthy enough to have the surgery then that's what I will do. Oops..that's right..it's already done!
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Scrafgal, of course you, and everyone, should make the decision that is right for themselves. And if that means removing the implants, then do it.
I was referring specifically to the comparison to a air bag replacement. Changing a part in a car and changing a part in a human body is not the same thing.
While I understand the anger and frustration with what appears to be the government and the medical community and Allergan dragging their feet on this, my point was that when it comes down to it, I think their current stance makes sense and is the wisest position to take for the population as a whole. That doesn't mean it's the right decision for you as an individual - I understand and respect that. If I recall from your posts, you were scheduled for a revision surgery and decided to have the implant replaced at that time. Makes sense. I'd do the same thing.
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Beesie
Thanks for your clarification. Like I said, I don't want to thread the needle on my comparison-point, which was really about who should pay for the surgery, in the context of the two previous posts.
More importantly, I try to respect whatever people feel is the right choice for them. On this particular thread, however, it seems that some comments are more judgmental about personal choices, than is necessary. There are some women who are coming here to seek advice. I hang around here mostly to make it clear that it is really okay to decide not to live with that very small risk of BIA-ACLC. I would not feel the need to stay to that, if I knew that women holding that position would not have their voices marginalized with comments that are laced with suggestions that they are somehow overreacting to the issue. You must admit that there are undertones of that sentiment expressed here.
As one physician put it, this BIA-ACLC is one cancer that nobody has to get diagnosed with...and, it does not mean necessarily that you are taking some huge unnecessary risk by having the implant exchanged. It depends on a person's individual situation, as you say.
It is also okay to decide to live with the risk, particularly if one does not want another surgery or is worried about the risk of a surgery. I've said this more than once here.
Finally, I do not have to have 100% faith and confidence in the FDA...and neither does every physician. So, on this issue, as far as I am concerned, let the FDA recommendations be damned. I am glad that I had my implant exchanged and covered by insurance, as part of my revision.
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Scar - of course you are correct that everyone should consult with their own physician and make their own decision. That is the patient in consultation with the doctors - not sitting in front of a television story.
I hang around here, as you put it, to make sure that some of the scare tactics are not frightening people into thinking they are for sure going to die & rushing into serious surgery that may be unnecessary. A friend called me in tears about my upcoming death because on her TV she both heard 60% will get BIA-ALCL and saw that number running in print across the bottom of the screen. The actual percent WORLDWIDE is 6%.
That said, if I have sounded judgemental, I apologize. I just believe we all need to step back and not panic. We need to talk with our doctors, and maybe more than one doc. Then we need to access our personal risk tolerance - pro & con for the possibility of BIA-ALCL vs major surgery.
Personally, I will lobby to have an MRI done when I see my MO in September.
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Interesting points, Scrafgal. I agree that some posts - not very many though - have been judgemental. It's also true that some posts have been alarmist, sowing fear.
I hang around here mostly to help steer the discussion to the facts, as we know them today. Like all things related to breast cancer, this is a very emotional issue. How we feel, our fears, our concerns, and so many other emotions play into all the decisions we make related to breast cancer. That's important, because our emotional health and well-being is important. But knowing the facts when we make our decisions is also important. Decisions should be made with consideration both to the facts and to how we feel. We each get to decide for ourselves where we put the heaviest weight.
When someone comes here scared to death because she saw something on the evening news about her implants causing cancer, the first thing I want to do is reassure her that this risk is a fraction of a percent and if she is experiencing no problems with her implants, then she should have no concerns. I agree that we should support anyone who decides that she does not want to live with the very small risk of BIA-ACLC. But I also believe that before encouraging someone to pursue surgery, we should ensure that she does understand that the risk is very small. I'm a big fan of educated decisions.
As for trusting the FDA, I don't blame you. But I'm in Canada, and I've had these implants for 13 years. I did a lot of reading and research before I got them. I even remember reading about BIA-ACLC back then. I read all the fine print in the lengthy product materials. These implants have been the primary implant in use in most countries other than the U.S. for the past 15+ years. So there are millions of these implants in use, and there is actually some pretty good long-term information about these implants, and the prevalence of BIA-ACLC, from the rest of the world. Reading reports from Canada, the UK, Europe, New Zealand and Australia, one number I've seen published puts the risk at 0.01%. More commonly, I see a rate of 0.002%. Might the risk end up being higher? No doubt. But even if it doubles or triples, we are looking at a risk that is a fraction of a fraction of a percent. Anyone worried about these implants and trying to decide what to do should know these numbers.
And then, if someone decides to have her implants removed, of course she should be fully supported. And of course the patient should not have to pay for the surgery.
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Scrafgal - I agree! We are intelligent women and we understand the risks of surgery. And yes we are angry and we are anxious for answers from reliable sources. But the FDA and the medical community have not been truthful or forthcoming about this. The truth is in our stories, but only if we tell them. The facts will come out, but only if they aren't covered up or brushed under the rug. The harms of silicone implants in the body have been known for years, but have been downplayed and covered up. Just look at the Dow Corning cases. If you are willing to take that risk - that's your choice. But if these risks are not disclosed, that is not a choice, that is a problem in my opinion.
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Beesie,
I agree with everything that you've just said and, along with many (I am certain), appreciate your focus on the facts. As an educator and marketing researcher, how could I feel otherwise? I also know that, despite everything, even when there is a rare risk of an event-occurrence, sometimes that event actually occurs. Sometimes people really don't consider that but I do. In my own bc journey, rare events have happened to me, which is why I always ask myself, "What if I am the rare occurrence? How would I feel about having readily accepted the risk?"
For example (and this is just a personal example--not a judgment on anyone's choice about saving their hair by cold-capping), I am one of the rare individuals who lost their hair permanently after chemo. No, I was not on Taxotere, either. It is a very rare event, and as I volunteer at MD Anderson, I often reassure women that their hair is highly likley to return. MinusTwo, I don't believe in scare tactics either! I am a rare event and readily acknowledge that, based on the facts. I took the risk knowing how small it was, and I made a fully-informed, conscious decision not to cold-cap. While I am disappointed about my hair, and went through a lot of emotional pain about it, I am not regretting my decision not to cold cap. I was willing to risk losing my hair by not cold-capping for my own personal reasons. Living bald is just something that I live with now, and it no longer is painful. And, btw, I made that decision in the context of the full facts about the evidence that supports the safety of cold-capping. It was a big decision for me, because I have the financial resources to cold cap and was on medical leave, so I had the time to deal with cold-capping. I weighed the facts and my feelings, made a decision, and I am living peacefully with my choice.
On the issue of these implants, when I ask those questions, "What if I am the rare occurrence? How would I feel about having readily accepted the risk?" I have a different response. I just could not live peacefully with that outcome. Is there a substantive difference in the situations? For me, yes, but there is nothing that explains this other than my personal risk tolerance, which is situational. I am sure that some women think that I should have cold-capped, but they don't know my situation and why I made my choices.
Beesie, I have seen you communicate well with women making choices about chemo, in terms of the risk of long-term, distant recurrence. You always present the facts and readily acknowledge that no one can or should make decisions for others--even those that seemingly go against the facts. This implant issue should be no different. I do agree that most of your comments have acknowledged this reality. But, Beesie, you have a very powerful, influential voice here (and well earned). So, if you even make ONE comment that seems to lean toward "don't over-react," it could have an inflated impact on others, especially since you have these implants. Of course, your influence is not a bad thing, because your comments are fact-based. You also cannot help how powerfully your comments might influence others. It is just a reality and what comes with the territory of having a powerful voice. And, for the record, you have used your voice powerfully and favorably, across the threads on these boards.
MinusTwo, I appreciate your comments. At times, I felt a bit judged, but at one point, you made it very clear that you were happy with your choice and had your own powerful reasons for making it--including the confidence in your medical team, which means a lot. So, then I understood why you expressed your feelings so strongly about the matter. We are all trying to live peacefully, happily and healthily, and the choices are not always easy. I wish nothing but the very best for you, and hope that you never have any problem with your implants. I honestly think that we've all suffered enough physical and emotional pain because of this disease. We should share our knowledge of the facts, as you do, and support the choices that each woman makes because, in the end, she has to live with the consequences, good or bad.
bc101, I have appreciated your posts, as well. You've provided links to third-party articles that have been factual and offered your opinion, which is welcomed here. I agree that sharing our stories gives us more to consider, as we navigate the facts and try to make decisions along this journey.
Right now, with a few exceptions, most women know the facts about the rarity of the event and the FDA recommendations about the implant, because the issue has been so broadly covered by the media. So now, I suspect that women who are undecided are seeking a place where they can find validation in their choices about the matter. If that is the case, then I think such a woman would find that she is not alone in her choice, either way, to keep the implant or exchange. In the end, I think that this is a good thing, which is why this forum is so valuable.
Peace
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For those interested, here is information and history about BIA-ACLC, and what's being going on around the world on this issue.
One of the most active jurisdictions on BIA-ACLC has been Australia. Here is their website explaining the issue, and providing the history of investigations and notifications. Their most recent update to the website was August 6, 2019.
Breast implants and anaplastic large cell lymphoma
- The Australian Society of Plastic Surgeons first posted guidance for patients on this issue in March 2010.
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Here is the website from GOV.UK, which provides a lot of information about the activity globally. This site is not quite as up-to-date, with the last update being April 4th 2019.
Breast implants and Anaplastic Large Cell Lymphoma (ALCL)
- In the U.K., their first alert about BIA-ACLC was issued by The Medicines and Healthcare Products Regulatory Agency (MHRA) on February 16th 2011.
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Here is the current Q&A page from the FDA, addressing questions about BIA-ACLC:
Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
For some background, here is the FDA's 2011 update on silicone implants, detailing the history of their safety investigations and on-going monitoring process.
Update on the Safety of Silicone Gel-Filled Breast Implants (2011) - Executive Summary
This is the link to the full 63 page report: https://www.fda.gov/media/80685/download
- The FDA announced a safety communication to warn about an association between breast implants and anaplastic large cell lymphoma on January 26th, 2011.
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There is a lot of information out there, if you look. There are detailed explanations as to why the current recommendations are what they are, which (from the FDA) is that
- We are not recommending the routine removal of these or other types of breast implants in patients who have no symptoms.
- You should inform your patients who have the implants and tissue expanders listed in the July 24, 2019 FDA Safety Communication about the risks of serious adverse health consequences, including the potential for the development of BIA-ALCL.
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Scrafgal,
I think we are pretty much landing in the same place, but we are coming to it from a different direction.
One question though. What's wrong with saying "Don't over-react"? To me, it just means 'get the facts before you jump to a conclusion or make a decision'. Perhaps the better wording is "Don't react and decide too quickly".
Where I have to disagree with you however is that "Right now, with a few exceptions, most women know the facts about the rarity of the event and the FDA recommendations about the implant, because the issue has been so broadly covered by the media.".
I don't think that's true at all, and that's precisely my concern. Most of the media articles and television news stories have focused on women who have experienced BIA-ACLC, and most barely mention, if they mention at all, how rare this occurrence is. What I see in the media is a lot of fear-mongering and not much calm rational discussion. And I see that reflected here when I read the various threads on this board about this topic. I see so many women who don't have any idea how rare this disease is. New threads seem to pop up every few days, with new members who are frightened to death that they have these implants that cause cancer.
That said, I'm a stats person. And I am the first person to tell anyone that if the chance of something happening is 1 in 5,000, someone is going to be that 1 person.
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Beesie,
Nothing is wrong with saying "Don't over react." I was only suggesting that when you make that comment, along with the facts, some women could interpret that with more meaning than you intend--as though it is your opinion that after interpreting the facts, a decision to explant would be an over-reaction. However, as I suggested, others' interpretation of your statement is not something that you need to own.
As for media reports, I suppose it depends on which media readers consume. So, while I have seen some coverage of women with the disease, I mostly watch CNN and major media outlets. On those, they tend to make the FDA recommendations very clear, as you have done.
Yet, it is possible that just the mere of the coverage of women that have the disease might have an outsized effect on perceptions of risk. Again, this is not something that we can control. How many women don't understand the rarity? I don't know. I do know that the media outlets that I view always mention the rarity.
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btw
After thinking about this discussion, it occurred to me, Beesie, that "it's hard to be Beesie." You, too, have a right to your opinion. So, even if you did think that explanting was an over-reaction, you have a right to feel that way. You, too, are a survivor of this disease and should have the freedom to have an opinion. You are in a difficult position because if you only stick with the facts, you would find it very hard to engage on an emotional-level here, as a survivor. You are not here to provide medical facts only, presumably. You are here to support and get supported. In this forum, you have taken on the role of giving the facts, but that should not keep you from expressing an opinion. I apologize for putting you in a position that puts you in a place where you would feel that you need to just stick with the facts. As much as you love the facts, Beesie, you are an emotional human being that has a need to connect, express and vent like the rest of us! So...just keep doing what you're doing. It is valuable to all of us!
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I don't post much, but y'all know where i stand... and my biggest issue is at first it was 1 in 20,000, now they are thinking it's more like 1 in 2000... and I bet the rate for the scarring / inflammation is much much higher. We just don't know yet. So using currently or outdated stats as a way to say 'calm down' irritates me because more and more women and even doctors are starting to recognize the symptoms of implant sickness rather than dismiss it.
So to say 99.9% of women are fine, is just wrong... When this shakes out, I bet at least 40% of woman have some form of implant illness or pain / scarring0 -
Scrafgal, thank you for your post. As an FYI, from a personal standpoint, my opinion is that there is no reason to explant if the patient is having no problems and is happy with her implant(s). However, if there have been any problems or pain with the implant, or if the patient had already been thinking about replacement, or if for some other reason the patient will be having surgery, then by all means have the textured implant(s) removed. I'm certainly not against explant; I'm against explant when it is in effect an unnecessary surgery because the patient is otherwise perfectly happy and comfortable with her implants.
Lisey... yes, we all know where you stand, to my point about fear-mongering.
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Understood, Bessie.. somewhere in an earlier post I even said that I was unsure as to whether I would have scheduled a special surgery just to remove my implant. My choice was conveniently aligned with a scheduled revision surgery. So, my choice, admittedly, was easier. As MinusTwo has stated, I am not trying to have any more surgeries really. I've had enough surgeries...but I wouldn't blame anyone for scheduling one if only to alleviate the concern.
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Thanks for the comments, Scrafgal
And here I sit, someone who had a BMX for a “mere” 6 mm of DCIS. I had the recalled implants placed in early 2016 and immediately hated them. Not a month later, I began hearing about ALCL.
As immediate as my decision was to have a BMX, so was the decision to get the 410’s out of my body! I am well aware of how “rare” stuff can happen. I have myasthenia gravis, a muscle disease that strikes 1 in 14,000 people. On top of that, I have a subset of it that is shared by only about 200 people in the United States. In addition, my daughter has autism and ADHD. Not as rare, but still out of the ordinary. Bad stuff happens with regularity in my family!
My body has shown it can make cancer. The boobs had to go and so did the 410’s! Only now do I feel comfortable with the remaining level of risk. Luckily I have found docs who respect all of my decisions.
If only I could have such “luck” when buying lottery tickets!
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bc101
Oh my gosh! Thank you for sharing about your symptoms. I just found out I have recalled implants from 2013 surgery (all preventative =BRCA positive; family history).
Received letter from my health care provider of recall. Was shocked!
Have appointment next month with PS. Implants have felt “heavy" last few months. Terrible insomnia since surgery. And brain fog!
Symptoms could be related to other issues, but definitely going to ask PS.
Thank you all for sharing info!
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VegGal...glad you found understanding doctors...mine understood and was very supportive too...sorry to hear about your rare conditions...I keep telling every breast cancer survivor that did chemo, and got their hair back, that I took one for the team with filling out the stats on permanent hair loss....somebody had to do it!
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Did your insurance cover the replacements/surgery? When I spoke to my PS they told me at this point insurance won't cover if I'm "not having problems" which really aggravates me because I lived through Breast Cancer twice! and don't want to live with the possibility of BIA-ALCL! I only have an implant on my mastectomy site and have the Natrelle Highly Cohesive 410. Just want the &($# thing out!
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Hi Jenene63,
We want to welcome you to our community here at BCO! We certainly understand and share your concerns. It sounds like at this point, the FDA is only recommending removal of textured implants in cases where people have documented problems with their implants. But we would suggest calling your insurance company and speaking with them directly to see if you have any options for removal available to you, as it looks like your implants are directly impacted by the voluntary recall. And stay up to date on the latest developments (which we will share here as soon as they're released), as this situation seems fluid and more information is likely to come.
The Mods
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For what it's worth, my oncoplastic surgeon told me that any revision or implant replacement surgery I want or need is covered by insurance for the rest of my life, since it is all considered reconstruction as a result of breast cancer. My understanding is that that should be the case for anyone in the US.
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Jenene, regardless of whether the FDA is recommending replacement. You can at ANY POINT in time demand they come out by law in the US. Clinton gave Breast Cancer patients lifetime support on this issue. I think perhaps the issue is you want a replacement rather than to explant correct? If so, just say you are in pain and out they will come. Ladies... Just use the PAIN card. There's nothing that they can say to block you if you use the PAIN card.
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I have been having pain issues for months & my implants have changed shape & feel, they just don't feel right, but I cant get a PS to see me because I'm stage IV. It is so frustrating. My original PS won't even respond to my GP's referral for appt. I've been on the hook waiting for him for 6 weeks. They are now sending out a referral to a fourth PS. I am so frustrated.
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Lisey - The problem with "playing the pain card" is that no one will ever be able to get an accurate assessment of side effects & causes. If we want to know what really has happened and is happening, about this issue, people need to be honest. In fact citing pain if you don't have any skews any number of BC records.
But Jenene - to the point - once you've had breast cancer you only have to ask for replacements. Since that was your first & only post and you didn't fill in your profile, we don't know your situation or your country. Please do post again if you want to give us some specifics.
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Pal218 - Glad my post helped you. I know....It is shocking that they waited so long to start contacting patients. I got my letter after my consultation for explanting! A few symptoms you listed (insomnia, brain fog) sound like Bii - breast implant illness. I had a long list of Bii symptoms that improved shortly after removing my implants. I also had pain and swelling for years, so they had to come out! Unfortunately your doctor may not believe in this disease, so be prepared for some resistance. Fortunately the FDA is finally recognizing Bii as a real issue, so the tide is starting to turn. Best of luck to you!
GG27 - my heart goes out to you! It just isn't right that your doctors are ignoring you. Keep pushing and kick the door down if you have to (metaphorically speaking, of course, lol). You deserve to be treated the same as anyone else. Please keep us posted. HUGS!
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MinusTwo, If I'm facing a roadblock due to the system, I'm going to do what I need to do to bypass the roadblock. At that point, my needs trump the 'skewing of BC records'. If I'm not being listened to, you use the weapons you have. And the ultimate weapon to bypass red tape is pain. Women need to be vocal, demanding and strong.
My PS was refusing to remove my TEs immediately when I told him I was in agony with them 1 week after getting them in. He blew me off saying I'd feel better with fills - and he had 'cancer patients to help' (uh.... duh dude) I not only brought a witness, I told him If he didnt' get them out within 72 hours, I'd be in his hospital parking lot, with my attorney on the phone and cut the f'ers out myself, Now i REALLY was in agony... I hated them and it felt so wrong to my body. But I've personally experienced the 'blow off' and I think my personality shows here. If he sniffed me wrong and thought I'd listen to him and back down, he clearly was mistaken, but not many women are as loud and assertive, or have an attorney on hand, like I do. they need a trump card and they need to know their rights.0 -
Thank you Scafgal for your post!!
I have finally found a PS I can be comfortable with. I had to find a new one because I moved to a new state. She had breast cancer and she knows how to do the Diep. Although I will have to have 2 surgeries - 1. Remove textured, put in smooths immediately. 2. lose weight to get more skin for the deip. Monday I go to get ultrasound and biopsy(syringe) the fluid to test first. The other ps just wanted to go in and remove and replace them. I will feel more comfortable going in to surgery knowing the results.
I have suffered since I got them in. I have had test, test and more tests to try to figure out why I felt so bad. Reading the symptoms of the disease I am almost sure that the implants could be why I have these issues.
Lisey, YES! You play whatever card you need to! I did the same until my oncologist finally heard me and ordered an MRI.
Ladies I don't trust the FDA because it is all about the $$$$. I still haven't heard from my former PS. I had to call them. Doesn't matter. I would not return to him anyway. I've had 3 different doctors who said they didn't understand why the PS used textured in the first place on a cancer patient. WOW! And they all said it must come out NOW! After my first surgery, I will talk to an attorney.
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Angel good for you! And totally agree about the FDA and the whole medical breast cancer industry. The pushback I received to go flat was unbelievable (they said I was too young to not have implants)
After watching Bleeding Edge, anyone can see the FDA is spineless and/or completely corrupt. I am horrified at the lack of testing these body devices have received and feel horrible for the hundreds of thousands of patients dealing with them now. That orthopedic surgeon who literally went insane due to cobalt poisoning from his hip implant? unbelievable and no one believed him - and he had to figure it all out himself because the FDA says cobalt hip replacements were safe. Nah, don't wait for the FDA to do something, when it comes to your own body. Trust your gut.0 -
So, Lisey, you are saying that one week out of surgery, you were in pain with the tissue expanders and you went ballistic on your surgeon to get the expanders removed?
I'm sorry that you had pain and I'm glad you found a solution that works for you. But this short experience with a tissue expander is the total basis of your expertise and your posts all over this board for the past 3 years about the horrors of implant reconstruction, as you do your best to steer other women away from this option?
As for your advice to Jenene, as MinusTwo said, why advise her to lie when as a patient with breast reconstruction due to cancer, she has every right to request and insist on an exchange? No need to lie, just point to the law.
There are many ways to approach difficult situations. I don't ever advise lying.
angelfaith, good luck with the DIEP.
To the relief of many, I will exit this thread now. Rather than try to continue to focus on the specifics of the Allergan recall and the risk of BIA-ALCL, which is my interest and concern, the discussion is now more focused on bad-mouthing implants and the FDA. As someone who is happy with my implant reconstruction, I'm obviously in the wrong place.
Edited for typos only (I know it's BIA-ALCL but I keep typing it wrong).
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Bessie, Sorry to see you go. But as you said you live in Canada. In the US it is profit driven.Your healthcare system, in my opinion, is great compared to some of the things we deal with in the US.
I follow this thread for the information about the recall. And hope that I am contributing to the conversation on what I have experienced personally. I think everyone should do what they feel is best for them. If you are happy with your implants that is great! But remember that everyone has different experiences.
We need to be tolerant of different views. Show compassion and listen to what someone may be saying without actually saying it.
That seems to be the glaring problem happening now in the world. No matter what, we are all breast cancer survivors. We should be lifting each other up no matter what we are going through.
I'm just saying....
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Beesie, my experience with TEs was an agonizing 1.5 weeks give or take - you can stalk my posts in the very beginning and see for yourself my journey. But that wasn't my sole experience, so don't try to minimize my history. I was never told about the option of going flat and how incredible it can be. So not just the pain of TEs, but the complete push from the medical team to go to implants in the first place. Had I of known there was an entire world of women who rocked being flat from the get go, I would have actually looked at flat as a possibility and avoided cutting my pec muscles in half. I soon got to know thousands of others who had much worse experiences with implants, and their stories of continual pain, hardness and infection, along with the fact the doctors ignored their wishes, or didn't give them options further fueled my desire to speak out for at the least, fair representation for going flat as an option.
That said, I and others have spoken our truths these past few years, I was in the times, and a friend was in Oprah, women are finally speaking out about 'going flat' so today, women at least understand its an option, which I'm grateful for. It was in 2017, that BCO finally made a page reference on going flat. In 2018 Good Morning America spread the word about flat as an option. I'm very happy about recent changes the general public is seeing. None of this was happening when I was pushed into implants in 2016.
edited to add: And yes, I'm very very distrustful of a system that runs on money and salaries are paid by surgeries. I'm distrustful of the FDA who seems to clean up messes after they affect thousands of people rather than prevent them in the first place. I should have researched more myself than trust the PS who said "I'd look and feel great with implants". So when the FDA is just super slow on the ball (see bleeding edge folks) then yes, I advocate that women everywhere go with their gut and fight for their bodies.0
