Health concerns of Allergan Textured implants
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sorry to hear that. Thanks for the heads up. I meet with the plastic surgeon this morning for consult on breast reconstruction and will add this to my list of questions
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UPDATE -- I am going in for surgery tomorrow morning to have the Allergan 410 removed and a smooth one put in. I was going to go flat, but after thinking about it I just was not ready to do that. This whole thing just sucks. All I can say is I will be happy to be rid of this one and hopefully move on. Hopefully recovery won't be that bad. I will update after the surgery, sometime next week.
I have had the Allergan implant since March 2009. I am so mad that neither Allergan or my PS did not notify me of the recall. I called my PS and was told yes that my implant was one of the ones being recalled. I just went for my MRI yesterday and have appointment with PS on 11/6. So this implant has been in for over 10 years (I was never totally thrilled with it) and no one bothers to let me know that its been recalled until I saw it on the news. I was told when I called that the chance is so low that many people are taking a wait & watch approach. Wait & watch for what?? For the cancer to come? When cars are recalled how many letters do you get from the manufacturer? This whole thing makes me extremely mad. Now what to do? I know I definitely want the implant removed, but what to put in? I am doing research, but I don't know who to believe anymore. Sorry just needed to vent!!
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colleen1960,
You should have received a letter in the mail from Allergan. WTH? I would be upset, too! The FDA, in the letter, is recommending "do nothing" if you have no symptoms. This is an outrage. No, I am not waiting. I've had mine since 2014 and it will come out. I hate it. The second PS I consulted with, thinks it may have flipped. I have side boob and so done with it. I had given thought to the DIEP surgery, but decided against it. I am 57 and while I have some tummy, I would not be able to tolerate the pain, nor the lengthy surgery. So he will replace the cancer causing implant and then remove the other (it was not under the recall, I just want it out).
There are o many options out there and it's overwhelming. Remove, replace, DIEP, go flat... trust your gut. Feel free to vent anytime, I know I have. We're in this together!
Claire
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I had the Allergan 410s and spent the last several years running to doctors with my concerns about the pain, swelling, itching, plus a host of other symptoms. No one could ever explain any of it medically. In fact, I'd not felt well since my mastectomies and expanders were placed in 2014.
I never received a letter either. I learned about this on social media and called my doc after listening to the FDA hearings in March of women who had been diagnosed with ALCL. The testimonies were heartbreaking and horrifying at the same time. After hearing about this new cancer and also about breast implant illness, a light bulb went off. I immediately made an appt. with my PS to talk about explanting in April. The next day I received an email blast from my clinic warning me about the implants. Hmm, really? I had them removed within a week. The pain is gone and so are all my other symptoms. That's the good news.
The bad news is many doctors still don't know the best way to diagnosis or treat this. Plus, they don't even know if removing the implants gives you the all clear. It's really hard to describe how I feel right now. I'm relieved to have them gone and feel fortunate that I'm feeling better physically. But when I think of the years I spent in pain and feeling sick, and the way my doctors brushed me off right up until just recently - it really does make me angry!
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I have the Allergan 410 Anatomical Textured implants. They were "installed" in 2011. I really like the implants so I determined to have some testing before jumping off the cliff. My MO ordered both a diagnostic ULS and an MRI. I went back to the radiologist who was 'spot on' for my original diagnosis.
I had already seen both the PS and the MO and both of them said they don't see any problems, but...
Today I had the ULS. This is a radiologist that I REALLY trust. He has seen a couple of ALCL instances out of a ton of people. I wanted an ULS to verify - and maybe an MRI follow up. In his opinion, he has seen either fluid or a mass if the patient has ALCL. He saw nothing abnormal on my films. My gut reaction is NO - I am not going to explant and I am not going to have any more surgery just now. As I suspected, my pain is likely from radiation after effects. When I pushed him for a 'survivorship plan', (my MO basically says do nothing) he suggested I come back every two years since I already had a recurrence 2 years after the original cancer & implants. He said many women come every year because they are worried and need reassurance or to have their hands held. Not a judgement, just a fact.
He said I can surely have the MRI if I want, but I am confident enough of his skills that I will pass on the MRI & extra radiation for now. And I will agree with my PS that I don't need to worry so much.
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MRI’s do not use radiation.
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I have been doing some real research. If you go on You Tube and type in 1st World Consensus Conference on BIA-ALCL, you will find a large number of professionals from around the world taking their knowledge and talking about this world wide topic. It is 11.55 hours long, yes, you heard me right! Some parts of it are dry and technical, but I have learned a lot. I feel like I have some good questions to ask my PS on the 24th. I am only 1/2 way through.
The US is really lacking registration of the implants and following up. The "industry" runs the implant game not the government or doctors.
They mentioned that explanting can cause more problems and no guarantee that the disease won't occur eventually. So, take a look and research!! Robin
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Yup - Thanks VegGal. I was thinking about the CT and/or Pet/CT that will follow if they find any suspicious areas. Second guessing myself anyway while I wait on the ULS reports to show up on MyChart. I may go ahead with the MRI since it's on order. But I keep hearing the voice of my PS in my head - 'so what are you planning to do if there's a problem'? I don't want another surgery. I'm unlikely to do chemo rounds again. Hmmmm.
Robin - I'm not sure I have the stamina for almost 12 hours. I hope you will be our guide and condense your findings for us. Interesting about explant procedure possibly causing more problems.
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Here's a new article with some brave plastic surgeons making some bold decisions.
https://www.insider.com/breast-implant-illness-sur...
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"Brave" "Bold". Goodness, Lisey, yet again your bias is showing. Yup, you bailed on expanders after a few weeks and think that everyone who has implants is an idiot. Got it.
From the article Lisey linked:
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Dr. Anne Peled, a board-certified plastic surgeon who specializes in breast-reconstructive procedures, told Insider most women with implants do well. "I can count on one hand women with symptoms they attribute to their implants. I think it's important we take it seriously and study it, but still remember that."
Peled said she's concerned that increased chatter about breast-implant illness could demonize the devices and limit options for women who might want breast reconstruction after a mastectomy.
"We're trying to do a better job to assess outcomes," she said. "I personally think refusing to do breast augmentation or reconstruction is more extreme than needed with the data we have available."
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I agree with Dr. Peled. BIA-ALCL and any other implant related illness, is serious and should be treated as such. But we don't need fear-mongering. Worldwide, the number of cases of BIA-ALCL remains below 1,000. If anyone is having problems with their implants, it's important to get it checked out. But most women with implants don't have problems and anyone considering implant reconstruction should know this and not be scared away.
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I just had a diagnostic ultrasound given & read by a radiologist doc who has seen a couple of examples of ALCL in 10 years time. Again he stated VERY FEW & like everything I've read - IT'S RARE. He saw nothing on the tests for me to be concerned about with the Allergan 410 implants I have had since 2011. His comment was that most women need reassurance & hand holding due to all the "fear mongering" out there, so I was welcome to come back in two years if I wanted. Or call him anytime I wanted to talk.
I had no intention of even considering explant but it was nice to have my decision validated.
Right on Beesie!!!
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Wow.. I said nothing of the sort Beesie. You are setting up a strawman argument. I posted an article directly related to this issue. Having implants IS a valid choice, but you have to acknowledge the risks. and there are lot more risks with having a foreign body in you than not. period. If you own the risks, then you do you.
The point here is we put shit in our bodies trusting the medical world... and they don't know the ramifications until people suffer or die. Google cobalt hip replacement. Google Essure. Now Allergan. we THINK the FDA does research, but it doesn't...
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I'm setting up a strawman argument? Lisey, you posted an article that quotes a few plastic surgeons who have decided to not use implants for breast enlargement surgery and which raises concerns about BIA-ALCL yet quotes patients who were all found to not have BIA-ALCL.
And in reference to implants (and other medical devices, some of which are life saving), you say "we put shit in our bodies" and yet you think you aren't biased?
Other interesting quotes from the article:
"The same lack of research that has led a few surgeons to abandon their breast-implant businesses is what other plastic surgeons cite as a reason to continue to offer the devices. Plus, the ubiquity of the symptoms makes it nearly impossible to rule out all other possible causes.
"There is no scientific research published in any credible medical journal that identifies a link between breast implants and any other generalized symptoms as described by some women online," Dr. Daniel Maman, a board-certified plastic surgeon, told Shape magazine. "There are more people walking around with breast implants than any other medical device, including cardiac pacemakers, so if 'breast implant illness' was a cause for concern, we'd know about it already.""
This one maybe gets to the heart of the issues:
"He suspects some women react to silicone the same way some people are allergic to penicillin. "A certain percentage [of people] just can't tolerate those materials because their body can't take them," he said." Maybe that's it. Maybe implants are perfectly fine for most women but some women just allergic to silicone. Bears looking into, I think.
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Beesie, It very well could be some people are more sensitive to silicon. And even saline implants are made with silicon bags. That's a very good point. It could also be scar tissue builds up more on some than others. But if we aren't tested for sensitivities before hand, how would one ever know until they had symptoms? That is an issue with foreign bodies inside of us. Even the titanium joints people put in their bodies are showing up in odd places as little slivers. everything degrades, even metal. Silicon as well. It's a risk that isn't discussed until just recently with this ban. I'm happy more doctors are speaking out with their concerns.
I disagree with this doctor saying this:
so if 'breast implant illness' was a cause for concern, we'd know about it already.""
Lupus was dismissed, until it wasn't... Same with Lyme Disease. I wonder how many women have symptoms of breast implant illness, yet have been dismissed until now.
It can take decades for scientists to recognize something or even name it. Autism has always existed yet wasn't identified or named until recently. Me thinks many women have symptoms they are dismissing due to these foreign bodies. My cousin has implants and has suffered joint pain and inflammation for years.. I wonder if there's a connection. She is now stage 4 BC, so has bigger things on her mind.
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Netflix has a film called 'The Bleeding Edge'. I recall that it explains how the FDA approves medical devices. If nothing else, it might give you ideas for your own 'research'.
❤️🐾🎶 NancyB
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okay everyone take a breath! It is apparent that there are many different views on this. But let’s not beat each other up. Respect all views and personal decisions. I think the most sad part about this is they knew the risks and should have told us the facts.
best wishes to all if us that have these implants. Robin0 -
Thanks for your post, Robin, - I agree with you!
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Robin: I agree. But I also agree with 3 of my docs who are concerned by the panic that is being caused when it's not a panic situation (reminds me of Chicken Little going around yelling "the sky is falling").
How are you coming on your massive reading project of the 12 hour consensus paper from the BIA conference? I'm being lazy and letting you do the work. I'm NOT going to explant, but I'm definitely interested in your prelim findings that explanting may cause more problems than leaving the implants alone and may not prevent future ALCL in any case.
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I agree with Robin! Watching Netflix, I became concerned. I already had my Titanium & Ceramic hip installed. If I learn nothing else, I learn questions to ask my healthcare providers. Good questions and good answers help us make good decisions?
NancyB 🎶0 -
Lisey, as I said in my earlier post, the medical community absolutely should be taking breast implant issues seriously. They should be investigating what might be causing the various symptoms that some women experience. If there is a possibility that this might be an allergic reaction to silicone, that should be further looked into and tested for. I'm 100% in agreement with that.
But just as penicillin hasn't been taken off the market because some people are allergic to it, neither is it admirable for doctors to have a knee-jerk reaction to breast implant concerns and to therefore stop using implants. Well, maybe it's okay for breast enhancement, since this is a strictly cosmetic procedure, but not for breast reconstruction, which is so important to so many women who have had a MX because of breast cancer. There is nothing "brave" or "bold" about denying women with with cancer this reconstruction option. Nor is it appropriate to tell women who choose implant reconstruction that they are putting "shit" into their bodies.
And yes, I agree too that we all have to be careful and informed patients. We should all realize that our doctors, in their haste (trying to be positive about it) may not tell us everything that we need to know. Before my implant reconstruction 14 years ago, I read every bit of fine print in the very long implant documentation available on-line from Allergan. I read about every possible side effect and complication. I suppose therefore that my lack of frustration about this issue coming into the news now is based in part on the fact that I already knew.
I respect everyone's choice. Lisey, I think you are a wonderful advocate for going flat, and if I knew someone considering that option, I would gladly send them to you for advice. But promoting going flat doesn't have to go hand-in-hand with denigrating the choice that others make to have implant reconstruction. And fear-mongering and celebrating doctors who deny patients this option doesn't help anyone.
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Beesie - interesting - we're in a similar place. I had my implants put in 9 years ago. I too read every single word of every Allergan document - both on line and voluminous printed info. I was in an ongoing national trial and only certain doctors were authorized to use these implants at the time so there was plenty of paperwork. I had 6 months between the initial BMX and TEs to digest everything & make my decision before reconstruction. I discussed my questions with my PS, my MO, my BS & Ob/Gyn (because I trusted them) & with the hospital research trials committee. So I too was not really surprised that implants cause some problems for some people.
Not to digress, but I'm getting ready for my first cataract surgery. Since my eyes are critical to who I am & my entire identity, I am more worried about this silly little operation that is done hundreds of times every single day than I am or was about implants.
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Aloha,
I have been off the threads of BC.ORG for awhile, but thought I should check in.... I had the Allergan biocell textured form stable silicone implants placed quite a while ago, 2013 I think. Got the letter warning of the very small risk of BIA-ALCL about 3 months ago and had a short visit with my PS and never gave it another thought.
For the past 2 weeks I have had serious fatigue and body aches, my DH said "honey, it's been going on longer than that!" Four days ago I found a painful lump in my left axilla, just had sonogram today and was told i will need to come back for a biopsy. All I have to say is SH_ _ ! SH_ _ ! SH_ _ ! I wish I would have been checking for the symptoms earlier. This waiting reminds me of the breast cancer wait. Thank goodness I'm so tired all I want to do is sleep.
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Shellshine - I don't think ALCL presents as a lump, but I'm not sure. In any case, good luck and please do let us know your results.
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hello all, today was my PS appointment-FINALLY! He let me talk a lot, and he talked too. I told him my concerns and a bit of anger about the whole thing. He checked my foobs and said they looked good and he felt nothing out of the ordinary. Again he said the risk of ALCL is very small. Surgery is more of a risk. But he is ordering an ultrasound for my peace of mind. At least if something is hiding we will know. I really don’t want to start over. I do like my results, I just wish they were a bit less stiff.
Robin
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robin - great news.
I was so relieved with the result of my ultrasound. If you can, request to talk directly to the radiologist doc who will "read" the films and do the report. Mine actually came into the room after the tech was finished - along with a student doing a fellowship - and spent quite a bit of time discussing the issues. Show time!!! I still have orders on file for an MRI but I feel like it's overkill. I sure don't want another surgery.
I'm particularly happy for you since we both seem to like the shape & looks of our 410s. I'm OK with the firm aspect. My original breast were so dense and hard these aren't really any different.
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Thanks Minus, he concurred with Dr. Mark Clemens at MDAnderson. My PS only used the 410’s for small volume reconstruction. But he is very skilled and did a beautiful job. He didn’t use any mesh or Alloderm. Just positioned them between the pecs.
I am relieved and satisfied with his judgement. Thanks for all the support. We all have to do what we feel is best. Robin
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Some salient counterargument points for Robin. In the end, I do think one must do their own research to understand the full scope of BIA ALCL ramifications. I have read an abundance of material by M. Clemens, Dr. Deva, and others on the topic to form my opinions and conclusion. I also think that the Mar. 2019 FDA online 2 day conference and most recent 1st BIA ALCL conference online are excellent sources to listen to and understand the current situation regarding BIA ALCL and somewhat Breast Implant Illness or BII.
Based on the FDA hearing 85% of implant patients Never suffer from BII and those who succumb have a 50% chance of cure with explantation. Since a personal or family history of autoimmune diseases increases risk for BII those having either may want to avoid BIs.
BIA ALCL is uncommon and is most often found associated with highly textured biocell implants; thus, the pulling off them off the market this year. I gather from the conference that it is unproven if explanting assymptomatic implants prevents BIA ALCL, but that was a statement based off a few antedotal cases where capsulectomy for other reasons was not later preventative of BIA ALCL. Yet, large clinical studies of thousands are needed to truly determine if propholactic explantation of text. implants prevents BIA ALCL to be of statistical significance to make appropriate clinical decisions on explantation. Nowhere in the most recent BIA ALCL Italy conference was a reference made to suggest that explantation of text implant causes later BIA ALCL or complications.
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I am not trying to step on toes, but I am not sure I heard from the 1st BIA ALCL conference that explanting prophylactically causes more problems as some have stated on this post. I only heard Dr. Clemens saying explanting/casulecomty is not necessarily preventive for BIA ALCL because some patients have developed BIA ALCL years later after capsulectomy done for other reasons, outside BIA ALCL. Just afterwards he claimed that cutting into a mass, during capsulectomy or en block can spread BIA ALCL and make it more aggressive. Of course, if someone had a BIA ALCL mass they would already have an upstaged disease, likely with many preop BIA ALCL symptoms, made worse by poor oncological technique of excision into the BIA ALCL tumor.
Explanting textured implants or not is the question for many of us here. Together we can attempt to answer this question, but In the end, I do think one must research to understand the full scope of BIA ALCL and answer the question with self-direction and independence.I recommend some great resources I found helpful by ASPS/ASPSP website, 2019 NCCN Consensus Guidelines ..., Dr., Brody, Dr. Clemens, Dr. Deva, the Mar. 2019 FDA online 2 day conference webcast and most recent 1st BIA ALCL conference webcast to increase your understanding about textured implants and BIA ALCL issues.
Good resources like these have helped me to realize BIA ALCL is uncommon; yet, even so highly textured biocell implants were pulled off the market this year due its 6x increased association with BIA ALCL, which can make one with textured implants nervous, including myself. Like me many of you are wondering if explanting a textured implant is key to prevent/dodge BIA ALCL. Of course, we know the FDA has yet to suggest explantation for those with textured implants-- likely as there are no large clinical studies with adequate follow-up to determine with statistical power if doing so is helpful, prevents BIA ALCL spreads BIA ALCL, or causes complications.I suppose one must follow their heart and intellect after doing the research and make the best intelligent choice possible when there are no solid answers. Ironically, if you currently have a textured implant whether you explant it or not prophylactically you will be the cohort that will be used in future clinical trials to determine whether explanation is advantageous or not- sadly the guinea pig effect. I get tired of feeling like a lab rat- oh well I am alive.
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Use plain text editor
FYI- Sorry for above post deletes- clicked something wrong there a couple times.
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rmgrmg. I attempted to post as well and it deleted the post on its own and was also adding things I wasn’t typing. Maybe someone can look at the site?
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