Health concerns of Allergan Textured implants
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I have textured implants Allergan 410 and honestly have no idea what to do. Do I want to leave implants in that have been banned because they are causing cancer? I don’t think so because I had a double mastectomy so I wouldn’t get cancer. Ideally I would love to avoid having to put implants in altogether and be done with it. But the unknown results of what it will look like and how I will deal with the look is making me really hesitant. I have no desire to have Extensive surgery. My pec muscles being used for the implants have really affected the sports in my life and I don’t want surgery that will affect other muscles. So at this point it’s feels like my only options are leave the textured in or put in smooth implants and risk cancer or risk surgical complications.
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Mantra, as I said in one of my earlier posts, there are a lot of stories in the press about this implant-related cancer, and that is scaring a lot of people and causing government approval bodies to react, but at this time, the most conservative assessments puts the risk at 0.2%.
- The average woman's risk to develop breast cancer is 12.5%.
- The risk to develop a localized breast cancer after a BMX is 1%-2%.
- The average woman's risk to develop ovarian cancer is 1.3%.
- The average person's risk to develop colon cancer is 5%.
- The average risk to develop melanoma, for someone with white skin, is 2.6%.
With all that, more women die of heart disease than of cancer.
That's just to put the 0.2% risk of BIA-ALCL in perspective. It's a risk, but relative to other health risks we face, it's a very low risk.
If someone is having implants put into today, this is certainly a risk to consider. If someone has had these implants for a while and is unhappy with her reconstruction, this risk could be what edges her into surgery to remove/exchange these implants. (Mantra, it sounds like this might be your situation.) If more data comes out that suggests that the risk is substantially greater than the current estimates, that could drive the medical community to recommend the removal of these implants - which at this point I don't think any one anywhere has suggested.
Mantra, have you talked to a PS yet? If you have been unhappy with your sub-pectoral implants all along, then this concern about BIA-ALCL might be the reason to consider either deconstructing or going with a different option. I suspect that round sub-pectoral implants will cause you the same muscle problems you have now, but you should ask about that. You mentio don't want surgery that affects other muscles. The only other option I can think of, apart from going flat, is pre-pectoral implants. I have noidea if that would be feasible in your case, but it is probably worth the discussion with a PS.
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thanks for the stats. Really interesting and shows I may be jumping the gun. I’ve been out of the country for six months and will return on Monday. I have two appointments set up with surgeons; one on Wednesday and one in two weeks. First one with the surgeon who did the mastectomy and the second with the surgeon who did the reconstruction. I absolutely love how the implants came out and although the muscle issue bothers and affects the sports in my life, I just accept it and wouldn’t go through surgery for that reason alone. Will really have to think about this.
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Mantra - for information on BIA-ALCL, you might want to check out this Facebook page. It is administered by several women diagnosed with the disease who testified at the FDA hearings. They are working with clinicians and reputable doctors to find the facts on this disease. Just type in "ALCL In Women With Breast Implants BIA-ALCL."
I agree the risk is low, but the truth is we just don't know how low at this point. The numbers are increasing the more we learn about it. The risks are not known because the true numbers are underreported as women are misdiagnosed. One thing is certain, the risk is much higher for those with Allergan textured silicone implants. Unfortunately, there are no current standardized tests for BIA-ALCL and many doctors are not familiar with the disease or how to diagnose or treat, which makes it really difficult to navigate. Right now there are more questions than answers. If you have no issues with your textured implants or no symptoms, then you're probably okay. Might be a good time to wait and see what shakes out of all this once everyone gets on board. That could take awhile, though.
I had symptoms for years, so the recent reports were very concerning. I had pain, swelling, and lumps under my armpits that would come and go. Plus many other symptoms I attribute to Breast Implant Illness. I had my implants removed last week and am glad they are gone. For me it was the right choice, although a difficult one as it meant not replacing with implants and going flat. I did have some fat grafting to try and create small mounds. I am still healing, but am already relieved to have the heavy bags off my chest. I had to convince my PS first though, before going through with it. She insisted I wasn't ready, but I think it was harder for her than it was for me, if that makes sense! I had my reasons...hubby never liked them - he said they were too big and I thought so, too, but didn't want to go through it all again. Also, implants are not lifetime devices. I understand implants really only last 10 years and since I was on year 6, I felt it was a good time to say goodbye to the foobs and start a new chapter.
Good luck with your decision!
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hi All
I’m in Canada and health Canada did announce that the sale of Allergan implants has been suspended not recalled they are conducting further investigation
My thinking is can you imagine if these were recalled? They wouldn’t have enough OR time to deal with all the women needing replacements.
I have these implants. Allergan Biocell textured implants. Lucky me. I already signed off on the paperwork and put myself on the growing surgical wait list. I figure I have some time to think about it since surgery will be months and months away
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rozem, I have Allergan 410s too. I suspect that the vast majority of women who've had implant reconstruction over the past 15 years in Canada have the Allergan Biocell 410s. Or at least Ontarians, but I think everywhere in the country. I did some rough math* and figure that there are about 15,000 of us in Canada with these implants, but that's for reconstruction only and does not include those who've had breast augmentation. I read one article that indicated that approx. 20,000 women a year have breast augmentation surgery in Canada. That number seems really high to me but if true and if about 1/2 get silicone and 1/2 of those are 410s, that would another 75,000 women over the past 15 years. As of today, 28 people in Canada have been identified as having BIA-ALCL, and 28 others have suspected cases.
*26k cases of breast cancer in Canada a year, 6k have MX (Canadian Cancer society), 1.2k have reconstruction; estimate that 80% have implant reconstruction and 20% have autologous reconstruction =
Here is the Health Canada suspension notice, including their recommendations for patients who have implants:
Health Canada advises Allergan of its intent to suspend its licences for Biocell breast implants as a precautionary measure
If you have breast implants
- Speak with your surgeon or healthcare professional about which type of breast implant you received.
- You can find some helpful information on the risks associated with breast implants, including the risk of BIA-ALCL, by visiting the breast implant section on Canada.ca.
- Conduct regular breast self-exams and see your healthcare professional for periodic follow-up.
- If you experience unusual changes to your breasts, including breast pain, sudden swelling, or a lump, consult a healthcare professional.
- Removing your breast implants is not recommended if you do not have any signs or symptoms suggesting BIA-ALCL. Patients should discuss the risks and benefits of removal with their healthcare professional.
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Thanks Bessie
I did sit down with my PS already to discuss. I know the risk is low. I don’t know that they can give an accurate % at this point? He rhymed off some stats and they were low
I’m trying not to be alarmist on this entire thing but if it’s enough of a concern that their license to sell has been suspended that it certainly gives me something to think about. I know all implants carry risk.
My gf treated at Mt Siani was not given textured implants and when she called to confirm they said they stopped using them years ago
It’s confusing for sure but I want to learn more before I make a decision
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it must feel good to have made the decision and that you feel good about it. Were your implants put in under the muscle ? If so what happens to that muscle? I’ve lost so much strength in my upper body and wonder if the implants are removed will I regain strength. I do sports that were definitely affected by the implants being put under the muscle.
Did you have nipple tattoos and if so was the doc able to keep them centred. What is recovery like. Drains? How long before I can return To sports if I Remove implants. Personal question. ... will you be going flat or are you going to wear padding.
I will ask my ps if she can create a little bitty boob for me. That would be my preference.
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I was just thinking, why hasn’t Allergan sent out a recall-type letter to everyone who has this implant? Like car manufacturers do when something happens to someone in one of their cars?! They know who has these because you get a registration card on each one and send it in. Like so many medical devices that have failures.
I sent an email to my PS inquiring about this topic. I am not overly concerned but would like to hear what he has to say.
Robin
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Robin, there is no recall.
And while Plastic Surgeons are supposed to give their patients the information cards with the serial numbers of their implants (I have mine), I don't know that Allergan have the names and addresses of everyone who has one of these implants. They might have a database of names (if the PSs were required to send the names to Allergan; I don't know if they were) but I doubt that they would have addresses or contact info for the patients.
rozem, while no one knows what the real number of cases might be, I think any serious cases where the implant was clearly compromised and the patient required cancer treatments would have been reported both to Allergan and to health authorities (in Canada, to Health Canada). As I understand it, the question is whether some of the less serious issues with implants that women have had treated for years - capsular contraction, for example, or swelling - might have been very early BIA-ALCL cases that never developed further because the implant was exchanged and nothing else was necessary to treat the concern and resolve the issue.
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Robin - I agree with Beesie - There has NOT been a recall - ANYWHERE. In some countries they are no longer allowing NEW implants. In no country that I know has anyone said we should race to get them removed. Slowly, slowly...each one of us is different (the same as it was with our original cancers)...moderation...no panic!!!!
As I've said before, I have NO intention of getting my Allergan 410's removed. They WERE implanted under a medical research trial when only a few of the top PS docs were allowed to use them - so my surgery was very controlled. I'll need to know a LOT more actual facts before I undergo another surgery.
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Minus Two, I agree with you. I just was wondering about how much was hype and how much was true. I emailed my PS and here is what he said:
"We are very aware of this issue and unfortunately, the news have blown it out of proportion. There are about 500 cases reported worldwide out of millions of breast implants that have been placed. It does occur, but very rarely. It can occur in the breast implant or breast reconstruction using a textured surface. That is almost any breast reconstruction patient. I, nor my colleagues have ever seen this, and we will probably never see it, but we're aware of the signs that happen when this occurs. The most consistent sign is a significant amount of selling around the breast implant with a fluid collection. If this occurs, then we take fluid samples. Again, this is very rare. We will keep on checking our patients every year like we usually do, Not much has changed otherwise."
I love my PS and trust him. I never ever had any thought of removing mine!! I am very happy as you know.
Maybe what he said will help someone else.
Blessings, Robin
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Robin, that's a great explanation from your plastic surgeon. Thank you for sharing it!
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I went to see my breast cancer surgeon today and also have an appointment with my plastic surgeon next week.
She told me she has personally had two patients with Allergan implants have this cancer but stressed she has done 1000s over her many years using textured implants. In both patients it was removed fully surgically and no further treatment was required. She is sending me for an MRI while I take some time to decide what to do. At this point she is not recommending removal but stressed there is a lot of data coming in all the time so it may turn out to be a larger problem then they currently are aware of.
She said the decision is mine and if I’m worried than she recommends removing them. It has to my decision what to do.
Knowing one doctor has had two patients develop this cancer is making me nervous although I have no idea of the number of patients who have had implants done at university health network in Toronto.
I’m looking forward to my appointment with my ps to hear what she suggests and what my options are.
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Does anyone here have the Mentor Memory Shape textured implants?
I am going to have mine replaced this fall, I believe.
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Here is the latest from the FDA:
So, no the FDA is not banning these implants as 30+ other countries chose to do. The FDA admits there needs to be a more accurate way of reporting cases. In the past, medical device reports with implants were not reported accurately. And they state there is a need for a black box warning for the possible risks, including breast implant illness, which they now admit is an actual thing. So, yes, to the black box warning and patient checklist, and I would add, a definite need to hold manufacturers responsible with valid studies behind their safety claims and accurate reporting of MDRs.
I feel it is inexcusable for doctors not to inform their own patients who've been implanted with these textured implants in question. I had to hear about it through Facebook and the news. Thankfully, I did my research and listened to the FDA hearings, so I was onboard with the issue when speaking to my PS. She on the other hand, seemed totally put off and at a loss for words. After my appointment, an email from the clinic was sent to all patients affected. Obviously at the time of my visit, they didn't even have a plan in place or protocol of what to say or offer their patients. Only when it rose to the level of mainstream media (thank goodness for social media) were they forced to make a statement. At this point, all medical providers should be scrambling to get onboard and inform themselves as they can no longer hide behind old and inaccurate statistics. The truth is coming out more and more each day as women are informed and invited to come forward and tell their stories.
Mantra, you ask an interesting question - wouldn't it be nice to look up the stats, on say, how many women had this disease in a certain geographical area. Currently the exact numbers would be impossible to find because of the different reporting formats between manufacturers. That needs to change.
If you are considering explanting - do your research, seek the facts, and not just what your doctors are telling you. You deserve to be fully informed, but the problem is that doctors don't seem to know much more than their patients at this point - and their viewpoints tend to be one-sided. Before your surgery, be sure your surgeon knows exactly how to explant correctly and how to test to rule out BIA-ALCL - because as you know, there is no going back to get that information if it is done incorrectly. Problem is, there are very few out there right now who are well-versed in this disease.
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bc101, the link I provided earlier from Health Canada, referencing the Canadian suspension of Allergan Biocell implants, specifies that there have been 28 identified cases in Canada, or which 24 were specific to the Allergan implant.
Mantra mentioned University Health Network in Toronto. UHN is a large hospital group that includes Princess Margaret Hospital, which is the largest cancer hospital in the country (it's a cancer-only hospital). So if there have been 28 cases in Canada, it would not be surprising to find that a number of them are from UHN.
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Yes, I did see that. I've read that the FDA has issues interpreting all the data and are looking at ways to improve registries worldwide. So many aspects of this we've yet to see - hopefully all for the better in understanding not only BIA-ALCL, but also BII. I found this interesting:
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when you talked about making sure the surgeon knows exactly how to explant can you please expand on that. I meet with my ps on Thursday and want to be armed with as much knowledge and info as possible.
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Implants - particularly the anatomically correct Allergan 410s - required a specially trained PS with lots of experience to install correctly. If you're having any implant removed, what does your PS plan to do with the space? with the concave hole(s) that will be left? with the extra skin? with the possible alloderm that was used? With the gap in the center? with the pec muscle. which was cut 9 times out of 10?
What about the scar tissue? What muscles might it involve? Did you have radiation damage to consider?
Oh - and if you didn't end up with Lymphadema from the initial surgeries - what precautions will the PS take to not disturb any more of your lymph system's pathways? My PS specifically said he couldn't guarantee there wouldn't be more lymph damage just with minor corrections to make the sagging side look more perky.
Just think about all the issues in reverse. If you had TE's to expand your skin before implants, how to you go backwards?
I'm sure others will have more definitive answers.
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Mantra,
As far as your PS, if you have reason to believe you might have BiaALCL, there are NCCN guidelines to follow in order to avoid misdiagnosis. Because there are many docs out there who don't believe in the disease or because they've never seen it (or plan to see it) are not familiar on how to test or treat it. I have the guidelines - let me know if you'd like me to PM you. Basically, if you have symptoms such as pain, swelling, asymmetry, rash, seroma, fluid, capsular contracture, enlarged lymph nodes, you may want to be tested to rule out BiaALCL. If the surgeon is unfamiliar or resistant to testing - as most are - it could be missed.
Even if you do not have symptoms, if you had textured implants, you will want them removed En Bloc with a total capsulectomy. This means that the implants and the capsules surrounding them are removed completely intact. You do not want the capsules left inside. Many women insist on photos taken afterwards to prove this was done, or have it written in the surgical contract to insure the PS will complete the surgery or testing as requested. BTW, explanting is considered treatment in most cases of BiaALCL.
To answer your questions, my implants were over the muscle. No nipples or tattoos. My PS went in over scars I already had under each breast and created an upside down T shape. I had 2 drains. The recovery was easy, except I had an allergic reaction to the surgical tape and ended up with a nasty rash that spread to my entire chest! I was miserable for 2 weeks. Thankfully at 3 weeks out the redness is almost gone, the incisions are healed and I have no pain, just soreness. I feel well enough to return to work and household duties, but am still on reduced activity as per Dr's orders. This is a very easy surgery compared to others, but it depends on what they run into during surgery and what other procedures you're doing. Going flat is the easiest recovery of all. For your consult, I suggest bringing pictures and look at pictures of his work, if possible. You can do fat transfer or the 'goldilocks' procedure to create small mounds. The upside is that what's there is all you - no foreign objects. The downside is that results can vary, depending on the skill of your PS. Some women do DIEP and love it, but that's a big surgery with a much longer recovery. Oh and some women replace with smooth implants. I've read this is what they do at MD Anderson and it's what my PS offered initially.
Feel free to PM me if you like to chat!
***P.S. If you do decide to go flat, even then, make sure you have a clear explanation of the surgeon's plan for incisions, recovery, and expectations.... we all have different bodies, different rib cages, etc. but like with all plastic surgery - your outcome has a lot more to do with surgical care and skill than anything else.
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just reread you message as I’m on my way to my ps appointment. I’m not sure what en bloc is. I will look it up. Thanks for the details. Very helpful !
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Mantra -
Here's an article explaining en bloc from the 2019 guidelines on treating BiaALCL:
https://academic.oup.com/asjopenforum/article/1/1/ojz005/5366236
Basically en bloc means they remove the entire capsule that surround the implants in one piece vs. leaving it in or removing it piecemeal. Capsules form around every implant and are composed of scar tissue. It is a natural process and the body's way of protecting itself from a foreign object. Some capsules are very thin or may have leakage or holes, but ideally you do not want the contents leaking into your body. Some PS's want to leave the capsules in and just pop out the implant and replace it. The problem is BiaALCL if left in the capsule or lymph nodes will spread. Any fluid or mass should be tested before surgery with ultrasound. If you have symptoms of alcl or any systemic chronic illnesses, and be sure you read up on this and insist on the proper testing and an en bloc capsulectomy. You probably don't have alcl if you aren't experiencing any issues, but just something to be aware of.
Good luck!
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From what I read the risk is much greater than 1 / 30,000... A study found that one in 6,920 women with breast implants will develop anaplastic large-cell lymphoma (ALCL) in the breast before they reach the age of 75.. Studies are now showing the risk for all implants overall is higher than that. https://lymphomanewstoday.com/2018/01/10/breast-implants-associated-with-increased-risk-of-anaplastic-large-cell-lymphoma/
I'm personally flat, and I feel I can wear clothing I never could with large breasts. If I had had a tummy, I may have done the DIEP, but I wouldn't harm my back muscles or ruin my ass just to get mounds on my chest... I hope people consider flat as option, women can truly look amazing being flat. My PS never once mentioned going flat as a true option for me and only when I had the TEs in did I start researching and realizing I could rock it.0 -
Yes, it's much higher than what everyone originally thought and the numbers are increasing every day. Also, the risk is highest if you have Allergan textured implants.
I agree - flat is something to consider but the problem is most PS only offer it as a last resort. My PS acted like someone had died once we started talking about going flat. No way could I do DIEP - my body does not do well with surgery and pain! I had to convince my PS that flat was what I wanted. She tried to talk me out of it right up to the end. But I love it now that I'm almost healed. In the last few weeks I've lost over 7 lbs of my buddha belly, which I think was inflammation due to the implants. I feel so much lighter and younger. While it's not for everyone, I wish I had gone flat from the beginning.
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Yes, the risk is higher than what everyone thought. And it does appear to be increasing as more investigation is being done. And yes, it is primarily Allergan Biocell 410s that are the problem.
All that said, the risk remains low - a fraction of a percent. As I said in one of my earlier posts, the highest rate of occurrence I've seen to-date, from one particular plastic surgery practice, is 0.2%. All other estimates I've seen, even recent ones, have been lower than this, most significantly lower.
Now that our awareness is high and our PSs know what to look for, if someone were to develop BIA-ALCL, the likelihood of catching it early is extremely high, and when caught early, in most cases the only treatment necessary is removal of the implant and the capsule.
It is important that we educate ourselves and others with implants about the risks, but we need to be careful to not scare people. Just as it has been irresponsible to not inform women with implants about this risk, it is also irresponsible to not put the risk in context, and to drive women who are happy with their implants and who are encountering no issues, into an unnecessary surgery. Surgery comes with it's own risks. And for those who choose to replace their implants or move to DIEP or GAP reconstruction (not everyone wants to go flat or would be happy being flat; we shouldn't shame women into thinking that wanting reconstruction is vain or silly),the risks of infection and complications are many times higher than the risk from these implants.
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Thanks Beesie. I agree totally. No one should act in panic mode. The percentages are VERY low considering the total number of implants.
I am one that could not do Diep and would definitely not be happy flat - so I'll keep going along exactly as I am with my Allergan 410s unless my docs or I see some reason to do further testing.
My reaction to breast cancer - 'get it out of me'. My reaction to this unwelcome possibility - wait & see.
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hi Mantra. I am very curious how your appointment went with your ps. Please share if you want. I’m still waiting to get an appointment. Thanks
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the appointment went well. I have decided against removing the implants. We talked about the risk of getting cancer and he said it’s one quarter of one percent and that in the cases they have seen it was easily removed with no radiation or chemo required. There are others they have not been involved in that spread.We talked about removing the capsule and he said removing it is not an easy surgery and not something they would recommend. He explained it would require removing scar tissue that has grown attached to my ribs and my pec muscle. They would remove some pieces to biopsy but removing all of it is just a long difficult surgery. He spent about an hour talking to me and my husband and we both felt leaving the current implants in place is the right decision fo me.
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Thanks so much Mantra for letting us know how your appointment went. Did he recommend any tests to check for ruptures or seromas such as an ultrasound or MRI
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