Health concerns of Allergan Textured implants
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Upcreek, not necessarily. I have recalled 410 MX put in 2016. I urge you and other woman who are concerned about BIA ALCL to join the closed Facebook group ALCL in Woman with Breast lmplants BIA-ALCL. That's where I learned of the upgraded recall class. A lot of us have the same question you have. This news is quite disturbing to me, when it was the lower class recall, I figured I'd take my chances but now that has changed. DH gets it and I will get a consult with my PS. My right breast has been itching in the same spot since BMX and this is my second set of implants. Capsule was not tested in 2016 when these defective implants went it. In fact I didn't have a choice of implants both times. Makes me angry.
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So an update from when I posted here earlier this summer!
Recap..I had my initial prophylactic bilateral mastectomies with direct to implant in April 2014. Had smooth Mentor rounds put in. Revision in 2015 to Allergan 410s to try and reduce rippling as fat grafting was not really feasible at time. The smooths actually felt good and were softer so had a more natural "feel" than the 410s, but we hoped maybe the 410s would reduce some of the rippling issues (and it did, a bit, though on my right breast side I can still see some "defects" where my skin is particularly thin).
Saw my PS yesterday (had to wait for new referral to come through as it has been a while!) and I am scheduled for removal and replacement of the implants (and capsulectomy) November 14.
My PS was very knowledgable about the recall, the risks compared to surgery, and 100% supportive of why I would want them removed. Of course like any good PS he would not tell me *what* to do, but did the old "if it was my wife, or even me, I know what I would feel comfortable doing". My sister's PS (she is still waiting for her PBMX) told her he stopped using textured implants long before the ban due to the early reports and noticing some other complications in patients with them.
Yes, the risk is low, but factoring in that I had my surgeries to reduce my risks in first place, and my auto-immune/hypothyroid issues (which developed a couple years ago and otherwise I had no other risk factors - healthy weight, active, no pregnancies, no family history), and I have had a bit of random uncomfortable armpit swelling time to time on one side (no explanation to date), its one that I don't really want. Its too bad in some ways as I have found my implants, while overly firm for me, to generally look okay and to be reasonably comfortable except when I am cold, or the odd nerve/pinching I have). I am 40 and otherwise very healthy and active, the risks of surgery are relatively low for me as well.
I will likely end up getting fat grafting as well, but that would be a separate surgery likely next year/summer; he does not like to do at the same time because he finds it to be less effective.
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"The above recall states the manufacturing dates of July 25th, 2014 to July 24th, 2019. Mine were done 2009 (Allergan 410). Does this mean the recall doesn't affect anyone before 2014"
I think recalls often tend to happen in "batches" as it is just based on what they were able to do studies on, etc.
Mine were implanted in 2015, but I would need to go dig out my card to know manufacturing date!
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I am 75, so while I've fought my way back to good health for my age after a BC recurrence and ALND surgery, I really would like to avoid more surgeries. I have truncal & breast lymphadema and wear compression bras 24/7, with sleeves & gauntlets for flying. Further surgeries will most likely exacerbate that. In addition, I'm stuck with permanent dead feet - neuropathy from chemo - and often numb fingers. My PS said hold. I'm seeing my MO Monday for my yearly check and will get his opinion. I'm leaning towards pushing for an MRI.
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MinusTwo,
I think if I was in your position with the truncal & breast lymphadema I'd feel the same about more surgery. My late mum had the same and there was definitely increased risks to her if she had further surgeries and the like.
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jill47, mine were done March 2015!!😩
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Divecat, I have Hashimotos thyroiditis, IBS, IgA deficiency, MGUS, who knows what else! So having a compromised immune system makes me so nervous about this whole thing. They are very stiff implants and COLD! I see my PS October 24.
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i pulled out my cards, no manufacturing date is on it. But I assume the Serial # tells that story.
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Divecat....good for you taking them out and getting capsulectomy. Did your PS say the capsule will be tested for CD30? Push for that, once they discard the capsule can't be tested.
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robinblessed - yes understandable. As noted I have hypothyroidism which has never been officially pinned down as Hashimoto's thyroiditis but I don't have any of the other usual risk factors (like postpartum, thyroid surgery, medications like lithium) but the potential auto immune issue certainly leaves me feeling a little more eager to swap.
Did you ever have anything other than the textured anatomicals/410s? I had smooth rounds initially and they were definitely a little more malleable and while still not as warm as my natural tissue seemed to be a bit less firm/cold to touch.
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jill47,
I will talk to my PS about that, as I am not sure what exactly they are doing or their SOP right now after removal of these implants is. Thank you!
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My surgery is tomorrow. But Friday my PS called to say my insurance had denied it 3 weeks ago and they had appealed it immediately. They were to get an answer Friday and had not. I called and was talking to them for over 2 hours. They wanted to approve the removal of the textured implants but did not want to approve replacement with smooth ones. They said it was "MEDICALLY UNNECESSARY!!" I lost it!!! I had to argue that no matter what they are to put me back together anyway that I choose. I found out that the person reviewing it was not a physician but a physician assistant! I finally got approval!
I am trying to relax so I'm not stressed going into this surgery tomorrow. But I am livid that I had to argue about this..Will update when I can..
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DiveCat, no other type. These are my originals. Did they do any imaging before they agreed to swap?
Angelfaith456, it is a federal law that you must be covered for any reconstructive surgery forever. It is like a revision, right? Well, the mere fact that the medical device can cause cancer and is part of a now class1 recall, I don’t think they should deny coverage for anyone. The “wait and see” frame of mine just isn’t going to happen for me! Yeah, right, let me wait to get cancer and then I probably couldn’t swap at the same time!!! So ridiculous.
I have about 6 weeks until my appointment.
Rob
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I am sorry you had to deal with that stress right before surgery. You should not have to do that as if you are in US or Canada at least, any further reconstruction/revisions should be covered. It really sucks when people like that, insurers included, treat it like it was all a cosmetic choice to get a mastectomy and reconstruction. Once you are done your surgery, recovered, and insurance all settled, I would definitely make a complaint about how your case was handled if you feel up to it. As usual, start lower and then go up chain (is there a state complaints board, an ombudsman, or anything?)
Best wishes for a smooth surgery and recovery!
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No they did not do any imaging before agreeing to swap them out. It was enough I had the textured ones. I am under provincial health care so don't have to worry about dealing with insurance or anything either.
My biggest hurdle was waiting for a referral back to my PS as I had not seen him in so long but I got on a cancellation list for an appointment once referral was made. I had tried to get a referral to a surgeon in town (my original one is 2 1/2 hours away) but they did not really want to get involved with someone else's work. So not as convenient as my husband is out of town most of week but my sister is going to fly in to drive me to hospital and back (day surgery) and stay with me a couple days until my husband is back. However, I am happy to be with my original PS again anyway, I like him and he has great bedside manner too. I will time the fat grafting for next summer sometime which will work better with my husband's schedule.
If it is anything like my last revision though, I *hope* to try and be back at work the following Monday or Tuesday, though I may need to rely on coworkers for rides for a little bit. Otherwise will work from home that following week.
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angelfaith, so sorry insurance was idiotic. I pray your surgery tomorrow is smooth, no pun intended, bye bye textured implants.
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Magari - were yours sub-pectoral (under muscle), or pre-pectoral (above muscle or just under the skin)? that makes a big difference for rippling and edge visibility. I've seen/heard of plenty of good results with smooth rounds on lean women, but all sub-pectoral.
- xo
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Andraxo - Both my original surgery and my revision were pre-pectoral. (My surgeon does almost exclusively this type of reconstruction, unless it's specifically contraindicated.)
I think direct to implant reconstruction can be only be done pre-pectorally, because tissue expanders are necessary to stretch the muscle first to make space for sub-pectoral implants.
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Magari, Did you have any imaging done before the implant swap? I am in SoCal and have my appointment with PS on October 24. I plan to swap my 410”s to smooth round. Plan to ask for Mentor if that is available. I don’t think I can trust Allergan! Did you stay with Allergan? Is recovery different? Sorry for all the questions, but you ladies that have gone through this already are Trail Blazers. Also, you are in CA, like me. Let me know if CA has anything different that I need to ask about. Thanks, Robin
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Thanks magari! I couldn't have direct to implant because I needed radiation (and chemo) due to a few positive nodes (which was unexpected). My PS would not do that because high failure risk radiating implant reconstruction. I think some people can have direct to implant subpec depending on the size and shape of implant, and because they detach part of the pec (which is often terrible for active people and why pre-pecs are great).
I had TEs placed 7-8 months after radiation ended. In retrospect, the expansion didn't end up that great - not symmetrical and not natural breast shaped. Wish I never spared my nipples because they ended up off kilter, especially on the radiated side because that skin doesn't stretch well, and covering them is annoying. I just can't see changing these textured cohesive anatomics (which are already rippled and sitting almost sideways with the fullest part medially/by sternum) to smooth round and getting a good result. Even PS said they would likely be more rippled, and they would still be fullest medially, not inferiorly like a real breast. I don't have enough fat to fat graft the edges and that doesn't often work well anyway unless multiple times. I'm also growing tired of how they feel when I move around in bed, especially when side lying. These are only 250cc each (pretty flat), so I don't how people with larger pre-pec implants tolerate them! They feel and look so obviously fake on me. I'm sad that I can't have anywhere close to natural looking breasts when naked. Stupid cancer! A least they have not interfered with sports much. Yay! That is most important to me - my activity level and comfort. One side starts to burn (for lack of a better word) if compressed too much under my hydration pack on long aggressive mountain bike rides. I also get episodes over the past year of a week of the burning with some swelling and nipple pain, which is why I'm looked to get them out. Trying to have the fewest surgeries, but ANY surgery risks having another problem or pain to deal with. No way to predict the outcome.
- xo
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Robin - My original shaped, textured implants were Sientra, highly cohesive gel (ie, "gummy bear"). My new smooth rounds are Sientra gummies as well - 300 cc "moderate plus" profile.
I think my surgeon likes Sientras because they have the largest variety of profile shapes. I wanted slightly more upper pole fullness than I had with the shaped, but told her that I definitely did not want the "tennis balls on the chest" look. And I'm quite happy with the look I got.
I did not have imaging before my revision surgery, because none of my imaging has been accurate since my diagnosis and my surgeon and I had already decided to do the revision. She didn't see anything concerning during the surgery, so hopefully this will be the last one I have for many years.
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thanks Jill and divecat. There may well be recaps from earlier batches. Trying to see my plastic surgeon...
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I just had a consult with a new PS this morning (one more consult on Oct. 3). Since I had my MX five years ago, the implant was under the muscle. I hate it and have my fingers crossed my new PS can go above the muscle. I want a smaller implant, because of I have "side boob", and will have my right implant replaced, for symmetry. But I am giving thought to having it removed, but not replaced. Has anyone had their implant removed?
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Magari how different is the recovery with smooth implants? Do they actually have movement? Can’t wait to find out. Robin
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Robin - My initial surgery was BMX with direct to implant, pre-pectoral reconstruction. My recent revision surgery essentially swapped out the implants and added some fat grafting.
It was about a 2-hour surgery, done as an outpatient procedure at a surgi-center. I did not need drains, and had minimal pain afterwards; more discomfort really, which lasted for about 4 days. (And that almost exclusively in my abdomen, where the fat harvesting had been done.)
My smooth round implants are a little softer than the shaped ones were, and they do move more. I'm dealing with a couple of adhesions (which I had the first time around as well) but am doing massage to try to get them to release and also break up some scar tissue where my ports were. It seems to be helping, but I have a checkup with my surgeon next week to make sure I'm doing everything I can while things are still malleable.
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Hello ladies, I have a website for you to checkout.
thepubmed.org
Go down to publications/resources and look at all the articles and information. They range from 2008-2019. Unbelievable what they knew so long ago! Ticks me off even more.
I also called the Allergan number and talked to a guy. He gave my information to the department that has the registration cards on our implants. I told him the FDA recall letter said that Allergan sent out notices on 3 campaigns- not to me!
It is an outrage that they knew so much about this and still decided to keep them on the market and not have preoperative counseling that included disease awareness, presenting symptoms, and sources for reporting this.
I have done so much research on this that my head is full! Hope everyone is well.Robin
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Thanks RobinBlessed54. I am also upset that the PS has known for so long and said nothing before the op. If anything he had positive things to say like how the textured implants are better and that they settle quickly and bond better! Seemed like a no brainer. Now I know better.
I have decided to wait for now, not up to having further surgeries. Also want to research more the stance on smooth implants. I don't trust the info we have access to anymore.
All the best.
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Well, here is the latest: Allergan didn't have any record of my implants even though I sent the registration card information on 3/5/15!! I wonder how many more haven't been recorded? So they sent me the paperwork and I sent it in today. Holy Cow! I guess the PS will have to use Allergan brand smooth ones if I get them swapped out in order to fulfill the warranty and give my health group credit for the faulty implants. How do I ever trust again? I am anxious to see my PS and find out what he will allow me to request. I really don't want another surgery, but do I want to wait until something happens? Having breast cancer one never really forgets about the possibility of a recurrence or metastasis. Now we have to worry about this. Just doesn't seem right.
God Bless, Robin
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Neither my PS nor my MO manually feel any problems. However I talked the latter into ordering both a ULS and an MRI since I haven't had either since 2013. Although he wasn't gracious about it. I'll schedule testing in the next month or so.
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I just came across this thread a few minutes ago. At my yearly visit with my oncologist, my mammogram and my blood work all came back normal. I told my oncologist about some swelling I had on my clavicle that I assumed to be from my lymphedema. He had me get a CT scan of my neck and chest. The chest scan came back normal but the neck scan prompted me to have a CT guided biopsy last Friday. I am still waiting on results. Meanwhile, a couple of nights ago my DH and I were watching the news and they mentioned a recall on Allergan implants. I received my implants in 2011 and when I looked up the FDA recall on these implants one of my implants is on this list. I never received any notice from Allergan about a problem with my implants. I still do not have any results from my biopsy and have been told that it could be another week before I have them. I have an appointment already scheduled with my oncologist next week and regardless of what the biopsy results are will be asking my oncologist about the implants. Someone mentioned that certain manufacturing dates were part of this recall but the FDA link that I read listed style numbers.
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