Health concerns of Allergan Textured implants
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I met with my PS today just to discuss the 410 issue. I've had them in for 8 years, and as I mentioned I love the shape & feel. I've have no symptoms or problems so far.
He found noting noteworthy by a manual exam. He does not believe in scans or imaging if there is not a problem. And as the FDA stated, he does NOT recommend explant and/or exchange to a smooth rounds if there are no problems. Since I REALLY don't want another surgery, and I trust this doc, I'm going to put the whole issue on the back burner for now. I'll just be aware of the symptoms in case things change. Or until different recommendations come out later after more research & feedback. I'll discuss it with my MO at my scheduled appointment in September.
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Thanks for the update...
Glad that he found nothing noteworthy!
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Just a note about MRI. I have the textured implants. I had two doctors examine me. Said they are soft, look good etc. One of the doctors said to do an MRI even though nothing seems amiss. Came back showing a ruptured implant. I feel absolutely nothing different nor did the doctors. No pain. No hardness. Zero. So I really believe that you can’t always tell something is wrong just by having an exam. Unfortunately this means surgery for me next month. Otherwise I had decided to keep them. Now with the rupture I can’t.
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the silent rupture is, I suppose why it is recommended to get the MRI at regular intervals. I will make sure to check mine regularly. Thanks for sharing your experience...
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Mantra - I agree, but I'm keeping careful track of the time between imaging or scans. My first MO believed in lots of imaging and often. When he retired, he told me I'd probably have to really push since most docs don't like to do them. I figure I'll discuss w/MO this September and shoot for more imaging in 2020, or at the 10 year mark in 2021.
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I believe even the FDA and the manufacturers recommend that you have an MRI every two or three years to check implants, but then there are cases as Mantra experienced where issues do not show up untimaging. In some cases BiaALCL is not visible on scans and can’t be seen until CD30 testing has been done or tumors are evident upon explant. I believe there is much resistance against testing for this, plus many docs just don’t know enough about it yet as it’s all so new. I also read somewhere that implants should be replaced after 10 years.
Copying from another site:
...It is the reporting of adverse events that seem to be the most important factor in creating change. Please report any issues with your medical devices even if you still have them implanted into you body and SHARE this post.
This is a great way for ALL of us to matter and create change!
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I also think that a very real issue is cost. Even if a woman wants to get tested or explant, she likely will assume the cost. MinusTwo, I totally get not wanting another surgery. Look at how many I've had. Glad it's over....and my exchange of the textured implant was conveniently a part of my last scheduled surgery. I am not sure whether I would want another one either to remove an implant.
However, what about women who just want to be tested or get it removed for peace of mind? If you cannot afford it, I guess you just have to suffer? This doesn't seem right. Haven't we suffered enough physical and emotional damage from bc?
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I haven't been on here for awhile, I am curious about the talk of the Allergan textured implants so I logged on to read the latest discussions. I had mine removed three months ago and went flat. I am in a new state from where I had them put in. The PS who did my recon said "these will last you your lifetime; when you are in your 70s your boobs will look like they do today". I fell in love with that thought. I have had chronic pain and inflammation all over my body for the last 3 years, neck, shoulder back mostly. Then other issues started too so my primary care doctor suggested maybe my body is fighting the implants. I dismissed it because I didn't want to face another surgery. Then I found a lump so in January i consulted with three surgeons in my new state here and all three of them suggested removing the textured implants, biopsy the lump and trying a smooth. Two of the three surgeons told me about the cancer risk and that "they would never have put allergan textured implants in a cancer patient". After much stress and research and listening to my gut, I decided to just have them removed. The surgeon I chose told me I was beating the rush as he predicted they would be on a recall list soon and that women would be wanting them removed. My lump ended up being scar tissue and necrosis but my implants and capsules were full of inflammation. I am hoping to feel better eventually. Mentally I am relieved, at least knowing I am not contributing to the health issues by keeping those implants in. Emotionally it has been rough. Not sugar coating it. I am angry and sad that I went through all of this. I think every woman should consult with a PS and decide what they need to do for themselves. We are lucky we can support each other in this new discovery! Hugs to you all.
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Congrats on joining us Flatties Lkscolo. I hope you join us over at Flat and Fabulous (private group on FB)… to hob nob with women rocking it.
Also, Scrafgal, if you are in the US, you can decide to explant at ANY point of time in your cancer journey and insurance is forced to cover it. We are protected in that regard. If your insurance pushes back, you just use the pain card and it's done. Some women feel that because they chose implants, they are stuck with them due to cost, and that just isn't true.
I chose implants, changed my mind halfway through the process, went flat, and the insurance says I can always reconsider my decision and try Diep or implants again down the road. The choice is ours.0 -
That's what I thought Lisey, but I thought that someone posted here to say that their PS would not do the surgery...maybe she was not in the US.
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Lkscolo,
I'm glad you ultimately had a good ending. My story was much the same. I had nothing but problems from the beginning, but little did I know they were due to my Allergan implants. I suffered from a multitude of symptoms over the past 5 years. I had random pain and swelling on my cancer side that would come and go, and had many ultrasounds and MRIs during that time - all the while fearing the worst, of course. All my tests were negative. I was referred to a psychiatrist and tried several antidepressants, PT, Yoga, meditation, and acupuncture. Nothing relieved my pain. The swelling and hardness above my breast was not explainable. Early this year I found the websites for BII and BIA ALCL and started reading other women's stories on Facebook (ALCL In Women With Breast Implants BIA-ALCL). I watched these women's testimonies at the FDA hearings, which were very disturbing. There was nothing in the literature about this, so the emerging stories, which had a common theme with other women with implants, led me to believe I was also having symptoms of either BII and/or Bia ALCL. I went to my PS and asked to have them removed and was able to do that within a week. I had to fight for testing, however, much like everyone else. There is resistance among doctors to test. You must have some very informed doctors to suggest your implants were causing your illnesses and to encourage you to remove them. Consider yourself very lucky!!
I had my implants removed in April. My CD30 test was negative for alcl, but pathology showed chronic inflammation, fat necrosis, and abnormal amounts of bacteria. No wonder I felt so lousy. Now I feel so much better, have more energy, my brain fog and insomnia are gone. But like you, it's been an emotional roller coaster. I'm resentful of the fact that my implants were placed 2 years after the FDA started investigating these devices. We should not have to fight for proper testing and the doctors who placed these implants should have our best interests at heart, but many do not. I suppose they are afraid of being sued, or are still in denial. But the tides are changing - thank goodness the FDA finally did the right thing, unfortunately at the cost of women's lives.
Best of luck to you!
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Scrafgal - I had my implants removed at no cost. They are covered as long as you have a history of breast cancer. Lisey is right - the pain card always works, but even if you say they're too big, too small, or you are concerned about the recent recall. It's all covered - whatever you decide to do - go flat, do fat transfer, switch to smooth implants, get nipples, whatever. So no worries - as long as you have insurance, you're covered under the Women's Health and Cancer Rights Act.
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I am happy to know this..
I had mine removed and replaced with a smooth one in May, when I having final revisions. So, I was avoiding another surgery and any issues with getting it done...just took the opportunity to get it done early!
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Lkscolo and bc101 thank you for your stories. I knew I wasn't going out of my mind. My implants have bothered me too since I got them 5 years ago. I've already consulted one plastic surgeon and have 2 more consult appts in the next few weeks. Again, one of my implants are leaking and I have the Mentor brand, but from my understanding they could have been manufactured by Allegan. The plastic surgeon I did see said he too would have never put textured implants in a cancer patient.
I'm hoping I can do the Diep procedure this time.
Thanks Ladies! This is so helpful to hear other stories!
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hi. I happened to find your post by chance through a google search for exchanging implants. I am Glad I did. I hope your recovery went well.
I am not sure if you will revive this message but I have a few questions.
What was involved in the exchange? Like the procedur. I'm not finding much information.
We had the same Textured ones and I'm Looking to exchange them for smooth as I too could not handle at this time in my life to go flat. I was also looking at fat transfer but it's not perfected yet and requires a lot of skin grafting so exchanges was suggested to me.
How long was recovery? Was it the same when you put your in
Thank you for taking the time.
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hi. I happened to find your post by chance through a google search for exchanging implants. I am Glad I did. I hope your recovery went well.
I am not sure if you will revive this message but I have a few questions.
What was involved in the exchange? Like the procedur. I'm not finding much information.
We had the same Textured ones and I'm Looking to exchange them for smooth as I too could not handle at this time in my life to go flat. I was also looking at fat transfer but it's not perfected yet and requires a lot of skin grafting so exchanges was suggested to me.
How long was recovery? Was it the same when you put your in
Thank you for taking the time.
I will add to this post after reading his entire thread.
I had an MRI and a few manual even as of today with my original Plastic surgeon
. Al is well in that sense. I however had numbness in my Face and down my arms and across my chest and back. That’s why the mri was ordered and a CT and I had also my spine and all that checked.
Most doctors I speak to do not recognize BII so I don’t even go there in topics. I explain all my symptoms and I went from neurologists to physiologist so I’ve seen everyone and am doing whatever I need to be well. But the pain is constant and burning and all this kind of thing. Now that fat transfer isn’t an option and I’m still Perplexed by that, my other options are going flat or smooth implant to remove the textured....will it make me feel better I don’t know. But the larger risk will be out I hope. I have 410. I feel after today one of the reasons my surgeon will operate is because I have a choice being my body and recalled. But she does not agree with removal as I’ve had a successful double Mastectomy and heeled very well and there are no “signs” of issues. Other than my daily pains.
Being in Ontario I don’t know other than one awesome doctor who does fat transfer. We met and it’s very challenging and he didn’t recommend being so many surgeries, my thinness, not perfected surgery etc.
Any suggestions or links is helpful.
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bluemorpho, where are you in Ontario?
In Toronto, I would guess that all of the Plastic Surgeons that work at the major breast cancer centres (PMH/UHN, Women's College, Sunnybrook) would do fat transfer.
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bluemorph - have you see a lymphadema trained physical therapist? I have truncal & breast LE. My numbness and occasional pain are definitely related to the LE caused both by node biopsies and by radiation. Most docs don't know much about LE but it is a very real issue. The link below will give you more information.
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Hi, all -
As I mentioned above, my implants were shaped/textured, but Sientra, not Allergan.
I'm now about 3 weeks out from my revision surgery and despite some lingering bruising/swelling from the fat grafting, I am feeling much better than I did pre-surgery. I think the bubbles I was feeling between the skin and my implants resulted in a lot of inflammation. Which made me uncomfortable and used a lot of my body's energy. And was of course causing some worry as well.
My surgeon did not find any fluid, and said, "Based on what I saw in the OR, I think that was just a pocket that developed from how the texturing of the implant stuck to the Alloderm." And that the switch to smooth implants should completely resolve that issue. Which is a huge relief. At my request, she used fairly small implants (Sientra Opus HSC+ 10721-355MP - these are moderate projection smooth round, cohesive gel.) And I am actually liking the way they look as well - not "tennis balls on the chest" at all!
So I'm happy with my results and relieved to have resolved the issues I was having.
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Magari - Thanks for chiming in. Glad to know you are comfortable with your new implants.
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Sounds good, Magari! Glad you are pleased!
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Good news Magari! Glad you are better!
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My younger sister has the Allergan impants and will have them removed next month. She had BC at age 27 and implants had ruptured a few yrs ago, so they were replaced with these. Apparently. the FDA knew of issues with them in 2011, but I guess didn't have enough information or stats to look into it further....or was just lazy. Who knows?!
I am the one that asked about hers and told her about the recall. She was never notified by Allergan or the FDA.....maybe they are still working on that. My sis is a "bury your head in the sand" kinda girl, so she didn't want to know much.She will be 49 this yr. and has high anxiety. Does anyone know of a resource to do more research on replacements, etc? I think she is relying on her surgeon only. TIA!
Hugs
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I have asked mine waiting for a reply. I have also sought another PS out of women’s college who is well known for this. It’s his specialization. I am thinking he should do it..
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hi.I have not. I will look into this and see if it applies. Thank you so much
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keepthefaith - There is a lot of information on the BCO site but please note - the recall does NOT include removing implants in place. The recall is only for stock on hand or any new orders. Most docs are NOT recommending "explant" unless there are specific problems or symptoms.
Actually in 2011 there was an on-going, active trial involving Allergan 410s. I got my implants in September 2011 under that trial, and only a limited number of select docs were allowed to use them at that time, with very stringent conditions. They were subsequently approved by the FDA.
If your sister is having symptoms or health issues, she should of course see her doc. Depending on that relationship, if she's not happy with the answer she could always go for a second opinion.
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Thanks Minus. I think she has already spoken with a PS and scheduled SX for removal. I have read other information that says insurance will cover it if the person has had BC, but not otherwise. I don't think she is having any issues, just wants them out, due to the recall. I guess if the insurance company approves, it becomes their issue on getting covered due to the recall.
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I believe that if one is having anxiety about the implants and wants them removed or switched, then that is reason enough. We all deserve to go through the cancer hell and aftermath with as much ease as possible.
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Agreed, VegGal! At this point, we are taking better care with auto recalls. My dealer just called about the Takata airbag exchange on my car, due to the recall from over 3 years ago. The part is now in stock and the exchange is free. The federal regulators didn't just recall Takada airbags that are sitting on the shelves of car manufacturers! Of course, nothing says that MY airbag is faulty with any certainty....but it might be...so they are exchanging them at the customer's request..for free. Makes sense for cars...makes sense for our bodies!
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Scrafgal, there is a big difference between replacing an air bag in a car, and replacing an implant in our bodies.
Most - over 99.9% - of these implants will not cause BIA-ACLC. On the other hand, people experience complications from surgery, some serious, some even deadly. About 15% of people experience minor complications, about 3% get infections, a very small percent experience more serious complications. An unnecessary surgery presents unnecessary risks.
There is also the question as to whether it is advisable to replace a well functioning implant. I talked to a PS about this about 18 months ago, before the BIA-ACLC stuff hit the news. My question related to the fact that my implant is 13 years old, and I wondered if replacement now made sense, rather than waiting until I was older. The PS strongly advised against, saying that since my implant was still intact and comfortable after 13 years, there was no reason to believe it would fail anytime soon, or even ever. On the other hand, some implants are duds, and fail early. So his point was that I could be replacing a sturdy well working implant with one that might fail within a few years.
Of course if someone has implants that are presenting problems, are uncomfortable, etc., then removal, with or without replacement, makes sense. But removing implants that are perfectly fine and that are causing no problems, out of fear of an extremely rare disease, is not, to use the medical term, "doing no harm". From this standpoint, the current actions - recalling implants on the shelf but not suggesting removal for those who currently have this implant -makes sense and is medically wise.
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