Health concerns of Allergan Textured implants
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Well - as I've said before - as has Robin and several others - I like my Allergan 410s.
I have had them for 8-1/2 years and have had no problems. I have had regular scans to make sure everything is OK, but that was happening from the beginning and all along before this issue came up. And regular scans will continue to happen per my plastic surgeon and my MO.
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Class action lawsuits are not inherently good or bad. It depends on the issue, in my opinion. In some cases the outcomes have driven benefit for all of us. The class action lawsuit against Dow Corning for their faulty silicone implants drove them into bankruptcy...did silicone implants go away forever? No. Innovative scientists started working on safer products for all of us. The power of that particular lawsuit seemed worth it for future generations since individual lawsuits were unlikely to result in the outcome: punishment of a bad actor against a vulnerable class. Allergan's are better than Dow's but let's face it. They could probably be a whole lot safer!
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Hi all. It has been a looong time since I posted here. I popped in to see what kind of discussions there were on this already, so have found this thread helpful
Recognize a few "faces" in here!I had a PBMX in April 2014, nipple-sparing and direct to implant. I had silicone rounds placed initially (can't recall offhand what brand/model). I was not very happy with them as on my right side I had rather extensive rippling due to already being fairly thin but also due to how much tissue they took out (credit to my breast surgeon, but not so great for cosmetics later) so my tissue over the implant was very thin, despite being under the muscle. Because of one of my hobbies (scuba diving) I was very self conscious people could see that at times because of my attire.
I was given option of revision to textured anatomical implants or fat grafting, but I did not have a whole lot of fat to graft at time and it did not appeal to me at the time. So I ended up with Allergan 410s about a year after my initial surgery. Revision surgery and recovery was rather smooth sailing for me. A weekend off and then back to work.
Cosmetically speaking, I have mostly liked my Allergan 410s for most part. Shape and feel is nice. I don't mind their firmness because I am rather active and after years of having natural 30DD/E's, the minimal bounce (still with 30DD/E's) was sort of appreciated. One side has always had a better cosmetic result than the other, but my natural breasts weren't perfectly matched either so I could deal with it as I did not want to have any further surgery as long as I could avoid it. The coldness of them can be a bit odd at times - I also get a big "chill" through my chest at times, especially when in cold air or cold water, which I did not get with the silicone rounds. Still, more a weird quirk than a concern.
However, in the last year or two I did start noting some weirdness with the one side (like it was "contracting" a bit at the bottom on one side, but without any pain or discomfort, and deforming it a little more). In last couple of weeks I have also noted it felt a little like my armpit on the left side was swollen on and off. At first I thought maybe it was an ingrown hair or something but it just has a weird fullness to it. Honestly, I still was not too concerned about it, it was more a passing "hmm, that's weird" thing.
However, more importantly...while at the time when I had them placed there were already some links being made to BIA-ACL, I was not too concerned about the risk for me at the time as I was a healthy 30-something, active, healthy, no chronic health issues. Since my surgeries though, I was diagnosed hypothyroid - about 2+ years ago now. My only symptoms before that hypothyroid diagnosis were severe fatigue, low mood, etc and the diagnosis was via regular blood work. I had chalked my severe fatigue and such all up to stress or long work hours or grief after my mum's passing from metastatic BC in December 2016 so it was a rather surprising diagnosis for me. Most common cause of hypothyroid is autoimmune related (otherwise I have no other increased risks: no family history, no pregnancies, no radiation, well under 60, etc). From what I have read more recently there is some theories that the BIA-ACL may be the final consequence of a low grade, ongoing infection that causes a type of immune response that ultimately, in very rare cases, results in BIA-ALCL. I don't necessarily think the implants resulted in my hypothyroid, but I am alert to how I may be at greater risk of immune responses and inflammation.
So, I am going to see my regular physician tomorrow to get a couple referrals to plastic surgeons to discuss replacement or other options even if they need to add fat grafting (in Canada, so want the referral to keep the chain going to ensure that provincial healthcare pays for everything).
As a note, my sister had a consult this week with her own plastic surgeon as she is moving towards doing her own PBMX. Her surgeon is very experienced and knowledgeable in reconstruction and implants generally, and when he found out from her I had the Allergan 410s he asked her if I had plans to change them out soon (and I don't live anywhere near her, so he would not be getting my business!). So while I know they are telling people that there is no worry to remove them if they have not had issues, that made me pause.
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DiveCat
I don't know whether you have a significant other, but a friend of friend got her husband to donate fat for her....maybe an option? I say this only because I now had a lot of fat grafting and it adds incredible softness and warmth. I am amazed at my outcomes but it was a long time coming if you look at the dates on my profile.
I hope the very best for you and all of us. Our choices are not easy.
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Thanks for your response. Unfortunately (or fortunately depending on perspective I suppose?) my husband does not have much to spare either. Perhaps I shall curse him for avoiding developing a middle-aged beer belly so far!
We will see what the PS says. I think from what I can tell there has been a lot of developments even in the last five years, so maybe they can do more with what I do have than they could do before. Besides, I have been doing my best to eat a little more chocolate than I used to
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just found out my left breast implant has a rupture. So now the decision has been made. No choice but to remove. Not what I was hoping to Hear.
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Mantra - so sorry about the rupture. Hope the surgery goes smoothly.
I'm one of those who is perfectly happy with my Allergan 410s and not in a rush to do anything. However I do have a five year check up scheduled for the end of the month with my PS. It will be interesting to hear what he says.
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Mantra,
Best of luck o your surgery. Please keep us posted.
UPDATE:
Allergan has called for a worldwide recall on their textured implants:
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bc101....just to add to your post, in a major reversal, the FDA asked for the recall...
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To be clear, Allergan are recalling implants that are unused / in inventory. They are not recalling implants that are in use.
The recommendation remains that no action be taken by women who have these implants and who are not experiencing any problems.
At this point there have been 573 cases of BIA-ALCL identified worldwide. I have no doubt that this number will go up as more cases are found, however based on the millions of these implants used worldwide, we are still looking at a risk level that is a fraction of a percent. Everyone with these implants needs to decide for themselves what they will do.
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Please note the important sentence in Bessie's post and in all the articles this morning.
"The FDA does NOT recommend removal or replacement of textured breast implants in asymptomatic patients."
She is correct, you need to talk with your own doctor if you have problems or questions.
I have an appointment to see my PS next Monday that I made several months ago - but I just want to talk. He is chief of plastic surgery at a major med center hospital and i trust his judgement. I have no intention of 'explanting' since I am having no problems. I will of course post again after I meet with him and hear his thoughts.
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I would not expect the FDA to recommend removal anytime soon, given the data thus far and how the FDA is inclined to operate. So, while there is no change recommendation, we can't really conclude that today's announcements have no meaning. The argument used to be "there's been no recall..." Now that there is a recall, we are just happy the there is no recommendation to remove....How much meaning today's announcements have is for everyone to judge on their own. Just as many women here often say that their doctors don't make decisions for them about treatment, the FDA doesn't make decisions for me either...As everyone has said, we own our own decisions based on our individual risk tolerance.
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Here is our Research News article on this topic:
Allergan Issues Worldwide Recall of Biocell Textured Breast Implants and Tissue Expanders
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Nice work, bc.org. Thanks for sharing this broadly, mods!
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Thanks mods.
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You're very welcome.
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After getting an MRI a few weeks ago because my oncologist heard my complaints of ongoing pain; one of my implants are leaking. And yes I have the textured ones. Met with new plastic surgeon who said if it was his family member, he’d recommended removing them “sooner rather than later”...SMH😡..I’m almost at my 5 year mark. He seemed perplexed that the first ps put in textured anyway. My mind was made up to get them out anyway because I really felt that something was wrong.
A very close girlfriend (and cancer survivor) works for a subsidiary of the company says they are all made by the same company. So 9 times out of 10, I have the recalled implants.
At what point does this end???
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Angelfaith...your plastic surgeon is not alone in expressing such a sentiment.
Also, some had already stopped using textured implants in new patients, before the recall...including my PS at MD Anderson....he exchanged mine for a smooth one back in May...My choice!
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I have had Allergen textures Since 2010. I was never offered MRI and finally asked to have one. It showed a rupture and of course we have no idea when it actually ruptured. They are being removed in a month and having smooth silicone put in. I considered a diep procedure but it was more than I wanted to do given risks and recovery.
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I had implants put in 10 years ago. They are not the textured ones that are being recalled but they are the same brand. A few years ago I went to the dr complaining about my breast size enlarging for no real reason... the implants were a c and I was now a ddd with no real weight gain. It didn't make sense for them to get that big in such a short amount of time. I was also having sharp pain in the nipple area. Now I see the recall and symptoms that are similar to those affected. Should I be worried? Should I get them removed? I am very concerned for myhealth.
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Shell - you should go see your plastic surgeon. It may be appropriate to have an MRI. Any further action is a decision you will have to make after consulting with your doctors. Each of us has different circumstances & bodies and different risk tolerance. There's no way to predict what you might discover and what you choose to do once you have the facts about your personal case.
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I agree with MinusTwo. You should consult with your PS and, after 10 years it seems that an MRI would be a likely next step. As I understand it, the known issue is with the textured, so that might give you some comfort if you don't have the textured implants by Allergan. The brand is huge is the US, so a lot if us have Allergans!
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Everyone should get an MRI first to determine anything. I was having swelling and pain in my legs and left breast. Because my doctor could not figure out (through other tests-vein and artery tests, bone scan, CT, etc..) why my body was reacting this way, she finally ordered an MRI. Low and behold it showed fluid around the implant. Sometimes persistence pays off..
Allergan owns most of these other brands. Or they have some hand in the manufacturing of them. If you have textured, get them checked. It has only been 5 years(Aug 12th will be 5yrs) since I had them placed and have felt not well the whole time. Doctors were perplexed until I read what it could be. My hunch was right. Listen to your body..
I'm scheduling my appointment for removal by next week.
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Angel - you are right - everyone should listen to her OWN body. I have had Allergan 410s for 9 years and never had a bit of trouble. We are all different.
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Hello all, I had my appointment with my MO yesterday and I asked her about the recent studies and recall. All she would say is that with so few, 600, globally, that she feels that there might not be a connection. It is such a small number, but I get it, it is nerve racking to have been through all of this to try to bring some kind of normalcy to our lives. Hey, I have the Allergan 410 anatomical implants, FF. I have had them for 4 1/2 years. I love them and have had no problems. Personally, I don’t know how any fluid could form in the pocket that I have. They are 475 cc implants in a 420 cc pocket as they are supposed to be in order to keep them from shifting. But I am glad they have recalled them to stop the possibility of anyone else getting ALCL. Just curious, has anyone on these boards suffered from this?
Take care and God bless, Robin
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I too would have kept mine. I unfortunately one ruptured so they need to be replaced with smooth silicone.
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I’ve heard similar stories with other types of medical devices implanted in people. There is an incredible documentary on this. I believe it is call The Bleeding Edge. My Allegans are being removed at the end of August. I really debated about having a Diep or another implant. I finally decided to have another implant and pray my body doesn’t go haywire and cause me problems. I have fibromyalgia and implants can cause it to flair up. Hopefully it won’t happen
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Praying for the best outcomes for you, Mantra. We've all just been through enough already. Thanks for the update.
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I saw the bleeding edge and it was incredibly eye-opening! A must watch!.. I know 3 women in my flat and fabulous FB group that got ALCL from implants. They all had them removed and are being treated.
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