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Health concerns of Allergan Textured implants

kjtm
kjtm Member Posts: 7
edited November 2020 in Breast Reconstruction

hello everyone,

I was diagnosed stage 3 breast cancer Dec.15. Had chemo, rads, node removal, bilateral mastectomy with TE placed. Had my reconstruction surgery June.2017. My surgeon didn't give me a choice or option of implant she just said "this is the one I use". So I was given a textured, gummy bear, anatomically shaped implant. My results were satisfactory but not happy with the fact that I have absolutely no cleavage and are very hard. Anyway....that aside. I have just found out I have the implants that are being recalled because of the risks of implant associated lymphoma. My oncologist and I both agree these implants need to come out!! I'm very worried about a safe implant option plus what implant options I have seeing as she wasn't very willing to give me options. I would like a round, smooth, high profile one. Does anyone out there have these and what are they like? Also wondering if anyone has had to do replacement surgery and how you healed and coped :(

Thanks


**UPDATE**

I have had my exchange surgery since this original post. Had it done March.19th textured 410's out smooth round high profile in. I'm now just shy of 5 weeks out and am soo happy I made the decision to do this. The first and foremost reason was the risks but there are so many other positives that came with it. These implants are soft, they move, they aren't cold to the touch and there isn't the feeling of 2 hard baseballs on my chest anymore!! The level of comfort from these implants to the textured ones is unreal!! That aside the surgery was successful and the drs didn't find anything suspicious or fluid of any sort so that is good. The first 2 days after surgery sucked but was tolerable when I took my pain meds....mostly I was just uncomfortable and tired because sleeping in that state is always a challenge. After the first few days I started feeling good again and it has just been putting in my time to heal and let the scar tissue/capsule form around implant. So in my experience this was a good decision for me and I'm happy I did it. I'm not at a point in my life emotionally that I could go flat without reconstruction. I know all implants carry a risk but I've choosen the least amount of risk and am hoping for the best. In this situation you kinda have to pick your poison......take a chance, or go flat. For me going flat was much more traumatizing. But this is all my own personal feelings and opinions. Every woman out there has to decide what is best for them and what will make you live your best possible life in the now. I wish only the best for all of you!!!! Take care.

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Comments

  • veggal
    veggal Member Posts: 261

    I switched from textured anatomical to round smooth extra high profiles. I like them so much. Tons of cleavage, although they are firm. I can send pics if you'd like. Just PM me. 

  • debal
    debal Member Posts: 600

    I have mentor smooth high profile extra. I like them too. My PS got away from the textured implants due to the lymphoma risk. Maybe you need a second opinion just to be sure you get what you want? Best wishes!

  • JennieKeaton
    JennieKeaton Member Posts: 24

    VegGal -

    Will you PM me pics? I'm going through this decision now. My PS says if I want teardrop shape (and I do), I need to do the textured. But I don't know that I'm as informed as I can be as to how the round can look.

    Jennie

  • kjtm
    kjtm Member Posts: 7

    JennieKeaton,

    Have you been told the risks of textured implants and that they are being recalled? That is the whole reason I'm in this mess.

  • SDWoman
    SDWoman Member Posts: 28

    kjtm Do you have a link with more information about recall?

  • kjtm
    kjtm Member Posts: 7

    It's not letting me post links?

  • SDWoman
    SDWoman Member Posts: 28

    kjtm I received your private messages. Thank you! However it it looks more like a warning than a recall for Canada. It does appear that they have been recalled in Europe.

    I knew about this risk before I had my implants put in and discussed at length with my doctor. I really do think think the risk is very small (1 in 30,000). While not ideal, it's a risk I thought I could live with. If you think about it, the risk of breast cancer coming back is far higher.

  • kjtm
    kjtm Member Posts: 7

    These breast implants have been recalled in 33 other countries......Canada just seems to be slow to respond to these concerns. I spoke with my oncologist about it yesterday and she said "they" are stating the lymphoma risks are low and rare but she has cases of them. She said so how rare can it actually be if she is actively treating cases. For me it isn't a risk I want to take. I suppose it is a personal choice. I do know that I wasn't told about lymphoma risks when I got mone done.

  • NotVeryBrave
    NotVeryBrave Member Posts: 169

    I had to sign a separate consent form before surgery - basically stating that I had been informed of the risks of lymphoma that had been associated with the textured implants. However, that was the recommendation from my PS and he felt it would be most successful for a direct-to-implant BMX surgery. And so I did.

    I asked my BS about it just the other day. They are still using them and they do not recommend having them removed and replaced unless there is some issue going on. The risk is still very low. I don't know this for a fact, but it's probably less than the possible risks with anesthesia or infection.

    BTW - The association has also been found with the smooth implants but is lower.

  • JameeCook
    JameeCook Member Posts: 3

    Good morning all,

    The European CE mark was denied on textured implants there recently because they asked for additional data from the companies while in review and didn't get it (at least that's my understanding). The ANSM, in France, had a two day meeting about textured implants and lymphoma this week. The resulting decision was that Allergan textured (biocell surface) would be removed from the market but they aren't making that same recommendation for other textured surfaces at this time. They also are NOT recommending removal for patients who already have the devices (yet).

    In the US, these products are still in use. The FDA has an Advisory Committee Panel meeting set for late March that will discuss this more in depth.

    Quick question for those who are exchanging from textured to smooth - Are your surgeons doing a total capsulectomy at time of exchange?

    Thanks:)

  • Lindseyc
    Lindseyc Member Posts: 11

    Hello!! I just had my propaylactic bilateral mastecomy 5 weeks ago. I currently have expanders and have one more fill to go. Prior to the surgery, I asked my PS about the risks of BIA-ALCL and he said current research suggested the textured implants raised the risk. Now all over the news, there is information stating both smooth and textured can put one at risk. Now I am getting worried, and wondering if I need to go without implant 😬. My PS was in surgery all day so hoping to get a hold of him tom

  • Lindseyc
    Lindseyc Member Posts: 11

    Hello!! I just had my propaylactic bilateral mastecomy 5 weeks ago. I currently have expanders and have one more fill to go. Prior to the surgery, I asked my PS about the risks of BIA-ALCL and he said current research suggested the textured implants raised the risk. Now all over the news, there is information stating both smooth and textured can put one at risk. Now I am getting worried, and wondering if I need to go without implant 😬. My PS was in surgery all day so hoping to get a hold of him tom

  • kjtm
    kjtm Member Posts: 7

    Since I made this post I have seen my surgeon. She said 50% of her patients are deciding to have them exchanged and 50% are leaving them. She said risk is 1 in 3000 which for me is too much. I am a worrier and I also got breast cancer young with no family or genetic connections. I go for my exchange to a smooth implant on March.29th and very nervous but also nervous about keeping these ones in. So fingers crossed all goes well on the 29th. Make sure you ask lots of questions, do some research and in the end do what is in your comfort zone. I do know there is still a possible chance of lymphoma even with smooth but odds are even lower than textured. Being only 38 years old I'm not ready to sport a flat chest. Best of luck to you

  • Lindseyc
    Lindseyc Member Posts: 11

    So the risk is 1:30,000 with a textured impant. Doesn’t seem like there is data regarding risk of smooth. This is all so very frustrating. And I know the odds are low- but I just hate the looming “what if.” I am 36 and too am not sure I want to go without having any sort of breasts. Am wondering if I can do tissue transfers as an option. I lost my mom 3 years on the 1st of Feb to IBC- and anything and everything related to cancer flips me out. Guess i will just wait to see what my PS has to say. Good luck Kjtm on your exchange.

  • rrobin0200
    rrobin0200 Member Posts: 76

    I have the smooth, round, high profile implants, and I absolutely love them. They look 100% real. I have cleavage and I am beginning to feel a “little” sensation.

  • Konacarol
    Konacarol Member Posts: 1

    I had the gummy bear ones remover over a year ago. They not only have the health risks but mine had made bed and were making me look dysmorphic and painful. Actually they always were so hard I was always uncomfortable. I now have Allergan round smooth ones....happy with these. Much softer and I look WAY better. Had some fat grafting too....but I really am happy with these implants. My surgeon had to put in bigger ones than I thought I wanted but I do not at all look like Dolly Patton....the muscles had stretched and I needed bigger ones. The surgery was easier than I expected...I think I have PTSD from the tissue expanders and this was nothing at all like it. It was simple and I am far happier with these implants.

  • kjtm
    kjtm Member Posts: 7

    same here! I'm not really deformed but they are very hard and feel uncomfortable. I always wondered if it was maybe because of the radiation or if it was normal? Anyway....I'm hopeful that the exchange surgery goes well and that I heal nicely. I'm traumatized from all of it and it always seems like it is never ending. I love hearing the positive feedback from you that everything turned out so good. Fingers crossed it's the same for me.

    Take care

  • trmtab
    trmtab Member Posts: 794

    Sept 2017 I woke up to find I had been exchanged to TCX800 - the round textured cohisives made from the gummy material...I had signed paperwork for SRX so was shocked and mad and scared re the lymphoma potential. Well the implant remained hard and uncomfortable the full 15 months I had it. I had an MRI at one year and there was fluid in the pocket which moved the exchange to front and center...either need to removed and replace or start aspirations of the fluid and testing. I exchanged to SRX700 Dec 17, 2018...this is what Whippetmom had suggested for me almost 3 years ago. Very happy, good shape, soft to touch, my healing was easy. Take care. TT

  • Sharon2010
    Sharon2010 Member Posts: 3

    For those who've had their textured implants exchanged for smooth ones, can you tell me if you used the round, smooth, but still highly cohesive gel (like the 410anatomical, but round), or a softer gel? I'm having my 410s removed in 2 weeks. I know the highly cohesive gel holds shape better, but I'm not so sure a round implant that has no movement is going to look so good, and I really haven't liked the firmness, especially in the radiated side. I know the company has a “middle of the road" cohesiveness that's softer than the highly cohesive, yet firmer than the soft ones. What do you ladies have, and how do you like them?


    Thank you

  • trmtab
    trmtab Member Posts: 794

    I switched from TCX to SRX 9 weeks ago...both are round, but the TCX was textured cohesive...I very much prefer the SRX which is solid but soft...I tried not to hug anyone for 2 years and there was a brick under my clothes. TT

  • Hood1980
    Hood1980 Member Posts: 168

    Will insurance (US) cover the cost for the exchange from textured implants to smooth

  • veggal
    veggal Member Posts: 261

    Hood, yes. 

  • Hood1980
    Hood1980 Member Posts: 168

    thank you VegGal. I think I will begin the process of having them exchanged

  • jaboo
    jaboo Member Posts: 368

    I currently have expanders in and I noticed my surgeon is using textured implants for some of the patients. Could anyone please post some links with information regarding the risk?

    JameeCook, I am in Europe and I don't know about the CE mark being declined for the textured implants.... do you maybe have a link bookmarked?

    Thank you.

    EDITING to add - of course I've found the links... I am sure I will go with smooth imlants, but I am very confused since I know of women who received the textured implants in February and one had her exchange surgery on the day I got my expanders...


  • Keepongoing
    Keepongoing Member Posts: 30

    I switched from textured to smooth round Naturelle inspira SSX 650. I like them better . They are softer and so far no ripples . I had a little scar tissue in the left side that I needed addressed but it hadn’t bothered me enough to go through another surgery but when I heard about the lymphoma concerns my PS suggested it was a good time to exchange the textured ones out and fix that issue at the same time . It’s been 3 months ago and so far I’m very pleased and feel less worry about the increased risk

  • rmgrmg
    rmgrmg Member Posts: 26

    Look at risks

    Breast implant‐associated anaplastic large cell lymphoma: Clinical and imaging findings at a large US cancer center


    Abstract

    Purpose

    Evaluate the clinical presentation and imaging findings of breast implant‐associated anaplastic large cell lymphoma (BIA ALCL) at a large US cancer center.

    Materials and Methods

    HIPAA‐compliant IRB approved retrospective study, for which informed consent was waived. The Hospital Information System was screened for women who underwent implant reconstruction and were diagnosed with BIA ALCL between 2010 and 2016. Two radiologists reviewed images in consensus. Clinical and imaging characteristics were summarized using means and ranges for continuous variables and percentages for categorical variables.

    Results––

    Patient cohort included 11 women with BIA ALCL (mean age at diagnosis = 54 years, range: 35‐77), including women with (9/11) and without (2/11) history of breast cancer. Mean time from breast implant placement to diagnosis was 10 years (range: 6‐14). BIA ALCL was identified in patients with saline (4/11) and silicone (5/11) implants. Implants were textured in 7/11 (63%) and unknown in 4/11 (36%) cases. All patients presented with a peri‐implant seroma, (9/11 documented on imaging). Two of 11 patients had a mass within this seroma. Ten of 11 patients (91%) presented with symptoms.Conclusions

    Conclusions

    Saline and silicone breast implants may predispose patients to a rare lymphoma subtype, BIA ALCL, which presents on imaging as a peri‐implant fluid collection ± mass.

  • rmgrmg
    rmgrmg Member Posts: 26

    Breast implant‐associated anaplastic large cell lymphoma: Clinical and imaging findings at a large US cancer center



    Evaluate the clinical presentation and imaging findings of breast implant‐associated anaplastic large cell lymphoma (BIA ALCL) at a large US cancer center.

    Materials and Methods

    HIPAA‐compliant IRB approved retrospective study, for which informed consent was waived. The Hospital Information System was screened for women who underwent implant reconstruction and were diagnosed with BIA ALCL between 2010 and 2016. Two radiologists reviewed images in consensus. Clinical and imaging characteristics were summarized using means and ranges for continuous variables and percentages for categorical variables.

    Results––

    Patient cohort included 11 women with BIA ALCL (mean age at diagnosis = 54 years, range: 35‐77), including women with (9/11) and without (2/11) history of breast cancer. Mean time from breast implant placement to diagnosis was 10 years (range: 6‐14). BIA ALCL was identified in patients with saline (4/11) and silicone (5/11) implants. Implants were textured in 7/11 (63%) and unknown in 4/11 (36%) cases. All patients presented with a peri‐implant seroma, (9/11 documented on imaging). Two of 11 patients had a mass within this seroma. Ten of 11 patients (91%) presented with symptoms.

    Conclusions

    Saline and silicone breast implants may predispose patients to a rare lymphoma subtype, BIA ALCL, which presents on imaging as a peri‐implant fluid collection ± mass.

  • rmgrmg
    rmgrmg Member Posts: 26

    In the same boat having Allergen Text implants and know the risks are small so far as FDA tells us. Just a note to anyone having these out make sure the whole en bloc capsule scar tissue around the implant comes out as well .

  • rmgrmg
    rmgrmg Member Posts: 26

    From FDA site risk acoording to smooth or text implant of ALCL numbers row 1, percentages row 2

    Implant Surface

    Textured

    310

    68

    Smooth

    24

    5

    Not specified

    123

    27

  • rmgrmg
    rmgrmg Member Posts: 26

    Thinking to have my assymptomatic textured implants removed as they are uncomfortably too large for me. I wonder if CD 30 and pathology should be done when I display no symptoms of ALCL but just have had textured implants for over 10 year?