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Topic: possible implant rupture

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Joined: May 2008
Posts: 5
  • Posted on: May 12, 2008 08:27 pm
mbrown4811 wrote:

Hi, everyone.  I am so glad I found this wonderful site.  I'll try to make this as brief as possible.  A bit of history:  two lumpectomies in May 07, chemo during the summer of 07, bilateral mast with expander placement in October 07, expander swap to Mentor high profile silicone (320's) on January 25, '08.  I recently went back to my ps thinking I was ready for nip tats.  My ps took one look and thought my right implant had ruptured.  There is alot of rippling, some hard knots and I can really feel it moving around when I am physical.  I feel a burning sensation many times during the day when I move around alot.  I do have a physical job (work with horses) and always thought it may be from over exertion on that side since I am right handed.  The skin is also thinner on the right - it was the cancer side.  I did not have radiation.  I still get Herceptin infusion every three weeks (til September).

My ps wanted to "watch it for two months".  I called him back the next day and told him I had been through so much in the last year that if something needed to be done to go ahead and do it.  I am so ready to move on!!  He has set the surgery for this Friday to swap the implant.

I have tried to read as much as I can about possible rupture, but haven't come across anything about what it feels like (pain-wise).  Some say the burning is possibly nerves - I did have 5 lymph nodes removed from that side as well.  I have read about some of you ladies with rippling and wonder if that's just what it is.  I am not looking forward to another surgery.

Anyone have any related issues?  All comments are gladly welcomed and appreciated!

Thanks in advance, Michele

Posts 1 - 24 (24 total)
roseg
Joined: Sep 2004
Posts: 7435
May 12, 2008 08:34 pm roseg wrote:

I have to wonder if they implants were nicked or damaged when he first put them in.  I don't care how physical your job is, they are supposed to last longer than that!

Are they under warranty?  

Rose
TenderIsOur…
Joined: May 2007
Posts: 2923
May 12, 2008 08:54 pm, edited May 12, 2008 09:02 PM by TenderIsOurMight TenderIsOurMight wrote:


I am sorry to hear this.

I must admit, I'm a tad concerned with my similar brand implant.

I have noticed an increase in almost daily burning, a thinned area of the skin, and just of late, visible contracture of the pectoralis muscle with just mild to moderate movement. I don't know what to make of the situation, as it still feels the same shape that it has always felt, and is continuous in form that I can tell.

So sorry to hear this for you. I wish you good forturne at your upcoming surgery.

Tender

It cannot be emphasized too strongly that treatment of each patient is a highly individualized matter. (FDA-approved labeling for warfarin (Coumadin) NDA 9-218/5-105)
mbrown4811
Joined: May 2008
Posts: 5
May 12, 2008 09:00 pm mbrown4811 wrote:

Hi, Rose:  Yes, they are under warranty, I think for five years.  I did not get the extended warranty.  I was thinking the same thing or they were "damaged goods" when they went in.  Maybe the ps is wondering that too.  I was the last surgery for that day and felt a bit rushed, especially in recovery.  He says there is no guaranteed way to know for sure of a rupture without going back in.  Even an MRI would be a 50-50 shot.  Maybe I think too much, but it did concern me a bit when I called the next day and they had already contacted Mentor, their insurance company and mine.  Don't get me wrong - I really like my ps and think he is quite capable and has my interest at heart.  But, I also know business is business.  I have asked that he contact Mentor and find out when and where the implants were made.  I have heard of implants sitting on shelves for years before use.  There I go again - thinking too much!

Michele

mbrown4811
Joined: May 2008
Posts: 5
May 12, 2008 09:05 pm mbrown4811 wrote:

Hi, Tender:  How long have you had your implant and how long have you had the burning?  Sorry to hear of your problems.   We only want to live and be normal again!

Michele

TenderIsOur…
Joined: May 2007
Posts: 2923
May 12, 2008 09:18 pm TenderIsOurMight wrote:


Let's see, about two years for the implant, but I can't remember when the burning started. I just know of late it's been more intense of late.

I don't believe my third generation implant sat around for a long time, as they were in trial, hence company motivation for all to go well. This should work to limit shelf lives, damaged goods (nicks, tears etc). The trial is to help clarify how many do rupture over the years.

I can't remember just now what the quoted frequency of rupture is.

Yes, we all wish to live and be normal again.

Good luck
Tender





It cannot be emphasized too strongly that treatment of each patient is a highly individualized matter. (FDA-approved labeling for warfarin (Coumadin) NDA 9-218/5-105)
MsSherry
Joined: Jul 2007
Posts: 159
May 13, 2008 07:12 am MsSherry wrote:

I signed the papers to join the trial yesterday.  I hope your swap out goes smooth.

Sherry
Dx 4/25/2008, DCIS, 6cm+, Stage 0, Grade 3, 0/2 nodes, ER+/PR+, HER2+
Marian
Joined: Jan 2008
Posts: 216
May 13, 2008 10:26 am Marian wrote:

Hi all, this is a real problem and I'm sorry you had to experience it..

Part of the problem as I see it is that the ps stock pile the implants that they are use to using and try to encourage the patients to take an implant from their supply.  The next time I have mine changed out I am going to ask for a new pair, that can be verified by the manufacturer.  It stands to reason that if they are sitting on the shelf (and there are no provisions for this under the FDA ruling) just like any product (say a tire) they can deteriorate.  You can all get the information as to how old your implants are by calling the manufacturer and having the implant card with you at the time.  I found out one of mine had been on the shelf for 4 years!  So we have a warranty for 10 years but who wants to start with a deficiet?

Best

Marian

hotsyta
Joined: May 2008
Posts: 27
May 14, 2008 10:00 am hotsyta wrote:

Can you find this info out prior to letting them put them in?

Ta


Dx 4/23/2008, IDC, 3cm, Grade 1, ER+/PR+, HER2-
TenderIsOur…
Joined: May 2007
Posts: 2923
May 14, 2008 10:59 am TenderIsOurMight wrote:


Ta,

You might ask for the expiration date, or date made of the implants to your plastic surgeon. This by and large has not surfaced as a big problem, yet individually it is a serious problem when it occurs.

Also, a reminder to the plastic surgeon to carefully go over the implant prior to insertion(s) does not seem unreasonable. We all can use a reminder in life to help ensure quality assurance is maintained.

Best,
Tender

It cannot be emphasized too strongly that treatment of each patient is a highly individualized matter. (FDA-approved labeling for warfarin (Coumadin) NDA 9-218/5-105)
AnneW
Joined: Oct 2002
Posts: 1953
May 14, 2008 11:54 am AnneW wrote:

Did anyone get a wallet-sized card from their manufacturer with the info about their implants? I did, but I don't think there is an expiration date. I think that's info worth having.

Anne

2002 IDC stage 1, grade 1, rads & AI
Dx 9/18/2007, ILC, <1cm, Stage I, Grade 1, 0/1 nodes, ER+/PR+, HER2-
tam1953
Joined: Dec 2006
Posts: 391
May 14, 2008 05:05 pm tam1953 wrote:

I don't know if this is helpful or not, but my mother had implants that ruptured when she fell down the stairs -- both of them. They were older when it happened and she was one of the first women i know to have silicone implants, so they were the old fashioned kind, but I do know that it can happen.

Marian
Joined: Jan 2008
Posts: 216
May 14, 2008 06:00 pm Marian wrote:

I got the card and no there is no expiration date on mine.  I just called up the manufacturer and with that card they can give you a great deal of detail.  As I said in another thread one of mine was made in Ireland 2007 the other was made in Costa Rico 4 years ago but even though they were produced in other countries they were suppose to follow the specs of the company to be under the FDA approved list.  It's interesting I would have thought that if they were approved by the FDA and since the companies are here the product would be produced here but that is not the case for most of them and that too is a concern - I guess they go to where they can get the best labor pricing!  

Ta the only way to get the info before they are placed is to call the ps office and ask them the serial numbers, size and brand of the one's they expect to place into your body and then call the manufacturer armed with that information.  They will give you the line about they are all guaranteed for 10 years but the less shelf time can have an impact on how long the implants can survice in your body.

I have read a few other sites where this is a problem and a concern but again it doesn't seem to be a high incidence.  AFter the implant has been in the body for awhile it forms an encasement around it and when or should I say if there is a rupture there usually isn't an immediate releast of silicone into the body.  First it (silicone bleed) has to penetrate the capsular so if you have just noticed it don't panic (if that's possibly) and know that you have caught it early.

Best

Marian

TenderIsOur…
Joined: May 2007
Posts: 2923
May 14, 2008 06:45 pm TenderIsOurMight wrote:


Marian

Thanks for writing your posts and for putting your information out there. I am truly dissappointed that effort to place a "matched set" isn't made when two silicone implaints are inserted and wasn't made in your case. Matched in the local made, approximate date made etc.

That seems a basic internal quality assurance tenat that should have gone hand in hand with the agreement at time of FDA re-approval of silicone in trial and beyond. Gosh, it's just not that difficult to work for the patient's best interests. I am very sorry for your problems and am glad you have alerted us to such craziness. Four years on the shelf prior to use in your person and this climate, that's what it is, craziness!

Tender

It cannot be emphasized too strongly that treatment of each patient is a highly individualized matter. (FDA-approved labeling for warfarin (Coumadin) NDA 9-218/5-105)
Marian
Joined: Jan 2008
Posts: 216
May 14, 2008 07:09 pm, edited May 14, 2008 07:10 PM by Marian Marian wrote:

Thanks Tender, it does seem to be rather easy when you think of it.  But they (manufacturers) are under no obligation to match them even though it makes good common sense!  I wish there was a push to change that but I've looked everywhere and there doesn't seem to be one.  If anyone else has heard of a congressional action or other appropriate action please let us know so we can add our names to the list.  Because, unfortunately just because we are done now doesn't mean we won't be faced with this again in the future.  Or I guess we could start a congressional action there certainly are enough of us!

Best

kimscharlie…
Joined: Oct 2007
Posts: 11
May 15, 2008 12:17 pm kimscharlie wrote:

I too have been having burning or pain in one of my implants

my ps said it was probably muscle spasam  or something.  It

has started to bother me all the time now.  When I bend over

it really stings.  How do you know if your implant is ruptured.

Kim

mbrown4811
Joined: May 2008
Posts: 5
May 16, 2008 09:59 am mbrown4811 wrote:

Kim - I guess I'll know here shortly if my burning/stinging is from a rupture.  I go under the knife in a couple of hours.  I'll keep everyone updated.

Michele

TenderIsOur…
Joined: May 2007
Posts: 2923
May 16, 2008 04:10 pm, edited May 16, 2008 04:11 PM by TenderIsOurMight TenderIsOurMight wrote:

Michele,

Sending good thoughts your way, knowing you had your surgery today.

Rest well over the weekend.

Tender 

It cannot be emphasized too strongly that treatment of each patient is a highly individualized matter. (FDA-approved labeling for warfarin (Coumadin) NDA 9-218/5-105)
kimscharlie…
Joined: Oct 2007
Posts: 11
May 16, 2008 05:31 pm kimscharlie wrote:

Michele

Let me know what you find out.  I have an appt with ps next wed

and I am going to ask about it.  It was bugging me a little bit

but now it is all the time and it is a burning feeling like you said

so I am a little concerned.   My original ps told me it could be

muscle.  I don't think I buy into that one ...

Kim

2bubbas
Joined: Aug 2007
Posts: 131
May 16, 2008 06:24 pm 2bubbas wrote:

so this thread got me curious and I got on the horn and tried to find out my manufacture date and location.  No go.  They were not giving out that information and said that I needed to ask my plastic surgeon.  I was honest and said I didn't have a problem and was just curious - so I don't know if I had lied would I have received a different response.  She did ask her manager (or so she told me) and that was the response I got.  I think I was the first person who has ever asked her that.  :-)

Anybody else try this?  You must have better phone skills than me Marian! Smile

Marian
Joined: Jan 2008
Posts: 216
May 17, 2008 01:24 pm Marian wrote:

Or maybe it was a different manufacturer?  Mine was McGann (allegan) and by law you have the right to the info - I guess that doesn't mean the manufacturer will cooperate but mine didn't even hesitate!

2bubbas
Joined: Aug 2007
Posts: 131
May 17, 2008 11:47 pm 2bubbas wrote: It was allergan, an inamed implant.  Maybe I just got the wrong phone operator.  Because she asked the boss, and maybe yours was more willing to just give the information.  Who knows?  PMS, the vog...  Tongue out
Stephanie
Dx 8/14/2006, DCIS, Stage 0, Grade 3, 0/7 nodes, ER-/PR-
Marian
Joined: Jan 2008
Posts: 216
May 18, 2008 12:42 pm Marian wrote:

Hummm..  I actually didn't even asked the question about where they were manufacturered that was put out there by the R&D department after I asked when they were manufactured.. so I guess if you really want to know try again because I found them friendly, informative and down right cooperative.  Didn't even have to use the "it's the law" thingy..

Good Luck!

mbrown4811
Joined: May 2008
Posts: 5
May 18, 2008 04:48 pm mbrown4811 wrote:

Hi, everyone.  Guess what - no rupture!!  What a relief, but hate I had to go through another surgery to find out.  Also, hardly any pain at all, since I am already mostly numb there.  I just have to remember not to use that side much since I can't really feel anything!  As far as finding out when and where my implants were made, I was told my ps would have to call and get the info.  Mine are by Mentor.  I have an appointment on Wednesday and hope to find out that info then.  As far as the burning, I guess it could be nerve endings, nerve regeneration, whatever....  My ps doesn't really know.  Gonna talk more about that at the appt.  I guess now I'll have one burning/ripply foob and one not!!  Just thankful for what I've got.

Thanks for all the well wishes and good thoughts.

Michele

TenderIsOur…
Joined: May 2007
Posts: 2923
May 18, 2008 05:43 pm TenderIsOurMight wrote:


Michele, it's necessary to know one way or the other on a possible rupture. I'm glad you posted, have thought of you over the last few days, and hope your recovery is swift.

I have the burning and some rippling too. Perhaps you have alerted us all to an as yet unknown affect of these new third generation implants, which now as a group we may monitor together with our plastic surgeons and proceed with as need be.

Take care,
Tender


It cannot be emphasized too strongly that treatment of each patient is a highly individualized matter. (FDA-approved labeling for warfarin (Coumadin) NDA 9-218/5-105)

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