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Anyone had a silicone gummy rupture?

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Old 09-28-2018, 12:10 AM
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Anyone had a silicone gummy rupture?

Just posting out of curiosity. Anyone here have a rupture of highly cohesive silicone gels? What were your symptoms or how did you find out it was ruptured?

I’ve seen a lot of posts about saline’s rupturing and even regular gels, but not really any of the new cohesive ones.
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Old 10-03-2018, 02:35 AM
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Well I guess no replies is a good thing! 😆
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Old 10-03-2018, 07:28 PM
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Originally Posted by Daisee View Post
Well I guess no replies is a good thing! 😆
*crickets*

I would say so too! I'm curious about this also so following. I've known plenty of ladies (mainly due to misinformation) thinking their cohesive gel silicone implants are "gummy bear" implants so when they've had a rupture they say their gummy bear implants ruptured, but come to find out they were not high cohesive gels. I have seen sooo many videos during my research phase on implants being cut, so I know if a tear were to happen on the newer implants, even a cohesive gel implant, I would imagine it would be very hard to detect. They are fairly form stable also. They do tend to stick to the knife or the scissors cutting the implant more than high cohesive gels. Here is a great example of what I mean https://www.youtube.com/watch?v=sQd61Arh4oU
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Old 10-04-2018, 05:36 AM
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Following this thread also, the only person i know of who had a scilicon implant rupture was a friend on another forum site but her implants were 27 years old , one had a small ruppture and the other one was fine just an old implant she said that her ps told her they were old and that the shell integrity was deteriorating and that the shell just looked very worn . She had them replaced and up sized 6 months ago.
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Old 12-20-2018, 09:18 AM
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Hi, read your post, and say I'm having mine out tomorrow! I really cant wait to hear how it looked, cuz it feels terrible!
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Old 12-20-2018, 09:38 AM
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Originally Posted by Alissabt View Post
Hi, read your post, and say I'm having mine out tomorrow! I really cant wait to hear how it looked, cuz it feels terrible!
Best wishes on your surgery tomorrow! I believe you mentioned you are having your 800cc silicone implants removed, an internal bra and saline implants placed o/f to 1200 cc.
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Old 12-20-2018, 12:55 PM
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Originally Posted by Daisee View Post
Just posting out of curiosity. Anyone here have a rupture of highly cohesive silicone gels? What were your symptoms or how did you find out it was ruptured?

I’ve seen a lot of posts about saline’s rupturing and even regular gels, but not really any of the new cohesive ones.
My Mom did. She had a rupture of the Highly Cohesive Silicone Gels in the left breast very early on. It was approximately 6 months post op the symptoms began. It started with pain and itching, then she developed CC (basically her body was overreacting to the loose silicone by producing excess scar tissue) then she found “lumps” which were tender and turned out to be silicone migration.

Her doctor swears up and down that her experience is freakishly rare though.
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Old 01-16-2019, 01:30 AM
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My left one has ruptured. I got an MRI two days ago to confirm and my first appointment with the surgeon to figure out our timeline is in two days. I have the Allergan style 410 highly cohesive, anatomical „real gummy bears“ that were pulled off the market last month. Over the past two days I‘ve done a ton of googling and I‘ve also found so many women sharing their stories about damaged and ruptured Allergan implants and their lawsuits.

I used to be an active member of this forum after my BA in 2009 and have just reactivated my account for my upcoming redo and to find more fellow girls with ruptured/damaged Allergan implants. :-(
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Old 01-16-2019, 12:36 PM
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Originally Posted by nyc2010 View Post
My left one has ruptured. I got an MRI two days ago to confirm and my first appointment with the surgeon to figure out our timeline is in two days. I have the Allergan style 410 highly cohesive, anatomical „real gummy bears“ that were pulled off the market last month. Over the past two days I‘ve done a ton of googling and I‘ve also found so many women sharing their stories about damaged and ruptured Allergan implants and their lawsuits.

I used to be an active member of this forum after my BA in 2009 and have just reactivated my account for my upcoming redo and to find more fellow girls with ruptured/damaged Allergan implants. :-(
I am so sorry to hear that your implant has ruptured. I don't have highly cohesive, form stable ("gummy bear") implants, but did sustain a silent implant rupture to cohesive gel implants. Did you have a routine surveillance MRI of your implants or did you have any symptoms (breast hardening, distortion, tingling, etc) and then have an MRI? It's possible that your implant may still be intact (fingers crossed). MRI for breast implant rupture detection has approximately an 80% rate in detecting rupture. MRI's certainly are not perfect as I found out. My MRI results indicated a false positive reading on the left implant and a false negative for rupture on the right implant. My right implant was found to be ruptured during a revision for CC a few months ago.

The Allergan 410 implants as I understand, have only been voluntarily recalled in Europe but not in the US at this point in time. Have you decided on what your plan for replacement (or not) is? I wish you all the best in your upcoming surgery. Please keep us posted.
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Old 01-16-2019, 10:14 PM
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Hey there,

thanks so much for the kind words. It’s amazing how this support group here (still) works and how big of a help all the girls on this forum are. It‘s such a relief knowing that there are a ton of educated women to discuss everything with.

Unfortunately, those implants haven’t been recalled *voluntarily*. Allergan didn‘t get their CE mark (our certification/quality mark) renewed. Here‘s an article regarding that topic: www.nytimes.com/2018/12/18/health/allergan-breast-implant-cancer.amp.html
Also, ever since I started googling, I‘ve found a ton of women here in Germany with ruptured and badly damaged Allergan implants who hadn’t suffered any kind of trauma prior either. :-( My PS has stopped working with Allergan altogether quite a while ago, as I have learned now.

About a week ago, I noticed that my left breast was pretty swollen and warmer than the other. On top of that I had this stinging sensation. I wasn’t in much pain yet pretty uncomfortable, so I took some painkillers, put some ointment on it to reduce the inflammation and started cooling it. Unfortunately, all that didn’t help much and the swelling went down only a bit. I then went to see my ob-gyn on Monday to do an ultrasound and check if there‘s anything going on in there. Even on the ultrasound you could see that there was a „cloud“ in the implant area that shouldn’t have been there (and hadn’t been there during my last checkup). She suspected the implant to be damaged and sent me to the MRI. And...yup. There‘s something majorly off on my left side, even I can see that on the pics. :-( Hence my appointment with the PS tomorrow.

I‘m not entirely sure on what to do now. Fact is that I‘ll need a redo asap. This time I’m going with Mentor, their reputation here is still better - according to my google researches. :-/ Due to the issues with the textured surfaces, I‘m leaning towards a smoother one - knowing that this would increase the risk of getting CC and rippling. Also, I‘d need to get round implants instead of anatomical ones since those only come with the „rough“ surface. Oh my. So much to consider. I‘m going to discuss all that at my appointment tomorrow and we‘ll see what the surgeon says. :-|
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Old 01-17-2019, 06:07 AM
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Unfortunately I have a feeling that we are not far off from a total recall of all silicone implants again. I also read a article from the FDA that the number of Antiplastic Lymphoma diagnosis from silicone implants has gone sky high and they’re expecting more lawsuits in the future.

https://www.drug-injury.com/drug_injury/2018/05/several-2018-breast-implant-lymphoma-cancer-lawsuits-already-filed.html
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Old 01-17-2019, 09:51 AM
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I just don't understand how a modern silicone implant can rupture so easily. You can jump up and down on the damn things and drive your car over them and they don't pop. It boggles my mind how they can spring a leak after a few months without the surgeon catching it with a scalpel or something. I'd love to see all leaking implants sent back to the manufacturer for analysis.
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Old 01-17-2019, 10:05 AM
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Originally Posted by Lennev View Post
Unfortunately I have a feeling that we are not far off from a total recall of all silicone implants again. I also read a article from the FDA that the number of Antiplastic Lymphoma diagnosis from silicone implants has gone sky high and they’re expecting more lawsuits in the future.

https://www.drug-injury.com/drug_inj...ady-filed.html
I don't see it happening (a recall) anytime soon. Considering the number of women with implants and the number of women affected (both textured, smooth, silicone and saline), it's still extremely rare. This is the link that was in the article link you posted.
https://www.fda.gov/MedicalDevices/P.../ucm481899.htm
As of September 30, 2017, the FDA has received a total of 414 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), including 9 deaths1. BIA-ALCL are counted for those with a confirmed pathology test, or ALK or CD30 biomarkers, or reported by health care professionals. There are 272 reports with data on surface information at the time of reporting. Of these, 242 were on textured implants and 30 on smooth implants. There are 413 reports with data on implant fill type. Of these, 234 reported the use of silicone gel-filled implants, and 179 reported the use of saline-filled implants.
I'm not concerned at all.
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Old 01-17-2019, 10:18 AM
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Originally Posted by Daisee View Post
Just posting out of curiosity. Anyone here have a rupture of highly cohesive silicone gels? What were your symptoms or how did you find out it was ruptured?

I’ve seen a lot of posts about saline’s rupturing and even regular gels, but not really any of the new cohesive ones.
I had an cohesive silicone rupture (Eurosilicone implants from 2009 done in Australia) that wasn't detected by ultrasound although the ultrasound did pick up silicone in my lymph nodes with the largest being 6x2cm. I had a small raised area in my cleavage too where the spilt apparently was. It wasn't until I had a revision in 2011 that it was found. A recent ultrasound also picked up smaller silicone particles as well.
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Old 01-17-2019, 10:21 AM
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Originally Posted by WillowWisp View Post
I just don't understand how a modern silicone implant can rupture so easily. You can jump up and down on the damn things and drive your car over them and they don't pop. It boggles my mind how they can spring a leak after a few months without the surgeon catching it with a scalpel or something. I'd love to see all leaking implants sent back to the manufacturer for analysis.
As far as I have learned, it seems to be a quality issue of the manufacturer. The others with ruptured Allergan implants have reported that their implant shells looked like they had been ripped into pieces. So, basically the outter shell „cracked“ and kind of corroded. Ever since my augmentation, I have never experienced any kind of trauma to my chest, have never had an accident or anything else that could’ve *caused* the shell to break. And as likely as it seems that the implant had been damaged back when they put it in, it‘s hard to believe that all those different surgeons had somehow used unnecessary sharp edged equipment during surgery.This is such a ginormous pain in the ass. :-(
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Old 01-17-2019, 10:37 AM
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Originally Posted by nyc2010 View Post
Hey there,

thanks so much for the kind words. It’s amazing how this support group here (still) works and how big of a help all the girls on this forum are. It‘s such a relief knowing that there are a ton of educated women to discuss everything with.

Unfortunately, those implants haven’t been recalled *voluntarily*. Allergan didn‘t get their CE mark (our certification/quality mark) renewed. Here‘s an article regarding that topic: http://www.nytimes.com/2018/12/18/he...ancer.amp.html
Also, ever since I started googling, I‘ve found a ton of women here in Germany with ruptured and badly damaged Allergan implants who hadn’t suffered any kind of trauma prior either. :-( My PS has stopped working with Allergan altogether quite a while ago, as I have learned now.

About a week ago, I noticed that my left breast was pretty swollen and warmer than the other. On top of that I had this stinging sensation. I wasn’t in much pain yet pretty uncomfortable, so I took some painkillers, put some ointment on it to reduce the inflammation and started cooling it. Unfortunately, all that didn’t help much and the swelling went down only a bit. I then went to see my ob-gyn on Monday to do an ultrasound and check if there‘s anything going on in there. Even on the ultrasound you could see that there was a „cloud“ in the implant area that shouldn’t have been there (and hadn’t been there during my last checkup). She suspected the implant to be damaged and sent me to the MRI. And...yup. There‘s something majorly off on my left side, even I can see that on the pics. :-( Hence my appointment with the PS tomorrow.

I‘m not entirely sure on what to do now. Fact is that I‘ll need a redo asap. This time I’m going with Mentor, their reputation here is still better - according to my google researches. :-/ Due to the issues with the textured surfaces, I‘m leaning towards a smoother one - knowing that this would increase the risk of getting CC and rippling. Also, I‘d need to get round implants instead of anatomical ones since those only come with the „rough“ surface. Oh my. So much to consider. I‘m going to discuss all that at my appointment tomorrow and we‘ll see what the surgeon says. :-|
(((NYC))), there certainly is much that needs to be considered in your situation and only who knows how many other women with silicone gel implants worldwide. May I ask how long you have had your Allergan 410's? I also want to thank you very much for clarifying that Allergan's recall for the textured, anatomical 410's in Europe was not "voluntary" (amazing how the company's "spin doctors" were quick to announce that this was voluntary).

I also want to thank you for coming back to JBI to share your experience. Women need to know from other womens' experience here and abroad what the issues are concerning the issues that Allergan is facing in Europe - the company's inability to maintain their certification due to issues of safety. Women in the US will need to remain vigilant concerning the upcoming 2019 silicone gel breast implant public hearings which takes us right back to the 1990's breast implant debacle, which was very frightening time for those of us who had silicone gel implants. I had the 1989 "Meme" polyurethane implants which were taken off the market due to safety issues concerning the carcinogenic properties caused by the degradation of the polyurethane coating. It seems we are coming full circle...again.

Have you considered the Motiva anatomical or round "nano-textured" breast implant that is approved in Europe? I have absolutely no idea whether the incidence of BIA-ALCL is lower in this implant with their "novel texturizing", however, Motiva may be something worth investigating.

As far as rupture is concerned, they all have the potential to rupture at any time. The estimate is that 50% of all implants will rupture by year 10. I have no idea how long my Mentor cohesive gel implant was ruptured, but I did find out that I have silicone lymphadenopathy to multiple lymph nodes in both axilla. Had I known this before going into my revision a little over 4 months ago, I honestly don't think I would have chosen silicone for my replacement. Too late now, I replaced them with Allergan "Inspira". I am considering replacing them with saline - perhaps the IDEAL structured saline implant.

Please continue to keep us posted.
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Old 01-17-2019, 11:05 AM
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Originally Posted by Lennev View Post
Unfortunately I have a feeling that we are not far off from a total recall of all silicone implants again. I also read a article from the FDA that the number of Antiplastic Lymphoma diagnosis from silicone implants has gone sky high and they’re expecting more lawsuits in the future.

https://www.drug-injury.com/drug_inj...ady-filed.html
Breast implants are an extremely lucrative business and have an extremely powerful lobby behind them. The industry is stronger than ever before and women want silicone implants. I do not believe that we will see a moratorium on silicone gel implants - even textured devices. Three of the voting panelists on breast implant devices have financial ties to the industry.

With marketplace demand and a supremely strong lobby, IMO silicone gel implants are not going anywhere. Having said this, the FDA does need to step up their game and insure that they implement a national breast implant registry as well as making sure that those responsible for ensuring safety have NO ties to industry. My PS never reported my ruptures, why should he? It happens so frequently and is part of the bread and butter of any PS's practice. I personally reported my last Mentor rupture to the FDA MedWatch Voluntary Reporting.
All women should report a device failure or suspected illness from breast implants. This is only one of many methods in order to obtain sufficient data in order to statistically determine ALL risk ratios, including rupture for any given manufacturer and device.
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Old 01-17-2019, 11:23 AM
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Originally Posted by WillowWisp View Post
I just don't understand how a modern silicone implant can rupture so easily. You can jump up and down on the damn things and drive your car over them and they don't pop. It boggles my mind how they can spring a leak after a few months without the surgeon catching it with a scalpel or something. I'd love to see all leaking implants sent back to the manufacturer for analysis.
They are medical devices and all medical devices are subject to failure. Jumping up and down on an implant or running over one with a car do not provide long term, scientific evidence of how implant ruptures occur when "in vivo" (implanted in the body). However, seeing a plastic surgeon on YouTube running over an implant in his/her car makes an implant look like it cannot rupture. This is a marketing ploy.

Implant ruptures are expected because they are not considered "lifetime devices". The FDA and breast implant manufacturers make this fact very clear in the mandated patient information that is given to each patient prior to surgery. The question that each of us
needs to ask is, "when will my implant rupture"?"Breast implants are not lifetime devices".
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Old 01-17-2019, 12:10 PM
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Well... yeah. I understand the engineering and the chemistry, but for so many reports of fast failure it's shocking that it could be a manufacturing issue that isn't caught.

If there's a type of immune response that can eat through a silicone shell in that short a time, that could use some studying too.

I'm just kinda curious as to who's looking at this, or more importantly who isn't.

Originally Posted by ANewPair View Post
They are medical devices and all medical devices are subject to failure. Jumping up and down on an implant or running over one with a car do not provide long term, scientific evidence of how implant ruptures occur when "in vivo" (implanted in the body). However, seeing a plastic surgeon on YouTube running over an implant in his/her car makes an implant look like it cannot rupture. This is a marketing ploy.

Implant ruptures are expected because they are not considered "lifetime devices". The FDA and breast implant manufacturers make this fact very clear in the mandated patient information that is given to each patient prior to surgery. The question that each of us
needs to ask is, "when will my implant rupture"?"Breast implants are not lifetime devices".
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Old 01-17-2019, 01:21 PM
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Originally Posted by WillowWisp View Post
Well... yeah. I understand the engineering and the chemistry, but for so many reports of fast failure it's shocking that it could be a manufacturing issue that isn't caught.

If there's a type of immune response that can eat through a silicone shell in that short a time, that could use some studying too.

I'm just kinda curious as to who's looking at this, or more importantly who isn't.
We would need to define what constitutes a "short time" until rupture. Would that be anything less than 1 year, 5 years or 10 years? Let's say for the purposes of this discussion that early rupture is anything within 12 months from implantation. I have heard of very few anecdotal reports of early rupture. However, it is possible that the numbers of early rupture are higher than we know due to silent rupture. I don't know of any studies that break down the incidence of rupture by months or years, only the cumulative rupture rates provided by implant manufacturers which is then extrapolated over time.

One of the many problems with this data is that the implant rupture would need to be consistently reported and the fact that the FDA has allowed device manufacturers to report multiple incidences of a complication as 1 event. The recent (2018) first long term postapproval US FDA study of 100,000 women with breast implants done by MD Anderson Cancer Center researchers (Coroneos, et al) gives relative rupture rates but acknowledges that not all data for any given complication was obtained from the manufacturer.

Here is the data regarding local complications and rates of reoperation by analyzing the US FDA's data from 100,000 women (well actually 99,999):

Edit to add: I was an original study participant for Mentor's Memory Gel. I signed a 60 page consent form and was told that I would be followed for 10 years. I was never once contacted for follow up during those 10 years. What kind of study is that?
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