For decades women getting breast implants have done so without being properly informed of the dangers. In fact, the dangers were downplayed or denied. Nearly every woman I know that has become sick from their implants, experienced device failure, or been permanently harmed said they had NO IDEA the harm they experienced was possible. Most express that if they’d known the truth they would never have gotten implants.

‘Nearly’ is a very generous word choice. Out of the tens of thousands of women I’ve met online over the past roughly nine years I can count on one hand, and still have fingers left over, those who say they felt they had been adequately informed of the dangers of breast implants.

Even today .. in 2020 .. many women are still not being properly informed by plastic surgeons. This must change.

If you’re considering getting breast implants please read this Informed Consent document. Bring it to your plastic surgeon. No one should ever get breast implants without being FULLY INFORMED.

Hopefully the information in the informed consent document will prevent most from getting implants once they understand what they’d be getting themselves into. For those who’ve read this document and follow through with getting breast implants at least they will have done so with their eyes wide open.

Knowledge is POWER. 

Would you get breast implants if you knew this could happen to you? It’s just one of the many ways breast implants can ruin your health and potentially leave you permanently harmed.

IF YOU’RE CONSIDERING GETTING BREAST IMPLANTS .. PLEASE DOWNLOAD, READ AND SIGN THIS INFORMED CONSENT DOCUMENT. PLEASE DO REVIEW IT WITH YOUR PLASTIC SURGEON.

PDF VERSION Informed Consent_Incl Black Box_and_Ingredient List_May2020

FEEL FREE TO SHARE THIS INFORMED CONSENT PDF!

SO YOU’VE BEEN PERMANENTLY HARMED BY BREAST IMPLANTS. NOW WHAT?

Technically, as things currently stand (and have stood for six decades) .. nothing. Nada. You’re S.O.L. (sh*t out of luck). Swept under the rug. Hung out to dry. Left to deal with the aftermath to your health on your own.

How is it that the breast implant industry has gotten away with not being held accountable for the millions of women they’ve harmed and/or killed? Without tracking us. Without following us in studies. Without admission. Without a commitment to cease harming more women. How have they gotten away with sweeping us under the rug for six decades? Why are they still getting away with it, unchallenged? How is it they are still able to claim that, after six decades, the long term impact of migrated silicone on health remains unknown?

Why has no one paid notice or cared? Where is the media? Where are the women’s health organizations? Where is the World Health Organization? Where is Health Canada / FDA / MHRA and other global regulatory bodies? Where are the politicians?

Why has there been no investigation into regulatory bodies and those in effect ‘paid to look away’? PEOPLE SHOULD BE IN JAIL.

Through the focus Breast Implant Associated – Analplastic Large Cell Lymphoma (BIA-ALCL) has received in the past few years and the sustained pressure from BII and BIA-ALCL advocates on regulatory bodies its led to a slow drip of recent articles and admissions suggesting there is an inflammatory response and that silicone isn’t as insert as once believed. And that the numbers of women impacted are staggering. None of it is ‘new’ information .. it merely reflects back to things known for decades .. to things buried and denied by the industry.

HOW HAS THE INDUSTRY BEEN ABLE TO GET AWAY WITH BURYING AND DENYING THE HARMS CAUSED BY BREAST IMPLANTS? How has the industry not been forced to follow the women they’ve harmed in order to continue receiving regulatory approval for their devices? HOW HAVE THEY BEEN ABLE TO BURY AND DENY REAL WORLD EVIDENCE?

Studies were created, but none that specifically followed women harmed. Once harmed, women were dropped from studies.

Why was mandatory reporting of harms not required until recently (Canada) and why is the scope of mandatory reporting so limited? It seems a deliberate design to fail. A way of avoiding disclosure of truth. An attempt to feign a desire and strategy to track breast implant failures and harm while having been designed to fail. (Just like every other industry study created to feign jumping through regulatory ‘hoops’ but, also designed to fail.)

In six decades there’s been no one within the breast implants industry or regulatory bodies capable of creating a successful study? No one who could figure out how to ascertain critical safety data? We can put someone on the moon, but no one can figure out how to create and execute a meaningful study? The mind boggles.

As an advocate and someone who’s been harmed by breast implants my key areas of focus moving forward are:

1. Creating studies that include life-long follow-up of women harmed, designed to both provide critical safety data and succeed in this intended goal.
2. What exactly does mandatory reporting look like / include and what so far has been the result? What data has been / will be collected and reported? And what’s being done with the data?
3. Industry accountability

If you’ve been permanently harmed by breast implants I would love to include your story as I push for studies to follow women harmed by breast implants. You can email me: breastimplantfailure at gmail dot com

I’ve done previous posts on this topic, but it can be hard for visitors to my blog to find older ‘archived’ blog posts. This cautionary ‘buyer beware’ / ‘be an informed consumer’ topic is worth repeating.

When I made an appointment with a plastic surgeon to get breast implants, in some regards, I was pretty asleep at the wheel of life. I defaulted to blind ‘white coat’ trust. I unquestioningly believed the sales pitch the plastic surgeon gave me that though ‘older’ implants had problems, the ‘new ones’ were safe and would last my lifetime. 

It would take twenty-three years (of which I spent 16 years in a declining health spiral that would take me to death’s doorstep) to realize I’d been duped, and that I’d been a naive consumer. When I discovered my implants were not only ruptured, but had leaked silicone irretrievably within me, for a brief time I felt like a fool. I was a complete health and fitness freak, but it was completely lost on me that I had toxic sacs of chemicals within me. I was completely unaware of the potential of silicone migration or the havoc it could wreak on my health.

To be sure, I’m not a fool and neither is any woman that has found themselves in a similar situation, harmed by implants.

********************************************************************

SALES PITCH:
WHAT I THOUGHT I WAS BUYING .. 

Actual catalogue sales pitch for the ‘Dow Corning Silastic II’ implants I had:

The SILASTIC II Mammary Implant. High Performance, in a direct comparison with current competitive ‘low bleed’ products. Superior Low Bleed characteristics and Greatly Enhanced Physical Properties.

Independent testing to be the Superior Implant in the marketplace today! SILASTIC II Mammary Implant, High Performance, represents years of research by Dow Corning, the recognized leader in silicone technology, to produce a ‘State of the Art’ mammary implant. The SILASTIC II Mammary Implant, High Performance, is the best product to meet today’s needs!

* Superior Low Bleed Characteristics

* Greatly Enhanced Physical Properties

* Available only from Dow Corning Wright

• High Performance Medical Grade Silicone Elastomer is available only from Dow Corning Wright.

********************************************************************

WHAT I ACTUALLY WASTED MY MONEY ON:

In 1990 I paid $5,000 (plus, taxes and travel expenses) believing I was purchasing ‘safe’ breast implants that would last my lifetime .. 

THIS is what I actually got:

I spent $5,000+ on breast implants that would be RECALLED within a year of getting them. Of course, I wasn’t notified.

Within 5-6 years my ‘lifetime’ breast implants catastrophically failed.

I spent 16 years sick and trying to find out what was going on.
**It should be noted that ‘experienced’ doctors and specialists didn’t figure out what was making me sick. It was a young ‘resident’ that saved my life. **

The shiny new implants women are shown when they’re being pitched the ‘breast implants are safe’ spiel don’t look like that long once they’re placed within a human body. They only look ‘shiny and new’ sitting on a shelf or packaged nicely in a box, or in a slick media campaign photograph.

Most women will remain unaware for years, or even decades, that they were sold a product under false pretence, without having been fully informed about potential complications; and without awareness of what the implants are doing within them.

I think many of us, upon learning our breast implants failed AND/OR caused ‘Breast Implant Illness’ experience a brief period of feeling troubled that we allowed ourselves to be conned. But, truly even women who did exhaustive research into breast implants prior to finally deciding to get them ended up just as duped because of the fact that the truth of implants has been hidden. The dangers and incidence of harms and failures, concealed. It’s only been through women harmed that the truth is finally being exposed.

If you’re considering getting breast implants LET US BE YOUR CAUTIONARY TALE. So much information is available online now, and in Facebook breast implant illness support forums.

Please don’t fall for a slick sales pitch. There’s a lot of them, such as the ‘gummy bears don’t usually rupture, but if they do its not a problem’ lie .. the ‘saline is safer’ crock .. the ‘smooth implants are safe because they don’t cause cancer’ deceit .. the ‘breast implants are the most studied medical devices in the history of implantable devices’ misinformation ..

I could go on and on listing misleading ‘sales pitches’.

Don’t fall for ‘the new ones are safe’ sales pitch. The new ones are NOT safer. THERE IS NO SUCH THING AS A ‘SAFE’ BREAST IMPLANT. They ALL FAIL. They ALL have potential serious complications.

PLEASE KNOW that in 2020 all silicone breast implants are non-compliant devices based on the 2006 conditional FDA re-approval. And that there is NO LONG TERM SAFETY DATA on breast implants. EVERY SINGLE WOMAN GETTING IMPLANTS IS A HUMAN GUINEA PIG. 

PLEASE BE A WISE and INFORMED CONSUMER. 

 

You can’t have a trial without witnesses and without evidence .. at least you can’t have a fair and honest trial that legitimately seeks truth without witnesses and evidence.

 

YOU CAN’T HAVE A STUDY THAT LOOKS AT LONG TERM SAFETY (THAT WILL RESULT IN TRUTH) IF IT EXCLUDES THOSE HARMED. And yet, for decades that’s exactly what the breast implant industry has been getting away with.

Thanks largely in part to the ICIJ investigation into implantable medical devices and the sustained efforts of Patient Advocates globally, breast implant safety is on trial once again.

In 2019, HEALTH CANADA reopened its review of breast implant safety. FDA has acknowledged that silicone is not as ‘inert’ (and breast implants aren’t as ‘safe’) as they’d once thought. Regulatory bodies globally have acknowledged what has come to be known as ‘BII’ (Breast Implant Illness). 

The BREAST IMPLANT INDUSTRY has failed to adequately prove safety through previous studies which were flawed and driven through industry bias. The industry funded studies were, in fact, designed to fail. The industry has known, and hidden, truths that could have prevented millions of women being harmed. Instead of protecting innocent women from harm, their greed (and corruption) resulted in women not only being implanted with devices touted as ‘safe’ that had no long term safety data, but with implanted women subsequently being told the illnesses they were experiencing weren’t related to their implants.

It’s easy to keep claiming that ‘the long term impact of migrated silicone is unknown’ when the industry has deliberately avoided studying women with migrated silicone. Given the serious harms, some of which include: systemic illness; acute inflammation; silicone migration (to lymph nodes, tissues near and distant, limbs, vital organs including the brain and lungs); cancers; chronic acute pain; respiratory tract impairment; silicone granulomas; silicone filled lesions and masses; and being *permanently and irreversibly harmed* continued failure to study women harmed should lead to criminal investigation. People in the industry and regulatory bodies should probably be in jail, IMHO.

Without the evidence and testimony of women already harmed by breast implants it is IMPOSSIBLE to reach a truthful conclusion on breast implant safety. 

Women harmed weren’t included long term in the safety reviews of the past decades, in fact they were dropped from studies once they reported either illness or device failure. There is NOT, nor HAS THERE EVER BEEN long-term safety data on breast implants. 

We must demand the inclusion of ‘women harmed’ in long term studies currently being created and/or that will be created in coming years. We must demand the creation of independent studies outside the reach of the ‘industry’. WE MUST DEMAND THE CREATION OF STUDIES THAT BOTH SEEK TRUTH AND ARE DESIGNED TO ESTABLISH TRUTH.

Without the evidence women already harmed can provide it will needlessly and recklessly put further generations of women in harms way. Women already harmed represent 40+ years of critical data.  

WE ARE THE STUDY RESULTS  

I hope others will join me in DEMANDING THE CREATION OF STUDIES and JUSTICE FOR WOMEN IMPACTED ADVERSELY THROUGH BREAST IMPLANTS. To be clear, I don’t mean ‘justice’ in a litigious sense – I mean justice through at least making the harms we’ve suffered count for something. Justice through preventing needless harm to more generations of women by creating studies that will provide critical missing safety data.

LET’S MAKE SOME NOISE .. LET’S DEMAND ACTION

 

 

🎉CELEBRATING MY 6th EXPLANT ANNIVERSARY (aka Explantaversary) !!! HAPPY EXPLANTAVERSARY TO ME!!!! WAHOO!!!! 🥳🤩🙌👏🙏

I woke up from my explant surgery, October 29, 2013, feeling such a sense of relief that my implants were actually out! Words fail to relate the degree that I felt it. The next thought, milliseconds after, was realizing that I could take a full breath for the first time in years. You don’t realize how heavy implants are until they’re removed. Or, how much they impacted breathing.

Even though I’m in the ‘permanently harmed club’ I felt a sense of celebration upon waking from explant that I’ve continued to feel every single day since then. I didn’t want to die with those freaking things still in me.

Six years after explant I’m no longer impacted by the post traumatic stress I experienced through being treated so horribly by doctors who had as little clue about my implants as I did. I don’t blame them for not knowing what to do, and for not realizing the terrible things going on within my chest wall and systemically from my badly ruptured implants. Working together to make things better moving forward is all I care about. Making things better for those who’ve come after me .. in my community … throughout Canada … and internationally.

This day has become more important to me than my birthday. 🎂

There are so many amazing things about no longer having breast implants. One of the absolute BEST is being able to feel real heart to heart hugs again ..  #priceless. 🤗

My heart goes out to all of the women who’ve realized their implants have failed, or feel they’ve got ticking time bombs within them and desperately want their implants removed, but can’t afford it. Or are having trouble finding a surgeon to properly remove their implants. I experienced that desperate ‘caught between a rock and a hard place’ feeling and it was terrible. May you be explanted soon. I will celebrate with you when your day comes! 

To anyone considering getting implants please know that NOBODY gets out of having implants unscathed. It’s a matter of degree, what & when. At very least there will be permanent destruction within the breasts and chest wall, and at worst they can ruin your health, potentially irreversibly. May you love yourself enough not to get them. For so many of us, we got that lesson the hard way. May you learn from those of us harmed without having to go down that path personally. 

This is a long-winded ‘Two thumbs up’ recommendation of  Gail Hamilton’s book, ‘Breast Implants and the D.I.R.T. Committee’. If you don’t want to read my entire comment you can stop here with me saying I can’t recommend Gail’s book highly enough. 🤗👏 
https://breastimplantsandthedirtcommittee.wordpress.com

The longer version .. 

When I found out my Dow Corning silicone gel implants had failed doctors insisted mine were the ‘old ones’ and the ‘new ones’ didn’t have the issues mine did.

The fact is, that for every generation that came before my implants, as each one failed, women were told the exact same thing.

Actual catalogue sales pitch for the implants I had:

The SILASTIC II Mammary Implant. High Performance, in a direct comparison with current competitive ‘low bleed’ products. Superior Low Bleed characteristics and Greatly Enhanced Physical Properties.

Independent testing to be the Superior Implant in the marketplace today! SILASTIC II Mammary Implant, High Performance, represents years of research by Dow Corning, the recognized leader in silicone technology, to produce a ‘State of the Art’ mammary implant. The SILASTIC II Mammary Implant, High Performance, is the best product to meet today’s needs!

* Superior Low Bleed Characteristics

* Greatly Enhanced Physical Properties

* Available only from Dow Corning Wright

* High Performance Medical Grade Silicone Elastomer is available only from Dow Corning Wright.

____________________________________________________________________________________________________________________________________________________________

THE REALITY:

SILASTIC II implants became the object of an international recall on September 13, 1991. In a class action lawsuit it was revealed that Dow Corning had falsified key fabrication data concerning these implants.

____________________________________________________________________________________________________________________________________________________________

Fast forward to when doctors were dismissing my implants as the ‘old ones’ .. the ‘new ones’ were already failing just as catastrophically.

The ‘new’ allegedly ‘safe’ implants are actually based on the same 60-70 year old technology as the ‘old’ implants, but some features and the sales pitches have been tweaked. The new tweaks often made the ‘new’ devices even more dangerous than their predecessors. Case in point, BIA-ALCL.

Already, since textured implants have been implicated with BIA-ALCL and Allergan Biocell textured implants have been recalled, new generations of implants with tweaks and new sales pitches are being approved by FDA and implanted in human guinea pigs.

If you’ll pardon my expression, it’s the ‘same shite, different pile’. Same continued experiment since the 60’s, same greed/profit driven ambitions driving the industry. Same ‘hands in pockets’ practices with surgeons, researchers and regulators.

In the Dow days, with the class action lawsuit that resulted in Dow Corning claiming bankruptcy, the women harmed by their implants were largely failed in the Dow settlement (there were other manufacturers involved as well). You can be sure lawyers were paid in spades.

Leaping forward to the present time, there are new lawsuits for other implants. It would be a mistake for contemporary claimants not to learn from the failures and oversights of the Dow class action.

Where I’m going with this ..

Gail Hamilton wrote ‘Breast Implants and the D.I.R.T. Committee’ offering insight into the deep corruption that was the breast implant industry, a parallel that continues to present day. Gail’s book is a ‘must have’ for every library, IMHO. Every time I read her book I marvel at how Gail was able to so brilliantly tie together details of industry corruption, cover-up, and her own personal experience with having Dow Corning silicone breast implants that left her desperately ill. The pages of my personal copy of the book are heavily ‘highlighted’ with different colours, flagging sentences or paragraphs that I want to be able to find easily again. Page after page. Jaw-dropping, staggering. I was angry. I was sad. I was enlightened. I am in awe of Gail’s ability to be researcher, truth teller and story teller (her own story). I highly recommend this book!

Though Breast Implants and the D.I.R.T. Committee is from the 90’s it’s still so relevant today. It’s hard to truly understand the current landscape of the industry without the benefit of this book.

BREAST IMPLANTS don’t look like THIS long once placed within us

You put high risk devices in us despite NO LONG TERM SAFETY DATA ... told us they couldn’t make us sick .. THEY DID .. 

THEY FAILED leaving many of us PERMANENTLY HARMED

After 60 years you STILL say the LONG TERM AFFECT OF MIGRATED SILICONE IS UNKNOWN … 

WE ARE THE LONG TERM DATA. WE CAN PROVIDE EVIDENCE OF THE LONG TERM AFFECTS OF MIGRATED SILICONE. 

You deceived us whether wittingly or unwittingly.  You failed us. You harmed us … 

you referred us to psychiatrists .. 

the LEAST YOU CAN DO is FOLLOW US to prevent unnecessary harm to more generations of women! You have an ethical obligation to do so.

WE ARE THE STUDY RESULTS 

We represent 40+ years of data .. 

** DON’T PUT MORE GENERATIONS OF WOMEN AT RISK **

It’s regrettable you’ve allowed this to happen, but it would be unforgivable to needlessly & knowingly put more generations of women at risk. 

It will take another 20-40 years to collect the data we can provide NOW!

We have silicone in our lymph nodes, lungs, liver, brain, and other vital organs; breasts; muscles; near & distant places. We have silicone granulomas, lesions & masses. We have implant related cancers.

DON’T BURY THE TRUTH OF SILICONE WITH US
WE deserve to at least provide scientific data that will benefit others. Its the ONLY way to redeem the senseless harm caused to us. OUR suffering cannot count for NOTHING.

The way forward is working together for TRUTH.

To be clear .. this isn’t about blame. It’s about taking responsibility and doing it better as we move forward. It’s about preventing further harm to unwitting women. There can be no path forward in truth if harmed women aren’t included in the conversation and studied. 

I’ve heard the excuse that the industry doesn’t like retrospective studies. This isn’t looking back, its looking foward. WHAT’s happening to us NOW and WHAT will happen to us in coming years.

We should be studied for the rest of our lives, and an autopsy done post mortem, with the intention of seeing the impact of migrated silicone within us. Will we be dead in 5 years? Will we live till we’re 90? Will our immune system eventually make peace with the silicone within us? Will we always be in pain? Will we get cancers? It’s no longer acceptable to say the long term impact of migrated silicone is unknown. It’s been 60 years. It’s about time that uncertainty is eliminated. It’s unthinkable to subject generations more women to this experiment while having swept their predecessors under the rug. 

Studying women with migrated silicone isn’t subject to speculation, nor is it subjective. It’s straight-forward and can easily prove scientifically the truth of migrated silicone. (Ultrasound, MRI, PET Scan, CAT Scan, Autopsy). 

WE ARE CALLING FOR INDUSTRY AND INDEPENDENT RESEARCHERS TO IMMEDIATELY ESTABLISH STUDIES WHICH INCLUDE WOMEN ALREADY HARMED – ESPECIALLY THOSE WITH BIA-ALCL AND MIGRATED SILICONE.

BIA-ALCL / BII / Migrated Silicone #StudyUS

 

You don’t get to do THIS to us then ignore and abandon us .. you don’t get to ignore THIS to the peril of more generations of women.

Michelle Miller is raising awareness about Breast Implant Associated – Squamous Cell Carcinoma (BIA-SCC), a rare ‘manmade cancer’ she has personally been diagnosed with.

Her personal message:
“If you would have asked me a year ago what month was breast cancer awareness month I wouldn’t have known. Now, I will forever know that it is in October. Breast cancer awareness month will live in my Octobers.
As I have made it publicly known I have cancer. I don’t actually have breast cancer but a very rare, and by rare I mean I am the 6th documented case worldwide, cancer that is / was in both breasts. Officially I have breast implant associated squamous cell carcinoma. (BIA SCC).
I have a cancer that has been caused by the recurring irritant known as my breast implants. Squamous cell cancer is not a genetic cancer. It is not a natural cancer. And by that I mean the genetic mutant kind of cancer, as most commonly known cancers are. It was caused by a foreign object.
My cancer is aggressive and basically it will kill me quickly or not at all. There is no known treatment for certain. There are no guarantees. So in hopes of surviving, I agreed to aggressive chemo and radiation in addition to bilateral mastectomy.
My goal, aside from surviving is to help raise awareness for breast implant education. Breast implants. KILL . PERIOD.
It might be slowly, so slow that you think that you are safe from harm. I had mine since 1995 with revisions and replacements due to pain and inflammation.
Please consider me before getting implants. Please consider EXPLANTING those toxic bags of shit from your body.
This is part of the NEW breast cancer awareness. Part of the cure for cancer is knowing the cause. Implants cause cancer.“

BIA-SCC was first diagnosed in the early 1990s.

We can only imagine how many others have had this cancer but, weren’t diagnosed. It wasn’t that long ago that the stats were this low for BIA-ALCL (Breast Implant Associated – Anaplastic Large Cell Lymphoma). Since they’ve started testing for BIA-ALCL there has been a sharp increase in diagnosed cases, including deaths. I’m sure we’ll see the incidence rate for BIA-SCC rise in coming years also. At least if they start testing more for it.

If you have breast implants and develop unusual symptoms, including sudden swelling, pain, itching, seroma (fluid), redness, hardness, lumps/masses you should seek medical attention. Symptoms of BIA-SCC can be similar to symptoms of BIA-ALCL.

Pain and swelling led to Michelle having a diagnostic ultrasound, which revealed she had a 6cm tumour in one breast, and 1cm in the other. A biopsy confirmed cancer.

It should be noted that although BIA-ALCL is associated with textured breast implants, Michelle had only smooth implants – Mentor smooth saline.

Though historically women have been implanted and left for years, or even decades, without follow-up we now know that annual follow-up with a plastic surgeon is imperative, no matter what surface implants one has.

I extend my well wishes and deep gratitude to Michelle. My personal message to her: “Michelle, thank you for your courage sharing your story even as you’re living through all that goes with having been diagnosed with BIA-SCC. You are a hero and champion. I wish you the very best and hold you in my thoughts and prayers.”

 

 

TODAY, SEPTEMBER 25, is an annual day of remembrance for women who have died after having breast implants.

THIS ANNUAL MEMORIAL HONOURS WOMEN GLOBALLY who’ve lost their lives because of Breast Implants and injectable materials; long time advocates; and women whose implants may or may not have definitively factored into their death. Just being a silicone sister is enough. If they were part of our community we want to acknowledge them. This year, 2018, marks its second observation. September 25th, the date chosen is the actual death date of BETTYE CAROLINE YALLER, but it’s representative of ALL of our fallen sisters.

‘REMEMBERING FALLEN ANGELS OF BREAST IMPLANT ILLNESS‘ was created for the sake of those within the BII community, though hopefully it will raise awareness outside of our community as well.

The women represented in this memorial event are but the ‘tip of the iceberg’