Explant Secrets Blog With Cheyenne Burnett/The Explant Secrets Podcast /Decades of Deception: The Shocking Truth Behind How Breast Implants Got Approved By The FDA

K so in the last episode we ended on the fact that a dog walking around with a breast implant prototype for two weeks was all it took for these doctors to say yep, we can put these inside women. It’ll be fine.

But how?


How in the world could the FDA approve a product with such little research and such high risk?

Explant Secret No. 02 - They didn’t.


The truth is the FDA didn’t actually start regulating medical devices until 1976, more than a decade after breast implants were created. Breast implants were simply grandfathered in and never required to do any safety reviews or clinical trials. Dr. Thomas Biggs, a plastic surgeon and colleague of Dr. Gerow is even quoted in Michelle Visage’s Explant Documentary saying “The kinds of studies one should engage oneself in we didn’t do. No body even thought about it.”

Which means breast implant manufacturers and the surgeons who put them in not only never had to prove the product was safe, they never had to care if it was or not because they were allowed to sell it to us either way.

There was however actually a lot of concern within the medical community about the safety of breast implants early on and though their advisory comity did tell them that, the FDA chose to do nothing about it.

And sure enough several years later documented reports of direct harm done to women by breast implants started surfacing and it came to light that these manufacturers had actually been getting negative reports from the beginning.

Then Internal documents from DOW the same silicone manufacturer that Dr.Gerow called about his great idea were leaked and they revealed DOW had actually been consealing just how dangerous silicone really is.

Dr. Diana Zuckerman a former congressional investigator actually end up with these internal documents because of a journalist (Thank god for journalists) and she ended up taking it straight to the FDA Commissioner.

DOW knew the breast implants they were making negatively stimulated the immune system by at least 1975, and thanks to Dr. Zuckerman the FDA subpoenaed the company documents that say that. Those documents also go as far as to call the product they were knowingly selling to us to put in our bodies “profoundly toxic.” That is their words. The internal documents from the people that make them call breast implants on paper, profoundly toxic.

And those same internal documents also contained memos from the sales men saying they were blatantly lying to the doctors about their being clinical trials in the works.

So let's just get really clear about what that means for us for just a sec. The company who makes the breast implants knows they are “profoundly toxic” their words not mine. They know their sales reps are lying to the plastic surgeons telling them clinical trials were under way. Thats all documented.

And THEN, also documented in these internal memos are complaints from the sales reps themselves saying the implants where literally leaving an oily residue when they placed it on the plastic surgeons desk. Gel bleed is a term we are going to talk about in length in a later episode but the short version is the toxic liquid inside implants is able to seep out the silicone shell and it happens from day 1, not over time, not only after a rupture, from day one. And because more than one surgeon questioned those sales guys about the product leaking its documented that DOW executives solution was not to fix the product, oh no they just told the sales guys to wash the implant really well with soap and water before every appointment so the doctors don't see the residue.

Is anyone else’s head spinning at this? Like this can’t be real right? But it is. And its all documents and laid out for us to see if we know where to look. The problem is none of us knew we should be looking.

Now don’t get me wrong, there is, in my opinion, a substantial portion of the blame that should rightfully be directed towards the plastic surgeons, and I'll explain why I think that but for the sake of our current discussion I think it’s really important you understand the foundation this entire empire of horrors is built on which is the sickening fact that breast implants were permitted to enter the market with ZERO safety testing because there was no system in place to prevent it and no one cared to check if they were actually safe first including all the plastic surgeons putting them in, and the manufacturers who called their own product profoundly toxic were happily paying salesmen all over to lie and say these things are safe to put inside women’s bodies.

If that doesn’t make your stomach turn, girl I don't know what would.

Now all of this was happening in the 60’s and 70’s. It wasn’t until 1988 when Syble Goldrich wrote an article detailing her story of four failed sets of breast implants after breast cancer and how sick they made her that the conversation about breast implant safety even really started. That is almost 30 years that these fuckers got to profit off knowingly making us sick with out any repercussions.

So they had a three decade head start and then the war started.

So Sybil the original Breast Implant Illness advocate the angel that she is gets her article published in Ms Magazine in 1988 and that same year she actually formed the first Breast Implant Illness support group called “The Command Trust Network” as a way for women to share their stories. This network is basically what we are now being able to recreate on a much larger scale with all the awesome Breast Implant Illness Facebook groups and other social media platforms. Which is why I could scream every time a hear a plastic surgeon say those groups are not helpful and why you’ll probably hear me mention the Explant Secrets Facebook group more than once during our time together because it’s crucial that we come together on this. We are the only way this stops happening to more women and you need to know what other women are going through right now so that when a doctor tells you your symptoms are “just because your getting older” or “thats what motherhood feels like” you know that it’s not true and you know you’re not the only one who feel like this.

K back to Syble real quick thought. So she gets her article published, she forms “The Command Trust Network” and then two years later in 1990 a reporter by the name of Connie Chung reaches out asking Syble if she would allow her to show a photo of Syble’s chest on TV showing the physical damage four sets of failed implants had caused during the first ever live report on the dangers of breast implants during prime time TV.

Syble said yes, and she does a whole interview and that makes her a hero in my book. But what happens next is exactly why (in my opinion) doctors and surgeons are just as responsible as the manufacturers. So Connie Chungs interview aires and understandably a flood of women start contacting their plastic surgeons, and instead of listening to these women the majority of doctors blew them off completely. So much so that between doctors they were making jokes and saying these women just have “Connie Chung Disease.”

Can you believe that?

Thankfully Syble and other remarkably strong women who’d suffered at the hands of these doctors didn’t stop fighting though.They took their complaints as far up the ladder as they could and spoke about their horrific experiences at hearings held by FDA commissioner David Kesler which ultimately contributed to the FDA banning silicone breast implants in 1992 after it was undeniable that manufacturers had not adequately addressed safety concerns about certain complications.

The complications they listed include:
- Pain
- Deformity
- Serious illness
- Implant rupture
- Silicone leakage
- Chronic inflammatory disease
- Hardening of the surrounding tissues
- Interference with cancer detection

That was in 1992. Ladies, I was born in 1991. At the time of this recording I am 32 years old which means this fight has been happening since way before I was born and I didn’t even get my breast implants put in until 2010 and I didn’t learn they could make us sick until four years ago. I don’t know about you but that screams red flag to me because the amount of effort it takes to silence that many women for that long is astounding especially with the ability we now have to connect through social media.

And when I tell you about the efforts made just to silence me you'll be shocked. And then when I introduce you to my friend and fellow advocate Amanda and you hear her story well, all I’m going to say is you’ll probably be double checking your doors are locked after that one.

But for right now we will wrap up todays history lesson here and f you want to see the original segment Connie Chung did on December 02, 1990 I’ve included a link in the show notes for you.

Until next time, remember knowledge is power and don’t be afraid to stay just a little bit rebellious.

But for right now we will wrap up todays history lesson here and f you want to see the original segment Connie Chung did on December 02, 1990 I’ve included a link in the show notes for you.

Until next time, remember knowledge is power and don’t be afraid to stay just a little bit rebellious.


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Creator Of Explant Secrets

I’m a Wife, Mother, Women’s Health Warrior, Breast Implant Illness Survivor, Author, Speaker, Coach, and the Host of my top-ranked Podcast, Explant Secrets With Cheyenne Burnett. Welcome to my little slice of the internet! Go ahead and kick those awesome shoes off and stay a while!

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