November 10, 2021 • 56 mins
Women and their supporters have been fighting to have Breast Implant Illness recognized for over 40 years! What is the history between the FDA and the Breast Implant Manufacturers? How can you report adverse events to the FDA going forward?
Special Guests: Sybil Goldrich and Maria Gmitro (IG: @trackmymaria). Follow us on Instagram: Kristin - @kristin_e_nobles Christine - @CTorres1017 For more information: www.sicktitties.com
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:00):
Close to the Chest with Kristin and Christine is brought
to you by I Heart Radio. My name is Kristin
Nobles and today is November six. This week's episode is
about the f d A, all of the lawsuits and
advocacy that's currently happening, and really something that's near and
dear to my heart. When I first found out that
my breast implants were the cause of over twenty years
(00:23):
of illness, I was angry, confused, and I felt very helpless.
I wanted to understand how this issue even came to be.
How was it that implants for on the market and
everybody was telling us they were safe. How was it
that doctors weren't recognizing b I I as an actual disease?
And how are women like me being sent home and
(00:43):
told that this was all on our heads and shamed
for not feeling well? And then I started to understand
what was happening. I started to really look through the
other advocates in the community, at the parties that are
necessary to educate and empower because if they know more,
they can do more. And through understanding the role the
f d A has how to work with them to
(01:05):
report adverse events and how to file complaints against doctors
who were actually gaslighting us and not treating us. Empowered
me and so many people in the community to start
to fight back, to provide the data so people recognized
us and hurt us. And lastly getting an attorney to
represent us and really explore how to hold the manufacturers
(01:27):
accountable was the most empowering moment of my life. So
to all the women in the community out there, the
key to our success is attacking the problem, not the people,
and knowing that through lobbing for full disclosure, through telling
the FDA that these implants are hurting us, and through
getting the word out to the doctors, they will know
better and do better. But most importantly, knowing that together
(01:48):
we're not alone and we never give up the sin
and then question up walking into the room heads turning out. Christine,
(02:08):
there's a long history of women fighting to raise awareness
about implant issues and lobbying for breast implant safety and
women's health. Today, we're talking to some brave advocates who
spent over forty years fighting to raise awareness about the
risks associated with breast implants. These advocates have been fighting
to get full disclosure peer reviewed studies and breast implant
(02:29):
illness recognized as a disease. Can you believe the first
breast reconstruction on a woman's chest was done back in
eighteen I'm not sure what was in them, because the
first silicon breast implants weren't invented until the nineteen sixties,
but since then millions of women have had implants. The
first successful class action lawsuit against them was one in
(02:52):
the late nineteen nineties, but that hasn't stopped the manufacturers
from profiting. Right. I remember that case, and I was
true in one of those women who assumed that if
these were back on the market, that they had to
be safe. When I learned that they were not revolutionized
and now being recalled, I was petrified. I was mad
and determined like those women. I'm a fighter and this
(03:13):
is now our fight. I spent the last three years
begging insurance companies and doctors to help me, researching manufacturers,
and waiting for the FDA to do something, and like
other advocates, all well bone deep in the effort of
trying to get my health back. This is no joke.
I am literally breaking my back doing this. But together
I know we are changing the world, you still have
(03:35):
another six to eight weeks until those vertebrae. Hell huh, Well,
I get to meet many of these women, and I
see you are in great company. Her first guest today
is Maria Gmtro, and she is a survivor and a
leader on the front lines and has dedicated her life
to this absolutely. Maria is a friend, a former teacher,
(03:55):
and someone I learned from Daly. Her organization is Lobbying
for Change. She is also part of a company that
I love, track My Solutions. They're helping to ensure medical
device safety and she's been key in teaching doctors, manufacturers,
and regulators how to treat us. I look forward to
hearing how she's been able to be the change we
need to see, all while surviving herself. So today welcome
(04:29):
everyone Too Close to the Chest with Christine and Kristen.
I am so excited to invite Maria Metro and I
wanted to recognize her today because she is not only
a medical device safety advocate and a survivor who's been
through breast implant illness. She's also the president and co
founder of Breast Implant Safety Alliance and director of Community
Outreach and Patient advocacy for track my Solutions. So Maria,
(04:52):
thank you first and foremost for joining us. I know
you're very busy doing a lot of work, and I
wanted to start today by asking how you got involved
in it. I can see if you don't mind. Yes.
In two thousand fourteen, I decided to think about getting
breast implants to correct some asymmetry. The plastic surgeon recommended
breast implants, and you know, my husband and I did
(05:13):
our research, or so we thought. He said that, you know,
all those issues from the nineties, they fixed all that
and these were the latest and greatest FDA approved, So,
you know, thinking that they put these into breast cancer survivors,
I thought this was, you know, a safe device. Had
them placed into my body, but they looked great. But
then in you know, the months that followed, I started
(05:34):
to have you know, symptoms, you know, mystery illness. It
just continued on, continued on. My health started to decline,
and at no point was it ever mentioned to me
that it could possibly be my breast implants. Fast forward
a few years and I was a teacher at the time.
I was seeing so many medical professionals and trying so
many new protocols to deal with these new, really developed
(05:57):
autoimmune issues, and I wasn't getting better, so I had
to stop working. I stopped teaching, and in following these
different protocols for you know, fibral myalgia and autoimmune issues,
I came upon breast implant illness and as soon as
I read what other women were experiencing, it clicked for
me because none of this started until after my implants
were placed. My medical records, you know, told the story
(06:19):
and even going back to my original plastic surgeon and
talking to him about he threw his hands up and
he said, the FDA says there's no connection, and my
husband and I are there And thought, well, that's interesting
because in the manufacturers paperwork these issues are actually mentioned.
So now what removed the implants and started to regain
my health and thought, this is an injustice and you know,
(06:41):
people need to know about this. I spoke at the
FDA hearing in Washington and the Safety of breast implants,
and there I met so many other advocates that were
experiencing exactly what I was experiencing. At that moment, I
really wanted to become more involved in creating change, and
from there you know, we founded Breast Implant Safety Alliance.
(07:03):
Since then, I've involved in several collaboratives, the Breast Implant
Collaborative Community, the National Center for Health Research, Breast Implant
Working Group, part of USA Patient Network, Patient Safety Action Network.
I'm part of Patients Rising. Recently rest I Plant Safety Alliance.
We usually call it VISA or visa nonprofit for short,
join the Medical Device Innovation Contortion and they are starting
(07:25):
some active surveillance on breast implants. Were also part of
the FDA's Patient Caregiver Connection. So, you know, there's a
lot of folks that do such a great job raising
awareness on social media, which is so needed, but there's
a space where we need to change legislation, you know,
really take the steps to create the change that's needed,
like the you know, the new labeling for rest implants,
(07:48):
the black box warning and getting informed consent out there.
If you can tell our listeners, what is your definition
of breast implant illness. It's interesting it's the FDA refers
to it as systemic symptom. It seems to be a
diagnosis of exclusion. So if it's not all these other things,
it might be breast implant illness. It impacts people differently.
(08:09):
I was part of a Delphi study that Dr Andrea
Pustick was working on, and she was part of the
American Society of Plastic Surgery Plastic Surgery Foundation at the time.
But you know, there we're basically narrowing it down to
you know, ten of the top symptoms. And I can't
exactly remember what those exact ten were, but basically it was,
you know, fatigue, weight, fluctuations, u rashes, pain, new development
(08:34):
of Ottawa immune issues, hair loss. Me personally, I noticed
I had g I issues that were new. I had
rashes that developed and they were on my face, my neck,
you know, my arms, in my chest. I went to
my doctor and I, you know, she told me to
scrub harder, and I'm thinking, I ex foliate. This doesn't
(08:56):
make any sense. I had bladder issues that gave me
medication for that. I had constipation issues. I noticed that
when I ate healthy food. Normally, when you eat healthy food,
you feel good. I noticed that I was, you know,
eating these healthy meals, and I didn't feel any different
whether I ate something good or bad. It was this.
It started to be this constant feeling of a hangover
(09:17):
without the joys of you know, drinking the night before,
and I actually, you know, went to see a psychiatrist
because I thought, Okay, there's there's something wrong in the
happiest stage of my life. I'm newly remarried, love of
my life, just you know, everything was absolutely lovely, but
why did I not feel great? So I thought it
must be something else I can't control. They tried different,
(09:39):
you know, medications, they kept having to up them, and
I was seeing a therapist at the same time. After
seeing her for about a year, she looked at me
and she said, you are doing everything that I'm asking
you to do. I do not think you're depressed. I
don't know if I should say this, but I think
you need to look further into your health. And I
really appreciated that coming from her because no other medical
(10:02):
professional had spent that type of time with me to
really understand what was going on in my life. One
of the functional medicine doctors I was seeing basically said,
you know, you've got to put your body in the
right conditions to heal, and you're not going to heal
with you know, your body fighting breast implants and recommend
that I get them removed. While you go and find out,
like you said, everything else was perfect. I really talk
(10:25):
a lot about the fact that we have to embrace
what they didn't know to heal what I wanted to know.
And you've really been active in helping all of us
understand and change. How did the FDA, because that's who
we learned, really regulates this right? How did they let
this happen? So do you mind sharing a bit with
the listeners in terms of what the process is to
(10:46):
regulate medical device specifically these implants absolutely there, There's a
lot want to cover here. But so to gain approval,
the manufacturers must present evidence that the device is reasonably
safe and effective for particular use, and there's two ways
to do this. There's pre market and there's post market.
Post market is also referred to as the five ten
(11:07):
K pathway. So pre market is similar to the way
drugs are approved, which include you know, human clinical trials,
but this process is not used very much for medical devices.
Most of them go through post market, which we know
it has been abused. The safety studies are much less vigorous.
The device is based on a previous, similar device that
(11:29):
was approved. It is actually a modification of a device
that the manufacturers say is similar but in reality may
not really be similar. And an example of this would
be the like robotic surgery device. They said it was
similar to a scalpel for approval, So I don't know
how a robotic surgery device is, you know, all that
(11:50):
similar to a scalpel. Back in the seventies, devices were
grand fathered in. An example is MESH and later uses
a predicate which means it never goes to human trial.
So they did use it on animals to study, but
animals can't give feedback the way that humans can, and
the five ten K process it's not adequate. If the
(12:11):
predicate has been recalled, so that device was recalled, it
doesn't matter. They can still use it as long as
the device has already been cleared. It's okay. Let me
say that again. A past device was used to help
approve a new device. It doesn't matter if the old
device was recalled for safety, so new does not equate
to safe. One of the things you and I've also
(12:32):
talked about is that all of these women have gone
through something emotionally, financially, physically horrible, and their first reaction
is I want to tell my friends, I want to
share my story. I want to prevent this from happening
to someone else. But we all came together and had
to accept that the solution we brought into was not
real and that also there was a lot of fake
facts out there. Do you remained explaining a bit about
(12:54):
the recall when it happened and what that's kind of
opened up in terms of the these things you're lobbying
for is potential solutions. So the Allergan textured bia cell
was a voluntary recall. The FDA did not recall those
The company did a voluntary recall, and most companies do
a market withdrawal rather than an FDA recall. They just
(13:17):
quietly take it off like it never existed. Allergan did
not track or you know, basically believe patients, so when
that recall happened, there was no way to alert any
of these patients. The manufacturers did reach out to some
patients because there was no digital alerting system in place.
Doctors really didn't have a way to you know, quickly
(13:41):
go through and check to see, you know, which of
their patients had this Allergan bio cell textured implant. A
lot of the women that I come in contact with
it's been so long they have you know, they don't
remember if they were given any implant I D Cards.
They don't, they don't have them anymore. They ast them,
they move, you know, their doctor no longer practices. You
(14:04):
only have to keep these records so long, seven to
ten years, and they can get rid of them. So
these patients, they were not alerted of this recall. In fact,
Allergan was trying to, you know, find people on social
media to try to alert them. Can you just describe
what full disclosure is a call to action really means
in terms of patient rights. What we need um, you know,
(14:24):
proper informed consent. There needs to be transparency exactly what
these implants cause. And when you talk about the recall,
we haven't really discussed why those Allergan bioso textured implants
are recalled. They're causing cancer B I A, A, L,
C L and a lot of surgeons like to say
that it's rare, but the problem is, you know, they
(14:45):
haven't been testing for it, they haven't been following it.
So as time goes on, the incidents is going up
and it's not as rare as they originally thought. And
if they have not been tracking any of these patients,
How do we know how rare it actually is. I
don't know any woman that wants to know walk around
with implants in their body that can possibly cause cancer,
(15:06):
especially when they've already survived breast cancer, had amassectomy, had
you know, these implants put in just to get cancer again. Well,
a lot of people don't understand, Maria, that's so important
that b I A L c L is a form
of blood cancer. So when you're going into your breast
surgeon and complaining that you're having masses and pain and
fluid and things on ammagram, et cetera, the diagnostic process
(15:28):
does not pick up B I A L c L
through the normal breast diagnostic current process. In the breakdown
in the healthcare, which is really important to understand it
is that a plastic surgeon is allowed to touch the implant,
a breast surgeon is allowed to touch the tissue. And
what you brought up earlier is unless you have a
functional medicine doctor translating what all these people say, you
(15:51):
end up getting bollocked back and forth. And so I
think full disclosure on the risk that if someone told
me up front not only that this could cause cancer,
but that they are not a lifetime device, that they
may have to be replaced, and there's more economic costs
because the other thing is that these are not cheap.
This is an expensive product to maintain. If your car
(16:13):
is going to cost you x amount of dollars to
maintain it, you get a warranty. These don't have a warranty,
do they right? Right? Right? And and when you think
about transparency, you know, in October, the FDA did listen, right,
They put out a recommendation for the black box warning
for the new labeling, you know, using the Unique Device
(16:34):
Identify or the u d I for tracking purposes. They
talk about this informed consent checklist. That's great. The FDA
can recommend that, they cannot mandate any surgeon to use it.
So we've got advocates that we work with that are
working state by state by state to pass and inform
consent bill to hold plastic surgeons accountable, just to make
(16:57):
what the FDA has recommended mandatory, because right now, even
though the FDA recommends it, it's not mandatory. You've also
been very vocal in that the solution comes from advocating
for change but also maintaining it's our body, our rights,
but what we want is real information and so on
(17:18):
that note, One of the questions I have for you
on the legislative side is that the Medical Device Guardians
Act has been something that we met Sibo gold Ridge.
I've talked to you in private about it. It's can
you just tell the listeners what that is and what
it means for consumers if it gets past And I
want to jump back for a second when you talk
about the state legislation, the Pioneer and the Informed Consent
(17:39):
Bill has been an advocate. Robin Tout and you know
the Arizona Advocates that we're able to, you know, push
that over the finish line, you know. I mean they've
done an incredible job. And the Medical Device Safety Act
and the Medical Device Guardians Act, I kind of talk
about them together a bit. I started working on the
Medical Device Safety Act and I met the Medical Device
(18:02):
Problems Advocates that was part of women that suffered from
the assured device. So what you learn with a Class
three medical device, the manufacturers are protected, only the investors
have a right to litigation. And Class three medical device
is something that sustains or supports life or as implanted
(18:24):
and you know, could potentially cause an unreasonable risk of
illness or injury. And examples of these devices would be
pacemakers and breast implants and you know, like the the
assured device. So there is no protection for the patient
for a Class three medical device. So the Medical Device
Safety Act wouldn't mend the Food and Drug, Food Drug
(18:47):
and Cosmetic Act to restore patient rights, hold manufacturers accountable,
and require safer medical devices. Now, we don't want to
stifle innovation. Innovation is important, but there is no accountability.
How can we be sure the devices are safe if
there's no accountability whatsoever, So we bear all the risk
(19:07):
is the patients is what I'm hearing your say, right,
and people don't know, they're not aware of this. When
you say that, I think for most people this becomes
unbelievable that in the modern day is my friends have
said that something can be sold to us that's not
properly researched, that if it goes bad, we have no recourse.
And so this law would not only you know, change
(19:30):
things and protect us, but you've also come up with
a solution. Say this law is enacted, you know that
puts a lot of companies in reactive mode, and I
think it is patients. Do you mindsuring a little bit
about track My Solutions and this concept of, like you said,
making yourself count, you know, registering yourself when you get
a medical device, you know, share a bit with the listeners.
What that means is a solution because if you get
(19:52):
the legislation, you need the resources to implement the care
right right, and so along with the Medical Device Safety
Act is the Medical of Vice Guardians Act, and what
that is is to mandate that medical professionals have to
report adverse events to the FDA. Right now, a doctor
does not have to report, right only manufacturers are mandated
(20:13):
to do so. But again that can be subjected. You
know again, how can we make informed decisions if we
don't have accurate data. So that's why we need to
pass the Medical Device Guardians Act. I met track My
Solutions when I was working with the GALS and d
C on these two bills, and I really liked their
mission was save patients lives through technology. Jeremy Elias, who's
(20:37):
the founder and CEO. He you know, his best friend's
grandfather had a pacemaker with a faulty battery. Well they
didn't know it had been recalled, and you know, unfortunately
he had passed away, and Jeremy thought, well, why don't
we know there's no digital learning system in place. So
Jeremy looked further in that and you know, knew that
this was a problem and he came up with the solution.
(20:59):
Part of what we do, a patient can input their
device information and if there's ever a recall, we will
notify them immediately listen as it happens. What we want
to see happen is that the patient not have to
go through this process of importing their information and tracking
it down because it can be very hard to track
down your information. You know. We also work with hospital
(21:20):
systems and surgery centers and doctors to create this digital
format when there is a recall, that doctor can just
pull up everyone that has this device and contact them
immediately so that they can take whatever steps are necessary
to move forward. So hospital should know who has these
recall devices, you know, in their body. You should really
(21:41):
be you know, contacted by a medic, your medical professional.
Most people hear about recalls through a you know, an
ad for a lawsuit on the TV, or they're hearing
about it on social media. So with what we're going
through and what you proposed as an innovative way to
approach this in real time data management. If we can
have the doctor to have the data input it in
(22:01):
real time, maintain that confidence and want to know. And
I do think that there's some amazing doctors out there
that we've spoken to, that you've spoken to, that have
a genuine now interest in being part of the solution.
And this really reverses the flow of data in the
medical system. And what I find interesting now is that
a lot of you know, different types of plastic surgeons
(22:23):
are standing up and saying, Okay, you know what, we're
seeing enough of this. I think it's hit the staturation
point where now you've like you've identified in Arizona, there
was this magic moment of we got this past, we're
getting full disclosure. But now step two is how do
we create legislation to mandate that it's implemented. If you
currently have an issue with your implants, where do you
(22:45):
go to be notified and make yourself count? Do you
mind sharing a bit with the listeners what's out there
for you? That's a great question, so you can go,
you know, search for you know, the recalled implants, you know,
on the FDA site and they'll give you a list. Unfortunately,
it's very very confusing because Allergan biocell textured implants went
(23:05):
by several different names. At some point they were, you know,
like they McGan. So if you have McGann implants, you're thinking, well,
I don't have the Allergan textured bio cell implants, so
I'm not worried about this. Well, they have gone by
several names, so it is extremely confusing. Even contact Allergan
and they do have a site where you might be
able to put in some information and they might be
(23:26):
able to tell you. You You can go to track my
Solutions dot us and you know, you can use our
solution track my Implants, put your information there and you know,
as you put in your information, you would get an
alert if your rest implants have been recalled. You know,
we've got some patient advocates that work with the company
and they will look into that for you. But there's
not this there's not an easy way. It's not very clear.
(23:48):
Does that make sense? A thousand percent you pointed out
and is so important for many women in terms of
the step one of this is being diagnosed in dealing
with this issue. Is that a lot of us contact
our plastic surgeon, we up to friends, we use Google,
and we also when you said adverse events, many of
these companies have changed names. And so what I'm realizing
(24:10):
through meeting you and through going through this process myself
and talking to so many people, is that track My
Solutions is going to create the ability for people to
be identified, register and notified. And it's a great next step.
Breast and plant illness has literally changed your life. I've
watched you know, you are teaching people how to treat
(24:30):
us and as a teacher, as a mother, as a wife,
as a woman. You know, what do you want to
say to women dealing with breast and plant illness? What
would you advise them, you know as they go on
their journey, is some just things to consider and some
tips to turn this into a survival and thriving, you know,
like you've done, because you've really taken this head on.
(24:52):
Thank you. Well. The number one is you are not
alone and there's a whole network of women that are you,
have gone through or are going through exactly what you
are going through. You know. One of our kind of
our our taglines, our hashtags is not our daughters. And
you know, we think about we say, are you know
(25:15):
our grandmothers have suffered, Our mothers have suffered, We have suffered.
The next generation will not suffer. They will be informed.
Hashtag not our daughters. I think that we don't want
to take any you know away, anybody's right to do
whatever they want to do to their body, but you
need to have, you know, a proper informed consent. And
we don't want other women to have to go through
(25:37):
what we went through. And you know, we would like
that insurance coverage for the removal when you've got breast
implant illness. We would like for medical professionals to for
this to be on their radar. We would like for
patients to be informed. And I think that women need
to understand if you develop, you know, these symptoms of
breast implant illness. Now I chose to put these implants
(25:58):
in my body. My husband and I we we chose
to spend this money on this. And you know, for
women that had cancer and sectomies, they really didn't have
I mean, they did have a choice. They could have
just gone flat, but they there aren't many choices, you know,
for reconstruction you know, it's all hard on the body.
I think we all need to understand that we all
made the best decision with the information we had at
(26:19):
the time, and there was information that was hidden, you know,
the data was hidden, and there were people trying to
sell the doctors a product and sell you a product,
so it was very bias information. So I think, you know,
you need to forgive yourself because you at the time
made the best decision with the information you were given.
And also when you're you know, when you're ready and
(26:40):
you fail up to it. We you know, there's a campaign.
Um you know, maybe it's your implants, and you know,
just sharing your story with other women their patients, they
can you know, make those connections because people don't know
what they don't know, So sharing your story it is,
you know, trying to raise the idea that maybe you know,
(27:02):
these issues are coming from your rest implants or other
medical devices. And since the medical community is not aware,
you know, we have to help each other and until
that changes, but we need to create change. But the
data is needed to create the change. So you need
to take those steps to report your symptoms, you know,
the adverse events to the FDA's MedWatch program, because that's
(27:27):
what's driving the changes. If we didn't have all of
these patients reporting to the FDA's MedWatch UM, we wouldn't
have the black box morning, we wouldn't have the changes
in the labeling, we wouldn't have those, you know, the
discussion of the systemic symptoms that we all refer to
as a breast implant illness. So we want to encourage
(27:48):
people to take that time, you know, to contact MedWatch
and let them know exactly what you've experienced. And if
you you know, do remove your implants and you have
gains in your health or changes go or bad, report
that as well, go back. I implore people to contact
their medical professionals. A lot of women don't go back
(28:08):
to their original plastic surgeon, you know, just you write
a letter, talk about what you've experienced in the changes
in your health, and you know, as your patient responsibility,
send that letter to the medical professionals you work with.
They don't know what they don't know, and you need
to take the time to tell them. And you know,
in that we can create something better for better consent,
(28:29):
give people the information they need to make informed decisions
in the future. Maria is building a community of survivors,
(28:50):
one brave warrior at a time. Kristen, she is Christine
and she's been a source of strength, hope, and inspiration
for me and so many other women, doctors and advoct kids.
I look forward to saying what February has in store
for us this year, as that is the official b
I I D. I don't know if I would have
made it this far without her, and I know together
we are not alone, and you are holding the legacy
(29:13):
of our next guest, Cibil Night and gold Rich. She
was instrumental in helping fight for women's health in the
Dow Corning class action lawsuit of the nine nineties. Yes,
as a cancer survivor and wife of a doctor, she
kick started this whole movement with her husband's support. They
took this all the way to being the largest settlement
(29:34):
of its time, like four and a half billion dollars
somewhere in that neighborhood. Yeah, And sadly the fight didn't
end there. The FDA approved silicone implants is safe in
late two thousand six, and just like that they were
back on the market. So, despite her fight, they were
reintroduced and the impact was identical. Now new lawsuits are
(29:55):
being filed and those same implants have been conclusively shown
to cause camps there. And this is a type of
blood cancer named b I A l c L, which
was first discussed in medical journals in ninety seven, But
the FDA didn't report the Lincoln until two thousand eleven,
and it wasn't until twenty sixteen that the Word Health
Organization established a diagnostic and treatment process and set guidelines
(30:20):
for this. Why does it take so long for someone
to do something about this? I mean, think about all
the women who had breast implants in that time and
are suffering because of it. They still sell these devices,
the breast implants as they like device to the Dow implants.
And Sybil started her fight in the nineteen eighties. She
published her story in Miss magazine. She bravely showed a
(30:42):
picture of how the implants disfigured her breasts in an
interview with Connie Chung on national television. I do look
forward to hearing how she feels about the issue and
what advice she has for you all as you lobby
for change. Absolutely, thank you for joining us for Close
(31:03):
to the Chest. Our guest today is Sybil Night and
gold Rich, who is a Shiro in the Breast Implant
Illness World CIBIL as a survivor, an advocate, and someone
who's been fighting since the eighties to raise awareness about
breast implants and the risk associated with them. Thank you
for joining us. Your knowledge as a pioneer is going
to not only help us save lives, but we're excited
(31:24):
to learn and grow with you today. So I wanted
to start the conversation, Sybil and ask you first and
foremost what your experience has been with breast implants and
how you became an advocate. If you don't mind, be
happy to tell you. Thank you for that lovely introduction.
I had breast cancer. I was forty three years old,
and I couldn't think of anything that I'd rather do
than be reconstructed and move on with my life. The
(31:50):
problem was I became. I was reconstructed once, then twice,
then three times, then four times, and I realized this
is not getting me on with my life. There's nothing
wrong with me. My cancer has been taken care of.
What could be the problem? And so I started researching.
Most doctors said that I was the problem because that
(32:12):
my body would not accept the implants, and I thought
to myself, I don't think that's the way it's supposed
to work. And I don't think that's right. I think
that the breast implant is supposed to work for us.
It didn't. By some miracle, I found out that. Well,
actually I did research and then I had a miracle
to find out that the FDA had not approved breast
(32:35):
implants when I was getting them. And I started to
look around and went to medical journals and there was
very little in it. And then I went to the
package insert that somebody gave me that was included in
the box implants. And that's what started me off because
the last sentence in the package insert that I read
(32:59):
it said the possibility of loops lucas, rhetory arthritis and
scleroderma exists. And I wrote, oh my goodness. Oh I
was freaking out. And then I called the f d
A and they said, oh no, we have at aproved
breast implants. And I'm saying, are you kidding me? You're
selling these to so many women? Made me feel used,
(33:21):
It made me feel had I've been done in? And
I wrote a book about my experiences, and no publisher
believed me, and so the agent who was handling has
said to me, right, twelve hundred words and I'll see
if I could sell it to a magazine. I said, okay.
So I wrote twelve hundred words and it went into
(33:44):
Miss magazine and that was in tune of And once
it was in Miss magazine, the lid blew off of
everything I ever knew, because the FDA called me and
asked me to come to Washington to speak to the
panel that was about to approve breast implants. And I'm saying, oh,
(34:05):
I better go. They sent me a ticket and I
went to Washington, and that was the first time I
ever testified, and they nodded very patronizingly, and I thought
to myself, well, nobody's heard me. I know it. I
just had a feeling in my gut. But they needed
somebody to cover them and said, well, we had a
patient here, and obviously she couldn't accept the breast implants.
(34:25):
Was probably her body, She's had a lot of surgery.
But what I did notice is that there was a
group of men in the middle row of this auditorium
with briefcases and suits. And I'm saying to myself, why
would all these men be here and on the far
right of the room, we're all a lot of press,
and say, how can they need so much press for this?
(34:47):
And the reason is the men in the middle were
the suits from all the manufacturers, Sue's meaning men in suits.
They all set their people, and I'm saying to myself, whoe.
And at that time, Sid Wolf, who was a physician
who was with a Ralph Nader's group of UM consumer advocates,
(35:12):
and he got up that day and he testified that
there is the possibility of cancer from breast implants, and
he pointed to several articles. My heart dropped down to
the ground. I've already done that. I I didn't want
to go back to the cancer routine at all. And
(35:35):
so I was shocked and I tried to process it all.
And one of the TV people came up to me
and asked me if I would go to the hall
and answer some questions, and I did, and once people
all over the country heard what I had to say
that these products haven't been approved, I don't think they're safe,
(35:58):
and we've just heard information that connects it to cancer.
Why would a cancer patient get a cancer causing product
inside of them? If they had told me, there wouldn't
be no way that I would have done that. The
level of strength you had to have at that time
two stand up against the doctors. You were married to
(36:18):
a physician, you had daughters, you had been through hell,
and you still got in that plane and you went
to that hearing and you stood there and you shared
your story. And so first and foremost to say thank you,
because when I watched this and I listened to what
you've been through, what one of my greatest questions for
you is where did you find that strength? Yeah? Well,
(36:43):
you know you have to have strength to get through cancer.
And so I found some strength there. But I realized
that a basic part of my personality is don't lie
any don't mess with me. I can handle the truth.
I can deal with almost anything if it's straightforward and honest.
(37:06):
Then I put the pieces together and figure out how
I can work on work with it. And it just
it hit my personality button so right in the middle,
and I knew I had no other path to go
but to fight these people and tell them you cannot
do this. I'm not the only woman who's having this problem,
and you cannot keep taking advantage and that's the end
(37:29):
of that, and I was not going to stop until
I finished with them. What was your goal, like, what
was the first step for you where you thought you
could genuinely make an impact? How did you decide how
to take action? The first thing I wanted to do
was make sure there was a universal truth, if that existed,
for every woman to be told that all of these
(37:52):
side effects not don't keep the information inside the box
that they opened in the operating room, tell us, show us,
give me a booklet that would have said that. It
took a long time to kind of crank all of
this out, but we ultimately got you know, got that
booklet form from the FDA one TV station interviewed me,
(38:13):
then a newspaper called Then, a magazine called then another
TV thing, and I kept going and going and going. Uh.
Years ago, Connie Chung had a show, and that's when
I did the most what I thought was courageous. My
daughters were just horrified at what I did when I
let them have a picture of what I looked like
(38:37):
with an implant that was ready to extrude, and I
gave it to the Connie Chung show and allowed them
to show it. Once women saw it exactly what that
looked like to encapsulated implants, one of them pushing through
a hole in the center of my breast. That women
(38:59):
relay it too. I wasn't the only woman in America
who was having that problem. And my phone started ringing
off the hook. My daughters were furious with me. But
that's the thing. What you know, I played bridge, and
there's a there's a line in bridge that says one
(39:20):
peak is worth two finesses. Do you know what's in
somebody else's hand, you can play a lot better. So
now women knew exactly what was on me, and if
they had it or anything close to it, they knew
they were not alone. What currently do you see these
companies doing after the FDA has mandated them to published
(39:41):
articles and announce these risks. Do you feel that we
are currently as women getting authentic information from the manufacturers
about the risk of implants. Absolutely not. And I'll tell
you what the hook is on a class action that
you would go ahead with. And I'm not a lawyer,
but I've been around a class accident for so long
(40:02):
that I know a little bit about them. And what's
happened is the manufacturers were required to do these post
market studies and they never did them. They blamed it
on the women from not participating in the studies, but
that is not true, and you can get enough women
to come and testify that I called and they didn't
(40:24):
want to hear from me. I called the f d
A and I was put through to four different phone numbers.
There is proof that they never seriously approached these post
market studies and you were entitled to that information when
you got this quote newly approved implant. To me, that's
(40:44):
the basis of the whole case. And I never asked
anybody about that. But we have a lawyer. Or is
that true? Yeah? Absolutely, I mean there's they're required to
give full disclosure and the fact that they don't and
that nobody. You know, the onus is really on the patient,
and that's not how it should be, but it is.
(41:06):
Of course, the onus is on the patient to find
all this stuff out. But if a patient, a woman,
does everything in her power, she calls the manufacturers. And
I want to report this because the FDA is collecting
this information and you also are required to do post
market studies, So I am reporting this to you, and
what you just touched on in in the case, and
(41:28):
I had a meeting on Monday yesterday with my intensivest
and she has the horrible job of helping me navigate
all of the effects the disease has had on my body.
So I've had a bilateral hip replacement, I've had my gallbladder,
my appendix removed, I've lost parts of my colon. I've
gone deaf in one ear from tumors traveling throughout the body.
(41:50):
And I think the most important thing for me and
any woman dealing with this is this isn't quote textbook
right Like, there is no textbook. There is no place
to go and say if you are diagnosed, here is
the protocol. So the second thing I see that is
a really important movement by some of the great doctors who,
like you said, are brave enough to stand up and
(42:10):
say this is an issue. We have a hippocratic oath.
We want to help solve this problem. Is creating a
protocol that states, you know, financially what this should cost
so it doesn't become a whole another exploitative business. And
then also what alternatives are available to us as women.
Because now you've gone through an ex plant, you've been disfigured.
(42:32):
You no longer look like you think you're going to look.
And so what I'm looking forward to is the fact
that you really encourage innovation, education and research to keep happening.
You've taken this position with women that we deserve better,
we deserve to be able to trust these stakeholders. Just
two final questions. You know, as someone who dealt with
(42:53):
us for years and you've been out there advocating, et cetera,
what advice would you give to a woman who's just
read that they have recalled implants. Be prepared for a fight.
Be prepared for a fight for your health, and be
prepared to take it beyond just your health. And make
(43:16):
sure that the next generation at least is equit to
know that they are also going to have to fight
if they go down this road of implants. And at
the same time as you're fighting that issue, there has
(43:38):
to be a movement two. Recall the approval that the
FDA has gotten because they have not done their homework
and received all these postmarket studies. Because we know what
the post market studies show that now we have a
l c L and a lot of other things, demand
(43:59):
that they recall disapproval and um develop a product that works.
You can put a man on the moon or Jeff
Casos into space, and you can't figure out how to
figure out a product that will fit in somebody's some
(44:19):
human beings. Body, come on, I mean, you know this
is this is century when I think commanding respect is.
One thing you touched on a lot is that you
went into those rooms, Sibyl, and you stood up and
you commanded respect in a way that was genuine, authentic,
and you were so inclusive. And I think as we
continue as women to organize and do exactly what you said,
(44:44):
we have tools available to us. Now we have attorneys
that are passionate about this issue. But most importantly, the
emotional side of this disease I think has been the
most grueling part of it. I think as women, we
take all of the internal resources we have to air
children and be fixers and be strong, and we use
that to cope and ultimately I've noticed for me, my
(45:07):
standard of health dropped from wanting to you know, be
bike miles and accomplish great things too. Can I get
out of bed this morning and put on makeup and
be articulate and string a sentence together, and I think
we work in a world where the second biggest impediment
for this has been financing it. And so one of
(45:27):
the big movements as part of Close to the Chest
and thank you to my Heart for allowing us to
share this story, is that the cost benefit of this disease.
The companies that you brought up are being injured the
most are ironically insurance companies. I would hate to know
what my insurance company is paid to manage my symptoms
and secondary diseases versus getting rid of the primary issue,
(45:50):
which are these implants. And so I've noticed recently and
Maria Dmitro and yourself and many people have been logging
lobbying to get us an insurance code and so to
have breast implant illness recognized. It's been a major milestone.
But now as we lay down the foundations for treatment
to get insurance companies to get behind this issue, do
(46:11):
you have any advice to us, as victims and as
advocates on how we can go out there and help
get an insurance code and get a protocol in place
so we can actually get discovered, Because I think the
manufacturers are taking advantage of the fact that, like you, said,
we financially end up upside down. We can't afford the
thirty dollars to do the appropriate explant in surgery. So
(46:34):
a lot of us go untreated and die from secondary
illnesses because we don't have coverage. Well, I think you
have to identify who the lobbyists for the insurance industries
are in Washington, and then you have to interview all
of them and find out who would be sympathetic to
this issue, because there are lots and lots of you know, lobbyists,
(46:57):
but they want all kinds of insurance but other things.
You may not come in as the pretty girl. You're
not the woman that they want to take to dinner.
You're the one that's saying, oh god, this is going
to get in the newspaper, that these women want to
have insurance coverage, and what are we gonna do? How
are we going to handle the ripple effect of this
(47:18):
that's gonna be awful. By the way, public relations is
your best friend. You have the Internet. I mean, you know,
if somebody could sit down and write a treatise or
a discussion or an argument about the importance of insurance.
(47:38):
For example, I always felt that if you paid a
manufacturer and extra fifty dollars to every implant sold that
they would be able to set up their insurance company
and pay for everything you needed after that. Uh. But
they knew that they were going to have to put
(47:59):
in a lot more because they knew that they had
a product that was awful. And as we go forward,
what I've learned that Christine and I can do as
part of sick titties dot com, which is the funny
website I created to describe this horrible illness. And what
happened to me is people kept asking what was wrong.
I would state to them, while I have sick titties,
because it was awkward. We just went through the meat
(48:21):
too movement and here we all are talking about our
boobs and that's an uncomfortable issue. And so, through the
great advice of some friends and with Christine's support and
the rest of the team, our mission is to create
a site that can you know, do what Command Trust
tried and was so successful with and using technology to
educate people to get you and all the information you
(48:42):
published on there. But most importantly, I think my marching
orders for the next couple of days are to find
myself somebody who gives a ship about women's issue that
wants to lobby for insurance coverage because ultimately, if we
make this a business to business issue and attack it
from both, I think if we educate women that they
(49:02):
have safer alternatives. I think if we commit continue to
build this community of she rose and for you to
meet you today, Sybil was not only an honor, but
I have to say it was life changing. You're like
a god shot of hope and as I go forward
in treatment, I decided to do what you did and
with your bravery and being willing to share what you
(49:22):
look like and what you went through. What Close to
the Chest is all about is I want to demystify
what's really happening. I want to give women access to lawyers,
to doctors, to survivors, to advocates, and to empower us because,
like you, I am not willing to sit around and
let my daughter and my granddaughters and other people struggle.
(49:43):
I think if knowledge is power and information creates action,
You've laid a foundation that gives this community strength. You've
given us courage, and you've shown people that you don't
just survive, but you really strive to change and be
the solution to the pro mom you need and without
use of But women like me would not have a voice,
(50:04):
we wouldn't have an option, and we wouldn't have hope. Well,
thank you for all those nice words, but I will
tell you that the work that I do and the
work that you do, it gives me more strength and
power to just keep doing more. And if I have
to do this till the day I die, I will
be doing it till the day I die, much to
(50:25):
the chagrin of my family. When don't you retire, Well no,
I'm afraid as long as they are bad actors out there,
it's not a real it's not even thinkable. So let
me help you in whatever way I can. I wish
all of our women so much. They need good luck
and they need to have the information upon which to
(50:49):
base a sensible decision for themselves, because in the end,
it's every single individual woman's journey. And where the manufacturers
and the insurance come. But these get into trouble is
when all of these individuals come together with a purpose.
So what I suggest is you make a mission stakement.
(51:10):
What is it you want, what is it you think
you can accomplish? Put all that together and there's your credo,
and this is what the manufacturers and the insurance government
is gonna have to deal with. And you know what,
they're not gonna like it, and you're gonna love it. Fine.
(51:34):
That was a life changing conversation, Chris. I am so
in awe of how strong, unafraid, and determine these women are.
I feel honored to call them my friends and fellow
change agents. I think the clear call to action and
organization is why we are winning this battle. Absolutely, I
would not want to be up against you. All the
facts and intent are clear, but that's just my opinion.
(51:57):
I mean, I'm not the attorney in this case or
any other really, because you know, I no longer practice,
but it does inspire me. You know how I get
riled up over injustice. Let's just talk about the three
initiatives and how your pain becomes an actionable purpose. Well,
let's start with full disclosure. Last week you mentioned the
(52:19):
black box morning. This is key. I knew if they
had told me the full risks and I had the
option to provide informed consent, there would be no toxic
sax in me. Yeah, that would be a great start, huh,
but I wish it required them also to do something
like a public service announcement so that you could reach
women on mass instead of just one on one. I mean,
(52:41):
it assumes that the doctors are going to do this
um and it will take time, and really, how can
we enforce these disclosure statements? I think the next call
to action is key. The Medical Device Safety Act needs
to be brought before Congress and past. I know, right,
we get notified when our break to recall, but why
not our boobs. This has to change. I also think
(53:05):
the class action suit should expand beyond b I A
l c L to include those suffering from b I I.
This is a horrible autoimmune disease that is wrecking our bodies.
Oh yeah, yeah, I've seen it firsthand on you. I mean,
we've talked to so many women. B I I needs
to be recognized as a disease, not just some afterthought,
and manufacturers being held accountable for their part in perpetuating
(53:28):
the misinformation that breast implants are always safe. Chris, I know,
I want the world to know that b I I
is awful. It is not something we choose, and women
have been harmed. We will not stop until there is
help and accountability. Well, I'm not going anywhere until we
see that happen. I am confident that things are about
to change, because, as you know, together we are not alone.
(53:54):
Close to the Chest with Kristen and Christine has been
brought to you by B Noble Media Group and Heart Radio.
A very special thanks to our guests Maria Gemitro and
Sybil Knight and Goldridge. To find out more about Maria's
organization on device safety, please visit www Dot prest Implant
Safety Alliance dot org. That's www Dot Breast Implant Safety
(54:21):
Alliance dot org. Now I'd like to share some gratitude,
a very special thanks to I Heart Radio, to our
Parker and her I Heart Radio marketing team, and a
big big thanks to our executive producer, Ramsey Young. If
you or someone you know would like to know more
about breast and plant illness, please visit Sick Titties dot com.
(54:42):
That's s I C K T I T T I
e s dot com. Also, please follow us on Instagram
at sick dot tittis and at B Noble Art that's
B N O B L e A r T. And
we would also low to have you join our Facebook
page at b Noble on B I I, and please
(55:05):
remember You're not alone. Together, we can beat this. The
views and opinions expressed are solely those of the podcast
author or individuals participating in the podcast, and do not
represent the opinions of my Heart Media or its employees.
This podcast should not be used as medical advice, mental
health advice, mental health counseling or therapy, or as imparting
(55:26):
any healthcare recommendations at all. Individuals are advised to seek
independent medical counseling, advice, and or therapy from a competent
healthcare professional with respect to any medical condition, mental health issues,
health inquiry, or matter, including matters discussed on this podcast.
Close to the Chest with Kristen and Christine is a
(55:47):
production of I Heart Radio and produced in our studios
located in Atlanta, Georgia. For more podcasts from my heart Radio,
visit the i heart Radio app, Apple Podcasts, or wherever
you listen to your favorite shows
Close to the Chest with Kristin and Christine is brought
to you by I Heart Radio. My name is Kristin
Nobles and today is November six. This week's episode is
about the f d A, all of the lawsuits and
advocacy that's currently happening, and really something that's near and
dear to my heart. When I first found out that
my breast implants were the cause of over twenty years
(00:23):
of illness, I was angry, confused, and I felt very helpless.
I wanted to understand how this issue even came to be.
How was it that implants for on the market and
everybody was telling us they were safe. How was it
that doctors weren't recognizing b I I as an actual disease?
And how are women like me being sent home and
(00:43):
told that this was all on our heads and shamed
for not feeling well? And then I started to understand
what was happening. I started to really look through the
other advocates in the community, at the parties that are
necessary to educate and empower because if they know more,
they can do more. And through understanding the role the
f d A has how to work with them to
(01:05):
report adverse events and how to file complaints against doctors
who were actually gaslighting us and not treating us. Empowered
me and so many people in the community to start
to fight back, to provide the data so people recognized
us and hurt us. And lastly getting an attorney to
represent us and really explore how to hold the manufacturers
(01:27):
accountable was the most empowering moment of my life. So
to all the women in the community out there, the
key to our success is attacking the problem, not the people,
and knowing that through lobbing for full disclosure, through telling
the FDA that these implants are hurting us, and through
getting the word out to the doctors, they will know
better and do better. But most importantly, knowing that together
(01:48):
we're not alone and we never give up the sin
and then question up walking into the room heads turning out. Christine,
(02:08):
there's a long history of women fighting to raise awareness
about implant issues and lobbying for breast implant safety and
women's health. Today, we're talking to some brave advocates who
spent over forty years fighting to raise awareness about the
risks associated with breast implants. These advocates have been fighting
to get full disclosure peer reviewed studies and breast implant
(02:29):
illness recognized as a disease. Can you believe the first
breast reconstruction on a woman's chest was done back in
eighteen I'm not sure what was in them, because the
first silicon breast implants weren't invented until the nineteen sixties,
but since then millions of women have had implants. The
first successful class action lawsuit against them was one in
(02:52):
the late nineteen nineties, but that hasn't stopped the manufacturers
from profiting. Right. I remember that case, and I was
true in one of those women who assumed that if
these were back on the market, that they had to
be safe. When I learned that they were not revolutionized
and now being recalled, I was petrified. I was mad
and determined like those women. I'm a fighter and this
(03:13):
is now our fight. I spent the last three years
begging insurance companies and doctors to help me, researching manufacturers,
and waiting for the FDA to do something, and like
other advocates, all well bone deep in the effort of
trying to get my health back. This is no joke.
I am literally breaking my back doing this. But together
I know we are changing the world, you still have
(03:35):
another six to eight weeks until those vertebrae. Hell huh, Well,
I get to meet many of these women, and I
see you are in great company. Her first guest today
is Maria Gmtro, and she is a survivor and a
leader on the front lines and has dedicated her life
to this absolutely. Maria is a friend, a former teacher,
(03:55):
and someone I learned from Daly. Her organization is Lobbying
for Change. She is also part of a company that
I love, track My Solutions. They're helping to ensure medical
device safety and she's been key in teaching doctors, manufacturers,
and regulators how to treat us. I look forward to
hearing how she's been able to be the change we
need to see, all while surviving herself. So today welcome
(04:29):
everyone Too Close to the Chest with Christine and Kristen.
I am so excited to invite Maria Metro and I
wanted to recognize her today because she is not only
a medical device safety advocate and a survivor who's been
through breast implant illness. She's also the president and co
founder of Breast Implant Safety Alliance and director of Community
Outreach and Patient advocacy for track my Solutions. So Maria,
(04:52):
thank you first and foremost for joining us. I know
you're very busy doing a lot of work, and I
wanted to start today by asking how you got involved
in it. I can see if you don't mind. Yes.
In two thousand fourteen, I decided to think about getting
breast implants to correct some asymmetry. The plastic surgeon recommended
breast implants, and you know, my husband and I did
(05:13):
our research, or so we thought. He said that, you know,
all those issues from the nineties, they fixed all that
and these were the latest and greatest FDA approved, So,
you know, thinking that they put these into breast cancer survivors,
I thought this was, you know, a safe device. Had
them placed into my body, but they looked great. But
then in you know, the months that followed, I started
(05:34):
to have you know, symptoms, you know, mystery illness. It
just continued on, continued on. My health started to decline,
and at no point was it ever mentioned to me
that it could possibly be my breast implants. Fast forward
a few years and I was a teacher at the time.
I was seeing so many medical professionals and trying so
many new protocols to deal with these new, really developed
(05:57):
autoimmune issues, and I wasn't getting better, so I had
to stop working. I stopped teaching, and in following these
different protocols for you know, fibral myalgia and autoimmune issues,
I came upon breast implant illness and as soon as
I read what other women were experiencing, it clicked for
me because none of this started until after my implants
were placed. My medical records, you know, told the story
(06:19):
and even going back to my original plastic surgeon and
talking to him about he threw his hands up and
he said, the FDA says there's no connection, and my
husband and I are there And thought, well, that's interesting
because in the manufacturers paperwork these issues are actually mentioned.
So now what removed the implants and started to regain
my health and thought, this is an injustice and you know,
(06:41):
people need to know about this. I spoke at the
FDA hearing in Washington and the Safety of breast implants,
and there I met so many other advocates that were
experiencing exactly what I was experiencing. At that moment, I
really wanted to become more involved in creating change, and
from there you know, we founded Breast Implant Safety Alliance.
(07:03):
Since then, I've involved in several collaboratives, the Breast Implant
Collaborative Community, the National Center for Health Research, Breast Implant
Working Group, part of USA Patient Network, Patient Safety Action Network.
I'm part of Patients Rising. Recently rest I Plant Safety Alliance.
We usually call it VISA or visa nonprofit for short,
join the Medical Device Innovation Contortion and they are starting
(07:25):
some active surveillance on breast implants. Were also part of
the FDA's Patient Caregiver Connection. So, you know, there's a
lot of folks that do such a great job raising
awareness on social media, which is so needed, but there's
a space where we need to change legislation, you know,
really take the steps to create the change that's needed,
like the you know, the new labeling for rest implants,
(07:48):
the black box warning and getting informed consent out there.
If you can tell our listeners, what is your definition
of breast implant illness. It's interesting it's the FDA refers
to it as systemic symptom. It seems to be a
diagnosis of exclusion. So if it's not all these other things,
it might be breast implant illness. It impacts people differently.
(08:09):
I was part of a Delphi study that Dr Andrea
Pustick was working on, and she was part of the
American Society of Plastic Surgery Plastic Surgery Foundation at the time.
But you know, there we're basically narrowing it down to
you know, ten of the top symptoms. And I can't
exactly remember what those exact ten were, but basically it was,
you know, fatigue, weight, fluctuations, u rashes, pain, new development
(08:34):
of Ottawa immune issues, hair loss. Me personally, I noticed
I had g I issues that were new. I had
rashes that developed and they were on my face, my neck,
you know, my arms, in my chest. I went to
my doctor and I, you know, she told me to
scrub harder, and I'm thinking, I ex foliate. This doesn't
(08:56):
make any sense. I had bladder issues that gave me
medication for that. I had constipation issues. I noticed that
when I ate healthy food. Normally, when you eat healthy food,
you feel good. I noticed that I was, you know,
eating these healthy meals, and I didn't feel any different
whether I ate something good or bad. It was this.
It started to be this constant feeling of a hangover
(09:17):
without the joys of you know, drinking the night before,
and I actually, you know, went to see a psychiatrist
because I thought, Okay, there's there's something wrong in the
happiest stage of my life. I'm newly remarried, love of
my life, just you know, everything was absolutely lovely, but
why did I not feel great? So I thought it
must be something else I can't control. They tried different,
(09:39):
you know, medications, they kept having to up them, and
I was seeing a therapist at the same time. After
seeing her for about a year, she looked at me
and she said, you are doing everything that I'm asking
you to do. I do not think you're depressed. I
don't know if I should say this, but I think
you need to look further into your health. And I
really appreciated that coming from her because no other medical
(10:02):
professional had spent that type of time with me to
really understand what was going on in my life. One
of the functional medicine doctors I was seeing basically said,
you know, you've got to put your body in the
right conditions to heal, and you're not going to heal
with you know, your body fighting breast implants and recommend
that I get them removed. While you go and find out,
like you said, everything else was perfect. I really talk
(10:25):
a lot about the fact that we have to embrace
what they didn't know to heal what I wanted to know.
And you've really been active in helping all of us
understand and change. How did the FDA, because that's who
we learned, really regulates this right? How did they let
this happen? So do you mind sharing a bit with
the listeners in terms of what the process is to
(10:46):
regulate medical device specifically these implants absolutely there, There's a
lot want to cover here. But so to gain approval,
the manufacturers must present evidence that the device is reasonably
safe and effective for particular use, and there's two ways
to do this. There's pre market and there's post market.
Post market is also referred to as the five ten
(11:07):
K pathway. So pre market is similar to the way
drugs are approved, which include you know, human clinical trials,
but this process is not used very much for medical devices.
Most of them go through post market, which we know
it has been abused. The safety studies are much less vigorous.
The device is based on a previous, similar device that
(11:29):
was approved. It is actually a modification of a device
that the manufacturers say is similar but in reality may
not really be similar. And an example of this would
be the like robotic surgery device. They said it was
similar to a scalpel for approval, So I don't know
how a robotic surgery device is, you know, all that
(11:50):
similar to a scalpel. Back in the seventies, devices were
grand fathered in. An example is MESH and later uses
a predicate which means it never goes to human trial.
So they did use it on animals to study, but
animals can't give feedback the way that humans can, and
the five ten K process it's not adequate. If the
(12:11):
predicate has been recalled, so that device was recalled, it
doesn't matter. They can still use it as long as
the device has already been cleared. It's okay. Let me
say that again. A past device was used to help
approve a new device. It doesn't matter if the old
device was recalled for safety, so new does not equate
to safe. One of the things you and I've also
(12:32):
talked about is that all of these women have gone
through something emotionally, financially, physically horrible, and their first reaction
is I want to tell my friends, I want to
share my story. I want to prevent this from happening
to someone else. But we all came together and had
to accept that the solution we brought into was not
real and that also there was a lot of fake
facts out there. Do you remained explaining a bit about
(12:54):
the recall when it happened and what that's kind of
opened up in terms of the these things you're lobbying
for is potential solutions. So the Allergan textured bia cell
was a voluntary recall. The FDA did not recall those
The company did a voluntary recall, and most companies do
a market withdrawal rather than an FDA recall. They just
(13:17):
quietly take it off like it never existed. Allergan did
not track or you know, basically believe patients, so when
that recall happened, there was no way to alert any
of these patients. The manufacturers did reach out to some
patients because there was no digital alerting system in place.
Doctors really didn't have a way to you know, quickly
(13:41):
go through and check to see, you know, which of
their patients had this Allergan bio cell textured implant. A
lot of the women that I come in contact with
it's been so long they have you know, they don't
remember if they were given any implant I D Cards.
They don't, they don't have them anymore. They ast them,
they move, you know, their doctor no longer practices. You
(14:04):
only have to keep these records so long, seven to
ten years, and they can get rid of them. So
these patients, they were not alerted of this recall. In fact,
Allergan was trying to, you know, find people on social
media to try to alert them. Can you just describe
what full disclosure is a call to action really means
in terms of patient rights. What we need um, you know,
(14:24):
proper informed consent. There needs to be transparency exactly what
these implants cause. And when you talk about the recall,
we haven't really discussed why those Allergan bioso textured implants
are recalled. They're causing cancer B I A, A, L,
C L and a lot of surgeons like to say
that it's rare, but the problem is, you know, they
(14:45):
haven't been testing for it, they haven't been following it.
So as time goes on, the incidents is going up
and it's not as rare as they originally thought. And
if they have not been tracking any of these patients,
How do we know how rare it actually is. I
don't know any woman that wants to know walk around
with implants in their body that can possibly cause cancer,
(15:06):
especially when they've already survived breast cancer, had amassectomy, had
you know, these implants put in just to get cancer again. Well,
a lot of people don't understand, Maria, that's so important
that b I A L c L is a form
of blood cancer. So when you're going into your breast
surgeon and complaining that you're having masses and pain and
fluid and things on ammagram, et cetera, the diagnostic process
(15:28):
does not pick up B I A L c L
through the normal breast diagnostic current process. In the breakdown
in the healthcare, which is really important to understand it
is that a plastic surgeon is allowed to touch the implant,
a breast surgeon is allowed to touch the tissue. And
what you brought up earlier is unless you have a
functional medicine doctor translating what all these people say, you
(15:51):
end up getting bollocked back and forth. And so I
think full disclosure on the risk that if someone told
me up front not only that this could cause cancer,
but that they are not a lifetime device, that they
may have to be replaced, and there's more economic costs
because the other thing is that these are not cheap.
This is an expensive product to maintain. If your car
(16:13):
is going to cost you x amount of dollars to
maintain it, you get a warranty. These don't have a warranty,
do they right? Right? Right? And and when you think
about transparency, you know, in October, the FDA did listen, right,
They put out a recommendation for the black box warning
for the new labeling, you know, using the Unique Device
(16:34):
Identify or the u d I for tracking purposes. They
talk about this informed consent checklist. That's great. The FDA
can recommend that, they cannot mandate any surgeon to use it.
So we've got advocates that we work with that are
working state by state by state to pass and inform
consent bill to hold plastic surgeons accountable, just to make
(16:57):
what the FDA has recommended mandatory, because right now, even
though the FDA recommends it, it's not mandatory. You've also
been very vocal in that the solution comes from advocating
for change but also maintaining it's our body, our rights,
but what we want is real information and so on
(17:18):
that note, One of the questions I have for you
on the legislative side is that the Medical Device Guardians
Act has been something that we met Sibo gold Ridge.
I've talked to you in private about it. It's can
you just tell the listeners what that is and what
it means for consumers if it gets past And I
want to jump back for a second when you talk
about the state legislation, the Pioneer and the Informed Consent
(17:39):
Bill has been an advocate. Robin Tout and you know
the Arizona Advocates that we're able to, you know, push
that over the finish line, you know. I mean they've
done an incredible job. And the Medical Device Safety Act
and the Medical Device Guardians Act, I kind of talk
about them together a bit. I started working on the
Medical Device Safety Act and I met the Medical Device
(18:02):
Problems Advocates that was part of women that suffered from
the assured device. So what you learn with a Class
three medical device, the manufacturers are protected, only the investors
have a right to litigation. And Class three medical device
is something that sustains or supports life or as implanted
(18:24):
and you know, could potentially cause an unreasonable risk of
illness or injury. And examples of these devices would be
pacemakers and breast implants and you know, like the the
assured device. So there is no protection for the patient
for a Class three medical device. So the Medical Device
Safety Act wouldn't mend the Food and Drug, Food Drug
(18:47):
and Cosmetic Act to restore patient rights, hold manufacturers accountable,
and require safer medical devices. Now, we don't want to
stifle innovation. Innovation is important, but there is no accountability.
How can we be sure the devices are safe if
there's no accountability whatsoever, So we bear all the risk
(19:07):
is the patients is what I'm hearing your say, right,
and people don't know, they're not aware of this. When
you say that, I think for most people this becomes
unbelievable that in the modern day is my friends have
said that something can be sold to us that's not
properly researched, that if it goes bad, we have no recourse.
And so this law would not only you know, change
(19:30):
things and protect us, but you've also come up with
a solution. Say this law is enacted, you know that
puts a lot of companies in reactive mode, and I
think it is patients. Do you mindsuring a little bit
about track My Solutions and this concept of, like you said,
making yourself count, you know, registering yourself when you get
a medical device, you know, share a bit with the listeners.
What that means is a solution because if you get
(19:52):
the legislation, you need the resources to implement the care
right right, and so along with the Medical Device Safety
Act is the Medical of Vice Guardians Act, and what
that is is to mandate that medical professionals have to
report adverse events to the FDA. Right now, a doctor
does not have to report, right only manufacturers are mandated
(20:13):
to do so. But again that can be subjected. You
know again, how can we make informed decisions if we
don't have accurate data. So that's why we need to
pass the Medical Device Guardians Act. I met track My
Solutions when I was working with the GALS and d
C on these two bills, and I really liked their
mission was save patients lives through technology. Jeremy Elias, who's
(20:37):
the founder and CEO. He you know, his best friend's
grandfather had a pacemaker with a faulty battery. Well they
didn't know it had been recalled, and you know, unfortunately
he had passed away, and Jeremy thought, well, why don't
we know there's no digital learning system in place. So
Jeremy looked further in that and you know, knew that
this was a problem and he came up with the solution.
(20:59):
Part of what we do, a patient can input their
device information and if there's ever a recall, we will
notify them immediately listen as it happens. What we want
to see happen is that the patient not have to
go through this process of importing their information and tracking
it down because it can be very hard to track
down your information. You know. We also work with hospital
(21:20):
systems and surgery centers and doctors to create this digital
format when there is a recall, that doctor can just
pull up everyone that has this device and contact them
immediately so that they can take whatever steps are necessary
to move forward. So hospital should know who has these
recall devices, you know, in their body. You should really
(21:41):
be you know, contacted by a medic, your medical professional.
Most people hear about recalls through a you know, an
ad for a lawsuit on the TV, or they're hearing
about it on social media. So with what we're going
through and what you proposed as an innovative way to
approach this in real time data management. If we can
have the doctor to have the data input it in
(22:01):
real time, maintain that confidence and want to know. And
I do think that there's some amazing doctors out there
that we've spoken to, that you've spoken to, that have
a genuine now interest in being part of the solution.
And this really reverses the flow of data in the
medical system. And what I find interesting now is that
a lot of you know, different types of plastic surgeons
(22:23):
are standing up and saying, Okay, you know what, we're
seeing enough of this. I think it's hit the staturation
point where now you've like you've identified in Arizona, there
was this magic moment of we got this past, we're
getting full disclosure. But now step two is how do
we create legislation to mandate that it's implemented. If you
currently have an issue with your implants, where do you
(22:45):
go to be notified and make yourself count? Do you
mind sharing a bit with the listeners what's out there
for you? That's a great question, so you can go,
you know, search for you know, the recalled implants, you know,
on the FDA site and they'll give you a list. Unfortunately,
it's very very confusing because Allergan biocell textured implants went
(23:05):
by several different names. At some point they were, you know,
like they McGan. So if you have McGann implants, you're thinking, well,
I don't have the Allergan textured bio cell implants, so
I'm not worried about this. Well, they have gone by
several names, so it is extremely confusing. Even contact Allergan
and they do have a site where you might be
able to put in some information and they might be
(23:26):
able to tell you. You You can go to track my
Solutions dot us and you know, you can use our
solution track my Implants, put your information there and you know,
as you put in your information, you would get an
alert if your rest implants have been recalled. You know,
we've got some patient advocates that work with the company
and they will look into that for you. But there's
not this there's not an easy way. It's not very clear.
(23:48):
Does that make sense? A thousand percent you pointed out
and is so important for many women in terms of
the step one of this is being diagnosed in dealing
with this issue. Is that a lot of us contact
our plastic surgeon, we up to friends, we use Google,
and we also when you said adverse events, many of
these companies have changed names. And so what I'm realizing
(24:10):
through meeting you and through going through this process myself
and talking to so many people, is that track My
Solutions is going to create the ability for people to
be identified, register and notified. And it's a great next step.
Breast and plant illness has literally changed your life. I've
watched you know, you are teaching people how to treat
(24:30):
us and as a teacher, as a mother, as a wife,
as a woman. You know, what do you want to
say to women dealing with breast and plant illness? What
would you advise them, you know as they go on
their journey, is some just things to consider and some
tips to turn this into a survival and thriving, you know,
like you've done, because you've really taken this head on.
(24:52):
Thank you. Well. The number one is you are not
alone and there's a whole network of women that are you,
have gone through or are going through exactly what you
are going through. You know. One of our kind of
our our taglines, our hashtags is not our daughters. And
you know, we think about we say, are you know
(25:15):
our grandmothers have suffered, Our mothers have suffered, We have suffered.
The next generation will not suffer. They will be informed.
Hashtag not our daughters. I think that we don't want
to take any you know away, anybody's right to do
whatever they want to do to their body, but you
need to have, you know, a proper informed consent. And
we don't want other women to have to go through
(25:37):
what we went through. And you know, we would like
that insurance coverage for the removal when you've got breast
implant illness. We would like for medical professionals to for
this to be on their radar. We would like for
patients to be informed. And I think that women need
to understand if you develop, you know, these symptoms of
breast implant illness. Now I chose to put these implants
(25:58):
in my body. My husband and I we we chose
to spend this money on this. And you know, for
women that had cancer and sectomies, they really didn't have
I mean, they did have a choice. They could have
just gone flat, but they there aren't many choices, you know,
for reconstruction you know, it's all hard on the body.
I think we all need to understand that we all
made the best decision with the information we had at
(26:19):
the time, and there was information that was hidden, you know,
the data was hidden, and there were people trying to
sell the doctors a product and sell you a product,
so it was very bias information. So I think, you know,
you need to forgive yourself because you at the time
made the best decision with the information you were given.
And also when you're you know, when you're ready and
(26:40):
you fail up to it. We you know, there's a campaign.
Um you know, maybe it's your implants, and you know,
just sharing your story with other women their patients, they
can you know, make those connections because people don't know
what they don't know, So sharing your story it is,
you know, trying to raise the idea that maybe you know,
(27:02):
these issues are coming from your rest implants or other
medical devices. And since the medical community is not aware,
you know, we have to help each other and until
that changes, but we need to create change. But the
data is needed to create the change. So you need
to take those steps to report your symptoms, you know,
the adverse events to the FDA's MedWatch program, because that's
(27:27):
what's driving the changes. If we didn't have all of
these patients reporting to the FDA's MedWatch UM, we wouldn't
have the black box morning, we wouldn't have the changes
in the labeling, we wouldn't have those, you know, the
discussion of the systemic symptoms that we all refer to
as a breast implant illness. So we want to encourage
(27:48):
people to take that time, you know, to contact MedWatch
and let them know exactly what you've experienced. And if
you you know, do remove your implants and you have
gains in your health or changes go or bad, report
that as well, go back. I implore people to contact
their medical professionals. A lot of women don't go back
(28:08):
to their original plastic surgeon, you know, just you write
a letter, talk about what you've experienced in the changes
in your health, and you know, as your patient responsibility,
send that letter to the medical professionals you work with.
They don't know what they don't know, and you need
to take the time to tell them. And you know,
in that we can create something better for better consent,
(28:29):
give people the information they need to make informed decisions
in the future. Maria is building a community of survivors,
(28:50):
one brave warrior at a time. Kristen, she is Christine
and she's been a source of strength, hope, and inspiration
for me and so many other women, doctors and advoct kids.
I look forward to saying what February has in store
for us this year, as that is the official b
I I D. I don't know if I would have
made it this far without her, and I know together
we are not alone, and you are holding the legacy
(29:13):
of our next guest, Cibil Night and gold Rich. She
was instrumental in helping fight for women's health in the
Dow Corning class action lawsuit of the nine nineties. Yes,
as a cancer survivor and wife of a doctor, she
kick started this whole movement with her husband's support. They
took this all the way to being the largest settlement
(29:34):
of its time, like four and a half billion dollars
somewhere in that neighborhood. Yeah, And sadly the fight didn't
end there. The FDA approved silicone implants is safe in
late two thousand six, and just like that they were
back on the market. So, despite her fight, they were
reintroduced and the impact was identical. Now new lawsuits are
(29:55):
being filed and those same implants have been conclusively shown
to cause camps there. And this is a type of
blood cancer named b I A l c L, which
was first discussed in medical journals in ninety seven, But
the FDA didn't report the Lincoln until two thousand eleven,
and it wasn't until twenty sixteen that the Word Health
Organization established a diagnostic and treatment process and set guidelines
(30:20):
for this. Why does it take so long for someone
to do something about this? I mean, think about all
the women who had breast implants in that time and
are suffering because of it. They still sell these devices,
the breast implants as they like device to the Dow implants.
And Sybil started her fight in the nineteen eighties. She
published her story in Miss magazine. She bravely showed a
(30:42):
picture of how the implants disfigured her breasts in an
interview with Connie Chung on national television. I do look
forward to hearing how she feels about the issue and
what advice she has for you all as you lobby
for change. Absolutely, thank you for joining us for Close
(31:03):
to the Chest. Our guest today is Sybil Night and
gold Rich, who is a Shiro in the Breast Implant
Illness World CIBIL as a survivor, an advocate, and someone
who's been fighting since the eighties to raise awareness about
breast implants and the risk associated with them. Thank you
for joining us. Your knowledge as a pioneer is going
to not only help us save lives, but we're excited
(31:24):
to learn and grow with you today. So I wanted
to start the conversation, Sybil and ask you first and
foremost what your experience has been with breast implants and
how you became an advocate. If you don't mind, be
happy to tell you. Thank you for that lovely introduction.
I had breast cancer. I was forty three years old,
and I couldn't think of anything that I'd rather do
than be reconstructed and move on with my life. The
(31:50):
problem was I became. I was reconstructed once, then twice,
then three times, then four times, and I realized this
is not getting me on with my life. There's nothing
wrong with me. My cancer has been taken care of.
What could be the problem? And so I started researching.
Most doctors said that I was the problem because that
(32:12):
my body would not accept the implants, and I thought
to myself, I don't think that's the way it's supposed
to work. And I don't think that's right. I think
that the breast implant is supposed to work for us.
It didn't. By some miracle, I found out that. Well,
actually I did research and then I had a miracle
to find out that the FDA had not approved breast
(32:35):
implants when I was getting them. And I started to
look around and went to medical journals and there was
very little in it. And then I went to the
package insert that somebody gave me that was included in
the box implants. And that's what started me off because
the last sentence in the package insert that I read
(32:59):
it said the possibility of loops lucas, rhetory arthritis and
scleroderma exists. And I wrote, oh my goodness. Oh I
was freaking out. And then I called the f d
A and they said, oh no, we have at aproved
breast implants. And I'm saying, are you kidding me? You're
selling these to so many women? Made me feel used,
(33:21):
It made me feel had I've been done in? And
I wrote a book about my experiences, and no publisher
believed me, and so the agent who was handling has
said to me, right, twelve hundred words and I'll see
if I could sell it to a magazine. I said, okay.
So I wrote twelve hundred words and it went into
(33:44):
Miss magazine and that was in tune of And once
it was in Miss magazine, the lid blew off of
everything I ever knew, because the FDA called me and
asked me to come to Washington to speak to the
panel that was about to approve breast implants. And I'm saying, oh,
(34:05):
I better go. They sent me a ticket and I
went to Washington, and that was the first time I
ever testified, and they nodded very patronizingly, and I thought
to myself, well, nobody's heard me. I know it. I
just had a feeling in my gut. But they needed
somebody to cover them and said, well, we had a
patient here, and obviously she couldn't accept the breast implants.
(34:25):
Was probably her body, She's had a lot of surgery.
But what I did notice is that there was a
group of men in the middle row of this auditorium
with briefcases and suits. And I'm saying to myself, why
would all these men be here and on the far
right of the room, we're all a lot of press,
and say, how can they need so much press for this?
(34:47):
And the reason is the men in the middle were
the suits from all the manufacturers, Sue's meaning men in suits.
They all set their people, and I'm saying to myself, whoe.
And at that time, Sid Wolf, who was a physician
who was with a Ralph Nader's group of UM consumer advocates,
(35:12):
and he got up that day and he testified that
there is the possibility of cancer from breast implants, and
he pointed to several articles. My heart dropped down to
the ground. I've already done that. I I didn't want
to go back to the cancer routine at all. And
(35:35):
so I was shocked and I tried to process it all.
And one of the TV people came up to me
and asked me if I would go to the hall
and answer some questions, and I did, and once people
all over the country heard what I had to say
that these products haven't been approved, I don't think they're safe,
(35:58):
and we've just heard information that connects it to cancer.
Why would a cancer patient get a cancer causing product
inside of them? If they had told me, there wouldn't
be no way that I would have done that. The
level of strength you had to have at that time
two stand up against the doctors. You were married to
(36:18):
a physician, you had daughters, you had been through hell,
and you still got in that plane and you went
to that hearing and you stood there and you shared
your story. And so first and foremost to say thank you,
because when I watched this and I listened to what
you've been through, what one of my greatest questions for
you is where did you find that strength? Yeah? Well,
(36:43):
you know you have to have strength to get through cancer.
And so I found some strength there. But I realized
that a basic part of my personality is don't lie
any don't mess with me. I can handle the truth.
I can deal with almost anything if it's straightforward and honest.
(37:06):
Then I put the pieces together and figure out how
I can work on work with it. And it just
it hit my personality button so right in the middle,
and I knew I had no other path to go
but to fight these people and tell them you cannot
do this. I'm not the only woman who's having this problem,
and you cannot keep taking advantage and that's the end
(37:29):
of that, and I was not going to stop until
I finished with them. What was your goal, like, what
was the first step for you where you thought you
could genuinely make an impact? How did you decide how
to take action? The first thing I wanted to do
was make sure there was a universal truth, if that existed,
for every woman to be told that all of these
(37:52):
side effects not don't keep the information inside the box
that they opened in the operating room, tell us, show us,
give me a booklet that would have said that. It
took a long time to kind of crank all of
this out, but we ultimately got you know, got that
booklet form from the FDA one TV station interviewed me,
(38:13):
then a newspaper called Then, a magazine called then another
TV thing, and I kept going and going and going. Uh.
Years ago, Connie Chung had a show, and that's when
I did the most what I thought was courageous. My
daughters were just horrified at what I did when I
let them have a picture of what I looked like
(38:37):
with an implant that was ready to extrude, and I
gave it to the Connie Chung show and allowed them
to show it. Once women saw it exactly what that
looked like to encapsulated implants, one of them pushing through
a hole in the center of my breast. That women
(38:59):
relay it too. I wasn't the only woman in America
who was having that problem. And my phone started ringing
off the hook. My daughters were furious with me. But
that's the thing. What you know, I played bridge, and
there's a there's a line in bridge that says one
(39:20):
peak is worth two finesses. Do you know what's in
somebody else's hand, you can play a lot better. So
now women knew exactly what was on me, and if
they had it or anything close to it, they knew
they were not alone. What currently do you see these
companies doing after the FDA has mandated them to published
(39:41):
articles and announce these risks. Do you feel that we
are currently as women getting authentic information from the manufacturers
about the risk of implants. Absolutely not. And I'll tell
you what the hook is on a class action that
you would go ahead with. And I'm not a lawyer,
but I've been around a class accident for so long
(40:02):
that I know a little bit about them. And what's
happened is the manufacturers were required to do these post
market studies and they never did them. They blamed it
on the women from not participating in the studies, but
that is not true, and you can get enough women
to come and testify that I called and they didn't
(40:24):
want to hear from me. I called the f d
A and I was put through to four different phone numbers.
There is proof that they never seriously approached these post
market studies and you were entitled to that information when
you got this quote newly approved implant. To me, that's
(40:44):
the basis of the whole case. And I never asked
anybody about that. But we have a lawyer. Or is
that true? Yeah? Absolutely, I mean there's they're required to
give full disclosure and the fact that they don't and
that nobody. You know, the onus is really on the patient,
and that's not how it should be, but it is.
(41:06):
Of course, the onus is on the patient to find
all this stuff out. But if a patient, a woman,
does everything in her power, she calls the manufacturers. And
I want to report this because the FDA is collecting
this information and you also are required to do post
market studies, So I am reporting this to you, and
what you just touched on in in the case, and
(41:28):
I had a meeting on Monday yesterday with my intensivest
and she has the horrible job of helping me navigate
all of the effects the disease has had on my body.
So I've had a bilateral hip replacement, I've had my gallbladder,
my appendix removed, I've lost parts of my colon. I've
gone deaf in one ear from tumors traveling throughout the body.
(41:50):
And I think the most important thing for me and
any woman dealing with this is this isn't quote textbook
right Like, there is no textbook. There is no place
to go and say if you are diagnosed, here is
the protocol. So the second thing I see that is
a really important movement by some of the great doctors who,
like you said, are brave enough to stand up and
(42:10):
say this is an issue. We have a hippocratic oath.
We want to help solve this problem. Is creating a
protocol that states, you know, financially what this should cost
so it doesn't become a whole another exploitative business. And
then also what alternatives are available to us as women.
Because now you've gone through an ex plant, you've been disfigured.
(42:32):
You no longer look like you think you're going to look.
And so what I'm looking forward to is the fact
that you really encourage innovation, education and research to keep happening.
You've taken this position with women that we deserve better,
we deserve to be able to trust these stakeholders. Just
two final questions. You know, as someone who dealt with
(42:53):
us for years and you've been out there advocating, et cetera,
what advice would you give to a woman who's just
read that they have recalled implants. Be prepared for a fight.
Be prepared for a fight for your health, and be
prepared to take it beyond just your health. And make
(43:16):
sure that the next generation at least is equit to
know that they are also going to have to fight
if they go down this road of implants. And at
the same time as you're fighting that issue, there has
(43:38):
to be a movement two. Recall the approval that the
FDA has gotten because they have not done their homework
and received all these postmarket studies. Because we know what
the post market studies show that now we have a
l c L and a lot of other things, demand
(43:59):
that they recall disapproval and um develop a product that works.
You can put a man on the moon or Jeff
Casos into space, and you can't figure out how to
figure out a product that will fit in somebody's some
(44:19):
human beings. Body, come on, I mean, you know this
is this is century when I think commanding respect is.
One thing you touched on a lot is that you
went into those rooms, Sibyl, and you stood up and
you commanded respect in a way that was genuine, authentic,
and you were so inclusive. And I think as we
continue as women to organize and do exactly what you said,
(44:44):
we have tools available to us. Now we have attorneys
that are passionate about this issue. But most importantly, the
emotional side of this disease I think has been the
most grueling part of it. I think as women, we
take all of the internal resources we have to air
children and be fixers and be strong, and we use
that to cope and ultimately I've noticed for me, my
(45:07):
standard of health dropped from wanting to you know, be
bike miles and accomplish great things too. Can I get
out of bed this morning and put on makeup and
be articulate and string a sentence together, and I think
we work in a world where the second biggest impediment
for this has been financing it. And so one of
(45:27):
the big movements as part of Close to the Chest
and thank you to my Heart for allowing us to
share this story, is that the cost benefit of this disease.
The companies that you brought up are being injured the
most are ironically insurance companies. I would hate to know
what my insurance company is paid to manage my symptoms
and secondary diseases versus getting rid of the primary issue,
(45:50):
which are these implants. And so I've noticed recently and
Maria Dmitro and yourself and many people have been logging
lobbying to get us an insurance code and so to
have breast implant illness recognized. It's been a major milestone.
But now as we lay down the foundations for treatment
to get insurance companies to get behind this issue, do
(46:11):
you have any advice to us, as victims and as
advocates on how we can go out there and help
get an insurance code and get a protocol in place
so we can actually get discovered, Because I think the
manufacturers are taking advantage of the fact that, like you, said,
we financially end up upside down. We can't afford the
thirty dollars to do the appropriate explant in surgery. So
(46:34):
a lot of us go untreated and die from secondary
illnesses because we don't have coverage. Well, I think you
have to identify who the lobbyists for the insurance industries
are in Washington, and then you have to interview all
of them and find out who would be sympathetic to
this issue, because there are lots and lots of you know, lobbyists,
(46:57):
but they want all kinds of insurance but other things.
You may not come in as the pretty girl. You're
not the woman that they want to take to dinner.
You're the one that's saying, oh god, this is going
to get in the newspaper, that these women want to
have insurance coverage, and what are we gonna do? How
are we going to handle the ripple effect of this
(47:18):
that's gonna be awful. By the way, public relations is
your best friend. You have the Internet. I mean, you know,
if somebody could sit down and write a treatise or
a discussion or an argument about the importance of insurance.
(47:38):
For example, I always felt that if you paid a
manufacturer and extra fifty dollars to every implant sold that
they would be able to set up their insurance company
and pay for everything you needed after that. Uh. But
they knew that they were going to have to put
(47:59):
in a lot more because they knew that they had
a product that was awful. And as we go forward,
what I've learned that Christine and I can do as
part of sick titties dot com, which is the funny
website I created to describe this horrible illness. And what
happened to me is people kept asking what was wrong.
I would state to them, while I have sick titties,
because it was awkward. We just went through the meat
(48:21):
too movement and here we all are talking about our
boobs and that's an uncomfortable issue. And so, through the
great advice of some friends and with Christine's support and
the rest of the team, our mission is to create
a site that can you know, do what Command Trust
tried and was so successful with and using technology to
educate people to get you and all the information you
(48:42):
published on there. But most importantly, I think my marching
orders for the next couple of days are to find
myself somebody who gives a ship about women's issue that
wants to lobby for insurance coverage because ultimately, if we
make this a business to business issue and attack it
from both, I think if we educate women that they
(49:02):
have safer alternatives. I think if we commit continue to
build this community of she rose and for you to
meet you today, Sybil was not only an honor, but
I have to say it was life changing. You're like
a god shot of hope and as I go forward
in treatment, I decided to do what you did and
with your bravery and being willing to share what you
(49:22):
look like and what you went through. What Close to
the Chest is all about is I want to demystify
what's really happening. I want to give women access to lawyers,
to doctors, to survivors, to advocates, and to empower us because,
like you, I am not willing to sit around and
let my daughter and my granddaughters and other people struggle.
(49:43):
I think if knowledge is power and information creates action,
You've laid a foundation that gives this community strength. You've
given us courage, and you've shown people that you don't
just survive, but you really strive to change and be
the solution to the pro mom you need and without
use of But women like me would not have a voice,
(50:04):
we wouldn't have an option, and we wouldn't have hope. Well,
thank you for all those nice words, but I will
tell you that the work that I do and the
work that you do, it gives me more strength and
power to just keep doing more. And if I have
to do this till the day I die, I will
be doing it till the day I die, much to
(50:25):
the chagrin of my family. When don't you retire, Well no,
I'm afraid as long as they are bad actors out there,
it's not a real it's not even thinkable. So let
me help you in whatever way I can. I wish
all of our women so much. They need good luck
and they need to have the information upon which to
(50:49):
base a sensible decision for themselves, because in the end,
it's every single individual woman's journey. And where the manufacturers
and the insurance come. But these get into trouble is
when all of these individuals come together with a purpose.
So what I suggest is you make a mission stakement.
(51:10):
What is it you want, what is it you think
you can accomplish? Put all that together and there's your credo,
and this is what the manufacturers and the insurance government
is gonna have to deal with. And you know what,
they're not gonna like it, and you're gonna love it. Fine.
(51:34):
That was a life changing conversation, Chris. I am so
in awe of how strong, unafraid, and determine these women are.
I feel honored to call them my friends and fellow
change agents. I think the clear call to action and
organization is why we are winning this battle. Absolutely, I
would not want to be up against you. All the
facts and intent are clear, but that's just my opinion.
(51:57):
I mean, I'm not the attorney in this case or
any other really, because you know, I no longer practice,
but it does inspire me. You know how I get
riled up over injustice. Let's just talk about the three
initiatives and how your pain becomes an actionable purpose. Well,
let's start with full disclosure. Last week you mentioned the
(52:19):
black box morning. This is key. I knew if they
had told me the full risks and I had the
option to provide informed consent, there would be no toxic
sax in me. Yeah, that would be a great start, huh,
but I wish it required them also to do something
like a public service announcement so that you could reach
women on mass instead of just one on one. I mean,
(52:41):
it assumes that the doctors are going to do this
um and it will take time, and really, how can
we enforce these disclosure statements? I think the next call
to action is key. The Medical Device Safety Act needs
to be brought before Congress and past. I know, right,
we get notified when our break to recall, but why
not our boobs. This has to change. I also think
(53:05):
the class action suit should expand beyond b I A
l c L to include those suffering from b I I.
This is a horrible autoimmune disease that is wrecking our bodies.
Oh yeah, yeah, I've seen it firsthand on you. I mean,
we've talked to so many women. B I I needs
to be recognized as a disease, not just some afterthought,
and manufacturers being held accountable for their part in perpetuating
(53:28):
the misinformation that breast implants are always safe. Chris, I know,
I want the world to know that b I I
is awful. It is not something we choose, and women
have been harmed. We will not stop until there is
help and accountability. Well, I'm not going anywhere until we
see that happen. I am confident that things are about
to change, because, as you know, together we are not alone.
(53:54):
Close to the Chest with Kristen and Christine has been
brought to you by B Noble Media Group and Heart Radio.
A very special thanks to our guests Maria Gemitro and
Sybil Knight and Goldridge. To find out more about Maria's
organization on device safety, please visit www Dot prest Implant
Safety Alliance dot org. That's www Dot Breast Implant Safety
(54:21):
Alliance dot org. Now I'd like to share some gratitude,
a very special thanks to I Heart Radio, to our
Parker and her I Heart Radio marketing team, and a
big big thanks to our executive producer, Ramsey Young. If
you or someone you know would like to know more
about breast and plant illness, please visit Sick Titties dot com.
(54:42):
That's s I C K T I T T I
e s dot com. Also, please follow us on Instagram
at sick dot tittis and at B Noble Art that's
B N O B L e A r T. And
we would also low to have you join our Facebook
page at b Noble on B I I, and please
(55:05):
remember You're not alone. Together, we can beat this. The
views and opinions expressed are solely those of the podcast
author or individuals participating in the podcast, and do not
represent the opinions of my Heart Media or its employees.
This podcast should not be used as medical advice, mental
health advice, mental health counseling or therapy, or as imparting
(55:26):
any healthcare recommendations at all. Individuals are advised to seek
independent medical counseling, advice, and or therapy from a competent
healthcare professional with respect to any medical condition, mental health issues,
health inquiry, or matter, including matters discussed on this podcast.
Close to the Chest with Kristen and Christine is a
(55:47):
production of I Heart Radio and produced in our studios
located in Atlanta, Georgia. For more podcasts from my heart Radio,
visit the i heart Radio app, Apple Podcasts, or wherever
you listen to your favorite shows
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