33. The Implants (Poly Implant Prothèse)
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Dow Corning.
In 1962, a woman named Timmy Jean Lindsay consulted a plastic surgeon in Houston about removing the large rose tattoos that were positioned above each one of her breasts.
The tattoos were unsightly reminders about a past life that Timmy Jean would rather forget.
She was a 29-year-old divorced mother of six who was ready for the next phase of her life, and she thought that getting rid of those tattoos would help her leave the past behind.
Frank Giroux, the doctor who performed the tattoo removal surgery on Timmy Jean, informed his patient about another way in which she could reinvent herself.
He told her that there had been a technological breakthrough in breast reconstruction surgery that involved silicone implants.
In fact, Dr.
Giroux, along with Dr.
Thomas Cronin, had actually invented the silicone implant, and they had been actively looking for volunteers to have the surgery.
Timmy Jean Lindsay, whose body had taken a toll birthing six children before the age of 30, was the perfect candidate.
She agreed to have the operation, but only if Dr.
Giroux agreed to reshape her ears as well.
The surgery was successful.
Timmy Jean had become the first person to undergo a modern-day breast augmentation, and she was happy with the results.
And so were the doctors.
It was hard to believe just how far the art of plastic surgery had come.
Less than two decades earlier, it had been reported that Japanese prostitutes were injecting goat's milk and paraffin wax into the breasts to cater to the taste of U.S.
servicemen stationed in their country after World War II.
Now, thanks to Dr.
Jarot and Dr.
Cronin, the breast implant seemed to have been perfected, and it would soon become the world's most popular form of plastic surgery.
The largest manufacturer of the silicone implants was a company named Dow Corning.
It was a joint venture between the Dow Chemical Company and Corning Incorporated that had been formed in 1943 to produce silicone products for the United States military.
After the war ended, Dow Corning had already begun exploring other ways to use the material before the invention of the silicone implant fell into their laps.
The company performed more than 300 studies of the implant's effects on animals with favorable results before they officially hit the market in the early 1960s.
By 1970, more than one million women had undergone the procedure and Dow Corning, who insisted that their silicone implants would last a lifetime, had grown into one of America's most profitable industrial companies until 1984.
That's when the lawsuits began.
My throat closes up and I feel like I'm suffocating and my face, I get hives on my face and my chest.
And I've had where where I went into the emergency room where my tongue was swelled shut the back of my throat and it's an ongoing thing it doesn't stop you know I'm always feeling like I'm going to suffocate as I'm doing any part of my day well about a year after I had the implants put in I started noticing an almost constant flu-like feeling
very tired all the time
a difficult breathing problem.
You can't take a deep breath.
It feels like the breath just stops in the middle of your chest.
Thousands of women filed suit, claiming that everything from lupus and rheumatoid arthritis to depression and breast cancer were caused by Dow Corning's silicone gel breast implants rupturing and leaking into their bodies.
Even worse, there were claims that not only were the implants harmful to the recipients, they were harmful to their children as well.
Five of the 93 women in this lawsuit are claiming that silicone from their implants may have harmed their children by seeping into their wombs and into their breast milk.
This may be the first implant case in the nation where women are claiming harm to both themselves and their children.
Dow Corning assured the public that their products were safe.
The company said it had become the target of ambulance chasing lawyers from all over America and reiterated the fact that there was no scientific evidence that the implants were harmful.
And they were correct.
There was no scientific evidence that the implants were harmful to humans.
And that was precisely the problem.
The product had not undergone sufficient testing.
There might not have been any scientific evidence to support the implants were harmful to humans.
but there was also no scientific evidence to prove that they were not harmful either.
In response, in 1992, the United States Food and Drug Administration put a temporary hold on the use of silicone implants until the science was settled.
This is Dr.
David Kessler, the commissioner of the FDA at the time.
I am requesting a moratorium on the further use of all silicone gel breast implants.
We still do not know how often the implants leak and when they do, we do not know exactly what materials get into the body.
The information we've acquired since the last panel meeting, rather than dispelling doubts, has increased our concerns about the safety of these products.
For example, we've recently received reports from rheumatologists that they are seeing an increasing number of autoimmune diseases among breast implant patients.
Meanwhile, the lawsuits against Dow Corning kept pouring in, and with millions of women worldwide potentially affected by the product, there were no signs of them stopping.
In fact, by May 1995, Dow Corning had already paid out more than $500 million in settlements, judgments, and legal costs, and it was facing another 200 trials in the next six months.
With potentially billions of dollars of claims levied against them, Dow Corning needed to slow the process down.
The Dow Corning Corporation today filed for bankruptcy protection.
The company says the number of lawsuits filed against it over breast implants has forced officers to seek financial protection.
By filing for bankruptcy, Dow Corning halted all new lawsuits against them from proceeding while it negotiated a settlement of the already existing claims.
Instead of negotiating thousands of individual amounts, the company's bankruptcy protection forced all claimants to draw from the same pool of money.
the amount of which would be approved by a court.
The company's initial offer of $2 billion to 410,000 plaintiffs over a 20-year period was shot down by a judge for its inadequacy.
By Dow Corning filing bankruptcy, they've manipulated the legal system
to avoid their responsibility in paying compensation to implant victims.
Women are frightened.
They're aggravated.
They have been waiting years to receive compensation, to have their implants removed, and to pay for the costs of medical treatment from the injuries that they received.
And now they don't know where to turn to to receive compensation.
Negotiations continued but Dow Corning's silicone implant business did not.
The company stopped producing the product shortly after the FDA moratorium.
This is Dow Corning's chairman, Richard Hazleton.
From a business judgment and viability point of view for my company, it was our conclusion that we could no longer participate in that business.
But it was also our judgment based on the way things developed after the FDA moratorium that there was not going to be a viable business for silicone breast implants, at least for the foreseeable future.
That's probably the right decision.
There was no foreseeable future in the silicone breast implant industry, especially not for Dow Corning.
In a 1997 Louisiana class action lawsuit, a jury found that, in addition to failing to test the silicone used in the implants adequately, the company had also knowingly deceived the women by not performing those tests, thereby hiding information about the health risk of that silicone.
Next tonight, the controversy over silicone gel breast implants.
Three years ago, the FDA put tough limits on their use, but those three years have brought new research and complicated legal development.
As the legal war waged on, more than 20 medical studies on the health effects of silicone implants have been completed, including a study conducted at Harvard Medical School that focused on 87,000 Boston area nurses.
This is Dr.
Matthew Yang, who helped perform that study.
We found found in a very large group of nurses who had had breast implants that there was no increased risk of having connective tissue diseases like rheumatoid arthritis, scleroderma, lupos erythematosis, and other connective tissue diseases.
An analysis of the nurses revealed that there was no correlation between silicone breast implants and an increased risk of connective tissue diseases.
Additional studies by the Mayo Clinic and the Institute of Medicine arrived at the same conclusion.
Silicone gel breast implants do not cause major diseases.
In its 400-page report, the Committee of the Institute of Medicine summed it up succinctly, quote, Some women with breast implants are indeed very ill, and the IOM committee was very sympathetic to their distress.
However, it can find no evidence that these women are ill because of their implants.
These conclusions were a vindication for Dow Corning, who had maintained that their silicone implants posed no danger.
David Bernstein, a law professor and advisor for the American Tort Reform Foundation, agreed that the studies made a very strong statement, and he added, quote, It would have been nice to have had this seven billion dollars ago.
Bernstein accused the courts of making legal judgments in the absence of science.
You're right about that, David.
The company could have used that seven billion dollars to, oh, I don't know, perform its own studies about the silicone's effects on the human body before it started sewing it into people.
Also, it's not clear how Mr.
Bernstein arrived at the $7 billion figure because in 1999, Dow Corning had emerged from bankruptcy after nine years and settled for $4.5 billion,
$3.2 billion of which went to the victims.
The victims of diseases that weren't actually caused by the product made by the company that would be paying them.
A very expensive lesson for a company to learn not to forego thorough safety testing.
Thousands of women who claim that breast implants have made them sick may soon be compensated for their problems.
Lawyers for 12,000 women who have sued have now come to an agreement with manufacturers, a proposed $4 billion settlement package that affects any woman who has ever had an implant.
As for the silicone implants, they came back bigger and better and firmer than ever.
In 2001, with ample scientific studies backing them up, The United States FDA ruled that silicone gel breast implants were safe and the moratorium was lifted.
We heard many points of view and we seriously considered all of them.
During the panel meetings, we heard from women who were dissatisfied with their implants.
We also heard from women who were satisfied and who told us they wanted to have a full range of safe and effective breast implant options available.
But less than a decade later, the safety concerns surrounding silicone breast implants would resurface.
Thanks to one man's greed.
A French breast implant manufacturer cuts costs to increase profits and creates a worldwide health scare in the process.
On this episode of Swindled,
they bribed government officials
and clear violations of the A-State law.
Dummied up its books and records and high points.
support for Swindled comes from Simply Safe.
For the longest time, I thought home security meant an alarm going off after someone broke in.
But if the alarm is already blaring, it's too late.
The damage is done.
That's a reactive approach, and it leaves you with that awful feeling of violation, even if the intruder runs away.
That's why I switched to Simply Safe.
They've completely changed the game with Active Guard outdoor protection, designed to stop crime before it starts.
Their smart, AI-powered cameras don't just detect motion.
They can tell you when there's a person lurking on your property.
That instantly alerts SimplySafe's professional monitoring agents in real time.
And here's the game changer.
The agents can actually intervene while the intruder is still outside.
Talk to them through two-way audio, hit them with a loud siren and spotlight, and call 911 if needed.
It's proactive security, and that's real security.
I trust SimplySafe because there are no long-term contracts, no hidden fees, and a 60-day money-back guarantee.
They've been named best home security systems by U.S.
News and World Report for five years in a row, and I can see why.
Get 50% off your new SimplySafe system at simplysafe.com/slash swindled.
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By the time Jean-Claude Maas quit his job at Bristol Myers Squibb in the late 1970s, he was considered one of the best medical sales representatives ever employed by the pharmaceutical giant.
Maas had worked at the company for over 15 years before leaving to sell something he was a bit more passionate about, sausage and wine.
This seems like a strange career change on the surface, but Jean-Claude was a natural salesman.
He had made a career out of selling everything from life insurance to dental equipment.
The Bristol Myers gig wasn't his first sales job, and selling wine and meat wouldn't be his last.
In fact, Moss would return to the world of medical supply sales a decade later in the late 80s after meeting a plastic surgeon named Henri Arion.
Arion was well known in the industry for having introduced breast implants to France in 1965.
Maas, the salesman, partnered with Arion, the subject matter expert, and the two began manufacturing and selling saline breast implants under the name Simoplast.
The company's production facility near Marseilles was literally a mom-and-pop shop.
Henri provided the recipe, while Jean-Claude and his lifelong companion and mother of his children, Dominique Luccieri, took turns inflating the saline implants.
The couple handled everything in-house.
While one served on the factory line, the other swept the floors.
Business was good, but the company nosedived when Henri Arion's plane crashed into the ground one day in 1990.
Simiplast probably would have folded eventually anyway.
Years later, in 1999, The U.S.
Institute of Medicine would discover that the implants produced by the company were prone to rupture.
But at the time, back in 1991, Jean-Claude Maas Maas still believed in his old friend's formula.
He launched a new company making the exact same thing in the exact same building and named it Polyimplant Protiste, or PIP for short.
The only noticeable difference between Simoplast and PIP, besides the absence of honorary, rest in peace, was that, in addition to saline breast implants, PIP would sell silicone breast implants as well.
expanding the product line.
Smart move, maybe, but very poor timing.
In 1995, as a result of the United States FDA issuing a moratorium on the use of silicone implants, France followed in the Americans' footsteps and issued a moratorium of their own.
Luckily, PIP was approved to sell saline implants in the U.S.
the following year, which helped ensure the company's survival.
When silicone was reintroduced as an option for breast implants in 2001, Jean-Claude Maas entered the marketplace aggressively to make up for lost time and lost revenue.
He traveled to conferences all across France and pressured medical professionals into buying his goods.
One doctor who remembered meeting Maas at one of those conferences described him as uncompromising, quote, He told me my implants were rubbish and that I should use his.
He was very pushy.
He seemed ready to do anything to grab a big market share, and he pursued this very aggressively.
It ended up with sort of a dumping of his products at a price no one could compete with.
Moss even flew to countries like Colombia, Venezuela, Mexico, the UK, pretty much everywhere breast implants were popular to pitch his product to plastic surgeons.
And his strategy paid off.
By the end of 2001, DIP was the third largest supplier of silicone breast implants in the world, selling over 100,000 implants a year.
Less than 10 years later, Jean-Claude's mom-and-pop shop had transformed into a legitimate operation with over 100 employees, with more than 2 million sets of silicone implants sold, many of which were part of PIP's innovative asymmetrical line.
Instead of the perfectly round beach ball staple-to-the-chest look that was popular in the 80s, PIP offered a product that more closely resembled a natural pear.
And although undercutting the competition and introducing innovative products certainly secured a share of the market, The real secret of PIP's financial success was in the ingredients.
The paperwork related to their product claimed that the prostheses contained an industry standard medical grade silicone called NewSil that was manufactured in California.
The truth was that the implants were inflated with John Claude Moss's own silicone recipe, which would soon be discovered to be a recipe for disaster.
I always wanted
big boobs and
when I was married I kept saying to my husband, Oh, can I have my boobs done?
He was like, No, no.
And then we separated,
must have been in about 2003.
And then I just thought to myself, you know, I'm gonna treat myself.
So I did.
I went and got a credit card and saved some money, and that's how I got them done.
So I found a lump under my right armpit.
I went to my GP, he referred me to the breast clinic, which I sat there for three hours thinking I had breast cancer.
I saw the doctor after having the mammogram and an ultrasound and she said it's not breast cancer it's your implants ruptured and leaked into your lymph node.
Between 2007 and 2009 regulatory authorities in France had begun receiving an alarming number of complaints from doctors around the world about potentially defective breast implants manufactured by Polyimplant Protiste.
Women were reporting lumps around their implants and under their arms.
Some were experiencing hardened and inflamed breasts with shooting pains throughout their bodies.
Other patients were lethargic and suffering from severe depression.
And when ultrasounds and mammograms were performed on these ailing women, an unnerving trend was revealed.
PIP silicone implants were rupturing at double the rate of other implants and leaking silicone into the bodies of the host.
where it was spreading to their lymph nodes.
The news alone became a psychological burden for some women with the PIP-branded implants.
An unnamed factory worker with the implants shared her worries with The Guardian, saying, quote, The tests say that they're still in place, but I'm having them removed anyway.
I'm terrified they'll rupture or explode at any moment.
I try to sleep on my back, if I sleep at all.
Some people try to avoid extreme physical exercise for fear of damaging the implants, but I do hard labor on a factory line.
I go to bed feeling bad.
I wake up feeling bad.
It's like living with a ticking time bomb inside of you.
For others, that ticking time bomb had already exploded.
A 57-year-old cancer survivor named Sylvie described to The Guardian what it was like to have an implant rupture.
Quote, the implant had leaked to such an extent, I had four swellings hanging from my armpits, which were full of silicone gel and had to be drained.
Sylvie could not have the implants removed immediately because she was in the middle of chemotherapy.
She had gotten the implants as a way to reconstruct her chest seven years after surviving breast cancer.
And not only had the cancer returned, but now this, quote, it's as if a foreign element is poisoning your body as well as the cancer.
If you think about it too much, you'd suffocate.
Further analysis revealed that there was an issue with the casings PIP used to house the implants.
This is Dr.
Grant Stevens, a world-renowned plastic surgeon in Los Angeles.
Well, it turns out that the silastic shell, or the casing, to use your term, deflates at a three to four times higher rate than the typical silastic shell.
This may be for a number of reasons, but one of the reasons certainly appears to be the way in which the silastic is cured.
PIP has a very unique method of curing the silicone or silastic, and they do this under heat, whereas the other manufacturers such as Allagon and Mentor do it at room temperature.
According to Dr.
Stevens, that difference in the curing rate made the implants more vulnerable to leakage or rupture.
And if that wasn't concerning enough, the silicone housed in the casings wasn't the medical-grade solution typically used in breast implants.
No, the silicone used in PIP's implants was industrial-grade silicone, the type that was commonly used to manufacture mattresses and fuel additives.
Although the end product of the two silicones looked similar and even felt the same, experts were worried that the hidden hidden differences and unknown effects of the industrial type could be substantial.
At the time, it was impossible to know because PIP followed none of the regulations required to manufacture breast implants.
Unlike medicine, medical devices including implants do not require years of clinical trials.
Medical devices are simply inspected and approved by governing bodies.
Although Tuf Reinland, the German firm responsible for granting safety certificates for European medical devices, had awarded PIP a quality certificate certificate for the production process.
That certificate did not apply to the industrial silicone used in the implants.
In fact, according to one of PIP's factory workers, the staff had been instructed to quote, use your best guess when mixing the materials.
And they were told to test the quality of the product by simply sticking a finger in it.
PIP had essentially poured its homebrew silicone into an inadequate bag without any testing at all and sold it to human guinea pigs all across the globe.
The silicone here in question, the PIP industrial strength silicone, has many contaminants.
We're not sure just how many.
There are a number of substances which are left behind when silicone is made and these substances are usually removed before it's used for medical use.
We presume that the industrial strength or industrial grade silicone will still have these minor contaminants.
We can't be certain just what all can go wrong.
We know there's an increased incidence of inflammation.
We're not certain about other health risks, but we certainly have concerns about cancer and other toxic exposures, including to platinum potentially.
So what we need to do is get these implants out of the women before they rupture.
We know they are going to rupture because the shells are defective.
We also know the silastic, excuse me, the silicone gel is industrial strength and it has many contaminants.
No one would want these contaminants in their chest.
In March 2010, during an unannounced visit to PIP's factory, health inspectors made a disturbing discovery before they even made it inside of the building.
Outside, along the wall of the facility, were six empty containers of siloprin, a type of liquid silicone designed for industrial use.
Just as suspected, PIP had been using the industrial silicone in about 75% of the implants it produced.
An approved medical-grade silicone was used in the other 25%,
but it was found that those implants cost five times as much to produce and were reserved for wealthier clients.
It was also discovered that PIP was using the industrial silicone for more than just breast implants.
PIP-branded butt implants contained the unapproved gel as well, and for the men of Latin America, the company had been exporting pectoral and testicle implants manufactured with the same untested material.
What the inspectors did not find at PIP headquarters, however, was PIP's 72-year-old founder, Jean-Claude Maas.
When armed police arrived at PIP about a week after the health inspection to bring Maas in for questioning, it was reported that they had disappeared to Costa Rica.
In Maas's absence, the world reacted to the news about the unapproved filling.
The United Kingdom banned all PIP-branded implants, which was followed by a complete recall of the products by France's medical safety agency.
Without any incoming revenue, the losses began to accumulate for PIP.
The company lost as much as $9 million in a few short months before the factory was shut down and the doors were closed for good.
A few months later, promotional materials for a new breast implant manufacturing company began circulating.
The name of this new company was France Implant Technology, and it was registered to Jean-Claude Maas's 27-year-old son Nicholas and his 24-year-old daughter Peggy using their mother's address.
Two former PIP managers were listed in senior positions in the company's business plan, and Jean-Claude Maas, who was described as a quote, creative genius in the document, was named as a technical commercial consultant.
But the company collapsed before it ever produced a single implant due to the media's extensive coverage of the PIP scandal.
Almost six months after the health inspection at PIP headquarters and the global ban of its products, Jean-Claude Maas was still getting drunk and gambling in Costa Rica, and he was notoriously bad at both.
In France, Maas had been banned from several casinos over the years for his unacceptable behavior, which seemed to have traveled with him to Central America.
In June 2010, he was charged with life and health offenses for driving while intoxicated in Costa Rica.
Maas returned to France before standing trial, which prompted Interpol to issue a warrant for his arrest.
Back in France, on November 18th and 19th of 2010, almost eight months after the unapproved silicone filling had been discovered, Jean-Claude Maas was finally interviewed by the police.
This is a relief.
It's come late, but at least it's happened.
He's been placed in preventative detention.
Let's see what the interrogation brings.
We're hoping for a formal investigation, perhaps with him being reminded in custody so that he does not leave French soil.
The founder of PIP openly admitted to deceiving European safety inspectors since the company's inception by instructing his employees to hide the truth.
A translated transcript of the conversation reads, quote,
Usually from 1997 onwards, we hid the products used to make the PIP jail.
I wasn't allowed to buy these products because they were not authorized.
We organized everything to escape being monitored.
We did it for 13 years without a problem.
When asked why he chose to use the industrial silicone instead of an approved product, Moss pointed to to the bottom line, quote, I always knew.
I did it knowingly because PIP gel, as far as the price performance ratio was concerned, was cheaper and of better quality.
The superiority of Moss's homemade gel is debatable, obviously, but there is no debating that it was cheaper to produce.
About 90% cheaper, in fact.
New Sil, the medical-grade American gel that was used in PIP's high-end implants, cost about 35 euros per liter in contrast to 5 euros per liter, which is how much it cost for Moss to produce his homemade concoction.
The Bate and Switch was saving the company as much as 1.2 million euros for every year of operation.
When one of the police officers asked Jean-Claude how he felt about the thousands of complaints from victims about his unapproved, self-described superior gel, Moss responded, quote, I have felt fine for 30 years.
He then described the complaining women as money-hungry and psychologically fragile, and told authorities that he had nothing to say to them.
After the interview, Moss's lawyer, Yves Haddad, spoke with reporters about his client's shocking admissions.
Haddad agreed that the optics were bad, but claimed that Moss was just trying to cut costs like any savvy businessman.
Quote, maybe it's shameful, but there you go.
We live in a capitalist world.
Yeah, thanks for the reminder.
Haddad was able to give at least some explanation for why PIP switched from medical-grade silicone to the type used for stuffing mattresses and sealing electronic components.
The PIP gel is less expensive, so the company is more profitable.
That's all.
It's a question of profitability, he told us.
Now, Mr.
Moss has said from the very beginning that it is not dangerous.
But Mr.
Moss is not exactly credible because he is under investigation.
In the years that PIP was actively manufacturing and selling both saline and silicone implants, there were plenty of signs of things to come that the capitalist world chose to ignore.
Regulatory findings from as far back as 2002 warned about issues with the company's manufacturing process.
Surgeons from all around the world were writing to the UK's Medicines and Healthcare Regulatory Agency, voicing their concerns about the PIP products.
Two years before those reports, the United States Food and Drug Administration wrote a letter to Moss listing 11 deviations from, quote, good manufacturing practices.
The FDA inspectors ultimately became so concerned that PIP's salient implants were adulterated, they banned them from the U.S.
market entirely.
That ban led to a worldwide slump in sales for the company, which led to the company doubling down on its cost-effective silicone implants instead.
Furthermore, Almost five years before the news about the unapproved silicone became public knowledge, PIP had been forced to pay 1.4 million euros to a group of British victims for its quote exploding implants.
Yet, PIP had been allowed to continue conducting business for years afterwards.
The good news, however, was that tests conducted on PIP's industrial-grade silicone found that although the ruptured implants could result in the formation of scar tissue that could change the shape and feel of the breast, despite the women's claims, there was no scientific evidence of an increased risk of cancer or autoimmune diseases.
However, removal of the implants would prove to be more difficult since they were leaking, like the difference between scooping out a cracked egg versus a hard-boiled one.
But as women lined up to have their PIP breast implants removed as a precautionary measure, a handful, no pun intended, were found to be suffering from medical issues ranging from lymphoma to leukemia.
The French and UK governments, and almost everywhere else, tried to ease fears by reminding everybody that correlation does not equal causation and that those women's ailments were most likely independent of their breast implants and had not been caused by the industrial silicone.
Those governments have decided that there was no reason to recommend their removal.
Women in Australia and Britain have been told there's no need to panic over claims that breast implants manufactured by the French company PIP are linked to a rare form of cancer.
The French government's reportedly considering ordering their removal after some were found to contain industrial rather than medical-grade silicon, but health regulators say there's no evidence to support the cancer claims.
But by the end of 2011, something happened that forced those governments to act.
A French woman with PIP implants had been diagnosed with anaplastic large cell lymphoma, ALCL.
a rare and aggressive form of cancer that affects the immune system.
If detected early, ALCL responds well to chemotherapy and has a high rate of long-term remission.
But on December 20th, just weeks after her diagnosis, that unnamed French woman was dead.
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We're trying to show the clinics that we are all supporting each other we all believe in the same thing and we all say that they have a moral duty to put right what they've done wrong.
Make the clinics pay!
Make the clinics pay!
Approximately 400 to 500,000 women in 65 different countries had received the faulty PIP implants.
There were over 30,000 recipients in France, almost 50,000 in the UK, another 30,000 in Eastern Europe, and more than 150,000 in Central and South America.
In late 2011, Women who had received the PIP implants stormed the streets of France and Britain, demanding action from their respective governments.
The protesters demanded more information about the possible health risk of the devices that had been implanted into their bodies, and they called for Europe to strengthen regulatory controls on their medical device oversight system.
Marie L.
Ayello, the president of the newly formed Victims Association, explained to the media how the women were dismayed with the lack of communication from those in a position to protect them.
Quote, they are afraid.
They are anxious and stressed out because every day they have received new information in a brutal way.
Information that sometimes hasn't been verified and it's devastating for them.
The protesters also aimed to dispel many of the stereotypes that had been circulating about the women who had received the implants.
That they were simply vain bimbos obsessed with their looks in the grips of a midlife crisis.
People had a very negative idea about us.
You know, we got operated because we wanted to be beautiful or get more men or all that.
It's not true.
I mean when you've been sick people think well you're cured so you don't need you know to have a nice breast.
Yes you do.
So I mean it's for yourself.
It's not for other people.
And all the women who did it for other reasons, they have good reasons and whatever the reason is, you're not supposed to get impoisoned, right?
The truth is that many of the PIP breast implant recipients were cancer survivors who were trying to rebuild their self-confidence and regain the parts of themselves, both physically and emotionally, that they had lost after such a traumatic diagnosis.
And a large portion of those women were living on low incomes.
They could not afford to simply return to the clinic and pay thousands of dollars to have the potentially toxic implants removed.
Many of them had paid for the initial surgeries with credit cards and loans.
Maybe not the most responsible financial decision, but who are we to judge?
These women needed help.
Three days after the death of the woman with ALCL, France's government buckled to the pressure and recommended that all women with the PAP-branded implants in its country seek removal.
And the government even offered to pay for the surgery.
as well as replacement implants for those whose initial surgeries were related to medical reasons.
For women that wanted to keep their implants, France offered a six-month ultrasound program to ensure their safety.
In total, these programs were estimated to cost the French government over 60 million euros.
Governments in Germany, Iceland, the Czech Republic, and Venezuela followed suit with similar accommodations.
In the United Kingdom, The National Health Service eventually offered to remove and replace the implants for the surgeries that it had performed.
However, the majority of women with PIP implants in the UK had received them from private clinics, private clinics who were not too keen on eating the cost of performing the removal surgeries free of charge.
The private clinics claimed that they were innocent victims too, and that the cost of removing the implants should fall onto the shoulders of the NHS and government agencies that failed to detect Jean-Claude Mots' scheme before it was too late.
As public scrutiny grew louder, the private clinics in the UK finally agreed to honor their moral obligation to remove the implants, but they refused to replace them for free.
Instead, at some of the clinics, victims were offered a discount on a future surgery, but only if they signed a waiver promising not to sue.
And if any lumps or other issues were found during the removal process, those patients would be referred to the National Health Service, charge it to the taxpayer.
Nearly 15,000 women underwent the implant removal surgery in the early months of 2012, and more than 2,500 women in France alone filed legal complaints against PIP, the company truly responsible for their pain and suffering.
Unfortunately, PIP wasn't much of a company anymore.
There were no assets to be seized, including Jean-Claude Maas' personal assets.
He had conveniently split from his lifelong partner and children who retained control of his fortune.
Jean-Claude Maas, a man who had reportedly earned almost 200,000 euros every year for 30 years, claimed that he was retired and living solely on his monthly pension of 1,800 euros.
Absolutely.
The company is the number one responsible party.
They made the faulty product.
They use substandard materials.
They ought to be paying for these replacements.
But as far as I know, PIP, this French company, is broke.
There isn't much money there.
And if you had to wait for them to come up with the money after lawsuits, most of the women who've gotten them would die of natural causes by old age.
Well, but there would be no compensation for the victims.
At the very least, maybe there would be some justice.
Unfortunately, justice seemed to be on the way.
72-year-old founder of the breast implant company was arrested in his home early this morning, and police are searching his home looking for evidence to support their notion that he should be charged with involuntary manslaughter and involuntary injury.
He's already under an investigation on fraud charges because police say he knowingly used second-rate silicon in the manufacture of the breast implants and that the breast implants themselves have a very high rate of rupture.
French medical authorities have said that the 30,000 women in France who've had the breast implants should have them removed.
Overall, worldwide, about 400 or 500,000 women have had the breast implants, which have been proven to be defective by medical authorities, at least here in France.
If, in fact, Jean-Claude Maas is found guilty, he could go to jail for five years under involuntary manslaughter charges.
He's yet to be charged, though, under either one of the investigations.
On January 26, 2012, just before 7 a.m., Jean-Claude Maas was arrested at the home of his lifelong partner.
The house was searched, evidence was seized, and he was taken to jail in Marseille.
where he awaited the new charges.
The deputy chief director of PIP, Claude Couti, and three other executives of the company were arrested as well.
All of the executives, including Jean-Claude Maas, were released on bail later that same day.
The owner of the French breast implant maker at the center of a global health scare has been released on bail after being charged with involuntary injury.
He will not be investigated for the graver charge of manslaughter.
Jean-Claude Maas has been told he cannot leave the country and must not meet former executives of his now-defunct PIP company.
His lawyer said Maas was still facing criminal charges and could stand trial for fraud in October.
The trial of all five of the PIP executives began on April 17th, 2013.
Officially, they had been charged with aggravated fraud for knowingly deceiving the public and regulators in regard to the unapproved silicone formula.
Charges related to the financial implications of the scandal, as well as involuntary manslaughter charges related to the death of the woman with ALCL, were still pending.
A normal courtroom was nowhere near large enough to accommodate the more than 5,000 women plaintiffs who were represented by more than 300 lawyers.
Not to mention the scores of media who wanted a first-hand look at one of the largest trials in French history.
The proceedings were relocated to a 700-seat Congress center where each PIP executive would testify in front of the massive crowd.
The deputy chief director of PIP and Jean-Claude Maas's right-hand man, Claude Couty, admitted on the stand that he had allowed the sell the implants knowing that they had never been authorized.
but claimed that he was unaware of any danger that those implants posed.
Couti also referred to his former boss as a, quote, know-it-all, who he disagreed with on a regular basis about the company's direction and operations.
Before the testimony of PIP's 32-year-old quality control director, Hanelari Font, was suspended by the judge due to her constant sobbing.
She expressed remorse and offered a heartfelt apology.
Quote, I'm sorry, I want to apologize.
I wasn't up to the job and I apologize to the patients who had to suffer due to this.
Font had actually blocked the sale of some implants in 2009, but by then, it was far too late.
When Jean-Claude Maas took the stand, he was greeted with a chorus of booze.
The prosecution described his behavior during the trial as, quote, disdainful, arrogant, and odious.
One prosecutor had even named him the quote, sorcerer's apprentice.
Moss's lawyer condemned the heckling and name-calling, saying, quote,
whatever happens, what you are doing to a 74-year-old man is not dignified.
During his testimony, Moss unapologetically reconfirmed everything he had already admitted to in the interview with police.
And on December 10th, 2013, all five PIP executives were found guilty, with Jean-Claude Maas receiving the harshest sentence of four years in prison.
But Maas slept in his own bed that night.
because he appealed the conviction.
The founder of a French company that manufactured 40 breast implants has been jailed for four years.
Jean-Claude Mass, who ran PIP, was found guilty of fraud after deliberately using substandard silicon in thousands of implants sold around the world.
He was also fined 75,000 euros, his lawyer said he would appeal.
In 2016, a French court upheld Maas's four-year prison sentence.
but he was allowed to return home again, this time to wait for the pending indictments related to the financial and manslaughter charges.
Pending indictments that never came.
In April 2019, Jean-Claude Maas, a diabetic with a history of heart problems, was admitted to a hospital for a routine operation, and he never woke up.
And other than the eight months that he spent in pretrial detention, Jean-Claude Maas never spent a day in jail for his crimes.
But life goes on.
The thousands of victims of the PIP scandal are still fighting for compensation to this day.
Some of them received a little in 2017 when a French court ordered German firm TOOF Rhineland to pay 60 million euros to 20,000 women who had received the defective PIP breast implants.
TOOF, who had successfully overturned an earlier ruling, maintained that it was never their job to check the actual implants.
The company insisted that they were only responsible for inspecting the manufacturing process.
The French court has ordered German firm TOOF Rhineland to pay compensation to hundreds of women who were fitted with defective breast implants.
TOOF awarded EU safety certificates to French manufacturer PIP, which was using substandard silicon gel that caused many implants to rupture.
And in TUF's defense, even if they had inspected the product, It's likely that Jean-Claude Maas would have attempted to deceive them anyway.
Sometimes not even the strictest of regulations can prevent such a deliberate fraud.
And sometimes even the products that pass all required inspections are not entirely safe.
It is the most popular type of plastic surgery.
About 11 million women around the world have breast implants.
But the FDA has a new warning about the link between implants and a rare form of cancer.
In March 2017, the United States Food and Drug Administration issued a statement indicating that women with textured breast implants have a, quote, very low but increased risk of developing anaplastic large cell lymphoma, the same cancer that killed the French woman during the PIP scandal about a decade earlier.
The textured implants in question feature a rough surface that adheres to the tissue surrounding them to keep the implants in place.
The breast tissue essentially grows into the microscopic grooves and becomes irritated over time.
with the possibility of developing the rare blood cancer.
Surgeons have reported a Velcro-like ripping sound when the textured implants are removed.
After the FDA's report and in an emotional hearing that featured testimony from survivors of ALCL, many women are choosing to have their textured implants removed.
As of March 2019, there have been almost 500 reported cases of textured implant-related ALCL.
Most women are cured as soon as the implants are taken out, but in the United States alone, At least nine women have already died.
And out of the 500 reported cases, none of the patients were ever informed about the possible risk.
Were any of you told about this before you got yourself?
I removed my chest to get rid of cancer, and I reconstructed it and put cancer back in.
So far, 38 countries have banned the textured implants.
France was one of the first to do so.
However, the implants remain legal in the United States and the United Kingdom.
Manufacturers like Allergan, who also makes Botox, have argued that the benefits of the textured implants outweigh the risk.
I mean, it's just a little blood cancer.
What's the big deal?
Fortunately, some surgeons in the States, like Dr.
Elizabeth Potter, are taking matters into their own hands.
I won't place them.
And actually, in my practice, I often say, if this doesn't pass the sister test, doesn't pass the sister test, i.e., that's correct.
You wouldn't give it to your sister.
you're not going to give it to your patients.
That's crack.
Since textured implants will apparently remain legal in some countries for the foreseeable future, hopefully information about these new revelations is being conveyed to those in the market for breast augmentation.
And even though she will not place them, Dr.
Potter recommends providing all the available information to the patients, the benefits, and the risk, and allow women to make the best decision for their own bodies.
What a novel concept.
The power should be in the woman's hands.
Let's give her the information
and let her choose.
This implant carries greater risk.
Would you like it in your body?
It's that simple.
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