It’s December 2013 and a french company executive is being sentenced to 4 years in
prison.
The event marks the end of a criminal investigation into probably one of cosmetic surgery's most
famous cases of scandal and fraud.
The executive is Jean-Claude Mas and he was the main driving force behind a truly horrifying
case of profit over safety.
The scandal put several thousand people at risk of serious injury and heightened cancer
as well as betraying the trust and defrauding of their customers from all over the world.
My name is John.
Welcome to another episode of scandal and today I am looking at the repulsive pip implant
affair.
Foreword
Ok so before we start I should say that I won’t be talking about the reasons why some
people get implants or on the wider plastic surgery industry, as it’s a personal choice.
Some cosmetic surgery’s restore a person's body after life saving surgeries like a mastectomy,
as such the end user so to speak of implants represents a multitude of reasons for going
under the knife.
Although I have never had any kind of cosmetic surgery included, I can still understand the
distress and suffering the victims have been subjected to during this scandal.
Oh and pronunciation warning there are a few french words I’ll be butchering throughout
the course of the video.
Well That’s enough of me gibbering let’s start our story at the probably the most suitable
point the beginning.
Background.
Meet Jean-Claude Mas, born in France in probably one of the worst years to be born there 1939.
Much of his early life is unknown but snippets of his adult life career can be priced together.
According to French daily Le Monde, Mas in the 1960s and 70s worked for US pharmaceutical
giant Bristol-Myers Squibb (BMS).
Mas’s career then went to the meat trade, some say butcher but this claim has been disputed,
officially he has said he worked in the dried sausage and wine industry.
It was during this time he became associated with surgeon Henri Arion, a man famed for
introducing breast implants into France in 1965.
Arions implants were the world's first inflatable Prosthesis, basically bags that were filled
with saline solution.
Now I should say here that different news agencies have reported Mas working in meat
before working for BMS and others have reported mas working in meat after BMS.
But the important takeaway is regardless of chronology, Mas's career involved a substantial
industry change, so just remember he knew about sausages being a medical rep and knowing
Henri Arion.
Basically it boils down to sales and product and after meeting Arion the product was implants.
Laboratoires Arion founded by Henri were one of the major players in the implant industry.
This was in the 1980s and Mas must have seen this as a prime business opportunity but his
mentor would tragically die in a plane crash in 1991.
But this didn’t apparently stop him as the same year he founded PIP Poly Implant Prothèse.
Upon the company's founding Mas hired 120 employees and set about traveling the world
to some of the biggest markets for breast implants.
One of which was the UK, this doesn’t surprise me one bit.
Any whose PIPs business plan worked pretty well, hundreds of thousands of ImPlants were
shipped around the world and an estimated 100,000 were produced each year.
Making the company the 3rd largest silicone implant manufacturer in the world.
The product was different to the saline filled implants that Henri Arion had pioneered.
Pip would use a solid silicone implant, which are seen as advantageous over saline ones
as they apparently look and feel more natural.
Interestingly pip would also later on in the 90s also make saline implants as well the
reason for this I’ll go into shortly.
All of their products were manufactured in La Seyne Sur Mer in southeastern France, which
included both saline and solid silicone implants as well as testicle and buttock silicone products.
However problems were on the horizon for the company when one of its biggest markets would
disappear from pips grip.
FDA Bans Silicone implants
It’s 1992 and the US food and drugs administration launched a voluntary moratorium on the sale
of silicone based implant products.
This is not good for PIP who predominantly produce silicone products.
You see American manufacturers of silicone implants had been racking up an ever increasing
number of lawsuits throughout the 1980s in regards to their implants rupturing.
Essentially silicone was banned in one of pips biggest markets, well mas sought to find
alternatives, this led him to start using hydrogel implants in 1994 followed by saline
implants in 1996.
So far so good but things would come crashing down in 2000, when an inspector from the FDA
was sent to the pip plant in France to carry out an inspection.
This was on the 15th of May and shortly after the inspector returned to the United States
a warning letter saying the implants were “adulterated” citing at least 11 deviations
from good manufacturing practices was sent to PIP.
So needless to say this would close the US market door to PiP, quickly the company also
withdrew its hydrogel implants presumably because they couldn’t prove the safety of
those units either.
The loss of the US market severely hit pips finances and even the resourceful Mas found
a way to make their product immensely more profitable, just by altering their products'
ingredients just a little bit.
You see the silicone used in implants has to be of a medical grade which is expensive,
very expensive and externally sourced, Mas thought why not use the much cheaper industrial
grade material and manufacture it in-house, it was nearly 90% cheaper after all.
This reduced materials cost would allow the company to weather the storm of losing the
US, clearly adulterating their products was not an issue to PIP.
I assume no one knew outside of PIPs management of the potential damage that can be caused
by industrial silicone.
So let’s look at what silicone is used for, officially it’s called polymerized siloxanes
or polysiloxanes.
And you can use it for pretty much any job that requires a water resistant and durable
sealant.
It’s also used in cock ware like this set I have, it can be used for rubber keypads,
or a lubricant or even molds, basically it’s used everywhere.
But vitally this is all industrial grade silicone and you don’t want it inside your body.
Needless to say pip didn’t do any testing of their new formula of the silicone, for
the surgeons using the implants little could be differentiated between the two silicone
types.
Only a small superficial change could be seen but only if the two are sat side by side.
So it wouldn’t take long for the first issues with pip implants to start rearing their ugly
head.
The scandal discovered.
Within just two years of the silicone change reports of premature rupture starting appearing
in the markets that pip had a stake in.
In 2003 lawsuits began piling up at pips door, but the company continued to grow the business
as they were able to keep these incidents out of public knowledge.
The cut price tag of pips implants created a greater demand, for example in the uk in
the Mid 2000s the cost per unit was in the region
of £100 the going rate at the time for other brands was closer to 700£.
The age old adage remains true if it’s too good to be true then it likely is.
By 2006 plastic surgeons across the world had seen a startlingly high number of pip
implants rupturing within 3 years, for context the expected life of them should have been
10 years minimum, which personally even that seems not long enough.
Around the same time The company was forced to pay 1.4 million euro to British victims.--
But this would be just the tip of the iceberg, by 2009 the number of failed implant cases
was in the thousands, and as such in France alone 2,000 women had filed lawsuits against
the company.
The french agency Francaise de Securite Sanitaire des Produits de Santé AFSSAPS, launched an
investigation in March 2010, around the same time PIP was put into liquidation, by now
it was at a loss of roughly 9 million euro.
The investigation quickly unraveled Mas’s deception, and revoked the companies ce mark,
banning the sale and export of the pip implants.
They found that the implants contained Baysilone, Silopren and Rhodorsil, chemicals that are
used as fuel additives, or in the production of rubber.
The criminal Case.
Criminal proceedings for Mas and PIP were just around the corner.
Mas was arrested in june 2010 in costa rica but not for what you might think, it was for
dangerous driving, after being handed a court date for november, he fled the country back
to france, landing himself a spot on an interpol list.
But he was jumping out of the frying pan into the fire.
It was discovered during interviews with mas in november 2010 that from 1993, the company
was facing a silicone shortage, Mas had ordered the staff to "hide the truth" and was quoted
as saying "We did it for 13 years without a problem".
They were almost right from the start of the company going into business defrauding their
customers, with 75% home made silicone mixed in with 25% medical grade silicone.
The non safe material was bought off the books and via proxies to avoid suspicion.
Needless to say with these revelations french authorities recommended the case be put to
the police for criminal proceedings.
In December 2011 a woman in France died of Anaplastic Large Cell Lymphoma she had been
implanted with Poly Implant Prothese (PIP) breast implants, the death was linked to the
pip implants.
Shortly after on 23rd december 2011 the french government advised the removal of all pip
implants in french women as a preventative measure, this would cost 60 million euro,
however strangely in the UK the Medicines and Healthcare products Regulatory Agency
did not give out the same advice.
Instead they advised to seek inspection by a medical professional and seek help if the
implants are suspected of rupture, personally this isn't very confidence inspiring.
By 2012 more women were linked to having at least 8 cases of breast tumors, but the number
would quickly rise to 20.
There was more than enough now to charge Jean-Claude Mas and On 26 January 2012 at 07:00 he was
arrested in the home of a friend under the charge of fraud.
Unsurprisingly this would result in a trial, the 74 year old put up a defense of I know
I was doing illegal stuff it wasn’t dangerous honest.
A proven method to guarantee a conviction and that’s what happened and after a month
long trial in April 2013 Mas was sentenced to 4 years in prison with a few other pip
executives seeing prison sentences but of less time.
He was also slapped with a 75k € fine in addition to being permanently banned from
working in medical services or running a company for life.
It seems pretty light to me as an estimated 300,000 people are affected by the dodgy implants.
This issue won’t go away anytime soon either with many countries taking the line of the
Anyway TUV had certified the PIP implant manufacturing process and in 2013, TÜV Rheinland was found
liable by a French court and made to pay 1600 women whose breast implants had ruptured compensation.
Tuv denied any knowledge
of