special report - the great french breast implant scandal

by:Keyuan     2020-07-01
Marseille, France (Reuters)-
On March 2010, a pair of health inspectors who acted on tips paid three pounds.
One day, visit a factory in the hilly town along the Mediterranean coast.
The factory is the headquarters of Poly Implant Prothese (PIP)
International leading breast augmentation manufacturer founded by French entrepreneur Jean-Claude Mas.
The inspectors found something strange: Six abandoned Silopren plastic containers, a liquid silicone designed for industrial rather than medical use, arranged along the exterior walls of the production site.
A week later, the military police came to the factory.
Más escaped in front of them and evaded the interrogation for nearly eight months, but his game was over.
In the past two years, cheap silicone used in PIP fake breasts has continued to penetrate into women.
In France, 1,262 of the roughly 300,000 breast implants sold by the company worldwide have been opened in the past two years.
PIP has been closed, Mas has been arrested and investigated for alleged physical injuries, and French and European security regulators have been pushed into the disturbing spotlight.
The 72-year-old is the son of a grocer from southern France who has not been trained in science.
However, in the first decade of this century, he was able to manufacture and sell defective breast implants that he and some of his employees knew were unqualified in the international market, according to the testimony of French police seen by Reuters.
The history of breast implants is full of defective equipment, a colorful lineup of intertwined players, and billions-Dollar lawsuit.
Reuters reviewed hundreds of pages of police investigation records and financial documents and interviewed former PIP employees of the company\'s suppliers, customers and health experts to piece together the latest chapter in the history.
This is a story of accidental operation and cash.
The company allegedly took desperate, sometimes deceptive steps to cut costs and hide the real ingredients of its equipment.
PIP\'s efforts have become easier because of the European regulatory regime, which is essentially outsourced to companies that should have been regulated.
In the new details that are coming up: PIP is able to save 1 of the estimates.
2 million euros (1.
0 million pounds)
In a year, through the use of industry-
According to data cited by police investigators, the silicone grade in their implants.
According to a former worker, it relies on a rough, unscientific test of the quality of the product, such as judging the silicone by sticking the finger to the silicone.
About 75% of implants use non-
Mas told police it was a cheaper gel approved.
\"It may be shameful, but you see,\" on behalf of Mas and his current lawyer, Yves Haddad --
The company closed down at the end of December.
\"We live in a capitalist world.
Más, who declined to comment on the matter, said his product was harmless.
After the Ministry of Health advised French women to dismantle the equipment, he told the French broadcasting network RTL last month that the decision was \"criminal\" and that the minister of health \"needed to commit \". ” Jean-
Claude Florence más, who was born in Talb near the Spanish border, is a salesman of different temperament.
He sells everything from life insurance to wine and dental equipment.
He entered health care in the medium term.
1960, working for a variety of laboratories, including those purchased in Bristol
Miles, in his 1970 s as a salesman in southern France, stayed until 1980.
Haddad, a lawyer for Mas, said his client was one of the company\'s top salesmen, despite Bristol-
Miles was unable to confirm this and could not say the reason for his departure.
After Bristol.
Mas involved in breast implants, Miles.
He began working with French plastic surgeon Henry Arion, who produced the first breast augmentation operation in France in 1965 and is now selling a saline breast augmentation operation called Simaplast.
This is not a good start.
According to a 1999 study in the United States, the implant of Simaplast was eventually found to be prone to ruptureS. non-
Institute of Medical profit.
Simaplast became a MAP-
Predecessor of PIP
\'From production to sweeping the floor, every job is done there,\' said Mas.
A small number of employees include a woman named Dominic Lucidi, who will be the partner and mother of the two children of MAS.
He told the police that they would take turns to refuel the prosthesis.
In 1991, at the age of 52, Mas established PIP, a limited liability company, and chose the old Simaplast plant as its headquarters.
He told police that during the preparation process, he applied for a patent for the sale of implants containing polyurethane foam covered with silica gel.
When he launched PIP, the breast augmentation scandal involving Dow Corning swept across the United States.
The US company was found to deliberately conceal the safety of its implants and, in 1992, the United StatesS.
The Food and Drug Administration has called for a moratorium on the use of the equipment.
In 1995, France also banned the use of silicone in breast implants, which ended on 2001.
Mas found that through innovation, he can still bring products to the market.
He went to the implant filled with salt water and introduced a pre-filled version;
Other brands need to be filled in when the patient is on the operating table.
PIP\'s new product saves time and surgeons like it.
Pip moved into the great United States. S.
According to company records, the US market soon accounted for 40% of its revenue in 1996.
In 2001, when France lifted the ban on silicone implants and the United States slowly began to approve more versions containing silicone gels, the opportunity for PIP grew in its home country, and mas already had a formula.
\"When I started PIP, I brought this formula that I saved,\" he told police . \". “Why change it?
\"The regulator has never checked this filler and has not approved it, but Mas insists to his staff that it is completely safe, his predecessor
Employees told Reuters.
In 2002, Mas introduced an asymmetric product based on the innovation of saline implants, which was welcomed by surgeons and patients, which brought a new turning point to silica gel, since it is more natural than the \"classic\" implant, it looks like a perfect circular sphere.
PIP\'s method of filling these implants is novel.
On paper, the company says it uses NuSil, a silicone mixture produced by a company of the same name in California that can be used for medical applications, including implant devices.
NuSil was founded by former Americans of PIP. S.
Dealer Donald mcguen was jailed for alleged fraud.
The company declined to comment on the PIP incident.
However, in reality, PIP mainly uses mas\'s own non-
The approved PIP gel looks and feels exactly like NuSil, but the price is seventh.
Thierry Brinon, former technical director in charge of R & D at PIP, told police that the price of a liter of NuSil was about 35 euros, while the price of the PIP version was 5 euros.
An average of 330 gel is used per implant.
This means it will cost 11.
55 euro, filling the implant with NuSil and 1 euro.
Gel with PIP is 65 euros, a difference of 9.
90 euros per implant produced.
PIP\'s former chief financial officer Claude Cuty told police that it would take an average of 38 to 42 euros to make an implant full of PIP gel, compared to 52 of the implant filled with NuSil.
Investigators in the legal case file estimate that in just one year, 2009 people using PIP gel instead of NuSil saved the company nearly 1. 2 million euros.
PIP sells implants to French surgeons at a price of 300 euros per piece.
According to former PIP staff and surgeons, the asking price is about 100 euros abroad.
\"This formula is perfect,\" Mas told police . \".
\"This is better than the recipe for making NuSil.
But since NuSil is a known quantity, and his gel formulation is not, Mas has concealed the composition of the implant from the regulator.
The flaws in the European regulatory system helped him.
There is a government regulator in France, Sante production company or AFSSAPS, which has the right to remove the product from the market without certification.
But the agency that certified PIP implants is actually a private company based in Germany.
TUV Rhine first approved the saline implantation of PIP in 1997.
Its officials visit the factory in Los Angeles every year. Seyne-sur-
According to the European guide, Mer announced these suggestions 10 days in advance.
This gives PIP enough time to hide the truth.
Prior to the TUV visit, the worker will clear the evidence of cheaper silicone that PIP is using and sort out a revised version of the document, which does not mention the use of unapproved silicone, Mas
The manager told the police
A former worker said all internal communication related to the TUV access was verbal.
According to the note in the case file, Mas told police: \"from 1997 onwards, we automatically hide products that allow us to make PIP gels, because I know they are not regulators.
In his second police interview, más said he had issued an \"order to hide the truth from TUV\" since 1993 \".
TUV sued PIP in February 2011, saying it damaged its reputation by bringing the name of TUV to market
It was systematically misled.
There are other gaps in the regulations that help PIP put its products on the market for a long time.
System does not need on-
On-site, unannounced visits to the contents of the implant.
Also does not require the chemical composition of the implant to be re-approvedtested.
A spokesman for the TUV said that it would only conduct unannounced inspections if there were very serious indications that something was wrong.
He added that there have been no unannounced inspections in Germany over the past 40 years.
In addition, the annual audit of TUV is basically an audit of the entire process;
They don\'t execute-site lab tests.
The German company believes PIP has deliberately cheated it.
AFSSAPS said it tested the interior of PIP implants in 2001 to make sure they were what PIP said when allowing silicone breast implants to return to the French market.
After 2001, however, the job went to two separate French laboratories: LEMI, the Laboratory for evaluation of material implantation and LNE, the National City Laboratory and essais.
Mas told police that the laboratory was tested on 2002 and 2008.
Afssap\'s deputy director general Francois Herbert told Reuters that the tests may have been ordered by PIP at the request of the surgeon who may have returned the defective implant and requested
LNE says its test is mechanical.
For example, how likely is PIP\'s implant to resist pressure
Further information was refused.
LEMI said its tests were related to toxicity but also declined to provide further information.
The first random test of AFSSAPS will not arrive until the medium term
2010 The police were investigating PIP at the time.
Just then, AFSSAPS released a report saying, \"this one does not meet the quality of the silicone gel used for breast augmentation.
This week, the French Ministry of Health and AFSSAPS submitted a report to the country\'s health minister acknowledging the gap between the French and European regulatory systems.
The report states that no unannounced visits were made
On-site testing of the implant, but said that PIP\'s alleged fraud was very complicated, \"the inspection, even if it was not announced, would not obviously work.
\"Silicone raw material for PIP --
Formula gel includes different products: Silopren-
In the container found by the inspector-and Baysilone.
PIP bought these silicone oils from German dealer Brenntag.
It sought a third oil from Gaches Chimie, a French distributor-the Rodo Hill 47V1000.
Brenntag confirmed that it sold silicone oil to PIP from 2001 to 2010, but stopped selling when it was told PIP was under investigation.
Brenntag spokesman Hubertus Spethmann said that PIP is a diversified supplier to Brenntag\'s knowledge, and its products include wound dressing pads and other filling products that can be filled with silicone, such as the oil it produces.
Brenntag will not comment on PIP\'s order or any payment issue from French companies.
Reuters could not independently confirm that the goods were sold by PIP.
According to a former employee, the representative of Brenntag regularly requested access to PIP\'s headquarters
PIP employee, this request caused a lot of concern within PIP.
Brenntag declined to comment on the visit.
The former worker said this month that the Brenntag sales representative had visited at least twice, but was welcomed by Mas in his office and did not visit the production lab.
\"Mas will tell them that we used silicone oil in the cream, not breast augmentation, of course,\" the formerworker.
\"We were very uncomfortable and had Mas do all the talking.
\"Gaches Chimie also confirmed that orders were discontinued from early 2000 to 2009 and that it occasionally sold silicone oil to PIP.
CEO Pierre Gaches said he did not believe his company was the main supplier of PIP and never worried about the final use of oil because it was used in many industrial applications.
Although PIP uses unapproved materials for its silicone implants, its innovative salt aquatic products have also encountered problems in the United States.
The lawsuit for hundreds of patients said that sometimes within a few months of surgery, they retreated.
The FDA never approved PIP\'s silicone product, but instead issued a warning on its website about the company\'s practices.
Mas made a reverse acquisition to try to open PIP to the USS.
The way Capital and preparation is renewedlaunch.
In 2003, Milo Finance, his Luxembourg holding company, acquired a majority stake in the United States. S. -
World Heritage list and transfer control of PIP to heritage.
In the first annual document submitted to the United StatesS.
The merged Securities and Exchange Commission Heritage disclosed that PIP lost $693,336 for the fiscal year ended June 23, 2003.
The loss increased to $5.
2004 6 million.
PIP has also turned to markets where regulation is not so strict.
Heritage said in its 2003 report that it found that distributors would sell in 10 new countries where \"regulatory issues are not expected.
Decline in export profits-
Foreign sales account for the third in French prices
But there is sales in the South American market, which soon became two big markets for PIP
Driven by Venezuela and Colombia, sales reached 30.
At 2005 and 2006, PIP shows profit.
A former employee said it was a \"brilliant day\" for the company to hire about 120 employees \".
Operating profit margins reached 20%, a level that early handset manufacturers could expect.
\"We will see a smile on the face of the gentleman.
Said a former manager.
Couty told police that in one year, the company bought a new BMW for Couty and Mas.
He did not respond to the reporter\'s request for an interview.
The 65-year-old accepted a chairman\'s \"supervision and advice --
In 2004, he received 5-360,000 euros a year-
Double his salary of 2003.
But PIP\'s liquidator, Xavier Huertas, wrote in a March 2010 report that Mas continued to control production, R & D and sales, \"In fact, leading the company around Mr. Couty.
However, the crisis is at hand.
The lawsuit and financial shock of 2008 sent Mas back to PIP\'s lab in an attempt to improve his \"perfect\" gel formula.
Mas has never been trained as a scientist.
He is an intuitive experimenter.
But even so, he realized that there was a problem with PIP gel: It leaked too much silicone oil.
Of the seven former PIP employees interviewed by Reuters, only two said they did not know the company was using homemade gel.
The other three advised them to remain silent because they were worried about their work.
After 2005, PIP staff became more outspoken.
That year, the head of the production, quality control and R & D department, together, asked Mas to fill all of PIP\'s implants with NuSil, and Hannelore Font, the company\'s director of quality control, told police.
Mas replied that this is economically impossible.
Font did not respond to the call asking for an interview.
PIP set aside 2008.
According to the liquidation documents, € 4 million was used to pay for potential litigation.
It is undervalued.
A British court ordered the company to pay 1.
The plaintiff claimed that the envelope implanted by PIP was not strong enough and the gel leaked, and the plaintiff paid 6 million euros for it. U. S.
The lawsuit also costs 160,000 euros.
\"All these lawsuits have weakened the health of the company,\" said Haddad, a lawyer for PIP and Mas . \".
Complaints are rising and PIP\'s customers are paying more slowly.
The liquidator noted that it would take PIP\'s export customers on average nearly nine months to settle.
Suppliers are also hesitant.
NuSil painting, due to the holding of a batch of non-
Nadine Carrodano, purchasing manager at PIP, told the police that the payment was made.
Coty wrote to Mas describing what he called \"fear of the future \".
PIP\'s debt reached £ 8 by June 30, 2009. 5 million euros.
\"In every area where the company crashed,\" Carrodano told police . \".
She declined to comment.
According to Couty, PIP invested 300,000 euros in 2008 to buy a new machine to make the housing of the implant, hoping to reduce the leakage more evenly.
Brinon, technical director of PIP, said Mas came to him in early 2008 and told him to start developing a new gel PIP 2.
Brinon refused, on the contrary, the task was handed over to another worker who had never had an implant before coming to PIP.
The goal, he said, is to make a gel that will not leak so much oil.
This is critical: oozing silica gel can cause irritation and inflammation in the female body.
The worker told Reuters that Mas relied on trials and errors to add this and that to the lab: \"He did not do a scientific test,\" the former worker said.
\"He would look and say, \'This is good, that\'s not good.
The worker said to judge whether the oil oozes out of the gel, \"you will look at it and put your finger in the gel and you will see if there is oil on your finger.
Finally, PIP 2 is ready in the middle of 2008.
Brinon expressed doubt about this.
He told police that his own mother had cancer and that he was worried that she had planted PIP.
He started his own testing on PIP gel and NuSil.
He told police that PIP 1 gel discharged more oil than PIP 2, much more oil than NuSil discharged, and the oil leaked by NuSil was \"unlimited in quantity \".
The last thumb.
Mas is engaged in export sales.
A copy of his passport is included in police documents showing the visit to Panama, Venezuela, Colombia, Brazil, Uruguay, Ecuador, China, Singapore and the Philippines on 2008 and 2009.
When I got home, the staff was low.
On May 4, 2009, a commercial court in Toulon city ordered PIP to be included in French equivalent to Chapter 11 proceedings.
About a dozen employees were fired a month. to-
According to the liquidation documents, the monthly worker\'s contract was cut and the night shift was reduced.
Font, quality-
The control told police that she issued an ultimatum to Mas at a meeting with other managers, saying that she would no longer sign the implants ready for shipment.
Instead, Cotti accepted this.
TUV conducted an audit in early 2010.
Carrodano, purchasing manager, told police that after TUV gave her thumbs up to PIP, she was \"almost crying \"--up.
To keep her away from work, the font had the doctor sign a medical agreement.
The unpaid supplier stops sending raw materials;
Production is at a standstill.
On March 16, 2010, AFSSAPS officials called for a five-day scheduled visit.
AFSSAPS recently received a letter from the Marseille surgeon indicating his concern about the PIP rupture rate.
Regulators also received non-empty containers in anonymous mail photos
Raw materials approved by PIP factory.
On the first day of their visit, the inspectors did not find any exceptions.
They visited PIP\'s production facilities the next morning without telling PIP.
They then found the empty container marked \"Silop\" by Silopren.
Lead inspectors estimate they contain nearly 9 tons of liquid silica gel.
A few days later, when the police came to the scene, Mas quickly slipped out.
When the French police finally asked him in November, they asked him why he left in such a hurry.
According to police records, he said he was no longer in charge of the company --
He had handed control over to the chief financial officer a few years ago.
\"I thought it was not me you came to see. . .
\"Within two weeks of the visit by the regulator, PIP was shut down and AFSSAPS withdrew its implants from the market.
About 29,000 products were seized. Laid-
The staff burned the tires and threw the discarded implants into the parking lot.
Mas went abroad again.
In 2010, his passport records included Colombia, Nicaragua, Spain and Venezuela.
In his brother, he was stopped by drunk driving.
According to Luxembourg\'s documents, on September 27, 2010, Mas transferred his ownership of a real estate holding company to his partner, Lucciardi, and their son.
That company has four.
Bedroom Villa, not far from PIP headquarters, with a swimming pool.
On January, the police arrested Mas here.
According to the real estate agent, the house is currently on sale for about £ 1. 6 million euros.
In his inquiry of Mas on October 2011, he told police that over the years, PIP 75% of the implants were filled with his homemade formula.
French regulators say there have been 1,262 cases of broken equipment in France so far.
Health experts say there is no specific link between PIP implants and breast cancer, but the French government recommends that women remove PIP implants.
The bail-out Mas was asked by the police what he thought of the women who complained about the failed equipment.
\"It\'s about vulnerable people, or people who do it for money,\" he said, according to the interview records . \". (
Alexander serch reports from Paris, Natalie Hutt reports from Los AngelesSeyne-sur-Mer and Jean-
Francois roisley from Marseille;
Marc Joanny\'s supplementary report in Los AngelesSeyne-sur-
Mel in Paris, Elena Burton, Ludwig Hamburg in Frankfurt and Maria Shane;
The work of Alexander serch;
Edited by Sara Ledwith and Simon Robinson)
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