User:Electron9/Poly Implants Prothèses

Poly Implants Prothèses (PIP) was a French company started in 1991 that produced breast implants. It was founded by the Frenchman Jean-Claude Mas, born in 1939, a former medical sales representative for the Bristol Myers company for 15 years. PIP went into liquidation in 2011. The company and its founder are at the heart of a public-health care scandal.

The company produced circa 100 000 implants per year, during circa 20 years. Approximately 300 000 women worldwide may have had their gel implant products implanted, used to enhance breast size or repair lost tissue. The implants have been exported to Latin American countries such as Brazil and Argentina, Western European markets including Britain (25 000), Germany, Spain and Italy, as well as Australia (8900).

Mas teamed up with plastic surgeon Henri Arion, who introduced breast implants to France in 1965. After Arion died in a plane crash, Mas went on alone and launched PIP in 1991.

Timeline
2000: Implant sales in USA stopped by an FDA launched moratorium on silicone implants.

2001: PIP began to use unapproved in-house manufactured industrial-grade instead of medical-grade silicone in the majority of its implants.

2003: the first signs of legal problems and financial losses can be traced by regulatory filings.

2009: Concerns surfaced in France first in 2009 when surgeons started reporting an abnormally high rupture rates. Which resulted in a flood of legal complaints and the company's bankruptcy.

2010: TÜV Rheinland, headquartered in Germany, gave a quality certificate to the production process used by the company until March 2010. However, this didn't apply to the type of silicone used.


 * A former PIP worker and union chief, Eric Mariaccia said "You had to have been a chemist to have noticed anything,". He also said that "The responsible ones aren't the workers but the heads of the company, notably the four who were linked to production and thus responsible for their quality,".

2010: In March 2010 PIP was placed into liquidation with losses of 9 million EUR after the French medical safety agency recalled its implants. In a subsequent inspection of the manufacturing site, the company was found to use unapproved industrial-grade, silicone, with a cost of only 10% of an approved gel.

2011: On December 20 French officials say that an action plan is underway following the death of a woman from ALCL. The French government recommended on December 23, 2011 that 30 000 women in France seek removal of breast implants made of a suspect silicone gel by the worldwide exporting PIP firm.

Issues
This is because breast implants could rupture and cause inflammation and irritation. There was no evidence of any increased cancer risk, the French government says. Removing implants "carries risks in itself," she said. Eight cases of breast tumours have been uncovered in women after removing the implants. Which has raised some concerns.

The UK medicines watchdog, the Medicines and Healthcare products Regulatory Authority (MHRA), says France has reported rupture rates of around 5% for PIP implants, compared with 1% in the UK. But a "leading cosmetic surgery firm", has privately warned ministers that the proportion of women at risk is as high as 8%. Symptoms can include lumps around the implant or in the under-arm, inflammation in the breast tissue and a hardening of the breast. Patient UK says French regulatory authority has reported a rupture rate of up to 10%. With a gel leak in 11% of cases.

Nigel Mercer of the British Association of Aesthetic Plastic Surgeons (BAAPS) says the French move was "certainly not unreasonable" but the British cosmetic surgeon Kevin Hancock said the divergent government responses would cause distress for British women. Plastic surgeon Hancock, of the Liverpool Women's Hospital, says there were concerns in the profession over a high rupture rate and that "We are worried about the rupture risk because it is the rupture that brings the contents into direct contact with the body's tissues," .. "We know that the contents were not what they were supposed to be. So in general we agree with the (French) decision to remove them.".

Patients are used as "guinea pigs" says Nigel Mercer a former president of the British Association of Aesthetic and Plastic Surgeons (BAAPS), because medical implants lacks the requirement of an independent clinical trial.

Cancer has been found in 20 women with the allegedly faulty PIP breast implants but French health authorities (AFSSAPS) insisted there was still no proven link with the disease.

AFSSAPS has per 28 december, registered 15 cases of breast adenocarcinoma, the most frequent form of breast cancer, 1 case of breast lymphoma, 2 cases of other lymphoma, 1 case of lung cancer and 1 case of acute myelogenous leukemia in women with the implants.

A French woman with PIP breast implant where capsular scar tissue formed in the breast. Which is a common occurrence with implants. This tissue developed Anaplastic large-cell lymphoma (ALCL), a rare form of cancer that affect the immune system cells. The cancer caused death in this case and made the French authorities to act.

During the 672 registered preventive extractions, in 43 cases (6.4%) the implants had ruptured and in 14 cases (2.1%) they were "oozing" AFSSAPS said.

France
The French government recommended per December 23, 2011 that 30 000 women in France seek removal of breast implants made by PIP. For women that want too keep their implants, the state will pay for a 6-monthly ultrasound scan.

French public healthcare funds will be used to finance the recommended implant removals, at a cost estimated at 60 million EUR. New implants will be paid for in cases where they were used initially for medical reasons, others will need to finance a new implant by themselves. Associations representing women with PIP implants demand that public funds cover all cases. "This announcement is just a smokescreen and the victims of PIP are angry," says Alexandra Blachere, head of the association of PIP implant users in France.

United Kingdom
In Britain, there's an estimated 30 000 - 40 000 affected women. The chief Medical Officer Dame Sally Davies says: "Women with PIP implants should not be unduly worried. We have no evidence of a link to cancer or an increased risk of rupture. If women are concerned they should speak to their surgeon.". Removing the implant "carries risks in itself," she also said.

Concerns was filed with the The UK MHRA in 2009 when a lump was found during a mammogram and ultrasound scan in a female patients breast but no action was taken by MHRA at the time.

Germany and Brazil
Germany's medical safety board and Brazil's health watchdog called for users of PIP implants to visit their doctor for checks.

Netherlands
The bad breast implants were sold to about 1000 Dutch women under the name "M-implants" by a dutch company. The Dutch healthcare spokeswoman Diana Bouhys says "We have advised them to consult their physician". But also declined to disclose the name of the Dutch company. PIP was the 3rd largest maker of breast implants in the world.

Sweden
Approximately 5000 implants have already been sold, corresponding to an estimated 2500 Swedish women with the controversial implants. Nine clinics in Sweden has sold them says Gert Bruse of the Swedish Medical Products Agency (Läkemedelsverket) told the Dagens Nyheter (DN) newspaper this week. The agency also recommends that the implants to be removed. Sweden banned the company's implants in March 2010, along with many other European countries, when it was discovered that substandard silicone gel was causing unusually many implants to burst. "We've had cases where the implants have burst in Sweden, but it's fewer than in France in relation to how many women have these implants in both countries," and "''Implants shouldn't burst and they shouldn't have an irritating effect that spreads throughout the body. What this company has done is criminal, simply put." says Bruse. PIP's implants have only been used in cosmetic breast augmentation surgery, not in reconstructive surgery.

Finland and Estonia
Many Finnish women go to Tallinn, to have plastic surgery done. Two months before 22 dec 2011 a Finnish woman in her 30s got another implant than agreed upon in advance. An M-implant which has exactly the same type code as the PIP implant was inserted instead of the promised an Allergan implant. At least two Estonian clinics operating in Tallinn offered M-implants as recently as two weeks before 22 dec 2011.

United States
Implants were sold up until May 2000 through Heritage Worldwide, documents filed with the US government show. When the FDA launched a moratorium on silicone implants. At the time, the US market accounted for 40% of Heritage Worldwide's revenues, or 3 million EUR, according to corporate documents filed in 2009 with the SEC. In 2007 significant losses started as both users and distributors filed complaints. Between 1996 - 2009, PIP was targeted by several dozen lawsuits in the United States, filed by users and business partners, claiming breach of contract or unmet payments. Starting in 2003 dozens of women began filing lawsuits mainly for product liability against PIP. But as of 2009, no trial date had yet been set. Many of the lawsuits were later dismissed.

Italy
On 29 dec Health Minister Renato Balduzzi said that hospitals and clinics are required to compile a list of women who has received breast implants from PIP. Even clinics that didn't use any PIP implants will be required to send a declaration stating that.

Latin America

 * Brazil - banned the breast implants on 30 dec 2011, taken off the market in 2010
 * Bolivia - implants replaced free of charge for some women on 29 dec 2011
 * Venezuela - promised to replace them free of charge
 * Ecuador - sales banned on 29 dec 2011
 * Argentina - ban
 * Chile - ban
 * Colombia - ban

New company
A new firm has been registred under the name France Implant Technologie (FIT), with Mas's son Nicolas Lucciardi, 27, and daughter, Peggy Lucciardi, 24, at the address of their mother, Dominique Lucciardi, who was Mas's former civil partner.

The local paper Nice-Matin obtained the business plan in which Mas is named as a "technical-commercial consultant" to the company and described as “a creative genius”. Two former PIP managers were listed in senior positions in the company. With the objective to export implants to the "European, South American and Chinese markets". An investment of 2 million EUR was planned to put the former PIP plant back into operation, aiming to manufacture 400 implants a day with about 20 workers. But Nicolas Lucciardi said that the project has collapsed due to media coverage of the scandal, adding, "That's obvious.".

Legal process
The lawyer Yves Haddad is represents Mas. Legal complaints has been filed by 2500 women in France and 250 women in Britain. Mas is wanted in Costa Rica for "life and health" offenses, a warrant issued by Interpol.

By February 2011 TÜV Rheinland sued PIP, claiming it had been "thoroughly and continuously misled" regarding the silicone used. Many executives are expected to face charges of aggravated fraud in an ongoing court case in France likely to be scheduled for next October, which carries the possibility of jail terms of up to 5-years. The death of a cancer victim who had such implants may result in more serious charges of involuntary manslaughter.

Frédéric Van Roekeghem, general director for La Caisse Nationale d'Assurance Maladie (French state social insurance agency, CNAM) will go to court regarding the complaints of bad implants. A criminal charge will be made within a few days he said to TF1 on 25 dec 2011. The decision has been made in consultation with minister of health, Xavier Bertrand.

Mas has recently undergone difficult surgery regarding a vascular problem that prevents him from walking said his lawyer Haddad. Sources say a Marseilles court could soon announce fraud charges against 4 -6 former PIP employees.

A fraud case was filed against PIP on 30 dec 2011 by France’s state-run health insurance fund (CNAM) officials in Marseille announced. Which is near the company’s laboratory at La Seyne-sur-Mer.