Poly Implant Prothèse (PIP) was a French company founded in 1991 that produced silicone gel breast implants. The company was preemptively liquidated in 2010 following the revelation that they had been illegally manufacturing and selling breast implants made from cheaper industrial-grade silicone since 2001 (instead of the mandated medical-grade silicone they had previously used).
The hundreds of thousands of unapproved implants sold globally by PIP from 2001 to 2010 were found to have a 500% higher risk of rupturing or leaking than approved models, as well as being implicated in several deaths due to systemic toxicity and several cases of induced breast cancer. The scandal, which produced fears of a massive health disaster, prompted a full recall of the company's implants by the French health ministry in 2010, by which time the company was already defunct.
History
PIP was founded in 1991 by the Frenchman Jean-Claude Mas, born in 1939, a former butcher and later medical sales representative for the Bristol Myers company for 15 years. Mas had previously teamed up with plastic surgeon Henri Arion, who had introduced breast implants to France in 1965. After Arion died in a plane crash, Mas went on alone and launched PIP in 1991.
Scandal Starting in 1991, the company produced approximately 2 million sets of silicone breast implants over a 20-year period. The implants were exported to Latin American countries such as Brazil, Venezuela and Argentina, Western European markets including Britain (25,000), Germany, Spain and Italy, as well as Australia (8900).
Following the FDA ruling in 2000 which banned silicone breast implants in the US market (leading to a slump in sales worldwide), Mas sought to "tighten PIP's belt" and recoup some of its lost market share by severely cutting costs. In particular, Mas was credited with the idea that by switching PIP's silicone from externally purchased medical-grade to in-house produced industrial-grade, huge savings (on the order of 90%) could be generated that would ensure profits remained high no matter the market. As one PIP engineer later noted, this decision involved a relatively small change in the formula for the silicone, enough so that only superficial differences in the end product were noted. However, none of the relevant regulations were followed for manufacturing medical implants, and no pre-launch tests were conducted.
Timeline 2000: Implant sales in the United States halted 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: PIP is acquired by Heritage Worldwide Inc. Regulatory filings show the first signs of legal problems and financial losses.
2009: Concerns surfaced in France first in 2009 when surgeons started reporting an abnormally high rupture rates, resulting 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 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 20 December French officials say that an action plan is underway following the death of a woman from ALCL. The French government recommended on 23 December 2011 that 30,000 women in France seek removal of breast implants made of a suspect silicone gel by the worldwide exporting PIP firm.
2013: Criminal trial is held in France, and Jean-Claude Mas was sent to prison for four years.
2021: French court found TUV Rheinland negligent and partially liable for damages.
Issues Medical problems arise when breast implants rupture and cause inflammation and irritation. Further, impure gel may also release toxic substances. Removing implants "carries risks in itself", says the French government. By the end of 2011, eight cases of breast tumours had been uncovered in women after removing the implants, yet, while of concern, according to the French government, there is no evidence of any increased cancer risk.
The UK medical 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.independent.co.uk – Exclusive: Silicone implant risk 'eight times greater , 2012-01-01 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 and 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", said Nigel Mercer, a former president of the British Association of Aesthetic and Plastic Surgeons (BAAPS), because medical implants lack the requirement of an independent clinical trial.
The company sold a high-end product that used approved silicone for wealthier clients and which cost five times more than products with silicon gel manufactured in-house. Most PIP implants were manufactured with the in-house silicon. The lawyer, Haddad, representing the founder, said "There is a product made by PIP which did not formally receive the [regulators'] approval and in this regard there was a violation of regulations,". The company did not ask France's medical device safety regulators for approval of their in-house manufactured product, but expected it would have received approval if the company asked for it.
Cancer has been found in 20 women with the allegedly faulty PIP breast implants but French health authorities (Agence française de sécurité sanitaire des produits de santé (AFSSAPS)) insisted there was still no proven link with the disease.medicalxpress.com – 20 cancer cases in French women with PIP implants: agency , 2011-12-30
AFSSAPS has as of 28 December 2011, registered 15 cases of breast adenocarcinoma, the most frequent form of breast cancer, one case of breast lymphoma, two cases of other lymphoma, one case of lung cancer and one case of acute myelogenous leukemia in women with the implants.
A French woman with a 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 affects the immune system cells. The cancer caused death in this case and caused 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.
The PIP implants have been resold as "Rofil M-implants". British Association of Aesthetic and Plastic Surgeons (BAAPS) believes many British women may have had the bad Rofil M-implants used when they bought cut-price breast enlargement surgery from clinics in Eastern and Central Europe.
The PIP factory was shut down and their products banned after it was found they had used the chemicals Baysilone, Silopren and Rhodorsil in their implants. These chemicals are normally used as fuel additives or in the manufacture of industrial rubber tubing.
In 1993, there was an availability crisis of silicone materials for use in medical long-term implant applications.nusil.com – Healthcare products , 2012, read 2012-01-26 In 1993, Mas ordered the staff to "hide the truth" and "We did it for 13 years without a problem". The PIP gel cost per litre while the authorized American gel Nusil cost per litre. The PIP implants were made with 75% non-authorised gel and 25% Nusil. "The material was better than that used to make the officially authorised gel," Mas said. "Usually, from 1997 onwards we hid the products used to make the PIP gel. I wasn't allowed to buy these products because they were not authorised. We organised everything to escape being monitored."
Investigators interviewed Mas on 18 and 19 November 2010 after the French health authority AFSSAPS discovered the PIP breast implants did not conform to regulations. They passed the case to a judge who ordered a police inquiry for "aggravated deception".guardian.co.uk – French breast implant firm boss unrepentant over unauthorised silicone , 2012-01-06
Chest, testicle and buttock implants The bad silicone has been used to make male chest, testicle and buttock implants as well. "Three people were specially trained to work with a machine that made silicon testicles'" said a former PIP worker.
Most of the male chest, buttock and testicle implants were exported to Latin America.
Impact per country
France The French government recommended per 23 December 2011 that 30,000 women in France seek removal of breast implants made by PIP.REUTERS/Interpol/Handout For women that want to keep their implants, the state will pay for a six-month ultrasound scan.
French public health care funds will be used to finance the recommended implant removals, at a cost estimated at . 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," said Alexandra Blachere, head of the association of PIP implant users in France.
A government hotline has been set up by December 2011.
United Kingdom In Britain, there are an estimated 30,00040,000 affected women. The chief Medical Officer Dame Sally Davies said, "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 said.
Concerns were filed with 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.
Shadow Health Secretary Andy Burnham said private clinics in Britain that fitted PIP implants must be forced to pick up the cost of removing them.
On 6 January 2012, NHS officials began to offer examinations and possible removal – in instances where a doctor ruled that necessary. They also called on private medical centers to offer the same deal to patients who had paid for private sector cosmetic surgery.bellinghamherald.com – Mixed advice in Europe over faulty breast implants, 2012-01-06