Poly Implant Prothèse (PIP) was a French company started in 1991 that produced silicone gel breast implants. It was founded by a Frenchman called Jean-Claude Mas, born in 1939, a former medical sales representative. Poly Implant Prothèse went into liquidation in 2011. The company and its founder are at the heart of a public health-care scandal.
The company is said to have produced around 100,000 implants per year, during approximately 20 years. It is estimated that approximately 400,000 women worldwide may have PIP implant products implanted to enhance breast size or correct breasts for tissue loss.
PIP was once the world’s third largest supplier of implants during their existence, PIP implants were supplied to women in 65 countries around the world who were thought to have had them fitted during surgery both for cosmetic reasons and in reconstructive surgery following treatment for breast cancer.
Breast implants were regulated under a European Union Medical Device Directive. PIP received a CE mark for their silicone gel breast implants in 2000 via the German Notified Body TÜV Rheinland, and started exports to the UK in that year. Between 2001 and 2009, about 80,000 implants (representing some 40,000 women) were sold in the UK.
PIP implants were also exported to Latin American countries such as Brazil, Venezuela and Argentina; Western European markets including Britain, Germany, Spain and Italy, as well as Australia. PIP implants were never licensed for use in the United States.
PIP implants were also used in the UK under the name ‘Rofil’ and elsewhere in the world as ‘M implants’.
It is estimated that between 2,000 and 3,000 of these implants were used by the National Health Service (NHS).
The majority of the remainder were used by the major Cosmetic Surgery Groups in the UK (including The Harley Medical Group, Transform and The Hospital Group) as well as other smaller providers and clinics.
It is believed that the implants were available to purchase for a mere £100 (up to £700 less than the medical-grade version), their low cost helped grow their popularity and helped PIP corner the market in cut-price prostheses.
From about 2006 onwards, concerns began to emerge among cosmetic surgeons in the UK about the performance of PIP implants. The alarm was originally raised after many patients and surgeons reported premature rupturing.
Implants are designed to last a minimum of ten years, however the lifespan of PIP implants was averaging at as little as just three years.
In 2008, the UK based Medicines and Healthcare Products Regulatory Agency (MRHA) who enhance and safeguard the health of the public ensuring that medicines and medical devices work and are acceptably safe, noted an increase in the number of reports of ruptures being presented to them by patients and surgical professionals. This led the MHRA to raise concerns with the manufacturer – Poly Implant Prothèse – and the German Notified Body TÜV Rheinland. The MHRA raised further concerns in 2009.
After numerous complaints and concerns received, in March 2010 the French medical regulatory authority, Agence Francaise de Securite Sanitaire des Produits de Sante AFSSAPS, began an investigation into the company.
On the 29th March 2010, AFSSAPS informed the MHRA in the UK that it had suspended the marketing, distribution, export and the use of silicone gel-filled breast implants manufactured by Poly Implant Prothèse (PIP), they also recalled all of these devices in France.
Following an inspection of the PIP manufacturing plant, AFSSAPS established from their investigation that breast implants manufactured since 2001 had been fraudulently manufactured, using unsanctioned silicone gel: the breast implants that were being manufactured were being filled with a silicone gel containing a composition different from that which had been initially approved.
Poly Implant Prothèse had been using industrial grade silicone to fill breast implants instead of the medical grade specified for the CE mark. The low-grade industrial silicone was the type used to fill mattresses – and was never approved by health authorities. AFSSAPS revoked the CE mark.
MHRA promptly issued a medical device alert to all UK clinicians and cosmetic surgery providers, asking them to cease using the implants.
The Poly Implant Prothèse (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 a fuel additive or in the manufacture of industrial rubber tubing.
Timeline
2001: PIP began to use unapproved in-house manufactured industrial-grade silicone instead of medical-grade silicone in the majority of its implants, although the French authorities have now said the use of defective PIP implants began earlier than 2001.
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 abnormally high rupture rates. This 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.
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 20th, French officials say that an action plan is underway following the death of a woman from ALCL (anaplastic large cell lymphoma). The French government recommended on December 23rd 2011, that 30,000 women in France seek removal of breast implants made of a suspect silicone gel by the worldwide exporting PIP firm.
Leaving aside the potential for the sale of some PIP implants prior to 2001, it is established that the non-approved silicone gel implants were manufactured and distributed principally between 2001 and 2009. These have the following model numbers:
•IMGHC-TX
•IMGHC-MX
•IMGHC-LS
But note: There is suspicion that PIP and Rofil implants that were manufactured before 2001 are also affected and are prone to a higher rupture rate and therefore silicone leakage. Therefore, all women with PIP implants should see a specialist.
The issues surrounding PIP implants keep growing. Even though the FDA warned French authorities about the substandard quality of PIP implants in 2000, they continued to allow their use. The U.S Food and Drug Administration (FDA) sent PIP founder Jean-Claude Mas a strongly worded letter listing 11 ‘deviations’ from ‘good manufacturing practices’, but that letter went ignored.
Psychological impact
A psychiatric study revealed that 80% of women affected by the recent Poly Implant Prothese (PIP) breast implant scandal will end up needing psychological counselling as a result of the stress caused.
The study, by the Clinical Partners and led by Richard Sherry, a counselling and clinical psychologist, discovered that nearly half (49%) had missed work due to stress about their potentially faulty implants. A further 40% admitted that their self-esteem had been ‘severely’ affected.
Over half (68%) confessed to feeling depressed after finding out about the breast implant scandal and a massive 92% admitted to suffering from stress-related insomnia since the news broke.
As a result of the upset caused, a third of women polled (33%) had sought help from a therapist or a doctor and 80% of them feel they will need psychological support in the future.
The participants of the study confessed to ‘being in tears all the time’ and being unable to think about anything but the ‘alien’ inside their body.
Richard Sherry stated that, ‘Following a number of enquiries from women seeking support for the emotional issues they were facing following the PIP scare, I felt it was important to understand the greater impact this situation was creating for them and their families. Having a specialist interest in the psychology of cosmetic surgery, I knew that breasts in themselves can be complicated embodiments of femininity, sexuality and maternal identity. So when things go wrong – as they have rather catastrophically in this instance – it can trigger deep levels of anxiety and depression. The comments we received in this study really highlight the sever levels of distress being felt by those affected. It is important to foster communities of support.’
For more advice on emotional support relating to PIP implants please contact your GP who may be able to refer you for specialist support, or locate a reputable counsellor via the contacts listed in the help list.
You are not alone and there is help, your GP must understand your needs and act on them as professionally required to do so in accordance with Department of Health Guidelines.
Summing Up
Poly Implant Prothèse (PIP) was a French company that produced and manufactured silicone gel breast implants between 2001 and 2010.
From 2006 onwards, concerns emerged amongst surgical professionals about the performance of the PIP implants following reports of premature rupturing.
In 2010, the French medical device regulatory authority (AFSSAPS) suspended the marketing, distribution, export and use of the implants manufactured by PIP, based on information gathered over the previous two years by the UK-based Medicines and Healthcare Products Regulatory Agency (MRHA).
PIP officially went into liquidation in 2011, and is now at the centre of a health-care scandal after it was discovered Poly Implant Prothèse had been fraudulently manufacturing their implants. Instead of filling their products with a silicone gel containing the composition that had been initially approved and specified to carry the CE mark, they had been using low-grade industrial silicone that had never been approved by any medical authority.
It is believed that some 40,000 women were given PIP implants in the UK, and following the investigation into PIP, anyone who has them is advised to speak to their doctor or the clinic the surgery was originally carried out.
