In 1991 a company called PIP (Poly Implants Prostheses) was founded in France. The company announced that they had developed firm silicone and they promoted lifelong durability of this product. In 1997 the company obtained European certification and was regularly inspected for quality insurance by a German QA company.
In 2009 the French authorities were informed about the increasing frequency of early rupture and the unusually high leakage of the PIP prostheses. An investigation found that an unusually high amount of industrial grade silicone had been purchased from a company in Germany. In contrast to medical grade silicone the substandard silicone had not undergone a cleaning process. As a result, a higher amount of low molecular weight products were left over as part of the manufacturing process and this showed high biological activity. This silicone can much more easily pass through the shell of the implant thereby causing irritation and inflammation in the surrounding tissues.
By omitting the cleaning process the company saved about 1 million Euros a year. The implants also contained a petroleum lubricant (Baysilone), as well as Silopren and Rhodorsil which are used in the rubber industry.
In April 2010 the implants were withdrawn from the market.
Investigations revealed that the gel used in the PIP implants consisted of a mixture of about 25% medical grade silicone and 75% industrial grade silicone. Whenever PIP was inspected by the Quality Assurance firm 10 days notice was given. During this time PIP used high-grade medical silicone and returned to the sub standard product after the inspectors left! Thus evidence of their illegal activity was concealed.
Furthermore, it was found that since 2006 the previously used double layered silicone shell had been replaced by a single layer to reduce production costs!
The French Health Product Safety Agency demonstrated through its own investigations that there was an increased inflammatory reaction caused by the silicone used in PIP implants.
Experiments on Mice showed no genetic changes nor increased risk of cancer.
On the 23rd December 2011 the French authorities recommended that women with PIP implants discuss their removal with their surgeon. Germany, the Netherlands and the Czech Republic all advised patients to remove their PIP implants. Other countries such as Britain (where about 50,000 patients are estimated to have received PIP implants) have advised twice yearly clinical examinations with imaging such as ultrasound and MRI.
The International Society of Aesthetic Plastic Surgery, based on its mission of patient safety, believes that there is only one option – removal of all PIP implants. This is because the material used in the PIP implants has definitely not been tested for medical safety, has not been approved for insertion into human beings and there is definitely no study showing that it is harmless.
In Australia the TGA (which is responsible for monitoring medical devices) has recommended that women with PIP implants discuss their options with their surgeon and have recommended an MRI examination.
It is important to note that rupture of these implants may not be detectable in its early stages. An ultrasound will reveal the rupture in about 30% of cases and an MRI in 90% of cases.
By now the scandal has extended to titanium coated implants that were also filled with sub standard PIP silicone. Fortunately only a relatively small number (728 implants) were sold worldwide.
In Australia, the Australian Society of Plastic Surgeons maintains a Breast Implant Register. All patients on the register who were known to receive PIP implants have been contacted and advised to be checked by their surgeon. However, because the Register has been optional, only 4% of the 12000 PIP implants known to have been sold in Australia are registered!
Patients who have had Breast Implants at Avenue Plastic Surgery can be reassured that PIP implants have never been used at this Hospital. We are happy to provide advice to women who have had PIP implants inserted elsewhere regarding follow up and replacement.