In the wake of Sweden’s announcement that, based on new evidence, all PIP implants in their country should be removed as a preventative measure, the British Association of Aesthetic Plastic Surgeons (BAAPS; www.baaps.org.uk) has reiterated its own call for similar analysis to take place in the UK as a matter of urgency.
The new recommendations from the Swedish Medical Products Agency and the National Board of Health and Welfare are based on a ‘changed state of knowledge’, resulting from analysis of explanted products rather than off-the-shelf products.
‘At the BAAPS we have long been warning that a major loophole in safety regarding these defective implants relates to the lack of in vivo testing of PIPs (that is, analysis performed on those that have been removed from the human body). The Swedish findings, which have been undertaken in this manner, show that when inside the body, the silicone alters in such a way that doesn’t ‘stick together as well, allowing it to disperse more easily,’ said BAAPS President Rajiv Grover.
The Swedish document states: ‘The examination of a number of removed PIP implants with large ruptures shows that the silicone gel within the coating has changed its character’.
Mr Grover continued: ‘It is known that there is a subgroup of PIP implants in which the concentration of an irritant compound (known as D4) is higher than in others, but there is no way of knowing which ones are affected. This is why the Swedish government has made the decision to remove all PIPs as a preventive measure.
‘The combination of higher concentrations of D4 and the changes in the silicone, which happen when the implant is within the body, finally explain the issues that surgeons and patients have been seeing and experiencing around the country. We urge the Government, who we know has collected in vivo specimens, to perform similar analyses — as a matter of urgency.’
The BAAPS has repeatedly warned that there remain unanswered questions about the devices, and welcomes the findings as ‘finally’ addressing some of the previously unexplained symptoms witnessed in patients.