PIP breast implants pose no long-term health threat, say experts
Substandard silicone gel will not damage cells or cause genetic mutation, medical team concludes after implant tests
Medical experts investigating the consequences of the PIP breast implant scandal in the UK have concluded the substandard silicone gel used in the implants does not pose a significant risk to women's health in the long term.
They say tests carried out in Britain, France and Australia showed no evidence the filler would damage cells or cause genetic mutations. Tests in Australia and France had also found no evidence it could cause skin irritation, contradicting earlier findings from French regulators.
But an expert group headed by Bruce Keogh, the NHS medical director, found PIP implants were significantly more likely to rupture or leak silicone than other implants. About 47,000 women in the UK have had PIP implants, most privately, but just under 900 on the NHS, mostly for breast reconstruction after cancer.
The group's final report said that after 10 years, PIP implants had a 15% to 30% chance of rupturing. Other breast implant brands had a 10% to 14% rupture rate in the same timeframe. It repeated earlier advice that all providers of breast implant surgery should contact women who have or may have PIP implants if they have not already done so.
Any women who had PIP implants fitted on the NHS can get them removed and replaced free of charge. In Wales the NHS will also replace those of private patients while in England and Scotland the NHS will remove implants of private patients but not replace them.
The experts said there was no need to commission further research into systemic symptoms reported by women with PIP implants – generalised pain, respiratory problems, anxiety and fatigue. Such symptoms were common to the general population and it would be difficult to establish a sufficiently robust control group with which to make a comparison, they said. Similar symptoms had been linked to other breast implants and previous studies had "uniformly failed to demonstrate any causal link between implants and symptom prevalence". In addition, "no evidence has yet been found that any of the chemical constituents of silicon gel are potentially harmful and no biologically plausible mechanisms have been suggested to link silicone gel with the symptoms described".
However, the experts did not dismiss "the reality or clinical importance" of such symptoms, adding that anxiety "is in itself a significant health issue and may well increase the risk of other health problems".
Keogh said: "This has been an incredibly worrying time for women. We have been determined to look thoroughly at all available evidence so we are able to give them the best clinical advice possible. We would therefore advise that women who have symptoms of a rupture – for example tenderness, soreness or lumpiness – should speak to their surgeon or GP. I would ask all GPs to refer any patient who has concerns about their PIP implants to a specialist.
"I sincerely hope this helps to reassure women that their long-term health is not at risk."
The British Association of Aesthetic Plastic Surgeons (BAAPS) said the report highlighted the need for all implant providers to remove the devices – even if there were no symptoms of rupture.
Fazel Fatah, the president of BAAPS, who was part of the expert group, said: "Despite rigorous testing showing no long-term danger to human health from the individual chemicals in the gel, the fact remains that PIPs are significantly more likely to rupture and leak and, therefore, cause physical reactions in an unacceptable proportion of the patients … It will come as no surprise to the many women affected that PIPs have been officially confirmed as defective – this has also been our long-held view, and that the choice of removal should be offered to them by their provider regardless of rupture or symptoms."
Last month, a separate review led by the health minister Lord Howe said the UK regulator the Medicines and Healthcare products Regulatory Authority needed to improve in order to better identify problems early and communicate with the public. He put the blame for the health scare on the "deliberate fraud" of the now-defunct French company Poly Implant Prothèse. Its owner is in prison awaiting trial.
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