The NHS Medical Director’s expert group reviewing the safety PIP breast implants has today published its final report concluding that the gel material within the implants does not cause a long-term threat to human health.
The report says that the implants do have double the rupture rate of other implants, but that the unauthorised silicone filler used instead of medical grade filler by the discredited French manufacturer, is neither toxic nor carcinogenic.
However, it added many women have been made anxious by this episode and should receive help that addresses their problems fully. Around 47,000 women in the UK have had the implants fitted, the majority privately.
In January Professor Keogh's team concluded there was insufficient evidence to recommend the routine removal of PIP implants because the evidence did not support a link with cancer and was inconclusive on increased rupture, but recognised that women were understandably concerned.
The expert group has now studied information on 240,000 implants of different makes used throughout England, along with detailed findings from 5,600 removal operations. It concluded that exhaustive world-wide testing of the PIP gel material has not revealed anything which could cause a long-term threat to human health, and that it is neither toxic nor carcinogenic.
PIP implants are associated with double the rupture rate of other implants. The rate of rupture appears to be around six to 12 per cent after five years, rising to 15 to 30 per cent after 10 years (compared with 10-14 per cent after 10 years for other brands).
Although the contents were of the implants were not found to be harmful, the inferior mechanical strength of the implants led the group to declare the implant a substandard product. Ruptured implants have been found to cause local reactions in a small proportion of women, which can result in symptoms such as tenderness or swollen lymph glands.
Professor Sir Bruce Keogh said: “Repeated tests on different batches of PIP implants have been carried out in the UK, France and Australia according to international standards. Those tests have shown that the implants are not toxic and therefore we do not believe they are a threat to the long-term health of women who have PIP implants.
“We have however found that these implants are substandard, when compared to other implants and that they are more likely to rupture. 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.”
The Department of Health advice to women who have PiP implants remains unchanged following the report.
Fazel Fatah, president of the British Association of Aesthetic Plastic Surgeons, who participated in the expert group, said: “We agree with the report findings that anxiety itself is a form of health risk and thus it is entirely reasonable for women to have the right to opt for removal - regardless of whether there has been rupture.
“Available data shows that should intact implants be left in the body there is still a 15-30% chance that patients may need removal or replacement surgery at some stage. That ‘silent’ ruptures do not manifest in outward symptoms will in all likelihood not reassure many of those affected, so we welcome the decision that any and all women should be given the option to discuss their individual needs and should be fully supported by their provider whatever their choice, removal or monitoring.”