The group, lead by Professor Sir Bruce Keogh, has been collecting and reviewing all available data including estimated rupture rates, data on clinical findings when implants are removed, and further examination of the chemical make up of PiP silicone gel. The expert group has studied information on 240,000 implants of different makes used throughout England which have been given to 130,000 women, along with detailed findings from 5,600 removal operations.
The group recognises the anxiety that many women have suffered during this episode and is determined that they receive help that addresses their problems fully.
The expert group has found that:
• Exhaustive world-wide testing of the PiP gel material has not revealed anything which could cause a long-term threat to human health - they are not toxic nor carcinogenic.
• They do, however, have a higher rupture rate - around two times higher. 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 (this compares to 10-14 per cent after 10 years for other brands of implants).
• PiP implants have a higher concentration of certain compounds called siloxanes - chemically similar to silicone but of a lower molecular weight and found in many consumer products, including hair and skin care products, antiperspirants and deodorants - but this does not present a health risk.
• Although the contents are not harmful and the gel has not been shown to contain any toxic substances, the inferior mechanical strength of the implants led the group to consider this a substandard product.
• If the implant does rupture, it has been found to cause local reactions around the implant area in a small proportion of women, which can result in symptoms such as tenderness or swollen lymph glands. There is no evidence that this causes any more significant general health concern however.
The expert group has said that the advice to women who have PiP implants remains unchanged. It is expected that all providers of PIP implants will contact their patients. If women are unsure of the make of their implant they should contact their surgeon or provider.
• Women who have PiP implants are advised to speak to their surgeon.
• Patients should be advised on the implication of undertaking further surgery and of leaving the implants in place.
• The NHS will support women if they decide to have their PiP implants removed.
• Women who have been refused help from a private clinic provider should see their GP. The GP should then refer them to a suitably qualified specialist who will provide further advice. Sir Bruce Keogh is writing today to NHS Medical Directors to emphasise this point.
The group is aware that women who underwent breast augmentation surgery had an expectation that their implants contained medical grade silicone. The providers of cosmetic surgery have a recognised duty of care to minimise the health risk to their patients. The group agrees that anxiety over possible health effects is in itself a form of health risk.
It is now clear that PiP implants are more likely than other implants to rupture early, and that some patients who experience implant rupture will develop local reactions to silicone. In line with good clinical practice those surgeons and clinics that have used PiP implants have a responsibility to take proactive steps to contact their former patients and to share with them the latest information regarding the health implication, including the evidence summarised in the report.
Professor Sir Bruce 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.
“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.
“I sincerely hope this helps to reassure women that their long term health is not at risk.”
So far 7,098 women who had their PiP implants put in privately have been referred to a specialist on the NHS; 4,349 scans have been done; and 490 women have decided to have their implants removed on the NHS.
Notes to editors
1. The report is available on the DH website.
2. Sir Bruce Keogh is currently carrying out a separate review of the wider system of regulation for cosmetic interventions. His review will also look at whether a breast implant registry could be put in place in this country, to help monitor any problems that occur and perhaps make it easier to trace people affected if there is ever a problem in the future. The terms of reference for Bruce Keogh’s review can be found on the DH website.