The NHS Medical Director’s expert group, which has been looking at PIP (Poly Implant Prothèse) breast implants has now published its final report. Led by Professor Sir Bruce Keogh, the group has been collecting and reviewing all available data including estimated rupture rates as well as data on clinical findings when implants are removed. The chemical make-up of PIP silicone gel has also received further scrutiny. In summary the group has concluded that whilst PIP implants are substandard given their increased rupture rates, there is no evidence of a significant increased risk of clinical problems in the absence of rupture.
The expert group considered information on 240,000 implants of different makes used throughout England, along with detailed findings from 5,600 removal operations and found that:
- Exhaustive worldwide testing of the PIP gel material has not revealed anything that could cause a long-term threat to human health – they are not toxic and not carcinogenic.
- PIP implants do have a higher rupture rate – around 2 times higher. The rate of rupture appears to be around 6 to 12% after 5 years, rising to 15 to 30% after 10 years (this compares to 10 to 14% 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. 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. This finding may well have significant implications for any product liability claims.
- 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 however no evidence that this causes any more significant general health issues.
The advice to women who have had PIP implants remains unchanged and the expectation is that all providers of PIP implants will contact their patients with an offer to discuss with a specialist the best way forward. If, in a particular patient’s individual circumstances, she wishes to have her implants removed the group re-stated that her healthcare provider should support her in carrying out this surgery. Where the original provider is unable or unwilling to help, the group re-stated that the NHS will remove but not normally replace the implant.
The group is aware that women who underwent breast augmentation surgery had an expectation that their implants contained medical grade silicone and has re-stated its belief that the providers of cosmetic surgery have a duty of care to minimise the health risk to their patients, including the risk posed by anxiety over possible health effects of the implants.
Those advising patients on potential claims for damages are hailing the report as extremely helpful: “We will now be inviting the Defendants to accept this report as definitive evidence that the PIP implants were defective. We would hope that the Defendants will now concede this point and move to compensating the PIP victims” . (Source: cosmeticsurgerylaw.co.uk)
- 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
- 490 women have decided to have their implants removed on the NHS
Sir Bruce Keogh is carrying out a separate review of the wider system of regulation for cosmetic interventions which will look at whether a breast implant registry could be put in place in this country, to help monitor any similar problems that occur in the future.