An expert group under the National Health Service (NHS) in Britain has published a thorough report on PIP implants.
The exhaustive worldwide testing of the PIP gel has not revealed anything that could cause a long-term threat to human health. The implants are not toxic and do not cause cancer.
But the risk that the PIP implants may rupture is around two times higher than it is for other brands of implants - around 6-12 % after 5 years, and 15-30 % after 10 years, whereas the risk associated with other brands is 10-14 % after 10 years.
The contents of the PIP implants are therefore not harmful, and the gel has not been shown to contain any toxic substances, but the poorer mechanical durability makes the PIP implants a substandard product.
If the implant does rupture, a small group of women may experience local reactions around the implant area, which can result in tenderness or swollen lymph glands, but there is no evidence that this causes any more significant general health concern.
It also appears from the report that PIP implants have a higher concentration of so-called siloxanes, which are chemically similar to silicone. Siloxanes are found in many consumer products, including hair and skin care products and deodorants – but this does not present a health risk.
The expert group has collected and reviewed all available data including data on clinical findings and information about the chemical make-up of the PIP silicone gel.
The report is based on information about 240,000 implants of different makes used throughout England, which have been given to 130,000 women.
The Danish Health and Medicines Authority's recommendation is unchanged, i.e. women are advised to contact the clinic responsible for their breast implant surgery. If the clinic has closed down, women are advised to contact their own doctor for an individual assessment of whether the implants should possibly be removed.
Report and guidance
Report published by the NHS: Poly implant Prothese (Pip) Breast Implants: Final report of the Expert Group
Danish Health and Medicines Authority's advice for doctors (in Danish only): Guidance for general practitioners on breast implants (in Danish only)