Policy paper

Final expert report on PiP breast implants published

The NHS Medical Director’s expert group, which has been looking at PIP breast implants has today published its final report.

Document

appendices (volume 2)

This file may not be suitable for users of assistive technology. Request a different format.

If you use assistive technology and need a version of this document in a more accessible format please email publications@dh.gsi.gov.uk quoting your address, telephone number along with the title of the publication ("appendices (volume 2)").

Detail

The NHS Medical Director’s expert group, which has been looking at PIP breast implants has today published its final report.

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 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 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 - 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.

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 a 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.

Currently:

  • 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

Cosmetic interventions regulation

Sir Bruce Keogh is currently carrying out a separate review of the wider system of regulation for cosmetic interventions.

This review will 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. Read the terms of reference for Bruce Keogh’s review.

Help us improve GOV.UK

Please don't include any personal or financial information, for example your National Insurance or credit card numbers.