Monday June 18 2012
Talk to your GP or surgeon if you are worried about PIP implants
Women concerned about PIP breast implants can find all the latest NHS information about the issue in our Health A-Z section on PIP implants.
Worries about the implants have emerged since news of a major investigation into them in France was widely covered in the media in December 2011.
Initially it was thought that around 40,000 women in the UK had the implants but on March 15 the Department of Health said new evidence meant a further 7,000 women in the UK might have them. About 95% of the implants were provided privately for purely cosmetic reasons.
The French implants caused global concern after it was revealed they contained industrial silicone rather than medical-grade fillers and that they may be more prone to rupture and leakage than other implants.
Initially reports also linked the implants to a rare form of cancer known as ALCL. This cancer link has been now been firmly discounted by medical experts here and in Europe.
What type of implants are involved?
The implants involved are called Poly Implant Prosthèse (PIP) and were made by a French company of the same name.
In a Medical Device Alert in March 2010, the Medical and Healthcare products Regulatory Agency (MHRA) said: " ... most breast implants manufactured by the company since 2001 have been filled with a silicone gel with a composition different from that approved".
That alert was based on advice from French regulators. However, after an investigation by the MHRA, the French authorities reported in March 2012 that PIP implants made before 2001 may also contain unauthorised silicone gel.
PIP gained approval to market its silicone implants in 1997 but it is not clear when it began using a cheap type of silicone gel intended for making mattresses.
The marketing, distribution and use of the PIP implants was suspended in March 2010.
Do the implants have to be removed early?
About one breast implant in five needs replacing within 10 years, whatever the make, so it is unlikely that all the 7,000 women who had PIP implants before 2001 still have the same implants.
An expert committee was set up recently to examine the specific risks associated with PIP implants. It concluded that there was not enough evidence to recommend their early removal. That advice has not changed. For more details, read the expert review group's final report (PDF, 163kb).
What does the final report from the expert review group say?
The final report from an expert review group chaired by Sir Bruce Keogh was published on June 18 2012. It has concluded that rigorous chemical and toxicological analyses of a wide variety of PIP implants have not shown any evidence of significant risk to human health, and that no further tests would change this conclusion. The only significant chemical variation in PIP implants is that they have higher levels of siloxanes than other silicone breast implants. No other organic impurities and no significant inorganic impurities were found in any batch of PIP implants. A very low level of caesium was found, but this is not thought to be a health risk.
The review also found that PIP implants are more likely to rupture or leak silicone than other implants (twice to six-times as likely). Rupture rate for PIP implants is estimated at around 6-12% at five years, and 15-30% at 10 years, although these estimates are not very certain. Patients with PIP implants are at greater risk of developing associated local reaction and lymph node enlargement from a rupture. Some failed PIP implants caused local reactions but the signs of this happening are usually obvious.
The expert group recommends that before any woman has breast implants removed, she considers that:
- any surgery involves a risk of harm, including unexpected death, even for generally healthy people
- evidence suggests that the risks of complications are greater for subsequent breast augmentation operations than for a first breast augmentation operation
- all kinds of breast implants have a risk of failure
- the more significant adverse consequences of rupture or leakage of PIP implants appear to occur mainly where there are clear signs on a clinical examination
- despite extensive testing in the UK and internationally, there is, to date, no evidence implicating PIP or any other silicone breast implants in other forms of long-term damage to health
The Department of Health and MHRA are continuing to monitor developments. The regulation of cosmetic surgery and other cosmetic procedures is under review.
When did the concerns first come to light?
Some papers have reported that a surgeon wrote to the MHRA in 2006 suggesting that PIP implants should be withdrawn from the market. According to a report into the authorities' actions on PIP, published by health minister Lord Howe (PDF,649kb) on May 14 2012, “adverse events” involving PIP implants, including ruptures, have been reported since 2002. In all, 269 adverse events were reported between 2001 and 2009 (of which 240 were ruptures).
Lord Howe’s report said that the MHRA passed its concerns on to the German organisation responsible for assessing PIP implants in April 2007. It concluded that the MHRA “was fulfilling its obligations in terms of reviewing in responding to the incidents reported to them”, was “active in pursuing PIP” about the problems, and took surgeons’ concerns into account.
Did the authorities act appropriately?
The report concluded that there is “no evidence that the MHRA acted inappropriately” and that “nothing about this case provides evidence to suggest the system for regulating medical devices is fundamentally unsound”.
What could the authorities have done better?
Some newspapers recorded concerns that Lord Howe’s report might be a “whitewash”. However, the report included key criticisms of the MHRA and the Department of Health and included 15 recommendations for action.
One of the main criticisms was levelled at the MHRA for “not making greater and more co-ordinated efforts to ensure that information reached people with a direct interest in it, specifically providers, health professionals and affected women”. It said: “the MHRA and the Department of Health must learn lessons so that they can continue to improve their approach to communicating with affected individuals and the general public.”
The report said: “Ultimately the responsibility for the great distress caused to UK women … lies squarely with the fraudulent manufacturer who actively covered up its deceit and showed a complete disregard for the welfare of its customers.”
Is the situation being investigated further?
Yes, the Department of Health has set a further review to look at how the PIP situation occurred and the issue of regulating the cosmetic surgery industry as a whole.
This second review will look at whether the cosmetic surgery industry needs to be regulated and, if so, how this should happen. This review is due to be submitted by March 2013 and will be led by Professor Sir Bruce Keogh, the NHS Medical Director, who said:
“I am working with experts from the plastic surgery field to look at what we can do to make sure people who choose to have cosmetic surgery and other cosmetic procedures are safe.
“I will be looking at all aspects of regulation – at the regulation of implants and fillers, at whether the people who carry out cosmetic interventions have the right skills, at whether the clinics look after the care and welfare of their patients."
The extensive report is due to be submitted by March 2013.