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08
Mar

NHS issues update on PIP implants


NHS medical director Bruce Keogh has revealed that an expert review group do not think it is necessary to recommend the routine removal of PIP implants.

Worries about PIP implants have emerged since news of a major investigation into them in France was widely covered in the media in December 2011.

Around 40,000 women in the UK have the implants - about 95% of them 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, starting in2001, by a French company of the same name. Implants made earlier by the firm are not thought to be affected.

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".

It is reported that the company had started 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?

Most breast implants need to be removed or replaced after 10-15 years.
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.

For more details of its findings read the expert review group's report (http://www.nhs.uk/news/2012/01January/Documents/pip-report.pdf).

However, the committee said the NHS would remove and replace the implants without charge if patients that the NHS had operated on remained concerned.

The government expects the private sector to follow suit.

NHS medical director Professor Sir Bruce Keogh, who led the expert review group, said: “On the basis of the information we have, we do not think it is necessary to recommend the routine removal of these implants.

“But we understand that some women will be very concerned so we support the government’s position that the NHS will support removal of PIP implants if the patient has concerns and, with her doctor, she decides that it is right to do so.”

Is the situation being investigated further?

Yes, the Department of Health has set up two reviews to look at how the PIP situation occurred and the issue of regulating the cosmetic surgery industry as a whole.

The first review will be led by Lord Howe and will address a number of specific issues, including:

  • what information about PIP implants was available from routine systems for reporting adverse events;
  • what external concerns about PIP implants were brought to the attention of regulators, and when;
  • how these concerns and any related information were handled;
  • what information was shared between MHRA and counterpart agencies abroad;
  • what action was taken to safeguard and advise patients;
  • whether action was sufficiently prompt and appropriate;


The report is due to be submitted to the health secretary by the end of March 2012.

The second review will look at whether the cosmetic surgery industry needs to be regulated and, if so, how this should happen.

It 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.

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