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Latest news on PIP breast implants

12:00pm Tuesday 15th May 2012 content supplied by

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.

Symptoms to watch for

If you have any of the following signs or symptoms, you should discuss them with your GP, who will refer you to a specialist:

• lumpiness of the breast
• lumpiness or swelling in the area around the breast
• change in shape of the breast
• deflation of the breast
• redness
• tenderness of the breast
• swelling of the breast
• pain or sensitivity

The Chief Medical Officer for England has issued GPs and surgeons with specialised guidance on how to check and care for women with PIP implants (PDF, 119kb).

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 report (PDF, 159kb).

If you are worried

• Find out if you have PIP implants by checking your medical notes.  You can get these free from your clinic or GP. If you had a PIP implant on the NHS, you will receive a letter.
• Speak to your GP, if you had them done on the NHS, or your clinic if you had them done privately.
• Agree what’s best for you – get advice on whether or not you need a scan then discuss removal with your doctor.
• If you decide you want your implants replaced, the NHS will do it free if your original operation was done on the NHS.
• If your original operation was in a private clinic you will need to speak to the clinic to see if they will replace them free.
• If your private clinic no longer exists or refuses to remove the implants, speak to your GP. The NHS will remove your implants if your doctor agrees there is a medical need.

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.

All women will be offered the same care by the NHS whether they had their implants before or after 2001, and should be offered the same care if they had them fitted by private providers.

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.”

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.