Q&A: PIP breast implants health scare
French breast implants caused a health scare across Europe and South America last year.
A UK report in June 2012 found the PIP implants, made from unauthorised silicone filler, had double the rupture rate of other implants.
The founder of PIP and four company executives are still on trial in France for aggravated fraud.
A German firm responsible for granting European safety certificates for the implants has been ordered by a French court to pay compensation to hundreds of women.
What was the problem?
The issue was with silicone breast implants made by the French company Poly Implant Prothese (PIP).
The firm's products were banned in 2010 after it emerged industrial grade silicone was being used. Implants should be made from medical grade material that has passed safety tests for use in a human body.
The implants had double the rupture rate of other implants, but were not found to be toxic or carcinogenic.
What happens when a silicone implant ruptures?
When an implant ruptures, the silicone gel filling can leak into the body. Some women will not notice anything at all, and there is no evidence of an increased cancer risk.
However, it can result in the formation of scar tissue that can change the shape and feel of the breast. The gel can be an irritant, causing pain and inflammation. It can also be more difficult to remove an implant once it has ruptured.
How many women were affected?
- December 2002: Surgeon writes to the Medicines and Healthcare Products Regulatory Agency (MHRA) about patient whose PIP implants have both ruptured within two years
- 2003-10: More than 20 letters from MHRA to PIP about adverse incidents
- March 2010: PIP implants are banned due to concerns over unapproved filler
- July 2010: Test results reveal no evidence that filler is harmful
- 23 Dec 2011: French government recommends all women with PIP implants have them removed as a precaution
- 23 Dec 2011: MHRA says no need for routine removal
- 6 Jan 2012: Expert committee says NHS will remove and replace PIP implants if women want and private firms should do same
- 18 June 2012: Final report by expert review panel finds PIP implants not toxic or carcinogenic but twice as likely to rupture as other implants
- Mid-2013: Review on whether the cosmetic surgery industry needs to be regulated expected
About 300,000 women in 65 countries are believed to have received PIP implants. Europe was a major market, but more than half went to South America. They were not sold in the United States.
It is thought that about 47,000 British women had the implants. Private clinics fitted 95% of the implants, mostly for breast reconstruction following cancer, the other 5% were performed by the NHS.
Should the implants be removed?
In France the answer is yes. Authorities said the implants should be removed as a precaution. Venezuela, Germany and the Czech Republic took the same stance.
In the UK, a review by NHS medical director Prof Sir Bruce Keogh said: "On the basis of the information we have, we do not think it is necessary to recommend the routine removal of these implants."
However, it highlighted that anxiety about the implants was itself a health concern and women should be able to have them removed if they wanted to.
The president of the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS), Tim Goodacre, said: "Given the fact there is a degree of uncertainty and a lack of knowledge, we're recommending all implants come out."
Who will pay?
The French government offered to foot the bill for the 30,000 French women affected to have their implants removed. In April 2012 the health safety authorities reported that nearly 15,000 women had had their PIP implants removed.
The Venezuelan Health Minister, Eugenia Sader, said the government would cover the costs of removing the implants but would not pay for replacements.
In the UK, the NHS will remove and replace the implants from women operated on by the health service. The then Health Secretary, Andrew Lansley, said private clinics had a moral obligation to do the same.
The NHS will pay to remove, but not replace, implants fitted privately if the clinics refuse the patient or have gone out of business.
Meanwhile, the Welsh government said it would pay to remove and replace privately fitted implants.
What happened to the French company that made the faulty implants?
The PIP company is now defunct. The founder, Jean-Claude Mas, is on trial in France, along with four other company directors, charged with aggravated fraud over the scandal.
The defendants could face up to five years in prison.
Mr Mas was arrested in January 2011 and spent eight months on remand in Marseille's Baumettes prison before being released on bail eight months later.
Has any other legal action been taken?
German firm TUV Rheinland, which awarded European safety certificates to PIP, has been ordered by a French court to pay damages to six implant distributors and 1,700 women.
The French court said TUV had "neglected its duties of checking and of vigilance".
The plaintiffs in the civil case will be given an initial payment of 3,000 euros (£2,500) per victim for surgery to have the implants removed.
TUV Rheinland had won two previous cases in Germany. This was the first such case in France.
The firm has said it will appeal against the verdict.
Where should women go for advice?
Women are being advised to speak to their GP if the implants were done on the NHS - if they were done privately they should contact their clinic.
What are the further implications to cosmetic surgery?
Sir Bruce has been asked to conduct a review into the cosmetic industry in general after concerns over PIP implants. He will report back to the government imminently.
The report's final recommendations will be informed by a public consultation carried out at the end of last year. Responses from patients, the public and industry showed strong support for a ban on cut-price deals and aggressive selling.
Sir Bruce said the responses "send a clear message that the current regulatory framework doesn't do enough to support consumer rights or patient safety".
Of the 180 responses to the consultation, the majority were in favour of tighter restrictions on the advertising of cosmetic surgery.
There was also "very strong support" for the banning of financial inducements or time-limited deals. Cosmetic surgeons said procedures should not be sold as "a commodity".
Some respondents said providing patients with photos of expected bruising, as well as more detail on the risks associated with surgery, should be standard procedure too.
The Royal College of Surgeons in England wants tougher laws and recommends only trained doctors, nurses and dentists should provide non-surgical cosmetic treatments such as Botox.
Currently people such as beauticians with no medical training can administer anti-wrinkle Botox injections, even though it is a potent neurotoxin.
The British Association of Aesthetic Plastic Surgeons (BAAPS), which represents a third of plastic surgeons in Britain, would also welcome stricter controls.
Estimates suggest that in 2011, there were about 700,000 surgical and non-surgical cosmetic procedures carried out in the UK. BAAPS own figures show 43,172 surgical procedures were carried out by BAAPS members in 2011.