Sarah Boseley and Kim Willsher 

PIP breast implants can be removed for free, says government

Women concerned over faulty implants should be allowed to have free removals by the NHS or cosmetic surgery centre
  
  

Breast Implant removed NHS
Breast implants should be removed for free on the NHS if women are concerned, the government has said. Photograph: Durand Florence/SIPA/Rex Features Photograph: Durand Florence/SIPA/Rex Features

Women who are concerned about breast implants made by the scandal-hit French company PIP should be able to have them removed for free, either by the NHS – if it is reconstruction after breast cancer – or by their cosmetic surgery clinic, the government has said.

There is no evidence that routine removal is necessary, said the government at the end of an expert inquiry into the safety of the implants, which were filled with industrial-grade silicone intended for mattresses.

But it accepted the argument that many women were distressed and anxious and did not want to wait for a rupture to occur.

The announcement came amid reports that the founder of the French firm had told police that he had ordered staff to "hide the truth" about the company's use of non-medical grade silicone in the manufacture of the implants.

The British government gave a pledge to women who have had the Poly Implant Prothese (PIP) implants on the NHS – thought to be a maximum of 3,000 women out of a total of 40,000 British patients – that they could have them removed for no charge.

It cannot require the same of the private clinics, but said it expects them to make the same offer.

A Department of Health statement said: "The NHS will support removal of PIP implants if – informed by an assessment of clinical need, risk or the impact of unresolved concerns – a woman with her doctor decides that it is right to do so.

"The NHS will replace the implants if the original operation was done by the NHS."

The statement continued: "The wellbeing of women who have had PIP breast implants is our main priority. That is why the health secretary asked an expert group – led by the NHS medical director, Professor Sir Bruce Keogh – to review all available evidence and data on PIP breast implants.

"The group has concluded that the advice given by the MHRA [Medicines and Healthcare Products Regulatory Agency] still stands and that there is not enough evidence to recommend routine explantation of these breast implants. The group also agrees there is no link with cancer. However, it is undeniably the case that these implants are made up of non-medical grade silicone and therefore should not have been implanted … in the first place. We recognise that this will be worrying for women with PIP implants and that they need to be properly supported by those that performed the implantations." All women who had a PIP implant on the NHS will be contacted, the department said, and offered advice. "If in the meantime NHS patients seek information about the make of their implant then this will be provided free of charge.

"Women who wish to will able to seek a consultation with their GP, or with the surgical team who carried out the original implant, to seek clinical advice on the best way forward.

"If the woman chooses, this could include an examination by imaging to see if there is any evidence that the implant has ruptured."

As 2,000-3,000 women have had PIP implants on the NHS, there will be a substantial cost to the health service if most elect for removal. The bills in the private sector, where most of the operations took place, will be much higher.

Plastic surgeons' associations, along with the Royal College of Surgeons, said the deal was welcome news.

"Surgeons' organisations applaud those private cosmetic clinics who have committed to offer treatment to their patients free of charge and fully back the government call for the rest to follow suit," they said. "This situation raises again the need for better regulation and surveillance for all surgical implants and the surgical profession believes mandatory databases should be the next step – not least because this issue has exposed poor record keeping."

The expert group under Keogh is expected also to recommend a register of implants. Members were appalled by the absence of reliable information on the numbers of women who have had breast implant surgery and the consequences of the operation.

Health secretary Andrew Lansley, who convened the rapid inquiry, had to order private cosmetic clinics to produce credible figures by the end of the week.

A previous attempt at a register failed because it required women to volunteer their data, something many were unwilling to do. The new register will be completed by clinics and surgeons in the NHS as well as in the private sector.

It will identify the manufacturer of each implant and include details of any adverse event, such as the rupture of the implant and its removal. The French authorities have said women should have the PIP implants removed, a call echoed by UK plastic surgeons.

Investigations have found no link to cancer, as was first feared after the death of a woman in France, but there have been accounts of a high rupture rate and oozing of filler, which spread in the body causing lumps and irritation.

The head of PIP, Jean-Claude Mas, 72, has admitted using cheap silicone gel in his products to cut costs but told police he had "nothing to say" to those affected, according to French reports. Questioned by fraud squad officers in November, Mas admitted using a silicone that was not authorised and said company staff were instructed to hide this from inspectors.

But, according to Le Parisien newspaper and TF1 TV, he said the implants, which surgeons have said have a higher risk of rupturing, posed no health threat to women.

"The material was better than that used to make the officially authorised gel," Mas reportedly told police. "Usually, from 1997 onwards we hid the products used to make the PIP gel. I wasn't allowed to buy these products because they were not authorised. We organised everything to escape being monitored."

He allegedly told police he had ordered staff to "hide the truth" in 1993, two years after the company was established.

According to the reports, he added: "We did it for 13 years without a problem."

A key concern for Keogh's group has been the early rupture rate of the implants, but they have been frustrated by the conflicting statistics.

The French reported a rate of 5.5%, the Transform group of cosmetic surgery clinics said that 7% of a group of 108 women suffered ruptures and the Independent Health Advisory Service (IHAS), an umbrella group including most private clinics, said the rupture rate across thousands of patients was 1-2%, which is within the expected range.

The expert group is likely to propose tightening of the regulation of the cosmetic surgery industry. The substandard implants and absence of data have shown up problems that have long caused concern.

The then chief medical officer, Sir Liam Donaldson, announced what were billed as major reforms in 2005.

But there has been little noticeable change in an industry that some accuse of exploiting the psychological distress of women, and to a lesser extent men, who are unhappy with their appearance.

Among the issues that were to have been addressed were aesthetic fillers, yet the British Association of Dermatologists says it is still concerned about their safety and the fact that people without professional qualifications can inject them.

As with breast implants, these fillers are classified as medical devices and require only a CE mark, rather than a licence as an injectable drug would do.

"Injection of intradermal fillers is a medical procedure, albeit for a cosmetic indication," said the association in a statement. "The trivialisation of these medical procedures by absence of direct regulation of who is allowed to administer them is hazardous."

Mas told the police that the PIP gel was seven times cheaper than medical-grade silicone. The PIP gel cost €5 (£4) a litre while the authorised American gel Nusil was €35 a litre. The PIP implants were made with 75% non-authorised gel and 25% Nusil, Mas allegedly said.

Mas was interviewed by investigators on 18 and 19 November 2010 after the French health authority AFSSAPS discovered the PIP breast implants did not conform to regulations. They passed the case to a judge who ordered a police inquiry for "aggravated deception".

Asked about the women who claimed to have suffered health problems after being fitted with the substandard implants, Mas replied: "The victims are only suing to get money … I have nothing to say to them."

Asked again if he had anything to say to the women, he said: "Nothing."

Le Parisien reported that an officer told Mas: "We have received up until now thousands of complaints from victims," and asked: "How do you feel about that?"

"I have felt fine for 30 years," Mas reportedly replied.

Laurent Gaudon, a lawyer representing several women who have suffered problems after being given PIP implants, said Mas showed "greed" and a "frightening cynicism".

Mas has refused to comment over recent allegations. This week his son Nicolas Lucciardi, admitted his father's company had acted fraudulently but said: "Nobody has proved they [PIP implants] cause cancer."

An investigation has been launched in France into charges of manslaughter and unintentional injury against PIP, which supplied 65 countries and was once the world's third largest manufacturer of breast implants. A second case of aggravated deception is under investigation.

 

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