Faulty breast implants ‘pose no long-term threat’

Ruptured PIP breast implants should not cause any long-term health problems, experts have said.

Worried women who have been given the faulty implants will welcome the news that if the devices rupture they could cause irritation but will not have any significant lasting effects.

Expert analysis revealed that although the devices could cause irritation, there was no evidence the gel inside was toxic or caused cancer.

The news will be a relief to around 47,000 British and the 1,100 Irish women believed to have been given the faulty implants manufactured by French company Poly Implant Prothese (PIP).

The NHS Medical Directors expert group said the gel materials used inside the implants are not toxic or carcinogenic.

The implants were filled with non-medical grade silicone, intended for use in mattresses, and have been linked to rupture and swelling in the body. But the experts warned that PIP implants were twice as likely to rupture as other brands.

The group, led by NHS medical director Professor Sir Bruce Keogh, found that after 10 years the PIP implants have a 15% to 30% chance of rupturing. Other breast implant brands have a 10% to 14% rupture rate in the same timeframe.

The implants also contain the chemical compound siloxane, which is chemically similar to silicone and is found in many consumer products including hair and skin products and antiperspirants and deodorants.

But in the final report on the implants, the experts said the chemical does not present a health risk.

They said that if a PIP implant does rupture, it has been found to cause local reactions in a small proportion of women, which can result in symptoms such as tenderness or swollen lymph glands.

Prof Keogh said: “This has been an incredibly worrying time for women. We have been determined to look thoroughly at all available evidence so we are able to give them the best clinical advice possible.”

More than 400,000 women worldwide are believed to have received implants made by PIP — which was shut down in 2010 — and many countries have urged women to have them removed.

Keogh said repeated tests on different batches of PIP implants had been carried out in Britain, France and Australia and shown that the implants were not toxic.

PIP’s founder Jean-Claude Mas, 73, was charged in January with causing “involuntary injuries” in the case and in March was jailed in the southern city of Marseille after failing to pay his €100,000 bail.

The NHS study looked at data on 240,000 implants of differing brands, given to 130,000 women in England.

The British Association of Aesthetic Plastic Surgeons (BAAPS) said the report highlighted the need for all implant providers to remove the devices — even if there were no symptoms of rupture.

BAAPS president Fazel Fatah, who was part of the expert group, said: “Despite rigorous testing showing no long-term danger to human health from the individual chemicals in the gel, the fact remains that PIPs are significantly more likely to rupture and leak and, therefore, cause physical reactions in an unacceptable proportion of the patients.

“We agree with the report findings that anxiety itself is a form of health risk and thus it is entirely reasonable for women to have the right to opt for removal — regardless of whether there has been rupture.

“Available data shows that should intact implants be left in the body, there is still a 15-30% chance that patients may need removal or replacement surgery at some stage.

“It will come as no surprise to the many women affected that PIPs have been officially confirmed as defective — this has also been our long-held view — and that the choice of removal should be offered to them by their provider regardless of rupture or symptoms.

“We fully support the report’s conclusions that all providers who implanted PIPs have a responsibility to proactively share with their patients objective and up-to-date information about the risks to their health so they can make an informed decision on the removal of their implants.”

Professor Norman Williams, president of The Royal College of Surgeons, said: “The PIP breast implant issue brought into sharp focus the need for better regulation and surveillance for all surgical implants”.

He said: “It is time to look to ensure no patient experiences unnecessary harm or distress from substandard surgical implants.”