'No long-term damage' from ruptured PIP breast implants, report says
Monday 18 June 2012
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.
The NHS Medical Directors expert group said the gel materials used inside the implants are not toxic or carcinogenic.
Around 47,000 British women are believed to have been given the implants manufactured by French company Poly Implant Prothese (PIP).
They 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 are 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.
“Repeated tests on different batches of PIP implants have been carried out in the UK, France and Australia according to international standards. Those tests have shown that the implants are not toxic and therefore we do not believe they are a threat to the long-term health of women who have PIP implants.
“We have, however, found that these implants are substandard when compared to other implants, and that they are more likely to rupture.
“We would therefore advise that women who have symptoms of a rupture - for example tenderness, soreness or lumpiness - should speak to their surgeon or GP. I would ask all GPs to refer any patient who has concerns about their PIP implants to a specialist.
“I sincerely hope this helps to reassure women that their long- term health is not at risk.”
The group, which studied information on 240,000 implants of differing brands that have been given to 130,000 women in England, also called for surgeons and clinics that have used PIP implants to contact their patients and share the latest information with them.
In January the Government announced that anxious women given PIP breast implants on the NHS would be able to have them removed free of charge, with private firms expected to offer the same deal.
However, it said any woman refused help by a private company would be able to visit their GP and access NHS care.
The latest data from the Department of Health shows that almost 750 women are to have the implants removed on the NHS - 490 of whom had their PIP implants put in at private clinics.
The British Association of Aesthetic Plastic Surgeons (BAAPS) said the report highlights the need for all implant providers to remove the devices - even if there are 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.
"With the publication of the final report by the expert group, it is time to look to the future to ensure no patient experiences unnecessary harm or distress from substandard surgical implants.
"It is the view of the College that we should, as a minimum, have mandatory databases for all surgical implants and associated techniques which would provide ongoing patient safety data.
"New surgical devices, and the techniques required to implant them, must be regulated so that they can be safely introduced into our healthcare system, disseminated appropriately and monitored in the long term."
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