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PIP breast implants: 'rupture rate low' say private clinics PIP breast implants: UK government says 'no evidence' to remove implants
(about 2 hours later)
By James Gallagher Health reporter, BBC NewsBy James Gallagher Health reporter, BBC News
The organisation which represents UK private breast implant clinics says the rupture rate of the banned PIP implants is not abnormally high. A government review into the rupture rate of banned PIP breast implants has, so far, found no evidence for removing them, according to the health secretary Andrew Lansley.
The implants caused a health scare after French authorities found a rupture rate of 5%. The review he ordered is due to report by the end of the week.
The Independent Healthcare Advisory Services (IHAS) says data collected from thousands of patients shows an average rate within the industry standard of 1-2%. The implants caused a health scare after French authorities found a rupture rate of 5% and recommended implants were removed.
A UK review of the risk is due soon. However, figures in the UK have suggested a much lower rate.
The implants by French firm Poly Implant Prothese (PIP) were banned in 2010 after they were found to contain industrial grade silicone gel, rather than medical grade. Mr Lansley told the BBC: "The overwhelming evidence continues to support the advice we've given women previously.
The French Government says the implants should be removed as a precaution. Current UK Government advice is that there is no need to have the implants removed as Medicines and Healthcare products Regulatory Agency (MHRA) data suggested that the rupture rate is 1% - in line with other implants. "It is not advisable for women to routinely have implants removed because the risk associated with an operation of that kind would outweigh the benefit of removing these implants."
However, the health secretary Andrew Lansley ordered of the rupture rate after conflicting data was submitted. Some reports suggested a rate of up to 7% in the UK. Rupture rate unknown
The latest figures support those from the MHRA. The implants by the French firm Poly Implant Prothese (PIP) were banned in 2010 after they were found to contain industrial grade silicone gel, rather than medical grade and had an increased risk of rupturing.
The Independent Healthcare Advisory Services - which represents companies including Transform, The Harley Medical Group, Spire Healthcare, BMI Hospitals and The Hospital Group - reported a rate of 1-2%. However, data from the Medicines and Healthcare products Regulatory Agency (MHRA) suggested that the rupture rate was 1% - in line with other implants.
Its director Sally Taber said: "We are concerned that recent reports on rupture rates do not give a true reflection of the situation and are misleading. It led the chief medical officer for England, Prof Dame Sally Davies, to say before Christmas that: "We currently have no evidence to make us think they should have the PIP breast implants removed.
"Following an audit of our members, which includes data on thousands of patients...we can confirm that the average rupture rates reported for PIP implants is within the industry standard of 1-2%." However, Mr Lansley ordered a review of rupture rates after conflicting data was submitted. Some reports suggested a rate of up to 7% in the UK.
Tim Goodacre, president of the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS), said: "Even if the rate is 1-2% I am still concerned as that is higher than the normal rate." The organisation which represents the majority of UK private breast implant clinics says the rupture rate of the banned PIP implants is not abnormally high.
Fazel Fatah, president of the British Assocation of Aesthetic Plastic Surgeons, said there were "many reasons for these figures not being reliable". The Independent Healthcare Advisory Services (IHAS) has submitted evidence to the investigation collected from thousands of patients with companies including Transform, The Harley Medical Group, Spire Healthcare, BMI Hospitals and The Hospital Group.
He said that without the implant history of every patient, you could not determine the rupture rate with any certainty. Its director Sally Taber said: "Following an audit of our members, which includes data on thousands of patients...we can confirm that the average rupture rates reported for PIP implants are within the industry standard of 1-2%."
UK response
Key officials responsible for the UK's response to the health scare surrounding faulty breast implants have met.
Mr Lansley held discussions with the chief medical officer, the Medicines and Healthcare products Regulatory Agency (MHRA) and Sir Bruce Keogh, the NHS medical director who is leading a review of the rupture rate data.
About 40,000 British women have been fitted with the implants.About 40,000 British women have been fitted with the implants.
The chief medical officer for England, Prof Dame Sally Davies, said before Christmas: "We currently have no evidence to make us think they should have the PIP breast implants removed." Never know
Tim Goodacre, president of the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS), said: "Even if the rate is 1-2% I am still concerned as that is higher than the normal rate."
Fazel Fatah, president of the British Association of Aesthetic Plastic Surgeons, said there were "many reasons for these figures not being reliable".
He said implants may have ruptured without the patient knowing or patients may have changed private clinicians or moved into NHS care if there was a problem.
"We do not know the exact rupture rate in the UK," he added.
The health secretary acknowledged that data from private companies had been "inconsistent" and was sometimes "inadequate" and of "poor quality".
This morning he held discussions with the chief medical officer, the Medicines and Healthcare products Regulatory Agency (MHRA) and Sir Bruce Keogh, the NHS medical director who is the review of the rupture rate data.
Prime Minister David Cameron's spokesman said: "We need to let Sir Bruce Keogh conduct the review before thinking about the next steps."Prime Minister David Cameron's spokesman said: "We need to let Sir Bruce Keogh conduct the review before thinking about the next steps."
The full review group will meet tomorrow to discuss the preliminary findings. An announcement is expected by the end of the week.The full review group will meet tomorrow to discuss the preliminary findings. An announcement is expected by the end of the week.
Globally more than 300,000 implants are believed to have been sold to 65 countries by PIP over the last 12 years.Globally more than 300,000 implants are believed to have been sold to 65 countries by PIP over the last 12 years.
More than half of its exports went to South America.More than half of its exports went to South America.