Review of breast implant safety
PIP implants were banned last year as they contain unauthorised silicone filler
Now that the Health Secretary Andrew Lansley has ordered a review of the safety data on the banned PIP breast implants, we may be closer to solving a puzzle.
The puzzle is this - why did the French medical watchdog find that the implants have a 5% rupture rate, whereas the equivalent body here, the Medicines and Healthcare products Regulatory Agency (MHRA), found a 1% rupture rate - no worse than other makes?
That was a key reason why the Health Secretary Andrew Lansley was adamant last week that the routine removal of the implants was unnecessary.
Around 40,000 British women have the implants, which were banned last year because they contain non medical-grade silicone. 95% of the operations were done in the private sector. The MHRA relies on data from private providers concerning safety problems with implants.
Yesterday a significant private health provider gave conflicting new evidence which revealed a higher rupture rate than their previous submitted data. This prompted Mr Lansley to launch a review of the evidence. He said he was "concerned and unhappy about the consistency and quality of data" given by private providers.
“Start Quote
End Quote Andrew Lansley Health SecretaryI want to give further reassurance to women that if there are any safety concerns we will act with whatever remedy that is required.”
The review body, led by the NHS Medical Director, Professor Bruce Keogh will analyse rupture data here and overseas and report back next week.
Mr Lansley said: "I want to give further reassurance to women that if there are any safety concerns we will act with whatever remedy that is required. But at present we don't evidence that would justify any routine removal of these implants, nor do we have safety concerns."
This review may have wider implications for the cosmetic surgery area, as it will look at the regulation of quality and safety of surgery in the private sector. Should the review team find that data collection is poor or that evidence is not passed on promptly, it may result in further action.
'No cancer risk'It is important to say what the review is not looking at - namely cancer risk. The authorities in France and Britain have already said categorically that the PIP implants do not carry a breast cancer risk.
The MHRA has also said there is no evidence of toxicity from the unauthorised filler. However, it is accepted that once an implant has ruptured it can be more difficult to remove. The French investigation spoke of the risk of inflammation of the breast and the unknown potential risk from the untested silicone filler.
Should a high rupture rate be detected here, the key question will be whether it will lead to the UK following the French decision to recommend the implants are removed.
The Department of Health would not speculate on this so we will have to wait to see the evidence of the review.
Although this announcement means a further period of uncertainty for many women, the speed of the review should mean that they will have clearer answers about the safety of the implants within a matter of a week or so.
In the meantime, the advice from surgeons is that women with PIP implants should make an appointment with the surgeon who treated them.
Last week the Health Secretary Andrew Lansley was adamant that there was no need for the routine removal of the banned PIP breast implants.
That remains his position, but it is now dependent on the results of a review of safety data.
~RS~q~RS~~RS~z~RS~50~RS~)




Afghan Taliban attack central Kabul
'Field of diamonds'
The dogulator
Rising anger
Selective disclosure
Art over politics
Click
Comment number 1.
Clariana31st December 2011 - 15:50
Wouldn't it have been better for the government to have done this before assuring us that these devices were safe? Who is going to believe them now?
Link to this (Comment number 1)
Comment number 2.
Clariana31st December 2011 - 16:00
"Yesterday a significant private health provider gave conflicting new evidence which revealed a higher rupture rate than their previous submitted data..."
Ie, they lied. Typical private sector.
Link to this (Comment number 2)
Comment number 3.
benbowlane31st December 2011 - 16:15
Women who have these things inserted into their bodies need their heads looking at.
Does that sound right?
Link to this (Comment number 3)
Comment number 4.
srnet31st December 2011 - 19:28
95% of these implants were carried out by private sector medicine.
I presume therefore that the same private sector is going to fund the removal of these implants, if deemed necessary.
Link to this (Comment number 4)
Comment number 5.
bluest-man31st December 2011 - 19:30
Happy to see an evidence review ... just as long as the women who have chosen to do this too themselves understand that they paid to have them put in and choose the cheap option and will have to pay for it to be sorted out just like buying the cheapo version of anything.... It is not the rest of the tax paying public to pay to have there cosmetic surgery sorted out!!
Link to this (Comment number 5)
Comments 5 of 31