Surgeons contacted the Medicines and Healthcare products Regulatory Agency in 2006 to highlight concerns that the PIP implants were splitting more frequently than other brands of implant, the report by health minister Lord Howe said.
However the implants were not removed from the market until March 2010 when the French authorities found silicone gel used as a mattress filler had been fraudulently substituted for the approved material.
Almost 50,000 women in Britain have had PIP implants, mostly through private clinics as part of cosmetic surgery.
There was widespread confusion as the French authorities recommended that the women there have the implants removed as a precaution, yet the UK government gave conflicting advice.
Women here were told they should contact the clinic that fitted their implants but that there was no need to remove them unless there is evidence of rupture. The NHS will remove implants where private clinics refuse to for free or at cost.
The internal review by Lord Howe said that serious lessons must be learned by the MHRA and reporting of problems with any medical device by surgeons and manufacturers needed to be improved.
However it concluded that the MHRA had acted properly and promptly on information available at the time.
The report said the MHRA could not be expected to act on the concerns raised by individual surgeons without corroborating evidence. Yet offers by surgeons, who were not named in the report, to carry out audits of their own records were not taken up by the regulator, the report said.
Instead the MHRA contacted German organisation which assessed the PIP implant and gave it the CE 'kite' mark and was given assurances, the report said.
It said: "While it is possible that the MHRA could have derived further helpful information had they followed up the offers made by individual surgeons, it seems unlikely that any further information would have done other than to reinforce the course of action the MHRA subsequently took in contacting the notified body about their concerns with PIP implants."
The MHRA needed to have evidence of a problem with the implant before making enquiries because of the effect that this can have on the market for a particular device, the report said.
Consultant plastic surgeon and president of the British Association of Aesthetic Plastic Surgeons, Fazel Fatah, said: "Poor post-marketing surveillance of medical devices lies at the root of the PIP crisis.
"At the BAAPS we feel there needs to be significantly more stringent monitoring of all medical devices including breast implants and all cosmetic injectables, via compulsory, regular reporting of adverse effects and mystery shopping which are all part of our regulation proposals.
"This is an opportunity for the Department of Health to get it right, and put the necessary systems and checks in place to avoid a repeat fiasco. Clearly changes are also needed at European level of the CE marking process.”
Consultant plastic surgeon and BAAPS president-elect Rajiv Grover, said: “We welcome the findings of the Government’s review into the PIP scandal, and agree in particular that there should be a better system of reporting for medical devices, with data gathered from a wider set of sources that should be routinely reviewed.
"For the last few years, the BAAPS has been championing the reinstatement of a compulsory implant register that would monitor not just breast but all types of implant put into the body. The register is part of our regulation proposals put forward earlier this year and would immediately address all the recommendations put forward in this report, as would a mandatory safety audit based on the model that the BAAPS requires annually of all its members.”
Professor Sir Kent Woods, Chief Executive of the MHRA, said: "We sympathise with all the women affected and we welcome Earl Howe’s review and the recommendations.
"We will act quickly to implement the recommendations and use the lessons learned to improve the regulatory system for medical devices in the UK and Europe."
The report recommended that the MHRAreview its communications and should be proactive in addressing the concerns of patients, professionals and the public.
Evidence should be sought from a wider group of sources, including better data from doctors and surgeons and the MHRA must be able to routinely check all information about high-risk medical devices so any problems can be identified early.
The wider review of regulation of cosmetic surgery devices being conducted by NHS medical director Sir Bruce Keogh should consider whether a register of all breast implants should be reinstated, the report said.
Lord Howe said: “It must be emphasised that this case was one of deliberate fraud by the Pip manufacturer which purposefully misled European regulators. Regulation alone cannot prevent fraudulent activity such as this.
“But serious lessons must be learned from this scandal.
“It is clear that problems occurred that weren’t reported to the regulator. A vigilance system is only as good as the information that is reported to it. More needs to be done to ensure that problems with medical devices are reported, so problems can be identified and action taken to address them.
“This report won’t repair the distress caused to women who have Pip implants, but it should give them and the public reassurance that we have identified the lessons; that we will take all steps to act on them; and that, should something like this happen again, our systems for dealing with it will be stronger."
source: telegraph.co.uk
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