The two reviews have different terms of reference:
The first, led by Sir Bruce Keogh, is tasked with assessing the regulation of cosmetic interventions in general. Sir Bruce's expert group will also continue to analyse the scientific evidence of risk arising from PIP implants.
The second, led by Earl Howe, is tasked with analysing the policy reaction, in particular by MHRA and DoH, to the announcement by the French authorities in March 2010 that PIP products did not comply with the requirements of their CE registration.
Following a brief inquiry into the background to these events the Committee concludes:
- Sir Bruce Keogh's preliminary report concluded that, although there is no evidence of likely long term negative health effects attributable to PIP implants, the quality of evidence available does not allow definitive conclusions to be drawn.
- The Committee agrees with Sir Bruce that further evidence gathering about the risks associated with non-compliant implants is urgently required.
- The Committee welcomes the Government's undertaking that the NHS will remove and replace any NHS implant which has failed, and agrees with the Government that all other care providers should make the same offer.
- The Committee welcomes the Government's undertaking that the NHS will remove non-NHS implants in circumstances where the woman is unable to obtain treatment from her original provider, but urges the Government to agree a protocol under which a replacement implant can be inserted in the same operation if that is the wish of the woman, with the support of her clinicians.
- The Committee recommends that the cost of all care provided in respect of non-NHS implants should be recovered, where possible, from the original care provider, or their insurers.
The Committee recommends that Earl Howe's review should focus on the following key policy issues:
- The Committee is concerned about the quality of information available about devices that have been implanted into patients; the Committee regards the maintenance of a full audit trail of devices implanted into patients as essential to good medical practice, and recommends that these procedures should apply in all care environments - in both the public and private sector - and that the information should be readily retrievable by a patient's clinicians.
- The Committee was concerned by evidence that MRHA notices withdrawing CE registration from individual products do not require any positive response from non-NHS users of those products; it recommends that Earl Howe's Review consider requiring all relevant care providers to confirm they have received and acted on such notices. The Committee also recommends that such obligations should apply equally to all care providers - both public and private sector.
- The Committee was concerned by evidence that some patients may have received implants without being fully aware of the medium and long term consequences of such implantation - in particular including the fact that all implants eventually require replacement. Surgeons working in this field have a professional obligation to ensure that their patients consent to treatment and that such consent is provided on a fully informed basis.
The Committee further recommends that the GMC review surgeons' performance of this obligation, and of the obligation to report adverse incidents concerning medical devices to the MHRA.
Comments from the Chair
Launching the report, Health Committee Chair Stephen Dorrell MP said,
"We are broadly supportive of the immediate actions taken by the Government in response to the events of December 2011, but we believe the wider facts surrounding the use of PIP breast implants raise some important concerns:
The information available is acknowledged to be insufficient either to allow the regulator to make evidence-based judgements about the safety or otherwise of implants that were in widespread use, or to allow patients' clinicians to know whether their individual patient is affected. This is clearly unsatisfactory.
Furthermore there are questions about whether care providers reacted properly to the notices issued by the MHRA in March 2010. The obligations on both care providers and the MHRA need to be urgently reviewed to ensure that proper safeguards exist around the use of devices intended for human implantation.
Finally there have been worrying suggestions that the quality of professional advice available to patients may have been variable - and has in some cases fallen short of the standards which are required of a doctor registered with the GMC. We believe these are issues for the GMC itself to take forward, in parallel with the work of the reviews led by Sir Bruce Keogh and Earl Howe."