PIP Breast Implants and Regulation of Cosmetic Interventions
HC 1816, Sixteenth Report of Session 2010-12 - Report, Together with Formal Minutes, Oral and Written Evidence
- House of Commons - Health Committee
- TSO (The Stationery Office)
After the decision of the French authorities to recommend the removal of breast implants sourced from PIP, 'PIP Breast Implants and Regulation of Cosmetic Interventions (HC 1816)' details the Government's decision to commission two reviews following public concerns about breast implant surgery.
The first review, led by Sir Bruce Keog, is tasked with assessing the regulation of cosmetic interventions in general.
The second review, led by Earl Howe, is tasked with analysing the policy reaction, in particular by the Medicines and Healthcare Regulatory Agency (MHRA) and the Department of Health (DoH), to the announcement by the French authorities in March 2010 that PIP products did not comply with the requirements of their CE registration (Conforming to European standards).
Sir Bruce Keogh's preliminary report concluded that there is no evidence of likely long term negative health effects attributable to PIP implants, though the quality of evidence available does not allow definitive conclusions to be drawn.
The Committee welcomes the Government's undertaking that the National Health Service (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 cost of all care provided in respect of non-NHS implants should be recovered (where possible) from the original care provider or their insurers.
Earl Howe's review should focus on key policy issues:
the quality of information available about devices that have been implanted into patients;
evidence that MRHA notices withdrawing CE registration from individual products do not require any positive response from non-NHS users of those products; and
evidence that some patients may have received implants without being fully aware of the medium and long term consequences.
|Format||Paperback||Published||28 Mar 2012|
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