PIP breast implants and regulation of cosmetic interventions

Following the PIP breast implant scandal, the Government has announced a number of reviews. Specifically: Sir Bruce Keogh will continue to assess the evidence relating to the risks of PIP implants; Earl Howe is conducting a review into the actions of the MHRA and the Department of Health; and Sir Bruce Keogh will also conduct a wider review into the regulation of cosmetic interventions in general.

Our Committee’s evidence session on PIP breast implants raised a number of issues that we feel ought to be considered by these reviews.

In particular, we recommend that Sir Bruce Keogh’s continuing review of the scientific evidence must gather all possible data, including patient-reported experiences, and, if new evidence still does not allow for a conclusive view on the safety of PIP implants, we expect the Department to bring forward a proposal for gathering the data. We recommend that the Department’s policy take into account new data on the inflammatory properties of PIP implants.

We recommend that Earl Howe’s review of Department of Health and MHRA actions considers both whether the MHRA had information that should have led it to take action prior to the withdrawal of PIP’s CE mark in March 2010, and also whether the MHRA and DH took sufficient action in the period between March 2010 and December 2011. In particular, the review ought to address why a high-profile policy response was not adopted sooner, and whether sufficient effort was made to contact affected women.

With regard to the current policy response, the Committee agrees that, in general, private clinics have an obligation to provide care and should adopt the same strategy as the NHS offer. Nevertheless, Earl Howe’s review ought to consider how well this policy fits with the capacity of private clinics to provide treatment. The NHS must recoup any additional costs incurred in the course of a procedure that ought rightly to have been carried out by a private provider.

The reviews must establish a clearer regime of responsibility and give a clear statement of the extent of the legal obligations on private clinics. The argument of a moral imperative may be compelling, but it is difficult to enforce.

The Committee agrees that replacement implants for private patients should only be provided on the NHS where there is a clinical need. However, the Committee invites the Department of Health to propose a framework that would allow women in certain circumstances to combine NHS removal of implants with paid-for private surgery to insert replacements.

We recommend that Sir Bruce Keogh’s review into the regulation of cosmetic interventions considers how the CE mark system can be strengthened, not only to ensure that changes in products are assessed, but also to ensure that the concerns of national regulators regarding implants manufactured and certified elsewhere are acted upon.