Breast Implants

Sarah Wollaston Excerpts

Wednesday 11th January 2012 Commons Chamber

[Mr Lansley]

I completely understand the right hon. Lady’s point, but this activity is not unregulated. For example, the Care Quality Commission is responsible for the registration of providers, and for ensuring that they meet essential standards of safety and quality. However, for precisely the reasons cited by the right hon. Lady, I am asking Sir Bruce Keogh’s group to consider wider issues relating to the regulation of cosmetic surgery and cosmetic interventions.

The registry to which the right hon. Lady referred was discontinued in 2004 because a substantial number of women were not consenting to the addition of their names to the register. I believe that, given the positive experience that has followed the establishment of the National Joint Registry, we can reassure women that their data can be entered without prejudicing their patient confidentiality.

I should make it clear that as yet we have no evidence demonstrating any significant difference between the rupture and leakage rates of PIP breast implants and those of other implants. Last June the American Food and Drug Administration published the findings of a study of normal implants, two of which had a 10% to 13% rupture rate over a 10-year period. It is important to appreciate that implants in themselves pose a distinct risk of rupture and leakage.

[Dr Sarah Wollaston (Totnes) (Con)]

I welcome the clear commitment to putting women’s health needs first in this context, but is not the heart of the problem the obvious conflict of interests for private clinics when it comes to the provision of long-term safety statistics? Will my right hon. Friend ensure that any future system allows women to self-report to the registry—albeit with a follow-up from specialists for confirmation purposes—so that we can have a complete picture of the long-term complications caused by devices of this kind?

[Mr Lansley]

My hon. Friend is right. When Sir Bruce and his colleagues are considering the establishment of a wider registry, they will consider not only the possibility of self-registration but the possibility of making clinical professionals responsible for the publication of such data. The responsibility should not rest solely on providers or manufacturers.