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Meeting of the Parliament 14 June 2012

14 Jun 2012 · S4 · Meeting of the Parliament

Item of business

PIP Silicone Breast Implants

Burgess, Margaret SNP Cunninghame South Watch on SPTV

I can only imagine the stress and anxiety that are felt by women who have PIP breast implants. For some time, they have lived with that worry day and daily. Although the expert advice suggests that there is no evidence to support routine removal of PIP implants, I absolutely understand why some women who have them want them to be removed and replaced. Those women know that they have in their bodies implants that are made of a material that is not approved for medical purposes, and they fear that those implants might rupture at any time. In such circumstances, I would be angry and worried and possibly a bit frightened, so I understand the sentiments of the action group.

I am sure that all members support the on-going criminal investigation in France into Jean-Claude Mas, the former owner of PIP. We must not forget that that fraudulent manufacturer has the ultimate responsibility for the distress that has been caused to so many women throughout the world, including, as I understand it, about 1,300 in Scotland. As stated in Lord Howe’s review, the company covered up its deceit and showed complete disregard for the welfare of its customers, which is absolutely shocking. The people who are responsible must be brought to justice.

I welcome the Scottish Government’s actions in responding quickly and giving a commitment that the NHS will provide help and support—including removal of implants, if that is clinically appropriate—for women whose private surgery provider refuses to do so or has gone out of business. Private providers of the procedure throughout the sector have a duty of care to all their patients. Women should not be charged for replacement and removal of PIP implants. People who are affected by the scandal have enough on their plate without having to worry about how they will get the money to put things right.

I hope that any clinical assessment of whether to remove and replace implants will include an assessment of the mental health impact on the individual if the implants are not replaced. As many members have said, lessons need to be learned in order to prevent such an incident from happening again. I therefore welcome the Scottish Government’s involvement in the existing UK-wide inquiries, which are covering a range of issues, including health issues surrounding the implants; improving adverse incident reporting; better communication methods on issues that cause public concern; regulation of the cosmetic surgery industry; and a register of implants, for which there is a strong case.

There is also a European inquiry that is considering better information sharing between EU countries, increasing the scope for EU countries to work together, increased product traceability, and a European database to bring together information about medical devices, economic operations, market surveillance and clinical investigations. Those inquiries and the recommendations that will flow from them should ensure that a similar situation does not arise again.

I understand the sentiments of those who call for a Scottish public inquiry but, as we have heard, the regulation of medical devices is a reserved matter and the licensing of the products is an EU matter. Therefore, a Scottish public inquiry could not properly investigate all the issues. I have no doubt that the Scottish Government and the Parliament will continue to do all that we can to ensure that people in Scotland who are affected by the scandal get the answers that they deserve.

11:04

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Meeting of the Parliament 14 June 2012

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