PIP Breast Implants

Maria Caulfield Excerpts

Monday 30th January 2023 Commons Chamber

[The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)]

I congratulate the hon. Member for Putney (Fleur Anderson) on securing this important debate. Let me begin by expressing my sympathy for the women who have suffered as a result of exposure to substandard PIP implants.

As soon as it was found that PIP had fraudulently changed the filler material used in its implants, they were withdrawn from use in the United Kingdom, back in 2010. It is true—as with all medical devices—that there are some risks associated with any breast implant, but the Medicines and Healthcare products Regulatory Agency, the UK regulator for medicines and medical devices, monitors all incidences reported to it, ensuring that they are investigated fully and any necessary action is taken. At the time, the MHRA worked with the NHS and other health partners to ensure that this specific issue was thoroughly investigated. It has undertaken extensive engagement work with PIP campaign groups such as PIP Action Campaign, and is committed to ongoing engagement with affected patients.

PIP implants were found to involve a higher risk of rupture than other implants, with a rupture rate roughly twice that of other types of implant. Ruptures often lead to unpleasant symptoms such as pain, hardness of the breast and swollen lymph glands, as well as many other side-effects to which the hon. Lady referred, although there is no evidence that ruptured implants—PIP implants or other types of implant—can cause serious long-term health risks.

[Sarah Champion]

I thank the Minister for engaging with this topic. I am aware that she knows about the field. Can she please explain why, more than a decade ago, both France and Sweden withdrew this device and facilitated the change in the process?

[Maria Caulfield]

I will come on to that. As I said earlier, we stopped the use of these implants immediately in 2010. As for the 47,000 women who were given PIP implants, mainly in private clinics, they are now able to come forward and have those implants removed on the NHS if their doctors agree. Many women have done that, either to avoid the risk of rupture or to prevent it from happening if they fear that it might.

The hon. Lady asked for an inquiry. As she mentioned, independent reviews have been conducted, expertly led by Lord Howe in 2012 and by Sir Bruce Keogh in 2012 and 2013. The Department has led a programme of work to ensure that the recommendations from all those reviews have been implemented, including a set of actions to prevent this from happening again. We have ensured that cosmetic surgery is effectively regulated, and that only doctors who are registered with the General Medical Council can perform surgical procedures. We have introduced a number of measures requiring all surgeons offering cosmetic procedures to follow the guidelines. The Care Quality Commission now has a duty to rate and assess the performance of providers of surgical cosmetic procedures to ensure that they meet fully the standards of safety and quality expected of them, and enforcement action is taken when they do not.

As the hon. Lady also mentioned, the Breast and Cosmetic Implant Registry was established in 2016. It collects detailed information on every implant, so that affected women can be traced and contacted in the event of a product recall or safety concern. The difficulty involved in doing that retrospectively is that many of the procedures took place in private clinics where there was no access to that information, either because it was not recorded at the time or because it was recorded but difficult to access. However, the registry covers both the NHS and the private sector, so that would not happen today, and it covers England, Scotland and Northern Ireland.

The lessons learned from the work on PIP and the recommendations made by Baroness Cumberlege in her report on medical devices have been used to drive wider-ranging improvements. NHS England now has speciality-level clinical steering boards for the top 10 medical devices implanted, which represent around 80% of the implants now used. The boards drive forward improvements for implants used in a range of medical devices, and are developing the medical device registry to ensure that the relevant patients can be traced and contacted if problems exist.

The MHRA intends to further drive forward this issue by improving the traceability of medical devices through the unique device identifier and implant cards. Again, those were not available when the incidents happened. The Medicines and Medical Devices Act 2021 introduced powers to allow the MHRA to improve transparency on medical device safety issues. As the hon. Lady indicated, we now have the plastic, reconstructive and aesthetic surgery expert advisory group, which looks for future issues around implants or other medical devices used in aesthetic surgery in a way that was not available back in 2010.

The breast cancer element is important for women to know. I take the hon. Lady's point about making that information more readily available. I also take her point about the black box labels that the FDA is using in the US, to see if we need to improve the information available for women. Any breast implant has the potential to cause a very rare form of non-Hodgkin’s lymphoma called breast implant-associated anaplastic large cell lymphoma. It is not breast cancer but a rare form of non-Hodgkin lymphoma that grows in response to the body’s reaction to a breast implant. It is not specifically related to PIP; there is a small risk from any breast implant. The MHRA has issued guidance for people with breast implants, but I take the hon. Lady’s point that women need to be informed of that small risk when deciding to go for a cosmetic procedure. We will follow up on that after this debate.

[Fleur Anderson]

I thank the Minister for her reassurance about what will happen now. I am thinking back to those women who have been affected; I take the point that it is hard to trace them. Could the Minister look at asking GPs if they know whether women have had implants, so that they can be contacted and informed about the links with the cancer, through those means if no other?

[Maria Caulfield]

Absolutely. It is important to ensure that women who have had PIP breast implants in the past are reassured and have the opportunity to come forward. As part of the women’s health strategy this year, we are developing a space on the NHS website—a go-to, informed place—specifically for women’s health. I am happy to raise this issue with officials to make sure that the information is there. PIP implants have a higher risk of rupture, but not necessarily a higher risk of the lymphoma that we have talked about. There is a small risk with any breast implant. We need to make that clear to women.

The company that produced the implants was the third biggest supplier of breast implants in the world. It went into liquidation in 2010. The founder was convicted of aggravated fraud and sentenced to four years in prison. The company had to take responsibility for its actions. I take on board the point that women who have had those implants can have them removed, but they need to know that that is available to them. I am happy to work with the hon. Lady to see whether we can improve that advice and information for women.

I reassure the House that the Government and I have patient safety and women’s health as a top priority. We will continue to keep current initiatives under review. We have put safeguards in place. I do not want to tempt fate, but we are not likely to see the same incident again, where we cannot trace women who have had the implants. We need to support those women who have been affected, and I am happy to work with the hon. Lady to make sure that that happens.

Question put and agreed to.