PIP Breast Implants
Debate between Sarah Champion and Maria Caulfield(1 year, 10 months ago)
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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As soon as it was found that PIP had fraudulently changed the filler material used in its implants, they were withdrawn from use in the United Kingdom, back in 2010.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.
Oral Answers to Questions
Debate between Sarah Champion and Maria Caulfield(2 years, 9 months ago)
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Maria Caulfield
I take the hon. Gentleman’s point, and of course he will lobby for more investment in his constituency. As I said, the funding envelope will be announced shortly, and it will be for his local area to decide how it spends that.
Sarah Champion (Rotherham) (Lab)
Palliative Care
Debate between Sarah Champion and Maria Caulfield(9 years, 1 month ago)
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Maria Caulfield
I thank the hon. Gentleman. I absolutely agree. That point is picked up in the Bill.
The most shocking statistic concerns the diseases that people are suffering from. The London School of Economics says that 92,000 people a year miss out on palliative care help. At the moment, 88% of our palliative care provision goes to people with cancer. As a cancer nurse, I am certainly not saying that that needs to be reduced, but the majority of deaths are due to other diseases. Only 29% of people die of cancer, with 28% of deaths due to heart disease, 15% due to respiratory illnesses, 10% due to stroke, not to mention Alzheimer’s disease, motor neurone disease and multiple sclerosis. Until we ensure that palliative care provision is mainstream, and not just for patients with cancer, the majority of people will be denied access to a good death.
The Bill introduced in the other place comes up with solutions to resolve this situation and place the responsibility firmly in the hands of local clinical commissioning groups to ensure that all patients, no matter where they want to die or what disease they have, will get access to palliative care services. That will take the pressure off existing acute facilities that are currently having to provide them. The Bill makes some key practical proposals. The first is about the ability to admit people directly to palliative care facilities. This happens really well in a lot of places, but it does not happen everywhere. That goes back to the point made by the hon. Member for Strangford (Jim Shannon) about investing in our hospices to ensure that it can happen more widely. The Bill talks about support for healthcare professionals in all settings, so that whether they are an intensive care unit nurse or someone who works with motor neurone disease, they have a signposted facility to access specialist palliative care that helps them to help patients manage their symptoms.
The Bill fits very firmly into the Government’s seven-days-a-week NHS in calling for the availability of seven-days-a-week palliative care services. As I know only too well, it is at 4.30 pm on a Friday that a patient will phone up in pain and say they cannot cope, when pharmacies are closed and it is possible to get a prescription but not a drug. Someone who is breathless and needs a chest drain often has to wait until the Monday morning, in the meantime being admitted to A&E or a medical assessment unit and then finding it very difficult to be discharged to go home. This is why we need a seven-days-a-week palliative care service.
The Bill calls for some really basic things that should exist now but do not, such as sufficient equipment for our community services. It is unbelievable that a ward nurse who wants to discharge someone with a morphine pump cannot do so because the pump belongs to the hospital. Unless the community has a spare pump, that patient will not go home. That is why only 30% of people are dying at home—they are stuck in hospital because communities do not have the necessary equipment to look after patients. There are shortages of mattresses and feeding pumps, which would make a crucial difference if they were available.
Sarah Champion (Rotherham) (Lab)
I congratulate the hon. Lady on calling this debate on such an important and often overlooked issue. I support what she is saying 100%, but does she agree that it is not just the NHS, the community and the charitable sector that need to join up? Joining up health and social care would enable the seamless transition she is talking about.
Maria Caulfield
Absolutely. I am touching on some of the Bill’s highlights, but we also need to incorporate social care, because that is often the kind of support that carers need in order to be able to look after relatives.
The Bill also highlights the fact that medication is not available at all times. I know only too well that if a patient’s pain needs to be better controlled, they can get a prescription but they cannot get the drugs on a Saturday or Sunday or during the night. Once again, they are admitted to A&E for help in managing their pain. That is not acceptable.
Practical solutions are available to enable people to choose where they want to die. I was disappointed by the response of Lord Prior of Brampton in the other place when he dismissed the Bill so easily by saying that we did not need to legislate for good palliative care. I strongly disagree. If we can legislate for a charter of budget responsibility, which I strongly supported because it is important for this country to run a surplus, and if we can legislate to freeze VAT and national insurance because that is also vital to this country, and to charge 5p for every carrier bag, why can we not legislate to provide good palliative care for every person who needs it?
I urge the Minister to consider the Access to Palliative Care Bill, which is currently going through the other place, as a way to improve access to palliative services and to support patients, families and NHS staff.