(1 year, 2 months ago)
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Fleur Anderson (Putney) (Lab)
I know, Mr Deputy Speaker, that despite this late hour you will be very interested to hear the shocking story I am about to tell, in this first ever parliamentary debate on a health scandal that is affecting at least 47,000 women across this country in one way or another. When I told people that I had secured this debate, it seemed that most, like me, remembered stories about the breast implant scandal from quite a few years ago. Like them, I thought the issue had been dealt with, and that the women had been recalled and supported, and the breast implants removed if necessary. But no.
A few months ago, local resident Jan Spivey from Putney came to my surgery with her shocking story. She is a victim of the Poly Implant Prothèse breast implant scandal, and she has had years of illness as a result. She also leads the national PIP Action Campaign, and I will start by thanking Jan, Louise, Wendy and Diane for all the work they have done to lead the campaign. I also thank all the women who wrote to me in advance of this debate telling me their stories, the relatives of the young women who have died as a result of this scandal, and the journalists who have exposed it.
Doctors estimate that, unless action is taken, there will be a peak of implant-related cancer deaths in 2026. Thousands of women and their families have been failed, by the implant companies that knew they were dangerous; by the Medicines and Healthcare products Regulatory Agency, which should never have allowed it to happen; by the medical clinics that restructured to avoid their duty of care towards PIP patients, and got away with it; and by the Government, who failed to take action over a decade ago when all the evidence was there. This just makes me angry. This is a women’s health issue, and I do not think it would have happened if it was men who had been affected. I think action would have been taken by now, but instead women have been suffering and dying in silence.
PIP stands for Poly Implant Prothèse, which was once the third biggest supplier of breast implants in the world, making an estimated 2 million sets of implants over 20 years. Following reports of abnormally high rupture rates, it was found in 2010 that the manufacturer had been filling implants with a sub-standard silicone gel made of a cocktail of chemicals intended for mattresses and not cleared for human use. The company went into liquidation in 2010, and its founder, Jean-Claude Mas, was convicted of aggravated fraud and sentenced to four years in prison in 2013. The French Government offered to pay for the removal and replacement of all PIP implants fitted in France, and after a decade-long battle, in 2021 a French court ruled that 2,500 victims are owed compensation. At the same time, 47,000 women in the UK have had PIP implants, but they have not been contacted to be told about the risks. Some have been offered and undergone removal, but many more have not been told about the risks of other illnesses and the links to cancer. They have not had the options.
Sarah Champion (Rotherham) (Lab)
I am incredibly grateful to my hon. Friend for securing this debate, because I do not think the general public know of the risk. But those 47,000 women do know, so does she share my concern that the mental health toll that is putting on them is almost as bad as the health risks they have?
Fleur Anderson
I absolutely agree. Someone knowing that they potentially have a ticking time bomb inside their body that might be causing poison is extremely worrying and causes huge anxiety. Many women have also not been told about the impact. For example, they have not been told by their GP of the links between having that in their body, and what they are experiencing.
Victims have reported a range of mental and physical health issues, including extreme pain, inflammation, headaches, infections, anxiety, digestive issues, sight issues, severe exhaustion and low energy. Many women suffered for years before realising that their health issues were a direct result of their faulty implants. GPs often are not putting the two together, and there is not the right information for them. One woman—she is an example of the many stories I heard—told me:
“I had the PIP implants placed in January 2009. Within a very short time I suffered from shortness of breath, heart palpitations, extreme fatigue, and my joints were swelling up to name a few symptoms. I was in and out of hospital for breathing difficulties and pains in my chest. At no stage were any of my symptoms ever recognised and I was told to take painkillers or, ‘It’s just your age’. I had the implants replaced in 2013 at my expense from the same company because they would not take any responsibility.”
She still has most of the capsules from the PIP implants, and she believes that they are still affecting her today. Her health has been compromised and the hazardous chemicals that remain inside her chest have taken a toll on her quality of life.
Women said to me that they were told that their implants were water-based and absolutely safe, and then they were not being listened to about their illness. They were often misdiagnosed and in so much pain. One woman told me of her “17 years of hell”, including that she could barely walk for two years. She also had sight loss and digestive issues. She felt that she was slowly dying inside from 2004, when the implants were put in. That was until September 2021, when the capsules were removed and she had her life back.
A serious impact is the link with cancer called breast implant-associated anaplastic large cell lymphoma, which is a rare type of cancer of the immune system. Susan Grieve, a mother of two young children, was the first person in the UK to have been recorded as dying from BIA-ALCL in 2013. As of 31 December 2021, the Medicines and Healthcare products Regulatory Agency has received 81 reports of confirmed BIA-ALCL. My first ask of the Minister is to review the link with cancer and to review the NHS website guidance. A long list of peer-reviewed papers—too long to include in my speech—evidences the link with cancer in the UK and internationally. However, the NHS website mentions six times that there is no cause for concern for women with PIP implants. It does say that there is a high risk of rupturing, but it should clearly explain the link with cancer to avoid GPs and PIP victims missing that important link and making a diagnosis too late.
One such diagnosis came too late for 36-year-old Lydia Bennett, who died from BIA-ALCL in 2019. Lydia’s family were not informed that she had died from breast cancer until 2022. The MHRA set up the plastic, reconstructive and aesthetic surgery expert advisory group and, based on the group’s advice, issued several medical device alerts stating that patients undergoing breast implants for any reason should be warned about BIA-ALCL before the operation. However, that does not go far enough. By contrast, in 2021 the US Food and Drug Administration made the links clear and placed so-called “black box” labels on breast implants, warning that they have been linked to a host of chronic medical conditions including autoimmune disease, joint pain, mental confusion, muscle aches and chronic fatigue, as well as to lymphoma.
In replying to my written questions on concerns about PIP implants last November, the Minister cited two reports from the MHRA in 2010 and 2012, which seemed to be the basis for deciding that there was not a risk and putting that guidance on the website. However, so much more evidence has come to light since then. Does she have a view on the new evidence and why that has not been taken into account? Evidence buried away on the website contradicts the view that people with PIP breast implants do not need to worry. The risks are clear and well evidenced, and women should be told the truth.
My second ask is that there needs to be a register, and it needs to be used. The Government’s initial response to the scandal in 2010 was to issue a medical device alert to all UK clinicians and cosmetic surgery providers, asking them to cease use of the implants but not proactively to offer advice, removal or support for women who had had the implants. That support has fallen short ever since. The Government conducted the Howe report into PIP breast implants in 2012 as well as the Keogh review of the wider system of regulation for cosmetic interventions and whether a breast implant registry could be put in place. Both reviews promised action that has not been taken, and neither addressed the need to recall the PIP implants and let women know about the risks, let alone went into the area of compensation for the women affected.
All the women affected should be on a register and should be contacted proactively. There is no central register now. Since 2016 there has been a breast and cosmetic implant registry, which collects data for England and Scotland, but the problem is that it does not include women who had their PIP implants removed or replaced up until 2016. In the Government’s February 2014 response to the Keogh review, three recommendations were singled out for agreement, one of which was
“creating a breast implant registry to reassure women that if problems arise they can be contacted, kept informed and called in for treatment if necessary”.
Even the limited new register has not been used to proactively contact all women on the register to offer them medical check-ups, advise them of the links with cancer and other illnesses and, if suitable, offer them removal of implants.
Officially, as I think the Minister is about to tell me, anyone who has a PIP breast implant can request that it be removed, but that has not been the experience for many women with PIP implants—even those who know that their implants have ruptured. Many applications have been turned down, leaving women with a ticking time bomb in their body. They are unable to afford to get their implants removed privately, are worried that they will rupture further, and are experiencing clear side effects. Not only are they suffering through no fault of their own, but they are costing the NHS more because of the treatments that are needed.
Another shocking fact is that for those PIP victims who had their implants privately, all the major clinics that treated them have avoided paying compensation by “financially restructuring”—changing their name and reopening with another name on the same premises, with the same staff and the same medical records for the same patients. How can that be allowed? I know that many women affected by the issue will be watching or reading this debate; I urge them to contact the patient safety commissioner and tell her what they have experienced.
I know that the Minister was not in post when the scandal initially happened, but the support that victims are receiving now can be changed. I know that she is professionally experienced in the area, and I thank her for her interest so far. I fervently hope that she will take a personal interest in looking into the scandal and the reality of how women affected can be supported. I hope that justice can be done, and that the deaths from cancer that have been predicted can be prevented. I ask the Minister to follow up on this debate by meeting me and members of the PIP Action Campaign group.
I will end with a list of nine actions that I would like the Government to take—I have quite a few more questions, but I will save them for our meeting. First, in the light of this scandal, will the Government please review and act on the Paterson inquiry and the Cumberlege review and their recommendations about patient information, complaints, recall, ongoing care and compensation? Secondly, will they please look at funding research into BIA-ALCL and creating and maintaining a national tissue bank of BIA-ALCL cases, including full genome sequencing, as recommended by the plastic, reconstructive and aesthetic surgery expert advisory group? Thirdly, will they please ask the MHRA to further investigate the evidence of the cancer link and change its guidance accordingly?
Fourthly, will the Government change the guidance on their website to give women all the information they need? Fifthly, will they change the guidance on the implants themselves so that they carry stronger warnings? Sixthly, will they set up a register for all women affected and proactively use it to offer them a full medical check-up and advice about their implants and tell them about all the risks of cancer and all other illnesses?
Seventhly, will the Government offer women removal of the implant and capsules? I know that that surgery carries risks, and that there is a balance of risk to be reached, but women need information and options. Eighthly, will the Government pursue companies for compensation for the women affected and stop the loophole that allows companies to shut down in one name without being liable and then carry on operating in the same building with the same patients? Lastly, will they hold an inquiry into how the whole scandal happened, so that the best support and treatment can be given now to women who were affected, and so that this can never happen again?
I am grateful to the Minister for the interest that she has taken in the matter. I hope that this debate will be the start of real action, taken at speed, to make up for the years of failure.
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.