I am joined by Ms Susan Reilly and Ms Eithne Byrne from the patient safety and quality unit. I thank the Chairman and the committee for the opportunity to speak with them on this subject. I will keep my introductory statement as brief as possible and I will be happy to reply to any questions and comments as best I can.
I am aware that my colleagues in the Irish Medicines Board, IMB, met with the committee on 29 March last and provided it with a comprehensive assessment of the current position on the regulation of medical devices and the Irish Medicines Board's role in regard to that. I am here to discuss the way the Department is working to ensure follow-up health care for the concerned women who received poly-implant prostheses, PIP, breast implants. Our priority at all times has been to ensure the safety and quality of services for the women concerned and we fully appreciate the anxiety and the concern this has generated. The Minister has requested that better information be put in place for people who in good faith use non-State service providers, especially for cosmetic surgery. He is also anxious to ascertain if anything more can be done in the short to medium term to alleviate the concerns of the women who received PIP implants, and both of those matters are being progressed, as I will detail.
By way of background brief to this issue, in March 2010 the Irish Medicines Board was informed by the French medical device regulatory authority, the Agency for the Safety of Health Products, that it had suspended the manufacture, marketing, distribution and export of PIP products. As members are aware, that company is now in receivership. Recall of these implants was taken following an inspection of its manufacturing plant when it was found that most implants manufactured were filled with an unauthorised industrial grade silicone gel which differs in composition from the originally approved material.
The IMB immediately instructed the three clinics in Ireland which received these devices to cease the use of the products, and they identified those by tracking the devices through the distribution chain, in this case a company called Cloverleaf. The board does not have information on individual patients. That is how they identified the distribution of these services.
In November 2010 the IMB instructed the clinics to identify and contact women who had been implanted with PIP silicone gel implants after 1 January 2001 to advise them of the issue and to provide reassurance that there is no current evidence of health risks associated with those implants. Hospital C did not write to its clients in Ireland in November 2010 when instructed to do so by the Irish Medicines Board, having stated in writing that it did do so. In the meantime it has written to all of its clients and has apologised to me and to the Irish Medicines Board for its misleading information.
After confirmation in April 2011 that there was no evidence of genotoxicity or chemical toxicity associated with the filler material in these implants, the French authorities confirmed that there may still be an increased risk of rupture.
In December 2011 the French media highlighted reports of cancer associated with PIP implants and the suggested association. The French authorities set up an expert committee to examine the issue.
On 23 December last year, the French ministry of health issued a statement indicating that there was no evidence to date of increased risk of cancer for women with this brand of implant and, as a preventive measure, suggested consideration of removal of the implants having regard to the risk of ruptures and inflammatory reactions.
The Irish Medicines Board tracks the number of implants and their dispersal to treating clinics via the product's United Kingdom distributors. As members are aware, approximately 1,500 Irish women were implanted with these devices through the different providers in Ireland. On 15 March of this year the IMB received further information from the French competent authority for medical devices suggesting that PIP silicone gel implants manufactured before 2001 may also have contained the unapproved non-medical grade silicone. Current information suggests that in the region of an additional 50 Irish recipients could be affected and as further information becomes available, the IMB has given an undertaken to make that available in public and to any potential women concerned.
Our current advice to women, which is based on the available scientific evidence, is that there is no evidence of increased risk of cancer for women with this implant; that the risk of rupture, at least in terms of reported rates to date, is within expected norms; that routine explantation without any other clinical considerations is not currently recommended; and that anyone with a concern about their breast implants should discuss those matters in the first instance with their general practitioner or their surgeon and be guided by that clinical assessment.
The Irish Medicines Board has advised that as of mid-April of this year, 138 ruptures of PIP breast implants have been reported. Reports received indicate that ruptures have occurred at or between one month to eight years following implantation. Factors that can contribute to the rupture rate seen include the fact that there is recent intensive patient follow-up, as members are aware, use of additional diagnostic scans, the length of time since implantation, which is lengthy in the case of some patients, and more active reporting by individual surgeons given the heightened awareness.
I refer to the European Scientific Committee on Emerging and Newly Identified Health Risks report of 1 February 2012, which is a scientific report. The report stated that all silicone breast implants can fail, regardless of the manufacturer, and the probability of failure increases with time since implantation. It is a matter of record that our general advice to surgeons is that this should be a matter of information provided to people in terms of informed consent when they are being provided with these procedures.
The committee also stated that estimates of breast implant rupture prevalence range widely, in part because of the methods of estimating rupture prevalence rates which differ among studies. On average, it is estimated that there is approximately a 10% to 15% rupture risk within ten years of the original implantation.
The European Union Commission is currently reviewing the regulatory framework for medical devices deriving from three EU directives. The Commission expects to publish its proposal for new medical devices later this year. The IMB has continued to liaise with European and international authorities on this issue and receives ongoing up-to-date information on testing conducted to date.
Referring back to the Irish situation and the women concerned, on the basis of the information we had received directly from individual patients through direct representations and representations with public representatives, we became concerned that women were finding it difficult to receive appropriate follow-up care through the various service providers. For that reason I sought to meet with each of the individual providers, which I have done. The response to the patients who received PIP implants in hospital A has been comprehensive and commenced at the time of notification in 2010, in other words, not when this became a matter of public concern in late 2011 but in 2010 when first alerted by the regulatory authorities. The service it has provided meets with the expectations I would have for women who find themselves in a situation through no fault of their own.
Hospital B, which did not respond as early as hospital A, also appears now to have largely dealt with the concerned women. The responses of both hospitals A and B, which together account for approximately 400 of the women involved, show that our expectations of the service they should receive are reasonable in that they have been met by those providers without incurring additional cost to the State and without involving any excessive delay for the women concerned. Those centres account for very few of the many concerns and complaints raised with the Department directly. That view would also echo the experience of the PIP Action Group. However, I have been much more concerned about the response by hospital C, both in terms of its delay in responding to the initial IMB correspondence and difficulties experienced by patients in accessing their clinical information and appropriate clinical follow-up. Over recent weeks, I have had very serious discussions and intense negotiations with hospital C to broker a better response and clinical care for the women concerned. During these negotiations, I continually emphasised the Department's belief that the company has an obligation to discharge its duties to its clients as the other providers have done.
I have been advised by the relevant provider in recent days that it recognises the shortfall in service it has provided to date. It is now developing a new care plan to provide for an early surgical consultation for all the women concerned who have received PIP breast implants, specifically at my request. All the women concerned will be offered an early face-to-face consultation with the surgeon and will have the option of breast implant removal. The removal of implants will be prioritised according to whether a rupture has been identified.
While the proposed care plan is to be welcomed as an improvement in the services offered by the company to date, I must stress that significant detail remains to be clarified with the Department. We are liaising continually with the company and the relevant provider on this matter. As late as early this morning, I received assurances from the company that it acknowledges and accepts that it has a duty of care to the women concerned and that it is fully dedicated to helping its PIP implant patients as much as it can. I intend to follow up with the provider to ensure it follows through on its commitment to me and, more important, its commitment to the woman who are its patients. I am happy to keep the committee advised on progress regarding that. Our first concern is that the women receive the service they require and, second, that the provider, not the taxpayer, will meet the cost of that provision.
Along with my colleagues from the IMB, I met the PIP action group on 23 March last and discussed its very reasonable concerns. The meeting was very constructive and the focus was almost exclusively on one provider, hospital C. The meeting identified a number of follow-on activities that the Department has subsequently engaged in to help the women in their unsatisfactory dealings with the provider. I have arranged to meet the group again and will be doing so tomorrow morning. I will discuss in more detail the provider's proposed care plan. Tomorrow morning's meeting was arranged before I was invited to attend this meeting this morning.
Members of the committee are concerned about the current lack of regulation of private cosmetic surgery providers in Ireland. Officials at the Department are currently working on licensing of health care facilities legislation which will provide for a mandatory system of licensing of both public and private health care service providers. The legislative proposals are being prepared broadly in line with the recommendations made by the Madden commission in 2008 and are designed to improve patient safety by ensuring health care providers do not operate below core standards that are applied consistently and systematically.
The intention is to have a proportionate system that has the confidence of the public. Standards and other requirements will be enforceable through inspection and the imposition of sanctions, as necessary. Licensing will be targeted at areas that are not currently subject to regulation. It is expected that outline proposals for the new system of licensing will be finalised by the end of the current year.
I cannot emphasise strongly enough the need for individuals planning to undergo cosmetic surgery, at home or abroad, to bear in mind some important guidelines before they undertake any procedure. These guidelines were first placed on the Department's website in November 2010 and are worth repeating today. Individuals considering cosmetic surgery should initially discuss the issue with their general practitioner to ensure they are suitable candidates for the procedure in question. The general practitioner will have knowledge of specialist doctors in the area and would help to choose the one most appropriate for the individual. Furthermore, the general practitioner would be able to help to interpret any claims made in advertisements about cosmetic surgery.
A service should not be chosen on the basis of price alone and people should always check that the procedure will be carried out by a person who is registered for the conduct of such a procedure. In Ireland, this can easily be checked through the Medical Council and its website. Many countries have professional regulatory authorities similar to the Medical Council. If an individual is considering surgery outside Ireland, it is highly recommended that he or she check with the regulatory authority in the state in question. Prior to any surgery, individuals should identify what follow-up care and medical support will or may be needed after surgery has been completed, by whom and how it will be provided. This is where the difficulty arises with regard to the women in question. In recent weeks, I have been in discussions with the Irish Association of Plastic Surgeons with a view to updating our recommendations and placing a public joint revised statement on the Department's website. We will be meeting the association again in the coming days.
As chief medical officer, my primary focus is on obtaining the best care for the women who received PIP breast implants. I will continue to work with my colleagues in the IMB and the treating clinics to ensure the best outcome for the women concerned. I will be happy to appear before the committee at a later stage to discuss how matters have progressed. I thank the members for the opportunity to address them. I will be happy to deal with questions they may have.
