I thank the Chairman and the members for this opportunity to speak with them. The Chairman has introduced us. In my introductory statement I will be as brief as I can and we will be happy to reply to as many comments and questions and we can deal with.
By way of a brief introduction, I will give a brief overview of the role of the Irish Medicines Board and in particular its remit in regard to medical devices. Our role is to protect and enhance public and animal health through the regulation of medicines, medical devices and health care products. We are involved in a wide range of these products. The IMB is the competent authority for medical devices in Ireland. We have a post-marketing role, which means we monitor products that have been placed on the market and are in use. The IMB is responsible for monitoring and vigilance of devices and we seek to detect, monitor, assess and act, when required, on safety issues that are identified. In addition, we designate and monitor the one notified body for medical devices which is based in Ireland, the NSAI.
There are many thousands of products classified as medical devices comprising a diverse array including, for example, syringes, crutches, contact lenses, diagnostic tests kits such as pregnancy test kits, devices such as CT scanners, and so-called invasive devices such as joint replacements, pacemakers, cardiac stents and breast implants, about which we are speaking this morning. Medical devices are widely used in health care and individual devices make a major contribution to health and well-being. Our role is to monitor the safety of these devices on the Irish market and in patient use in this country. We are committed to ensuring that any safety issue identified, be it through national incident reports or international data, is acted upon swiftly and decisively.
The IMB has no direct role in approving or certifying medical devices for marketing purposes in Ireland or any other country. I will set out how devices are approved in Europe. To place a medical device such as a breast implant on the Irish or EU market the manufacturer must be authorised to do so following an assessment conducted by a "notified body" for medical devices. There are currently over 80 such notified bodies based in Europe, and there is one in this country, the NSAI. A manufacturer can choose any designated notified body to award the CE mark for a particular product. Following its assessment and once satisfied that the device meets the relevant requirements, the notified body will issue a certificate for the medical device. This entitles the manufacturer to affix a CE mark to the device and thereafter market the product throughout the whole of Europe.
On the PIP silicone breast implant medical device under discussion today, this product was manufactured by the Poly Implant Prothèse Companybased in France which received a CE mark from a notified body based in Germany called TÜV Rheinland. As stated, this CE mark allowed the product to be sold throughout the EU, and it was exported worldwide with more than 300,000 units sold.
The product received its CE mark based on the details contained in the pre-market file reviewed by TÜV Rheinland. We now know that the PIP company acted fraudulently in changing the approved medical grade silicone to a lower non-medical grade and cheaper silicone. When this fraud was identified in 2010 by the French regulatory authority, the IMB, as well as other EU and international regulatory agencies, immediately moved to ensure this product ceased being used and was recalled. Since then, a series of actions have been undertaken in the interests of the women affected including a detailed investigation and testing of product to identify any potential safety risks, the issuing of specific advice, and at European level an assessment is under way to ensure that any lessons learned from this event are incorporated into the reform of the medical devices regulations which is currently being progressed by the European Commission.
Our absolute focus is patient safety. This was and continues to be the case with regard to PIP silicone breast implants. We fully appreciate the anxiety and concern this issue has caused the women affected and I will outline the actions we have taken to date. There is far more detail in the written submission we presented.
In summary, this issue began as an event on 30 March 2010 - two years ago tomorrow. The IMB was informed by the French regulatory body that it had suspended the manufacture, marketing, distribution and export of the PIP products. This action was taken following an inspection by it of the PIP manufacturing plant where it was found that most implants manufactured since 2001 were filled with an unauthorised silicone gel which differs in composition from the originally approved material. The inspection conducted by the French agency was prompted when an increase in the number of incident reports regarding device rupture and local complications associated with these products was noted in France. At that time the IMB had no reports of a device rupture in this country. The IMB immediately advised all clinics in this country that used these devices of the issue and advised them to cease the use of these products immediately.
From March 2010 to October 2011, the IMB continued to keep this matter under review and had repeated contact with the implanting clinics to whom we recommended that they directly contact all their patients who had received the implicated implants. We advised women with any concerns or queries to contact their implanting surgeon for clinical advice. During this period a range of test results also became available confirming that there was no evidence of toxicity in the unapproved silicone material.
In October 2011, the French agency was informed of the death of a patient who developed a lymphoma. This patient coincidentally had a PIP breast implant. That led to speculation in France that the implants might be associated with a risk of cancer and there was ensuing media interest. That led to a range of things happening in recent months. On 23 December 2011, following a detailed investigation in France, the French Ministry of Health issued a statement indicating "that to date there is no increased risk of cancer in women who have PIP implants compared to other implants." They dealt with the specific issue in regard to the patient.
On 21 and 23 December 2011 and 4 January 2012, teleconferences were conducted by the European Commission's Health Security Committee to discuss the PIP issue and to share the latest available information. The Scientific Committee on Emerging and Newly Identified Health Risks, SCENIHR, was requested to provide a rapid scientific opinion on the safety of PIP breast implants. In early February the committee published its initial findings. I noted its scientific opinion which concluded that "further work is proposed to establish with greater certainty the health risks, if any that may be associated with PIP silicone breast implants". It also concludes the important point that each case needs to be assessed individually. All of the women involved must be treated individually.
Over the Christmas 2011 period, the Minister for Health in the UK also established an expert committee to advise him on the issue. Following the review of all available evidence and data by this UK expert committee, it concluded that the existing advice given by our equivalent in the UK, the MHRA, remained valid and that there was not enough evidence to recommend routine explantation of these breast implants. The group also agreed that there was no evidence suggesting a link with cancer.
A co-ordinated approach to further laboratory testing continues and an international group of agencies, which includes the IMB, which is chaired by the Australian TGA, our equivalent body in Australia, has been established. To date, all the PIP implants that the TGA has tested have met the requirements of the standards. In particular, the TGA has not identified any toxic or irritant chemicals in either the shell of the implant or in the unauthorised gel, and the tests conducted by the TGA on the strength of the silicone shell and the consistency of the gel have also met all relevant standards. Laboratory testing of breast implants that have been surgically removed is also ongoing. It is not just unused retained samples; they have also been testing implants that have been removed. In mid-March 2012, the French authorities issued a further update to advise that it is possible that PIP implants manufactured prior to 2001 may have also contained the unauthorised silicone gel. I indicated previously that it was considered to be products from 2001 onwards, now it is believed that there could have been some fraudulent use of an unauthorised gel before 2001. While the number of Irish women involved during this period is not fully known at this time, current information suggests that fewer than approximately 50 additional patients in Ireland could be affected. The IMB continues to advise women with these implants that if they have any concerns about their breasts or implants, they should seek clinical advice from their implanting surgeon.
Since 20 December 2011, there has been a lot of media interest and, as a consequence, members of the public have contacted the IMB directly on the issue. We have dealt with more than 200 queries during this period. A significant number of these calls have resulted from lack of communication from one of the providers, namely, the Harley Medical Group, HMG. Following IMB recommendations in October 2010 to the three implanting clinics to contact their patients, the HMG confirmed in writing to the IMB on two separate occasions in November 2010 that it had written to all its Irish patients implanted with the PIP breast implants. Following a telephone call from a member of the public on 5 January 2012 to say that she had not been contacted by the HMG we contacted it for an explanation. It then informed us that in fact this direct specific patient contact letter was never sent and communication to patients was via its website. The IMB was extremely concerned and asked for an immediate explanation from the HMG. The explanation provided on the day was totally unacceptable and the IMB issued a statement to the press to this effect on the afternoon of 6 January 2012. The IMB also informed the UK's regulatory body of this development in Ireland as the HMG also operates in the UK where 18,000 women were involved with the Harley Medical Group, and, as in this country, they had not been contacted directly by the clinic.
Three private Irish clinics were involved in implanting these devices which are listed in the report. The Harley Medical Group was the larger of them, involving more than 1,100 women. The second was the Clane Hospital cosmetic surgery department, which treated approximately 250, and approximately 100 women were treated in the Shandon Street Hospital. Approximately 1,550 Irish patients were implanted with these PIP products. I mentioned the 50 cases which were before 2001 but are part of that total figure.
The Irish Medicines Board, IMB, has met with members of the patient-led PIP Action Group and discussed their concerns about the products and the follow-up they are receiving from the implanting centres. We have also kept the Department of Health fully informed on the matter.
If I may, I will briefly comment on the revision of medical devices legislation, which is an issue the members may want to probe today. The three primary European directives relating to medical devices, which establish all the regulatory framework about which I have spoken, are being substantially revised by the European Commission and it is expected that the Commission will adopt two new regulations relating to medical devices before the end of July of this year. These will then be subject to debate at the European Council and the Parliament.
Notwithstanding that, in early February the Commissioner for Health and Consumers, Commissioner Dalli, wrote to all national ministers for health across Europe indicating the need to increase control on medical devices, provide an appropriate level of protection to European citizens and restore trust and confidence in the regulatory system. Commissioner Dalli recognised in that letter that legislative revision would take several years to come into effect and identified the need to act immediately to achieve certain objectives in the coming months, as set out in his communication.
The IMB fully appreciates the anxiety and concern this issue has caused the 1,550 women affected in Ireland. We have been speaking individually to many of the women who have contacted us and have met a group of representatives. We are ensuring they have all the available information on this issue and are assisting them with their individual concerns.
We were also recently invited to attend a series of meetings arranged by the Department of Health and the chief medical officer with some of the cosmetic clinics and have added our voice to urging the clinics to have a duty of care to all their patients and to ensure that all their patients receive appropriate review.
The advice of the IMB, based on the evidence available from the ongoing investigation, remains unchanged, that is, there is no current evidence of particular health risks associated with the PIP silicone breast implants. The IMB continues to advise women with these implants that if they have any concerns about their breasts or their breast implants, they should seek clinical advice from their implanting surgeon.
The best interests of the affected women is our primary concern, and we are monitoring the situation rigorously and liaising closely with our European and international regulatory colleagues to ensure any new information that may emerge is assessed swiftly and that we continue to provide expert advice to the patients and to the cosmetic clinics involved.
