The AEMPS updates the information on Poly Implant PIP breast prostheses, manufactured by the French company POLY IMPLANT PROTHESE, following the opinion issued by the Scientific Committee of the European Commission. The opinion states the absence of association of breast prostheses with cancer and the lack of evidence of higher health risks of PIP prostheses compared to other breast prostheses for the carriers of these implants.
UPDATE OF INFORMATION ON POLY IMPLANT BREAST PROSTHESES (PIP)
Date of publication: February 2, 2012
Category: SANITARY PRODUCTS, SAFETY.
Reference: PS, 03/2012
The Spanish Agency of Medicines and Health Products (AEMPS), in view of the opinion issued by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) of the European Commission, which has carried out an assessment of the risk derived from PIP prostheses in a group of experts constituted for this purpose, where the data available in the different Member States have been analyzed, considers it necessary to update the information on PIP breast prostheses.
This opinion determines that there is no evidence of an association between PIP prostheses and the development of cancer or connective tissue diseases. Likewise, with the limited data available, there is no evidence that women with these prostheses are exposed to a greater risk to their health than women with other breast implants. However, due to the limited clinical data available, and the results of the physical, chemical and irritation tests carried out, the possibility of health effects cannot be excluded1.
Therefore, the SCENIHR recommends that further work be done to establish with greater certainty the health risks that may be associated with PIP implants, if such risks exist.
BACKGROUND
On March 31, 2010, the AEMPS published Safety Note Ref.: 005/March 2010: Poly Implant Breast Prostheses (PIP), in which it reported the cessation of the implantation of these breast prostheses and recommended that carriers check, through the implantation card or the medical report they received at the time of the intervention, whether their prostheses were PIP and that if this were the case or they had doubts, they should request an appointment with the center or surgeon who operated on them to plan a follow-up.
Subsequently, the AEMPS has updated this information with the data available at any given time and has issued recommendations for the follow-up of PIP prosthesis wearers.
The Ministry of Health, Social Services and Equality (MSSSI) has also issued two communiqués updating the information on these prostheses.
All the information published so far can be found on the AEMPS website, “Information on Poly Implant PIP breast prostheses“(http://www.aemps.gob.es/productosSanitarios/prodSanitarios/infor_PIP/home.htm) and on the website of the Ministry of Health, Social Services and Equality(www.msssi.gob.es). These pages are kept permanently updated with the latest information available to date.
CURRENT SITUATION AND ACTIONS
On January 9, the MSSSI published a communiqué with the measures adopted jointly with the Autonomous Communities (CCAA) to guarantee the continuity of care for women with PIP prostheses and which included: the recommendations for patients regarding the need to undergo a medical follow-up to check the state of their prostheses; the individualized decision to have them explanted, after a joint assessment with their surgeon; the way in which these patients are assisted in the centers of the National Health System when they have been implanted in it and the way in which women should proceed in the event that it is not possible to go to the private clinic where they were operated on for a medical consultation.
Since then, the MSSSI and the AEMPS have continued to work with the Autonomous Communities, as well as with other entities, to advance in the analysis of the situation and to adopt measures aimed at protecting the health and well-being of the people affected.
The actions carried out since then have been as follows:
- Autonomous Communities: The Technical Inspection Committee (CTI) has continued to collect data from public and private health centers in Spain on the number of women implanted with PIP prostheses. At this moment, all the Autonomous Communities have provided practically all their data and it is estimated that the number of women carrying PIP prostheses in Spain is 18,500 women and that some 37,000 prostheses have been implanted. Only 4.2% of the patients were implanted in health centers of the National Health System and all of them are being duly attended in these centers. For women who have been attended in private centers and who have not been able to go to the private clinic where they were operated for a medical consultation, the Autonomous Communities have provided a list of reference centers to which women who do not receive adequate attention in the center where the implantation was performed can go. This list will be published on the web site of the AEMPS, the MSSSI and the related Medical Societies that consider it appropriate in the next few days.
- Committee of Experts to monitor the situation of PIP prostheses in Spain.Through the Permanent Commission of this Committee, made up of experts from the Spanish Society of Senology and Breast Pathology, the Spanish Society of Plastic, Reconstructive and Aesthetic Surgery, representatives of the Carlos III Health Institute (National Epidemiology Center), the General Directorate of Public Health, Quality and Innovation and the AEMPS, the following actions have been carried out:An explantation protocol has been drawn up which must be applied in all explantations of PIP breast prostheses carried out in Spain. This protocol also indicates the actions to be carried out in the follow-up of patients with PIP breast prostheses.We are working on the elaboration of a general protocol for the implantation, explantation and follow-up of breast prostheses, on the elaboration of information for people who are considering breast prostheses and on the design and development of the breast implants registry.Steps are being taken to carry out an epidemiological study by the National Epidemiology Center to obtain information on the behavior of PIP prostheses as suggested in the report of the Scientific Committee of the European Commission SCNEHIR.
- Federation of Private ClinicsContacts have been maintained with the National Federation of Private Clinics requesting and obtaining their collaboration in the establishment of actions to guarantee the continuity of care for women with PIP breast prostheses, and it has also been agreed that they inform their associates of the obligations regarding the reporting of adverse incidents to the Medical Devices Surveillance System and the completion of the implantation cards, one copy of which must be given to the patient in compliance with the regulations in force.
- Spanish Federation of Health Technology Companies (FENIN) Contacts have been maintained with FENIN, requesting and obtaining their collaboration in order to obtain from the companies the information required by the health authorities at any given time.
- The AEMPS, within the framework of the Medical Devices Surveillance System, permanently monitors the situation and has continued to receive notifications of incidents involving PIP prostheses. If at the time of the alert 13 notifications had been received, the current number of notifications of incidents with these prostheses amounts to 269 notifications, and according to the information submitted in the same, 391 prostheses have been explanted, with 275 prostheses showing rupture.The Agency will continue to closely evaluate with the health authorities and with the relevant medical societies the information on the follow-up of the carriers of these prostheses.
