The Ministry of Health, Social Services and Equality and the Autonomous Communities adopt measures to guarantee continuity of care for women with PIP prostheses.
Poly Implant Prothese Breast Prostheses
So far, there is no evidence linking prostheses with the development of tumors, and explantation is not necessary unless there is breakage or symptoms that make it advisable.
The Ministry maintains the recommendations of the European Union for periodic medical follow-up.
The Technical Inspection Committee of the Agency of Medicines and Health Products meets to coordinate the actions of the Health Departments
January 9, 2011. The Technical Inspection Committee of the Spanish Agency of Medicines and Health Products, where the Autonomous Communities are represented, held a meeting this morning to determine the actions to be taken regarding Poly Implant Prothese (PIP) breast implants. At the meeting, the Ministry of Health, Social Services and Equality (MSSSI) and the Autonomous Communities have adopted measures to guarantee the continuity of care for women with PIP prostheses. The Ministry and the Regional Ministries of Health have jointly analyzed the opportunity to establish a breast unit of reference in each health service where women with these implants can go for assessment and consultation, in those cases where it is not possible to go to the private clinic where they were implanted.
This meeting is part of a series of actions that are being carried out in relation to the recommendations for patients who wear these prostheses. Last week, meetings were held with experts from scientific societies and the Spanish Medical Association (Organización Médica Colegial). The Health Safety Committee of the European Commission also met to review the latest information available on implants, and to assess whether the recommendations currently in force for female carriers should be maintained.
As a result of these meetings, it has been established that there is no link between PIP prostheses and the development of tumors. Likewise, it has been concluded that there is not enough evidence to systematically recommend immediate and preventive removal. Therefore, the current recommendations remain in full force and effect.
According to these recommendations, explantation is not necessary unless there is rupture or breast symptoms that make it advisable. The carriers of a PIP prosthesis should go to their surgeon, clinic or medical service where the implant was performed to review the condition of the prosthesis and decide together with the surgeon if it is appropriate to proceed to its removal.
Only in those cases in which it is not possible to return to the private clinic for a medical consultation, the MSSSI and the Autonomous Regions have considered the opportunity to establish a referral unit. In addition, the Spanish Society of Plastic, Reconstructive and Aesthetic Surgery will collaborate by offering its network of surgeons to provide individualized care to patients who so wish.
MASTECTOMIZED PATIENTS
The decision of the explantation is individual. The priority of the National Health System is the health and safety of women who have undergone PIP breast implants, and supports the removal if, after consultation with the surgeon, the patient is still concerned and both consider that it is best to perform the intervention. The SNS will replace the implants if the original surgery was performed by the same, according to its clinical protocols in mastectomized women (reparative surgery). Re-implants for cosmetic surgery are not in the NHS service portfolio.
Likewise, the follow-up of women implanted in the public health services of the SNS has been verified.
The Ministry expects the private sector to offer the same service to its patients. Private insurers have a duty to provide appropriate follow-up and care to the patients they have treated. The health authorities will ensure that no women are left untreated when there is a medical indication for explantation.
To monitor the situation of PIP prostheses in Spain and review the protocols for the implantation of breast prostheses, a permanent commission has been set up, made up of experts from the medical societies involved, representatives of the Carlos III Health Institute (National Epidemiology Center) and the MSSSI. This commission will study the information gathered on breast prostheses and the health situation of the women affected by this alert, which will allow the elaboration of an epidemiological study. An appropriate procedure will be established for this purpose.
The MSSSI is in permanent contact with the working group created for the same purpose by the European Commission to ensure coordinated action in Europe, which has undertaken to issue a scientific opinion and carry out the corresponding safety studies, and is at all times watching over the health and well-being of the women affected.
