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Breast Prosthetic Implant Registers Now Operational in All Regions: Ministry Note

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Breast prosthetic implant registers have become fully operational in every Italian Region and autonomous Province Starting from May 17, 2024, marking significant progress in patient safety and healthcare monitoring in Italy. This initiative colors the entire country blue, signifying the widespread implementation of these registers.
The data collected from these regional registers feed into a National platform established at the Ministry of Health. This platform remains the sole competent authority at the international level with an effective tool for supervising and monitoring patients with breast implants, ensuring traceability in case of necessity. To address various inquiries from across the country, the Ministry issued a ministerial circular on June 5, 2024, titled “Indications for the registration of breast implant implantation or removal operations in the regional/provincial registers by healthcare professionals and clarifications on the requirements for the application of breast prostheses.”

Breast Prosthetic Implants: Guidelines and Qualifications for Healthcare Professionals Detailed in New Document

This document provides technical and operational guidelines on how to register breast prosthetic implants and details the necessary qualifications and surgical experience that healthcare professionals must possess or acquire to implant breast implants.

Law 86/2012 had already limited the application of breast implants for aesthetic purposes to professionals with specializations in plastic surgery, general surgery, gynecology and obstetrics, thoracic surgery, or those who had performed equivalent surgical activities in plastic surgery within five years prior to the law’s enactment.

The circular also references the then-current MIUR Ministerial Decree of August 1, 2005, and the current MIUR Ministerial Decree of February 4, 2015, n. 68, to specify the mandatory professionalizing surgical activities in the Plastic Surgery sector. It provides guidelines on the minimum surgical experience required for healthcare workers to implant prostheses for aesthetic purposes in the absence of specific specialist qualifications.

Additionally, the note emphasizes that the implantation of breast prostheses for aesthetic purposes is only permitted for adults, except in cases of serious certified congenital malformations. This regulation underscores the commitment to patient safety and proper medical standards.

The establishment of these registers marks a crucial step in enhancing the supervision and safety of patients undergoing breast prosthetic implantation. For healthcare professionals, this means adhering to stringent qualifications and surgical experience requirements. The circular issued by the Ministry provides clear instructions on the registration process and the qualifications needed, ensuring that only adequately trained professionals perform these procedures.


Breast Prosthetic Implants: New Guidelines for Healthcare Professionals Ensure Comprehensive Documentation and Enhanced Patient Safety

Healthcare professionals must now follow the specified guidelines to register implantations or removals in the regional/provincial registers. This ensures that all procedures are documented, and the data is centralized in the National platform, allowing for effective monitoring and traceability. This system not only improves patient safety but also facilitates quick responses in case of complications or recalls.

For patients, this initiative translates to enhanced safety and assurance that their procedures are performed by qualified professionals. The comprehensive monitoring system ensures that any issues related to breast prosthetic implants can be swiftly addressed. The Ministry’s emphasis on professional qualifications and surgical experience is a significant move towards maintaining high standards in medical procedures, reducing the risk of complications and improving overall patient outcomes.

The full implementation of breast prosthetic implant registers across Italy represents a significant advancement in the country’s healthcare system. By ensuring that all implantations and removals are meticulously recorded and monitored, the Ministry of Health is taking robust steps to safeguard patient health and enhance the quality of medical care. The initiative not only aligns with international best practices but also sets a precedent for other countries to follow in ensuring patient safety and effective healthcare monitoring.

This development reflects the Ministry’s ongoing commitment to medical innovation and regulatory compliance, aiming to build a sustainable and patient-centered healthcare system. The active participation and adherence to these new regulations by healthcare professionals will be crucial in realizing the full potential of this initiative, ultimately benefiting the patients and the broader healthcare community.

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Resource: Ministry of Health, June 11, 2024

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