Breast implants are increasingly safe
Breast implants are increasingly safe
Article written by Dr. Julio Terrén, Plastic Surgeon and Doctor of Medicine
Current implants are extremely safe because manufacturers must incorporate a reference sheet in the National Registry of Breast Implants
The Spanish Agency of Medicines and Health Products (AEMPS) has developed the National Registry of Breast Implants that has been active since January 2018.
The National Registry is integrated into the National Implant Registries created by Order SCO / 3603/2003, of December 18.
The General Health Act 14/1986, of April 25, entrusts the State Health Administration with assessing the safety, efficacy and efficiency of technologies relevant to health and healthcare. The national registers of implants constitute a tool for the exercise of such functions.
On the other hand, breast implants are medical devices, regulated by Royal Decree 1591/2009, of October 16, which establishes the requirements for the marketing of these products in Spain and the functions of the AEMPS and other health authorities related to the control and surveillance of these products.
Health professionals and plastic surgery clinics are obliged to enter in the National Registry of Breast Implants, information related to the interventions carried out with breast implants; especially everything related to the implantation, extirpation and behavior of the same. This information makes it possible to guarantee the safety of implant-bearing patients.
With this registry it is possible to know, in case of necessity, the people who carry a specific breast implant, in order to adopt the appropriate measures or establish the adequate follow-up for the protection of their health.
The registry also helps the health authorities when making health decisions and provides information of interest in the clinical practice of health professionals.
Each doctor has only access to the data of their patients, while the health administration can study all the data collected. With the information deposited can be extracted data of interest, such as:
- Number of interventions carried out in Spain
- More or less used techniques
- What is the most characteristic location of the implants
- Percentage of satisfactory results
- Most common complications
The main objective of the registry is to avoid potential problems and to be able to take action sufficiently in advance before further damage occurs, as was the case with PIP prostheses. A scandal that came to light in 2011 when it was discovered that the French company PolyImplantProthèse (PIP), one of the leaders in breast prostheses, manufactured their implants using industrial-grade silicone.
Dr. Julio Terrén, Plastic Surgeon and Doctor of Medicine
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