Dr. Fernández Blanco informs all his patients and the general public that he has never used Macrolane or any other filler material in breast augmentation for aesthetic purposes.
Below we transcribe part of the information notice received, sent to all surgeon professionals who are members of Aecep:
The French Agency for the Safety of Health Products (AFSSAPS) informed the Spanish Agency of Medicines and Medical Devices (AEMPS), as well as the rest of the European health authorities, of its decision, as a precautionary measure, to restrict the use of injectable filler implants for breast volume augmentation for aesthetic purposes.
The reports received by the AEMPS from medical societies have concluded that these fillers injected into the breast can cause the formation of accumulations, due to fragmentation and encapsulation of the product, which interfere with physical breast examination and with the interpretation of complementary examinations such as mammograms.
On the other hand, and with regard to the product Macrolane, the authorities of Sweden have informed this Agency and the rest of the health authorities that the company Q-Med AB, Sweden, is going to cease the marketing of the product Macrolane for the indication of breast volume augmentation. The company Q-Med, a division of Galderma, is sending a Notice to inform healthcare professionals of its decision not to continue with the indication of breast volume augmentation. The injectable filler implant Macrolane is distributed in Spain through the company Q-Med Spain-
In Spain, other injectable filler implants are also marketed that are indicated for body volume augmentation, which, if used for breast volume augmentation, could present the same interferences.
RECOMMENDATIONS: Taking into account the available data and the reports from the medical societies received by the AEMPS, the following actions should be adopted:
Healthcare centers and professionals:
- Cease the use of the product Macrolane and any other injectable filler implant for breast volume augmentation for aesthetic purposes.
- Taking into account the interference in physical breast examinations and in the reading of mammograms, carry out complementary diagnostic techniques in the early detection of breast cancer in patients treated with Macrolane or any other injectable filler implant in the breast.
For patients treated with Macrolane or with any other injectable filler implant for breast augmentation:
- Inform the professionals who perform routine breast controls that they have been treated with this type of injectable implant, before undergoing the controls.
- They must continue with the scheduled follow-up visits after the treatment.
If you would like more information, write to us at contacto@drfernandezblanco.com or visit our Facebook.
Dr. Alfredo Fernández Blanco
The plastic surgeon Dr. Alfredo Fernandez Blanco stands out in his branch of medicine, as the best breast surgeon, he is also a pioneer in the so-called secondary surgeries or sequelae. With more than 30 years of experience and thousands of successful cases, he continues to achieve the most natural results that can be expected in a cosmetic surgery operation.
