The Spanish Agency for Medicines and Medical Devices (AEMPS) has announced that the French manufacturer Groupe Sebbin has ceased manufacturing and marketing all of its medical devices as of March 3, 2025, following a court order. In Spain, Sebbin products were partly distributed by Tecnomédica Canaria SL. The company has ceased marketing products such as breast implants, leaving healthcare professionals without a supply of these products in the country.
The products affected by Groupe Sebbin's cessation of operations include a variety of medical devices and implant products. These include skin expanders, skin expander medical devices with associated injection sites, breast implants, breast testers, Fat Washers, chin, calf, cheek, gluteal, and smooth testicular implants, as well as the nasal corrector and injection valve associated with skin expanders. All of these products, manufactured before March 3, 2025, comply with safety requirements and may continue to be used, albeit without the manufacturer's commercial guarantees, after the cessation of operations.
This cessation primarily affects soft tissue implants, such as those for the breast, buttocks, chin, and calf, among others. The products manufactured up to that date continue to meet safety and performance requirements, so healthcare professionals can continue to use them, although without the manufacturer's commercial guarantees. The AEMPS has been informed through the competent authority in France, the ANSM, which confirms that the previously manufactured products are valid for implantation, although they lack the usual commercial support.
In Spain, Sebbin products were distributed by Sebbin Ibérica Productos Médicos SL and Tecnomedica Canaria SL. Both companies have ceased marketing these products, leaving healthcare professionals without a supply of them in the country.
According to authorities, this cessation of activity is due to commercial reasons and not to safety issues with the products in circulation. However, the end of commercial guarantees alerts professionals to the possibility of future difficulties in the handling and repair of these implants. The AEMPS recommends that healthcare centers check their stock of Sebbin products and make the necessary decisions based on the lack of support from the manufacturer.
