Medical devices manufactured by the Sebbin Group

The Division of Pharmacy and Medicines (Division de la pharmacie et des médicaments - DPM) was informed by the French National Agency for the Safety of Medicinal and Health Products (Agence nationale de sécurité du médicament et des produits de santé - ANSM) that the Sebbin Group had ceased trading further to being placed in compulsory liquidation. Sebbin stopped manufacturing and marketing all of its products, including its breast implants, on 3 March 2025.

The list of medical devices manufactured by the Sebbin Group can be found at the bottom of this page, in the 'More information' box.

According to the information provided by ANSM, Sebbin medical devices that were manufactured before 3 March 2025 – the date on which the CE-Mark certificate expired – can still be used and implanted, but will not be covered by the manufacturer's commercial warranties.

Sebbin ceased trading for commercial reasons, and not for product-safety reasons. Sebbin products that were manufactured before 3 March 2025 meet the general safety and performance requirements applicable to them.

It should be noted that Sebbin has no legal successor that will continue to fulfil the manufacturer's obligations under Regulations (EU) 2017/745 on medical devices (MDR). These obligations include, among other things, post-market surveillance, which includes investigating incidents and, where applicable, implementing field safety corrective actions. Furthermore, the safety and effectiveness of Sebbin medical devices that are still on the market are no longer monitored by the manufacturer.

Action to take: guidance for healthcare professionals

  • Check whether you have Sebbin implants in your establishment.
  • Please note that these products – which were manufactured before 3 March 2025 – can still be implanted, but will not be covered by the manufacturer's commercial warranty.
  • If you decide to continue using Sebbin medical devices that you have already purchased, the DPM recommends heightened vigilance as to their safety. General practitioners or health institution operators should determine – based on an assessment of risks and benefits – whether continuing to use these medical devices already purchased is in their patients' best interests.
  • The DPM draws attention to the fact that closer monitoring of the functionality of these medical devices is needed.
  • Please report any incidents that occur with a Sebbin device in any of your patients to the DPM, at meddevices.vigilance@ms.etat.lu, using this Notification Form (FR/DE) (Word, 181 Kb).

'Incident' should be understood to mean any malfunction or alteration in the characteristics or performance of a device placed on the market, including errors in use due to its ergonomic features, lack of manufacturer information, and side effects.

'Serious incident' should be understood to mean any incident that resulted in, could have resulted in, or is likely to result in, either directly or indirectly:

  • The death of a patient, a user or any other person;
  • A temporary or permanent serious deterioration in a patient's, user's or other person's health;
  • A serious threat to public health.

Guidance on filling in the notification form, and a document on data protection, are also available:

 

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