Suspension of medical devices manufactured by Silimed

News Category: Regulatory news

Date: 24/09/2015

The HPRA, jointly with medical device regulators of the European Member States, have been informed of the suspension of the CE certificate for all medical devices made by the Brazilian manufacturer Silimed. The German notified body, responsible for conducting the assessment and granting the CE mark for the devices, recently carried out an inspection of the manufacturing plant in Brazil. This established, following preliminary testing, the presence of particles on the surface of some of the devices. While a range of implants* are impacted by this suspension, the HPRA understands from the distributor that breast implants, gluteal implants and tissue expanders only have been supplied to the Irish market.

The HPRA is investigating the background to this suspension in collaboration with other European regulators and recommends that none of these devices should be implanted until further advice is issued.

It emphasises that to date there has been no indication that these issues could pose a threat to the implanted person’s safety. EU health regulators have initiated testing of samples of product to establish if there are any health risks.

The HPRA is working with the supplier to identify if products which have been supplied to Ireland are affected by the issues under review. As a priority, it is also working with the EU regulatory authorities, the notified body in Germany and the manufacturer Silimed to carry out a risk assessment, in particular to establish whether or not there is any clinical risk from the issues identified. 

Until the risk assessment is completed, the recommendation of the HPRA is that recipients of implants do not need to take any action. The measures being introduced at this time are precautionary but any person concerned should contact their implanting surgeon or clinic. 

The priority of the HPRA is to ensure that patients have acceptably safe medical devices. It monitors all adverse incident reports and takes prompt action to address any safety or performance concerns. In this instance, the issue has been identified by the notified body and the HPRA has not received any adverse incident reports associated with the use of these implants in Ireland.

In general, a medical device cannot be marketed in Europe without carrying a CE mark of conformity. A CE mark is applied by the manufacturer and means that the device meets the relevant regulatory requirements and, when used as intended, works properly and is acceptably safe. CE marking for a device is a claim of compliance with the essential requirements of European Directives. The HPRA continually monitor the safety of all medical devices.

The HPRA will provide a further update when additional information becomes available.

Further Information:

- Weber Shandwick (01) 679 8600
- Siobhan Molloy / Orla Molloy 086 817 5066 / 087 770 5108

Notes to Editor:

*List of products impacted across Europe: 
• Silicone Implants for plastic surgery: implants: breast implants, pectoral implants, gluteal implants, calf implants, implants for hand surgery, tissue expanders, facial implants, nostril retainers, suspension sheets for breast surgery

• Bariatric Surgery: Gastric bands and balloons

• Implants for urology: testicular implants, penile implants, vesical conformers, periurethal constrictors, tubes for hypospadias, vaginal stents

• Silicone implants for general surgery: blocks and sheets

• Silicone invasive devices: sizers for silicone implants

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