MHRA Suspends CE Certification for Silimed Products

The UK’s Medicines and Healthcare products Regulatory Agency, along with other European health regulators, have suspended CE certification for all products made by Brazilian implant maker Silimed after particle contamination was discovered during a facility inspection.

The unknown particles were detected by German health officials during an annual reinspection earlier this year. A March 2014 inspection found compliance with all German good manufacturing practice requirements.

Regulators recommend against using the implants until the problem is resolved.

Affected by the suspension are:

• Silicone implants for plastic surgery, including those for the breast, facial, gluteal and calf;
• Gastric bands and balloons;
• Testicular and penile implants, vesical conformers, periurethal constrictors, tubes for hypospadias and vaginal stents;
• Silicone implants for general surgery; and
• Sizers for silicone implants.

Australian authorities also are monitoring the situation. After consulting with the Therapeutic Goods Administration, Silimed’s Australian distributor, Device Technologies, has begun contacting surgeons to recommend that any planned implant surgeries be postponed. The distributor has halted further supplies of Silimed products until the situation is clarified.

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