Imports on brand of breast implant halted over contamination concerns

The halt was ordered following an inspection that found the surfaces of some medical devices made by the company were "contaminated with particles". Photo / iStock

Imports of a brand of Brazilian-made breast implants have been halted following an inspection that found the surfaces of some medical devices made by the company were "contaminated with particles".

The Government's medicines and medical devices regulator Medsafe has issued an alert late this afternoon about devices made by Brazilian manufacturer Silimed Silicone e Instrumental.

The alert notice says: "Medsafe has been informed that European medical device regulators have suspended the approval for all medical devices manufactured by Silimed Silicone e Instrumental, Brazil, following an inspection of a manufacturing site.

"Many of these devices are implantable and include breast implants.

"The inspection was conducted by officials from a German regulatory organisation and discovered that the surfaces of some devices were contaminated with particles.

"Medsafe is urgently investigating this matter with the New Zealand supplier of Silimed devices, Device Technology New Zealand. There is no indication of any safety concerns for patients that have received Silimed implants.

"Device Technology New Zealand has suspended further supply of Silimed devices in New Zealand and is contacting all surgeons known to be using these devices to advise them to stop use of these devices until further notice."

Medsafe said patients who had concerns about a Silimed implant should contact the surgeon who implanted it.

"Surgeons are requested to immediately quarantine all Silimed medical devices in their possession and to defer or to suspend all planned surgery involving Silimed medical devices. Use of alternative products should be considered."

"Testing of samples of products has been initiated in Europe and Australia to determine if there are any health risks. Medsafe has not received any reports of adverse patient reactions relating to Silimed devices."

Silimed devices that have been supplied in New Zealand include breast implants, appetite-suppression gastric balloons, rigid-penile prostheses, and prosthetic toe joints.

Device Technologies says in a written statement that following a routine inspection by European authorities of the Silimed manufacturing facility in Brazil, the criteria for defining acceptable particle levels that may be found on the external surface of the implants was questioned.

"The presence of particles does not mean that the product is contaminated, however until such time that the European authorities are satisfied with the criteria, the CE certificate for all Silimed products has been temporarily suspended".

Britain's medical devices regulator says manufacturers place a CE mark on medical devices to assert they meet European regulatory requirements and devices can generally not be marketed in Europe without one.

A Device Technologies spokesman estimates the company supplies 6000 to 8000 breast implants a year in New Zealand and Australia - 30 to 40 per cent of the transtasman market.

Device Technologies says in a written statement that following a routine inspection by European authorities of the Silimed manufacturing facility in Brazil, the criteria for defining acceptable particle levels that may be found on the external surface of the implants was questioned.

"Particles have been identified as being a combination of silica and cotton fibres.

"The presence of particles does not mean that the product is contaminated, however until such time that the European authorities are satisfied with the criteria, the CE certificate for all Silimed products has been temporarily suspended."