Brazilian breast implants distributed in New Zealand could be contaminated

The use of breast implants made by a Brazilian company Silimed had been suspended in New Zealand after concerns about an ...
Reuters

The use of breast implants made by a Brazilian company Silimed had been suspended in New Zealand after concerns about an unknown particles.

Breast implant operations have been halted in New Zealand after contamination fears were raised at a Brazilian factory.

Medsafe has started an "urgent investigation" into all Silimed silicon breast implants. The New Zealand distributor suspending sale and is contacting all surgeons to advise them not to use the implants.

Both the distributor, Device Technology New Zealand, and Medsafe said there were no safety concerns about the products at this stage but their use has already been halted in both Australia and Europe. 

In a statement, Device Technology said surgeons have been advised to no longer use the implants after an inspection of a Brazilian factory by European authorities raised questions about the "particle levels" on the surface of the implants.

Until these concerns were addressed, Silimed has its rights to distribute in Europe suspended and Device Technology had taken a similar precautionary step here. Other Silimed implants, including gastric belts, penile implants and prosthetic chins, have also had their European distribution rights suspended, but only breast implants have been used in New Zealand.

"We emphasise that there is no evidence or indication of safety concerns for patients who have previously received Silimed implants."

A spokesman for Device Technology was unable to say how many Silimed implants were in circulation in New Zealand. However there are about 20,000 breast implant operations in Australia and New Zealand combined each year, with Silimed accounting for between 6000 and 8000. Silimed breast implants have been used in New Zealand since 2010.

Despite an alert stating an "urgent investigation" was underway, a Ministry of Health spokesman said at this stage Medsafe was just keeping a watching brief on overseas reports concerning the implants.

Anyone concerned about their Silimed implants should talk to their GP or surgeon.

Have you got Silimed breast implants? Contact newstips@stuff.co.nz

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