Regulator bans Brazilian-made silicone implants

Sales of a Brazilian-manufactured silicone implant already used by almost 1,000 Irish women have been suspended due to safety concerns.

The Irish regulator for medical devices, along with regulators in other EU states, has suspended certification for the devices made by Silimed after contamination was found during an audit of the company's plant in Brazil.

The Health Products Regulatory Authority said this inspection detected the presence of particles on the surface of some devices.

It said that while the ban affected a range of devices, only breast implants, gluteal implants and tissue expanders have been supplied to the Irish market.

The authority estimates up to 980 women may have received these breast implants since 2009.

It says to date there is no indication that the contamination detected could pose a threat to the safety of women who received implants. EU health bodies have started test samples to establish whether there are any health risks.

Irish supplier

The authority is working with the Irish supplier to identify if products imported into Ireland are affected by these issues, and is also working with Silimed and the testing body based in Germany to establish the level of risk involved.

“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.”

In 2010, it was found that one of the world’s leading breast implant makers, France’s Poly Implant Prothèse (PIP), was not using medical-grade silicone in its devices, leading them to have double the rupture rate of other implants.

Hundreds of thousands of patients across Europe and South America were affected, and PIP’s president, Jean-Claude Mas, was given a four-year jail sentence in December 2013.

Thousands of Irish women who were fitted with the PIP devices are still struggling to obtain legal redress.