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Silimed breast implants suspended in EU

Women in Ireland who received breast implants made by a Brazilian manufacturer are being warned that use of the product has been suspended in the EU.

The Irish Association of Plastic Surgeons (IAPS) said it has advised its doctors and surgeons to identify all the women they may have supplied the Silimed implant to.

It is understood it involves only a minority of women in Ireland.

No adverse side effects have been discovered from the Silimed products, the Health Products Regulatory Authority (HPRA) said.

But safety concerns were raised after contamination was detected during an audit of the company's manufacturing practices in Brazil.

Women who received the implants do not need to take any action, the HPRA said, as they will be contacted.

"If a patient has concerns, or is unsure of the manufacturer of their breast implants, they should contact their surgeon, or the hospital in which they had their surgery, for further information," the IAPS said.

It is understood only breast and buttock implants and tissue expanders have been supplied to the Irish market.

Silimed also makes pectoral implants for men's chests, urological devices including testicular and penile implants and vaginal stents, as well as other surgical devices, including gastric bands and balloons.

EU health chiefs are carrying out further tests to establish whether or not there is any clinical risk from the issues identified and checks are also ongoing to establish if implants supplied to Ireland are affected.

Between 900 and 1,000 Silimed implants were imported into Ireland over the last seven years but it is not yet known if they were all used on patients.

There is no national register of the number of these implants used in surgery and public and private hospitals have been asked to check individual medical records.

Dr Margaret O'Donnell, president of the IAPS, said the latest concerns about implants add to the need for a central database on plastic surgery.

"There's no register. There's no system. We'd like a breast implant register, there isn't in Ireland and it would be an easy way of finding out who was supplied with what," she said.

All hospitals where breast implant plastic surgery has been carried out will keep a record of products used on patients but commercial clinics may or may not, Dr O'Donnell said.

The latest implant concerns follows the 2010 controversy involving one of the world's leading manufacturers, France's Poly Implant Prothese (PIP). It did not use medical-grade silicone in some of its devices, leading them to have double the rupture rate of other implants.

Dr O'Donnell said: "We have been calling for a register of the whole cosmetic surgery sector. Practices is one, practitioners is another - to identify who is using them and where - and then the premises. At the moment there's no way of doing that."

While hospitals are checking files, women who believe they have received SiIimed implants are being asked to contact their surgeons.

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