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Extension to suspension of Silimed medical devices (all - including breast implants) |
 The TGA has extended the suspension of all medical devices manufactured by Silimed from the Australian Register of Therapeutic Goods to 4 November 2016.
The extension to the suspension means that the products cannot be supplied in Australia while the suspension remains in force.
Update 3 - Extension to suspension
06 May 2016
Update 2 - Products suspended from ARTG until quality standards met
30 November 2015
The TGA has suspended all medical devices manufactured by Silimed from the Australian Register of Therapeutic Goods from 20 November 2015 until 6 May 2016 as the sponsor cannot currently demonstrate that the devices meet the necessary requirements for safety and quality.
These products cannot be supplied to the Australian market while the suspension is in force.
A suspension can be lifted when the sponsor provides sufficient evidence of compliance with the requirements for safety and quality. In addition to information supplied by the sponsor, the TGA will be taking into consideration its own investigations as well as actions by the certification body TUV Sud and other regulatory authorities before the suspension of the ARTG entries is lifted.
Update 1 - particles provisionally identified as silica and cotton
25 September 2015
The TGA has received information from the Australian sponsor of Silimed implants that the unknown particles mentioned below have been identified as silica and cotton.
While we have no reason to doubt this information, we will seek to confirm this finding through testing and through collaboration with overseas regulators. We have also been advised that a root cause analysis is under way at the manufacturing site.
Until the investigation is complete, distribution of the Silimed implants remains on hold.
Safety advisory
24 September 2015
The TGA is aware that European Union (EU) health regulators have suspended approval(link is external) for all devices manufactured by the Brazilian company Silimed following an inspection of a manufacturing site.
The TGA is urgently investigating what, if any, action is required in Australia and will be testing samples of Silimed products in its laboratories.
Silimed's CE certificate was suspended after German health officials inspected Silimed's manufacturing plant and found that the surfaces of some devices were contaminated with unknown particles. In general, a medical device cannot be marketed in Europe without carrying a CE mark of conformity.
The Brazilian manufacturer was inspected in March 2014 and found to comply with all requirements. The present issues were identified during the annual re-inspection.
Silimed manufactures a wide range of devices supplied to the Australian market, but breast implants make up the overwhelming proportion of Silimed products used in this country. See the 'Additional information' section below for a list of all affected products.
As a precautionary measure and in consultation with the TGA, the Australian distributor (Device Technologies) has been contacting surgeons who have been supplied with these implants to recommend any planned implant surgeries be postponed. Device Technologies has ceased supply of all Silimed products until the situation is clarified.
The TGA has had no adverse event reports relating to these products and there has been no indication that these issues would pose a threat to the implanted person's safety.
The TGA is seeking further information from the manufacturer and other regulators and will provide updated information when it becomes available. In the meantime, the TGA is working with professional groups to provide as much information to patients as possible.
Information for consumers
If you have received a Silimed implant be reassured that there is no indication that this issue poses a threat to your safety.
If you have any questions or concerns about this issue, contact your general practitioner or surgeon for individual clinical assessment and advice.
Information for health professionals
If you have a patient who has received a Silimed implant, be alert to the issue. Reassure them that there is no indication that this issue poses a threat to their safety.
Refer them to their implanting surgeon if they have any concerns.
Information for surgeons
Surgeons are advised to postpone operations using Silimed implants, or substitute alternative products, until the situation is clarified.
The TGA recommends that you consider contacting patients who have been implanted with these devices to inform them of this issue.
Implanting surgeons are advised to maintain their routine follow-up protocol for patients who have been implanted with Silimed devices. The need for any additional follow-up or actions should be determined on a case-by-case basis following a detailed assessment of the patient's clinical circumstances.
Additional informationAll affected devices in Australia| Australian Register of Therapeutic Goods number | Device type |
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| 141293 | Skin expander | | 143151 | Tissue reconstructive material, synthetic, silicone, sheet | | 143152 | Tissue reconstructive material, synthetic, silicone, block | | 143181 | Prosthesis, internal, band, gastroplasty | | 143651 | Balloon, gastric, appetite-suppressing | | 144004 | Prosthesis, internal, testicle | | 144268 | Prosthesis, internal, chin | | 144269 | Prosthesis, internal, ear | | 144270 | Prosthesis, internal, muscle | | 144271 | Prosthesis, internal, muscle | | 144272 | Prosthesis, internal, muscle | | 144273 | Prosthesis, internal, nose | | 144274 | Prosthesis, internal, zygomatic | | 144275 | Prosthesis, internal, zygomatic | | 144276 | Prosthesis, internal, urethral, sphincter | | 144278 | Prosthesis, internal, penile, rod | | 144436 | Prosthesis, internal, stent, vaginal | | 145286 | Dressing, occlusive, silicone | | 147758 | Prosthesis, internal, joint, digit | | 147759 | Prosthesis, internal, tendon sheath | | 148763 | Mammary Implant - Silicone Gel - Textured Surface - Prosthesis, internal, mammary, gel filled | | 148764 | Mammary Implant-Silicone Gel-Smooth Surface - Prosthesis, internal, mammary, gel filled | | 148765 | Mammary Implant-Silicone Gel-Polyurethane Foam Coated - Prosthesis, internal, mammary, gel filled | | 149172 | Catheter, urological, coude | All affected devices in Australia Australian Register of Therapeutic Goods number Device type |
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141293 | Skin expander | 143151 | Tissue reconstructive material, synthetic, silicone, sheet | 143152 | Tissue reconstructive material, synthetic, silicone, block | 143181 | Prosthesis, internal, band, gastroplasty | 143651 | Balloon, gastric, appetite-suppressing | 144004 | Prosthesis, internal, testicle | 144268 | Prosthesis, internal, chin | 144269 | Prosthesis, internal, ear | 144270 | Prosthesis, internal, muscle | 144271 | Prosthesis, internal, muscle | 144272 | Prosthesis, internal, muscle | 144273 | Prosthesis, internal, nose | 144274 | Prosthesis, internal, zygomatic | 144275 | Prosthesis, internal, zygomatic | 144276 | Prosthesis, internal, urethral, sphincter | 144278 | Prosthesis, internal, penile, rod | 144436 | Prosthesis, internal, stent, vaginal | 145286 | Dressing, occlusive, silicone | 147758 | Prosthesis, internal, joint, digit | 147759 | Prosthesis, internal, tendon sheath | 148763 | Mammary Implant - Silicone Gel - Textured Surface - Prosthesis, internal, mammary, gel filled | 148764 | Mammary Implant-Silicone Gel-Smooth Surface - Prosthesis, internal, mammary, gel filled | 148765 | Mammary Implant-Silicone Gel-Polyurethane Foam Coated - Prosthesis, internal, mammary, gel filled | 149172 | Catheter, urological, coude |
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