Safety Information

Trans-Tasman Early Warning System — Alert Communication

Medical Devices Manufactured by Silimed, Brazil

Information for consumers and caregivers
Information for healthcare professionals
Data Summary
What actions are Medsafe taking?
How to report adverse events
Further information

Description

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 Technologies New Zealand. There is no indication of any safety concerns for patients that have received Silimed implants.

Device Technologies 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.

Products Affected

A summary of the range of Silimed medical devices supplied in New Zealand is included in a table appearing in the Further Information section at the end of this notice

Information for consumers and caregivers

There is no indication of any safety concerns for patients that have received Silimed implants. However, should a patient have any concerns about a Silimed medical device they have had implanted they should contact the implanting surgeon.

Information for healthcare professionals

Surgeons are requested to immediately quarantine all Silimed medical devices in their possession and to defer or suspend all planned surgery involving Silimed medical devices. Use of alternative products should be considered. Healthcare professionals should maintain awareness of this matter in patients who have received these devices and who may present with concerns.

Data Summary

Currently there is no indication that these issues would pose a threat to the safety of the implanted person. 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.

What actions are Medsafe taking?

Medsafe is working with the New Zealand supplier of Silimed medical devices to investigate this matter, is in communication with professional bodies concerning the use of these devices, and is also in communication with other medical device regulators internationally concerning the testing of Silimed medical devices.

How to report adverse events

Medsafe cannot give advice about an individual’s medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

Further information

Product	Description
Silimed Mammary Implants	Silicone gel-filled breast implan
Silimed gastric balloon	Appetite-suppression gastric balloon
Silimed muscle prosthesis	Prosthesis, muscle
Silimed Sizers for mammary implants	Invasive breast implant sizer, single-use
Silimed Tissue Expanders	Tissue expander
Silimed Medgel	Non-sterile scar management dressing, reusable
Silimed Pouch for gastroschisis	Visceral retainer
Silimed Gastric band	Prosthesis, internal, band, gastroplasty
Silimed Penile implants	Rigid penile prosthesis
Silimed Vaginal stent	Vaginal stent, expandable
Silimed Ear Prosthesis	Ear prosthesis
Silimed Testicular implant	Testicle prosthesis
Silimed Chin prosthesis	Chin prosthesis
Silimed Periurethral constrictor	Urethral sphincter prosthesis system
Silimed finger, thumb, toe joint prosthesis	Prosthesis, digit, internal
Silimed Tendon spacer	Flexor tendon prosthesis
Flexor tendon prosthesis	Silicone-block tissue reconstructive material
Silimed Silicone sheet	Silicone-sheet tissue reconstructive material, non-sterile
Silimed Tube for hypospadias	Urethral catheter, coude
Silimed Vesical Conformer	Bladder-supporting prosthesis
Silimed Nasal implants	Nose prosthesis, implantable
Silimed Zygomatic implant	Zygoma prosthesis