Post-market review of breast implants with micro transponders

The Therapeutic Goods Administration (TGA) has undertaken a post-market review of all breast implants with micro transponders included in the Australian Register of Therapeutic Goods (ARTG).

All breast implant devices with a micro transponder sold in Australia have been cancelled from the ARTG.

Breast implants with micro transponders

Some breast implants include a device called a micro transponder. A micro transponder is a type of radiofrequency identification device (RFID) that stores information about the implant. Using a handheld scanner, a healthcare professional can access details, including:

• the breast implant’s unique electronic serial number
• manufacturing date and lot number
• implant size, volume and projection
• model and surface type.

These details can help with tracking and identifying implants during follow up care of if any issues arise.

Background

We received a safety signal for breast implant medical devices that have micro transponders, specifically how the micro transponder interacts with magnetic resonance imaging (MRI). When these implants are exposed to the MRI environment, the micro transponder interferes with the magnetic field generated by MRI.

The interference of these devices with MRI of the thorax (chest), including breasts and surrounding tissues and organs, results in image distortions. This can prevent important details being displayed in the scan such as whether the implant has ruptured, if there is a lesion, or other issues that requires attention.

As part of the review, we required the sponsor of the devices included in the ARTG to provide us with information about these products, including clinical data evidencing the safety of the micro transponder within the MRI environment.

The review was to determine whether the benefit of these devices (information traceability) outweighs the risk of a patient not being assessed properly when needing a chest MRI.

Overview

As part of ARTG inclusion, sponsors and manufacturers have post-market obligations. This includes maintaining evidence that the device does not compromise the health and safety of the user/patient and that the benefits of the device outweigh the risks.

During the review, we considered evidence provided by the sponsor and manufacturer of the devices and sought expert advice from our advisory committee and working group on the risks and benefits relating to these devices.

Following review of evidence provided by the sponsor and manufacturer, we have taken regulatory action in relation to all breast implants with micro transponders.

Outcomes and actions

The post-market review of breast implants with micro transponders is now complete. As part of the review, we have cancelled (removed) these devices from the ARTG. These devices are not being physically recalled from the market and do not need to be removed from patients if already implanted. The cancellation means no new patients will receive these implants.

The devices that have been removed from the ARTG are listed below under ‘Regulatory Decisions’. This information has also been updated on the current status of all breast implant devices on the ARTG page.

The proposed main benefit of a micro transponder is the ability to provide specific and traceable information about a patient’s breast implants, such as the implant’s serial number. A patient and/or healthcare professional may require access to this information in the event of recall action or in cases where a patient requires medical investigations or intervention because of their breast implants. A healthcare professional must be in possession of a specific handheld device to retrieve the information held by the micro transponder.

Australia’s current traceability for implanted medical devices, specifically breast implants, is managed through the following:

• Patient implant cards (issued to the patient at the time the device is implanted)
• Key legislative requirements for the safety and performance of medical devices included in the ARTG that require manufacturer’s to (unless impracticable or inappropriate to do so) include information that is required to be provided with a medical device on the device itself
• The Australian Breast Device Registry (ABDR) which is a Commonwealth Government health initiative that records information on surgeries involving breast devices, including breast implants.

In addition to the above, the TGA is currently implementing the Unique Device Identification (UDI) system for medical devices in Australia. With the introduction of UDI, manufacturers supplying medical devices in Australia will identify their devices through barcoding on all packaging and labelling and submit this data to the TGA. This UDI information can be used in hospital systems and patient records like My Health Record to clearly identify the model of medical device used or implanted. A public database of UDI information, the Australian UDI Database (AusUDID), will allow patients to access the relevant information about their device.

Considering the traceability mechanisms Australia has in place, the sponsor and manufacturer were unable to provide evidence that there is additional benefit from having the micro transponder, which would offset the additional risk if a patient needed MRI. Therefore, these devices have been removed from the ARTG.

Information for healthcare professionals

Healthcare professionals should ensure they provide sufficient information about the possible risks of these devices when treating patients with these devices already implanted.

Surgeons should:

• caution patients (in particular, high-risk breast cancer patients) about the potential risks associated with the device’s interference with MRI, the impact to MR image quality, and potential inability to use MRI to problem-solve a patient’s condition. The impact of the micro transponder may not be known until after the MRI has been undertaken.
• consider additional imaging dependent on the patient’s clinical circumstances.

Radiologists and radiographers should:

• anticipate the presence of artifacts on MRI of patients with these breast implants
• follow the “instructions for patients undergoing MRI” as stipulated with the instructions for use leaflet, if available. Consider seeking such instructions online.

To date, we have not received any reports of these devices interfering with MRI that has led to the inadequate evaluation of a condition, or inadequate detection of a lesion or missed diagnosis of cancer.

Healthcare professionals should report all adverse events associated with breast implants with micro transponders (artifacts) to the TGA. Healthcare professionals should further ensure their patients are aware of how to report device concerns to the sponsor and the TGA.

Information for consumers

Although all breast implants with micro transponders have been cancelled from the ARTG, they are not being physically recalled from the market and do not need to be removed if already implanted.

Following our review, advice for all implants is as follows:

• Even if your breast implants with micro transponders have been cancelled from the ARTG, you do not need to have these removed.
• Routine follow-up and standard breast screening remain appropriate and safe (mammography, tomosynthesis and ultrasound).
• Prior to a routine or investigative MRI, discuss the risk of distorted images with your healthcare professionals and ensure you inform the radiologist of the presence of the micro transponder within the implants. Your healthcare professionals will consider your individual circumstances and determine whether you require additional investigations.

Image distortions caused by the micro transponder can be effectively managed using existing MRI guidelines or alternative imaging types. Your healthcare professional will consider what is best for your circumstances.

You should consult your treating healthcare professional if you have any questions regarding the safety or risks associated with breast implants with micro transponders.

Reporting problems

Patient safety is a priority for the TGA.

Consumers and healthcare professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a healthcare professional if you are concerned about the use, outcomes, risks, possible complications, and possible alternatives.

Regulatory decisions

We have cancelled all breast implants with micro transponders included in the ARTG.