Breast Screening Information
Believing Is Achieving
THE INFORMATION PROVIDED HERE SHOULD NOT BE USED AS A SUBSTITUTE FOR THE ADVICE OF AN APPROPRIATELY QUALIFIED AND LICENSED PHYSICIAN OR OTHER HEALTH CARE PROVIDER. THIS INFORMATION IS FOR INFORMATIONAL PURPOSES ONLY AND IS MEANT TO BE USED ONLY AS A GENERAL GUIDE.
Why are Motiva Implants® available with RFID technology?
Motiva Implants® are available with a radio-frequency identification (RFID) microtransponder embedded in the silicone gel known as the Q Inside Safety Techonology™. When interrogated by an external, secure hand-held reader a unique electronic serial number (ESN) will be transmitted by the microtransponder.
With this technology, Motiva Implants® give healthcare providers and patients access to secure, non-invasive verification of the electronic serial number (ESN). This unique number can then be referenced back to the implant’s serial number, manufacturer name, date of manufacture, implant style and volume.
The ESN codes can never be lost or misplaced, unlike product and warranty cards, providing a permanently readable code for traceability and quality assurance purposes.
Are there any safety concerns for patients with Motiva Implants® with Q Inside Safety Technology?
Q Inside Safety Technology™ has been shown to tolerate all conditions to which it will generally be exposed. Activated externally by the reader, it doesn’t require a battery and has an indefinite life expectancy.
Q Inside Safety Technology™ is Magnetic Resonance (MR) conditional per ISO Standard 14630: ”Non-active Surgical Implants”, meaning that it is a device that has been shown not to pose any hazards under specific magnetic resonance conditions.
Can Q Inside Safety Technology™ affect MRI evaluation for a potential implant rupture?
MRI scanning is the imaging modality of choice for breast implant rupture surveillance or diagnosis. In the event of a suspected rupture in Motiva Implants® with Q Inside Safety Technology™, MRI should be the first imaging of choice. The Q Inside Safety Technology™ is a small and light device, with an integrated circuit and ferrite coil/antenna assembly. Due to the presence of the ferrite, an MRI of Motiva Implants® with Q Inside Safety Technology™ may produce a small shadow in imaging, also known as an artifact, immediately behind the device. If a rupture is not found, but still suspected to be present in this specific area, a second imaging modality, such as CT or ultrasound, should be employed.
What specifically causes artifacts?
Artifacts are commonplace in MRI and may cause visualization challenges when reading tissue structures. Artifacts may be present as shadows, distortions or voids within the imaging field and can be caused by a variety of phenomena such as:
- Underlying physics of the energy-tissue interaction
- Data acquisition errors (for example, patient movement during the test)
- Poor reconstructive algorithms (unable to properly represent the anatomy)
- Presence of metallic objects (orthopedic hardware, vascular ports, pacemakers and the like).
Breast implants also commonly interfere with imaging examinations by creating shadows or voids that obscure some breast tissue, and may cause complications in obtaining a mammography of the entire breast. If you are unfamiliar with the previously mentioned terminology and would like to learn more, please contact your doctor or surgeon.
What information needs to be provided to a radiologist prior to an MRI of Motiva Implants® with Q Inside Safety Technology™?
The radiologist should be informed of the presence of the microtransponder and that it is embedded in the interior of the breast implant. The presence of an imaging void artifact should be anticipated along with the expected size.
Are there alternative or additional imaging modalities that will improve visualization of the artifact-affected area?
Currently, MRI imaging is the preferred method of choice for cancer detection or identification of implant rupture in breast implant evaluation. However, there are other technologies that may be used in addition to MRI. Additional imaging modalities to be considered include the following:
- Breast ultrasound
- Digital tomosynthesis
- Automated ultrasound
- Dual energy contrast subtraction digital mammography
- Dual-energy enhanced mammography.
If you are unfamiliar with the previously mentioned terminology and would like to learn more, please contact your doctor or surgeon.
Other than improved imaging visualisation are there any other benefits to adding a second imaging modality?
When clinically indicated, following an MRI scan with a second imaging modality, such as an ultrasound, may actually improve cancer detection accuracy – with or without the presence of Motiva Implants® with Q Inside Safety Technology™.