QID® / Screening
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Qid® is the world’s first microtransponder for clinical use in a breast implant. It is the only transponder with a CE mark (which indicates compliance with the health, safety, and environmental protection standards for products sold in the European Economic Area), and the United States Food & Drug Administration (FDA) cleared it for use in 2004. Qid® is placed in the gel filling inside Motiva® Implants.
A handheld reader is used to externally scan the transponder, providing an electronic serial number (ESN) that can be used to retrieve important implant information such as manufacturing date, implant type, volume, and more.
Qid® is an optional feature in Motiva® Implants that is particularly useful to patients and surgeons to identify the implant type after the surgery, and to verify implant details during the event of a product recall.
Product information or warranty on cards can be lost or misplaced. With its unique ESN permanently located within the breast implant, Qid® provides the confidence of instant implant traceability and verification.
A radio frequency identification (RFID) microtransponder (Qid®) is a passive component (without a battery) placed in the gel that provides each implant device with a unique electronic serial number which is only accessible through the use of a handheld scanner specific to Motiva. The Electronic serial number does not contain patient-specific or identifiable information, only device-specific information such as the manufacturing date, serial number, lot number, implant volume, size and projection, model and surface type).
The Qid is 9mm in length.
The components of the Qid® are:
- Copper Polystermide Estersol 180 wire,
- Nickel-Zinc Ferrite core,
- Photobond4442 Acrylate adhesive,
- 4305 Application Specific Integrated Circuit (ASIC),
- and Soda-lime Silicate glass.
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Motiva® Implants are available with a radio-frequency identification (RFID) microtransponder embedded in the silicone gel known as the Qid®. 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 assures that healthcare providers and patients have 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. Furthermore the ESN codes can never be lost or misplaced, unlike product and warranty cards, providing a permanently readable code that ensures safety and well being in the event of any issue or device recall.
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Currently, MRI imaging is the preferred method of choice for identification of implant rupture in breast implant evaluation. However, there are other technologies that may be used in addition to MRI and are recommended complement visualization and improve overall diagnosis. Additional imaging modalities to be considered include the following:
- Breast ultrasound.
- Digital tomosynthesis.
- Automated ultrasound.
- Scintimammography.
- Dual energy contrast subtraction digital mammography.
- Dual-energy enhanced mammography.
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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 Qid®, MRI should be the first imaging of choice. Qid® is a small and light device comprising an integrated circuit and ferrite coil/antenna assembly. Due to the presence of the ferrite, an MRI of Motiva® Implants with Qid® may produce in some of the imaging a small shadow, 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.
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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 (e.g., patient movement during the test)
- Poor reconstructive algorithms (unable to properly represent the anatomy)
- Presence of metallic objects (orthopedic hardware, vascular ports, pacemakers).
Breast implants also commonly interfere with imaging examinations by creating shadows or voids that obscure some breast tissue as well and may cause complications in obtaining mammography of the entire breast.
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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.
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The risks associated with the microtransponder include the following:
- Adverse tissue reaction
- Migration of the transponder
- Failure of the microtransponder to operate properly
- Failure of the inserter
- Failure of the electrical scanner
- Electromagnetic interference
- Electrical hazards
- MRI disturbances
These risks have been mitigated through the establishment of certain testing requirements by the FDA for this device, including the requirement to perform biocompatibility testing, migration testing, performance testing, electromagnetic compatibility testing, electrical safety testing, and MRI compatibility testing.
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Q Inside® Safety Technology is the world’s first micro transponder for clinical use in a breast implant. It is the only transponder with CE mark (which indicates compliance with the health, safety, and environmental protection standards for products sold in the European Economic Area), and the United States Food & Drug Administration (F.D.A.) cleared it for use in 2004. Q Inside® is placed in the gel filling inside Motiva Implants®.
A handheld reader is used to externally scan the transponder, providing an electronic serial number (ESN) that can be used to retrieve important implant information such as manufacturing date, implant type, volume, and more.
Q Inside® is an optional feature in Motiva Implants® that is particularly useful to patients and surgeons to identify the implant type after the surgery, and to verify implant details during the event of a product recall.
Product information or warranty cards can be lost or misplaced. With its unique ESN permanently located within the breast implant, Q Inside® provides the confidence of instant implant traceability and verification.
Qid® does not pose any safety concerns for patients. It has been proven to be both safe and effective. Activated externally by the reader, it doesn’t require a battery and has an indefinite life expectancy. Qid® is magnetic resonance (MR) conditional, meaning that it is a device that is shown not to pose any hazards under specific magnetic resonance conditions.
Please see the attached documents for more information:
- Qid facts for the surgeon
- Qid facts for radiologists
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