Indications for Use and Safety Information
Indications for use, as approved by Health Canada
The SoftScan system is intended to be used as an adjunct to mammography and clinical breast examination in patients who have equivocal mammographic findings. When interpreted by a trained physician, SoftScan images and indices provide physiological information, which may be associated with cancer development and response to anti-cancer therapies.
Indications for use, as approved by the EU
The SoftScan system is intended to be used as an adjunct to mammography, and clinical breast examination in patients who have equivocal mammographic findings. When interpreted by a trained physician, SoftScan images and indices provide physiological information, which may be associated with cancer development.
Safety Information
Exposure to the laser
This risk is minimal because, under normal conditions of use, the SoftScan laser operates at a level considered safe, including when directly hitting the eye. As a result, patients and physicians are not required to wear protective eyewear during the SoftScan procedure. All personnel operating the SoftScan device are fully trained in laser safety procedures.
The heat produced by the laser can cause discomfort associated with overheating depending on how long the skin is exposed and how much light it absorbs. However, heat damage on exposed breast tissue is very unlikely because the laser never exceeds the recommended maximum level considered safe. Also, the laser only stays in one location for a fraction of a second, and the scanner is in motion before and during laser operation.
SoftScan has a built-in safety feature that closes the laser shutter if the scanner stops moving for any reason.
Discomfort for the breast
There is little discomfort or pain during the SoftScan imaging procedure. SoftScan does not compress the breast. During the SoftScan procedure, the breast is gently placed between two glass plates inside a fluid-filled container that cushions the breast. Mild discomfort may occur in women who have a history of sensitive breasts or who have very large breasts. Women who experience breast enlargement associated with their menstrual cycle at the time of imaging may also experience mild discomfort. Patients may discontinue the procedure at any time.
Physical discomfort and anxiety during the procedure
Patients need to lie on their stomach with their head resting on one side and their arm resting alongside their head for up to two hours. This may cause minor physical discomfort (i.e., muscle aches or stiffness in the neck, back, ribs and/or shoulder). Hospital staff will try to help patients who experience some pain or discomfort by changing their position or trying other measures. If the discomfort is too great, the procedure can be stopped.
This medical procedure, as any other, may cause anxiety or fear. If this happens, a member of the hospital staff will try to help the patient to calm down. Again, the procedure can be stopped at any time.
Optical Compensation Medium
Optical breast imaging requires that a liquid with light properties similar to breast tissue be used to fill any air spaces around the breast. This liquid mixture is composed of de-ionized water, soybean oil, sucrose, polysorbate 80, oleic acid, EDTA, benzalkonium chloride, FD&C caramel colour #900640, butylated hydroxyanisole and sodium hydroxide. Patients who have allergies or sensitivities to any of the substances in the liquid mixture will not be able to complete the SoftScan procedure. There is a minimal risk that this liquid will be toxic to exposed breast tissue although .there have been no reports of tissue toxicity from any past studies using this or similar liquids.
Other
The SoftScan device has the same potential risks as some FDA-approved mammography devices. These include excessive breast compression, electric shock, infection, skin irritation, skin abrasion and puncture wounds. There have been no reports of any of these occurrences from any past studies using SoftScan. Patients who notice any side effects should immediately tell the hospital personnel. Unanticipated side effects may occur that have not been reported. Any unusual symptoms should be report immediately to the health professional.