Talk to your healthcare provider about any potential side effects you might experience with the Priya Sensor. You should also report any adverse events to Customer Service. Possible side effects may include:
- Vaginal Irritation – The Priya Sensor is made of durable, medical-grade non-absorbent silicone. It should not irritate the inside of your vagina if cleaned and cared for properly. If at any time during your use of the Priya Sensor you experience any discomfort, discontinue use and contact your healthcare provider.
- Vaginal Sensitization – One could have a sensitivity to any substance, but it is extremely rare to have a sensitivity to silicone. Studies indicate that silicone is biocompatible with the body. This is why silicone has been used in healthcare applications for over 50 years. If you do experience skin sensitivity, immediately discontinue use and contact your healthcare provider.
- Vaginal Infection – Vaginal infections should be treated with appropriate antimicrobial therapy before using the Priya System. If a vaginal infection develops during use of the Priya System, then the Priya Sensor should be removed (see Section 5.9), and you should contact your healthcare provider.
- Sensor Removal Difficulty – On rare occasions, the Priya Sensor may adhere to the vaginal wall, making the Priya Sensor removal difficult. Vaginal wall ulceration or erosion should be carefully evaluated. If an ulceration or erosion has occurred, consideration should be given to leaving the Priya Sensor out and not replacing it until healing is complete, in order to prevent the Priya Sensor from adhering to the healing tissue.
If you are unable to remove your Priya Sensor, don't panic. Refer to the instructions for sensor removal in this IFU (Section 5.9 “Removing and Turning Off the Sensor” and Section 11 “Frequently Asked Questions”). It may also be helpful to bear down (like when you are having a bowel movement) to assist with sensor removal. If you continue to have difficulty, call your healthcare provider and schedule an appointment.
Note: it may help to use water-based lubrication gel on your finger for sensor removal.
- Toxic Shock Syndrome (TSS) – Although the Priya Sensor is not made of a highly-absorbable material; Toxic Shock Syndrome is a rare condition caused by the bacterium Staphylococcus aureus growing on blood or fluids in the vagina. For this reason, the Priya Sensor should not be worn during your menstrual period. Some of the symptoms are much the same as the flu, but they can become serious. STOP using the Priya Sensor immediately and call your healthcare provider right away if you have the following symptoms:
- sudden high fever (above 102°F or 39°C)
- a sunburn-like rash
- muscle aches
- fainting or feeling faint when standing up
- Expulsion – the Priya Sensor can be accidentally expelled, for example during intercourse, or with straining during a bowel movement. If the Priya Sensor is accidentally expelled, wash your hands, and clean the Priya Sensor according to cleaning instructions (see Section 4) before you re-insert.
- Partner Discomfort – if your partner experiences any discomfort from the Priya Sensor (i.e., penis discomfort or irritation), the Priya Sensor can be removed during intercourse. If the Priya Sensor was removed during intercourse, clean according to cleaning instructions (see Section 4) before you re-insert. To achieve the most accurate fertile window prediction, the sensor should be re-inserted as soon as possible (within 1-2 hours).
- Tampon Use – you should not be wearing a Priya Sensor during your menstrual period, and therefore, you should not be using a tampon at the same time that you’re wearing the Priya Sensor.
- Other Possible Side Effects – this includes foreign body sensation, tissue irritation inside your vagina or cervix, vaginal discharge, and vaginal discomfort. Should you have any concerns about allergies, please consult your physician or dermatologist.