About Colpexin

Safety Information

Contraindications

You should not use the Colpexin Sphere if you have any of the following:

Vaginal infection, breaks in the vaginal skin, or abnormal vaginal/uterine bleeding
You have had recent vaginal surgery
Severe pelvic nerve damage with no perineal sensation
Pelvic inflammatory disease, endometriosis, pelvic mass, prolapse limited to a large rectocele, or retroversion of the uterus
Pregnancy
You have an intrauterine device (IUD)
During sexual intercourse
During menstruation

Warnings

Contact your health care professional immediately if you experience any changes in color, amount, odor, and consistency of vaginal discharge, and/or if you have bleeding, discomfort, burning with urination, increased urinary frequency, and/or vaginal itching.

Cautions

The Colpexin Sphere should not be worn continuously for longer than 24 hours without removing and properly cleaning the device. (See Instructions for Care in Patient Product Information). Remember to remove the device before having sexual intercourse.

What Every Woman Needs to Know about Toxic Shock Syndrome

An association has not been established between the use of the Colpexin Sphere and toxic shock syndrome (TSS). However, wearing the device for prolonged periods of time may promote the growth of certain bacteria in the vaginal tract, especially during menstruation. Under certain conditions, the overgrowth of these bacteria could lead to symptoms of toxic shock syndrome. Primary symptoms of TSS are sudden high fever (usually 102°F or more), vomiting, diarrhea, fainting or near fainting when standing up, dizziness, or a rash that looks like sunburn. There may also be other signs of TSS, such as aching of muscles and joints, redness of the eyes, sore throat, and general weakness. If you have a sudden high fever and one or more of the other symptoms, remove the Colpexin Sphere at once and consult your health care professional immediately.