SAFETY AND RESEARCH
• FDA status: Class II medical device cleared in 2023 as a vaginal dilator
• Indications for use: The Milli Vaginal Dilator is a tool intended for controlled dilation of the vagina. It can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.
• Clinical research: XXXX
CONTRAINDICATIONS
• Do not use Milli if you have active pelvic (lower abdomen) infections or open wounds in the tissue inside or surrounding the vagina.
• Pregnant women should refer to their physician for guidance prior to purchasing or using Milli.
SYMPTOMS REQUIRING PROFESSIONAL ASSESSMENT
The following symptoms require assessment by a healthcare professional prior to purchasing Milli:
• Abnormal vaginal discharge (fluid/material coming out of vagina), such as a discharge that is thick, white, green or yellow, may have bad odor, or is a change in what the discharge usually looks like.
• Abnormal uterine bleeding, such as bleeding between monthly periods or when periods are extremely heavy or prolonged.
• Abnormal skin changes around or inside the vagina, like itching, burning, bumps, or discoloration.
WARNINGS AND PRECAUTIONS
• If symptoms, such as bleeding, vaginal discharge, unpleasant odor, pain, or severe itching occur, stop use of the device and contact your healthcare provider.
• Prolonged use of Milli Vaginal Dilator may cause vaginal abrasion (scratching) or ulceration (break in the skin).
• Contact your physician if prolonged or worsening symptoms occur.
• Milli is for single patient use only. Do not share your device with others.
• Do not soak Milli’s handle or submerge Milli under water.
• Do not bathe with Milli.
• Use only water-based lubricant with Milli. Do not use silicone-based lubricant with Milli.
• Do not use if you have a sensitivity to silicone.
• Do not use Milli if the silicone cover, device, or case is damaged.
• Do not place Milli in the microwave, dishwasher, or refrigerator.
• Do not store Milli near extreme heat or cold.
• Do not wash Milli with products containing alcohol, acetone, or petroleum.
• Do not squeeze, twist, or bend Milli’s wand.
• Do not use Milli in body parts other than the vagina.
• Do not force Milli into your vagina.
• Once inserted into the vagina at desired depth, and at least halfway, gradually increase the dilation diameter at a comfortable level.