Milex brand of pessaries from CooperSurgical are made of non-toxic medical-grade silicon. Milex Pessaries are available in 25 styles, each having a range of sizes to ensure optimal fit and comfort for the patient. The Milex pessaries are made in the U.S.A. and are manufactured in pink for single patient use; a limited variety of products are produced in yellow for use by the clinician when fitting the patient.
Benefits of the Milex nontoxic medical grade silicone:
- Milex silicone provides high consistency elastomers designed for optimal performance
- Milex silicone does not absorb odors or secretions and has a longer shelf and use life
- Milex silicone significantly reduces the chance of an allergic reaction
- Milex silicone can withstand repeated sterilization by autoclaving
Note: All pessaries, when new, are coated with a corn starch powder and must be washed off with a mild soap and thoroughly rinsed prior to initial use.
Prior to insertion of any pessary it is important to thoroughly clean and remove any matter that may be on the outer surface. CooperSurgical recommends washing with mild soap and thoroughly rinsing with water prior to initial use. Although there is no need to sterilize the pink pessary for single patient use, if the bag is open a sterilization cycle maybe performed to provide an extra degree of assurance when initially fitting the pessary. We find this practice is a good policy to avoid any inadvertent contamination. The yellow pessaries are designed to be used for selecting and fitting the right pessary for individual patient use and should only be worn in 15 minute increments. CooperSurgical strongly recommends and advises the yellow fitting pessary be sterilized prior to fitting each patient.
With the realization that many different techniques are practiced in the health care community, we attempted to optimize methods to afford the best coverage for our customers. It is vital that every facility fully validate its own equipment and parameters before processing any medical device.
- Decontamination/Disinfection: CIDEX OPA for 12 minutes
- The agent must be thoroughly rinsed off with water
- Pre-vacuum parameters of 132ºC +3ºC for 4 minutes
- Gravity Displacement parameters of 121ºC +3ºC for 40 minutes
The same validated sterilization parameters are to be used for both the pink and yellow products as they are manufactured from the same medical grade silicone-based resin. The only difference between the two products is the color additive; both have been challenged for cytologic and biologic compliance. The pink Ring pessaries come with nylon pegs for support, while the yellow fitting Ring pessaries do not.
WHEN IS A PESSARY INDICATED?
Patients are candidates for a pessary when …
- There is a need to postpone having surgery
- The patient is a poor surgical candidate – underlying medical problems, age, etc.
- A pessary may be used as a diagnostic tool for physicians to determine if surgery will correct the problem
- The use of a pessary may provide temporary relief while awaiting surgery
- It may hasten postoperative healing: Wearing a pessary prior to surgery helps relieve congestion of mucosa and improves circulation to the area
- A patient refuses surgery
- If the patient plans on having children in the future
Contraindication to supportive pessaries:
- Local infections – Active infections of the vagina or pelvis, such as vaginitis or pelvic inflammatory disease, preclude the use of a pessary until the infection has been resolved.
- Noncompliance – Noncompliance with follow-up could be harmful since an undetected and untreated erosion could put the patient at risk of developing a fistula.
- Inability to manage the pessary – Sexually active women who are unable to remove and reinsert the pessary
PESSARY MAINTENANCE AND FOLLOW-UP RECOMMENDATIONS
- Make sure the patient immediately reports any discomfort
- Have patient return within 24 hours for first exam
- Return again within three days for the second exam
- Return every four to six weeks per clinicians discretion for regular re-exams
These are recommendations and may be adjusted to suit the needs of the patient and the physician.
During each visit:
- Remove pessary
- Carefully examine vaginal vault to ensure there is no area of pressure necrosis, ulceration or allergic reaction. The patient should be questioned concerning discharge, disturbance of bowel function or urination. It may be necessary to fit another size or an entirely different type of pessary
- Clean pessary with mild soap and water. Rinse thoroughly before reinserting.
- A vaginal irrigation should be considered prior to initial insertion of the pessary
- Reinsert pessary. DO NOT assume that a replacement will be the same size as the previous one. Check the fitting to ensure patient comfort and relief of symptoms. At each checkup, the pessary is removed and cleaned. If there are no contraindications, the pessary is reinserted