VIDAL
Parapharmacy
Update of 18/06/2025
(Latex-free, phthalate-free, no products of animal origin.)
The pessary may also be indicated:
Choosing the size:
Inserting the pessary:
Removal of the pessary:
Recommended follow-up:
Cleaning, disinfection and sterilization:
Fitting of the pessary should be avoided or postponed in the following cases:
See instructions for use.
CE marking 0086 (93/42/EEC as amended by directive 2007/47/EC).
Manufacturer: CooperSurgical, Inc., 75 Corporate Drive, Trumbull, CT 06611, USA.
GAYA
10, rue de Penthièvre. 75008 Paris
Tel: 01 84 60 24 22
E-mail: contact@gaya-women.com
www.mylittlepessaire.com
Parapharmacy
Update of 18/06/2025
CE MILEX PESSARIES
Forms and presentations
Pessary: 7 models available:- Ring (T0 to T10, from 44 to 108 mm in diameter).
- Ring with support (T0 to T10, from 44 to 108 mm in diameter).
- Cube perforated (T0 to T7, from 25 to 57 mm in diameter).
- Urethral dish (T0 to T6, from 55 to 85 mm in diameter).
- Urethral dish with Milex support (T0 to T6, from 55 to 85 mm in diameter).
- Donut (T0 to T7, from 51 to 95 mm in diameter).
- Gellhorn (T1 to T10, from 38 to 95 mm in diameter).
Composition
Medical silicone.(Latex-free, phthalate-free, no products of animal origin.)
PROPERTIES AND INDICATIONS
The pessary provides mechanical support to the pelvic organs and the perineum, and is indicated to correct or prevent:- Genital prolapse (cystocele, hysterocele, rectocele).
- Stress urinary incontinence.
The pessary may also be indicated:
- As transitional treatment, while awaiting surgery in order to relieve the patient of her symptoms.
- As a diagnostic and decision-support tool, to assess and anticipate the effects of surgery on symptoms (and in particular to reveal possible masked incontinence).
- In preparation for surgery, to optimise the conditions of the operation by reducing possible mucosal ulceration secondary to tissue extrusion, and by limiting the infection risk.
- As occasional or comfort treatment, particularly during pregnancy or postpartum, or during certain physical activities.
- As prevention, particularly for women engaging in so-called "high-impact" sports.
| Model | Main indications |
| Ring | Mild or moderate prolapse (grade I or II) of the bladder and/or uterus. Can be kept in place. |
| Ring with support | Mild or moderate prolapse (grade I or II) of the bladder and/or uterus. Can be kept in place. |
| Perforated cube | All types of prolapse (grade I, II, III or IV). Stress urinary incontinence. Must be removed every evening. |
| Urethral dish | Stress urinary incontinence. Mild or moderate prolapse + stress urinary incontinence. Can be kept in place. |
| Urethral dish with Milex support | Stress urinary incontinence. Moderate to severe prolapse + stress urinary incontinence. Can be kept in place. |
| Donut | Moderate or severe prolapse (grade III or IV). Stress urinary incontinence. Can be kept in place. |
| Gellhorn | Moderate or severe prolapse (grade III or IV). Can be kept in place. |
Directions for use
See instructions for more information specific to each model.Perform a standard pelvic examination. Make a first approximation of the size by measuring the length and width of the vaginal vault with the index and middle fingers (from the pouch of Douglas to the pubic symphysis). This measurement generally allows determining the appropriate size, to within one or two sizes. It is then important to trial the pessary thus selected.
- Instructions to share with the patient:
-
- Wear dry gloves.
- If necessary, lubricate the insertion end of the pessary with a water-based lubricating gel.
- Compress the pessary as much as possible (fold it in 2 in the case of the Ring).
- Advance the pessary past the cervix into the posterior vaginal fornix. Allow the pessary to regain its shape after passing the vaginal introitus.
- Ask the patient to sit, stand and bear down lightly. If there is no leakage and the patient feels no discomfort with the pessary in place, ask her to empty her bladder. A correctly fitted pessary corrects tissue relaxation and lifts the uterus back up within the vagina. If the patient can empty her bladder without difficulty and the pessary stays in place after re-examination, and if the patient feels no discomfort from the pessary, this indicates the correct size has been selected. Sensations may vary between patients.
If the patient is unable to urinate once the pessary is in place, remove it and insert a pessary one size smaller. Repeat the procedure.
- Examine the patient while standing to ensure the pessary has not moved. Once in place, the patient should not feel the pessary. The pessary should not be too small, as it could rotate or be expelled, and it should not be too large so as not to cause discomfort.
Note: a pessary that rotates or falls out is not necessarily too small. A pessary that is too large, unable to position correctly at the bottom of the vagina, may also rotate or even fall out.
- The healthcare professional should be able to pass, with a little force, a finger between the pessary and the vaginal walls. If the space is too small to do so, try the next smaller size. If the space is too large, the pessary will be ineffective and may rotate, and even be expelled.
- It is sometimes necessary to fit a pessary of a different size or type in the same patient after a certain period of time. Do not assume that a replacement will automatically be made with a pessary of the same size. Check the fit of the device to ensure the patient's comfort and the correction of her symptoms.
- The lifespan of a pessary is limited. Frequently look for signs of deterioration (cracks or breaks in the silicone surface). A damaged pessary must be replaced.
- Ulceration and erosion frequently occur in complete prolapse, due to irritation of the cervix or vaginal walls. If possible, reducing the mass and treating the irritation are the first steps to take before using a pessary. Reduction of the prolapse may resolve irritation of the cervix or vagina. Check cervical cytology (smear) and/or biopsy as clinically indicated.
- At each visit, the vagina should be carefully examined for signs of pressure or allergic reaction. The patient should be questioned about her vaginal discharge, bowel or urinary problems. It may be necessary to fit a different size or an entirely different type of pessary.
- The healthcare professional may show the patient how to remove, clean and reinsert her pessary herself. This procedure can be carried out by the patient every evening or even once a week under ideal circumstances.
- Wear dry gloves.
- Instructions to share with the patient:
- Use a finger to press on the vulvar fourchette. Hook the pessary with one or two fingers and pull gently, applying slight pressure toward the posterior vaginal wall, until the pessary is completely out. Use a water-based lubricating gel if needed to assist removal.
- Instructions to share with the patient:
- For patients who are not self-sufficient, ask the patient to:
-
- Return within 24 hours for a first examination.
- Return within 3 days for a second examination.
- Return regularly for examinations spaced 3 months apart.
- Return within 24 hours for a first examination.
- Note: the scheduling of follow-up examinations may be modified at the discretion of the healthcare professional, depending on the patient's needs and how often she removes and cleans her pessary.
- All pessary models can be self-managed by patients.
- Cleaning:
-
- Instructions to share with the patient:
-
- Prepare a cleaning solution by mixing a mild soap with tap water, following the soap manufacturer's concentration instructions. Prepare this solution in a container large enough to fully immerse the device.
- Soak and scrub:
- Soak the device in the cleaning solution container for at least 5 minutes.
- After the soaking period of 5 minutes, scrub the device for at least 15 seconds with a soft-bristled brush, such as a toothbrush or tube brush. Scrub the device under water to avoid dispersal of contaminants into the air.
- After scrubbing, visually check that no dirt residue remains on the device.
- Soak the device in the cleaning solution container for at least 5 minutes.
- Rinse:
- Remove the device from the cleaning solution and rinse it thoroughly under running water for at least 30 seconds.
- Allow the device to air dry.
- Remove the device from the cleaning solution and rinse it thoroughly under running water for at least 30 seconds.
- Prepare a cleaning solution by mixing a mild soap with tap water, following the soap manufacturer's concentration instructions. Prepare this solution in a container large enough to fully immerse the device.
- High-level disinfection:
- Prepare a container of high-level disinfecting solution large enough to fully immerse the device.
-
- Transfer the device to the soaking container. Ensure the device is fully immersed in the disinfecting solution. Soak the device for 15 minutes, or for the time indicated in the disinfecting solution's instructions for use.
- Rinse the device thoroughly in sterile water for 5 minutes.
- Allow to dry.
- Transfer the device to the soaking container. Ensure the device is fully immersed in the disinfecting solution. Soak the device for 15 minutes, or for the time indicated in the disinfecting solution's instructions for use.
- Sterilisation:
-
Sterilization method Exposure temperature Exposure duration Drying time Partial vacuum 134 °C 3 minutes 30 minutes Partial vacuum 132 °C 4 minutes 30 minutes Severity 121 °C 30 minutes 30 minutes
Contraindications
Do not use in case of silicone allergy.Fitting of the pessary should be avoided or postponed in the following cases:
- Abnormal bleeding.
- Abnormal vaginal discharge.
- Presence of genital infection.
- Presence of vaginal ulcerations.
- Endometriosis.
See instructions for use.
Precautions for use
- Do not pull on the cord of the Cube pessary before having released the suction effect it exerts on the vaginal wall. The patient risks hurting herself or even injuring herself, and the cord risks breaking; to avoid this.
- Use only water-based lubricating gel in contact with the pessary. Other lubricating gels (silicone-based, oil-based or petroleum jelly-based) are likely to damage the pessary.
- Clean the pessary before first use (it is covered with a thin layer of food-grade powder when new). Clean it as regularly as possible.
- Sizes 11, 12 and 13 of the Ring pessary and of the Ring pessary with support contain a metal rod. They must be removed before an X-ray or an MRI.
ADMINISTRATIVE INFORMATION
LPPR rate:
Medical device of class IIa (cube) or IIb (ring, ring with support, urethral dish, urethral dish with support, donut, Gellhorn).| LPPR rate and public price: | 45,84 euros (LPPR code 6158392). |
| Prescribing and use conditions: | |
| The prescription of a pessary is carried out either by a physician, a midwife, a physiotherapist, or an advanced practice nurse, trained in the management of prolapse and urinary incontinence. | |
| Before prescription, a trial period, extending until validation of the pessary that suits the patient, must allow the most suitable size and/or shape for the patient to be determined. To this end, trial kits (including different shapes and sizes) are made available to prescribers by operators or retail distributors. | |
| The prescription specifies the shape and size of the prescribed device. Close follow-up during the trial period is essential; a consultation must be carried out within a maximum of 4 to 6 weeks after the start of use of a new pessary. | |
| Indications for coverage: | |
| Coverage is provided for the following indications: | |
| - genital prolapse, regardless of stage; | |
| - stress urinary incontinence, in particular when associated prolapse exists, for patients at very high surgical risk or who refuse surgery or as a waiting solution before surgery. | |
| Conditions for renewal of coverage: | |
| The renewal of coverage for a pessary cannot occur before a minimum period of 2 years. In accordance with the provisions of article R. 165-24, the renewal of the product may take place before the period of 2 years if the latter is out of service, recognised as irreparable or unsuitable for the patient. | |
CE marking 0086 (93/42/EEC as amended by directive 2007/47/EC).
Manufacturer: CooperSurgical, Inc., 75 Corporate Drive, Trumbull, CT 06611, USA.
GAYA
10, rue de Penthièvre. 75008 Paris
Tel: 01 84 60 24 22
E-mail: contact@gaya-women.com
www.mylittlepessaire.com
Source: VIDAL · Updated on 11/11/2026. This information does not replace advice from a healthcare professional.