Are Silicone Pessaries Safe? Complete Side-Effects and Safety Guide (2026)
Are silicone pessaries safe? Complete side-effects and safety guide
Silicone ring pessaries have decades of real-world safety data and are recommended as first-line non-surgical treatment for pelvic organ prolapse by ACOG (Practice Bulletin 214) and AUGS. This guide covers what's common, what's rare, when to call your provider, and how to keep long-term use safe.
Direct answer: yes, silicone ring pessaries are safe
A silicone ring pessary is an FDA-cleared Class II medical device (HCPCS A4562, FDA Product Code HHW) that has been used clinically since the 1950s. Modern medical-grade USP Class VI silicone is well-tolerated by the vaginal tissue, latex-free, BPA-free, and does not release systemic hormones or medications. Nothing in the device is absorbed into your bloodstream.
Peer-reviewed data supports safety at both short-term and long-term horizons. The 2024 TOPSY randomized controlled trial (NCBI Bookshelf NBK603994) evaluated patient self-management of silicone pessaries and found that patients who cleaned and re-inserted their own devices had comparable safety outcomes to those managed in clinic — supporting the modern self-management model.
Common side effects (most patients experience one or more)
Vaginal discharge
Common · 40–60%A small amount of clear or milky discharge is normal, especially in the first few weeks. The pessary slightly increases baseline vaginal secretions. This is not an infection.
Mild odor
Common · 20–35%Some patients notice a mild musky odor that improves with regular removal + cleaning.
Mild pressure sensation or awareness
Common · 15–25% in first 2 weeksYou may feel the pessary during the first few days as your vaginal tissue accommodates. This usually resolves within 1–2 weeks.
Difficulty removing at first
Common · 10–20% in first monthLearning to remove the pessary at home takes practice.
Uncommon but manageable side effects
Bacterial vaginosis or recurrent yeast
Uncommon · 5–10%Some patients develop recurrent BV or yeast, particularly post-menopausal patients.
Constipation or bowel-emptying difficulty
Uncommon · 4–8%Occasionally the pessary shifts and creates mild pressure on the rectum.
Urinary changes — new incontinence or difficulty voiding
Uncommon · 3–7%Some patients notice new stress incontinence AFTER inserting a pessary ("occult" incontinence). Others may struggle to empty their bladder.
Rare but serious complications (seek care)
Vaginal wall erosion or ulceration
Rare · 1–3% at 5+ yearsProlonged pressure from a poorly-fit or infrequently-cleaned pessary can erode the vaginal mucosa. Post-menopausal patients on no topical estrogen are at higher risk.
Embedded pessary
Rare · <1% at 5+ yearsA pessary left in place for many years without removal can become embedded in vaginal tissue. Almost always caused by patients who stop follow-up care.
Urinary retention
Rare · 1–3% at initial fittingA too-large pessary can compress the urethra and prevent bladder emptying.
Fistula (extremely rare)
Very rare · <0.1%A vaginal fistula from a neglected embedded pessary. Nearly always the consequence of years of neglect.
Signs everything is going right
Signs to remove and call your provider
- Persistent pelvic or vaginal pain
- Heavy or unusual vaginal bleeding
- Foul-smelling discharge
- Fever >100.4°F
- Inability to empty your bladder
- Persistent constipation
- Skin irritation or new sores
- New pelvic pressure
Contraindications — when NOT to use a pessary
- Active vaginal or pelvic infection
- Unexplained vaginal bleeding
- Vaginal ulceration or open sores
- Unwilling or unable to attend follow-up appointments — single biggest predictor of complications
- Severe vaginal atrophy without topical estrogen
Long-term safety data
Silicone ring pessaries have been in clinical use since roughly the 1950s. Modern USP Class VI medical-grade silicone has been standard since the 1980s. Main long-term safety concerns — erosion, embedded devices, fistula — are almost always the consequence of stopping follow-up care, not device failure.
The 2024 TOPSY RCT specifically evaluated patient-managed silicone pessaries and found the safety profile comparable to clinic-managed care.
Frequently asked questions
Is a silicone pessary safe to wear during sex?
A ring pessary without support can typically be worn during intercourse without removal. A ring with support membrane usually needs to be removed before sex.
Can I sleep with a pessary in?
Yes. Continuous wear including sleeping is normal.
Can I exercise, run, or swim with a pessary in?
Yes to all three. Chlorine and ocean water do not affect the silicone.
What if the pessary shifts or falls out?
Occasional shifting is normal. Consistent falling out → size is too small, return for a re-size. See our troubleshooting guide.
How often should I remove and clean the pessary?
Follow your provider's guidance. Common intervals: weekly, monthly, or every 3 months. The 2024 TOPSY RCT supports weekly patient self-management.
Is a pessary safe during pregnancy?
A pessary is sometimes used during pregnancy — only under provider direction. Do not self-fit during pregnancy.
Can a pessary affect my Pap smear?
The pessary is removed before Pap smear and re-inserted afterward. Does not affect results.
Is a pessary safe with an IUD?
Yes. Different anatomical planes, no interaction.
Any medications that interact with a pessary?
No. Silicone is inert. All medications are safe with a pessary in place.
Persistent odor or discharge — what should I do?
Persistent strong odor or unusual discharge warrants a same-week provider visit for BV or yeast culture.
How long can I safely use the same silicone pessary?
Typically 12–24 months. Replacement cost: $49.99 direct.
Is there any cancer risk from pessary use?
No. No established link between pessary use and cancer. Silicone is chemically inert.
📖 Related reading
Pessary side effects
The most common pessary side effects are increased vaginal discharge, mild irritation, and odor if the ring is not cleaned often enough. Less common side effects include spotting, discomfort during fitting while you find the right size, and urinary changes in the first days of wear. Serious complications are rare with a correctly fitted silicone ring, and most side effects resolve with a size change, a better cleaning routine, or a short break from wear.
Risks of a pessary
The main risks of a pessary come from neglecting it: a ring left in for months without removal or cleaning can cause vaginal erosion, infection, or, in rare cases, embedding in the vaginal wall. These risks are why a ring pessary should be removed and cleaned regularly and checked by a clinician periodically if you do not self-manage. For women who clean and check their ring routinely, a silicone ring pessary is considered a low-risk, reversible alternative to prolapse surgery.