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 HHN) 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.