Silicone Gellhorn Pessary Waitlist — Coming Q1 2027 for Stage 3-4 Prolapse
Silicone Gellhorn Pessary — the missing option for stage 3-4 prolapse
The first US silicone Gellhorn pessary for advanced pelvic organ prolapse — priced direct-to-patient, no prescription required. Join the waitlist for early-access pricing at launch.
Join the Waitlist →Only your email is required. First-1000 waitlist members get 20% off launch price.
Ring pessaries work for most people with stage I-II prolapse. But if you have stage 3 or stage 4 uterovaginal prolapse — the kind where the ring keeps slipping out, or your uterus prolapses past the vaginal opening — the ring isn't enough. Your gynecologist has probably said Gellhorn pessary or cube pessary, and then handed you a prescription for a Milex or Bioteque device that costs $80-$150 through their distributor channel, requires a fitting visit, and comes in PVC — the older, less comfortable material.
We're building the first US medical-grade silicone Gellhorn — direct-to-patient at a fraction of the traditional distributor price, following the same model that made our silicone ring pessary $49.99 direct (vs $80-120 through the Rx channel).
Why silicone Gellhorn — why now
The Milex/Bioteque/MedGyn Gellhorn is PVC. Silicone is softer against sensitized tissue, doesn't retain odor, and per the 2024 Int Urogynecol J RCT (DOI 10.1007/s00192-024-05933-x), silicone users self-manage more successfully.
Target launch price: $75-89 direct. Milex Gellhorn through traditional distribution is typically $80-150 + the fitting visit cost. FDA-cleared device, no prescription required for purchase.
Planned sizes 0-7 (32-89 mm plate diameter). Milex offers 8 sizes; we're aligning with the same clinical size distribution and adding a smaller "0" for postmenopausal patients underserved by current options.
Designed with the emerging patient-self-management model in mind (TOPSY RCT, 2024). Removable stem for patient home-removal, insertion instructions video at launch.
Who this is for
- Stage 3-4 uterovaginal prolapse where a ring pessary keeps slipping out or dislodging
- Post-hysterectomy vaginal vault prolapse with significant descent past the hymen
- Patients whose gynecologist has specifically recommended a Gellhorn or space-filling pessary
- Anyone currently using a Milex or Bioteque PVC Gellhorn looking for a softer silicone alternative
- Patients who want the direct-to-patient purchase model instead of Rx + distributor + insurance pre-auth
How SciMed's silicone Gellhorn will compare
| Feature | Milex Gellhorn (PVC) | Bioteque Gellhorn (PVC) | SciMed Silicone Gellhorn (Q1 2027) |
|---|---|---|---|
| Material | PVC | PVC (silicone available in some regions) | 100% USP Class VI medical silicone |
| Prescription required | Yes (via distributor) | Yes (via distributor) | No — direct to patient |
| Direct patient purchase | No | No | Yes (via scimedstore.com) |
| Typical patient cost | $80-150 + fitting | $60-95 + fitting | Target $75-89, no fitting-visit gate |
| Size range | 2 in / 51 mm to 3.75 in / 95 mm | Similar range | Planned 32-89 mm (US 0-7) |
| Stem for removal | Yes | Yes | Yes — patient-self-removal friendly |
| HSA/FSA eligible (HCPCS A4562) | Yes | Yes | Yes — receipt lists A4562 |
| Waitlist early-access discount | — | — | 20% off launch price (first 1000) |
Launch timeline
Collecting waitlist signups + provider input to validate the size distribution and pricing target before committing production tooling.
3 prototype sizes distributed to a small panel of urogynecologists + pelvic PTs for fit and feedback. Waitlist members invited to the beta panel.
Filing under the same predicate device pathway as our silicone ring pessary (FDA Product Code HHN, 21 CFR 884.5350).
Waitlist members get 20% off launch price + first shipment priority. Full public launch shortly after.
Reserve your spot on the Silicone Gellhorn waitlist
Free to join. Only your email is required. First 1000 waitlist members get 20% off launch price + first shipment priority.
Email sales@scimedstore.com → Join WaitlistWe'll email you (max 1x per quarter) with development updates + a launch-day notification. Unsubscribe anytime.
Frequently asked questions
What's the difference between a ring and a Gellhorn pessary?
A ring pessary (with or without support) provides mild-to-moderate structural support and is the first-line device for stage I-II prolapse. A Gellhorn pessary is a space-filling design — shaped like a disk with a stem — that provides more retention force and is used for stage 3-4 prolapse where a ring dislodges or slips out. Both are FDA Class II silicone (or PVC) devices under HCPCS A4562.
When exactly will the SciMed Silicone Gellhorn be available?
Target launch: Q2 2027. Full timeline: waitlist collection now → Q4 2026 prototype panel → Q1 2027 FDA filing → Q2 2027 first shipments. We'll email waitlist members before public launch.
How much will it cost?
Target launch price: $75-89 per device. Waitlist members (first 1000 signups) get 20% off launch price. Same 30-day return policy as our ring pessary line.
Will it require a prescription?
No. Like our silicone ring pessary, the Gellhorn will be sold direct to patients — FDA Class II device (HCPCS A4562, 21 CFR 884.5350) does not require a prescription. Provider-assisted fitting is strongly recommended for a first Gellhorn but not a legal requirement.
Will it be HSA/FSA and Medicare eligible?
Yes. HCPCS A4562 covers all non-rubber pessaries. Medicare Part B currently reimburses A4562 at $69-$89 depending on region — meaning a Medicare-covered patient may be reimbursed for more than they paid at launch pricing.
Why silicone instead of PVC?
Silicone is softer against sensitized vaginal tissue, does not retain odor, is easier to clean, and per the 2024 Int Urogynecol J RCT (DOI 10.1007/s00192-024-05933-x), silicone pessary users self-manage more successfully than PVC users. Silicone is the modern standard.
What sizes will you offer?
Planned launch sizes: 0-7 (approximately 32-89 mm plate diameter, following the standard Milex-equivalent size chart). If you know your current Gellhorn size, mention it in your waitlist signup so we can validate demand.
What if the ring pessary isn't working for me right now?
Two immediate options: (1) try a larger ring size — many stage 2-3 prolapse patients succeed on our Ring Pessary With Support sizes 7-8. (2) Ask your gynecologist about a current PVC Gellhorn from Milex or Bioteque — they're the only US options right now for advanced prolapse.
Can I be part of the clinical feedback panel?
Yes. Note "provider" or "clinical feedback panel interest" in your waitlist email. Q4 2026 we're distributing 3 prototype sizes to a small panel of urogynecologists + pelvic floor PTs for real-fit feedback before production.
Will there be a Cube pessary too?
The Cube is on our roadmap for after the Gellhorn launches. If you want the Cube specifically, mention it in your waitlist email and we'll track that separately.