CooperSurgical Milex® Pessaries

CooperSurgical Milex Pessaries are vaginal devices made of liquid silicone intended to provide nonsurgical support to pelvic organs. Three pessary styles are included: Shaatz (for Stage I–II prolapse with mild cystocele), Gellhorn (for Stage III prolapse or procidentia), and Ring Folding (for uterine prolapse, cystocele, rectocele, and stress urinary incontinence).

The Milex pessaries are manufactured from liquid silicone and available in multiple shapes and sizes via injection molding. Size ranges are slightly larger than the predicate (Shaatz and Gellhorn: 1.50–3.75 inches; Ring: 1.75–4.25 inches). The liquid silicone formulation and colorant may differ from the predicate, but these differences do not raise safety or effectiveness concerns.

ISO 10993 biocompatibility standards including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021), irritation (ISO 10993-23:2021), subacute/subchronic toxicity (ISO 10993-11:2017, 10993-6:2016), pyrogenicity (ISO 10993-11:2017), acute toxicity (ISO 10993-11:2017), genotoxicity (ISO 10993-3:2014, 10993-33:2015, 10993-11:2017), implantation (ISO 10993-6:2016), and chronic toxicity (ISO 10993-6:2016, 10993-11:2017).

The Milex pessaries share identical intended use and fundamental scientific principle with the predicate (Mentor EvaCare Vaginal Pessaries, K993308): both are removable vaginal structures providing nonsurgical pelvic organ support. Both are manufactured from silicone in multiple shapes and sizes. The broader range of indications and additional pessary shapes in this submission are supported by reference devices (K231786, K132313), demonstrating these are not novel uses. Minor differences in sizing and material formulation do not raise new safety or effectiveness questions, supported by comprehensive biocompatibility testing showing non-cytotoxic, non-sensitizing, and non-irritant properties.