An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber outer shell, made of polysiloxane(s), with a single lumen inflated with sterile isotonic saline to the desired size; the shell surface is smooth. The impl
| Company | Devices | Share |
|---|---|---|
| Mentor Texas L.P. | 129 | 70% |
| Allergan, Inc. | 55 | 30% |
Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| FWM | Prosthesis, breast, inflatable, internal, saline | 129 |
| FWM | Prosthesis, Breast, Inflatable, Internal, Saline | 55 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
184 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Saline-filled breast implant, unstructured, smooth-surface ", from 2 companies. The largest labeler is Mentor Texas L.P. with 70% of records.
FWM (Prosthesis, breast, inflatable, internal, saline), FWM (Prosthesis, Breast, Inflatable, Internal, Saline)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.