An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel; the shell surface is smooth. The implant may vary in shape
| Company | Devices | Share |
|---|---|---|
| Allergan, Inc. | 397 | 43% |
| Mentor Texas L.P. | 217 | 23% |
| Establishment Labs S.A. | 162 | 17% |
| Sientra, Inc. | 150 | 16% |
Company = labeler of record on GUDID. 4 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 |
|---|---|---|
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Fi | 749 |
| FTR | Prosthesis, breast, noninflatable, internal, silicone gel-fi | 230 |
| MRD | Mammary sizer | 6 |
Use these as the dimensions to specify in a tender line.
926 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Silicone gel-filled breast implant, smooth-surface", from 4 companies. The largest labeler is Allergan, Inc. with 43% of records.
FTR (Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Fi), FTR (Prosthesis, breast, noninflatable, internal, silicone gel-fi), MRD (Mammary sizer)
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.