FDASeptember 30, 2021device
MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available with SILTEX Textur...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.
What to do
FDA enforcement status: Ongoing
Brands named
mentor texas lpmentormentor texas
UPCs
813170011719528016955822381317001195813170012018131700121881317001225813170012328131700124981317001256813170012638131700127081317001287
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)2026-02-18
- FDAArtoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc2026-02-18
- FDACPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc2026-02-18
- FDAArtoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,2026-02-18
- FDACPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc2026-02-18
- FDAArtoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc2026-02-18
- FDACPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc2026-02-18
- CPSCNazzaro Recalls Children Bowling Pin Sipper Cups Due to Risk of Lead Poisoning; Violation of Federal Lead Content Ban2025-02-20
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