Reported signals
prosthesis, breast, noninflatable, internal, silicone gel-filled
Registration status unknownMedical devicealgemeen
193,293
reports (FAERS)
98.9%
reported as serious
48
fatal reports (0.0%)
0
signals above threshold
2026-07
last updated
Signal ranking · ROR
What stands out in the reports.
No disproportionate signals with sufficient data to plot. This may indicate the substance has too few reports, or that reported effects are in line with background rates.
Interpretation
Summary not yet available — will be auto-generated.
Label versus report
On the label
No signals currently mapped to the label.
Newly reported
No novel signals above threshold.
Recall history · 0 on record
No recalls on record.
Compare within ALGEMEEN
implant
Reports3,932,418
Compare with prosthesis, breast, noninflatable, internal, silicone gel-filled →
minoxidil foam 5% (womens)
Reports3,436,075
Compare with prosthesis, breast, noninflatable, internal, silicone gel-filled →
dental implant
Reports3,208,206
Compare with prosthesis, breast, noninflatable, internal, silicone gel-filled →
Source & citation
HealthProves. prosthesis, breast, noninflatable, internal, silicone gel-filled — reported signals. Retrieved 2026-07-05. Source: openFDA (FAERS). healthproves.com/prosthesis-breast-noninflatable-internal-silicone-gel-filled/
MAUDE193,293 records
Retrieved2026-07-05
MethodROR / disproportionality