Devices › Prosthesis, breast, inflatable, internal, saline
Device brand name · Prosthesis breast inflatable internal saline
MENTOR Smooth Round High Profile: medical device reports filed with FDA
4,432 reports name it, 2018–2026. Manufacturer given most often on reports: Mentor Texas. Product code FWM.
- 4,432
- device reports naming the brand
- 0% of all MAUDE reports · about 522 a year
- 337
- reports, 12 months to August 2026
- 370 in the 12 months before
- 1.7%
- classified as malfunction
- 2.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 4,432 reports that name the brand "MENTOR Smooth Round High Profile" (prosthesis breast inflatable internal saline), received between January 2018 and August 2026; the manufacturer given most often on reports is Mentor Texas. Spellings of one product vary from report to report.
337 reports arrived in the 12 months to August 2026, close to the 370 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (98.3%) and malfunction (1.7%); across all prosthesis, breast, inflatable, internal, saline reports (product code FWM) death is recorded in 0.1% and malfunction in 2.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material rupture (60.6%), migration (2.2%) and connection problem (0.6%). The patient problems coded most often are deformity/ disfigurement, capsular contracture and appropriate clinical signs, symptoms and conditions term/code not available. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 118,312 reports carrying product code FWM. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Material rupture | 2,685 | 60.6% | 31.3% |
| Migrationthe device moved from where it was placed | 99 | 2.2% | 1% |
| Connection problema connection problem | 25 | 0.6% | 0.1% |
| Off-label use | 25 | 0.6% | 0.1% |
| Deflation problem | 19 | 0.4% | 1.3% |
| Microbial contamination of device | 15 | 0.3% | 0.1% |
| Migration or expulsion of device | 12 | 0.3% | 0.2% |
| Device contamination with chemical or other material | 10 | 0.2% | 0.1% |
| Air/gas in device | 5 | 0.1% | 0% |
| Defective component | 5 | 0.1% | 0% |
| Contamination of device ingredient or reagent | 4 | 0.1% | 0% |
| Breakthe device broke | 3 | 0.1% | 0.1% |
| Contamination /decontamination problem | 3 | 0.1% | 0% |
| Insufficient device problem information | 2 | 0% | 0.5% |
| Material deformation | 2 | 0% | 0% |
| Material discolored | 2 | 0% | 0% |
| Short fill | 2 | 0% | 0% |
| Unsealed device packaging | 2 | 0% | 0% |
| Filling problem | 1 | 0% | 0% |
| Fluid/blood leak | 1 | 0% | 36.8% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Deformity/ disfigurement | 1,431 | 32.3% |
| Capsular contracturescar tissue tightening around an implant | 1,011 | 22.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 261 | 5.9% |
| Painpain, site not specified | 244 | 5.5% |
| Breast discomfort/pain | 185 | 4.2% |
| Wrinkling | 93 | 2.1% |
| Autoimmune reaction | 86 | 1.9% |
| Autoimmune disorder | 71 | 1.6% |
| Breast mass | 70 | 1.6% |
| Local reaction | 54 | 1.2% |
| Post operative wound infection | 37 | 0.8% |
| Paresthesia | 32 | 0.7% |
| Cyst(s) | 27 | 0.6% |
| Injurya physical injury | 27 | 0.6% |
| Cancer | 21 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | MENTOR Smooth Round High Profile | Product code FWM | All MAUDE reports |
|---|---|---|---|
| Reports | 4,432 | 118,312 | 26,136,888 |
| Share of that pool | — | 3.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 98.3% | 95.1% | 36.2% |
| Classified as malfunction | 1.7% | 2.3% | 62.3% |
| Filed by the manufacturer | 100% | 92.9% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code FWM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Style 68 Saline Filled Breast Implant | 36,336 | 3,064 | 0% |
| MENTOR Smooth Round Moderate Profile | 16,263 | 1,082 | 0% |
| UNK Mammary Implant | 14,425 | 1,887 | 0.2% |
| MENTOR Smooth Round Moderate Plus Profile | 6,562 | 535 | 0% |
| UNK Saline Implant | 6,336 | 671 | 0% |
| Unknown Saline Implants | 5,897 | 292 | 0% |
| Style 168 Saline Filled Breast Implant | 3,917 | 318 | 0.1% |
| Style 468 Saline Filled Breast Implant | 2,391 | 176 | 0.1% |
| MENTOR SILTEX Round Moderate Profile | 2,325 | 85 | 0% |
| Ideal Implant Structured Breast Implant | 1,547 | 0 | 0% |
| Pip Inc | 1,295 | 0 | 0% |
| Unknown Saline Implants Smooth | 999 | 98 | 0% |
| Hutchison | 987 | 0 | 0.1% |
| MENTOR Smooth Round SPECTRUM | 901 | 52 | 0% |
| Mentor | 788 | 0 | 0.1% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about MENTOR Smooth Round High Profile reports
How many FDA reports name MENTOR Smooth Round High Profile?
4,432 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 337 in the latest 12 months.
What kinds of events are reported?
injury (98.3%) and malfunction (1.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material rupture (60.6%), migration (2.2%), connection problem (0.6%), off-label use (0.6%) and deflation problem (0.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that MENTOR Smooth Round High Profile was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.