Devices › Prosthesis, breast, inflatable, internal, saline
Device brand name · Mammary prosthesis
Smooth High Profile Saline Prosthesis: medical device reports filed with FDA
235 reports name it, 2002–2003. Manufacturer given most often on reports: Mentor. Product code FWM.
- 235
- device reports naming the brand
- 0% of all MAUDE reports · about 10 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 6.4%
- classified as malfunction
- 2.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
235 medical device reports received by FDA name the brand "Smooth High Profile Saline Prosthesis" (mammary prosthesis); the manufacturer given most often on reports is Mentor; received from April 2002 to May 2003. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none in 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 other (78.7%), injury (14%) and malfunction (6.4%); 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 deflation, cause unknown (83.4%), explanted (75.3%) and leak/splash (4.3%). The patient problems coded most often are surgical procedure, failure of implant and surgical procedure, additional. 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
No report naming Smooth High Profile Saline Prosthesis was received in the five years to August 2026; the latest was received in May 2003.
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 |
|---|---|---|---|
| Deflation, cause unknown | 196 | 83.4% | 4% |
| Explanted | 177 | 75.3% | 5.7% |
| Leak/splashthe device leaked | 10 | 4.3% | 0.4% |
| Deflation problem | 5 | 2.1% | 1.3% |
| Difficult to insertthe device was hard to insert | 5 | 2.1% | 0% |
| Device remains implanted | 4 | 1.7% | 0.2% |
| Implant, removal of | 4 | 1.7% | 0.7% |
| Other (for use when an appropriate device code cannot be identified) | 4 | 1.7% | 0.1% |
| Tears, rips, holes in device, device material | 4 | 1.7% | 0.1% |
| Defective component | 2 | 0.9% | 0% |
| Device issuea problem with the device | 1 | 0.4% | 0.2% |
| Filling problem | 1 | 0.4% | 0% |
| Foreign material | 1 | 0.4% | 0% |
| Gel leak | 1 | 0.4% | 0.1% |
| Hole in material | 1 | 0.4% | 0.1% |
| Material puncture/hole | 1 | 0.4% | 0% |
| Out-of-box failure | 1 | 0.4% | 0% |
| Valve(s), defective | 1 | 0.4% | 0% |
| Valve(s), failure of | 1 | 0.4% | 0% |
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 |
|---|---|---|
| Surgical procedure | 171 | 72.8% |
| Failure of implant | 10 | 4.3% |
| Surgical procedure, additional | 9 | 3.8% |
| Capsular contracturescar tissue tightening around an implant | 2 | 0.9% |
| Surgical procedure aborted/stopped | 1 | 0.4% |
| Surgical procedure, repeated | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Smooth High Profile Saline Prosthesis | Product code FWM | All MAUDE reports |
|---|---|---|---|
| Reports | 235 | 118,312 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 14% | 95.1% | 36.2% |
| Classified as malfunction | 6.4% | 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% |
| MENTOR Smooth Round High Profile | 4,432 | 337 | 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% |
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 Smooth High Profile Saline Prosthesis reports
How many FDA reports name Smooth High Profile Saline Prosthesis?
235 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
other (78.7%), injury (14%) and malfunction (6.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
deflation, cause unknown (83.4%), explanted (75.3%), leak/splash (4.3%), deflation problem (2.1%) and difficult to insert (2.1%). 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 Smooth High Profile Saline Prosthesis 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.