Devices › Prosthesis, breast, inflatable, internal, saline
Device brand name · Breast implant
Mentor: medical device reports filed with FDA
788 reports name it, 1994–2024. Manufacturer given most often on reports: Mentor. Product code FWM.
- 788
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 30.1%
- classified as malfunction
- 2.3% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
788 medical device reports received by FDA name the brand "Mentor" (breast implant); the manufacturer given most often on reports is Mentor; received from February 1994 to August 2024. 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 injury (51.3%), malfunction (30.1%) and other (15.2%); 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 explanted (66.2%), replace (34.1%) and deflation, cause unknown (18.8%). The patient problems coded most often are surgical procedure, surgical procedure, repeated and capsular contracture. 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 |
|---|---|---|---|
| Explanted | 522 | 66.2% | 5.7% |
| Replace | 269 | 34.1% | 2.4% |
| Deflation, cause unknown | 148 | 18.8% | 4% |
| Implant, removal of | 134 | 17% | 0.7% |
| Rupture, cause unknown | 103 | 13.1% | 0.8% |
| Material rupture | 40 | 5.1% | 31.3% |
| Device issuea problem with the device | 33 | 4.2% | 0.2% |
| Leak/splashthe device leaked | 33 | 4.2% | 0.4% |
| Fluid/blood leak | 25 | 3.2% | 36.8% |
| Device remains implanted | 24 | 3% | 0.2% |
| Elective replacement | 22 | 2.8% | 0.1% |
| Deflation problem | 14 | 1.8% | 1.3% |
| Inflation problem | 11 | 1.4% | 0.1% |
| Migration or expulsion of device | 11 | 1.4% | 0.2% |
| Insufficient device problem information | 10 | 1.3% | 0.5% |
| Other (for use when an appropriate device code cannot be identified) | 10 | 1.3% | 0.1% |
| Gel leak | 9 | 1.1% | 0.1% |
| Defective devicethe device was defective | 7 | 0.9% | 0.1% |
| Patient-device incompatibilitythe device did not suit the patient | 7 | 0.9% | 3.9% |
| Tears, rips, holes in device, device material | 7 | 0.9% | 0.1% |
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 | 301 | 38.2% |
| Surgical procedure, repeated | 248 | 31.5% |
| Capsular contracturescar tissue tightening around an implant | 149 | 18.9% |
| Painpain, site not specified | 67 | 8.5% |
| Failure of implant | 60 | 7.6% |
| Hospitalization required | 44 | 5.6% |
| Rupturethe device burst | 43 | 5.5% |
| Therapy/non-surgical treatment, additional | 25 | 3.2% |
| Other (for use when an appropriate patient code cannot be identified) | 23 | 2.9% |
| Disability | 20 | 2.5% |
| Fatiguetiredness | 20 | 2.5% |
| Arthralgiajoint pain | 15 | 1.9% |
| Deformity/ disfigurement | 13 | 1.6% |
| Treatment with medication(s) | 13 | 1.6% |
| Bacterial infectiona bacterial infection | 12 | 1.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Mentor | Product code FWM | All MAUDE reports |
|---|---|---|---|
| Reports | 788 | 118,312 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 1 | 1 | 9 |
| Classified as injury | 51.3% | 95.1% | 36.2% |
| Classified as malfunction | 30.1% | 2.3% | 62.3% |
| Filed by the manufacturer | 1.9% | 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 Mentor reports
How many FDA reports name Mentor?
788 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?
injury (51.3%), malfunction (30.1%) and other (15.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
explanted (66.2%), replace (34.1%), deflation, cause unknown (18.8%), implant, removal of (17%) and rupture, cause unknown (13.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
voluntary reports (52.9%) and manufacturer reports (1.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Mentor 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.