Devices › Prosthesis, breast, noninflatable, internal, silicone gel-filled
Device brand name · Prosthesis breast noninflatable internal silicone gel-filled
UNK Gel Breast Implant: medical device reports filed with FDA
5,302 reports name it, 2011–2026. Manufacturer given most often on reports: Allergan Costa Rica. Product code FTR.
- 5,302
- device reports naming the brand
- 0% of all MAUDE reports · about 356 a year
- 782
- reports, 12 months to August 2026
- 632 in the 12 months before
- 0.2%
- classified as malfunction
- 1.6% across the product code
- 0.4%
- classified as death, as reported
- 21 reports · not verified by FDA
5,302 medical device reports received by FDA name the brand "UNK Gel Breast Implant" (prosthesis breast noninflatable internal silicone gel-filled); the manufacturer given most often on reports is Allergan Costa Rica; received from August 2011 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
782 reports arrived in the 12 months to August 2026, up 24% from 632 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 (99.4%), death (0.4%) and malfunction (0.2%); across all prosthesis, breast, noninflatable, internal, silicone gel-filled reports (product code FTR) death is recorded in 0.1% and malfunction in 1.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material rupture (66%), device appears to trigger rejection (23.9%) and patient-device incompatibility (9.2%). The patient problems coded most often are failure of implant, capsular contracture and seroma. 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 231,877 reports carrying product code FTR. 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 | 3,499 | 66% | 42.7% |
| Device appears to trigger rejection | 1,269 | 23.9% | 21.6% |
| Patient-device incompatibilitythe device did not suit the patient | 489 | 9.2% | 6.6% |
| Migrationthe device moved from where it was placed | 163 | 3.1% | 2.4% |
| Fluid/blood leak | 65 | 1.2% | 0.2% |
| Malposition of device | 56 | 1.1% | 0.5% |
| Gel leak | 50 | 0.9% | 1.9% |
| Migration or expulsion of device | 25 | 0.5% | 0.2% |
| Insufficient device problem information | 15 | 0.3% | 0.2% |
| Breakthe device broke | 5 | 0.1% | 0.5% |
| Device handling problem | 4 | 0.1% | 0.2% |
| Contamination | 2 | 0% | 0% |
| Deformation due to compressive stress | 2 | 0% | 0% |
| Difficult to open or remove packaging material | 2 | 0% | 0.1% |
| Loss of or failure to bond | 2 | 0% | 0% |
| Off-label use | 2 | 0% | 0.1% |
| Biofilm coating in device | 1 | 0% | 0% |
| Extrusion | 1 | 0% | 0% |
| Material deformation | 1 | 0% | 0.2% |
| Material integrity problema problem with the device material | 1 | 0% | 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 |
|---|---|---|
| Failure of implant | 2,808 | 53% |
| Capsular contracturescar tissue tightening around an implant | 1,734 | 32.7% |
| Seromaa collection of fluid under the skin | 321 | 6.1% |
| Lymphomaa cancer of the lymphatic system | 113 | 2.1% |
| Anaplastic large cell lymphoma | 99 | 1.9% |
| Swollen lymph nodes/glands | 70 | 1.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 45 | 0.8% |
| Breast implant associated anaplastic large cell lymphoma (bia alcl) | 39 | 0.7% |
| Granuloma | 37 | 0.7% |
| Swollen lymph nodes | 37 | 0.7% |
| Breast mass | 35 | 0.7% |
| Wound dehiscencea wound reopened | 24 | 0.5% |
| Necrosisdeath of tissue | 22 | 0.4% |
| Deaththe patient died; cause not stated by this term | 15 | 0.3% |
| Painpain, site not specified | 14 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | UNK Gel Breast Implant | Product code FTR | All MAUDE reports |
|---|---|---|---|
| Reports | 5,302 | 231,877 | 26,136,888 |
| Share of that pool | — | 2.3% | 0% |
| Classified as death, per 1,000 reports | 4 | 1 | 9 |
| Classified as injury | 99.4% | 97.7% | 36.2% |
| Classified as malfunction | 0.2% | 1.6% | 62.3% |
| Filed by the manufacturer | 100% | 95% | 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 FTR
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| MENTOR MemoryGel Breast Implant | 57,771 | 7,708 | 0% |
| Inspira Smooth Silicone Gel Filled Breast Implant | 35,634 | 6,782 | 0% |
| Inspira Textured Silicone Gel Filled Breast Implant | 24,795 | 2,766 | 0% |
| Style 410 Cohesive Silicone Gel Filled Breast Implant | 15,287 | 1,841 | 0.1% |
| Style 15 Silicone Gel Filled Breast Implant | 9,567 | 1,529 | 0.1% |
| Style 20 Silicone Gel Filled Breast Implant | 6,368 | 981 | 0.1% |
| Sientra Silicone Gel Breast Implants | 6,014 | 1,682 | 0% |
| Style 115 Silicone Gel Filled Breast Implant | 5,710 | 546 | 0% |
| Unknown Gel Implants | 5,337 | 703 | 0% |
| MENTOR MemoryGel Xtra Breast Implant | 4,910 | 1,387 | 0% |
| Inspira Smooth Cohesive Silicone Gel Filled Breast Implant | 4,636 | 1,076 | 0% |
| Sientra Opus Silicone Gel Breast Implant | 4,613 | 0 | 0% |
| Style 110 Silicone Gel Filled Breast Implant | 3,364 | 279 | 0% |
| Style 10 Silicone Gel Filled Breast Implant | 3,353 | 479 | 0.1% |
| Style 120 Silicone Gel Filled Breast Implant | 2,881 | 212 | 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 UNK Gel Breast Implant reports
How many FDA reports name UNK Gel Breast Implant?
5,302 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 782 in the latest 12 months.
What kinds of events are reported?
injury (99.4%), death (0.4%) and malfunction (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material rupture (66%), device appears to trigger rejection (23.9%), patient-device incompatibility (9.2%), migration (3.1%) and fluid/blood leak (1.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that UNK Gel Breast Implant 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.