Devices › Prosthesis, breast, noninflatable, internal, silicone gel-filled
Device brand name · Mammary implant
Gel-Filled Mammary Implant: medical device reports filed with FDA
165 reports name it, 1994–1998. Manufacturer given most often on reports: Dow Corning. Product code FTR.
- 165
- device reports naming the brand
- 0% of all MAUDE reports · about 5 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 1.2%
- classified as malfunction
- 1.6% across the product code
- 0.6%
- classified as death, as reported
- 1 reports · not verified by FDA
165 medical device reports received by FDA name the brand "Gel-Filled Mammary Implant" (mammary implant); the manufacturer given most often on reports is Dow Corning; received from February 1994 to September 1998. 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 (86.1%), malfunction (1.2%) and death (0.6%); 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 rupture, cause unknown (33.9%), explanted (26.1%) and gel leak (20.6%). The patient problems coded most often are pain, surgical procedure and fatigue. 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 Gel-Filled Mammary Implant was received in the five years to August 2026; the latest was received in September 1998.
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 |
|---|---|---|---|
| Rupture, cause unknown | 56 | 33.9% | 1.3% |
| Explanted | 43 | 26.1% | 1.7% |
| Gel leak | 34 | 20.6% | 1.9% |
| Leak/splashthe device leaked | 9 | 5.5% | 0.3% |
| Material perforation | 8 | 4.8% | 0% |
| Implant, removal of | 7 | 4.2% | 0.4% |
| Reactiona reaction, type not specified | 7 | 4.2% | 0.1% |
| Replace | 7 | 4.2% | 0.4% |
| Material rupture | 3 | 1.8% | 42.7% |
| Migration or expulsion of device | 3 | 1.8% | 0.2% |
| Device, or device fragments remain in patient | 2 | 1.2% | 0% |
| Material disintegration | 2 | 1.2% | 0% |
| Rupture due to trauma | 2 | 1.2% | 0% |
| Disconnection | 1 | 0.6% | 0% |
| Hole in material | 1 | 0.6% | 0% |
| Rupture due to capsulotomy | 1 | 0.6% | 0% |
| Tears, rips, holes in device, device material | 1 | 0.6% | 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 |
|---|---|---|
| Painpain, site not specified | 75 | 45.5% |
| Surgical procedure | 65 | 39.4% |
| Fatiguetiredness | 55 | 33.3% |
| Memory loss/impairment | 48 | 29.1% |
| Capsular contracturescar tissue tightening around an implant | 34 | 20.6% |
| Headachehead pain | 31 | 18.8% |
| Rashskin rash | 30 | 18.2% |
| Arthritis | 28 | 17% |
| Connective tissue disease | 26 | 15.8% |
| Fibromyositis | 24 | 14.5% |
| Swellingswelling | 21 | 12.7% |
| Hair loss | 18 | 10.9% |
| Neurological deficit/dysfunction | 18 | 10.9% |
| Disability | 17 | 10.3% |
| Emotional changes | 17 | 10.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Gel-Filled Mammary Implant | Product code FTR | All MAUDE reports |
|---|---|---|---|
| Reports | 165 | 231,877 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 6 | 1 | 9 |
| Classified as injury | 86.1% | 97.7% | 36.2% |
| Classified as malfunction | 1.2% | 1.6% | 62.3% |
| Filed by the manufacturer | 13.3% | 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% |
| UNK Gel Breast Implant | 5,302 | 782 | 0.4% |
| 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% |
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 Gel-Filled Mammary Implant reports
How many FDA reports name Gel-Filled Mammary Implant?
165 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 (86.1%), malfunction (1.2%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
rupture, cause unknown (33.9%), explanted (26.1%), gel leak (20.6%), leak/splash (5.5%) and material perforation (4.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
voluntary reports (84.8%) and manufacturer reports (13.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Gel-Filled Mammary 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.