Reported Reactions

Devices › Prosthesis, breast, noninflatable, internal, silicone gel-filled

Device brand name · Ergonomix round silksurface with qid

Motiva Implants: medical device reports filed with FDA

2,515 reports name it, 2024–2026. Manufacturer given most often on reports: Establishment Labs. Product code FTR.

2,515
device reports naming the brand
0% of all MAUDE reports · about 1,210 a year
1,729
reports, 12 months to August 2026
777 in the 12 months before
4.6%
classified as malfunction
1.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

2,515 medical device reports received by FDA name the brand "Motiva Implants" (ergonomix round silksurface with qid); the manufacturer given most often on reports is Establishment Labs; received from June 2024 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

1,729 reports arrived in the 12 months to August 2026, up 123% from 777 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 (95.4%) and malfunction (4.6%); 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 device appears to trigger rejection (56.3%), break (35.1%) and fracture (0.3%). The patient problems coded most often are capsular contracture, breast discomfort/pain and ptosis. 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

090180Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 6Jul 2024: 2Aug 2024: 1Sep 2024: 2Oct 2024: 33Nov 2024: 65Dec 2024: 422025Jan 2025: 51Feb 2025: 55Mar 2025: 68Apr 2025: 76May 2025: 103Jun 2025: 95Jul 2025: 83Aug 2025: 104Sep 2025: 129Oct 2025: 175Nov 2025: 133Dec 2025: 1802026Jan 2026: 119Feb 2026: 162Mar 2026: 158Apr 2026: 116May 2026: 156Jun 2026: 124Jul 2026: 146Aug 2026: 131

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

06261,2522024: 15120242025: 1,25220252026: 1,1122026

Event type and report source

Event type, as classified on the report

Death0%0
Injury95.4%2,400
Malfunction4.6%115
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%2,515
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Device appears to trigger rejection1,41656.3%21.6%
Breakthe device broke88435.1%0.5%
Fracturea broken bone80.3%0%
Loss of or failure to bond80.3%0%
Device slipped70.3%0%
Unintended movement70.3%0%
Gel leak60.2%1.9%
Insufficient device problem information60.2%0.2%
Leak/splashthe device leaked50.2%0.3%
Material discolored40.2%0.1%
Patient-device incompatibilitythe device did not suit the patient40.2%6.6%
Device handling problem20.1%0.2%
Malposition of device20.1%0.5%
Mechanical problema mechanical problem20.1%0%
Migration or expulsion of device20.1%0.2%
Communication or transmission problemthe device could not communicate or transmit10%0%
Crackthe device cracked10%0%
Deflation problem10%0%
Filling problem10%0%
Filtration problem10%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)ReportsShare
Capsular contracturescar tissue tightening around an implant1,40755.9%
Breast discomfort/pain31812.6%
Ptosis1475.8%
Seromaa collection of fluid under the skin1124.5%
Physical asymmetry692.7%
Impaired healingslow healing672.7%
Wound dehiscencea wound reopened582.3%
Deformity/ disfigurement491.9%
Failure of implant461.8%
Wrinkling401.6%
Hematomaa collection of blood under the skin or in tissue341.4%
Swollen lymph nodes/glands321.3%
Rupturethe device burst281.1%
Discomfortdiscomfort180.7%
Implant pain170.7%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureMotiva ImplantsProduct code FTRAll MAUDE reports
Reports2,515231,87726,136,888
Share of that pool—1.1%0%
Classified as death, per 1,000 reports019
Classified as injury95.4%97.7%36.2%
Classified as malfunction4.6%1.6%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
MENTOR MemoryGel Breast Implant57,7717,7080%
Inspira Smooth Silicone Gel Filled Breast Implant35,6346,7820%
Inspira Textured Silicone Gel Filled Breast Implant24,7952,7660%
Style 410 Cohesive Silicone Gel Filled Breast Implant15,2871,8410.1%
Style 15 Silicone Gel Filled Breast Implant9,5671,5290.1%
Style 20 Silicone Gel Filled Breast Implant6,3689810.1%
Sientra Silicone Gel Breast Implants6,0141,6820%
Style 115 Silicone Gel Filled Breast Implant5,7105460%
Unknown Gel Implants5,3377030%
UNK Gel Breast Implant5,3027820.4%
MENTOR MemoryGel Xtra Breast Implant4,9101,3870%
Inspira Smooth Cohesive Silicone Gel Filled Breast Implant4,6361,0760%
Sientra Opus Silicone Gel Breast Implant4,61300%
Style 110 Silicone Gel Filled Breast Implant3,3642790%
Style 10 Silicone Gel Filled Breast Implant3,3534790.1%

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 Motiva Implants reports

How many FDA reports name Motiva Implants?

2,515 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,729 in the latest 12 months.

What kinds of events are reported?

injury (95.4%) and malfunction (4.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device appears to trigger rejection (56.3%), break (35.1%), fracture (0.3%), loss of or failure to bond (0.3%) and device slipped (0.3%). 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 Motiva Implants 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.