Devices › Tissue expander and accessories
Device brand name · Expander skin inflatable
Unknown Tissue Expanders: medical device reports filed with FDA
320 reports name it, 2018–2026. Manufacturer given most often on reports: Mentor Texas. Product code LCJ.
- 320
- device reports naming the brand
- 0% of all MAUDE reports · about 39 a year
- 24
- reports, 12 months to August 2026
- 25 in the 12 months before
- 6.6%
- classified as malfunction
- 15.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
320 medical device reports received by FDA name the brand "Unknown Tissue Expanders" (expander skin inflatable); the manufacturer given most often on reports is Mentor Texas; received from April 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
24 reports arrived in the 12 months to August 2026, close to the 25 of 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 (93.4%) and malfunction (6.6%); across all tissue expander and accessories reports (product code LCJ) death is recorded in 0.1% and malfunction in 15.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material rupture (52.8%), off-label use (5.3%) and migration (4.7%). The patient problems coded most often are deformity/ disfigurement, post operative wound infection and hematoma. 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 5,173 reports carrying product code LCJ. 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 | 169 | 52.8% | 35.3% |
| Off-label use | 17 | 5.3% | 2% |
| Migrationthe device moved from where it was placed | 15 | 4.7% | 1% |
| Connection problema connection problem | 2 | 0.6% | 0.6% |
| Defective component | 2 | 0.6% | 0.3% |
| Defective devicethe device was defective | 2 | 0.6% | 1% |
| Insufficient device problem information | 2 | 0.6% | 1.2% |
| Component missing | 1 | 0.3% | 0.2% |
| Deflation problem | 1 | 0.3% | 1.6% |
| Filling problem | 1 | 0.3% | 0.4% |
| Inflation problem | 1 | 0.3% | 1.2% |
| Labelling, instructions for use or training problem | 1 | 0.3% | 0.1% |
| Material deformation | 1 | 0.3% | 0.3% |
| Material integrity problema problem with the device material | 1 | 0.3% | 0.1% |
| Peeled/delaminated | 1 | 0.3% | 0.3% |
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 |
|---|---|---|
| Deformity/ disfigurement | 72 | 22.5% |
| Post operative wound infection | 47 | 14.7% |
| Hematomaa collection of blood under the skin or in tissue | 26 | 8.1% |
| Seromaa collection of fluid under the skin | 26 | 8.1% |
| Capsular contracturescar tissue tightening around an implant | 18 | 5.6% |
| Impaired healingslow healing | 17 | 5.3% |
| Painpain, site not specified | 13 | 4.1% |
| Necrosisdeath of tissue | 12 | 3.8% |
| Breast discomfort/pain | 10 | 3.1% |
| Pocket erosion | 9 | 2.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 7 | 2.2% |
| Breast cancerbreast cancer | 6 | 1.9% |
| Wound dehiscencea wound reopened | 6 | 1.9% |
| Local reaction | 5 | 1.6% |
| Autoimmune disorder | 4 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Tissue Expanders | Product code LCJ | All MAUDE reports |
|---|---|---|---|
| Reports | 320 | 5,173 | 26,136,888 |
| Share of that pool | — | 6.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 93.4% | 82.4% | 36.2% |
| Classified as malfunction | 6.6% | 15.5% | 62.3% |
| Filed by the manufacturer | 100% | 89.1% | 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 LCJ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unk Tissue Expander | 481 | 63 | 0% |
| MENTOR CPX 4 Breast Tissue Expander with Suture Tabs | 319 | 37 | 0% |
| ARTOURA Breast Tissue Expander | 314 | 8 | 0% |
| MENTOR Tissue Expander | 215 | 15 | 0% |
| Mentor Cpx 4 Breast Tissue Expander | 182 | 4 | 0% |
| Mcghan | 468 | 0 | 0% |
| Mentor | 788 | 0 | 0.1% |
| Motiva Implants | 2,515 | 1,729 | 0% |
| Breast Implant | 1,136 | 97 | 1.3% |
| Non Mentor Product | 418 | 22 | 0% |
| MENTOR MemoryGel Breast Implant | 57,771 | 7,708 | 0% |
| Unknown Gel Implants | 5,337 | 703 | 0% |
| Saline Breast Implant | 186 | 0 | 1.1% |
| Unknown Mentor Implant | 424 | 16 | 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 Unknown Tissue Expanders reports
How many FDA reports name Unknown Tissue Expanders?
320 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 24 in the latest 12 months.
What kinds of events are reported?
injury (93.4%) and malfunction (6.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material rupture (52.8%), off-label use (5.3%), migration (4.7%), connection problem (0.6%) and defective component (0.6%). 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 Unknown Tissue Expanders 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.