Tissue expander and accessories: medical device reports filed with FDA

5,173 reports carry this product code, 1993–2026; 15 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

5,173
reports with this product code: 0% of all MAUDE reports; 447
reports, 12 months to August 2026: 467 in the 12 months before; 15.5%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code LCJ is FDA's classification for "Tissue expander and accessories" (unknown panel), a class U device. 5,173 medical device reports carry this product code, 0% of the MAUDE database, from July 1993 to August 2026.

447 reports arrived in the 12 months to August 2026, close to the 467 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 (82.4%), malfunction (15.5%) and other (1%). 15 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Unk Tissue Expander	481	63	0%	3.1%
MENTOR CPX 4 Breast Tissue Expander with Suture Tabs	319	37	0%	15%
Unknown Tissue Expanders	315	24	0%	6.6%
ARTOURA Breast Tissue Expander	313	8	0%	9.9%
MENTOR Tissue Expander	215	15	0%	25.1%
Mentor Cpx 4 Breast Tissue Expander	182	4	0%	13.2%
Mcghan	39	0	0%	26.7%
Mentor	31	0	0.1%	30.1%
Motiva Implants	29	1,729	0%	4.6%
Breast Implant	3	97	1.3%	11.4%
Non Mentor Product	3	22	0%	0.5%
MENTOR MemoryGel Breast Implant	2	7,708	0%	1.7%
Unknown Gel Implants	2	703	0%	0.2%
Saline Breast Implant	1	0	1.1%	10.2%
Unknown Mentor Implant	1	16	0%	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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Mentor Texas	2,352	45.5%
Allergan Costa Rica	1,780	34.4%
Mentor	159	3.1%
Allergan	113	2.2%
Mcghan Medical	104	2%
Sientra	87	1.7%
Establishment Labs	72	1.4%
Mentor Worldwide	43	0.8%
B Braun Medical	25	0.5%
Medical Engineering	11	0.2%
Allergan Irvine	10	0.2%
Tiger Aesthetics Medical	9	0.2%
Dow Corning	4	0.1%
Lifecell	2	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.1%4

Injury82.4%4,262

Malfunction15.5%802

Other1%54

Not given1%51

Who filed

Manufacturer report89.1%4,607

Voluntary report5.2%268

User facility report0%0

Distributor report0.1%5

Not given5.7%293

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Material rupture	1,827	35.3%
Fluid/blood leak	802	15.5%
Explanted	217	4.2%
Breakthe device broke	157	3%
Device appears to trigger rejection	144	2.8%
Leak/splashthe device leaked	112	2.2%
Off-label use	104	2%
Deflation, cause unknown	94	1.8%
Patient-device incompatibilitythe device did not suit the patient	90	1.7%
Deflation problem	82	1.6%
Improper or incorrect procedure or method	68	1.3%
Inflation problem	63	1.2%
Insufficient device problem information	63	1.2%
Replace	61	1.2%
Implant, removal of	55	1.1%
Defective devicethe device was defective	52	1%
Migrationthe device moved from where it was placed	50	1%
Device contamination with chemical or other material	45	0.9%
Device handling problem	33	0.6%
Connection problema connection problem	31	0.6%

Questions about tissue expander and accessories reports

What is product code LCJ?

FDA's classification code for "Tissue expander and accessories", class U, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,173 reports through August 2026, 447 of them in the latest 12 months.

Which brands appear most often?

Unk Tissue Expander (481), MENTOR CPX 4 Breast Tissue Expander with Suture Tabs (319), Unknown Tissue Expanders (315), ARTOURA Breast Tissue Expander (313) and MENTOR Tissue Expander (215). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.