Device manufacturer, as written on reports

Mentor Texas: medical device reports filed with FDA

118,706 reports name it as the manufacturer of the device involved, 1998–2026.

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.

118,706
reports naming it as manufacturer: 0.5% of all MAUDE reports; 14,322
reports, 12 months to August 2026: 14,511 in the 12 months before; 1.9%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

118,706 medical device reports received by FDA give Mentor Texas as the manufacturer of the device involved, 0.5% of the MAUDE database, from April 1998 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

14,322 reports arrived in the 12 months to August 2026, close to the 14,511 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 (98.1%) and malfunction (1.9%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
MENTOR MemoryGel Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	57,375	7,708	0%
MENTOR Smooth Round Moderate Profile	Prosthesis, breast, inflatable, internal, saline	16,092	1,082	0%
MENTOR Smooth Round Moderate Plus Profile	Prosthesis, breast, inflatable, internal, saline	6,497	535	0%
Unknown Saline Implants	Prosthesis, breast, inflatable, internal, saline	5,820	292	0%
Unknown Gel Implants	Prosthesis, breast, noninflatable, internal, silicone gel-filled	5,297	703	0%
MENTOR MemoryGel Xtra Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	4,853	1,387	0%
MENTOR Smooth Round High Profile	Prosthesis, breast, inflatable, internal, saline	4,370	337	0%
MENTOR SILTEX Round Moderate Profile	Prosthesis, breast, inflatable, internal, saline	2,285	85	0%
MENTOR MemoryShape Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	1,646	170	0%
MENTOR MemoryGel BOOST Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	1,427	599	0%
Unknown Saline Implants Smooth	Prosthesis, breast, inflatable, internal, saline	982	98	0%
MENTOR Smooth Round SPECTRUM	Prosthesis, breast, inflatable, internal, saline	890	52	0%
Unknown Gel Implants Smooth	Prosthesis, breast, noninflatable, internal, silicone gel-filled	658	75	0%
Unknown Mentor Gel Implants	Prosthesis, breast, noninflatable, internal, silicone gel-filled	541	134	0%
Unknown Saline Implants Textured	Prosthesis, breast, inflatable, internal, saline	408	31	0%
Non Mentor Product	Prosthesis, breast, inflatable, internal, saline	403	22	0%
Unknown Mentor Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	394	16	0%
Unknown Gel Breast Prosthesis	Prosthesis, breast, noninflatable, internal, silicone gel-filled	380	127	0%
Unknown Gel Implants Textured	Prosthesis, breast, noninflatable, internal, silicone gel-filled	374	30	0%
Unknown Mentor Saline Implants	Prosthesis, breast, inflatable, internal, saline	371	74	0%
MENTOR CPX 4 Breast Tissue Expander with Suture Tabs	Tissue expander and accessories	314	37	0%
Unknown Mentor	Prosthesis, breast, noninflatable, internal, silicone gel-filled	304	0	0%
Unknown Tissue Expanders	Tissue expander and accessories	287	24	0%
Unknown Saline Breast Prosthesis	Prosthesis, breast, inflatable, internal, saline	285	56	0%
ARTOURA Breast Tissue Expander	Tissue expander and accessories	284	8	0%
MENTOR Tissue Expander	Tissue expander and accessories	193	15	0%
Unknown Saline Implant	Prosthesis, breast, inflatable, internal, saline	171	19	0%
Mentor Cpx 4 Breast Tissue Expander	Tissue expander and accessories	170	4	0%
MENTOR SILTEX CONTOUR PROFILE High	Prosthesis, breast, inflatable, internal, saline	163	7	0%
MENTOR SILTEX CONTOUR PROFILE Moderate	Prosthesis, breast, inflatable, internal, saline	112	10	0%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
FTR	Prosthesis, breast, noninflatable, internal, silicone gel-filled	76,120	64.1%
FWM	Prosthesis, breast, inflatable, internal, saline	40,213	33.9%
LCJ	Tissue expander and accessories	2,352	2%
MUU	System, suction, lipoplasty	100	0.1%
OTN	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	16	0%
FTL	Mesh, surgical, polymeric	12	0%
FTM	Mesh, surgical	3	0%
LEI	Implant, anti-gastroesophageal reflux	2	0%
FHW	Device, impotence, mechanical/hydraulic	1	0%
FMF	Syringe, piston	1	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

Death0%0

Injury98.1%116,452

Malfunction1.9%2,235

Other0%16

Not given0%3

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Mentor Texas reports

How many FDA device reports name Mentor Texas as manufacturer?

118,706 reports through August 2026, 14,322 of them in the latest 12 months.

Which of its brands appear most often?

MENTOR MemoryGel Breast Implant (57,375), MENTOR Smooth Round Moderate Profile (16,092), MENTOR Smooth Round Moderate Plus Profile (6,497), Unknown Saline Implants (5,820) and Unknown Gel Implants (5,297).

Which device types does it report on?

prosthesis, breast, noninflatable, internal, silicone gel-filled (64.1%), prosthesis, breast, inflatable, internal, saline (33.9%), tissue expander and accessories (2%) and system, suction, lipoplasty (0.1%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.