Device manufacturer, as written on reports

Allergan Costa Rica: medical device reports filed with FDA

182,554 reports name it as the manufacturer of the device involved, 2011–2026.

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.

182,554
reports naming it as manufacturer: 0.7% of all MAUDE reports; 24,283
reports, 12 months to August 2026: 21,605 in the 12 months before; 0.6%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

182,554 medical device reports received by FDA give Allergan Costa Rica as the manufacturer of the device involved, 0.7% of the MAUDE database, from February 2011 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

24,283 reports arrived in the 12 months to August 2026, up 12% from 21,605 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 (99.4%) and malfunction (0.6%). 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
Style 68 Saline Filled Breast Implant	Prosthesis, breast, inflatable, internal, saline	35,877	3,064	0%
Inspira Smooth Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	35,300	6,782	0%
Inspira Textured Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	24,571	2,766	0%
Style 410 Cohesive Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	15,023	1,841	0.1%
UNK Mammary Implant	Prosthesis, breast, inflatable, internal, saline	12,351	1,887	0.2%
Style 15 Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	9,424	1,529	0.1%
Style 20 Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	6,264	981	0.1%
Style 115 Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	5,672	546	0%
UNK Saline Implant	Prosthesis, breast, inflatable, internal, saline	5,391	671	0%
Inspira Smooth Cohesive Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	4,590	1,076	0%
UNK Gel Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	4,516	782	0.4%
Style 168 Saline Filled Breast Implant	Prosthesis, breast, inflatable, internal, saline	3,835	318	0.1%
Style 10 Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	3,313	479	0.1%
Style 110 Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	3,292	279	0%
Style 120 Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	2,824	212	0.1%
Style 468 Saline Filled Breast Implant	Prosthesis, breast, inflatable, internal, saline	2,335	176	0.1%
Style 45 Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	1,110	176	0%
Style 410 Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	1,013	254	0.2%
Style 40 Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	695	80	0%
CUI Smooth Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	609	78	0%
Unk Tissue Expander	Tissue expander and accessories	436	63	0%
Style 153 Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	321	22	0%
Style 363 Saline Filled Breast Implant	Prosthesis, breast, inflatable, internal, saline	276	12	0.7%
CUI Textured Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	162	46	0%
Orbera Intragastric Balloon	Implant, intragastric for morbid obesity	128	0	1.3%
Lap-Band Ap Adjustable Gastric Banding System Small	Implant, intragastric for morbid obesity	11	0	1.1%
Lap-Band Ap Adjustable Gastric Banding System Standard	Implant, intragastric for morbid obesity	9	0	0.4%
Lap-Band Ap Adjustable Gastric Banding System Large	Implant, intragastric for morbid obesity	8	0	1.1%
Lap-Band Adjustable Gastric Banding System Unk Size	Implant, intragastric for morbid obesity	7	0	2%
Lap-Band Adjustable Gastric Banding System 10 0cm	Implant, intragastric for morbid obesity	5	0	0.4%

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	122,705	67.2%
FWM	Prosthesis, breast, inflatable, internal, saline	60,382	33.1%
LCJ	Tissue expander and accessories	1,780	1%
LTI	Implant, intragastric for morbid obesity	182	0.1%
KDD	Kit, surgical instrument, disposable	2	0%
LMH	Implant, dermal, for aesthetic use	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%67

Injury99.4%181,377

Malfunction0.6%1,110

Other0%0

Not given0%0

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

Questions about Allergan Costa Rica reports

How many FDA device reports name Allergan Costa Rica as manufacturer?

182,554 reports through August 2026, 24,283 of them in the latest 12 months.

Which of its brands appear most often?

Style 68 Saline Filled Breast Implant (35,877), Inspira Smooth Silicone Gel Filled Breast Implant (35,300), Inspira Textured Silicone Gel Filled Breast Implant (24,571), Style 410 Cohesive Silicone Gel Filled Breast Implant (15,023) and UNK Mammary Implant (12,351).

Which device types does it report on?

prosthesis, breast, noninflatable, internal, silicone gel-filled (67.2%), prosthesis, breast, inflatable, internal, saline (33.1%), tissue expander and accessories (1%) and implant, intragastric for morbid obesity (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.