Devices › Transcervical contraceptive tubal occlusion device
Device brand name · Transcervical contraceptive tubal occlusion device
Essure: medical device reports filed with FDA
74,072 reports name it, 2004–2026. Manufacturer given most often on reports: Bayer Pharma. Product code HHS.
- 74,072
- device reports naming the brand
- 0.3% of all MAUDE reports · about 3,305 a year
- 435
- reports, 12 months to August 2026
- 802 in the 12 months before
- 1.4%
- classified as malfunction
- 1.4% across the product code
- 0.2%
- classified as death, as reported
- 135 reports · not verified by FDA
74,072 medical device reports received by FDA name the brand "Essure" (transcervical contraceptive tubal occlusion device); the manufacturer given most often on reports is Bayer Pharma; received from February 2004 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
435 reports arrived in the 12 months to August 2026, down 46% from 802 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 (97.9%), malfunction (1.4%) and other (0.3%); across all transcervical contraceptive tubal occlusion device reports (product code HHS) death is recorded in 0.2% and malfunction in 1.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (22.9%), patient-device incompatibility (7.5%) and biocompatibility (7.4%). The patient problems coded most often are pain, abdominal pain and heavier menses. 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 74,519 reports carrying product code HHS. 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 |
|---|---|---|---|
| Insufficient device problem information | 16,940 | 22.9% | 22.9% |
| Patient-device incompatibilitythe device did not suit the patient | 5,592 | 7.5% | 7.6% |
| Biocompatibility | 5,468 | 7.4% | 7.3% |
| Device dislodged or dislocated | 5,297 | 7.2% | 7.1% |
| Breakthe device broke | 4,931 | 6.7% | 6.6% |
| Migrationthe device moved from where it was placed | 4,802 | 6.5% | 6.5% |
| Migration or expulsion of device | 3,374 | 4.6% | 4.6% |
| Expulsion | 2,251 | 3% | 3% |
| Device operates differently than expectedthe device behaved unexpectedly | 1,042 | 1.4% | 1.4% |
| Patient device interaction problem | 498 | 0.7% | 0.7% |
| Malposition of device | 417 | 0.6% | 0.6% |
| Difficult to removethe device was hard to remove | 369 | 0.5% | 0.5% |
| Difficult to insertthe device was hard to insert | 359 | 0.5% | 0.5% |
| Mechanical problema mechanical problem | 277 | 0.4% | 0.4% |
| Material integrity problema problem with the device material | 196 | 0.3% | 0.3% |
| Positioning failure | 195 | 0.3% | 0.3% |
| Entrapment of device | 185 | 0.2% | 0.3% |
| Material fragmentation | 164 | 0.2% | 0.2% |
| Fracturea broken bone | 160 | 0.2% | 0.2% |
| Extrusion | 153 | 0.2% | 0.2% |
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 |
|---|---|---|
| Painpain, site not specified | 37,013 | 50% |
| Abdominal painstomach or belly pain | 12,396 | 16.7% |
| Heavier menses | 11,244 | 15.2% |
| Headachehead pain | 8,775 | 11.8% |
| Hemorrhage/blood loss/bleeding | 8,736 | 11.8% |
| Foreign body in patientpart of a device left in the patient | 8,721 | 11.8% |
| Uterine perforationa hole in the wall of the womb | 7,580 | 10.2% |
| Fatiguetiredness | 7,145 | 9.6% |
| Menstrual irregularities | 6,480 | 8.7% |
| Weight changes | 5,974 | 8.1% |
| Hair loss | 4,983 | 6.7% |
| Device embedded in tissue or plaque | 4,646 | 6.3% |
| Depressionlow mood | 3,965 | 5.4% |
| Cramp(s) | 3,172 | 4.3% |
| Hypersensitivity/allergic reaction | 3,124 | 4.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Essure | Product code HHS | All MAUDE reports |
|---|---|---|---|
| Reports | 74,072 | 74,519 | 26,136,888 |
| Share of that pool | — | 99.4% | 0.3% |
| Classified as death, per 1,000 reports | 2 | 2 | 9 |
| Classified as injury | 97.9% | 97.8% | 36.2% |
| Classified as malfunction | 1.4% | 1.4% | 62.3% |
| Filed by the manufacturer | 86.3% | 85.9% | 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 HHS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Colleague Volumetric Infusion Pump | 13,678 | 0 | 0.1% |
| Filshie Clips | 245 | 6 | 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 Essure reports
How many FDA reports name Essure?
74,072 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 435 in the latest 12 months.
What kinds of events are reported?
injury (97.9%), malfunction (1.4%) and other (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (22.9%), patient-device incompatibility (7.5%), biocompatibility (7.4%), device dislodged or dislocated (7.2%) and break (6.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (86.3%) and voluntary reports (13.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Essure 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.