MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("medical device removal") in a 37 year-old female patient who had essure inserted for female sterilisation.The patient had a medical history of hypogastric pain in 2019, back pain in 2018 and cesarean section.The patient had a family history of breast cancer (breast cancer) and depression.Concurrent conditions were listed as iliac fossa pain and fatigue since 2018 as well as nickel allergy since 2009.Concomitant products included bromazepam, glucosamine and yurelax (cyclobenzaprine hydrochloride).On (b)(6) 2015, the patient had essure inserted.Essure was removed on (b)(6) 2019.An unknown time later she underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery (hysterectomy & bilateral partial salpingectomy).At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure administration.The reporter commented: she is still trying to get healthy, and still assessing the suffered sequelae while under treatment.Diagnostic results (normal ranges are provided in parenthesis if available): [abdominal x-ray] on (b)(6) 2015: both implants symmetrical up to bilateral intramural portion, normal ovaries) the correct placement of both implants is verified, so the method is now considered effective.The patient can stop using additional contraception.[breast scan] on (b)(6) 2017: bilateral.Breast parenchyma of medium density, with no evidence of malignancy in the imaging study performed.Simple cyst in upper outer quadrant of the left breast of 7 mm, typically benign, no other focal breast lesions are seen.Breast study without signs of malignancy at the current time [pathology test] on (b)(6) 2019: uterus and tubes.Macroscopic description: uterus measuring 9 x 6 x 4.5 cm.Cervix without alterations.Endometrial thickness of 0.3 cm.Separately, two 3.6 cm uterine tubes.No residual essures are identified.Representative inclusion block a1: anterior cervix, a2: posterior cervix, a3: isthmus, a4: endometrium, a5: tube 1, a6: tube 2.Diagnosis: uterus with chronic cervicitis and proliferative endometrium with initial secretory changes.Uterine tubes without relevant alterations quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 13-sep-2023: medical record received.Event injury nos is replaced with medical device removal , medical history, concomitant conditions added.Patient, product, information updated.Essure insertion & removal date updated.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("medical device removal") in a 37 year-old female patient who had essure inserted for female sterilisation.The patient had a medical history of hypogastric pain in 2019, back pain in 2018 and cesarean section.The patient had a family history of breast cancer (breast cancer) and depression.Concurrent conditions were listed as iliac fossa pain and fatigue since 2018 as well as nickel allergy since 2009.Concomitant products included bromazepam, glucosamine and yurelax (cyclobenzaprine hydrochloride).On (b)(6) 2015, the patient had essure inserted.Essure was removed on (b)(6) 2019.An unknown time later she underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery (hysterectomy & bilateral partial salpingectomy).At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure administration.The reporter commented: she is still trying to get healthy, and still assessing the suffered sequelae while under treatment.Diagnostic results (normal ranges are provided in parenthesis if available): [abdominal x-ray] on (b)(6) 2015: both implants symmetrical up to bilateral intramural portion, normal ovaries) the correct placement of both implants is verified, so the method is now considered effective.The patient can stop using additional contraception.[breast scan] on (b)(6) 2017: bilateral.Breast parenchyma of medium density, with no evidence of malignancy in the imaging study performed.Simple cyst in upper outer quadrant of the left breast of 7 mm, typically benign, no other focal breast lesions are seen.Breast study without signs of malignancy at the current time [pathology test] on (b)(6) 2019: uterus and tubes.Macroscopic description: uterus measuring 9 x 6 x 4.5 cm.Cervix without alterations.Endometrial thickness of 0.3 cm.Separately, two 3.6 cm uterine tubes.No residual essures are identified.Representative inclusion block a1: anterior cervix, a2: posterior cervix, a3: isthmus, a4: endometrium, a5: tube 1, a6: tube 2.Diagnosis: uterus with chronic cervicitis and proliferative endometrium with initial secretory changes.Uterine tubes without relevant alterations.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 23-sep-2023: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 17775537
• MDR Text Key: 323755314
• Report Number: 2951250-2023-02892
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BROMAZEPAM; BROMAZEPAM; GLUCOSAMINE; GLUCOSAMINE; YURELAX; YURELAX
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female