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

Model Number ESS305

Device Problems Separation Failure (2547); Activation, Positioning or Separation Problem (2906)

Patient Problem Pain (1994)

Event Date 07/01/2011

Event Type  Injury  

Event Description

The below report was received by health authority ansm (reference number: (b)(4) on (b)(6) 2017.The most recent information was received on (b)(6) 2023.This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a 40 year-old female patient who had essure inserted (lot no.761433).Additional non-serious events are detailed below.Product or product use issues identified: device deployment issue ("defective release of catheter" on 01-jul-2011), device difficult to use ("difficult withdrawal using biopsy forceps" on 01-jul-2011) and device material corroded ("mineralogical analysis confirmed release of heavy metals included tin into patient's body").There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, 168 days after essure insertion, she experienced pelvic pain (seriousness criterion intervention required), back pain ("lower back pain"), abdominal pain lower ("cramps"), heavy menstrual bleeding ("heavy menstrual periods with large clots of blood"), menstruation irregular ("very irregular cycles"), pain in extremity ("diffuse pain in legs and soles of feet"), migraine ("incapacitating migraines"), facial pain ("facial pain including the right eye and sinus"), dark circles under eyes ("very pronounced dark circles under the eyes"), nausea ("migraines with nausea"), hyperhidrosis ("very heavy sweating - excessive perspiration"), rhinitis allergic ("allergic rhinitis"), dermatitis contact ("contact eczema"), tachycardia ("tachycardia"), depression ("depression"), sinus pain ("facial pain including the right eye and sinus") and eye pain ("facial pain including the right eye and sinus").Essure was removed on (b)(6) 2017.An unknown time later she experienced disturbance in attention ("disturbance in attention"), ear, nose and throat disorder ("ear, nose and throat disorder"), headache ("headache"), memory impairment ("memory impairment") and musculoskeletal pain ("musculoskeletal pain").The patient was treated with surgery (hysterectomy).At the time of the report, the pelvic pain was resolving.The outcomes for back pain, abdominal pain lower, heavy menstrual bleeding, menstruation irregular, pain in extremity, migraine, facial pain, dark circles under eyes, nausea, hyperhidrosis, rhinitis allergic, dermatitis contact, tachycardia, depression, sinus pain, eye pain, disturbance in attention, ear, nose and throat disorder, headache, memory impairment and musculoskeletal pain were unknown.The reporter considered disturbance in attention, ear, nose and throat disorder, headache, memory impairment and musculoskeletal pain to be related to essure administration.No causality assessment was received for essure with regard to abdominal pain lower, pain in extremity, migraine, facial pain, dark circles under eyes, nausea, heavy menstrual bleeding, pelvic pain, hyperhidrosis, rhinitis allergic, dermatitis contact, tachycardia, depression, menstruation irregular, sinus pain, back pain or eye pain.The reporter commented: frequent migraine requiring sick leave each time.Test for heavy metals found presence of nickel.Various tests to investigate the symptoms, i.E.Ct-scan, mri, x-ray, doppler ultrasound, blood tests, etc.Numerous examinations over 5 years improvement of patient's state was noticed after removal of essure.The most recent follow-up information incorporated above includes data received on: (b)(6) 2023: upon receipt of follow up it was identified this case is duplicate of 2023-024275.All relevant information, source documents, references, reporters events (disturbance in attention, ear, nose and throat disorder, headache, , memory impairment, musculoskeletal pain and mineralogical analysis confirmed release of heavy metals included tin into patient's body) are transferred to retained case.Date of birth & lot number added.( legacy device number 2951250-2023-01815).Further company follow-up with the regulatory authority is not possible.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

The below report was received by health authority ansm (reference number: (b)(4) and (b)(4)) on (b)(6) 2017.The most recent information was received on (b)(6) 2023.This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a 40 year-old female patient who had essure inserted (lot no.761433).Additional non-serious events are detailed below.Product or product use issues identified: device deployment issue ("defective release of catheter" on (b)(6) 2011), device difficult to use ("difficult withdrawal using biopsy forceps" on (b)(6) 2011) and device material corroded ("mineralogical analysis confirmed release of heavy metals included tin into patient's body").There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, 168 days after essure insertion, she experienced pelvic pain (seriousness criterion intervention required), back pain ("lower back pain"), abdominal pain lower ("cramps"), heavy menstrual bleeding ("heavy menstrual periods with large clots of blood"), menstruation irregular ("very irregular cycles"), pain in extremity ("diffuse pain in legs and soles of feet"), migraine ("incapacitating migraines"), facial pain ("facial pain including the right eye and sinus"), dark circles under eyes ("very pronounced dark circles under the eyes"), nausea ("migraines with nausea"), hyperhidrosis ("very heavy sweating - excessive perspiration"), rhinitis allergic ("allergic rhinitis"), dermatitis contact ("contact eczema"), tachycardia ("tachycardia"), depression ("depression"), sinus pain ("facial pain including the right eye and sinus") and eye pain ("facial pain including the right eye and sinus").Essure was removed on (b)(6) 2017.An unknown time later she experienced disturbance in attention ("disturbance in attention"), ear, nose and throat disorder ("ear, nose and throat disorder"), headache ("headache"), memory impairment ("memory impairment") and musculoskeletal pain ("musculoskeletal pain").The patient was treated with surgery (hysterectomy).At the time of the report, the pelvic pain was resolving.The outcomes for back pain, abdominal pain lower, heavy menstrual bleeding, menstruation irregular, pain in extremity, migraine, facial pain, dark circles under eyes, nausea, hyperhidrosis, rhinitis allergic, dermatitis contact, tachycardia, depression, sinus pain, eye pain, disturbance in attention, ear, nose and throat disorder, headache, memory impairment and musculoskeletal pain were unknown.The reporter considered disturbance in attention, ear, nose and throat disorder, headache, memory impairment and musculoskeletal pain to be related to essure administration.No causality assessment was received for essure with regard to abdominal pain lower, pain in extremity, migraine, facial pain, dark circles under eyes, nausea, heavy menstrual bleeding, pelvic pain, hyperhidrosis, rhinitis allergic, dermatitis contact, tachycardia, depression, menstruation irregular, sinus pain, back pain or eye pain.The reporter commented: frequent migraine requiring sick leave each time.Test for heavy metals found presence of nickel.Various tests to investigate the symptoms, i.E.Ct-scan, mri, x-ray, doppler ultrasound, blood tests, etc.Numerous examinations over 5 years.Improvement of patient's state was noticed after removal of essure.Quality-safety evaluation of ptc: for essure: as a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical event cannot be totally excluded.However, the reported medical event is not indicative of a quality deficit per se.The most recent follow-up information incorporated above includes data received on: (b)(6) 2023: quality-safety evaluation of ptc.Further company follow-up with the regulatory authority is not possible.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this 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: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj
• MDR Report Key: 16871877
• MDR Text Key: 314620636
• Report Number: 2951250-2023-01851
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Model Number: ESS305
• Device Lot Number: 761433
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female