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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Pain (1994); Weakness (2145); Disability (2371); Palpitations (2467)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 20-sep-2017.The most recent information was received on 28-sep-2017.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("episodes of strong right pelvic pain preventing all activity") and asthenia ("asthenia") in a (b)(6) female patient who had essure (batch no.C68791) inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included dermatitis due to metals.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), asthenia (seriousness criterion disability), allergy to metals ("doubtful nickel sensitivity"), diarrhoea ("diarrhea"), fatigue ("fatigue") and palpitations ("palpitations").The patient was treated with spasfon, nsaid's and surgery (implants were removed via laparoscopic hysterectomy with salpingectomy on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, allergy to metals, fatigue and palpitations outcome was unknown, the asthenia had not resolved and the diarrhoea had resolved.The reporter provided no causality assessment for allergy to metals, asthenia, diarrhoea, fatigue, palpitations and pelvic pain with essure.The reporter commented: the patient's mostly digestive symptoms arose 12 months after essure insertion.The symptoms were resistant to usual treatments.These pains got worse with each attack.Patient's asthenia has a constant impact on her quality of life.No complications following removal.Good healing.No urinary or digestive functional signs.Patient still asthenic after removal, and had her sick leave prolonged by two weeks.Diagnostic results: prior to essure removal: x-ray (result not provided).Ct : no cause identified for patient's pain.Colonoscopy : no cause identified for patient's pain.Two abdominal/pelvic ultrasounds: no cause identified for patient's pain.Allergy testing : doubtful nickel sensitivity.The 2 blood tests: not provided.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on 29-sep-2017 for the following meddra preferred term: pelvic pain.The analysis in the global safety database revealed 4.522 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Quality-safety evaluation of ptc: unable to confirm complaint further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 28-sep-2017: quality safety evaluation of ptc.Incident.At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental 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 07981-0915
• MDR Report Key: 6955543
• MDR Text Key: 89605501
• Report Number: 2951250-2017-04855
• Device Sequence Number: 1
• Product Code: HHS
• 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: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: ESS305
• Device Lot Number: C68791
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2014
• 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): Other; Required Intervention
• Patient Age: 42 YR