MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS305

Device Problem Occlusion Within Device (1423)

Patient Problems Pain (1994); Vomiting (2144); Weakness (2145); Heavier Menses (2666)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a consumer via regulatory authority (case# (b)(4)) in (b)(6) on 21-jul-2016 which refers to a female consumer of unspecified age who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2010.The insertion was extremely painful, especially in the placement of the device on the right side, that day the consumer was admitted with analgesia and the next day patient was sent to her house.Since the implantation, her health has gotten worse; she suffered vomiting after some months and had pelvic pain on the right with worsening in days of menstruation the patient commented that she had her menstruation always the same day and after essure implantation she presented it 2 times per month or sometimes she did not present her period for six weeks; she had abundant bleeding, pain, weakness and lack of energy and pain during sexual intercourse.Since three years, the pelvic pain got worse and the patient lost her job.After medical appointments with several physicians she was referred to the pain management unit, infiltration analgesia and analgesics and they told her that it could be arthritis or stress.Because nobody could explain her symptoms she thought that she may need psychological help.Patient read an article and she realized that her symptoms have a cause.After three medical consultations, only one physician confirmed that the essure cause the pain.The patient had a failed hysteroscopy and on (b)(6) she signed the papers to remove essure.All the events were considered as related by consumer.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and experienced pelvic pain on the right.It was reported that consumer signed the papers to remove essure.The event is listed in the reference safety information for essure.Pelvic pain may occur with essure therapy.In this case, consumer experienced this event since essure insertion.Based on its nature and in the lack of alternative explanation, a causal relationship with suspect insert cannot be excluded.This case was regarded as incident since essure removal will be performed in line with health authority's assessment.Additionally, non-serious events were reported.Further information and product technical analysis are being sought.

Manufacturer Narrative

Follow up 22-aug-2016: quality-safety evaluation of ptc (b)(4).No sample available for this investigation.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation on with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Follow-up from 31-aug-2016: no more information has been received.No further information is expected.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 25-aug-2016 for the following meddra preferred term: pelvic pain.The analysis in the global safety database revealed 1427 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.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and experienced pelvic pain on the right.It was reported that consumer signed the papers to remove essure.The event is listed in the reference safety information for essure.Pelvic pain may occur with essure therapy.In this case, consumer experienced this event since essure insertion.Based on its nature and in the lack of alternative explanation, a causal relationship with suspect insert cannot be excluded.This case was regarded as incident since essure removal will be performed, and in line with health authority's assessment.Additionally, non-serious events were reported.According to the product technical analysis, a product quality defect could not be confirmed but is considered plausible.

Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 5881976
• MDR Text Key: 52295130
• Report Number: 2951250-2016-01295
• Device Sequence Number: 1
• Product Code: HHS
• 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: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/14/2016; 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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