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

Model Number ESS305

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Death, Intrauterine Fetal (1855); Laceration(s) (1946); Abnormal Vaginal Discharge (2123); Pregnancy (3193)

Event Type  Injury  

Event Description

This case is a solicited case report received via social media (website) from a member of an essure problems support group in united states on (b)(6) 2015 which refers to a female consumer of unspecified age who had essure (fallopian tube occlusion insert) inserted for contraception (no details reported).The reporter informed a case which occurred with one of the women from the group who was pregnant with essure implanted.She found out she was expecting twins and posted on the group that she lost her babies.Her placenta obtained a tear (metal coils could and did migrate out of fallopian tubes into uterus), she leaked fluid from her placenta at 15 weeks and ended up having to bury 2 beautiful little girls.No additional information was provided.There are two linked child cases: (b)(4).The product technical complaint (ptc) investigation and final assessment were received on (b)(6) 2015.The bayer reference number for the ptc report is: (b)(4).Final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to look for any manufacturing deficiencies.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.Medical assessment: this ptc was initiated due to a lack of efficacy.A contraceptive failure may occur under the use of any contraceptive and is not indicative of a quality deficit per se.No complaint sample was provided for a technical investigation.The technical assessment concluded unconfirmed quality defect.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.The reported adverse events are not indicative of a quality deficit per se.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Company causality comment: this non-medically confirmed, solicited case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and got pregnant with essure.Her placenta obtained a tear (interpreted as placental disorder).Metal coils could and did migrate out of fallopian tubes into uterus (interpreted as device migration).She leaked fluid from her placenta at 15 weeks and ended up having to bury 2 beautiful little girls (interpreted as amniorrhexis and abortion late).The events placental disorder, amniorrhexis and abortion late are serious due to medical importance and unlisted in the reference safety information for essure.Device migration is serious due to medical importance and listed.Pregnancy is non-serious and listed.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place.Also, during essure micro-insert therapy there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body) or migration (distal fallopian tube or peritoneal cavity).In this case, the exact date and the mechanism of migration and pregnancy are not known.A causal relationship between pregnancy, device migration and suspect insert cannot be excluded.The consumer presented placental disorder (not specified) and amniorrhexis during gestation, which could be an alternative explanation for the death of twins.However, a mechanical interference between essure and the developing pregnancy cannot be excluded.Thus, this case was regarded as incident.No follow-up information can be obtained since this is a social media case.The product technical analysis concluded unconfirmed quality defect.There is no reason to suspect a causal relationship to a potential quality deficit.

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: 4520906
• MDR Text Key: 5493647
• Report Number: 2951250-2015-00121
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other