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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590)

Patient Problems Hair Loss (1877); Hemorrhage/Bleeding (1888); Pain (1994); Perforation (2001); Burning Sensation (2146); Discomfort (2330); Foreign Body In Patient (2687); Pregnancy (3193)

Event Date 01/01/2011

Event Type  Injury  

Event Description

This case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee which took place in september 2015 (case# fda-2014-n-0736-1784, awareness date 27-oct-2015).It refers to a female patient of unspecified age in united states who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2011.Additional information received on 18-nov-2015.The consumer reported it took an hour long to install the right coil and the left was installed two weeks later, because it was not dilated.She reported from there she had chronic pelvic pain and did have a cycle for a year and when she finally did, she bled for one whole month at a time.She went back to the doctor and had an mri done and blood and nothing showed up.She stated she spent years with the pain, bloating, bleeding, hair falling off, bad acne, rashes on her skin and pelvic pain.In (b)(4) 2014, she became pregnant and throughout her pregnancy was hell, horrible pelvic pain.After she had her baby (b)(6) 2015, her tubes were removed on (b)(6) 2015 and her left tube was punctured by the coil and the right coil was lost in her uterus.Her doctor left her uterus and, at time of the report, she was suffering pain, and felt her uterus contracting with pain, it felt like it was burning.She reported if she got approved by health insurance, she will get an x-ray done to detect the lost right coil.Product technical complaint (ptc) investigation result received on 18-nov-2015 (b)(4).Final assessment: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where a insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.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 the quality defect or device malfunction al this time.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events, the lack of efficacy and a quality defect.The reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar adverse event cases is not applicable.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer, who had pelvic pain and bleeding after essure (fallopian tube occlusion insert) insertion.Additionally, 3 years after device placement she became pregnant.After the delivery, she underwent a salpingectomy.During this surgery, her left tube was found punctured by the coil and the right coil was lost in her uterus.All events are listed according to essure's reference safety information.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place.Some of these pregnancies occurred due to patient non-compliance including failure to return for the essure confirmation test (hsg).In this particular case, no information was provided about hsg.According to consumer's report, after the delivery, essure was found perforating the fallopian tube on left side and expelled into the uterus in right side.These events could be alternative explanations for the reported device failure (pregnancy).However, since their mechanism is unknown (if they occurred before or after pregnancy onset) and as pregnancy occurred 3 years after devices placement; causality with essure cannot be excluded.Regarding the reported pain and bleeding, based on essure safety profile and events nature; causality cannot be excluded.Additionally, non-serious events were reported.This case was regarded as incident, since device removal was required (salpingectomy performed).Based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events, the lack of efficacy and a quality defect.No active follow-up will be pursued (case identified during health authority website monitoring).

Manufacturer Narrative

On (b)(6) 2017: follow up from lawyer: (b)(6) (initial added) had essure implanted on (b)(6) 2011.As a result of her implantation with essure she suffered injuries, including: skin rash, pelvic pain, migration of implant, hair loss, and newly reported: hysterectomy, perforation of organs, pain, memory loss, painful intercourse, vertigo.She had surgery to remove the essure implant on (b)(6) 2015.Company causality comment: this spontaneous case report refers to a female plaintiff who had chronic pelvic pain/horrible pelvic pain and heavy bleeding after essure insertion.Additionally, 3 years after device placement she became pregnant.After the delivery, she underwent a hysterectomy and essure removal.During the surgery, her left tube was found punctured by the coil (reported with perforation of organs) and it was noticed migration of implant: the right coil is lost in her (my) uterus.All events are anticipated according to essure's reference safety information.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place.Some of these pregnancies occurred due to patient non-compliance including failure to return for the essure confirmation test (hsg).In this particular case, no information was provided about hsg.According to plaintiff's report, after the delivery, essure was found perforating the fallopian tube on left side and expelled into the uterus in right side.These events could be alternative explanations for the reported device failure.However, the exact time point and mechanism of perforation and expulsion are not known, therefore causality with essure cannot be excluded.Regarding the reported pain and bleeding, based on essure safety profile and events nature, causality cannot be excluded.In addition, non-serious events were reported.This case was regarded as incident as a surgical intervention was required.Based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events, the lack of efficacy and a quality defect.Further information will be obtained through litigation process.

• 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; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 5247936
• MDR Text Key: 32145651
• Report Number: 2951250-2015-01704
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2017

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
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/20/2017; 02/06/2017
• 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