• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAYER PHARMA AG ESSURE INSERT, TUBAL OCCLUSION Back to Search Results
Model Number ESS205
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 meeting, which took place in september 2015 (case# fda-2014-n-0736-2147, awareness date 27-oct-2015). It refers to a female consumer of unspecified age in united states who had essure inserted in (b)(6) 2006, under anesthesia during the procedure. She woke up in horrible pain. She could barely walk for a week after the procedure. Then, she experienced lower back pain that was constant, extreme fatigue, gained weight, and menstrual cycles that lasted months at a time; the longest being 4 1/2 months. She was incredibly moody constantly. It was too painful to have sexual relationship with her partner and they would have to stop due to pain or bleeding. She developed type 2 diabetes and fatty liver disease due to not being able to lose weight. On (b)(6) 2015 after nearly 9 years, a total hysterectomy was performed. She has more energy, lost 20 pounds and was no longer in daily pain. Product technical complaint investigation received on 18-nov-2015: the bayer reference number for the ptc report is: (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 an 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 any quality defect or device malfunction at 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 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 ae cases is not applicable. Company causality comment: this spontaneous non-medically confirmed case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and her menstrual cycles lasted months at a time. She underwent a total hysterectomy 9 years after essure insertion. Type 2 diabetes was also reported. These events are serious due to medical significance. Menstrual cycles lasted months at a time is a listed event in the reference safety information for essure, the other event is unlisted. After essure insertion, menses pattern changes may occur. Given the nature of the event menstrual cycles lasted months at a time and in the lack of an alternative explanation, causality with essure cannot be excluded. Type 2 diabetes was assessed as unrelated to essure, considering the pathophysiology of the event and the local effect of essure in the fallopian tubes. Non-serious events were also reported. This case was regarded as incident since a surgical intervention was performed. The product technical analysis concluded that based on the available information, there is no reason to suspect a causal relationship between the reported medical events and a quality defect. No active follow-up will be pursued, as this case was identified during health authority website monitoring.

 
Manufacturer Narrative

Data correction: the product code knh was replaced with hhs.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameESSURE
Type of DeviceINSERT, TUBAL OCCLUSION
Manufacturer (Section D)
BAYER PHARMA AG
müllerstr. 178
berlin, CA 13353
GERMANY 13353
Manufacturer (Section G)
BAYER PHARMA AG
müllerstr. 178
berlin, CA 13353
GERMANY 13353
Manufacturer Contact
k shaw lamberson
100 bayer blvd.
p.o. box 915
whippany , NJ 07981-0915
MDR Report Key5246931
Report Number2951250-2015-01699
Device Sequence Number1
Product CodeHHS
Report Source Manufacturer
Source Type CONSUMER,OTHER
Type of Report Initial,Followup
Report Date 01/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberESS205
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2015
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 TREATMENT DATA
Date Received: 11/24/2015 Patient Sequence Number: 1
-
-