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

Model Number ESS205

Device Problems Migration or Expulsion of Device (1395); Material Perforation (2205)

Patient Problems Cyst(s) (1800); Pain (1994)

Event Type  Injury  

Event Description

This case report from (b)(6) was derived from medical literature on 06-sep-2016, article entitled "does essure cause significant de novo pain? a retrospective review of indications for second surgeries following essure placement." it refers to a female patient of unspecified age who had essure inserted.The objective of the study was to examine the surgical indications and pathologic findings in patients undergoing a second surgery following placement of the essure permanent birth control system to determine the role of essure in developing new onset pelvic pain.This was a retrospective chart review at a single center over 11 years.The inclusion criteria were women having a second surgical procedure that included removal of the fallopian tubes and essure inserts after unilateral or bilateral essure placement and subsequent imaging.The exclusion criteria were women who had essure inserts places as part of a clinical trial.Abstract: study objectives: to examine the surgical indications and pathologic findings in patients undergoing a second surgery following placement of the essure permanent birth control system to determine the role of essure in developing new onset pelvic pain.Design: retrospective cohort (canadian task force classification ii-2).Setting: tertiary level hospital.Patients: women who have had essure placement and subsequent second surgery.Intervention: charts from women undergoing pelvic surgery following essure placement from june 2002 to june 2013 were reviewed and the indication for the procedure, surgical and pathologic findings were noted.Measurements and main results: a total of 62/1430 (4.3%) patients had a second surgery following essure placement, 24 (1.6%) of these had a surgical indication not related to pain.The remaining 38 (2.7%) had either new onset (n = 27) or worsening pre-existing pain (n = 11).In the new onset pain group 15 (1%) had surgical findings or pathology consistent with a painful gynecologic condition.One of patient from this group had ovarian cyst - borderline.In the remaining 12, 8 (0.5%) seemed to be related to some perforation or migration of the essure device.In 4 patients (0.3%) there no other obvious cause for the new onset pain, it was thus attributed to the essure microinsert.Authors comment: we believe that our data demonstrates that the development of new onset or worsening pre-existing pain necessitating a second surgery is a rare event after placement of the essure insert for permanent contraception.Assessment of any patient with pain following essure sterilization should take into account other common causes for gynecologic pain rather than simply assuming it is related to the essure inserts.Conclusion: essure sterilization can be associated with new onset pain or a worsening of a pre-existing painful gynecologic condition although both are very rare.A careful and complete consent prior to placement and a thorough examination if pain does occur will usually show some aetiology for the pain other than the essure insert.Company causality comment: this medically confirmed, case report derived from medical literature, article entitled "does essure cause significant de novo pain? a retrospective review of indications for second surgeries following essure placement, refers to a female patient who had essure inserted and experienced new onset pain (seen as pelvic pain).A second surgery was performed.This event is listed in the reference safety information for essure.In this case, it was reported that the patient had surgical findings or pathology consistent with a painful gynecologic condition.She had ovarian cyst - borderline (non-serious and unlisted), which could be an alternative explanation for occurrence of new onset pain.However, considering that pain may also occur with essure therapy, a causal relationship with suspect insert cannot be totally excluded.This case was regarded as incident since surgical intervention was performed.A product technical analysis is being sought.Follow-up information will not be possible.

Manufacturer Narrative

Quality-safety evaluation of ptc: sample not available.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.No specific quality issue was defined, therefore no meddra llt can be provided.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 with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 6-dec-2016: quality-safety evaluation received.Company causality comment: this medically confirmed, case report derived from medical literature, article entitled "does essure cause significant de novo pain? a retrospective review of indications for second surgeries following essure placement, refers to a female patient who had essure inserted and experienced new onset pain (seen as pelvic pain).A second surgery was performed.This event is listed in the reference safety information for essure.In this case, it was reported that the patient had surgical findings or pathology consistent with a painful gynecologic condition.She had ovarian cyst - borderline (non-serious and unlisted), which could be an alternative explanation for occurrence of new onset pain.However, considering that pain may also occur with essure therapy, a causal relationship with suspect insert cannot be totally excluded.This case was regarded as incident since surgical intervention was performed.According to the product technical analysis, product quality defect could not be confirmed but is considered plausible.Follow-up information will not be possible.

• 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: 5986987
• MDR Text Key: 55927370
• Report Number: 2951250-2016-02072
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2016

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: ESS205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 09/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/28/2016
• 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