MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Genital Bleeding (4507)

Event Date 02/01/2012

Event Type  Injury  

Event Description

The below report was received by health authority us fda (reference number: mw5112943) on 19-dec-2018.The most recent information was received on 02-nov-2022.This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of genital haemorrhage ("general abnormal bleeding/ abnormal bleeding (general)") in an adult female patient who had essure inserted (lot no.869764) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of weight gain, hair loss and depression.Concomitant products included norco (hydrocodone bitartrate;paracetamol) from 2013 to 2019 and ibuprofen from 2013 to 2019.On (b)(6) 2012, the patient had essure inserted.In february 2012 she experienced genital haemorrhage (seriousness criteria disability and medically important), dysmenorrhoea ("dysmenorrhea (cramping)/i have non-stop pain"), pelvic pain ("pelvic pain/ pain"), loss of libido ("hormonal changes describe: not interested in sex/lost my sex drive"), depression ("psychological or psychiatric problems condition: depression"), migraine ("migraines / headaches"), weight fluctuation ("weight gain / loss: weight gain/weight loss"), fatigue ("fatigue"), abdominal pain upper ("gastrointestinal or digestive system condition type: stabbing pain in the stomach/i have non stop pain like periodically/pain in my stomach non stop") and alopecia ("hair loss/hair fell out").In (b)(6) 2012 she experienced blindness ("vision/eye problems type: poor vision").An unknown time later she experienced heavy menstrual bleeding ("menorrhagia (heavy menstrual bleeding)"), intermenstrual bleeding ("metrorrhagia"), cystitis ("bladder infection"), vaginal infection ("vaginal infection"), abdominal pain ("abdominal pain"), eye disorder ("eye problems"), affective disorder ("i have mood disorders"), irritability ("a lot of times i'm irritable"), deafness ("hearing loss") and mood swings ("mood swings") and was found to have weight decreased ("have sever weight loss").The patient was treated with needed eye glasses.Essure treatment was not changed.At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal pain, abdominal pain upper, affective disorder, alopecia, blindness, cystitis, deafness, depression, dysmenorrhoea, eye disorder, fatigue, genital haemorrhage, heavy menstrual bleeding, intermenstrual bleeding, irritability, loss of libido, migraine, mood swings, pelvic pain, vaginal infection, weight decreased and weight fluctuation to be related to essure administration.The reporter commented: on (b)(6) 2004, she implanted essure (discrepancy noted.As reported in pfs).Trailing number of coils: right side: 4, left side: 6.Did you undergo an essure confirmation test? yes and no (as written discrepancy noted).She had dye test.Discrepancy noted in date of insertion (b)(6) 2012 and (b)(6) 2012.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 26.653 kg/sqm.[hysterosalpingogram] in (b)(6) 2012: total bilateral occlusion.[imaging procedure] in 2012: dye showed it was in place; (date unknown): result not provided.Lot number:869764 manufacture date: 2011-06 expiration date: 2014-06.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: (b)(6) 2022: event hearing loss & mood swings are added.Regulatory authority reporter added.Case was upgraded to serious incident.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj
• MDR Report Key: 15750980
• MDR Text Key: 303235967
• Report Number: 2951250-2022-01287
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2014
• Device Model Number: ESS305
• Device Lot Number: 869764
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2011
• 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
• Treatment: IBUPROFEN; NORCO
• Patient Outcome(s): Disability; Other
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 73 KG