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

Model Number ESS305

Device Problems Break (1069); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Uterine Perforation (2121); Bowel Perforation (2668); Fallopian Tube Perforation (4506); Insufficient Information (4580)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer via lawyer and describes the occurrence of pelvic pain ('chronic pelvic pain / severe pain'), device breakage ('essure had broken'), fallopian tube perforation ('perforation of the fallopian tubes'), uterine perforation ('perforation of the uterus / essure had pierced her uterine wall'), intestinal perforation ('perforation of the bowel'), device dislocation ('implantation displacement') and postoperative wound infection ('shortly after surgery (essure removal) she returned to hospital due to infection in the surgical wound') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's medical history included parity 3 and multigravida (3 previous pregnancies).On (b)(6) 2016, the patient had essure inserted.In (b)(6) 2019, the patient experienced abortion spontaneous ("miscarriages").On an unknown date, the patient experienced pelvic pain (seriousness criterion intervention required), device breakage (seriousness criterion medically significant), fallopian tube perforation (seriousness criterion medically significant), uterine perforation (seriousness criterion medically significant), intestinal perforation (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), postoperative wound infection (seriousness criterion hospitalization), headache ("headaches"), groin pain ("groin pain"), pain in extremity ("leg pain, foot pain"), fatigue ("fatigue"), muscular weakness ("muscle weakness"), swelling ("swelling"), genital haemorrhage ("abnormal bleeding"), menstrual disorder ("menstrual cycle changes"), dysmenorrhoea ("severe menstrual cramps"), bladder disorder ("bladder problems"), dyspareunia ("dyspareunia (painful intercourse)"), loss of libido ("loss of libido"), alopecia ("hair loss"), depression ("depression"), nail disorder ("weakening of the nails"), tooth disorder ("weakening of the teeth"), urinary tract infection ("urinary tract infections") and amnesia ("memory loss"), was found to have weight increased ("weight gain") and hormone level abnormal ("hormonal problems") and was found to have a pregnancy with contraceptive device ("unwanted pregnancies / failed tubal occlusion").The patient was hospitalized for 14 days.The patient was treated with surgery (salpingectomy in (b)(6) 2020 and hysterectomy in (b)(6) 2020).Essure was removed in (b)(6) 2020.In (b)(6) 2019, the abortion spontaneous had resolved.At the time of the report, the pelvic pain, device breakage, fallopian tube perforation, uterine perforation, intestinal perforation, device dislocation, postoperative wound infection, headache, groin pain, pain in extremity, fatigue, muscular weakness, swelling, weight increased, genital haemorrhage, menstrual disorder, dysmenorrhoea, bladder disorder, dyspareunia, loss of libido, alopecia, hormone level abnormal, depression, nail disorder, tooth disorder, urinary tract infection, amnesia and pregnancy with contraceptive device outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 4, para 3.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abortion spontaneous, alopecia, amnesia, bladder disorder, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, genital haemorrhage, groin pain, headache, hormone level abnormal, intestinal perforation, loss of libido, menstrual disorder, muscular weakness, nail disorder, pain in extremity, pelvic pain, postoperative wound infection, pregnancy with contraceptive device, swelling, tooth disorder, urinary tract infection, uterine perforation and weight increased to be related to essure.The reporter commented: a new insertion date of essure was received: (b)(6) 2016.After experiencing severe pain, the patient sought help at the hospital.A salpingectomy was performed in (b)(6) 2020, and she continued to suffer from all symptoms, severe and constant pain, and bleeding.Shortly after surgery, she returned to the hospital due to an infection in the surgical wound and required hospitalization for two weeks.The doctor felt she had to open her surgical wound to prevent her from getting an anchor-shaped scar.The additional case (b)(4) was created to capture the second episode of pregnancy with essure by the same patient.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-feb-2022: the following information were added: patient´s date of birth, medical history, essure indication, essure removal date and the adverse events: headaches, chronic pelvic pain, groin pain, leg pain, foot pain, fatigue, muscular weakness, swelling, weight increase, abnormal bleeding, menstrual disorder, severe menstrual cramps, implantation displacement, bladder problems, dyspareunia (painful intercourse), loss of libido, perforation of the fallopian tubes, uterine perforation, hair loss, hormonal problems, depression, nail disorder, tooth disorder, urinary tract disorder, memory loss, perforation of the bowel, unintended pregnancy with contraceptive,m device breakage, miscarriage and infection in the surgical wound.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a consumer via lawyer and describes the occurrence of pelvic pain ('chronic pelvic pain / severe pain'), device breakage ('essure had broken'), fallopian tube perforation ('perforation of the fallopian tubes'), uterine perforation ('perforation of the uterus / essure had pierced her uterine wall'), intestinal perforation ('perforation of the bowel'), device dislocation ('implantation displacement') and postoperative wound infection ('shortly after surgery (essure removal) she returned to hospital due to infection in the surgical wound') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's medical history included parity 3 and multigravida (3 previous pregnancies).On (b)(6) 2016, the patient had essure inserted.In (b)(6) 2019, the patient experienced abortion spontaneous ("miscarriages").On an unknown date, the patient experienced pelvic pain (seriousness criterion intervention required), device breakage (seriousness criterion medically significant), fallopian tube perforation (seriousness criterion medically significant), uterine perforation (seriousness criterion medically significant), intestinal perforation (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), postoperative wound infection (seriousness criterion hospitalization), headache ("headaches"), groin pain ("groin pain"), pain in extremity ("leg pain, foot pain"), fatigue ("fatigue"), muscular weakness ("muscle weakness"), swelling ("swelling"), genital haemorrhage ("abnormal bleeding"), menstrual disorder ("menstrual cycle changes"), dysmenorrhoea ("severe menstrual cramps"), bladder disorder ("bladder problems"), dyspareunia ("dyspareunia (painful intercourse)"), loss of libido ("loss of libido"), alopecia ("hair loss"), depression ("depression"), nail disorder ("weakening of the nails"), tooth disorder ("weakening of the teeth"), urinary tract infection ("urinary tract infections") and amnesia ("memory loss"), was found to have weight increased ("weight gain") and hormone level abnormal ("hormonal problems") and was found to have a pregnancy with contraceptive device ("unwanted pregnancies / failed tubal occlusion").The patient was hospitalized for 14 days.The patient was treated with surgery (salpingectomy in (b)(6) 2020 and hysterectomy in (b)(6) 2020).Essure was removed in (b)(6) 2020.In (b)(6) 2019, the abortion spontaneous had resolved.At the time of the report, the pelvic pain, device breakage, fallopian tube perforation, uterine perforation, intestinal perforation, device dislocation, postoperative wound infection, headache, groin pain, pain in extremity, fatigue, muscular weakness, swelling, weight increased, genital haemorrhage, menstrual disorder, dysmenorrhoea, bladder disorder, dyspareunia, loss of libido, alopecia, hormone level abnormal, depression, nail disorder, tooth disorder, urinary tract infection, amnesia and pregnancy with contraceptive device outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 4, para 3.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abortion spontaneous, alopecia, amnesia, bladder disorder, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, genital haemorrhage, groin pain, headache, hormone level abnormal, intestinal perforation, loss of libido, menstrual disorder, muscular weakness, nail disorder, pain in extremity, pelvic pain, postoperative wound infection, pregnancy with contraceptive device, swelling, tooth disorder, urinary tract infection, uterine perforation and weight increased to be related to essure.The reporter commented: a new insertion date of essure was received: (b)(6) 2016.After experiencing severe pain, the patient sought help at the hospital.A salpingectomy was performed in (b)(6) 2020, and she continued to suffer from all symptoms, severe and constant pain, and bleeding.Shortly after surgery, she returned to the hospital due to an infection in the surgical wound and required hospitalization for two weeks.The doctor felt she had to open her surgical wound to prevent her from getting an anchor-shaped scar.The additional case (b)(4) was created to capture the second epidode of pregnancy with essure by the same patient.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 15-mar-2022: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation 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: 13757861
• MDR Text Key: 287117609
• Report Number: 2951250-2022-00205
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2022
• 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; Hospitalization
• Patient Sex: Female