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

Model Number ESS205

Device Problems Break (1069); Biocompatibility (2886); Material Integrity Problem (2978); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('embedded in her tissues') and device breakage ('due to the device remains that the (b)(6) employees left in the body of my client during the surgical procedure, she still suffers various ailments') in a (b)(6) female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: no relevant past medical history.On (b)(6) 2004, the patient had essure (ess205) inserted.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), complication of device removal ("due to the device remains that the (b)(6) employees left in the body of my client during the surgical procedure, she still suffers various ailments"), pelvic pain ("pelvic pain"), swelling ("swelling"), hypersensitivity ("allergic reactions"), back pain ("lumbar pain for more than 10 years"), abdominal pain ("abdominal pain"), vulvovaginal pain ("vaginal pain"), abdominal pain lower ("cramps"), alopecia ("loss of hair"), allergy to metals ("allergic to nickel and titanium sulphate"), inflammation ("abdominal inflammation"), coccydynia ("moderate coccyx pain"), endometriosis ("focal endometriosis"), muscle disorder ("muscle hyperplasia"), diarrhoea ("chronic diarrhoea"), arthralgia ("joint pain"), myalgia ("muscle pain"), tremor ("heavy hand tremors"), spinal osteoarthritis ("lumbar spondylosis with pinching of spaces l4-l5 and l5-s1") and facet joint syndrome ("facet syndrome").The patient was treated with surgery (bilateral radical salpingectomy in (b)(6) 2019).At the time of the report, the embedded device, device breakage, complication of device removal, pelvic pain, swelling, hypersensitivity, abdominal pain, vulvovaginal pain, abdominal pain lower, alopecia, allergy to metals, diarrhoea, arthralgia, myalgia and tremor outcome was unknown and the back pain, inflammation, coccydynia, endometriosis, muscle disorder, spinal osteoarthritis and facet joint syndrome had not resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, arthralgia, back pain, coccydynia, complication of device removal, device breakage, diarrhoea, embedded device, endometriosis, facet joint syndrome, hypersensitivity, inflammation, muscle disorder, myalgia, pelvic pain, spinal osteoarthritis, swelling, tremor and vulvovaginal pain to be related to essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): allergy test - on an unknown date: allergic to nickel and titanium sulphate.Computerised tomogram on an unknown date: allergy to nickel in left fallopian tube essure, very superficial.X-ray on (b)(6) 2019: no metallic remains.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 lawyer and describes the occurrence of embedded device ('embedded in her tissues') and device breakage ('due to the device remains that the sas employees left in the body of my client during the surgical procedure, she still suffers various ailments') in a 40-year-old female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: no relevant past medical history.On (b)(6) 2004, the patient had essure (ess205) inserted.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), complication of device removal ("due to the device remains that the sas employees left in the body of my client during the surgical procedure, she still suffers various ailments"), pelvic pain ("pelvic pain"), swelling ("swelling"), hypersensitivity ("allergic reactions"), back pain ("lumbar pain for more than 10 years"), abdominal pain ("abdominal pain"), vulvovaginal pain ("vaginal pain"), abdominal pain lower ("cramps"), alopecia ("loss of hair"), allergy to metals ("allergic to nickel and titanium sulphate"), inflammation ("abdominal inflammation"), coccydynia ("moderate coccyx pain"), endometriosis ("focal endometriosis"), muscle hypertrophy ("muscle hyperplasia"), diarrhoea ("chronic diarrhoea"), arthralgia ("joint pain"), myalgia ("muscle pain"), tremor ("heavy hand tremors"), spinal osteoarthritis ("lumbar spondylosis with pinching of spaces l4-l5 and l5-s1") and facet joint syndrome ("facet syndrome").The patient was treated with surgery (bilateral radical salpingectomy in (b)(6) 2019).At the time of the report, the embedded device, device breakage, complication of device removal, pelvic pain, swelling, hypersensitivity, abdominal pain, vulvovaginal pain, abdominal pain lower, alopecia, allergy to metals, diarrhoea, arthralgia, myalgia and tremor outcome was unknown and the back pain, inflammation, coccydynia, endometriosis, muscle hypertrophy, spinal osteoarthritis and facet joint syndrome had not resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, arthralgia, back pain, coccydynia, complication of device removal, device breakage, diarrhoea, embedded device, endometriosis, facet joint syndrome, hypersensitivity, inflammation, muscle hypertrophy, myalgia, pelvic pain, spinal osteoarthritis, swelling, tremor and vulvovaginal pain to be related to essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): allergy test - on an unknown date: allergic to nickel and titanium sulphate.Computerised tomogram - on an unknown date: allergy to nickel in left fallopian tube essure, very superficial.X-ray - on (b)(6) 2019: no metallic remains.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-may-2020: 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.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of embedded device ("embedded in her tissues") and device breakage ("due to the device remains that the sas employees left in the body of my client during the surgical procedure, she still suffers various ailments") in a 40 year-old female patient who had essure (ess205) inserted.Additional non-serious events are detailed below.Product or product use issues identified: contraceptive device removal incomplete ("due to the device remains that the sas employees left in the body of my client during the surgical procedure, she still suffers various ailments").The patient had a medical history of sacral pain and lumbar pain in 2011 and parity 2, gravida ii, paraesthesia of limbs and cervicobrachialgia.No relevant past medical history.Previously administered products included: oral contraceptive nos, nsaid n and benzodiazepine derivatives.On (b)(6) 2004, the patient had essure (ess205) inserted.Essure (ess205) was removed on (b)(6) 2019.An unknown time later she experienced embedded device (seriousness criteria medically important and intervention required), device breakage (seriousness criterion medically important), pelvic pain ("pelvic pain"), swelling ("swelling"), hypersensitivity ("allergic reactions"), back pain ("lumbar pain for more than 10 years"), abdominal pain ("abdominal pain"), vulvovaginal pain ("vaginal pain"), abdominal pain lower ("cramps"), alopecia ("loss of hair"), allergy to metals ("allergic to nickel and titanium sulphate"), inflammation ("abdominal inflammation"), coccydynia ("moderate coccyx pain"), endometriosis ("focal endometriosis"), muscle hypertrophy ("muscle hyperplasia"), diarrhoea ("chronic diarrhoea"), arthralgia ("joint pain"), myalgia ("muscle pain"), tremor ("heavy hand tremors"), spinal osteoarthritis ("lumbar spondylosis with pinching of spaces l4-l5 and l5-s1") and facet joint syndrome ("facet syndrome").The patient was treated with surgery (bilateral radical salpingectomy in (b)(6) 2019).At the time of the report, the back pain, inflammation, coccydynia, endometriosis, muscle hypertrophy, spinal osteoarthritis and facet joint syndrome had not resolved.The outcomes for embedded device, device breakage, pelvic pain, swelling, hypersensitivity, abdominal pain, vulvovaginal pain, abdominal pain lower, alopecia, allergy to metals, diarrhoea, arthralgia, myalgia and tremor were unknown.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, arthralgia, back pain, coccydynia, device breakage, diarrhoea, embedded device, endometriosis, facet joint syndrome, hypersensitivity, inflammation, muscle hypertrophy, myalgia, pelvic pain, spinal osteoarthritis, swelling, tremor and vulvovaginal pain to be related to essure (ess205) administration.The reporter commented: coil rings in right tube: 3; coil rings in left tube: 8.In addition, due to the remains of the devices that the healthcare professionals at sas left inside her body, she still experiences ailments to this day: abdominal inflammation, low back pain, moderate tailbone pain, focal endometriosis and muscle hyperplasia.Diagnostic results (normal ranges are provided in parenthesis if available): [allergy test] (date unknown): allergic to nickel and titanium sulphate [computerised tomogram] (date unknown): allergy to nickel in left fallopian tube essure, very superficial.[x-ray] on (b)(6) 2004: it was confirmed that the insertion had been achieved successfully.The patient did not require treatment after the insertion of the device and her menstrual pattern had not changed.The patient¿s own assessment of the method was that it was very satisfactory.; on (b)(6) 2019: no metallic remains.Quality-safety evaluation of ptc: for essure (ess205): unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 03-jan-2023: patient date of birth, medical history, lab data, product removal date, reporter causality comment added.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, NJ 07981
• MDR Report Key: 10066864
• MDR Text Key: 196773428
• Report Number: 2951250-2020-07834
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: ES
• 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,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• 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?: No
• Date Manufacturer Received: 01/03/2023
• 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): Required Intervention; Other
• Patient Age: 40 YR
• Patient Sex: Female