| Model Number ESS305 |
| Device Problems
Break (1069); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); Insufficient Information (3190)
|
| Patient Problems
Pain (1994); Pelvic Inflammatory Disease (2000); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Genital Bleeding (4507)
|
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('essure fragmented'), device dislocation ('essure dislocated') and uterine inflammation ('uterine inflammation') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), uterine inflammation (seriousness criterion medically significant), pelvic pain ("sharp pelvic pain"), breast pain ("mastalgia"), abdominal distension ("distension"), oedema ("edema"), headache ("intense headache"), pain in extremity ("pain in legs"), peripheral swelling ("swelling of legs"), hypoaesthesia ("numbness"), tremor ("tremor"), back pain ("lumbar pain"), feeling abnormal ("uterine perforation sensation"), pain nos ("sharp pain"), fatigue ("fatigue"), loss of libido ("loss of libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), general body pain ("generalized body pain") and vaginal discharge ("vaginal discharge with odor") and experienced menorrhagia ("prolonged and heavy menstruation with clots"), lasting 15 days.The patient was treated with analgesics and diclofenac diethylamine (anti inflammatory).Essure treatment was not changed.At the time of the report, the device breakage, device dislocation, uterine inflammation, pelvic pain, breast pain, abdominal distension, oedema, headache, pain in extremity, peripheral swelling, hypoaesthesia, tremor, back pain, feeling abnormal, pain nos, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, general body pain and vaginal discharge had not resolved and the menorrhagia had resolved.The reporter considered abdominal distension, adenomyosis, alopecia, arthralgia, back pain, breast pain, coital bleeding, device breakage, device dislocation, dyspareunia, fatigue, feeling abnormal, headache, hypoaesthesia, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, oedema, pain in extremity, pain nos, pelvic pain, peripheral swelling, tremor, uterine inflammation, vaginal discharge and general body pain to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on (b)(6) 2019: essure dislocated and fragmented.Further company follow-up with the consumer is not possible.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 device breakage ('essure fragmented'), device dislocation ('essure dislocated') and uterine inflammation ('uterine inflammation').In a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), uterine inflammation (seriousness criteria medically significant and intervention required), pelvic pain ("sharp pelvic pain"), breast pain ("mastalgia"), abdominal distension ("distension"), oedema ("edema"), headache ("intense headache"), pain in extremity ("pain in legs"), peripheral swelling ("swelling of legs"), hypoaesthesia ("numbness"), tremor ("tremor"), back pain ("lumbar pain"), uterine pain ("uterine perforation sensation"), pain ("sharp pain"), fatigue ("fatigue"), loss of libido ("loss of libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), general body pain ("generalized body pain") and vaginal discharge ("vaginal discharge with odor").And experienced menorrhagia ("prolonged and heavy menstruation with clots"), lasting 15 days.The patient was treated with analgesics and diclofenac diethylamine (anti inflammatory).Essure treatment was not changed.At the time of the report, the device breakage, device dislocation, uterine inflammation, pelvic pain, breast pain, abdominal distension, oedema, headache, pain in extremity, peripheral swelling, hypoaesthesia, tremor, back pain, uterine pain, pain, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, general body pain and vaginal discharge had not resolved.And the menorrhagia had resolved.The reporter considered abdominal distension, adenomyosis, alopecia, arthralgia, back pain, breast pain, coital bleeding, device breakage, device dislocation, dyspareunia, fatigue, headache, hypoaesthesia, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, oedema, pain, pain in extremity, pelvic pain, peripheral swelling, tremor, uterine inflammation, uterine pain, vaginal discharge and general body pain to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray: on (b)(6) 2019, essure dislocated and fragmented.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer is not possible.Most recent follow-up information incorporated above includes: on 29-jun-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 reported by a lawyer and describes the occurrence of device breakage ('essure fragmented'), device dislocation ('essure dislocated') and uterine inflammation ('uterine inflammation') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), uterine inflammation (seriousness criteria medically significant and intervention required), pelvic pain ("sharp pelvic pain"), breast pain ("mastalgia"), abdominal distension ("distension"), oedema ("edema"), headache ("intense headache"), pain in extremity ("pain in legs"), peripheral swelling ("swelling of legs"), hypoaesthesia ("numbness"), tremor ("tremor"), back pain ("lumbar pain"), uterine pain ("uterine perforation sensation"), pain ("sharp pain"), fatigue ("fatigue"), loss of libido ("loss of libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), general body pain ("generalized body pain") and vaginal discharge ("vaginal discharge with odor") and experienced menorrhagia ("prolonged and heavy menstruation with clots"), lasting 15 days.The patient was treated with analgesics and diclofenac diethylamine (anti inflammatory).Essure treatment was not changed.At the time of the report, the device breakage, device dislocation, uterine inflammation, pelvic pain, breast pain, abdominal distension, oedema, headache, pain in extremity, peripheral swelling, hypoaesthesia, tremor, back pain, uterine pain, pain, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, general body pain and vaginal discharge had not resolved and the menorrhagia had resolved.The reporter considered abdominal distension, adenomyosis, alopecia, arthralgia, back pain, breast pain, coital bleeding, device breakage, device dislocation, dyspareunia, fatigue, headache, hypoaesthesia, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, oedema, pain, pain in extremity, pelvic pain, peripheral swelling, tremor, uterine inflammation, uterine pain, vaginal discharge and general body pain to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray on (b)(6) 2019: essure dislocated and fragmented.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer is not possible.Most recent follow-up information incorporated above includes: on 29-jun-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 (subsequently medically confirmed) and describes the occurrence of pelvic pain ("sharp pelvic pain / chronic pelvic pain"), device breakage ("essure fragmented"), device dislocation ("essure dislocated") and uterine inflammation ("uterine inflammation") in a 40 year-old female patient who had essure inserted.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2022, 2854 days after essure insertion and 447 days after its most recent use, she experienced nephrolithiasis ("kidney stones bilateral").An unknown time later she experienced pelvic pain (seriousness criteria medically important and intervention required), device breakage (seriousness criterion medically important), device dislocation (seriousness criterion medically important), uterine inflammation (seriousness criterion medically important), breast pain ("mastalgia"), abdominal distension ("distension"), oedema ("edema"), heavy menstrual bleeding ("prolonged and heavy menstruation with clots"), headache ("intense headache"), pain in extremity ("pain in legs"), peripheral swelling ("swelling of legs"), hypoaesthesia ("numbness"), tremor ("tremor"), back pain ("lumbar pain"), uterine pain ("uterine perforation sensation"), pain ("sharp pain"), fatigue ("fatigue"), loss of libido ("loss of libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), general body pain ("generalized body pain"), vaginal discharge ("vaginal discharge with odor"), dizziness ("constant dizziness"), abdominal pain lower ("lower abdominal pain") and paraesthesia ("tingling sensation").The patient was treated with analgesics and anti inflammatory (diclofenac diethylamine) as well as surgery (salpingectomy on (b)(6) 2020).Essure was removed on (b)(6) 2020.At the time of the report, the heavy menstrual bleeding had resolved and the pelvic pain, device breakage, device dislocation, uterine inflammation, breast pain, abdominal distension, oedema, headache, pain in extremity, peripheral swelling, hypoaesthesia, tremor, back pain, uterine pain, pain, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, general body pain and vaginal discharge had not resolved.The outcomes for dizziness, abdominal pain lower, paraesthesia and nephrolithiasis were unknown.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, arthralgia, back pain, breast pain, coital bleeding, device breakage, device dislocation, dizziness, dyspareunia, fatigue, headache, heavy menstrual bleeding, hypoaesthesia, intra-abdominal fluid collection, loss of libido, mood altered, oedema, pain, general body pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, tremor, uterine inflammation, uterine pain and vaginal discharge to be related to essure administration.No causality assessment was received for essure with regard to nephrolithiasis.The reporter commented: essure insertion information: description: 1- patient in gynecological position.2- placed a collin nº2 vaginal speculum.3- introduction of the 2.9mm 30º hysteroscope with double lume "bettocchi" type inner jacket through the external orifice and cervical canal until it surpasses the internal orifice of the cervix.4- visualization of the cervical canal, without alterations.5- visualization of the uterine cavity without alterations with patent right and left tubal ostia.6- introduction of the essure microdevice into the right tubal ostium, then introduction into the left tubal ostium.7- removed medical instruments.8- removed patient from gynecological position.9- the patient was instructed to continue the contraceptive method for another 90 days until returning for a review.Salpingectomy / essure removal sugery description: 1.Bladder catheterization under aseptic technique.2.Position: horizontal supine position.3.Broad antisepsis + placement of sterile drapes.4.Suprapubic transverse incision.5.Opening the abdominal wall in planes with proper hemostasis care.6.Cavity inventory: uterus and annex without alterations, without adhesions, without signs of perforation and without inflammatory characteristics; on bilateral tubal palpation, we noticed an essure device in both tubes, located entirely in the middle and distal portion of the tube on the right, and on the left with a small portion in the isthmic region.7.On the left: identification, clamping, sectioning and ligation of the mesosalpinx was performed until it was completely released, coagulation of the entire circumference of the tube in its isthmic portion, release of fibrosis from the device, its clamping with the traction forceps and complete removal of its isthmic portion with removal en bloc with the tube.8.Right: identification, clamping, section and ligation of the mesosalpinx with removal of the tube after confirmation of the complete presence of the device.9.Rigorous review of hemostasis.10.Closure of the abdominal wall in layers with proper hemostasis care.11.Intradermal suture of the skin.12.Compressive dressing.13.Biological material sent for histopathological study.Diagnostic results (normal ranges are provided in parenthesis if available): [computerised tomogram] on (b)(6) 2022: 6mm obstructive stone in left uvj causing mild ureterohydronephrosis [pathology test] on (b)(6) 2021: "left tube" = fragmented fallopian tube measuring together 7.0 x 1.0 cm.Congested and smooth outer surface.When cutting, the light is virtual and the wall is thin and filled with spongy material."right tube" = fragmented fallopian tube measuring together 4.0 x 0.7 cm.Congested and smooth outer surface.When cutting, the light is virtual and the wall is thin and filled with spongy material.Conclusion: both fallopian tubes: vasocongestion and edema [ultrasound scan] on (b)(6) 2020: transvaginal: uterus in anteversoflexion with a volume of 80cm³, endometrium of 4mm; right ostium 2.68cm³; left ostium 1.91 cm³; normopositioned essures.; on (b)(6) 2022: microlithiasis in the right kidney (3mm) and in the left kidney, with a 7mm kidney stone [x-ray] on (b)(6) 2019: abdominal: two dense linear images measuring approximately 35mm, located in right and left pelvic cavity topography suggestive of essure.; on (b)(6) 2019: essure dislocated and fragmented.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 26-aug-2022: patient date of birth informed; essure start and stop date updated; adverse events "constant dizziness"; "lower abdominal pain"; "tingling sensation"; "kidney stones bilateral" added to the case; lab data updated.Further company follow-up with the consumer is not possible.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 (subsequently medically confirmed) and describes the occurrence of pelvic pain ("sharp pelvic pain / chronic pelvic pain"), device breakage ("essure fragmented"), device dislocation ("essure dislocated") and uterine inflammation ("uterine inflammation") in a 40 year-old female patient who had essure inserted.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2022, 2854 days after essure insertion and 447 days after its most recent use, she experienced nephrolithiasis ("kidney stones bilateral").An unknown time later she experienced pelvic pain (seriousness criteria medically important and intervention required), device breakage (seriousness criterion medically important), device dislocation (seriousness criterion medically important), uterine inflammation (seriousness criterion medically important), breast pain ("mastalgia"), abdominal distension ("distension"), oedema ("edema"), heavy menstrual bleeding ("prolonged and heavy menstruation with clots"), headache ("intense headache"), pain in extremity ("pain in legs"), peripheral swelling ("swelling of legs"), hypoaesthesia ("numbness"), tremor ("tremor"), back pain ("lumbar pain"), uterine pain ("uterine perforation sensation"), pain ("sharp pain"), fatigue ("fatigue"), loss of libido ("loss of libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), general body pain ("generalized body pain"), vaginal discharge ("vaginal discharge with odor"), dizziness ("constant dizziness"), abdominal pain lower ("lower abdominal pain") and paraesthesia ("tingling sensation").The patient was treated with analgesics and anti inflammatory (diclofenac diethylamine) as well as surgery (salpingectomy on (b)(6) 2020).At the time of the report, the heavy menstrual bleeding had resolved and the pelvic pain, device breakage, device dislocation, uterine inflammation, breast pain, abdominal distension, oedema, headache, pain in extremity, peripheral swelling, hypoaesthesia, tremor, back pain, uterine pain, pain, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, general body pain and vaginal discharge had not resolved.The outcomes for dizziness, abdominal pain lower, paraesthesia and nephrolithiasis were unknown.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, arthralgia, back pain, breast pain, coital bleeding, device breakage, device dislocation, dizziness, dyspareunia, fatigue, headache, heavy menstrual bleeding, hypoaesthesia, intra-abdominal fluid collection, loss of libido, mood altered, oedema, pain, general body pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, tremor, uterine inflammation, uterine pain and vaginal discharge to be related to essure administration.No causality assessment was received for essure with regard to nephrolithiasis.The reporter commented: essure insertion information: description: 1- patient in gynecological position.2- placed a collin nº2 vaginal speculum.3- introduction of the 2.9mm 30º hysteroscope with double lume "bettocchi" type inner jacket through the external orifice and cervical canal until it surpasses the internal orifice of the cervix.4- visualization of the cervical canal, without alterations.5- visualization of the uterine cavity without alterations with patent right and left tubal ostia.6- introduction of the essure microdevice into the right tubal ostium, then introduction into the left tubal ostium.7- removed medical instruments.8- removed patient from gynecological position.9- the patient was instructed to continue the contraceptive method for another 90 days until returning for a review.Salpingectomy / essure removal sugery description: 1.Bladder catheterization under aseptic technique.2.Position: horizontal supine position.3.Broad antisepsis + placement of sterile drapes.4.Suprapubic transverse incision.5.Opening the abdominal wall in planes with proper hemostasis care.6.Cavity inventory: uterus and annex without alterations, without adhesions, without signs of perforation and without inflammatory characteristics; on bilateral tubal palpation, we noticed an essure device in both tubes, located entirely in the middle and distal portion of the tube on the right, and on the left with a small portion in the isthmic region.7.On the left: identification, clamping, sectioning and ligation of the mesosalpinx was performed until it was completely released, coagulation of the entire circumference of the tube in its isthmic portion, release of fibrosis from the device, its clamping with the traction forceps and complete removal of its isthmic portion with removal en bloc with the tube.8.Right: identification, clamping, section and ligation of the mesosalpinx with removal of the tube after confirmation of the complete presence of the device.9.Rigorous review of hemostasis.10.Closure of the abdominal wall in layers with proper hemostasis care.11.Intradermal suture of the skin.12.Compressive dressing.13.Biological material sent for histopathological study.Diagnostic results (normal ranges are provided in parenthesis if available): [computerised tomogram] on (b)(6) 2022: 6mm obstructive stone in left uvj causing mild ureterohydronephrosis [pathology test] on (b)(6) 2021: "left tube" = fragmented fallopian tube measuring together 7.0 x 1.0 cm.Congested and smooth outer surface.When cutting, the light is virtual and the wall is thin and filled with spongy material."right tube" = fragmented fallopian tube measuring together 4.0 x 0.7 cm.Congested and smooth outer surface.When cutting, the light is virtual and the wall is thin and filled with spongy material.Conclusion: both fallopian tubes: vasocongestion and edema [ultrasound scan] on (b)(6) 2020: transvaginal: uterus in anteversoflexion with a volume of 80cm³, endometrium of 4mm; right ostium 2.68cm³; left ostium 1.91 cm³; normopositioned essures.; on (b)(6) 2022: microlithiasis in the right kidney (3mm) and in the left kidney, with a 7mm kidney stone [x-ray] on (b)(6) 2019: abdominal: two dense linear images measuring approximately 35mm, located in right and left pelvic cavity topography suggestive of essure.; on (b)(6) 2019: essure dislocated and fragmented.Quality-safety evaluation of ptc: for essure: 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.The most recent follow-up information incorporated above includes data received on: 01-sep-2022: quality safety evaluation of product technical complaint.Further company follow-up with the consumer is not possible.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 (subsequently medically confirmed) and describes the occurrence of pelvic pain ("sharp pelvic pain / chronic pelvic pain"), device breakage ("essure fragmented"), device dislocation ("essure dislocated") and uterine inflammation ("uterine inflammation") in a 36 year-old female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of caesarean section, vaginal bleeding, spontaneous abortion, parity 3 and multi gravida.The only concomitant product mentioned was doralgina dipcaf (caffeine;metamizole sodium).On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2017, 1230 days after essure insertion, she experienced vulvovaginal burning sensation ("burning in the vagina prescribed lubricant").On (b)(6) 2019 she experienced synovial cyst ("synovial cyst").On (b)(6) 2019 she experienced ocular hyperaemia ("bloodshot eyes").On (b)(6) 2019 she experienced toothache ("toothache").On (b)(6) 2019 she experienced oropharyngeal pain ("sore throat after eating fish").On (b)(6) 2022 she experienced nephrolithiasis ("kidney stones bilateral").An unknown time later she experienced pelvic pain (seriousness criteria medically important and intervention required), device breakage (seriousness criterion medically important), device dislocation (seriousness criterion medically important), uterine inflammation (seriousness criterion medically important), breast pain ("mastalgia"), abdominal distension ("distension"), oedema ("edema"), heavy menstrual bleeding ("prolonged and heavy menstruation with clots"), headache ("intense headache"), pain in extremity ("pain in legs"), peripheral swelling ("swelling of legs"), hypoaesthesia ("numbness"), tremor ("tremor"), back pain ("lumbar pain"), uterine pain ("uterine perforation sensation"), pain ("sharp pain"), fatigue ("fatigue"), loss of libido ("loss of libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), general body pain ("generalized body pain"), vaginal discharge ("vaginal discharge with odor"), dizziness ("constant dizziness"), abdominal pain lower ("lower abdominal pain"), paraesthesia ("tingling sensation") and fallopian tube enlargement ("oedema¿ in both uterine tubes").The patient was treated with analgesics, anti inflammatory (diclofenac diethylamine) and dipyrone (metamizole sodium) as well as surgery (salpingectomy on 22-dec-2020).At the time of the report, the heavy menstrual bleeding had resolved and the pelvic pain, device breakage, device dislocation, uterine inflammation, breast pain, abdominal distension, oedema, headache, pain in extremity, peripheral swelling, hypoaesthesia, tremor, back pain, uterine pain, pain, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, general body pain and vaginal discharge had not resolved.The outcomes for dizziness, abdominal pain lower, paraesthesia, nephrolithiasis, oropharyngeal pain, toothache, ocular hyperaemia, synovial cyst, fallopian tube enlargement and vulvovaginal burning sensation were unknown.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, arthralgia, back pain, breast pain, coital bleeding, device breakage, device dislocation, dizziness, dyspareunia, fallopian tube enlargement, fatigue, headache, heavy menstrual bleeding, hypoaesthesia, intra-abdominal fluid collection, loss of libido, mood altered, ocular hyperaemia, oedema, oropharyngeal pain, pain, general body pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, synovial cyst, toothache, tremor, uterine inflammation, uterine pain, vaginal discharge and vulvovaginal burning sensation to be related to essure administration.No causality assessment was received for essure with regard to nephrolithiasis.The reporter commented: essure insertion information: description: 1- patient in gynecological position.2- placed a collin nº2 vaginal speculum.3- introduction of the 2.9mm 30º hysteroscope with double lume "bettocchi" type inner jacket through the external orifice and cervical canal until it surpasses the internal orifice of the cervix.4- visualization of the cervical canal, without alterations.5- visualization of the uterine cavity without alterations with patent right and left tubal ostia.6- introduction of the essure microdevice into the right tubal ostium, then introduction into the left tubal ostium.7- removed medical instruments.8- removed patient from gynecological position.9- the patient was instructed to continue the contraceptive method for another 90 days until returning for a review.Salpingectomy / essure removal sugery description: 1.Bladder catheterization under aseptic technique.2.Position: horizontal supine position.3.Broad antisepsis + placement of sterile drapes.4.Suprapubic transverse incision.5.Opening the abdominal wall in planes with proper hemostasis care.6.Cavity inventory: uterus and annex without alterations, without adhesions, without signs of perforation and without inflammatory characteristics; on bilateral tubal palpation, we noticed an essure device in both tubes, located entirely in the middle and distal portion of the tube on the right, and on the left with a small portion in the isthmic region.7.On the left: identification, clamping, sectioning and ligation of the mesosalpinx was performed until it was completely released, coagulation of the entire circumference of the tube in its isthmic portion, release of fibrosis from the device, its clamping with the traction forceps and complete removal of its isthmic portion with removal en bloc with the tube.8.Right: identification, clamping, section and ligation of the mesosalpinx with removal of the tube after confirmation of the complete presence of the device.9.Rigorous review of hemostasis.10.Closure of the abdominal wall in layers with proper hemostasis care.11.Intradermal suture of the skin.12.Compressive dressing.13.Biological material sent for histopathological study.Diagnostic results (normal ranges are provided in parenthesis if available): [computerised tomogram] on (b)(6) 2022: 6mm obstructive stone in left uvj causing mild ureterohydronephrosis [pathology test] on (b)(6) 2021: "left tube" = fragmented fallopian tube measuring together 7.0 x 1.0 cm.Congested and smooth outer surface.When cutting, the light is virtual and the wall is thin and filled with spongy material."right tube" = fragmented fallopian tube measuring together 4.0 x 0.7 cm.Congested and smooth outer surface.When cutting, the light is virtual and the wall is thin and filled with spongy material.Conclusion: both fallopian tubes: vasocongestion and edema [ultrasound scan] on (b)(6) 2020: transvaginal: uterus in anteversoflexion with a volume of 80cm³, endometrium of 4mm; right ostium 2.68cm³; left ostium 1.91 cm³; normopositioned essures.; on (b)(6) 2022: microlithiasis in the right kidney (3mm) and in the left kidney, with a 7mm kidney stone [x-ray] on (b)(6) 2019: which makes it difficult to determine the proper positioning of the implants; on (b)(6) 2019: abdominal: two dense linear images measuring approximately 35mm, located in right and left pelvic cavity topography suggestive of essure.; on (b)(6)2019: essure dislocated and fragmented quality-safety evaluation of ptc: for essure: 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.The most recent follow-up information incorporated above includes data received on: 23-nov-2023: quality safety evaluation of ptc.Further company follow-up with the consumer is not possible.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 (subsequently medically confirmed) and describes the occurrence of pelvic pain ("sharp pelvic pain / chronic pelvic pain"), device breakage ("essure fragmented"), device dislocation ("essure dislocated") and uterine inflammation ("uterine inflammation") in a 36 year-old female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of caesarean section, vaginal bleeding, spontaneous abortion, parity 3 and multi gravida.The only concomitant product mentioned was doralgina dipcaf (caffeine;metamizole sodium).On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2017, 1230 days after essure insertion, she experienced vulvovaginal burning sensation ("burning in the vagina prescribed lubricant").On (b)(6) 2019 she experienced synovial cyst ("synovial cyst").On(b)(6) 2019 she experienced ocular hyperaemia ("bloodshot eyes").On (b)(6) 2019 she experienced toothache ("toothache").On (b)(6) 2019 she experienced oropharyngeal pain ("sore throat after eating fish").On (b)(6) 2022 she experienced nephrolithiasis ("kidney stones bilateral").An unknown time later she experienced pelvic pain (seriousness criteria medically important and intervention required), device breakage (seriousness criterion medically important), device dislocation (seriousness criterion medically important), uterine inflammation (seriousness criterion medically important), breast pain ("mastalgia"), abdominal distension ("distension"), oedema ("edema"), heavy menstrual bleeding ("prolonged and heavy menstruation with clots"), headache ("intense headache"), pain in extremity ("pain in legs"), peripheral swelling ("swelling of legs"), hypoaesthesia ("numbness"), tremor ("tremor"), back pain ("lumbar pain"), uterine pain ("uterine perforation sensation"), pain ("sharp pain"), fatigue ("fatigue"), loss of libido ("loss of libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), general body pain ("generalized body pain"), vaginal discharge ("vaginal discharge with odor"), dizziness ("constant dizziness"), abdominal pain lower ("lower abdominal pain"), paraesthesia ("tingling sensation") and fallopian tube enlargement ("oedema¿ in both uterine tubes").The patient was treated with analgesics, anti inflammatory (diclofenac diethylamine) and dipyrone (metamizole sodium) as well as surgery (salpingectomy on (b)(6) 2020).At the time of the report, the heavy menstrual bleeding had resolved and the pelvic pain, device breakage, device dislocation, uterine inflammation, breast pain, abdominal distension, oedema, headache, pain in extremity, peripheral swelling, hypoaesthesia, tremor, back pain, uterine pain, pain, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, general body pain and vaginal discharge had not resolved.The outcomes for dizziness, abdominal pain lower, paraesthesia, nephrolithiasis, oropharyngeal pain, toothache, ocular hyperaemia, synovial cyst, fallopian tube enlargement and vulvovaginal burning sensation were unknown.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, arthralgia, back pain, breast pain, coital bleeding, device breakage, device dislocation, dizziness, dyspareunia, fallopian tube enlargement, fatigue, headache, heavy menstrual bleeding, hypoaesthesia, intra-abdominal fluid collection, loss of libido, mood altered, ocular hyperaemia, oedema, oropharyngeal pain, pain, general body pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, synovial cyst, toothache, tremor, uterine inflammation, uterine pain, vaginal discharge and vulvovaginal burning sensation to be related to essure administration.No causality assessment was received for essure with regard to nephrolithiasis.The reporter commented: essure insertion information: description: 1- patient in gynecological position.2- placed a collin nº2 vaginal speculum.3- introduction of the 2.9mm 30º hysteroscope with double lume "bettocchi" type inner jacket through the external orifice and cervical canal until it surpasses the internal orifice of the cervix.4- visualization of the cervical canal, without alterations.5- visualization of the uterine cavity without alterations with patent right and left tubal ostia.6- introduction of the essure microdevice into the right tubal ostium, then introduction into the left tubal ostium.7- removed medical instruments.8- removed patient from gynecological position.9- the patient was instructed to continue the contraceptive method for another 90 days until returning for a review.Salpingectomy / essure removal sugery description: 1.Bladder catheterization under aseptic technique.2.Position: horizontal supine position.3.Broad antisepsis + placement of sterile drapes.4.Suprapubic transverse incision.5.Opening the abdominal wall in planes with proper hemostasis care.6.Cavity inventory: uterus and annex without alterations, without adhesions, without signs of perforation and without inflammatory characteristics; on bilateral tubal palpation, we noticed an essure device in both tubes, located entirely in the middle and distal portion of the tube on the right, and on the left with a small portion in the isthmic region.7.On the left: identification, clamping, sectioning and ligation of the mesosalpinx was performed until it was completely released, coagulation of the entire circumference of the tube in its isthmic portion, release of fibrosis from the device, its clamping with the traction forceps and complete removal of its isthmic portion with removal en bloc with the tube.8.Right: identification, clamping, section and ligation of the mesosalpinx with removal of the tube after confirmation of the complete presence of the device.9.Rigorous review of hemostasis.10.Closure of the abdominal wall in layers with proper hemostasis care.11.Intradermal suture of the skin.12.Compressive dressing.13.Biological material sent for histopathological study.Diagnostic results (normal ranges are provided in parenthesis if available): [computerised tomogram] on (b)(6) 2022: 6mm obstructive stone in left uvj causing mild ureterohydronephrosis.[pathology test] on (b)(6) 2021: "left tube" = fragmented fallopian tube measuring together 7.0 x 1.0 cm.Congested and smooth outer surface.When cutting, the light is virtual and the wall is thin and filled with spongy material."right tube" = fragmented fallopian tube measuring together 4.0 x 0.7 cm.Congested and smooth outer surface.When cutting, the light is virtual and the wall is thin and filled with spongy material.Conclusion: both fallopian tubes: vasocongestion and edema.[ultrasound scan] on (b)(6) 2020: transvaginal: uterus in anteversoflexion with a volume of 80cm³, endometrium of 4mm; right ostium 2.68cm³; left ostium 1.91 cm³; normopositioned essures.; on (b)(6) 2022: microlithiasis in the right kidney (3mm) and in the left kidney, with a 7mm kidney stone.[x-ray] on (b)(6) 2019: which makes it difficult to determine the proper positioning of the implants; on (b)(6) 2019: abdominal: two dense linear images measuring approximately 35mm, located in right and left pelvic cavity topography suggestive of essure.; on (b)(6) 2019: essure dislocated and fragmented.Quality-safety evaluation of ptc: for essure: 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.The most recent follow-up information incorporated above includes data received on: 11-oct-2023: medical record received.Synovial cyst, bloodshot eyes, sore throat & tooth ache & uterine enlargement, burning in the vagina prescribed lubricant added.Medical history, concomitant drugs, lab data & reporter information updated.Further company follow-up with the consumer is not possible.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.
|
| |
|
Search Alerts/Recalls
|
|
