| Model Number ESS305 |
| Device Problems
Break (1069); Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590); Patient-Device Incompatibility (2682); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Fatigue (1849); Skin Irritation (2076); Thyroid Problems (2102); Uterine Perforation (2121); Abnormal Vaginal Discharge (2123); Anxiety (2328); Weight Changes (2607); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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| Event Date 07/30/2013 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of the first episode of uterine perforation ("on the left, the essure insert protruded from the left cornua, just next to the root of the tube / uterine cornua had been perforated by the device during the first procedure / the device on the left had perforated the uterine cornua"), pelvic adhesions ("pelvic adhesion / filiform adhesion with the lower part in the omental fat / small adhesion, measuring about 1 cm / removed an adhesion with the omentum"), the second episode of uterine perforation ("device on the right was probably ectopic/ right insert was not visible/ no device found on the right/ implant having probably migrated to the greater omentum/ insert situated in greater omentum, probably corresponding to the right, had perforated") and device breakage ("presence of a small fragment separated from the lower part of the insert on the right, also apparently in an intraperitoneal position") in a (b)(6)-year-old female patient who had essure (batch no.A82457, a69943) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use error "initial attempt to place the insert on the right led to an irreversible kink in the first device.Biopsy forceps were used to enlarge the tubal orifices, which subsequently made it possible to insert the essure inserts" on (b)(6) 2013, device difficult to use "initial attempt to place the insert on the right led to an irreversible kink in the first device.Biopsy forceps were used to enlarge the tubal orifices, which subsequently made it possible to insert the essure inserts" on (b)(6) 2013 and wrong technique in device usage process "the device on the left had perforated the uterine cornua.He had cut off the projecting part / extremity that protruded from cornua was cut" on (b)(6) 2014.The patient's past medical history included parity 3 (first child, male baby born on (b)(6) / second child, male baby born on (b)(6) / third child, female baby born on (b)(6)) and multigravida.The patient had no pain prior to the procedures that were performed.Concurrent conditions included local anaesthesia since (b)(6) 2013.Concomitant products included meglumine gadoterate (dotarem) since (b)(6) 2014.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced the first episode of uterine perforation (seriousness criteria medically significant and intervention required) with abdominal pain lower, procedural pain ("procedure was much more painful than had been led to believe / the post-operative course was particularly complicated for her, as she experienced sharp pain, estimated at 9 on a scale of 10") and complication of device insertion ("failed in his attempt to place the insert on the right / unilateral failure of placement of tubal sterilisation with essure / procedure duration requiring 45 minutes instead of 10 minutes").In (b)(6) 2013, the patient experienced the second episode of uterine perforation (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient experienced pelvic adhesions (seriousness criteria medically significant and intervention required), pelvic fluid collection ("slight pelvic effusion of 2 to 4 cc of orangey liquid was present") and complication of device removal ("one small metallic fragment was in the left uterine cornua, compatible with a residual fragment of the insert").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), asthenia ("feels weakened, both physically and morally / loss of energy"), fatigue ("fatigability"), anxiety ("she now lives with the anxiety that she will suffer perforation of the internal organs, given the presence of the fragments"), eczema ("eczema as result of the anxiety caused by the situation"), thyroid mass ("thyroid nodule"), decreased appetite ("loss of appetite") and weight decreased ("marked weight loss since placement of the inserts").The patient was treated with anxiolytics, etifoxine hydrochloride (stresam), betamethasone dipropionate (diprosone), calcipotriol (daivonex), ketoprofen (bi-profenid), omeprazole (omeprazol), paracetamol (dafalgan), phloroglucinol (spasfon-lyoc), paracetamol (paralyoc), naproxen sodium (apranax), betamethasone dipropionate (diprosone), paracetamol (efferalgan), fexofenadine (telfast), alprazolam (xanax), zopiclone (imovane), alprazolam, paracetamol, spasfon, surgery (video-assisted laparoscopy on (b)(6) 2014: cut off the projecting part, lysis of pelvic adhesions/ removed an adhesion with the omentum).At the time of the report, the pelvic adhesions, procedural pain, complication of device insertion, the last episode of uterine perforation, device breakage, pelvic fluid collection, complication of device removal, thyroid mass, decreased appetite and weight decreased outcome was unknown and the asthenia, fatigue, anxiety and eczema had not resolved.The reporter considered anxiety, asthenia, complication of device insertion, decreased appetite, device breakage, complication of device removal, eczema, fatigue, pelvic adhesions, pelvic fluid collection, procedural pain, thyroid mass, weight decreased, the first episode of uterine perforation and the second episode of uterine perforation to be related to essure.The reporter commented: on (b)(6) 2013 vaginoscopy and catheter insertion of uterine cervix were done with no difficulty leading to good visibility of uterine cavity, which was normal in size.Tubal ostia appeared to be narrow and punctiform.Biopsy forceps were used to enlarge tubal orifices, which subsequently made possible to insert essure with no difficulty, leaving 4 or 5 trailing spires on right and 3 or 4 trailing spires visible in left uterine cornua (batch number a82457 on left and right, and batch a69943 on left).In view of the failure to place essure on one side and the fact that the device on the right was probably ectopic, physician planned to do a further procedure by exploratory laparoscopy.On (b)(6) 2014 video-assisted laparoscopy for bilateral tubal sterilisation with hulka clips + lysis of pelvic adhesions were performed.The hulka clip was placed on proximal portion of uterine tubes.The rest of the abdominal exploration found nothing abnormal.The uterus was normal in size and position, fallopian tubes and ovaries were normal in appearance.No suspect peritoneal granulation was noted and no signs of external endometriosis.On the left, essure created a filiform adhesion with the lower part in omental fat, where most of the length of the device was located.Small adhesion, measuring about 1 cm, was coagulated with bipolar forceps and sectioned without incident, flush with the wall of uterine cavity.On the right, investigation of entire pelvic cavity and lower part of abdomen proved to be negative.Letter from physician described that he removed an adhesion with the omentum.On (b)(6) 2014 other doctor stated that if they wanted to remove the inserts, it would be necessary to perform omentectomy.It was reported that she also received the treatment drug advilmed 400 mg in (b)(6) 2014, and aprana 550 mg in (b)(6) 2017.She now lives with the anxiety that she will suffer perforation of internal organs, given the presence of the fragments.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6) kg/sqm.On (b)(6) 2013, in the context of the confirmatory test on obstruction of the fallopian tubes, physician provided to the patient with a prescription to undergo hysterosalpingography in a radiology centre within 5 days after the end of menstruation, in the absence of any vaginal discharge or pelvic pain.An ultrasonographic check was performed at the same time.On (b)(6) 2013 hysterography did not find satisfactory tubal opacification.The essure insert seems to be correctly positioned on the left, and the position of the insert on the right was not satisfactory.The tube was not opacified.On (b)(6) 2014, x-ray found presence of two radio-opaque inserts parallel to the pelvic plan.The inserts were correctly deployed.On both sides, three radio-opaque landmarks within the inserts were visualised, and the fourth was remote from the insert.The precise topography of the inserts could not be determined.Radio-opaque clips were present in the lateral pelvic region.In (b)(6) 2014, plain film of abdomen showed the two essure inserts in the abdomen, in addition to the clips.It would appear that the insert on the right, which had not been visualised on laparoscopy, was perhaps in place in the fallopian tube.Pelvic mri on (b)(6) 2014 showed one essure insert in the left cornua and the other seems to have migrated.The insert on the left had been found and had partially perforated the uterine tube, however the essure on the right was not visualised.Several images of metallic fragments, compatible with the inserts, were present in addition to the two tubal clips: one small metallic fragment was in the left uterine cornua, compatible with a residual fragment of the insert.Images corresponding to the essure inserts situated anterior to the uterus, one in a horizontal left para-median position and the other situated in a higher vertical right para-median position, implant having probably migrated to the greater omentum.Presence of a small fragment separated from the lower part of the insert on the right, also apparently in an intraperitoneal position.On (b)(6) 2014 it was noted that a fragment of the insert remains in the left uterine cornua.There are three small fragments of the inserts, situated in the greater omentum, probably corresponding to the insert on the right, which had perforated.A fragment of the insert on the left remains, since the extremity that protruded from cornua was cut off.Blood tests, as well as ultrasound are to be performed shortly since the patient has been found to have a thyroid nodule.Thyroid ultrasound and blood test were also prescribed.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred terms: uterine perforation.The analysis in the global safety database revealed 990 cases.Pelvic adhesions.The analysis in the global safety database revealed 20 cases.Device breakage.The analysis in the global safety database revealed 2207 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pts.Further company follow-up with the lawyer is not possible.Incident.At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of the first episode of uterine perforation ("on the left, the essure insert protruded from the left cornua, just next to the root of the tube / uterine cornua had been perforated by the device during the first procedure / the device on the left had perforated the uterine cornua"), peritoneal adhesions ("pelvic adhesion / filiform adhesion with the lower part in the omental fat / small adhesion, measuring about 1 cm / removed an adhesion with the omentum"), the second episode of uterine perforation ("device on the right was probably ectopic/ right insert was not visible/ no device found on the right/ implant having probably migrated to the greater omentum/ insert situated in greater omentum, probably corresponding to the right, had perforated") and device breakage ("presence of a small fragment separated from the lower part of the insert on the right, also apparently in an intraperitoneal position") in a 41-year-old female patient who had essure (batch no.A82457/ a69943) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "initial attempt to place the insert on the right led to an irreversible kink in the first device.Biopsy forceps were used to enlarge the tubal orifices, which subsequently made it possible to insert the essure inserts" on (b)(6) 2013, device use error "initial attempt to place the insert on the right led to an irreversible kink in the first device.Biopsy forceps were used to enlarge the tubal orifices, which subsequently made it possible to insert the essure inserts" on (b)(6) 2013 and wrong technique in device usage process "the device on the left had perforated the uterine cornua.He had cut off the projecting part / extremity that protruded from cornua was cut" on (b)(6) 2014.The patient's past medical history included parity 3 (first child, male baby born on (b)(6) 1995 / second child, male baby born on (b)(6) 2000 / third child, female baby born on (b)(6) 2008) and multigravida.The patient had no pain prior to the procedures that were performed.Concurrent conditions included local anaesthesia since (b)(6) 2013.Concomitant products included meglumine gadoterate (dotarem) since (b)(6) 2014.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced the first episode of uterine perforation (seriousness criteria medically significant and intervention required) with abdominal pain lower, procedural pain ("procedure was much more painful than had been led to believe / the post-operative course was particularly complicated for her, as she experienced sharp pain, estimated at 9 on a scale of 10") and complication of device insertion ("failed in his attempt to place the insert on the right / unilateral failure of placement of tubal sterilisation with essure / procedure duration requiring 45 minutes instead of 10 minutes").In (b)(6) 2013, the patient experienced the second episode of uterine perforation (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient experienced peritoneal adhesions (seriousness criteria medically significant and intervention required), pelvic fluid collection ("slight pelvic effusion of 2 to 4 cc of orangey liquid was present") and complication of device removal ("one small metallic fragment was in the left uterine cornua, compatible with a residual fragment of the insert").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), asthenia ("feels weakened, both physically and morally / loss of energy"), fatigue ("fatigability"), anxiety ("she now lives with the anxiety that she will suffer perforation of the internal organs, given the presence of the fragments"), eczema ("eczema as result of the anxiety caused by the situation"), thyroid mass ("thyroid nodule"), decreased appetite ("loss of appetite") and weight decreased ("marked weight loss since placement of the inserts").The patient was treated with anxiolytics, etifoxine hydrochloride (stresam), betamethasone dipropionate (diprosone), calcipotriol (daivonex), ketoprofen (bi-profenid), omeprazole (omeprazol), paracetamol (dafalgan), phloroglucinol (spasfon-lyoc), paracetamol (paralyoc), naproxen sodium (apranax), betamethasone dipropionate (diprosone), paracetamol (efferalgan), fexofenadine (telfast), alprazolam (xanax), zopiclone (imovane), alprazolam, paracetamol, spasfon, surgery (video-assisted laparoscopy on (b)(6) 2014: cut off the projecting part), surgery (video-assisted laparoscopy 29-jan:lysis of pelvic adhesions/ removed an adhesion with the omentum ) and surgery (video-assisted laparoscopy on (b)(6) 2014).At the time of the report, the peritoneal adhesions, the last episode of uterine perforation, device breakage, procedural pain, complication of device insertion, pelvic fluid collection, complication of device removal, thyroid mass, decreased appetite and weight decreased outcome was unknown and the asthenia, fatigue, anxiety and eczema had not resolved.The reporter considered anxiety, asthenia, complication of device insertion, complication of device removal, decreased appetite, device breakage, eczema, fatigue, pelvic fluid collection, peritoneal adhesions, procedural pain, thyroid mass, weight decreased, the first episode of uterine perforation and the second episode of uterine perforation to be related to essure.The reporter commented: on (b)(6) 2013 vaginoscopy and catheter insertion of uterine cervix were done with no difficulty leading to good visibility of uterine cavity, which was normal in size.Tubal ostia appeared to be narrow and punctiform.Biopsy forceps were used to enlarge tubal orifices, which subsequently made possible to insert essure with no difficulty, leaving 4 or 5 trailing spires on right and 3 or 4 trailing spires visible in left uterine cornua (batch number a82457 on left and right, and batch a69943 on left).In view of the failure to place essure on one side and the fact that the device on the right was probably ectopic, physician planned to do a further procedure by exploratory laparoscopy.On (b)(6) 2014 video-assisted laparoscopy for bilateral tubal sterilisation with hulka clips + lysis of pelvic adhesions were performed.The hulka clip was placed on proximal portion of uterine tubes.The rest of the abdominal exploration found nothing abnormal.The uterus was normal in size and position, fallopian tubes and ovaries were normal in appearance.No suspect peritoneal granulation was noted and no signs of external endometriosis.On the left, essure created a filiform adhesion with the lower part in omental fat, where most of the length of the device was located.Small adhesion, measuring about 1 cm, was coagulated with bipolar forceps and sectioned without incident, flush with the wall of uterine cavity.On the right, investigation of entire pelvic cavity and lower part of abdomen proved to be negative.Letter from physician described that he removed an adhesion with the omentum.On (b)(6) 2014 other doctor stated that if they wanted to remove the inserts, it would be necessary to perform omentectomy.It was reported that she also received the treatment drug advilmed 400 mg in dec-2014, and aprana 550 mg in (b)(6) 2017.She now lives with the anxiety that she will suffer perforation of internal organs, given the presence of the fragments.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 19.5 kg/sqm.On (b)(6) 2013, in the context of the confirmatory test on obstruction of the fallopian tubes, physician provided to the patient ith a prescription to undergo hysterosalpingography in a radiology centre within 5 days after the end of menstruation, in the absence of any vaginal discharge or pelvic pain.An ultrasonographic check was performed at the same time.On (b)(6) 2013 hysterography did not find satisfactory tubal opacification.The essure insert seems to be correctly positioned on the left, and the position of the insert on the right was not satisfactory.The tube was not opacified.On (b)(6) 2014, x-ray found presence of two radio-opaque inserts parallel to the pelvic plan.The inserts were correctly deployed.On both sides, three radio-opaque landmarks within the inserts were visualised, and the fourth was remote from the insert.The precise topography of the inserts could not be determined.Radio-opaque clips were present in the lateral pelvic region.In (b)(6) 2014, plain film of abdomen showed the two essure inserts in the abdomen, in addition to the clips.It would appear that the insert on the right, which had not been visualised on laparoscopy, was perhaps in place in the fallopian tube.Pelvic mri on (b)(6) 2014 showed one essure insert in the left cornua and the other seems to have migrated.The insert on the left had been found and had partially perforated the uterine tube, however the essure on the right was not visualised.Several images of metallic fragments, compatible with the inserts, were present in addition to the two tubal clips: one small metallic fragment was in the left uterine cornua, compatible with a residual fragment of the insert.Images corresponding to the essure inserts situated anterior to the uterus, one in a horizontal left para-median position and the other situated in a higher vertical right para-median position, implant having probably migrated to the greater omentum.Presence of a small fragment separated from the lower part of the insert on the right, also apparently in an intraperitoneal position.On (b)(6) 2014 it was noted that a fragment of the insert remains in the left uterine cornua.There are three small fragments of the inserts, situated in the greater omentum, probably corresponding to the insert on the right, which had perforated.A fragment of the insert on the left remains, since the extremity that protruded from cornua was cut off.Blood tests, as well as ultrasound are to be performed shortly since the patient has been found to have a thyroid nodule.Thyroid ultrasound and blood test were also prescribed.Lot number: a69943, manufacturing date: nov-2012, expiration date: nov-2015.Lot number: a82457, manufacturing date: jan-2013, expiration date: jan-2016.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on 16-mar-2018 for the following meddra preferred terms: uterine perforation.The analysis in the global safety database revealed 1.037 cases.Pelvic adhesions.The analysis in the global safety database revealed 20 cases.Device breakage.The analysis in the global safety database revealed 2.249 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pts.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on 14-mar-2018: quality-safety evaluation of ptc.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of the first episode of uterine perforation ("on the left, the essure insert protruded from the left cornua, just next to the root of the tube / uterine cornua had been perforated by the device during the first procedure / the device on the left had perforated the uterine cornua"), peritoneal adhesions ("pelvic adhesion / filiform adhesion with the lower part in the omental fat / small adhesion, measuring about 1 cm / removed an adhesion with the omentum"), the second episode of uterine perforation ("device on the right was probably ectopic/ right insert was not visible/ no device found on the right/ implant having probably migrated to the greater omentum/ insert situated in greater omentum, probably corresponding to the right, had perforated") and device breakage ("presence of a small fragment separated from the lower part of the insert on the right, also apparently in an intraperitoneal position") in a 41-year-old female patient who had essure (batch no.A82457/ a69943) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "initial attempt to place the insert on the right led to an irreversible kink in the first device.Biopsy forceps were used to enlarge the tubal orifices, which subsequently made it possible to insert the essure inserts" on (b)(6) 2013, device use error "initial attempt to place the insert on the right led to an irreversible kink in the first device.Biopsy forceps were used to enlarge the tubal orifices, which subsequently made it possible to insert the essure inserts" on (b)(6) 2013 and wrong technique in device usage process "the device on the left had perforated the uterine cornua.He had cut off the projecting part / extremity that protruded from cornua was cut" on (b)(6) 2014.The patient's past medical history included parity 3 (first child, male baby born on (b)(6) 1995 / second child, male baby born on (b)(6) 2000 / third child, female baby born on (b)(6) 2008), multigravida, limb injury nos, penicillin allergy and termination of pregnancy - elective in 2005.Pregnancies and deliveries without problem.The patient had no pain prior to the procedures that were performed.Previously administered products included for contraception: oestrogen-progesteron specialties.Past adverse reactions to the above products included hypercholesterolaemia with oestrogen-progesteron specialties.Concurrent conditions included local anaesthesia since (b)(6) 2013.Concomitant products included meglumine gadoterate (dotarem) since (b)(6) 2014.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced the first episode of uterine perforation (seriousness criteria medically significant and intervention required) with abdominal pain lower, procedural pain ("procedure was much more painful than had been led to believe, strong pain during the procedure/ the post-operative course was particularly complicated for her, as she experienced sharp pain, estimated at 9 on a scale of 10") and complication of device insertion ("failed in his attempt to place the insert on the right / unilateral failure of placement of tubal sterilisation with essure / procedure duration requiring 45 minutes instead of 10 minutes").In (b)(6) 2013, the patient experienced the second episode of uterine perforation (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient experienced peritoneal adhesions (seriousness criteria medically significant and intervention required), pelvic fluid collection ("slight pelvic effusion of 2 to 4 cc of orangey liquid was present") and complication of device removal ("one small metallic fragment was in the left uterine cornua, compatible with a residual fragment of the insert").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), asthenia ("feels weakened, both physically and morally / loss of energy"), fatigue ("fatigability"), anxiety ("she now lives with the anxiety that she will suffer perforation of the internal organs, given the presence of the fragments"), eczema ("eczema as result of the anxiety caused by the situation"), thyroid mass ("thyroid nodule"), decreased appetite ("loss of appetite"), weight decreased ("marked weight loss since placement of the inserts") and dyspareunia ("pains during sexual intercourse").The patient was treated with anxiolytics, etifoxine hydrochloride (stresam), betamethasone dipropionate (diprosone), calcipotriol (daivonex), ketoprofen (bi-profenid), omeprazole (omeprazol), paracetamol (dafalgan), phloroglucinol (spasfon-lyoc), paracetamol (paralyoc), naproxen sodium (apranax), betamethasone dipropionate (diprosone), paracetamol (efferalgan), fexofenadine (telfast), alprazolam (xanax), zopiclone (imovane), alprazolam, paracetamol, spasfon, paracetamol (doliprane), surgery (video-assisted laparoscopy on (b)(6) 2014: cut off the projecting part), surgery (video-assisted laparoscopy 29-jan:lysis of pelvic adhesions/ removed an adhesion with the omentum) and surgery (video-assisted laparoscopy on (b)(6) 2014).At the time of the report, the peritoneal adhesions, the last episode of uterine perforation, device breakage, procedural pain, complication of device insertion, pelvic fluid collection, complication of device removal, thyroid mass, decreased appetite, weight decreased and dyspareunia outcome was unknown and the asthenia, fatigue, anxiety and eczema had not resolved.The reporter considered anxiety, asthenia, complication of device insertion, complication of device removal, decreased appetite, device breakage, dyspareunia, eczema, fatigue, pelvic fluid collection, peritoneal adhesions, procedural pain, thyroid mass, weight decreased, the first episode of uterine perforation and the second episode of uterine perforation to be related to essure.The reporter commented: on (b)(6) 2013 vaginoscopy and catheter insertion of uterine cervix were done with no difficulty leading to good visibility of uterine cavity, which was normal in size.Tubal ostia appeared to be narrow and punctiform.Biopsy forceps were used to enlarge tubal orifices, which subsequently made possible to insert essure with no difficulty, leaving 4 or 5 trailing spires on right and 3 or 4 trailing spires visible in left uterine cornua (batch number a82457 on left and right, and batch a69943 on left).In view of the failure to place essure on one side and the fact that the device on the right was probably ectopic, physician planned to do a further procedure by exploratory laparoscopy.On (b)(6) 2014 video-assisted laparoscopy for bilateral tubal sterilisation with hulka clips + lysis of pelvic adhesions were performed.The hulka clip was placed on proximal portion of uterine tubes.The rest of the abdominal exploration found nothing abnormal.The uterus was normal in size and position, fallopian tubes and ovaries were normal in appearance.No suspect peritoneal granulation was noted and no signs of external endometriosis.On the left, essure created a filiform adhesion with the lower part in omental fat, where most of the length of the device was located.Small adhesion, measuring about 1 cm, was coagulated with bipolar forceps and sectioned without incident, flush with the wall of uterine cavity.On the right, investigation of entire pelvic cavity and lower part of abdomen proved to be negative.Letter from physician described that he removed an adhesion with the omentum.On (b)(6) 2014 other doctor stated that if they wanted to remove the inserts, it would be necessary to perform omentectomy.It was reported that she also received the treatment drug advilmed 400 mg in (b)(6) 2014, and aprana 550 mg in (b)(6) 2017.The expert indicates that the disorders presented by pain in the left iliac fossa are related to essure intervention on (b)(6) 2013.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 19.5 kg/sqm.Clinical examination on the day of the expert assessment: the patient is in good general condition.The general examination and gynecological is strictly normal.To note simply the existence of a vertical inferior umbilical scar, of 1 cm in length, practically invisible and solid, 2 small scars in the right and left iliac fossa of 5 mm length each, aesthetically perfect and solid.On clinical examination, no pain caused by gynecological examination.The essure placement intervention was less easy than expected.The patient reported that she felt a strong pain during the procedure, which persisted throughout the day and relieved later.The following day, it is noted in the form that the pain is estimated at 2/10.Later, on clinical examination, patient reported moderate pain on palpation of the left iliac fossa.On (b)(6) 2013, in the context of the confirmatory test on obstruction of the fallopian tubes, physician provided to the patient ith a prescription to undergo hysterosalpingography in a radiology centre within 5 days after the end of menstruation, in the absence of any vaginal discharge or pelvic pain.An ultrasonographic check was performed at the same time.On (b)(6) 2013 hysterography did not find satisfactory tubal opacification.The essure insert seems to be correctly positioned on the left, and the position of the insert on the right was not satisfactory.The tube was not opacified.On (b)(6) 2014, x-ray found presence of two radio-opaque inserts parallel to the pelvic plan.The inserts were correctly deployed.On both sides, three radio-opaque landmarks within the inserts were visualised, and the fourth was remote from the insert.The precise topography of the inserts could not be determined.Radio-opaque clips were present in the lateral pelvic region.In (b)(6) 2014, plain film of abdomen showed the two essure inserts in the abdomen, in addition to the clips.It would appear that the insert on the right, which had not been visualised on laparoscopy, was perhaps in place in the fallopian tube.Pelvic mri on (b)(6) 2014 showed one essure insert in the left cornua and the other seems to have migrated.The insert on the left had been found and had partially perforated the uterine tube, however the essure on the right was not visualised.Several images of metallic fragments, compatible with the inserts, were present in addition to the two tubal clips: one small metallic fragment was in the left uterine cornua, compatible with a residual fragment of the insert.Images corresponding to the essure inserts situated anterior to the uterus, one in a horizontal left para-median position and the other situated in a higher vertical right para-median position, implant having probably migrated to the greater omentum.Presence of a small fragment separated from the lower part of the insert on the right, also apparently in an intraperitoneal position.On (b)(6) 2014 it was noted that a fragment of the insert remains in the left uterine cornua.There are three small fragments of the inserts, situated in the greater omentum, probably corresponding to the insert on the right, which had perforated.A fragment of the insert on the left remains, since the extremity that protruded from cornua was cut off.Blood tests, as well as ultrasound are to be performed shortly since the patient has been found to have a thyroid nodule.Thyroid ultrasound and blood test were also prescribed.Lot number: a69943 manufacturing date: nov-2012 expiration date: nov-2015.Lot number: a82457 manufacturing date: jan-2013 expiration date: jan-2016.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on 22-oct-2018: information received from a lawyer via legal department.Past medical history updated.Essure placement intervention was less easy than expected.The patient reported that she felt a strong pain during the procedure.The following day, it is noted in the form that the pain is estimated at 2/10 and that the patient took a tablet of doliprane.On clinical examination, patient reported moderate pain on palpation of the left iliac fossa, and she episodically takes spasfon and doliprane treatments.At the time of the report, the patient presented with painful phenomena in the left iliac fossa, possibly in relation to the persistence of a metal fragment in the uterine horn left.The expert retains an evaluation of the sufferings endured at 1/7, an aesthetic damage at 0.5 / 7, a permanent functional deficit of 1%, and a sexual prejudice qualified as very moderate (pains during sexual intercourse).Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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