| Model Number ESS305 |
| Device Problems
Break (1069); Component Falling (1105); Positioning Failure (1158); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Or Device Fragments Location Unknown (2590); Patient-Device Incompatibility (2682); Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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| Patient Problems
Hemorrhage/Bleeding (1888); Pain (1994); Uterine Perforation (2121); Abdominal Cramps (2543); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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| Event Date 01/01/2014 |
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Event Type
Injury
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Event Description
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This is a spontaneous case report received from consumer's husband in united states on (b)(6) 2014 which refers to a (b)(6) female who had essure (fallopian tube occlusion insert) and experienced the following events.On (b)(6) 2014, the reporter's wife had the essure done (inserted) for permanent birth control.He reported that one side went well but her physician had dropped the other inside of her uterus because his wife went into spasm.The physician said to wait if the essure will fall off by itself, and if not, he will remove it next week.The reporter stated that his wife was in a little bit of pain, and she's having light bleeding, more than spotting.At time of report, essure was not removed.No further information provided.Ptc investigation result was received on (b)(4) 2014.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc local number (b)(4) and ptc global number (b)(4).Final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect at this time.Medical assessment: the reported events are not indicative of a quality defect.No batch number was reported.Without this information neither a technical batch evaluation nor a batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.Due to lack of sample return and any valid batch information the rqu was unable to confirm any quality defect and therefore concluded "unconfirmed quality defect".In summary, there is no suspicion of a quality defect based on this report.Follow-up information received on (b)(6) 2014: consumer`s weight and height were added.Consumer did not have any gynecological problems or procedures.She did not have any other relevant medical history.On (b)(6) 2014, essure was inserted.The insertion was performed 8 weeks after last delivery.Consumer used depo-shot 6 weeks after delivery, before essure was inserted.On (b)(6) 2014, on the day of this report, consumer was getting a x-ray done, no result was provided.Consumer confirmed all events that were previously reported.She reported that when the physician went to insert essure, her tubes spammed and it was not inserted properly, but it was still in right place on one side.Consumer stated that she had moderate bleeding and some pretty bad pain, lot of cramping.She stated that she was on narco medication so she was not feeling where exactly the pain was.The symptoms started right after the procedure and it is ongoing.She stated that her physician said that essure may come out by itself because it was not in the right place.Consumer reported that essure caused her condition; she did not experience any of the symptoms before essure.Follow up information received on (b)(6) 2014 from consumer: she stated that essure will be removed on (b)(6) 2014.No further information was provided.Follow up (b)(6) 2014: follow up information received from the consumer who reported laparoscopic removal of essure was attempted on (b)(6) 2014.The right was still in place but the left was not seen in the tube.Hcp (health care professional) scraped the uterus and did not find it there either.Consumer stated that she was not recovered and had more pain than before in her left side (previously reported as a little of pain).She would have a second opinion scheduled for (b)(6) 2014.The case was upgraded to incident due to reported intervention.Follow-up information was received on (b)(6) 2014.She did not get the essure removed yet because the doctor wanted her to wait a couple of months.She was still in pain and still bleeding.She would follow-up after the next appointment in (b)(6) 2014.No further information was provided.Company causality comment: this non medically-confirmed, spontaneous case report refers to a (b)(6) female consumer who had essure (fallopian tube occlusion insert) inserted and was having light bleeding; then during an attempt to remove essure (by laparoscopy) the device on left was not seen, hcp scraped the uterus and did not find it there either.The reported events were considered serious, as medically significant and are listed according to the reference safety information for essure.These events were regarded as incidents due to the reported surgical intervention (laparoscopic surgery).During and immediately following essure insertion genital bleeding and spotting may occur; also there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body) or dislocation (distal fallopian tube or peritoneal cavity).In this particular case, it was reported a difficult essure insertion on left side due to tubal spasm, and consumer stated that her physician said the device may come out by itself (device expulsion?); later at laparoscopy the left device was not found.Given these events nature and considering their close temporal relationship with essure insertion, causality with the suspect insert cannot be excluded.In addition, non-serious events were reported.A product technical analysis was performed and concluded that there is no suspicion of a quality defect based on this report.During follow-up attempt the consumer stated that she is still bleeding (considered a serious event) and in pain, essure was not removed yet, further follow-up to obtain consumer's outcome is being sought.
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Manufacturer Narrative
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Follow up information received on 27-aug-2015 from consumer: the consumer mentioned that hsg (hysterosalpingogram) test was not done.The consumer said one coil took properly and the other coil fell out during the procedure.The only thing the doctor told her, after essure procedure, is that he went to put the coil and it did not take.She talked to her doctor.She decided to get her tubes tied.She did that about a few weeks or a month later.After that, she bled for over a month.She saw another doctor to see what he thought because she had a lot of pain that did not subside.Pain was on left side where the coil was.During the tubal ligation, the physician could not figure out where missing coil migrated to.The doctor did not find the missing coil.After time, she saw doctor again because she continued to have pain on left side and she had fatigue, felt tired, was nauseous and had headaches.Another doctor put her on pain medication and talked to her about removing the fallopian tube that had an essure coil in it.The first doctor (essure doctor) had talked to her about having a hysterectomy.The second doctor said he wanted to take the fallopian tube with coil out.Her conversation with both doctors was during (b)(6) 2014.She said to doctors that she would decide by the end of the year (2014).She said the pain would go away sometimes and would come back randomly.The pain would be once a week and sometimes twice a week or she may go a whole week with no pain.She said she tried to live with the pain instead of having surgery.Then, the next year (2015), about the end of (b)(6) 2015, she had severe pain.She went back to first doctor (essure doctor) and he gave her pain medication.He said he wanted her to have a hysterectomy.She then went back to second doctor who also recommended a hysterectomy.She had an ultrasound at that time and the test showed the coil (on the right side) had embedded into uterine wall.On (b)(6) 2015, she had a hysterectomy performed by the second doctor.At the time of report, the consumer was (b)(6) and was recovering from last surgery.During her hysterectomy, the doctor found missing coil from her left side.It had punctured her fallopian tube.She added she had an ultrasound about one year earlier, and it was normal (the coil had not yet punctured through the fallopian tube).At time of the report, the consumer stated that she felt pain from essure was gone.However, she continued to have pain from recent hysterectomy and she was working through her hysterectomy pain and was still recovering.Updated ptc result received on 11-sep-2015: final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due to a request for confirmation of quality.The ae case refers also to a usability issue and a device use error.The reported adverse events are known possible undesirable events and not indicative of a quality defect.No batch number was reported.Without this information neither a technical batch evaluation nor a batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.Due to lack of sample return and any valid batch information the rqu was unable to confirm any quality defect and therefore concluded unconfirmed quality defect.In summary, there is no suspicion of a quality defect based on this report.Company causality comment: this non medically-confirmed, spontaneous case report refers to a (b)(6) female consumer who had essure (fallopian tube occlusion insert) inserted and bled over a month (interpreted as genital bleeding).An ultrasound showed the coil (on the right side) had embedded into uterine wall (previously interpreted as device dislocation as essure was not seen).She had a hysterectomy.During this surgery the missing coil was found.It had punctured through fallopian tube (interpreted as fallopian tube perforation).The genital bleeding and fallopian tube perforation events are serious due to required interventions and are listed in the reference safety information for essure.During and immediately following essure insertion genital bleeding and spotting may occur; also there is a risk of uterine and fallopian perforation.In this particular case, it was reported a difficult essure insertion on left side due to tubal spasm.Considering the nature of these events, the compatible temporal relationship and lack of alternative explanation, the causal relationship with suspected insert cannot be excluded.In addition, non-serious events were reported.This case is regarded as incident since a device removal was required.Since no product was provided and no batch number was provided a quality defect cannot be confirmed.Based on available information, there is no reason to suspect that the events were caused by a potential quality defect.No active follow-up will be pursued, as this case was identified during health authority website monitoring.No further information was obtained despite follow-up attempts.
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Manufacturer Narrative
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Follow-up from 07-apr-2015: follow-up attempts have been completed, with no response to date.Company causality comment: this non medically-confirmed, spontaneous case report refers to a (b)(6) female consumer who had essure (fallopian tube occlusion insert) inserted and was having light bleeding; then during an attempt to remove essure (by laparoscopy) the device on left was not seen, hcp scraped the uterus and did not find it there either.The reported events were considered serious, as medically significant and are listed according to the reference safety information for essure.These events were regarded as incidents due to the reported surgical intervention (laparoscopic surgery).During and immediately following essure insertion genital bleeding and spotting may occur; also there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body) or dislocation (distal fallopian tube or peritoneal cavity).In this particular case, it was reported a difficult essure insertion on left side due to tubal spasm, and consumer stated that her physician said the device may come out by itself (device expulsion?); later at laparoscopy the left device was not found.Given these events nature and considering their close temporal relationship with essure insertion, causality with the suspect insert cannot be excluded.In addition, non-serious events were reported.A product technical analysis was performed and concluded that there is no suspicion of a quality defect based on this report.During follow-up attempt the consumer stated that she is still bleeding (considered a serious event) and in pain, essure was not removed yet.No further information could be obtained.
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Manufacturer Narrative
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Follow-up information received on 09-nov-2015: the required number of follow-up attempts has been completed with no response to date.Follow-up from 23-nov-2015: no new information provided.Follow-up information received on 22-jun-2016: lawyers were added as reporters and the case became a legal case upon receipt of the legal claim.Plaintiff had the device removed due to complications.No further information was reported.Company causality comment: this non medically-confirmed, spontaneous legal case report refers to a (b)(6) female consumer who had essure (fallopian tube occlusion insert) inserted and bled over a month (interpreted as genital bleeding).An ultrasound showed the coil (on the right side) had embedded into uterine wall (previously interpreted as device dislocation as essure was not seen).She had a hysterectomy.During this surgery the missing coil was found.It had punctured through fallopian tube (interpreted as fallopian tube perforation).The genital bleeding and fallopian tube perforation events are serious due to required interventions and are listed in the reference safety information for essure.During and immediately following essure insertion genital bleeding and spotting may occur; also there is a risk of uterine and fallopian perforation.In this particular case, it was reported a difficult essure insertion on left side due to tubal spasm.Considering the nature of these events, the compatible temporal relationship and lack of alternative explanation, the causal relationship with suspected insert cannot be excluded.In addition, non-serious events were reported.This case is regarded as incident since a device removal was required.Since no product was provided and no batch number was provided a quality defect cannot be confirmed.Based on available information, there is no reason to suspect that the events were caused by a potential quality defect.Further information will be obtained through litigation process.
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Manufacturer Narrative
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Data correction for us reporting: the code knh was replaced with hhs.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("essure had punctured her fallopian tube, the coil (on the right side) had embedded into uterine wall/perforation/migration") and genital haemorrhage ("she¿s having light bleeding / bleeding for over a month") in a (b)(6) year-old female patient who had essure inserted for birth control.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use error "doctor had dropped the other essure inside of her uterus / other coil fell out during procedure" on (b)(6) 2014 and device difficult to use "laparoscopic removal of essure was attempted, the right was still in place but the left was not seen" on (b)(6) 2014.The patient's past medical history included body mass index normal.Concurrent conditions included postpartum state.In 2014, 5 days before insertion of essure, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, headache ("headaches"), fatigue ("fatigue / felt tired") and nausea ("nauseaus").On (b)(6) 2014, the patient had essure inserted.On the same day, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain ("a little bit of pain, and had more pain than before in her left side / pain as being on left side where the coil was / bad cramping / severe pain"), fallopian tube spasm ("went into spasm"), the first episode of complication of device insertion ("the doctor said to wait if the essure will fall off by itself") and the second episode of complication of device insertion ("complication of device insertion").In (b)(6) 2015, the patient experienced procedural pain ("pain from recent hysterectomy").On an unknown date, the patient experienced investigation noncompliance ("hsg est not done").The patient was treated with surgery (removal of essure) and surgery.Essure was removed on (b)(6) 2015.At the time of the report, the fallopian tube perforation, genital haemorrhage, fallopian tube spasm, headache, the last episode of complication of device insertion, investigation noncompliance, fatigue and nausea outcome was unknown and the abdominal pain and procedural pain had not resolved.The reporter considered abdominal pain, fallopian tube perforation, fallopian tube spasm, fatigue, genital haemorrhage, headache, nausea and procedural pain to be related to essure.The reporter provided no causality assessment for investigation noncompliance, the first episode of complication of device insertion and the second episode of complication of device insertion with essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.5 kg/sqm.Quality-safety evaluation of ptc: final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due to a request for confirmation of quality.The ae case refers also to a usability issue and a device use error.The reported adverse events are known possible undesirable events and not indicative of a quality defect.No batch number was reported.Without this information neither a technical batch evaluation nor a batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.Due to lack of sample return and any valid batch information the rqu was unable to confirm any quality defect and therefore concluded unconfirmed quality defect.In summary, there is no suspicion of a quality defect based on this report.Most recent follow-up information incorporated above includes: on 10-nov-2017: reporter added, stop date was updated, event migration was added.Incident: no lot number or sample available for investigation.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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Cutaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("essure had punctured her fallopian tube, /pthe coil (on the right side) had embedded into uterine walle perforation"), fallopian tube perforation ("essure had punctured her fallopian tube, /pthe coil (on the right side) had embedded into uterine walle perforation"), device dislocation ("migration of essure: abdominal wall"), device expulsion ("expulsion of essure device"), pelvic adhesions ("pelvic adhesions"), genital haemorrhage ("she¿s having light bleeding / bleeding for over a month") and autoimmune disorder ("autoimmune disorder") in a 31-year-old female patient who had essure (batch no.C03093) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use error "doctor had dropped the other essure inside of her uterus / other coil fell out during procedure" on (b)(6) 2014 and device difficult to use "laparoscopic removal of essure was attempted, the right was still in place but the left was not seen" on (b)(6) 2014.The patient's past medical history included body mass index normal.Concurrent conditions included postpartum state.Concomitant products included macrogol 3350 (miralax), metformin, ondansetron (zofran), oxycocet (percocet), topiramate (topamax) and vicodin (norco).On (b)(6) 2014, the patient had essure inserted.In june 2014, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), nausea ("nauseaus") and anxiety ("increased anxiety").In 2014, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device expulsion (seriousness criteria medically significant and intervention required), headache ("headaches"), fatigue ("fatigue / felt tired"), dysmenorrhoea ("dysmenorrhea"), constipation ("constipation"), chronic sinusitis ("chronic sinus infection"), migraine ("migraines"), visual impairment ("decreased vision") and vision blurred ("blurry vision").On (b)(6) 2014, the patient had essure inserted.On the same day, the patient experienced genital haemorrhage (seriousness criterion medically significant).On (b)(6) 2014, the patient experienced fallopian tube spasm ("went into spasm") and complication of device insertion ("complication of device insertion/the doctor said to wait if the essure will fall off by itself").On (b)(6) 2014, the patient experienced abdominal pain ("a little bit of pain, and had more pain than before in her left side / pain as being on left side where the coil was / bad cramping / severe pain") and myalgia ("muscular pain").In 2015, the patient experienced autoimmune disorder (seriousness criterion medically significant), bladder disorder ("bladder problem"), urinary tract disorder ("urinary problems"), tooth disorder ("dental problems"), dyspareunia ("dyspareunia") and blood testosterone decreased ("low testosteron").In june 2015, the patient experienced pain of skin ("skin painful to the touch").On (b)(6) 2015, the patient experienced misophonia ("hypersensitive to sound"), photophobia ("hypersensitive to light") and hyperaesthesia ("hypersensitive to touch").In august 2015, the patient experienced procedural pain ("pain from recent hysterectomy").On an unknown date, the patient experienced pelvic adhesions (seriousness criterion medically significant), investigation noncompliance ("hsg test not done"), perineal pain ("perineal pain") and pain in extremity ("leg pain").The patient was treated with surgery (hysterectomy, removal of essure), surgery (hysterectomy, removal of essure), surgery (hysterectomy, removal of essure), surgery (hysterectomy, removal of essure) and surgery (adhesion removal).Essure was removed on (b)(6) 2015.At the time of the report, the uterine perforation, fallopian tube perforation, genital haemorrhage, fallopian tube spasm, headache, complication of device insertion, investigation noncompliance, fatigue and nausea outcome was unknown and the device dislocation, device expulsion, pelvic adhesions, autoimmune disorder, abdominal pain, procedural pain, misophonia, photophobia, hyperaesthesia, bladder disorder, urinary tract disorder, tooth disorder, dysmenorrhoea, dyspareunia, constipation, blood testosterone decreased, chronic sinusitis, migraine, anxiety, pain of skin, visual impairment, vision blurred, perineal pain, pain in extremity and myalgia had not resolved.The reporter provided no causality assessment for complication of device insertion and investigation noncompliance with essure.The reporter considered abdominal pain, anxiety, autoimmune disorder, bladder disorder, blood testosterone decreased, chronic sinusitis, constipation, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, fallopian tube perforation, fallopian tube spasm, fatigue, genital haemorrhage, headache, hyperaesthesia, migraine, misophonia, myalgia, nausea, pain in extremity, pain of skin, pelvic adhesions, perineal pain, photophobia, procedural pain, tooth disorder, urinary tract disorder, uterine perforation, vision blurred and visual impairment to be related to essure.The reporter commented: dr took pics during my surgery of my perforated tube diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.5 kg/sqm.Most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs received- new event hypersensitive to touch, hypersensitive to light, hypersensitive to sound, autoimmune disorder, bladder problem, urinary problems, dental problems, dysmenorrhea, dyspareunia, constipation, low testosterone, chronic sinus infection, migraines, increased anxiety, skin painful to the touch, decreased vision, blurry vision, perineal pain, pelvic adhesions, leg pain, expulsion of essure device, migration of essure: abdominal wall, muscular pain were added.Lot number, reporter, concomitant medication were added.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 uterine perforation ("essure had punctured her fallopian tube, /pthe coil (on the right side) had embedded into uterine walle perforation"), fallopian tube perforation ("essure had punctured her fallopian tube, /pthe coil (on the right side) had embedded into uterine walle perforation"), device dislocation ("migration of essure: abdominal wall"), device expulsion ("expulsion of essure device"), pelvic adhesions ("pelvic adhesions"), genital haemorrhage ("she¿s having light bleeding / bleeding for over a month") and autoimmune disorder ("autoimmune disorder") in a 31-year-old female patient who had essure (batch no.C03093) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use error "doctor had dropped the other essure inside of her uterus / other coil fell out during procedure" on (b)(6) 2014 and device difficult to use "laparoscopic removal of essure was attempted, the right was still in place but the left was not seen" on (b)(6) 2014.The patient's medical history included body mass index normal.Concurrent conditions included postpartum state.Concomitant products included hydrocodone bitartrate;paracetamol (norco), macrogol 3350 (miralax), metformin, ondansetron (zofran), oxycodone hydrochloride;paracetamol (percocet) and topiramate (topamax).In 2014, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device expulsion (seriousness criteria medically significant and intervention required), headache ("headaches"), fatigue ("fatigue / felt tired"), dysmenorrhoea ("dysmenorrhea"), constipation ("constipation"), chronic sinusitis ("chronic sinus infection"), migraine ("migraines"), visual impairment ("decreased vision") and vision blurred ("blurry vision").In (b)(6) 2014, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), nausea ("nauseaus") and anxiety ("increased anxiety").On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant) and experienced fallopian tube spasm ("went into spasm") and complication of device insertion ("complication of device insertion/the doctor said to wait if the essure will fall off by itself").On (b)(6) 2014, the patient experienced abdominal pain ("a little bit of pain, and had more pain than before in her left side / pain as being on left side where the coil was / bad cramping / severe pain") and myalgia ("muscular pain").In (b)(6) 2015, the patient experienced pain of skin ("skin painful to the touch").In 2015, the patient experienced autoimmune disorder (seriousness criterion medically significant), bladder disorder ("bladder problem"), urinary tract disorder ("urinary problems"), tooth disorder ("dental problems") and dyspareunia ("dyspareunia") and was found to have blood testosterone decreased ("low testosteron").On (b)(6) 2015, the patient experienced misophonia ("hypersensitive to sound"), photophobia ("hypersensitive to light") and hyperaesthesia ("hypersensitive to touch").In (b)(6) 2015, the patient experienced procedural pain ("pain from recent hysterectomy").On an unknown date, the patient experienced pelvic adhesions (seriousness criterion medically significant), investigation noncompliance ("hsg test not done"), perineal pain ("perineal pain") and pain in extremity ("leg pain").The patient was treated with surgery (adhesion removal and hysterectomy, removal of essure).Essure was removed on (b)(6) 2015.At the time of the report, the uterine perforation, fallopian tube perforation, genital haemorrhage, fallopian tube spasm, headache, complication of device insertion, investigation noncompliance, fatigue and nausea outcome was unknown and the device dislocation, device expulsion, pelvic adhesions, autoimmune disorder, abdominal pain, procedural pain, misophonia, photophobia, hyperaesthesia, bladder disorder, urinary tract disorder, tooth disorder, dysmenorrhoea, dyspareunia, constipation, blood testosterone decreased, chronic sinusitis, migraine, anxiety, pain of skin, visual impairment, vision blurred, perineal pain, pain in extremity and myalgia had not resolved.The reporter provided no causality assessment for complication of device insertion and investigation noncompliance with essure.The reporter considered abdominal pain, anxiety, autoimmune disorder, bladder disorder, blood testosterone decreased, chronic sinusitis, constipation, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, fallopian tube perforation, fallopian tube spasm, fatigue, genital haemorrhage, headache, hyperaesthesia, migraine, misophonia, myalgia, nausea, pain in extremity, pain of skin, pelvic adhesions, perineal pain, photophobia, procedural pain, tooth disorder, urinary tract disorder, uterine perforation, vision blurred and visual impairment to be related to essure.No further causality assessment were provided for the product.The reporter commented: dr took pics during my surgery of my perforated tube diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.5 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-jan-2019: quality-safety evaluation of ptc incident we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('essure had punctured her fallopian tube, /pthe coil (on the right side) had embedded into uterine walle perforation/coil was protruding from fallopian tube'), fallopian tube perforation ('essure had punctured her fallopian tube, /pthe coil (on the right side) had embedded into uterine walle perforation'), device dislocation ('migration of essure: abdominal wall'), device expulsion ('expulsion of essure device'), pelvic adhesions ('pelvic adhesions'), genital haemorrhage ('she¿s having light bleeding / bleeding for over a month'), autoimmune disorder ('autoimmune disorder') and urinary retention ('unable to complete empty my bladder') in a 31-year-old female patient who had essure (batch no.C03093) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use error "doctor had dropped the other essure inside of her uterus / other coil fell out during procedure" on (b)(6) 2014 and device difficult to use "laparoscopic removal of essure was attempted, the right was still in place but the left was not seen" on (b)(6) 2014.The patient's medical history included body mass index normal and caesarean section.Concurrent conditions included ovarian cyst since july 2014 and postpartum state.Concomitant products included alprazolam (xanax), hydrocodone bitartrate;paracetamol (norco), macrogol 3350 (miralax), metformin, ondansetron (zofran), oxycodone hydrochloride;paracetamol (percocet) and topiramate (topamax).In 2014, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device expulsion (seriousness criteria medically significant and intervention required), fatigue ("fatigue / felt tired"), constipation ("constipation"), chronic sinusitis ("chronic sinus infection"), visual impairment ("decreased vision") and vision blurred ("blurry vision").In june 2014, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), headache ("headaches"), nausea ("nauseaus"), migraine ("migraines") and anxiety ("increased anxiety").On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant) and experienced fallopian tube spasm ("went into spasm"), complication of device insertion ("complication of device insertion/the doctor said to wait if the essure will fall off by itself") and dysmenorrhoea ("dysmenorrhea(cramping)").On (b)(6) 2014, the patient experienced abdominal pain ("a little bit of pain, and had more pain than before in her left side / pain as being on left side where the coil was / bad cramping / severe pain") and myalgia ("muscular pain/muscle pain").In 2015, the patient experienced bladder disorder ("bladder problem"), urinary tract disorder ("urinary problems"), tooth disorder ("dental problems") and toothache ("tooth pain") and was found to have blood testosterone decreased ("low testosteron") and hormone level abnormal ("currently waiting on additional tests for hormonal imbalance").In june 2015, the patient experienced pain of skin ("skin painful to the touch") and dry eye ("eye dry").In july 2015, the patient experienced dyspareunia ("dyspareunia(painful sexual intercourse)").On (b)(6) 2015, the patient experienced misophonia ("hypersensitive to sound"), photophobia ("hypersensitive to light") and hyperaesthesia ("hypersensitive to touch").In august 2015, the patient experienced procedural pain ("pain from recent hysterectomy").In august 2015, the patient experienced bone pain ("bone pain") and urinary retention (seriousness criterion medically significant).In september 2015, the patient experienced autoimmune disorder (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic adhesions (seriousness criterion medically significant), investigation noncompliance ("hsg test not done"), perineal pain ("perineal pain"), pain in extremity ("leg pain") and pelvic floor dyssynergia ("pelvic spasm").The patient was treated with surgery (adhesion removal and hysterectomy, removal of essure).Essure was removed on (b)(6) 2015.At the time of the report, the uterine perforation, fallopian tube perforation, genital haemorrhage, fallopian tube spasm, headache, complication of device insertion, investigation noncompliance, fatigue, nausea, bone pain, urinary retention, pelvic floor dyssynergia, toothache, dry eye and hormone level abnormal outcome was unknown and the device dislocation, device expulsion, pelvic adhesions, autoimmune disorder, abdominal pain, procedural pain, misophonia, photophobia, hyperaesthesia, bladder disorder, urinary tract disorder, tooth disorder, dysmenorrhoea, dyspareunia, constipation, blood testosterone decreased, chronic sinusitis, migraine, anxiety, pain of skin, visual impairment, vision blurred, perineal pain, pain in extremity and myalgia had not resolved.The reporter provided no causality assessment for complication of device insertion and investigation noncompliance with essure.The reporter considered abdominal pain, anxiety, autoimmune disorder, bladder disorder, blood testosterone decreased, bone pain, chronic sinusitis, constipation, device dislocation, device expulsion, dry eye, dysmenorrhoea, dyspareunia, fallopian tube perforation, fallopian tube spasm, fatigue, genital haemorrhage, headache, hormone level abnormal, hyperaesthesia, migraine, misophonia, myalgia, nausea, pain in extremity, pain of skin, pelvic adhesions, pelvic floor dyssynergia, perineal pain, photophobia, procedural pain, tooth disorder, toothache, urinary retention, urinary tract disorder, uterine perforation, vision blurred and visual impairment to be related to essure.The reporter commented: dr took pics during my surgery of my perforated tube diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.5 kg/sqm.Ultrasound scan - in 2014: results: normal (the coil had not yet punctured the tube); in 2015: results: riight side coil embedded into uterine wall.Ultrasound scan vagina - on (b)(6) 2014: unilateral occlusion (left tube occluded), migration of essure device.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 19-nov-2019: pfs and mr received: new events added: bone pain, unable to complete empty my bladder, pelvic spasm, tooth pain, eye dry, currently waiting on additional tests for hormonal imbalance.Reporter information were updated.Event onset date, patient history, lab data and concomitant drugs were added.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('i feel that fibers were left in my body'), uterine perforation ('essure had punctured her fallopian tube, /pthe coil (on the right side) had embedded into uterine walle perforation/coil was protruding from fallopian tube'), fallopian tube perforation ('essure had punctured her fallopian tube, /pthe coil (on the right side) had embedded into uterine walle perforation'), device dislocation ('migration of essure: abdominal wall'), device expulsion ('expulsion of essure device'), pelvic adhesions ('pelvic adhesions') and urinary retention ('unable to complete empty my bladder') in a 31-year-old female patient who had essure (batch no: c03093) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use error "doctor had dropped the other essure inside of her uterus / other coil fell out during procedure" on (b)(6) 2014 and device difficult to use "laparoscopic removal of essure was attempted, the right was still in place but the left was not seen" on (b)(6) 2014.The patient's medical history included body mass index normal and caesarean section.Concurrent conditions included ovarian cyst since on (b)(6) 2014 and postpartum state.Concomitant products included alprazolam (xanax), hydrocodone bitartrate;paracetamol (norco), macrogol 3350 (miralax), metformin, ondansetron (zofran), oxycodone hydrochloride;paracetamol (percocet) and topiramate (topamax).In 2014, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device expulsion (seriousness criteria medically significant and intervention required), fatigue ("fatigue / felt tired"), constipation ("constipation"), chronic sinusitis ("chronic sinus infection"), visual impairment ("decreased vision") and vision blurred ("blurry vision").On (b)(6) 2014, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), headache ("headaches"), nausea ("nauseaus"), migraine ("migraines") and anxiety ("increased anxiety").On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced genital haemorrhage ("she¿s having light bleeding / bleeding for over a month") and experienced fallopian tube spasm ("went into spasm"), complication of device insertion ("complication of device insertion/the doctor said to wait if the essure will fall off by itself") and dysmenorrhoea ("dysmenorrhea(cramping)").On (b)(6) 2014, the patient experienced abdominal pain ("a little bit of pain, and had more pain than before in her left side / pain as being on left side where the coil was / bad cramping / severe pain") and myalgia ("muscular pain/muscle pain").In 2015, the patient experienced bladder disorder ("bladder problem"), urinary tract disorder ("urinary problems"), the first episode of toothache ("dental problems/tooth pain") and the second episode of toothache ("tooth pain") and was found to have blood testosterone decreased ("low testosteron") and hormone level abnormal ("currently waiting on additional tests for hormonal imbalance").On (b)(6) 2015, the patient experienced pain of skin ("skin painful to the touch") and dry eye ("eye dry").On (b)(6) 2015, the patient experienced dyspareunia ("dyspareunia(painful sexual intercourse)").On (b)(6) 2015, the patient experienced misophonia ("hypersensitive to sound"), photophobia ("hypersensitive to light") and hyperaesthesia ("hypersensitive to touch").On (b)(6) 2015, the patient experienced procedural pain ("pain from recent hysterectomy").On (b)(6) 2015, the patient experienced bone pain ("bone pain") and urinary retention (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced autoimmune disorder ("autoimmune disorder").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic adhesions (seriousness criterion medically significant), investigation noncompliance ("hsg test not done"), perineal pain ("perineal pain"), pain in extremity ("leg pain"), ovarian cyst ("cyst rrowing on my left ovary"), pelvic floor dyssynergia ("pelvic spasm"), hepatic lesion ("liver lesion"), pain in jaw ("jaw hurts"), adnexa uteri pain ("ovarian pain"), neck pain ("neck pain"), memory impairment ("memory issues"), paraesthesia ("tingling in arms and face"), fibromyalgia ("fibromyalgia"), burning sensation ("burning sunbrn that ove across my body"), back pain ("back pain"), muscular weakness ("weak right hand") and bipolar disorder ("bipolar disorder").The patient was treated with surgery (hysterctomy (everything removed , but my ovaries) and adhesion removal).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, uterine perforation, fallopian tube perforation, genital haemorrhage, fallopian tube spasm, headache, complication of device insertion, investigation noncompliance, fatigue, nausea, bone pain, ovarian cyst, urinary retention, pelvic floor dyssynergia, the last episode of toothache, dry eye, hormone level abnormal, hepatic lesion, pain in jaw, adnexa uteri pain, neck pain, memory impairment, paraesthesia, fibromyalgia, burning sensation, back pain, muscular weakness and bipolar disorder outcome was unknown and the device dislocation, device expulsion, pelvic adhesions, autoimmune disorder, abdominal pain, procedural pain, misophonia, photophobia, hyperaesthesia, bladder disorder, urinary tract disorder, dysmenorrhoea, dyspareunia, constipation, blood testosterone decreased, chronic sinusitis, migraine, anxiety, pain of skin, visual impairment, vision blurred, perineal pain, pain in extremity and myalgia had not resolved.The reporter provided no causality assessment for complication of device insertion and investigation noncompliance with essure.The reporter considered abdominal pain, adnexa uteri pain, anxiety, autoimmune disorder, back pain, bipolar disorder, bladder disorder, blood testosterone decreased, bone pain, burning sensation, chronic sinusitis, constipation, device breakage, device dislocation, device expulsion, dry eye, dysmenorrhoea, dyspareunia, fallopian tube perforation, fallopian tube spasm, fatigue, fibromyalgia, genital haemorrhage, headache, hepatic lesion, hormone level abnormal, hyperaesthesia, memory impairment, migraine, misophonia, muscular weakness, myalgia, nausea, neck pain, ovarian cyst, pain in extremity, pain in jaw, pain of skin, paraesthesia, pelvic adhesions, pelvic floor dyssynergia, perineal pain, photophobia, procedural pain, urinary retention, urinary tract disorder, uterine perforation, vision blurred, visual impairment, the first episode of toothache and the second episode of toothache to be related to essure.The reporter commented: dr took pics during my surgery of my perforated tube.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.5 kg/sqm.Ultrasound scan: in 2014: results: normal (the coil had not yet punctured the tube); in 2015: results: riight side coil embedded into uterine wall.Ultrasound scan vagina: on (b)(6) 2014: unilateral occlusion (left tube occluded), migration of essure device.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('i feel that fibers were left in my body'), uterine perforation ('essure had punctured her fallopian tube, /pthe coil (on the right side) had embedded into uterine walle perforation/coil was protruding from fallopian tube'), fallopian tube perforation ('essure had punctured her fallopian tube, /pthe coil (on the right side) had embedded into uterine walle perforation'), device dislocation ('migration of essure: abdominal wall'), device expulsion ('expulsion of essure device'), pelvic adhesions ('pelvic adhesions') and urinary retention ('unable to complete empty my bladder') in a 31-year-old female patient who had essure (batch no.C03093) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use error "doctor had dropped the other essure inside of her uterus / other coil fell out during procedure" on (b)(6) 2014 and device difficult to use "laparoscopic removal of essure was attempted, the right was still in place but the left was not seen" on (b)(6) 2014.The patient's medical history included body mass index normal and caesarean section.Concurrent conditions included ovarian cyst since (b)(6) 2014 and postpartum state.Concomitant products included alprazolam (xanax), hydrocodone bitartrate;paracetamol (norco), macrogol 3350 (miralax), metformin, ondansetron (zofran), oxycodone hydrochloride;paracetamol (percocet) and topiramate (topamax).On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device expulsion (seriousness criteria medically significant and intervention required), fatigue ("fatigue / felt tired"), constipation ("constipation"), chronic sinusitis ("chronic sinus infection"), visual impairment ("decreased vision") and vision blurred ("blurry vision").In (b)(6) 2014, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), headache ("headaches"), nausea ("nauseaus"), migraine ("migraines") and anxiety ("increased anxiety").On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced genital haemorrhage ("she¿s having light bleeding / bleeding for over a month") and experienced fallopian tube spasm ("went into spasm"), complication of device insertion ("complication of device insertion/the doctor said to wait if the essure will fall off by itself") and dysmenorrhoea ("dysmenorrhea(cramping)").On (b)(6) 2014, the patient experienced abdominal pain ("a little bit of pain, and had more pain than before in her left side / pain as being on left side where the coil was / bad cramping / severe pain") and myalgia ("muscular pain/muscle pain").In 2015, the patient experienced bladder disorder ("bladder problem"), urinary tract disorder ("urinary problems"), the first episode of toothache ("dental problems/tooth pain") and the second episode of toothache ("tooth pain") and was found to have blood testosterone decreased ("low testosteron") and hormone level abnormal ("currently waiting on additional tests for hormonal imbalance").In (b)(6) 2015, the patient experienced pain of skin ("skin painful to the touch") and dry eye ("eye dry").In (b)(6) 2015, the patient experienced dyspareunia ("dyspareunia(painful sexual intercourse)").On (b)(6) 2015, the patient experienced misophonia ("hypersensitive to sound"), photophobia ("hypersensitive to light") and hyperaesthesia ("hypersensitive to touch").In (b)(6) 2015, the patient experienced procedural pain ("pain from recent hysterectomy").In (b)(6) 2015, the patient experienced bone pain ("bone pain") and urinary retention (seriousness criterion medically significant).In (b)(6) 2015, the patient experienced autoimmune disorder ("autoimmune disorder").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic adhesions (seriousness criterion medically significant), investigation noncompliance ("hsg test not done"), perineal pain ("perineal pain"), pain in extremity ("leg pain"), ovarian cyst ("cyst rrowing on my left ovary"), pelvic floor dyssynergia ("pelvic spasm"), hepatic lesion ("liver lesion"), pain in jaw ("jaw hurts"), adnexa uteri pain ("ovarian pain"), neck pain ("neck pain"), memory impairment ("memory issues"), paraesthesia ("tingling in arms and face"), fibromyalgia ("fibromyalgia"), burning sensation ("burning sunbrn that ove across my body"), back pain ("back pain"), muscular weakness ("weak right hand") and bipolar disorder ("bipolar disorder").The patient was treated with surgery (hysterctomy (everything removed , but my ovaries) and adhesion removal).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, uterine perforation, fallopian tube perforation, genital haemorrhage, fallopian tube spasm, headache, complication of device insertion, investigation noncompliance, fatigue, nausea, bone pain, ovarian cyst, urinary retention, pelvic floor dyssynergia, the last episode of toothache, dry eye, hormone level abnormal, hepatic lesion, pain in jaw, adnexa uteri pain, neck pain, memory impairment, paraesthesia, fibromyalgia, burning sensation, back pain, muscular weakness and bipolar disorder outcome was unknown and the device dislocation, device expulsion, pelvic adhesions, autoimmune disorder, abdominal pain, procedural pain, misophonia, photophobia, hyperaesthesia, bladder disorder, urinary tract disorder, dysmenorrhoea, dyspareunia, constipation, blood testosterone decreased, chronic sinusitis, migraine, anxiety, pain of skin, visual impairment, vision blurred, perineal pain, pain in extremity and myalgia had not resolved.The reporter provided no causality assessment for complication of device insertion and investigation noncompliance with essure.The reporter considered abdominal pain, adnexa uteri pain, anxiety, autoimmune disorder, back pain, bipolar disorder, bladder disorder, blood testosterone decreased, bone pain, burning sensation, chronic sinusitis, constipation, device breakage, device dislocation, device expulsion, dry eye, dysmenorrhoea, dyspareunia, fallopian tube perforation, fallopian tube spasm, fatigue, fibromyalgia, genital haemorrhage, headache, hepatic lesion, hormone level abnormal, hyperaesthesia, memory impairment, migraine, misophonia, muscular weakness, myalgia, nausea, neck pain, ovarian cyst, pain in extremity, pain in jaw, pain of skin, paraesthesia, pelvic adhesions, pelvic floor dyssynergia, perineal pain, photophobia, procedural pain, urinary retention, urinary tract disorder, uterine perforation, vision blurred, visual impairment, the first episode of toothache and the second episode of toothache to be related to essure.The reporter commented: dr took pics during my surgery of my perforated tube diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.5 kg/sqm.Ultrasound scan - in 2014: results: normal (the coil had not yet punctured the tube); in 2015: results: riight side coil embedded into uterine wall.Ultrasound scan vagina - on (b)(6) 2014: unilateral occlusion (left tube occluded), migration of essure device.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-feb-2020: content from social media received.New events device breakage, hepatic lesion, ovarian pain, neck pain, memory issues, tingling in arms and face, fibromyalgia, burning sensation, back pain, weak hand right, bipolar disorder were added.Events of genital hemorrhage and autoimmune disorder downgraded to non-serious.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('i feel that fibers were left in my body'), uterine perforation ('essure had punctured her fallopian tube, / the coil (on the right side) had embedded into uterine wall perforation / coil was protruding from fallopian tube'), fallopian tube perforation ('essure had punctured her fallopian tube, / the coil (on the right side) had embedded into uterine wall perforation'), device dislocation ('migration of essure: abdominal wall'), device expulsion ('expulsion of essure device'), pelvic adhesions ('pelvic adhesions') and urinary retention ('unable to complete empty my bladder') in a 31-year-old female patient who had essure (batch no: c03093) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use error "doctor had dropped the other essure inside of her uterus / other coil fell out during procedure" on (b)(6)2014, device difficult to use "laparoscopic removal of essure was attempted, the right was still in place but the left was not seen" on (b)(6) 2014 and device monitoring procedure not performed "hsg test not done".The patient's medical history included body mass index normal, caesarean section, fractured coccyx, back muscle spasms and headache.Concurrent conditions included ovarian cyst since on (b)(6) 2014 and postpartum state.Concomitant products included alprazolam (xanax), hydrocodone bitartrate; paracetamol (norco), macrogol 3350 (miralax), metformin, ondansetron (zofran), oxycodone hydrochloride; paracetamol (percocet) and topiramate (topamax).In 2014, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device expulsion (seriousness criteria medically significant and intervention required), fatigue ("fatigue / felt tired"), constipation ("constipation"), chronic sinusitis ("chronic sinus infection"), visual impairment ("decreased vision") and vision blurred ("blurry vision").On (b)(6) 2014, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), headache ("headaches"), nausea ("nauseous"), migraine ("migraines") and anxiety ("increased anxiety").On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced genital haemorrhage ("she¿s having light bleeding / bleeding for over a month") and experienced fallopian tube spasm ("went into spasm"), complication of device insertion ("complication of device insertion / the doctor said to wait if the essure will fall off by itself") and dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2014, the patient experienced abdominal pain ("a little bit of pain, and had more pain than before in her left side / pain as being on left side where the coil was / bad cramping / severe pain") and myalgia ("muscular pain/muscle pain").In 2015, the patient experienced bladder disorder ("bladder problem"), urinary tract disorder ("urinary problems"), the first episode of toothache ("dental problems / tooth pain") and the second episode of toothache ("tooth pain") and was found to have blood testosterone decreased ("low testosterone") and hormone level abnormal ("currently waiting on additional tests for hormonal imbalance").On (b)(6) 2015, the patient experienced pain of skin ("skin painful to the touch") and dry eye ("eye dry").On (b)(6) 2015, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").On (b)(6) 2015, the patient experienced misophonia ("hypersensitive to sound"), photophobia ("hypersensitive to light") and hyperaesthesia ("hypersensitive to touch").On (b)(6) 2015, the patient experienced procedural pain ("pain from recent hysterectomy").On (b)(6) 2015, the patient experienced bone pain ("bone pain") and urinary retention (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced autoimmune disorder ("autoimmune disorder").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic adhesions (seriousness criterion medically significant), perineal pain ("perineal pain"), pain in extremity ("leg pain"), ovarian cyst ("cyst growing on my left ovary"), pelvic floor dyssynergia ("pelvic spasm"), hepatic lesion ("liver lesion"), pain in jaw ("jaw hurts"), adnexa uteri pain ("ovarian pain"), neck pain ("neck pain"), memory impairment ("memory issues"), paraesthesia ("tingling in arms and face"), fibromyalgia ("fibromyalgia"), burning sensation ("burning sunburn that move across my body"), back pain ("back pain"), muscular weakness ("weak right hand"), bipolar disorder ("bipolar disorder") and coccydynia ("tailbone hurts each time she stands up").The patient was treated with surgery (hysterectomy (everything removed , but my ovaries) and adhesion removal).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, uterine perforation, fallopian tube perforation, genital haemorrhage, fallopian tube spasm, headache, complication of device insertion, fatigue, nausea, bone pain, ovarian cyst, urinary retention, pelvic floor dyssynergia, the last episode of toothache, dry eye, hormone level abnormal, hepatic lesion, pain in jaw, adnexa uteri pain, neck pain, memory impairment, paraesthesia, fibromyalgia, burning sensation, back pain, muscular weakness, bipolar disorder and coccydynia outcome was unknown and the device dislocation, device expulsion, pelvic adhesions, autoimmune disorder, abdominal pain, procedural pain, misophonia, photophobia, hyperaesthesia, bladder disorder, urinary tract disorder, dysmenorrhoea, dyspareunia, constipation, blood testosterone decreased, chronic sinusitis, migraine, anxiety, pain of skin, visual impairment, vision blurred, perineal pain, pain in extremity and myalgia had not resolved.The reporter provided no causality assessment for complication of device insertion with essure.The reporter considered abdominal pain, adnexa uteri pain, anxiety, autoimmune disorder, back pain, bipolar disorder, bladder disorder, blood testosterone decreased, bone pain, burning sensation, chronic sinusitis, coccydynia, constipation, device breakage, device dislocation, device expulsion, dry eye, dysmenorrhoea, dyspareunia, fallopian tube perforation, fallopian tube spasm, fatigue, fibromyalgia, genital haemorrhage, headache, hepatic lesion, hormone level abnormal, hyperaesthesia, memory impairment, migraine, misophonia, muscular weakness, myalgia, nausea, neck pain, ovarian cyst, pain in extremity, pain in jaw, pain of skin, paraesthesia, pelvic adhesions, pelvic floor dyssynergia, perineal pain, photophobia, procedural pain, urinary retention, urinary tract disorder, uterine perforation, vision blurred, visual impairment, the first episode of toothache and the second episode of toothache to be related to essure.The reporter commented: dr took pics during my surgery of my perforated tube diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.5 kg/sqm.Ultrasound scan: in 2014: results: normal (the coil had not yet punctured the tube); in 2015: results: right side coil embedded into uterine wall.Ultrasound scan vagina: on (b)(6) 2014: unilateral occlusion (left tube occluded), migration of essure device.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: new event "tailbone hurts each time she stands up" added.Patient information updated.New social media reporter added.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Search Alerts/Recalls
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