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BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Back to Search Results |
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| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Erosion (1750); Micturition Urgency (1871); Headache (1880); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Laceration(s) (1946); Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Rash (2033); Urinary Tract Infection (2120); Burning Sensation (2146); Hot Flashes/Flushes (2153); Urinary Frequency (2275); Discomfort (2330); Numbness (2415); Prolapse (2475); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Respiratory Insufficiency (4462); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Fecal Incontinence (4571); Urinary Incontinence (4572); Swelling/ Edema (4577)
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| Event Date 06/27/2013 |
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Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that an advantage fit was implanted during a midurethral sling tension-free vaginal tape placement procedure performed on (b)(6) 2013 to treat a patient with stress incontinence.On (b)(6) 2017, a letter was sent by the physician for a consult for a patient who complained of "a vaginal pouch filling up with feces." on examination, she appeared to have a degree of rectocele.However, there were no palpable masses.The patient was previously advised about performing pelvic floor exercises.On (b)(6) 2017, a letter was sent by the physician for a consult for a patient who has bulge symptoms.In addition, since the surgery, every time the patient laid down, she wets herself.On (b)(6) 2017, a letter was sent by the physician to the patient informing her of her current symptoms of bulging when she opened her bowels.In the physician's assessment, there was good support of the back wall of the vagina.The patient noticed that her bladder leaks when she laid down and in the physician's assessment, the patient has urge incontinence.The physician asked the patient to keep a bladder diary to check her daily result and emptying.The physician also requested a urine specimen to be sent to rule out infection.On (b)(6) 2017, a letter was sent by the physician to the patient informing her of her recent symptoms of evacuatory difficulties and a feeling of bulging forward into the vagina when she tried to open the bowels.Upon examination, the physician did not note any mesh exposure.The patient has a prolapse at the back wall of the vagina, although it was not as bad as it was.The patient would like to have it repaired.The physician showed the patient bsug data with good success rates and low complication rates.The patient was given the iuga information leaflet, and a consent was taken and risks including bleeding, infection, thrombosis, failure and pain were discussed.On (b)(6) 2017, a referral was sent by the physician to a gi physiologist regarding the patient's fecal urgency.In the physician's assessment, this may be associated with sudden onset fecal urgency incontinence.The physician was referring the patient for a possible physiology testing.On (b)(6) 2018, a letter was sent by the physician to the patient informing her of her urodynamics which other than a more protracted flow after the patient's tvt, were normal and the patient emptied properly.The patient had quite marked bowel symptoms and she was awaiting endoanal ultrasound scan.On (b)(6) 2018, a letter was sent by the physician to the patient informing her of their assessment.The investigations showed that there was a defect in the external anal sphincter muscle and so the functional length of the back passage muscle was shortened.In the physician's assessment, this was the reason why the patient was having some fecal urgency.Although, the patient had some protected flow of her urine.The other problem that the patient have is that she did not have any sensation during intercourse.Upon examination, there was no mesh exposure in the vagina and no particular prolapse.There was a little bit of a gape on the introitus but there was no real indication for an operation.The patient reported good pelvic floor muscle contractions when using electrical stimulation.However, upon examination, when the patient was asked to squeeze, there was absolutely nothing.In the physician's assessment, there might be a problem with the patient's nerve supply from her back into her pelvis.On the same date, a letter was also sent by the physician for a referral regarding the patient lifting something heavy and had pain and was told that she had trapped nerve in her back.On the same date, another referral was sent by the physician for the patient's urinary symptoms.It was noted that the biggest problem of the patient at the moment is her fecal urgency.And has no sensation during intercourse.A physician scanned her and there was a defect noted in the external sphincter low down.Upon examination, her oxford score on pelvic floor muscle squeeze is zero.The patient has an electric stimulator at home.The patient has had physiotherapy and they discussed about loperamide syrup use, but she did not have any problems with anything other than firm stool.On (b)(6) 2019, the patient had a telephone consult due to an on-going problem with urinary incontinence in the past few weeks.The patient also had a history of thrush symptoms, and she was requesting for fluconazole or and cream to be sent to pharmacy.In addition, the patient vaginal itch and discomfort.On (b)(6) 2019, a referral was made for the patient due to urinary incontinence.The patient was not keen in taking tablets.However, she has done pelvic floor exercises.The patient did not note any blood in the urine and no red flags, no acute infection symptoms.The patient declined a urine dip examination.The patient was referred to genitourinary clinic.On (b)(6) 2019, a letter was sent by the physician to the patient regarding a significant pain experienced by the patient.The pain was noted over the mid-section of the tape, especially during intercourse.The patient also reported chronic symptoms of incontinence, of a mixed nature and troublesome nighttime symptoms.Upon examination, the physician can feel an edge of the tape that was quite superficial, and it was certainly very tender.In the physician's assessment, it was best to remove that mid-section of the tape.The physician explained to the patient that there was a risk that things will get worse before they get better.It may be that leakage gets worse for example and there was a small risk of damaging the urethra and needing a catheter for a fair number of days.The patient was also going to undergo a bilateral mastectomy with a laparascopic gastric bypass in february.Ideally, the physician would like to have the exposed mesh removed before then.On (b)(6) 2020, the patient underwent an excision of her mid portion of tvt under general anesthesia.The procedure was successful and uncomplicated.The patient was expected to be discharged later.The tissue has been sent for histology and the patient was expected for follow up in the urogynecology clinic in three months' time.On (b)(6) 2020, the patient felt like her mesh came through her skin underneath the urethra.The patient was scheduled for surgery on the (b)(6) for the removal mesh.The patient felt the area was very swollen.The patient was passing urine regularly and did not note any bleeding.On (b)(6) 2020, the patient had a nitrofurantoin allergy.It manifested thru rash that was settled with oral prednisone and piriton.The medication was later changed to trimethoprim.The patient also noted a burning sensation around her vaginal mesh region.She thought the mesh came through her skin.The patient did not note a painful urination nor was there any burning or stinging when pulling.The patient did not experience hematuria.The patient was also started with abx.The patient stated that she had hives occurring all over the body.The patient felt like her throat was closing-in and her head was exploding.On (b)(6) 2020, the patient had nitrofuration allergy.In addition, the patient was experiencing menopausal flushing.She noted flushes and mood swings.On (b)(6) 2020, a letter was sent by the physician to the patient.In the physician's assessment, the patient was experiencing significant pain related to her tape.Prognostically, it was good that the only pain she was having was where they touched the tape rather than having a more global pain.As they discussed, the aim was to remove the tape that was causing the problem and they were going to do this vaginally.The plan was to go as wide as they could to remove the tape but would not formally be making a cut in the stomach to try and remove absolutely all of the mesh that was inserted because the physician thought it was causing a problem for the patient and this would probably cause the patient more problems.They went through the risks of the surgery and in particular, the physician was expecting to be able to remove the mesh vaginally without a problem.There was a small chance that the physician may need to do a martius flap which was swinging some fatty tissue from the labia in underneath the urethra.The physician would need to do this if the mesh was cutting into the urethra but normally, they were able to get away without doing this.Finally, the physician also discussed the possibility that stress incontinence might come back and they would re-evaluate other options.On (b)(6) 2020, the patient's pathology results provided the following information.The patient had a history of dyspareunia following tvt insertion.Specimen sent for pathology was tvt excision.Two pieces of ragged grey-white tissue measuring 30 mm in maximum dimension each with a 10 mm of blood clot.The specimen consists of squamous mucosa showing reactive changes in squamous epithelium and hyperplasia.The underlying stroma was fibrotic and contained fragments of embedded refractile foreign material and clefts eliciting a histiocytic reaction.There was a mild chronic inflammation.There was no evidence of vain or malignancy.On (b)(6) 2021, a letter was sent to the patient by the physician.The patient reported that since her mesh removal, she has had pain on the left side.This pain was sharp and was only present during intercourse and went afterwards.She felt the pain has only occurred since having the procedure.She has no discharge or bleeding.In terms of her incontinence, she felt that she was constantly wet, that she passed about an egg cup worth of urine each time and she was constantly wearing pads.Her main symptom was stress incontinence but sometimes she felt a bit of urgency as well.She felt all of the symptoms of her incontinence worsened with the removal of the middle part of the mesh.She denied any prolapse symptoms.On examination with verbal consent and chaperone present, her post void residual was nil.There was no evidence of prolapse today and stress urinary incontinence was not elicited.The physician was unable to locate the point of her pain and could not illicit the pain that she has in the vagina.The physician was unable to see any marked tethering or scarring either.The physician spoke to the patient about the findings and as a result they felt that they should start investigating her from the beginning.She was happy to proceed with repeat video urodynamics.The physician will be sending her a questionnaire if she could kindly fill that in and they will speak to her about their findings and then move forward.Depending on what they find they would see if the patient needed further imaging such as an mri but the physician has explained to her that with scar tissue, the more she did, the more scar tissue she would get so it might be a case that there might not be any benefit from performing further imaging.On (b)(6) 2021, a letter was sent by the physician to the patient.Further to seeing the patient for her urodynamics today, not surprisingly these have confirmed what they suspected, that she has recurrent stress incontinence, as they have removed the offending piece of her tape.The physician was delighted for the patient that her symptoms of pain with the mesh extrusion have completely subsided but disappointed that they were a bit back to square one.The physician spent some time going through the various options and in essence she told the physician that she has done pelvic floor re-education and therefore, would not want a further referral to physiotherapy and would want to look for a surgical solution.In essence there were three options that they considered.The first being a bulking agent which was to inject a polyacrylamide substance into the walls of the urethra to try and give it some more resistance or they could consider conventional surgery of either a colposuspension or a fascial sling.The patient would also be a good candidate for the pursuit study which was a randomized controlled trial comparing a bulking agent against either a colposuspension or a fascial sling.The physician was arranging for her to be seen back in clinic just to make the final decision and the patient will probably be contacted by another healthcare professional who was the nurse running the pursuit study as well.In accordance with the patient's wishes today, they have listed the patient for surgery but obviously they will modify exactly what they were going to do with the waiting list once they have seen the patient and made the final decision based on her reading of the information leaflets.On (b)(6) 2022, a referral was sent by the physician.The patient was admitted today for elective procedure on the gynecology unit.She underwent colposuspension for stress urinary incontinence.During surgery, they also removed the right arm of the retropubic tvt as this was causing some scarring in the retropubic space.The procedure was uneventful.They would expect the patient to be discharged in three days and follow-up would be in three months' time.On (b)(6) 2022, a letter was sent by the physician to the patient.Following the surgery, the patient did have some voiding dysfunction.Things have improved and these symptoms only occur on occasion.Since the surgery, she reported that she has had a couple of urine infections.She has self-catheterized in the past and she felt that she might benefit from this on occasion.On examination with verbal consent and chaperone present, her scar was well healed.There was a small subdermal cyst felt, which should resolve with time.Her post void residual was 0 ml.On examination, there was a good elevation of the urethra.The physician was unable to appreciate any mesh and there was no obvious prolapse seen.The physician explained the findings to her and that to investigate her voiding a little bit more.The patient was happy with the plan.
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Manufacturer Narrative
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As per eu gdpr (general data protection regulation), only the patient's weight, gender, and age can be reported in any regulatory report.Thus, the patient initials, date of birth and race will not be documented/reported.Date of event: date of event was approximated to on (b)(6) 2013, procedure date, as no event date was reported.The complainant was unable to provide the upn and lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).
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Manufacturer Narrative
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Block a1: as per eu gdpr (general data protection regulation), only the patient's weight, gender, and age can be reported in any regulatory report.Thus, the patient initials, date of birth and race will not be documented/reported.Block b3 date of event: date of event was approximated to (b)(6) 2013, procedure date, as no event date was reported.Block d4, h4: the complainant was unable to provide the upn and lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6), (b)(6) hospital, phone: (b)(6), fax: (b)(6).Block h6: patient code e2311 captures the reportable event of discomfort.Patient code e2330 captures the reportable event of pain.Patient code e1705 captures the reportable event of burning sensation.Patient code e2006 captures the reportable event of erosion.Patient code e1405 captures the reportable event of dyspareunia.Patient code e1621 captures the reportable event of muscle weakness.Patient code e1311 captures the reportable event of voiding dysfunction.Patient code e1906 captures the reportable event of infection.Patient code e0123 captures the reportable event of nerve damage.Patient code e1310 captures the reportable event of urinary tract infection.Patient code e2326 captures the reportable event of inflammation.Patient code e2338 captures the reportable event of swelling.Impact code f2302 captures the reportable event of medication required.Impact code f1905 captures the reportable event of device revision.Impact code f1901 captures the reportable event of additional surgery.Impact code f1903 captures the reportable event of explantation.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: block e1 has been corrected.Blocks b5, h6 and h10 have been corrected based on the review from medical safety received on december 21, 2022.
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Event Description
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It was reported to boston scientific corporation that an advantage fit was implanted during a midurethral sling tension-free vaginal tape placement procedure performed on (b)(6) 2013 to treat a patient with stress incontinence.On (b)(6) 2017, a letter was sent by the physician for a consult for a patient who complained of "a vaginal pouch filling up with feces." on examination, she appeared to have a degree of rectocele.However, there were no palpable masses.The patient was previously advised about performing pelvic floor exercises.On (b)(6) 2017, a letter was sent by the physician for a consult for a patient who has bulge symptoms.In addition, since the surgery, every time the patient laid down, she wets herself.On (b)(6) 2017, a letter was sent by the physician to the patient informing her of her recent symptoms of evacuatory difficulties and a feeling of bulging forward into the vagina when she tried to open the bowels.Upon examination, the physician did not note any mesh exposure.The patient has a prolapse at the back wall of the vagina, although it was not as bad as it was.The patient would like to have it repaired.The physician showed the patient bsug data with good success rates and low complication rates.The patient was given the iuga information leaflet, and a consent was taken and risks including bleeding, infection, thrombosis, failure and pain were discussed.On (b)(6) 2017, a letter was sent by the physician to the patient summarizing her visit on (b)(6) 2017 where she noted her current symptoms of bulging when she opened her bowels despite a posterior repair performed in june.In the physician's assessment, there was good support of the back wall of the vagina.The patient noticed that her bladder leaks when she laid down and in the physician's assessment, the patient has urge incontinence.The physician asked the patient to keep a bladder diary to check her daily result and emptying.The physician also requested a urine specimen to be sent to rule out infection.On (b)(6) 2017, a referral was sent by the physician to a gi physiologist regarding the patient's fecal urgency.In the physician's assessment, this may be associated with sudden onset fecal urgency incontinence.The physician was referring the patient for a possible physiology testing.On (b)(6) 2018, a letter was sent by the physician to the patient informing her of her urodynamics which other than a more protracted flow after the patient's tvt, were normal and the patient emptied properly.The patient had quite marked bowel symptoms and she was awaiting endoanal ultrasound scan.On (b)(6) 2018, a letter was sent by the physician to the patient informing her of their assessment.The investigations showed that there was a defect in the external anal sphincter muscle and so the functional length of the back passage muscle was shortened.In the physician's assessment, this was the reason why the patient was having some fecal urgency.Although, the patient had some protected flow of her urine.The other problem that the patient have is that she did not have any sensation during intercourse.Upon examination, there was no mesh exposure in the vagina and no particular prolapse.There was a little bit of a gape on the introitus but there was no real indication for an operation.The patient reported good pelvic floor muscle contractions when using electrical stimulation.However, upon examination, when the patient was asked to squeeze, there was absolutely nothing.In the physician's assessment, there might be a problem with the patient's nerve supply from her back into her pelvis.On the same date, a letter was also sent by the physician for a referral regarding the patient lifting something heavy and had pain and was told that she had trapped nerve in her back.On the same date, another referral was sent by the physician for the patient's urinary symptoms.It was noted that the biggest problem of the patient at the moment is her fecal urgency.And has no sensation during intercourse.A physician scanned her and there was a defect noted in the external sphincter low down.Upon examination, her oxford score on pelvic floor muscle squeeze is zero.The patient has an electric stimulator at home.The patient has had physiotherapy and they discussed about loperamide syrup use, but she did not have any problems with anything other than firm stool.On (b)(6) 2019, the patient had a telephone consult due to an on-going problem with urinary incontinence in the past few weeks.The patient also had a history of thrush symptoms, and she was requesting for fluconazole or and cream to be sent to pharmacy.In addition, the patient vaginal itch and discomfort.On (b)(6) 2019, a referral was made for the patient due to urinary incontinence.The patient was not keen in taking tablets.However, she has done pelvic floor exercises.The patient did not note any blood in the urine and no red flags, no acute infection symptoms.The patient declined a urine dip examination.The patient was referred to genitourinary clinic.On (b)(6) 2019, a letter was sent by the physician to the patient regarding a significant pain experienced by the patient.The pain was noted over the mid-section of the tape, especially during intercourse.The patient also reported chronic symptoms of incontinence, of a mixed nature and troublesome nighttime symptoms.Upon examination, the physician can feel an edge of the tape that was quite superficial, and it was certainly very tender.In the physician's assessment, it was best to remove that mid-section of the tape.The physician explained to the patient that there was a risk that things will get worse before they get better.It may be that leakage gets worse for example and there was a small risk of damaging the urethra and needing a catheter for a fair number of days.The patient was also going to undergo a bilateral mastectomy with a laparascopic gastric bypass in february.Ideally, the physician would like to have the exposed mesh removed before then.On (b)(6) 2020, the patient underwent an excision of her mid portion of tvt under general anesthesia.The procedure was successful and uncomplicated.The patient was expected to be discharged later.The tissue has been sent for histology and the patient was expected for follow up in the urogynecology clinic in three months' time.On (b)(6) 2020, the patient felt like her mesh came through her skin underneath the urethra.The patient was scheduled for surgery on the 5th of october for the removal mesh.The patient felt the area was very swollen.The patient was passing urine regularly and did not note any bleeding.On (b)(6) 2020, the patient reported a burning sensation around her vaginal mesh region.She thought the mesh came through her skin.The patient did not note a painful urination nor was there any burning or stinging when pulling.The patient did not experience hematuria.Urine dipstick was positive for leukocytes and blood and she was started on nitrofurantoin for a urinary tract infection.Later that day, the patient started the nitrofurantoin and experienced an allergic reaction described as hives occurring all over the body, felt like her throat was closing in and her head was exploding, and a rash.The patient was seen in the accident and emergency department where the allergic reaction was treated with oral prednisone and piriton.The symptoms resolved and her antibiotics were changed to trimethoprim.On (b)(6) 2020, the patient had reported experiencing menopausal flushing.She noted flushes and mood swings and wanted to start hormone replacement therapy but was not advised to given she was brca positive and was awaiting mastectomy.On (b)(6) 2020, a letter was sent by the physician to the patient.In the physician's assessment, the patient was experiencing significant pain related to her tape.Prognostically, it was good that the only pain she was having was where they touched the tape rather than having a more global pain.As they discussed, the aim was to remove the tape that was causing the problem and they were going to do this vaginally.The plan was to go as wide as they could to remove the tape but would not formally be making a cut in the stomach to try and remove absolutely all of the mesh that was inserted because the physician thought it was causing a problem for the patient and this would probably cause the patient more problems.They went through the risks of the surgery and in particular, the physician was expecting to be able to remove the mesh vaginally without a problem.There was a small chance that the physician may need to do a martius flap which was swinging some fatty tissue from the labia in underneath the urethra.The physician would need to do this if the mesh was cutting into the urethra but normally, they were able to get away without doing this.Finally, the physician also discussed the possibility that stress incontinence might come back and they would re-evaluate other options.On (b)(6) 2020, the patient underwent tvt excision for dyspareunia following tvt insertion.Pathology results of the specimen consisted of squamous mucosa showing reactive changes in squamous epithelium and hyperplasia.The underlying stroma was fibrotic and contained fragments of embedded refractile foreign material and clefts eliciting a histiocytic reaction.There was a mild chronic inflammation.There was no evidence of vain or malignancy.On (b)(6) 2021, a letter was sent to the patient by the physician.The patient reported that since her mesh removal, she has had pain on the left side.This pain was sharp and was only present during intercourse and went afterwards.She felt the pain has only occurred since having the procedure.She has no discharge or bleeding.In terms of her incontinence, she felt that she was constantly wet, that she passed about an egg cup worth of urine each time and she was constantly wearing pads.Her main symptom was stress incontinence but sometimes she felt a bit of urgency as well.She felt all of the symptoms of her incontinence worsened with the removal of the middle part of the mesh.She denied any prolapse symptoms.On examination with verbal consent and chaperone present, her post void residual was nil.There was no evidence of prolapse today and stress urinary incontinence was not elicited.The physician was unable to locate the point of her pain and could not illicit the pain that she has in the vagina.The physician was unable to see any marked tethering or scarring either.The physician spoke to the patient about the findings and as a result they felt that they should start investigating her from the beginning.She was happy to proceed with repeat video urodynamics.The physician will be sending her a questionnaire if she could kindly fill that in and they will speak to her about their findings and then move forward.Depending on what they find they would see if the patient needed further imaging such as an mri but the physician has explained to her that with scar tissue, the more she did, the more scar tissue she would get so it might be a case that there might not be any benefit from performing further imaging.On (b)(6) 2021, a letter was sent by the physician to the patient.Further to seeing the patient for her urodynamics today, not surprisingly these have confirmed what they suspected, that she has recurrent stress incontinence, as they have removed the offending piece of her tape.The physician was delighted for the patient that her symptoms of pain with the mesh extrusion have completely subsided but disappointed that they were a bit back to square one.The physician spent some time going through the various options and in essence she told the physician that she has done pelvic floor re-education and therefore, would not want a further referral to physiotherapy and would want to look for a surgical solution.In essence there were three options that they considered.The first being a bulking agent which was to inject a polyacrylamide substance into the walls of the urethra to try and give it some more resistance or they could consider conventional surgery of either a colposuspension or a fascial sling.The patient would also be a good candidate for the pursuit study which was a randomized controlled trial comparing a bulking agent against either a colposuspension or a fascial sling.The physician was arranging for her to be seen back in clinic just to make the final decision and the patient will probably be contacted by another healthcare professional who was the nurse running the pursuit study as well.In accordance with the patient's wishes today, they have listed the patient for surgery but obviously they will modify exactly what they were going to do with the waiting list once they have seen the patient and made the final decision based on her reading of the information leaflets.On (b)(6) 2022, a referral was sent by the physician.The patient was admitted today for elective procedure on the gynecology unit.She underwent colposuspension for stress urinary incontinence.During surgery, they also removed the right arm of the retropubic tvt as this was causing some scarring in the retropubic space.The procedure was uneventful.They would expect the patient to be discharged in three days and follow-up would be in three months' time.On (b)(6) 2022, the patient was seen and did report having some voiding dysfunction after the surgery.Things have improved and these symptoms only occur on occasion.Since the surgery, she reported that she has had a couple of urine infections.She has self-catheterized in the past and she felt that she might benefit from this on occasion.On examination with verbal consent and chaperone present, her scar was well healed.There was a small subdermal cyst felt, which should resolve with time.Her post void residual was 0 ml.On examination, there was a good elevation of the urethra.The physician was unable to appreciate any mesh and there was no obvious prolapse seen.The physician explained the findings to her and that to investigate her voiding a little bit more.The patient was happy with the plan.
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