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BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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| Model Number M0068318170 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
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| Patient Problems
Erosion (1750); Micturition Urgency (1871); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Prolapse (2475); Hematuria (2558); Dysuria (2684); Constipation (3274); Dyspareunia (4505); Unspecified Tissue Injury (4559); Fecal Incontinence (4571); Urinary Incontinence (4572); Insufficient Information (4580)
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| Event Date 07/19/2016 |
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Event Type
Injury
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Manufacturer Narrative
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Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2019, was chosen as a best estimate based on the date of the mesh removal surgery.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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Note: this manufacturer report pertains to the first of two devices used during the procedure.It was reported to boston scientific corporation that an uphold lite device and an obtryx ii system - halo device were implanted into the patient during a procedure performed on (b)(6) 2018.After the procedure, the patient has experienced an unspecified injury and underwent a device removal on (b)(6) 2019.
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Event Description
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Note: this manufacturer report pertains to the first of two devices used during the procedure.It was reported to boston scientific corporation that an uphold lite device and an obtryx ii system -- halo device were implanted into the patient during a procedure performed on (b)(6) 2018.After the procedure, the patient has experienced an unspecified injury and underwent a device removal on (b)(6) 2019.Boston scientific received an additional information on (b)(6) 2022 as follows: it was reported to boston scientific corporation that an uphold lite and an obtryx ii system -- halo device were implanted into the patient during a transobturator tape mid-urethral sling, cystocele repair, vaginal colpopexy procedure performed on (b)(6) 2016 for the treatment of grade 3 cystocele, vaginal vault prolapse and stress urinary incontinence.According to reports, the patient tolerated the treatment well and was afterwards woken from anesthesia and moved to the recovery area in stable condition.The patient was seen on (b)(6) 2019 for treatment of recurrent vaginal vault prolapse, mixed incontinence, hematuria, and fecal incontinence.In 2016, the patient underwent a bladder lift treatment, according to the patient, the surgeon corrected a grade 3 cystocele with an uphold lite in 2016 after reviewing the surgical results.She was also wearing a transobturator sling at the time.Her symptoms have reappeared in the last year, and she can see and feel her bulge once more.She also mentioned that she has recurrent stress incontinence and that she leaks when she coughs or sneezes, as well as when she moves.She has also experienced urgency urine incontinence in the last six to twelve months.The patient reports voiding 7-8 times per day and 3 times per day, as well as leaking with urgency.In (b)(6) 2018, she also experienced hematuria with large blood clots.Her urologist, examined her and ordered a cystoscopy and ct scan, both of which came out normal.Every three months, the patient complains fecal incontinence.She claims to be constipated, with incomplete emptying and the need to splint on sometimes because to stool trapping.The patient hasn't used any dietary or stool supplements in a long time.She has anal incontinence on occasion, along with gas and loose stool loss.She is diabetic, but claims that her most recent hemoglobin a1c (hba1c) was normal, and that she is now on a controlled diet.A review of the patient's system should also include the following: genitourinary system: hematuria, lack of bladder control, urinary frequency, urine has a foul odor and causes a burning sensation.Gastrointestinal: abdominal pain and nausea the patient was examined for a follow-up appointment on (b)(6) 2019, and she still had pelvic pain and dyspareunia.The patient currently has stage 2 prolapse and stress urinary incontinence and would like to be handled further.She claims she wants to wait until next year to get surgery.The patient expressed concern that her prolapse has worsened since her last visit.For the treatment of pelvic pain and dyspareunia, the patient had an excision of vaginal uphold lite and transobturator sling mesh, as well as a cystoscopy, on (b)(6) 2019.During the surgery, allis clamps were used to hold the anterior wall of the vagina and a dilute epinephrine solution was administered under the vaginal muscularis.This was done until the uphold mesh in the midline was found.The mesh was identified and transacted in the midline using meticulous sharp dissection.Each side of the mesh was then carefully dissected free until its attachment to the sacrospinous ligament and was transacted as far back as safely possible.The focus was then shifted to the sling excision part of the procedure.The mesh was distal and close to the urethral meatus, according to the findings.After that, the mesh was removed.The wound was irrigated extensively, reported to be hemostatic, and closed with a running layer of 0 vicryl.In stable condition, the patient was extubated and transported to the recovery room.The patient was seen for post-operative follow-up on (b)(6) 2020.The patient claims that she is in great shape and that she is no longer in discomfort.She has been sexually active without trouble, and she is free of any additional discomfort.The patient does reported urine incontinence, which she claims was at its worst in the first two weeks after surgery but has since improved.However, she dribbles urine on her way to the restroom and leaks urine if she raises anything over her head, according to reports.Although she reports occasional leaking in response to stress, she denies that sui is the most bothersome complaint of mesh excision.The patient visited a clinic on (b)(6) 2021, and indicated that she continues to have occasional pelvic pain and frequent urination.With infection, she also have blood in her urine on occasion.She's had a cystoscopy as well as imaging.Her urinary system was said to be mesh-free.Intercourse is also a source of discomfort for her.She isn't taking any estrogen supplements.She does suffer urge and stress incontinence, but she is not interested in any further operations.Tenderness over palpable hard parts in the vagina is evident on the patient's exam.The surgeon is unsure if the grommets from her anterior vaginal wall mesh surgery or the mesh itself.She isn't tender in any other way.She also has some significant vaginal atrophy and urethral hypermobility.Her main complaint is that she is in pain.A substantial amount of blood is seen in her urinalysis.Although there are no white blood cells and it is nitrate negative, the surgeon will have the catheterized for culture.Her leftover pee is less than an ounce, indicating that she is not in urinary retention.There are a lot of things going on in her life.She is apprehensive about undergoing any type of surgery.The surgeon believes that the best approach to treat her is to take it slowly and figure out what we need to do to have her feeling better.The surgeon believes that transvaginal estrogen replacement might be beneficial at initially.She is postmenopausal, and her vaginal tissues have atrophy.Because her sensitivity is limited to specific locations, thickening the vaginal lining may aid in pain reduction, particularly during intercourse.Premarin vaginal cream is prescribed by the surgeon.For the next two months, the surgeon wants her to apply the cream three times a week.They'll switch to two evenings a week at that point.The surgeon explained to her and her husband how this could assist with her discomfort as well as infection prevention.Her surgeon prescribed a myrbetriq 50 mg tablets once a day to aid with her urine frequency, urgency, and incontinence.
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Manufacturer Narrative
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Block h2: additional information: blocks a2, a4, b5, b7, e1 and h6 have been updated based on the additional information received on may 25, 2022.Correction: blocks b3, d6a, d6b and g2 have been updated based on the additional information received on may 25, 2022.Block b3 date of event: the exact event onset date is unknown.The provided event date of december 31, 2019, was chosen as a best estimate based on the date of the mesh removal surgery.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) dr.(b)(6) hospital.The explant surgeon is: (b)(6) dr.United states block h6: patient code e1405, e1302, e1301, e2330, e1310 capture the reportable events of dyspareunia, hematuria, dysuria, pain and urinary tract infection.Impact code f1903 captures the reportable event of mesh removal.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Manufacturer Narrative
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Block h2: correction.Block b5 narrative updated.Block h6 device code a1502 (positioning problem) added to capture the mesh was distal and close to the urethral meatus.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2019, was chosen as a best estimate based on the date of the mesh removal surgery.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) hospital.The explant surgeon is: dr.(b)(6).(b)(6).Block h6: patient code e1405, e1302, e1301, e2330, e1310 capture the reportable events of dyspareunia, hematuria, dysuria, pain and urinary tract infection.Impact code f1903 captures the reportable event of mesh removal.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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Note: this manufacturer report pertains to the first of two devices used during the procedure.It was reported to boston scientific corporation that an uphold lite device and an obtryx ii system - halo device were implanted into the patient during a procedure performed on (b)(6) 2018.After the procedure, the patient has experienced an unspecified injury and underwent a device removal on (b)(6) 2019.Boston scientific received an additional information on may 25, 2022 as follows: it was reported to boston scientific corporation that an uphold lite and an obtryx ii system -- halo device were implanted into the patient during a transobturator tape mid-urethral sling, cystocele repair, vaginal colpopexy procedure performed on (b)(6) 2016 for the treatment of grade 3 cystocele, vaginal vault prolapse and stress urinary incontinence.According to reports, the patient tolerated the treatment well and was afterwards woken from anesthesia and moved to the recovery area in stable condition.The patient was seen on (b)(6) 2019 for treatment of recurrent vaginal vault prolapse, mixed incontinence, hematuria, and fecal incontinence.Her symptoms have reappeared in the last year, and she can see and feel her bulge once more.She also mentioned that she has recurrent stress incontinence and that she leaks when she coughs or sneezes, as well as when she moves.She has also experienced urgency urine incontinence in the last six to twelve months.The patient reports voiding 7-8 times per day and 3 times per day, as well as leaking with urgency.She also reported that in (b)(6) 2018, she experienced hematuria with large blood clots.Her urologist examined her and ordered a cystoscopy and ct scan, both of which came out normal.Every three months, the patient experienced fecal incontinence.She claims to be constipated, with incomplete emptying and the need to splint occasionally due to stool trapping.The patient hasn't used any dietary or stool supplements in a long time.She has anal incontinence on occasion with loss of gas and loose stool.She is diabetic, but claims that her most recent hemoglobin a1c (hba1c) was normal, and that she is now on a controlled diet.A review of the patient's system included the following: genitourinary system: hematuria, lack of bladder control, urinary frequency, urine has a foul odor, and burning sensation with urination.Gynecologic exam revealed normal external genitalia and vagina, no mesh erosion or exposure, tenderness at the sacrospinous arms and distally at the site of the sling arms.The assessment was urinary frequency, urge incontinence of urine, stress incontinence, fecal incontinence, and vaginal vault prolapse.The plan was for urodynamics, urinalysis and culture, and oxybutynin.The patient noted that the fecal incontinence was a bother but that she did not desire any interventions at this time; she was recommended dietary changes and addition of fiber and probiotics.Due to recurrence after vaginal mesh repair, the patient was recommended robotic scp for surgical management of vaginal vault prolapse.On (b)(6) 2019, the patient presented for surgical consult.The patient felt her prolapse had worsened since her last visit and she also reported pelvic pain and dyspareunia.She wanted to wait until next year to have surgery.The assessment was stress incontinence, vaginal vault prolapse, urinary pain, and complication of implanted vaginal mesh.The patient was advised that there is a risk when performing scp with existing pain that it could be difficult to differentiate causes of pain in the future.The plan was for excision of uphold and obtryx ii mesh first, assess for improvement in pain following removal, and if improved, proceed with robotic scp and tvt sling.For the treatment of pelvic pain and dyspareunia, the patient had an excision of vaginal uphold lite and transobturator sling mesh, as well as a cystoscopy, on (b)(6) 2019.During the surgery, allis clamps were used to hold the anterior wall of the vagina and a dilute epinephrine solution was administered under the vaginal muscularis.This was done until the uphold mesh in the midline was found.The mesh was identified and transacted in the midline using meticulous sharp dissection.Each side of the mesh was then carefully dissected free until its attachment to the sacrospinous ligament and was transacted as far back as safely possible.The focus was then shifted to the sling excision part of the procedure.The mesh was distal and close to the urethral meatus, according to the findings.After that, the mesh was removed.The wound was irrigated extensively, reported to be hemostatic, and closed with a running layer of 0 vicryl.Cystoscopy revealed a normal bladder with no evidence of mesh erosion or injury.In stable condition, the patient was extubated and transported to the recovery room.The patient was seen for post-operative follow-up on (b)(6) 2020.The patient claims that she is in great shape and that she is no longer in discomfort.She has been sexually active without trouble, and she is free of any additional discomfort.The patient reported urinary incontinence, which she claims was at its worst in the first two weeks after surgery but has since improved.However, she dribbles urine on her way to the restroom and leaks urine if she raises anything over her heads.Although she reports occasional leaking in response to stress, she denies that sui is the most bothersome complaint.The patient was started on vesicare for urge incontinence.The patient visited a clinic on (b)(6) 2021, and indicated that she continues to have intermittent pelvic pain and frequent urination.She also reported having blood in her urine occasionally with infection.She's had a cystoscopy as well as imaging.Her urinary system was said to be mesh-free.Intercourse is also a source of discomfort for her.She isn't taking any estrogen supplements.She does suffer urge and stress incontinence, but she is not interested in any further operations.Exam revealed urethral hypermobility and moderate atrophy.The assessment noted that the exam was impressive for tenderness over palpable firm areas in the vagina.The physician was unsure if the firm areas were grommets from her anterior vaginal wall mesh surgery or the mesh itself.She was not tender anywhere else.She also had some significant vaginal atrophy and urethral hypermobility.Her main complaint was that she is in pain.A substantial amount of blood was seen in her urinalysis.Although there were no white blood cells and it was nitrate negative, the urine sample obtained via catheterization was sent for culture.Residual urine was less than an ounce, indicating that she was not in urinary retention.The patient's sensitivity was limited to specific locations and the patient was hesitant to have any surgery.Premarin vaginal cream was prescribed to thicken the vaginal lining and hopefully aid in pain reduction, particularly during intercourse.For the next two months, the surgeon wants her to apply the cream three times a week.They'll switch to two evenings a week at that point.The surgeon explained to her and her husband how this could assist with her discomfort as well as infection prevention.Her surgeon prescribed a myrbetriq 50 mg tablets once a day to aid with her urine frequency, urgency, and incontinence.
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Manufacturer Narrative
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Block h2: correction block h6 device code of a1502 (positioning problem) has been removed and corrected to a24 (adverse event without identified device or use problem).Block b3 date of event: the exact event onset date is unknown.The provided event date of july 19, 2016 was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The explant surgeon is: (b)(6).Block h6: patient code e1405, e1301, e232401, e1310, e1302, e2015, e2006, e2330 capture the reportable events of dyspareunia, dysuria, fecal incontinence, urinary tract infection, hematuria, atrophy, erosion and pain impact code f1903 and f2303 captures the reportable events of mesh removal and medication required.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a device analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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Note: this manufacturer report pertains to the two of two devices used during the procedure.It was reported to boston scientific corporation that an uphold lite device and an obtryx ii system - halo device were implanted into the patient during a procedure performed on (b)(6) 2018.After the procedure, the patient has experienced an unspecified injury and underwent a device removal on (b)(6) 2019.Boston scientific received an additional information on may 25, 2022 as follows: it was reported to boston scientific corporation that an uphold lite and an obtryx ii system -- halo device were implanted into the patient during a transobturator tape mid-urethral sling, cystocele repair, vaginal colpopexy procedure performed on (b)(6) 2016 for the treatment of grade 3 cystocele, vaginal vault prolapse and stress urinary incontinence.According to reports, the patient tolerated the treatment well and was afterwards woken from anesthesia and moved to the recovery area in stable condition.The patient was seen on march 28, 2019 for treatment of recurrent vaginal vault prolapse, mixed incontinence, hematuria, and fecal incontinence.Her symptoms have reappeared in the last year, and she can see and feel her bulge once more.She also mentioned that she has recurrent stress incontinence and that she leaks when she coughs or sneezes, as well as when she moves.She has also experienced urgency urine incontinence in the last six to twelve months.The patient reports voiding 7-8 times per day and 3 times per day, as well as leaking with urgency.She also reported that in december 2018, she experienced hematuria with large blood clots.Her urologist examined her and ordered a cystoscopy and ct scan, both of which came out normal.Every three months, the patient experienced fecal incontinence.She claims to be constipated, with incomplete emptying and the need to splint occasionally due to stool trapping.The patient hasn't used any dietary or stool supplements in a long time.She has anal incontinence on occasion with loss of gas and loose stool.She is diabetic, but claims that her most recent hemoglobin a1c (hba1c) was normal, and that she is now on a controlled diet.A review of the patient's system included the following: genitourinary system: hematuria, lack of bladder control, urinary frequency, urine has a foul odor, and burning sensation with urination.Gynecologic exam revealed normal external genitalia and vagina, no mesh erosion or exposure, tenderness at the sacrospinous arms and distally at the site of the sling arms.The assessment was urinary frequency, urge incontinence of urine, stress incontinence, fecal incontinence, and vaginal vault prolapse.The plan was for urodynamics, urinalysis and culture, and oxybutynin.The patient noted that the fecal incontinence was a bother but that she did not desire any interventions at this time; she was recommended dietary changes and addition of fiber and probiotics.Due to recurrence after vaginal mesh repair, the patient was recommended robotic scp for surgical management of vaginal vault prolapse.On october 2, 2019, the patient presented for surgical consult.The patient felt her prolapse had worsened since her last visit and she also reported pelvic pain and dyspareunia.She wanted to wait until next year to have surgery.The assessment was stress incontinence, vaginal vault prolapse, urinary pain, and complication of implanted vaginal mesh.The patient was advised that there is a risk when performing scp with existing pain that it could be difficult to differentiate causes of pain in the future.The plan was for excision of uphold and obtryx ii mesh first, assess for improvement in pain following removal, and if improved, proceed with robotic scp and tvt sling.For the treatment of pelvic pain and dyspareunia, the patient had an excision of vaginal uphold lite and transobturator sling mesh, as well as a cystoscopy, on december 31, 2019.During the surgery, allis clamps were used to hold the anterior wall of the vagina and a dilute epinephrine solution was administered under the vaginal muscularis.This was done until the uphold mesh in the midline was found.The mesh was identified and transacted in the midline using meticulous sharp dissection.Each side of the mesh was then carefully dissected free until its attachment to the sacrospinous ligament and was transacted as far back as safely possible.The focus was then shifted to the sling excision part of the procedure.The mesh was distal and close to the urethral meatus, according to the findings.After that, the mesh was removed.The wound was irrigated extensively, reported to be hemostatic, and closed with a running layer of 0 vicryl.Cystoscopy revealed a normal bladder with no evidence of mesh erosion or injury.In stable condition, the patient was extubated and transported to the recovery room.The patient was seen for post-operative follow-up on february 5, 2020.The patient claims that she is in great shape and that she is no longer in discomfort.She has been sexually active without trouble, and she is free of any additional discomfort.The patient reported urinary incontinence, which she claims was at its worst in the first two weeks after surgery but has since improved.However, she dribbles urine on her way to the restroom and leaks urine if she raises anything over her heads.Although she reports occasional leaking in response to stress, she denies that sui is the most bothersome complaint.The patient was started on vesicare for urge incontinence.The patient visited a clinic on may 3, 2021 and indicated that she continues to have intermittent pelvic pain and frequent urination.She also reported having blood in her urine occasionally with infection.She's had a cystoscopy as well as imaging.Her urinary system was said to be mesh-free.Intercourse is also a source of discomfort for her.She isn't taking any estrogen supplements.She does suffer urge and stress incontinence, but she is not interested in any further operations.Exam revealed urethral hypermobility and moderate atrophy.The assessment noted that the exam was impressive for tenderness over palpable firm areas in the vagina.The physician was unsure if the firm areas were grommets from her anterior vaginal wall mesh surgery or the mesh itself.She was not tender anywhere else.She also had some significant vaginal atrophy and urethral hypermobility.Her main complaint was that she is in pain.A substantial amount of blood was seen in her urinalysis.Although there were no white blood cells and it was nitrate negative, the urine sample obtained via catheterization was sent for culture.Residual urine was less than an ounce, indicating that she was not in urinary retention.The patient's sensitivity was limited to specific locations and the patient was hesitant to have any surgery.Premarin vaginal cream was prescribed to thicken the vaginal lining and hopefully aid in pain reduction, particularly during intercourse.For the next two months, the surgeon wants her to apply the cream three times a week.They'll switch to two evenings a week at that point.The surgeon explained to her and her husband how this could assist with her discomfort as well as infection prevention.Her surgeon prescribed a myrbetriq 50 mg tablets once a day to aid with her urine frequency, urgency, and incontinence.Boston scientific received an additional information on july 28, 2022, as follows: on (b)(6) 2019, the patient underwent an ultrasound due to pelvic pain.According to reports, the patient's bladder had collapsed again, and she would require some sort of surgical surgery when she saw another doctor earlier for an evaluation of her hematuria.On (b)(6) 2022, the patient had her yearly gynecologic exam.The patient's gynecologic concerns include pelvic pain brought on by the removal of the bladder mesh and pain during sexual activity.The patient reported having a dull aching discomfort that got worse when standing and increased activity.When she engages in sexual activity, the pain becomes noticeably stronger and more acute.The patient claims that since having her mesh removed in december 2019, there has been no improvement.A grade 2 cystocele was found in the patient's vagina and bladder during a physical examination.The patient visits the clinic on june 27, 2022, for follow-up on her urge and stress incontinence.According to her medical history, she had some surgery done using a sling anterior repair.She claims that even after having partial mesh exposure removed, she still experiences some pelvic pain and pain during sexual activity.The patient started transvaginal estrogen replacement, which she claims has somewhat reduced her pain.She still leaks when under stress.When necessary, she does take myrbetriq.The stress incontinence is her main problem.
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Event Description
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Note: this manufacturer report pertains to the two of two devices used during the procedure.It was reported to boston scientific corporation that an uphold lite device and an obtryx ii system - halo device were implanted into the patient during a procedure performed on (b)(6) 2018.After the procedure, the patient has experienced an unspecified injury and underwent a device removal on (b)(6) 2019.Boston scientific received an additional information on may 25, 2022 as follows: it was reported to boston scientific corporation that an uphold lite and an obtryx ii system -- halo device were implanted into the patient during a transobturator tape mid-urethral sling, cystocele repair, vaginal colpopexy procedure performed on (b)(6) 2016 for the treatment of grade 3 cystocele, vaginal vault prolapse and stress urinary incontinence.According to reports, the patient tolerated the treatment well and was afterwards woken from anesthesia and moved to the recovery area in stable condition.The patient was seen on (b)(6) 2019 for treatment of recurrent vaginal vault prolapse, mixed incontinence, hematuria, and fecal incontinence.Her symptoms have reappeared in the last year, and she can see and feel her bulge once more.She also mentioned that she has recurrent stress incontinence and that she leaks when she coughs or sneezes, as well as when she moves.She has also experienced urgency urine incontinence in the last six to twelve months.The patient reports voiding 7-8 times per day and 3 times per day, as well as leaking with urgency.She also reported that in (b)(6) 2018, she experienced hematuria with large blood clots.Her urologist examined her and ordered a cystoscopy and ct scan, both of which came out normal.Every three months, the patient experienced fecal incontinence.She claims to be constipated, with incomplete emptying and the need to splint occasionally due to stool trapping.The patient hasn't used any dietary or stool supplements in a long time.She has anal incontinence on occasion with loss of gas and loose stool.She is diabetic, but claims that her most recent hemoglobin a1c (hba1c) was normal, and that she is now on a controlled diet.A review of the patient's system included the following: genitourinary system: hematuria, lack of bladder control, urinary frequency, urine has a foul odor, and burning sensation with urination.Gynecologic exam revealed normal external genitalia and vagina, no mesh erosion or exposure, tenderness at the sacrospinous arms and distally at the site of the sling arms.The assessment was urinary frequency, urge incontinence of urine, stress incontinence, fecal incontinence, and vaginal vault prolapse.The plan was for urodynamics, urinalysis and culture, and oxybutynin.The patient noted that the fecal incontinence was a bother but that she did not desire any interventions at this time; she was recommended dietary changes and addition of fiber and probiotics.Due to recurrence after vaginal mesh repair, the patient was recommended robotic scp for surgical management of vaginal vault prolapse.On (b)(6) 2019, the patient presented for surgical consult.The patient felt her prolapse had worsened since her last visit and she also reported pelvic pain and dyspareunia.She wanted to wait until next year to have surgery.The assessment was stress incontinence, vaginal vault prolapse, urinary pain, and complication of implanted vaginal mesh.The patient was advised that there is a risk when performing scp with existing pain that it could be difficult to differentiate causes of pain in the future.The plan was for excision of uphold and obtryx ii mesh first, assess for improvement in pain following removal, and if improved, proceed with robotic scp and tvt sling.For the treatment of pelvic pain and dyspareunia, the patient had an excision of vaginal uphold lite and transobturator sling mesh, as well as a cystoscopy, on (b)(6) 2019.During the surgery, allis clamps were used to hold the anterior wall of the vagina and a dilute epinephrine solution was administered under the vaginal muscularis.This was done until the uphold mesh in the midline was found.The mesh was identified and transacted in the midline using meticulous sharp dissection.Each side of the mesh was then carefully dissected free until its attachment to the sacrospinous ligament and was transacted as far back as safely possible.The focus was then shifted to the sling excision part of the procedure.The mesh was distal and close to the urethral meatus, according to the findings.After that, the mesh was removed.The wound was irrigated extensively, reported to be hemostatic, and closed with a running layer of 0 vicryl.Cystoscopy revealed a normal bladder with no evidence of mesh erosion or injury.In stable condition, the patient was extubated and transported to the recovery room.The patient was seen for post-operative follow-up on (b)(6) 2020.The patient claims that she is in great shape and that she is no longer in discomfort.She has been sexually active without trouble, and she is free of any additional discomfort.The patient reported urinary incontinence, which she claims was at its worst in the first two weeks after surgery but has since improved.However, she dribbles urine on her way to the restroom and leaks urine if she raises anything over her heads.Although she reports occasional leaking in response to stress, she denies that sui is the most bothersome complaint.The patient was started on vesicare for urge incontinence.The patient visited a clinic on (b)(6) 2021 and indicated that she continues to have intermittent pelvic pain and frequent urination.She also reported having blood in her urine occasionally with infection.She's had a cystoscopy as well as imaging.Her urinary system was said to be mesh-free.Intercourse is also a source of discomfort for her.She isn't taking any estrogen supplements.She does suffer urge and stress incontinence, but she is not interested in any further operations.Exam revealed urethral hypermobility and moderate atrophy.The assessment noted that the exam was impressive for tenderness over palpable firm areas in the vagina.The physician was unsure if the firm areas were grommets from her anterior vaginal wall mesh surgery or the mesh itself.She was not tender anywhere else.She also had some significant vaginal atrophy and urethral hypermobility.Her main complaint was that she is in pain.A substantial amount of blood was seen in her urinalysis.Although there were no white blood cells and it was nitrate negative, the urine sample obtained via catheterization was sent for culture.Residual urine was less than an ounce, indicating that she was not in urinary retention.The patient's sensitivity was limited to specific locations and the patient was hesitant to have any surgery.Premarin vaginal cream was prescribed to thicken the vaginal lining and hopefully aid in pain reduction, particularly during intercourse.For the next two months, the surgeon wants her to apply the cream three times a week.They'll switch to two evenings a week at that point.The surgeon explained to her and her husband how this could assist with her discomfort as well as infection prevention.Her surgeon prescribed a myrbetriq 50 mg tablets once a day to aid with her urine frequency, urgency, and incontinence.Boston scientific received an additional information on july 28, 2022, as follows: on (b)(6) 2019, the patient underwent an ultrasound due to pelvic pain.According to reports, the patient's bladder had collapsed again, and she would require some sort of surgical surgery when she saw another doctor earlier for an evaluation of her hematuria.On (b)(6) 2022, the patient had her yearly gynecologic exam.The patient's gynecologic concerns include pelvic pain brought on by the removal of the bladder mesh and pain during sexual activity.The patient reported having a dull aching discomfort that got worse when standing and increased activity.When she engages in sexual activity, the pain becomes noticeably stronger and more acute.The patient claims that since having her mesh removed in (b)(6) 2019, there has been no improvement.A grade 2 cystocele was found in the patient's vagina and bladder during a physical examination.The patient visits the clinic on (b)(6) 2022, for follow-up on her urge and stress incontinence.According to her medical history, she had some surgery done using a sling anterior repair.She claims that even after having partial mesh exposure removed, she still experiences some pelvic pain and pain during sexual activity.The patient started transvaginal estrogen replacement, which she claims has somewhat reduced her pain.She still leaks when under stress.When necessary, she does take myrbetriq.The stress incontinence is her main problem.
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Manufacturer Narrative
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Correction: block b3: date of event updated.Block h6: patient and impact codes updated.Block b3 date of event: the exact event onset date is unknown.The provided event date of july 19, 2016 was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) hospital.The explant surgeon is: dr.(b)(6).Block h6: patient code e1405, e1301, e232401, e1310, e1302, e2015, e2006, e2330 capture the reportable events of dyspareunia, dysuria, fecal incontinence, urinary tract infection, hematuria, atrophy, erosion and pain impact code f1903 and f2303 captures the reportable events of mesh removal and medication required.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a device analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Search Alerts/Recalls
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