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BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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| Device Problems
Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
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| Patient Problems
Erosion (1750); Purulent Discharge (1812); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Hernia (2240); Urinary Frequency (2275); Deformity/ Disfigurement (2360); Prolapse (2475); Sleep Dysfunction (2517); Dysuria (2684); Fibrosis (3167); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Unspecified Tissue Injury (4559); Fecal Incontinence (4571); Urinary Incontinence (4572)
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| Event Date 06/21/2011 |
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Event Type
Injury
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Event Description
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Note: this manufacturer report pertains to the second of two devices used during the same procedure.Please refer to mfr report 3005099803-2021-00908 for the associated device.It was reported to boston scientific corporation that an obtryx system and uphold or a pinnacle prolapse repair mesh device was implanted into the patient during a procedure performed on (b)(6) 2011, for the treatment of pelvic organ prolapse (pop) and stress urinary incontinence (sui).The implant procedure was performed without intraoperative complications.On (b)(6) 2018, with surgical indications including pelvic pain and mesh eroding into her vagina.The patient underwent surgery to revise and partially remove the mesh implant.On (b)(6) 2019, after experiencing pelvic pain, bleeding and incontinence, the patient sought consult and it was noted by the physician that an additional exposed mesh in multiple areas was seen and the physician recommended an additional surgery to attempt to remove the remaining mesh.However, the physician noted that it may not be possible to remove all of the mesh from inside the patient.As a result of having the mesh implanted in the patient, she has experienced significant mental and physical pain and suffering, has sustained permanent injury and permanent and substantial physical deformity, has undergone and likely will continue to undergo corrective surgery or surgeries, and has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses.
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Manufacturer Narrative
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Date of event: date of event was approximated to june 21, 2011, implant date, as no event date was reported.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6).(b)(6) hospital, (b)(6).United states.The explanting surgeon is: dr.(b)(6).(b)(6) hospital.(b)(6).United states.The following imdrf patient codes capture the reportable events of: e0206 - significant mental and physical pain and suffering; e0506 - bleeding; e2330 - pelvic pain; e2006 - exposed mesh in multiple.The following imdrf impact code capture the reportable event of: f12 - device revision or replace ment.
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Manufacturer Narrative
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Blocks a1, a4, b5, b6, b7, and h6: patient codes, impact codes, and device codes have been updated based on the additional information received on october 17, 2023.Block b3 (date of event): date of event was approximated to (b)(6) 2011, implant date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6).The explanting surgeon is: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e0206 - significant mental and physical pain and suffering; e0506 - bleeding; e2330 - pelvic pain; e2006 - exposed mesh in multiple; e1310: infection, urinary tract; e1304: urinary urgency; e232401: incontinence, fecal; e2015: atrophy; e2319: hernia; e2326: inflammation; e1007: constipation - constipation with laxatives; e2313: fibrosis; e1405: dyspareunia - interested in becoming sexually active.Impact code f1905 captures the reportable event of revision procedure.Block 11: the above impact code has been corrected.(f12 has been updated to f1905: device revision/replacement capturing the revision procedure).
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Event Description
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Note: this manufacturer report pertains to one of the two devices implanted during the same procedure.Please refer to mfr report 3005099803-2021-00908 for upsylon device.It was reported to boston scientific corporation that an obtryx system and uphold or a pinnacle prolapse repair mesh device was implanted into the patient during a procedure performed on (b)(6) 2011, for the treatment of pelvic organ prolapse (pop) and stress urinary incontinence (sui).The implant procedure was performed without intraoperative complications.On (b)(6) 2018, with surgical indications including pelvic pain and mesh eroding into her vagina.The patient underwent surgery to revise and partially remove the mesh implant.On (b)(6) 2019, after experiencing pelvic pain, bleeding and incontinence, the patient sought consult and it was noted by the physician that an additional exposed mesh in multiple areas was seen and the physician recommended an additional surgery to attempt to remove the remaining mesh.However, the physician noted that it may not be possible to remove all of the mesh from inside the patient.As a result of having the mesh implanted in the patient, she has experienced significant mental and physical pain and suffering, has sustained permanent injury and permanent and substantial physical deformity, has undergone and likely will continue to undergo corrective surgery or surgeries, and has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses.Additional information received on october 17, 2023: on (b)(6) 2018, it was stated that on (b)(6) 2018 the patient had difficulty sleeping, abnormal vaginal bleeding and recurrent urinary tract infection.Per history of present illness, patient had a history of recurrent uti and is status post sling and cystocele repair with vaginal colpopexy/sacrospinous fixation using mesh in 2011.She presented to the clinic for a cystoscopy.She was informed about this by her gynecologist, that her mesh is out of place during the time of her pap smear.She describes an intermittent pinching sensation in her pelvis.She notes she has been having intermittent urge incontinence.She denies any dysuria, gross hematuria, and any stress incontinence.Cystoscopy was performed showing normal urethra and bladder.Patient tolerated the procedure well without complications and left the office in good condition.Assessment/plan: regarding urinary tract infection, benign cystoscopic findings noted.Bactrim was given for prophylaxis.The patient was counseled to return to the clinic if she becomes symptomatic so a urinalysis and urine culture can be completed.For microscopic hematuria, urinalysis reveals moderate rbcs and is negative for infection.Differential diagnosis was reviewed with the patient including the benign and malignant entities.A ct urogram will be obtained to further assess this, and the patient will be contacted with the results.In light of her benign cystoscopy, and being a low-risk patient, no further evaluation will be warranted if her ct urogram is benign.The patient was counseled to return to the clinic if she has any episodes of gross hematuria for further evaluation.Regarding prolapse of female genital organs, further treatment was outlined in the form of removal and replacement of her mesh.The patient was prescribed with fluconazole, ibu (ibuprofen), levothyroxine, methocarbamol, nitrofurantoin monohydrate/macrocrystals, and tizanidine.On (b)(6) 2018, pathology results reported vaginal mucosa with chronic inflammation and embedded surgical mesh material.In a clinical note of (b)(6) 2020, the patient's pelvic exam on (b)(6) 2018 demonstrated eroded central portion of folded mesh (mid anterior wall to proximal) and grade 2+ cystocele.She underwent vaginal eroded mesh removal (uphold mesh device).Pathology was negative for any malignancy.She was having urinary frequency and urgency with incontinence.She was instructed on daily kegel exercises and restarting vaginal estrogen cream.She was having fecal incontinence and incontinence with a full bladder and was referred to pelvic floor physical therapy.At her last visit on (b)(6) 2019 she felt as if she was having mesh erosion in her vagina.Pelvic exam revealed exposed mesh to the left side of midline distally and proximally, firmness and possible mesh band felt at proximal right anterior edge with thinning of vaginal mucosa.She was to schedule excision of her mesh.She returns today for follow up of her mesh erosion.She has not had any vaginal bleeding or discharge since her last visit.She has rare urge incontinence approximately once a month.She states this typically happens when she wakes too long to void.She denies any hematuria, dysuria, or urinary tract infections.She has not been using vaginal estrogen cream.Patient is interested in becoming sexually active.She has a colonoscopy scheduled this year.Assessment and plan included disorders of urogenital prostheses or implants: unspecified complication of genitourinary prosthetic device, implant and graft, initial encounter.Atrophic vaginitis: postmenopausal atrophic vaginitis, prescribed vaginal cream.Urinary incontinence of urine: urge incontinence.Herniation of rectum into vagina: rectocele.Cystocele: unspecified.The patient was counseled on only treating symptomatic infections.Excision of vaginal mesh was discussed with patient; this may need to be performed if she is interested in becoming sexually active.Advised to restart vaginal estrogen three times a week for atrophy and prevent infections.Follow up for urge incontinence and follow up appointment in six months to reassess symptoms.At her last visit on (b)(6) 2019, she noted having a small amount of blood discharge after using the applicator to apply the estrogen cream.During her visit today, she reported she occasionally feels the mesh when she walks.She is no longer wearing a pad for urinary leaking and states she leaks less while she is at work.She uses the vaginal estrogen cream once a day for 2 weeks.Her leg pain has resolved since her last surgery in (b)(6) 2018.She denies bloody vaginal discharge, hematuria, dysuria, or urinary tract infections.In an assessment, her stress incontinence has improved.At (b)(6) 2022 appointment, the patient noticed a strange vaginal odor.She had an intermittent urine stream with decreased sensation.She had constipation and is taking laxatives - following with gastrointestinal.She denied any utis.She was still having intermittent right leg pain starting at the pelvis and radiating down.On (b)(6) 2022, vaginal estrogen cream improved her urinary symptoms.She stated the cream turns pink after being inserted and denied any discharge.On (b)(6) 2023, she returned for follow up of her vaginal mesh erosion and urge incontinence status post vaginal mesh removal on (b)(6) 2023, pathology with fibromuscular tissue with embedded mesh and chronic inflammation.She continued using vaginal estrogen cream three times a week.She had constipation and had not taken anything to manage constipation.In an assessment and plan, she was advised to take miralax daily or fiber and increased water intake to manage constipation; and refill and continue vaginal estrogen cream three times per week for atrophy.The patient was scheduled for a follow up appointment in one year.
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Event Description
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Note: this manufacturer report pertains to one of the two devices implanted during the same procedure.It was reported to boston scientific corporation that an obtryx system and uphold or a pinnacle prolapse repair mesh device was implanted into the patient during a procedure performed on (b)(6) 2011, for the treatment of pelvic organ prolapse (pop) and stress urinary incontinence (sui).The implant procedure was performed without intraoperative complications.On (b)(6) 2018, with surgical indications including pelvic pain and mesh eroding into her vagina.The patient underwent surgery to revise and partially remove the mesh implant.On (b)(6) 2019, after experiencing pelvic pain, bleeding and incontinence, the patient sought consult and it was noted by the physician that an additional exposed mesh in multiple areas was seen and the physician recommended an additional surgery to attempt to remove the remaining mesh.However, the physician noted that it may not be possible to remove all of the mesh from inside the patient.As a result of having the mesh implanted in the patient, she has experienced significant mental and physical pain and suffering, has sustained permanent injury and permanent and substantial physical deformity, has undergone and likely will continue to undergo corrective surgery or surgeries, and has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses.***additional information received on october 17, 2023*** on (b)(6) 2018, it was stated that on (b)(6) 2018 the patient had difficulty sleeping, abnormal vaginal bleeding and recurrent urinary tract infection.Per history of present illness, patient had a history of recurrent uti and is status post sling and cystocele repair with vaginal colpopexy/sacrospinous fixation using mesh in 2011.She presented to the clinic for a cystoscopy.She was informed about this by her gynecologist, that her mesh is out of place during the time of her pap smear.She describes an intermittent pinching sensation in her pelvis.She notes she has been having intermittent urge incontinence.She denies any dysuria, gross hematuria, and any stress incontinence.Cystoscopy was performed showing normal urethra and bladder.Patient tolerated the procedure well without complications and left the office in good condition.Assessment/plan: regarding urinary tract infection, benign cystoscopic findings noted.Bactrim was given for prophylaxis.The patient was counseled to return to the clinic if she becomes symptomatic so a urinalysis and urine culture can be completed.For microscopic hematuria, urinalysis reveals moderate rbcs and is negative for infection.Differential diagnosis was reviewed with the patient including the benign and malignant entities.A ct urogram will be obtained to further assess this, and the patient will be contacted with the results.In light of her benign cystoscopy, and being a low-risk patient, no further evaluation will be warranted if her ct urogram is benign.The patient was counseled to return to the clinic if she has any episodes of gross hematuria for further evaluation.Regarding prolapse of female genital organs, further treatment was outlined in the form of removal and replacement of her mesh.The patient was prescribed with fluconazole, ibu (ibuprofen), levothyroxine, methocarbamol, nitrofurantoin monohydrate/macrocrystals, and tizanidine.On (b)(6) 2018, pathology results reported vaginal mucosa with chronic inflammation and embedded surgical mesh material.In a clinical note of (b)(6) 2020, the patient's pelvic exam on (b)(6) 2018 demonstrated eroded central portion of folded mesh (mid anterior wall to proximal) and grade 2+ cystocele.She underwent vaginal eroded mesh removal (uphold mesh device).Pathology was negative for any malignancy.She was having urinary frequency and urgency with incontinence.She was instructed on daily kegel exercises and restarting vaginal estrogen cream.She was having fecal incontinence and incontinence with a full bladder and was referred to pelvic floor physical therapy.At her last visit on (b)(6) 2019 she felt as if she was having mesh erosion in her vagina.Pelvic exam revealed exposed mesh to the left side of midline distally and proximally, firmness and possible mesh band felt at proximal right anterior edge with thinning of vaginal mucosa.She was to schedule excision of her mesh.She returns today for follow up of her mesh erosion.She has not had any vaginal bleeding or discharge since her last visit.She has rare urge incontinence approximately once a month.She states this typically happens when she wakes too long to void.She denies any hematuria, dysuria, or urinary tract infections.She has not been using vaginal estrogen cream.Patient is interested in becoming sexually active.She has a colonoscopy scheduled this year.Assessment and plan included disorders of urogenital prostheses or implants: unspecified complication of genitourinary prosthetic device, implant and graft, initial encounter.Atrophic vaginitis: postmenopausal atrophic vaginitis, prescribed vaginal cream.Urinary incontinence of urine: urge incontinence.Herniation of rectum into vagina: rectocele.Cystocele: unspecified.The patient was counseled on only treating symptomatic infections.Excision of vaginal mesh was discussed with patient; this may need to be performed if she is interested in becoming sexually active.Advised to restart vaginal estrogen three times a week for atrophy and prevent infections.Follow up for urge incontinence and follow up appointment in six months to reassess symptoms.At her last visit on (b)(6) 2019, she noted having a small amount of blood discharge after using the applicator to apply the estrogen cream.During her visit today, she reported she occasionally feels the mesh when she walks.She is no longer wearing a pad for urinary leaking and states she leaks less while she is at work.She uses the vaginal estrogen cream once a day for 2 weeks.Her leg pain has resolved since her last surgery in (b)(6) 2018.She denies bloody vaginal discharge, hematuria, dysuria, or urinary tract infections.In an assessment, her stress incontinence has improved.At (b)(6) 2022 appointment, the patient noticed a strange vaginal odor.She had an intermittent urine stream with decreased sensation.She had constipation and is taking laxatives - following with gastrointestinal.She denied any utis.She was still having intermittent right leg pain starting at the pelvis and radiating down.On (b)(6) 2022, vaginal estrogen cream improved her urinary symptoms.She stated the cream turns pink after being inserted and denied any discharge.On (b)(6) 2023, she returned for follow up of her vaginal mesh erosion and urge incontinence status post vaginal mesh removal on (b)(6) 2023, pathology with fibromuscular tissue with embedded mesh and chronic inflammation.She continued using vaginal estrogen cream three times a week.She had constipation and had not taken anything to manage constipation.In an assessment and plan, she was advised to take miralax daily or fiber and increased water intake to manage constipation; and refill and continue vaginal estrogen cream three times per week for atrophy.The patient was scheduled for a follow up appointment in one year.
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Manufacturer Narrative
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Block h6 (patient codes) has been corrected.The imdrf codes were added: e2308 - disfigurement, e2333 - prolapse and e1308 - urinary frequency.Block b3 (date of event): date of event was approximated to june 21, 2011, implant date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6) at (b)(6) hospital, united states.The explanting surgeon is: dr.(b)(6) at (b)(6) hospital, united states block h6: the following imdrf patient codes capture the reportable events of: e0206 - significant mental and physical pain and suffering, e0506 - bleeding, e2330 - pelvic pain, e2006 - exposed mesh in multiple, e1310: infection, urinary tract, e1304: urinary urgency, e232401: incontinence, fecal, e2015: atrophy, e2319: hernia, e2326: inflammation, e1007: constipation - constipation with laxatives, e2313: fibrosis, e1405: dyspareunia - interested in becoming sexually active, e2308 - substantial physical deformity.The following imdrf impact code capture the reportable events of: impact code f1905 captures the reportable event of revision procedure.
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