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BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM - CURVED; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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| Model Number M0068504110 |
| Device Problems
Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Erosion (1750); Diarrhea (1811); Dyspnea (1816); Micturition Urgency (1871); Inflammation (1932); Nerve Damage (1979); Pain (1994); Perforation (2001); Scar Tissue (2060); Urinary Tract Infection (2120); Anxiety (2328); Deformity/ Disfigurement (2360); Depression (2361); Numbness (2415); Prolapse (2475); Sleep Dysfunction (2517); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Fecal Incontinence (4571); Urinary Incontinence (4572)
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| Event Date 08/11/2016 |
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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 obtryx ii system - curved was implanted during a procedure performed on (b)(6) 2016, for the treatment of stress urinary incontinence.The patient experienced erosion of the mesh through her vaginal wall, damage to the patient's nerves, and severe adverse reactions to the mesh including scarring and inflammation.The patient, as a result of these defects and the problem with the obtryx ii, has in the past and will in the future suffer from disfigurement, chronic pain, disability, continued urinary problems, the cost of the surgery to remove the mesh and repair the vaginal defect, as well as pain, inconvenience, emotional distress and potential or probable future procedures, medications, and medical treatment.On (b)(6) 2020, the mesh was then explanted.
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Manufacturer Narrative
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The event date was approximated to (b)(6) 2016, the date the sling was implanted, as no event date was reported.This event was reported by the patient's legal representatives: atty.(b)(6).Atty.(b)(6).The implant surgeon is: dr.(b)(6).(b)(6) hospital.Patient codes (b)(4).Impact codes (b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure 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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Blocks a2 (patient's date of birth), b5, e1 (explant surgeon's name), and h6 (patient, impact and device codes) were updated based on the additional information received on march 14, 2023.Block b3 date of event: the event date was approximated to (b)(6) 2016, the date the sling was implanted, as no event date was reported.Block e1: this event was reported by the patient's legal representatives: atty.(b)(6).Atty.(b)(6).The implant surgeon is: dr.(b)(6).The explant surgeon is: dr.(b)(6).Block h6: imdrf patient codes: e2308 captures the reportable event of deformity/disfigurement (disfigurement).E1715 captures the reportable event of scar tissue (scarring).E2006 captures the reportable event of erosion (erosion of the mesh through patient's vaginal wall).E2114 captures the reportable event of perforation (trocar perforated the vagina).E2326 captures the reportable event of inflammation.E2330 captures the reportable event of pain (chronic pain).E0123 captures the reportable event of nerve damage (damage to patient's nerves).E1311 captures the reportable event of unspecified kidney or urinary problem (continued urinary problems).E0206 captures the reportable event of unspecified mental, emotional or behavioural problem (emotional distress).E1405 captures the reportable event of dyspareunia (pain with intercourse).Imdrf impact codes: f1202 captures the reportable event of disability.F1903 captures the reportable event of device explantation (mesh explantation).F19 captures the reportable event of surgical intervention (repair of the vaginal defect).F1901 captures the reportable event of additional surgery (vaginal tissue removal around the mesh).F23 captures the reportable event of unexpected medical intervention.F2303 captures the reportable event of medication required.
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Event Description
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It was reported to boston scientific corporation that an obtryx ii system - curved was implanted during a transobturator taping with cystoscopy procedure performed on (b)(6) 2016, for the treatment of stress urinary incontinence.The patient experienced erosion of the mesh through her vaginal wall, damage to her nerves, and severe adverse reactions to the mesh, including scarring and inflammation.During the implant procedure on (b)(6) 2016, the trocar perforated the vagina, which was only noted after the mesh was pulled through and the vagina had to be excised around the mesh and closed over the mesh.As a result of these defects and the issue with the obtryx ii, the patient has suffered in the past and will continue to suffer from disfigurement, chronic pain, disability, continued urinary problems, the cost of the surgery to remove the mesh and repair the vaginal defect, as well as pain, inconvenience, emotional distress, and potential or probable future procedures, medications, and medical treatment.During the implant procedure, the right trocar was placed, and the physician noted some difficulty coming around the pubic bone, but it was ultimately placed into the correct position.The left trocar was placed with some difficulty coming the pubic bone.Initially, the left trocar was noted to be in the vagina in the periurethral space and the vagina was free.However, when the physician returned to the site to begin mesh placement the trocar had pulled through the vagina.The trocar was pulled back and replaced into the periurethral space with a hole noted in the vagina.The mesh was then attached inside and pulled through.Upon evaluation of the mesh, the trocar had again poked through the vagina and the mesh was pulled through the vagina.At that point, the physician examined the area with a cystoscope and noted that the bladder was free of injury.The physician decided to cut out the vagina around the mesh and close the vagina over the mesh that was in an improper place.The vaginal tissue was then closed, and the mesh was pulled tight with appropriate tension against the urethra.The remaining vaginal incision was closed, and patient's left was noted to be free of any mesh in the vagina and closed in it's entirety.The patient was reported to have tolerated the procedure well and was taken to the recovery room in stable condition.On (b)(6) 2020, the patient underwent removal of the obtryx vaginal sling, removal of vulvar mesh with exploration of the obturator space, urethral lysis, vaginal paravaginal, dissection and mesh removal from the deep obturator internus muscles, and anterior colporrhaphy under general endotracheal anesthesia.The patient's diagnoses were pain with intercourse, mesh exposure, foreign material in the vagina, and urethral scarring.The patient was taken to the operation room and placed on the operating table in a comfortable supine position.Following an adequate level of general endotracheal anesthesia, the patient was repositioned in the modified dorsal lithotomy position and prepped and draped in the usual manner for abdomino-vaginal surgery.This was a difficult surgery due to the scarring from the large mesh exposure that required repair to the vaginal defect and made it difficult to remove the mesh from the left groin that was very deeply implanted.A left lateral vulvular incision was then made below the adductor longos over the obturator space.The lateral end of the mesh was identified and freed from the adductor muscles with sharp dissection and from the soft tissue muscular attachments to the pubic ramus.This was very difficult due to the significant muscle mass as well as the very deep mesh placement.The same was performed on the right.The mesh was identified on the left and on the right.The foley was inserted and noted to be draining clear, yellow urine.The mesh exposure to the right of the midline was noted, and the anterior vaginal wall was opened.The scar tissue was dissected cephalad, caudad, and laterally.The previous sling mesh was identified and noted to be exposed on the right of the midline.It was cut in the midline and freed from the vaginal scar tissue on the left and right.A urethral lysis was performed using sharp dissection to further free the scar tissue.The vaginal and paravaginal spaces were opened for further dissection and visualization of the mesh trajectory.The mesh was freed and dissected into the paravaginal space through the scar tissue as far laterally as possible.With the vaginal paravaginal spaces opened, further dissection and visualization of the mesh trajectory permitted mobilization of the mesh within the obturator internus muscles and off the pubic ramus that was freed from the bone from the vaginal side as well as from the vulvar side, and the mesh was fully excised.The entire obtryx was removed.The deep subcutaneous layer on the left was approximated with interrupted sutures of #2-0 dexon, and the skin was approximated with interrupted sutures of #3-0 plain.The anterior vaginal wall from the exposure was closed with interrupted sutures of #2-0 dexon, and the anterior vaginal wall was closed with a running locked layer of #2-0 dexon.The vagina was lightly packed with iodoform gauze packing.The foley was connected to gravity drainage.The needle, sponge, and instrument count were correct times two.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.
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Event Description
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It was reported to boston scientific corporation that an obtryx ii system - curved was implanted during a transobturator taping with cystoscopy procedure performed on (b)(6) 2016, for the treatment of stress urinary incontinence.The patient experienced erosion of the mesh through her vaginal wall, damage to her nerves, and severe adverse reactions to the mesh, including scarring and inflammation.During the implant procedure on (b)(6) 2016, the trocar perforated the vagina, which was only noted after the mesh was pulled through and the vagina had to be excised around the mesh and closed over the mesh.As a result of these defects and the issue with the obtryx ii, the patient has suffered in the past and will continue to suffer from disfigurement, chronic pain, disability, continued urinary problems, the cost of the surgery to remove the mesh and repair the vaginal defect, as well as pain, inconvenience, emotional distress, and potential or probable future procedures, medications, and medical treatment.During the implant procedure, the right trocar was placed, and the physician noted some difficulty coming around the pubic bone, but it was ultimately placed into the correct position.The left trocar was placed with some difficulty coming from the pubic bone.Initially, the left trocar was noted to be in the vagina in the periurethral space and the vagina was free.However, when the physician returned to the site to begin mesh placement the trocar had pulled through the vagina.The trocar was pulled back and replaced into the periurethral space with a hole noted in the vagina.The mesh was then attached inside and pulled through.Upon evaluation of the mesh, the trocar had again poked through the vagina, and the mesh was pulled through the vagina.At that point, the physician examined the area with a cystoscope and noted that the bladder was free of injury.The physician decided to cut out the vagina around the mesh and close the vagina over the mesh that was in an improper place.The vaginal tissue was then closed, and the mesh was pulled tight with appropriate tension against the urethra.The remaining vaginal incision was closed, and the patient's left was noted to be free of any mesh in the vagina and closed in its entirety.The patient was reported to have tolerated the procedure well and was taken to the recovery room in stable condition.On august 18, 2017, the patient called with complaints of problems with her bladder mesh and other complaints.Additionally, an appointment was made with the physician.On november 25, 2019, during an office visit, the patient presented with complaints of vaginal pain and concern that she might have exposed mesh from her trans-obturator tape procedure.She stated that she had some pain in the vagina, and when she was feeling around for the site, she felt something sharp.She was wondering if this could be exposed mesh.The physician and the patient discussed that it could be.However, the exam was somewhat difficult as she was uncomfortable during the exam.She also had complaints of some prolapse symptoms but did not wish to have anything done for these.Due to the possible exposed mesh and recurrent incontinence, the physician recommended that the patient should see for further evaluation.She was given his name and will call if she has any difficulty with getting an appointment.During the review of systems, the patient was positive for cough, tingling, memory loss, and insomnia.Furthermore, during the physical exam, possibly a mesh was felt but it was not clear.No mesh was seen on the speculum exam.On january 23, 2020, during the office visit, the patient presented mesh problems.The symptoms began 3 years ago and generally lasted three years.The symptoms were reported as being moderate.The symptoms occur daily.She stated that the symptoms were chronic and poorly controlled.The patient reported that she had been feeling right-sided vaginal pain and exposed mesh over the past 3 months.Had an obtryx ii sling placed in 2016.There were reports of relief of stress urinary incontinence (sui) immediately following surgery until 2017 when her urinary incontinence returned.There were reports of the onset of bilateral groin pain following obtryx sling placements.The patient mentioned that she also had spontaneous leakage of urine, but that sui was worse.She denied nephrolithiasis, hematuria, and nocturia.A history of previous recurrent utis has made behavioral modifications (diet, hygiene) and they were resolved.Furthermore, there were reports of fecal incontinence and ibs (diarrhea predominant) with leakage of liquid stool.There were reports that prior to bowel movements, there had been leakage of clear fluid from the top of her buttocks.The patient also reported significant vaginal prolapse since the delivery of her first child in 2001.Her prolapse had worsened with defecation.Moreover, the patient is currently sexually active.She stated that she had positional dyspareunia and pain with deep penetration.Her partner had not perceived the mesh exposure with intercourse.The patient also had a history of endometriosis excision in 1998 and laparoscopic salpingectomy in 2018.She had a spontaneous vaginal delivery (svd) with the presentation of subsequent hematoma which required urgent evacuation.She also history of cardiac ablation for svt in 2019, and hypertensive heart changes.Currently, the patient sees cardiology every 6 months, taking lisinopril and metoprolol.During the review of the systems, the patient stated that she had a chronic cough, memory impairment, numbness in extremities, anxiety, depression, and insomnia.Also, she experienced blood in stool, diarrhea, fecal incontinence, and flatulence.The patient indicated fecal incontinence experienced was liquid.The patient also had prolapsed uterus, stress incontinence, and urge incontinence.Additionally, during her physical exam, it was observed that there was an exposed mesh in the right sulcus of her vagina.It was non-palpable and bilateral.During the assessment of the mechanical complications of other prosthetics devices, implants, grafts of the genital tract (initial encounter), pelvic/ perineal pain, midline cystocele, and rectocele.The physician suggested pre-op urodynamic evaluation and follow-up.Surgery had been offered for the removal of the previous obtryx sling mesh, paravaginal dissection, urethral lysis, and anterior colporrhaphy, as well as the removal of mesh from the obturators and adductors.The patient was extensively counseled that even with the removal of her mesh, she may continue to have pain, and there is no guarantee that she will be pain-free or even improved from the pain.She was also counseled that she would not undergo reconstruction with this surgery as this would be only to remove the mesh.The patient has been counseled on the risks and benefits of surgery, alternate approaches, and procedures, as well as complications which include but were not limited to bleeding, infection, and failure to achieve the desired physiologic result.The patient stated that she understood, had no questions, was allowed to ask questions, and wished to proceed with surgery.On (b)(6) 2020, the patient reported to the physician that she has been having some issues with bladder mesh which needs to be removed, and was scheduled for surgery sometime within the next 2 months.She had felt well overall.Vital signs were stable.Per the physician, no cardiac testing was needed prior to her surgery and she should be at low cardiovascular risk.The physician encouraged the patient to get into a regular exercise routine once she recovers from surgery and beforehand.The physician reviewed her medications and made no changes.No cardiac testing was indicated currently.There were no restrictions to her activities.She should return to the office in 6 months unless problems develop.During the review of systems, the patient mentioned that she experienced dyspnea on exertion and perineal pain.On (b)(6) 2020, the patient had another urogynecology office visit and presented with mesh problems.The voiding diary showed large bladder capacity (800 +ml voids), 7 voids in 24 hours, one episode of urgency, and one episode of leakage upon standing.Urodynamics revealed no retention, urgency without leakage, and stress at 400ml.The patient was counseled on surgical procedures, pre-op instructions, post-op restrictions, post-op medications, catheter care, packing and packing removal, and post-op expectations.Ude results were reviewed as well.The patient was counseled on urinary urgency, urinary retention, bladder function, and stress incontinence.The physician explained to the patient that the surgery is to remove the mesh and that urinary symptoms may remain unchanged or even worsen.The patient verbalized her understanding and is agreeable.The frequently asked questions packet was reviewed, and all questions were answered.Also discussed are the risks of surgery, including but not limited to infection, bleeding that requires blood transfusion, perforation of the bladder or bowel, and blood clots.The patient verbalized her understanding and is agreeable.On (b)(6) 2020, the patient underwent removal of the obtryx vaginal sling, removal of vulvar mesh with an exploration of the obturator space, urethral lysis, vaginal paravaginal, dissection and mesh removal from the deep obturator internus muscles, and anterior colporrhaphy under general endotracheal anesthesia.The patient's diagnoses were pain with intercourse, mesh exposure, foreign material in the vagina, and urethral scarring.The patient was taken to the operating room and placed on the operating table in a comfortable supine position.Following an adequate level of general endotracheal anesthesia, the patient was repositioned in the modified dorsal lithotomy position and prepped and draped in the usual manner for abdomino-vaginal surgery.The physician noted that this was a difficult surgery due to the scarring from the large mesh exposure that required repair to the vaginal defect and made it difficult to remove the mesh from the left groin that was very deeply implanted.A left lateral vulvular incision was made below the adductor longos over the obturator space.The lateral end of the mesh was identified and freed from the adductor muscles with sharp dissection and from the soft tissue muscular attachments to the pubic ramus.This was very difficult due to the significant muscle mass as well as the very deep mesh placement.The same was performed on the right.The mesh was identified on the left and the right.The foley was inserted and noted to be draining clear, yellow urine.The mesh exposure to the right of the midline was noted, and the anterior vaginal wall was opened.The scar tissue was dissected cephalad, caudad, and laterally.The previous sling mesh was identified and noted to be exposed on the right of the midline.It was cut in the midline and freed from the vaginal scar tissue on the left and right.A urethral lysis was performed using sharp dissection to further free the scar tissue.The vaginal and paravaginal spaces were opened for further dissection and visualization of the mesh trajectory.The mesh was freed and dissected into the paravaginal space through the scar tissue as far laterally as possible.With the vaginal paravaginal spaces opened, further dissection and visualization of the mesh trajectory permitted mobilization of the mesh within the obturator internus muscles and of the pubic ramus that was freed from the bone from the vaginal side as well as from the vulvar side, and the mesh was fully excised.The entire obtryx was removed.The deep subcutaneous layer on the left was approximated with interrupted sutures of #2-0 dexon, and the skin was approximated with interrupted sutures of #3-0 plain.The anterior vaginal wall from the exposure was closed with interrupted sutures of #2-0 dexon, and the anterior vaginal wall was closed with a running locked layer of #2-0 dexon.The vagina was lightly packed with iodoform gauze packing.The foley was connected to gravity drainage.The needle, sponge, and instrument count were correct times two.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.The pathology report showed mesh removal and the site was not cited.The specimen was an obtryx transobturator tape mesh.It was a fibrous tissue with a foreign body giant cell reaction to foreign material consistent with mesh.On may 14, 2020, the patient had a post-op visit after the removal of the obtryx vaginal sling, removal of vulvar mesh with the exploration of the obturator space, urethral lysis, vaginal paravaginal, dissection, and mesh removal from the deep obturator internus muscles, anterior colporrhaphy.The patient was well and pain-free.She reported that her urinary leakage with laugh/cough/sneeze had returned.Also, the patient's tissues were healed, and her pathology results were reviewed.During the assessment of exposure of implant vaginal prosthetic material into the vagina, the initial encounter, the patient was well after the surgery and continued regular gynecological care with regular provided with follow-up if needed.
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Manufacturer Narrative
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Additional information: blocks b5, e1 (healthcare facility address and phone number), and h6 (patient and impact codes) were updated based on the additional information received on july 12, 2023.Block b3 date of event: the event date was approximated to (b)(6) , 2016, the date the sling was implanted, as no event date was reported.Block e1: this event was reported by the patient's legal representatives: atty.(b)(6) the implant surgeon is: (b)(6) other physicians and healthcare facilities:(b)(6) united states phone number: (b)(6) captures the reportable event of deformity/disfigurement (disfigurement) e1715 captures the reportable event of scar tissue (scarring) e2006 captures the reportable event of erosion (erosion of the mesh through patient's vaginal wall/exposed mesh in the right sulcus of her vagina) e2114 captures the reportable event of perforation (trocar perforated the vagina) e2326 captures the reportable event of inflammation e2330 captures the reportable event of pain (right sided vaginal pain, bilateral groin pain, perineal pain) e0123 captures the reportable event of nerve damage (damage to patient's nerves) e1311 captures the reportable event of unspecified kidney or urinary problem (continued urinary problems) e0206 captures the reportable event of unspecified mental, emotional or behavioural problem (emotional distress) e1405 captures the reportable event of dyspareunia (positional dyspareunia, pain with deep penetration) e1310 captures the reportable event of infection, urinary tract e232401 captures the reportable event of incontinence, fecal e020201 captures the reportable event of anxiety e020202 captures the reportable event of depression imdrf impact codes: f1202 captures the reportable event of disability f1903 captures the reportable event of device explantation (mesh explantation) f19 captures the reportable event of surgical intervention (repair of the vaginal defect) f1901 captures the reportable event of additional surgery (vaginal tissue removal around the mesh) f23 captures the reportable event of unexpected medical intervention f2303 captures the reportable event of medication required.
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