MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068505000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Chest Pain (1776); Dyspnea (1816); Ecchymosis (1818); Fatigue (1849); Fever (1858); Hematoma (1884); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Discomfort (2330); Palpitations (2467); Sleep Dysfunction (2517); Unspecified Mental, Emotional or Behavioural Problem (4430); Thrombosis/Thrombus (4440); Unspecified Heart Problem (4454); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580); Unspecified Skin and Subcutaneous Tissue Problem (4927)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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's initials will not be documented.Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2023, was chosen as a best estimate based on the date of the mesh was implanted.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block d4 unique identifier (udi) #: detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.The following imdrf patient code capture the reportable event of: e2401 - captures the reportable event of unspecified personal injury.The following imdrf impact code capture the reportable event of: f12 - captures the reportable event of patient had sought for a legal recourse for unknown injuries related to the device.
Event or Problem Description
It was reported that the patient was implanted with an obtryx system device.After the mesh had been implanted, the patient had experienced an unspecified injury.Additional details regarding this event were not provided.
Additional Manufacturer Narrative
Block h11: blocks b2, b5, b6, b7, d4, d6b, h2, h4, and h6 have been updated based on the additional information received.Continuation of block b5: on (b)(6) 2024, the patient presented for evaluation following prior surgical management of stress urinary incontinence.She had undergone placement of a suburethral transobturator tape on (b)(6) 2023, which was performed without intraoperative complications and followed by an initially uncomplicated postoperative course with discharge within the expected timeframe.Approximately one week later, she presented to the emergency department with pain localized along the right-sided sling pathway, involving the inguinal fold and right thigh, as well as malodorous vaginal discharge.Gynecologic examination was largely unremarkable aside from tenderness on palpation in the affected areas.She was treated with antibiotics and analgesics; however, her course was notable for persistent and debilitating perineal pain, prompting hospitalization and further evaluation.Doppler ultrasound of the right lower extremity identified a superficial thrombosis, for which anticoagulation therapy was initiated, resulting in subsequent vascular improvement.Additional investigations, including a pelvic ct scan, showed no evidence of deep fluid collection or infection, and laboratory studies were within normal limits without evidence of an inflammatory process.A thoracic ct angiogram was performed to evaluate complaints of dyspnea and rule out pulmonary embolism; results were normal.After several days of hospitalization, the patient was discharged with analgesics and appropriate follow-up.However, she returned shortly thereafter due to persistent, disabling pain involving the perineal region, right inguinal fold, and right thigh.Repeat clinical and gynecological examinations remained unremarkable.Given the severity and daily impact of her symptoms, multiple emergency visits, and the patient's request, a surgical revision was performed on (b)(6) 2023, consisting of complete removal of the right arm of the sling.Although there was initial improvement, the pain recurred and was described as stabbing and throbbing in nature, consistent with neuropathic pain affecting the right inguinal fold and thigh.Further evaluation of pelvic mri was recommended to assess for possible endometriosis or deep collections, along with physical therapy and multidisciplinary pain management consultation.Despite these interventions, her symptoms persisted.By (b)(6) 2024, she reported significant improvement on the right side but noted the onset of similar disabling pain on the left side, involving the left inguinal fold and thigh.After discussion, she expressed a desire for removal of the remaining left arm of the sling and is now seeking further evaluation and opinion regarding this management option.On (b)(6) 2024, the patient presented for follow-up evaluation of persistent and disabling neuropathic pain following prior placement of a transobturator (tot) sling for urinary incontinence.She has demonstrated intolerance to several treatments, including gabapentin, which was discontinued.She is currently managed on laroxyl 20 drops in the evening and lorazepam 2 mg.While laroxyl has provided partial pain relief and is well tolerated, she continues to experience sleep disturbances and notable psychological impact, including declining mood.She has recently been evaluated by a pain clinic psychologist.The patient is awaiting a scheduled consultation on (b)(6) 2024, for consideration of sling removal.In the interim, it was recommended to increase laroxyl up to 50 mg in the evening in tablet form, and zopiclone was introduced on an as-needed basis for insomnia.The option of lidocaine infusions in a day hospital setting was also discussed in the event of inadequate response or intolerance to current therapy; however, the patient prefers to defer this intervention at this time.On (b)(6) 2024, the patient presented for pain consultation in the context of stress urinary incontinence (sui) refractory to perineal rehabilitation.In (b)(6) 2023, a vaginal section of the tot was performed without improvement in symptoms.Follow-up resulted in trials of gabapentin, amitriptyline (laroxyl), solifenacin (vesicare), and bromazepam; only pregabalin (lyrica) provided partial pain relief.The pain remains localized primarily to the right thigh root and significantly limits ambulation.Moderate sui persists, requiring one to two pads per day, and the patient reports cessation of sexual activity.Symptom assessment demonstrated significant severity, with usp scores of 9/9 for stress urinary incontinence, 15/21 for overactive bladder symptoms, and 2/9 for dysuria, along with an iciq score of 10/21 and a maximal quality-of-life impact score of 10/10.Translabial ultrasound showed minimal urethral mobility with an angle of 1 degree.Cystoscopic evaluation revealed a patent urethra without evidence of urethral or bladder erosion, normal ureteral orifices, and intact bladder mucosa, while vaginoscopy demonstrated no evidence of prosthetic exposure.Gynecologic examination was limited due to severe pain, preventing speculum insertion.Uroflowmetry demonstrated a small bell-shaped curve with a voided volume of 300 ml, a maximum flow rate (qmax) of 18 ml/s, and no post-void residual.Overall, these findings are consistent with a pelvic pain syndrome, most likely secondary to the transobturator sling.Complete sling removal via laparoscopy and bilateral inguinal approach is recommended and scheduled for (b)(6) 2024.The potential for concurrent or subsequent placement of an autologous pubovaginal sling or bulkamid was discussed, along with associated risks.The patient demonstrated clear understanding of the proposed procedure and associated risks.On (b)(6) 2024, the patient presented for thrombosis monitoring in the context of a history significant for multiple thrombotic events.Anticoagulant therapy had been discontinued, and there was no evidence of pelvic compression syndrome.She is planned to undergo a pubovaginal aponeurotic sling procedure.Doppler ultrasound evaluation of the venous system demonstrated normal findings, with complete patency and compressibility of the inferior vena cava, as well as the common iliac, femoral, popliteal, and lower leg veins.There was no evidence of deep, superficial, or muscular venous thrombosis, nor any post-thrombotic sequelae.Venous flow was normal, with no reflux observed, and the primitive iliac veins were well visualized without abnormalities.Overall, the examination was entirely reassuring, showing no current thrombosis or residual thrombotic changes.Given the patient's history of recurrent thrombosis in association with pelvic surgical procedures, prophylactic measures to prevent thromboembolic events in the upcoming postoperative period are strongly recommended.On (b)(6) 2024, the patient underwent a cardiological evaluation as part of her preoperative assessment for planned urological surgery.Her current medications included lormetazepam 2 mg nightly and decapeptyl 11.5 mg injections administered every three months, with the most recent dose given in (b)(6) 2024.Clinically, she described intermittent left-sided chest pain occurring mostly at rest in the evening, characterized as stabbing in nature, lasting approximately one hour, and resolving spontaneously without treatment.She also reported persistent dyspnea since (b)(6) 2023 following a prior urologic procedure, along with occasional palpitations.Electrocardiogram demonstrated a regular sinus rhythm with a normal pr interval and narrow qrs complex with normal axis.There was an incomplete right bundle branch block with t-wave inversions in leads v1 and v2, and a corrected qt interval (qtc).Overall, no acute cardiac abnormalities were identified.Echocardiography also demonstrated a normal-sized left ventricle with preserved systolic function and normal wall motion.Ventricular relaxation was good, with low left filling pressures.The left atrium was normal in size.The aortic valve was tricuspid with no stenosis or significant regurgitation.Mild mitral regurgitation was noted without stenosis.Right heart cavities were normal, with preserved right ventricular function and no indirect signs of pulmonary hypertension.The pericardium appeared normal.Laboratory results from (b)(6) 2024, were within normal limits.In summary, there are no cardiac contraindications for surgery.The ecg showed sinus rhythm with an incomplete right bundle branch block.A holter ecg was proposed to further evaluate palpitations.The patient will continue her current medications, and the referring physician may consider iron supplementation given the ferritin level.On (b)(6) 2024, the patient was admitted for evaluation of chest pain and dyspnea, describing left-sided chest discomfort radiating to the left lateral neck, characterized as a "stretching" sensation in the context of stress and concern about her health.Clinical examination was overall normal.Cardiovascular assessment revealed atypical, non-anginal chest pain with no signs of heart failure or phlebitis; heart sounds were regular, and ecg obtained during symptoms showed sinus rhythm at 101 bpm with an incomplete right bundle branch block.Pulmonary examination was unremarkable, with no cough or dyspnea and normal, symmetrical breath sounds.Abdominal examination showed a soft, non-tender but mildly bloated abdomen without signs of peritoneal irritation.Neurological evaluation was normal, with a glasgow coma scale score of 15 and no focal deficits.Laboratory evaluation, including cardiac enzymes (cpk, troponin) and d-dimer, was within normal limits.Repeat ecg prior to discharge demonstrated sinus rhythm at 58 bpm with no dynamic changes.The patient's symptoms resolved spontaneously following reassurance after the initial normal ecg.Overall, the presentation was consistent with atypical chest pain, with normal electrocardiographic and laboratory findings.Cardiac monitoring and blood gas analysis were performed, and no acute pathology was identified.On (b)(6) 2024, the patient underwent mesh revision with removal of the remaining transobturator tape and creation of an autologous fascial sling.During the procedure, a strip of fascia lata measuring approximately 10x1.5 cm was harvested from the right lateral thigh through a 6 cm incision, with careful hemostasis and layered closure of the aponeurosis, subcutaneous tissue, and skin.The left arm of the transobturator tape was identified at the level of the obturator foramen, transected at the endopelvic fascia, and meticulously dissected free along its transobturator course.A separate approximately 5 cm incision at the root of the left thigh allowed access through the fascia and aponeurosis, with dissection between the gracilis and adductor brevis muscles to reach the obturator membrane.The left arm of the sling was then fully identified and removed in continuity under direct visualization, with both dissection planes connected, yielding a specimen measuring approximately 7 cm.Attention was then directed to the right side through a similar incision at the root of the thigh; however, the right arm of the transobturator tape could not be identified and was not palpable on vaginal examination.A robotic approach was utilized to carefully retract the endopelvic fascia and separate the fibers of the obturator musculature while preserving the branches of the obturator nerve and vessels.Dissection revealed a fibrotic sheath consistent with the prior course of the tape, from which three small polypropylene fiber fragments were identified and removed.No intact right obturator arm was found, a finding later confirmed with laparoscopic ultrasound, which demonstrated no residual mesh within the obturator foramen.A suburethral tunnel was then created at the level of the mid-urethra, followed by a small vaginal incision that was subsequently closed with a running v-loc suture.A suprapubic incision of approximately 3 cm was made to access the rectus abdominis fascia, and the previously harvested fascia lata graft was introduced.The autologous sling was secured bilaterally at the bladder neck using four vicryl 4-0 sutures to ensure appropriate positioning and distribution.Suspension was achieved by placing pds 2-0 sutures through the suprapubic incision using a reverdun needle, anchoring the four corners of the sling and tying them in pairs with minimal tension approximately 4 cm above the rectus fascia.The retropubic space was then closed with a running v-loc suture, and pneumoperitoneum was released.All trocars were removed under direct visualization.Closure was performed in layers, including reapproximation of the gracilis aponeuroses at the thigh incisions, closure of the suprapubic subcutaneous tissue with polysorb sutures, and skin closure with running monocryl sutures.The trocar sites were similarly closed, with fascial closure at the 12 mm ports and skin closure using monocryl.On (b)(6) 2024, the patient presented for evaluation following recent surgical intervention and was noted to have significantly limited mobility.Given her condition, she requires special assistance to facilitate safe return transport to lille.It was certified that she is only able to move minimally and requires accompaniment as well as the use of a wheelchair for transport.On (b)(6) 2024, the patient underwent vaginal sectioning of the aponeurotic sling.During the procedure, a 4 cm inverted u-shaped vaginal incision with the apex positioned at the mid-urethra was created.Careful dissection of the ventral and lateral aspects of the urethra was performed, allowing access to the retropubic aponeurotic sling.The left lateral aspect of the urethra was approached, and a dissector was successfully passed around the sling, which was then transected.Methylene blue was injected via the urethra to confirm the integrity of the urethral wall, with no evidence of injury.The incision was subsequently closed in standard fashion.On (b)(6) 2024, the patient was evaluated for pain management due to persistent neuropathic pelvic pain following prior placement of transobturator suburethral slings in (b)(6) 2023 and subsequent surgical interventions, including robotic-assisted removal and replacement with a fascial sling, as well as a recent vaginal procedure for sling removal due to severe dysuria.She reports intense neuropathic pain characterized by burning sensations and constant shooting pain, contributing to reactive depression and sleep disturbances.Physical examination revealed dysesthesia along the surgical sites, particularly in the right thigh and suprapubic region.Her current medications include laroxyl and acupan; she had previously trialed gabapentin but was unable to tolerate it.Laroxyl was resumed and increased to 50 mg for improved symptom control.Plans were made for hospital admission for lidocaine infusions to address refractory neuropathic pain, with close follow-up scheduled during the week.Additionally, referral to a psychologist was arranged to support the psychological impact of her chronic pain.On november 7, 2024, it was documented that the patient had been hospitalized from (b)(6) 2024, for scheduled evaluation and management of dysuria related to a previously placed aponeurotic fascia lata sling.Her history included prior removal of residual transobturator tape on (b)(6) 2024, during which the right arm was not identified, having reportedly been removed previously, and a fascia lata graft was placed.She subsequently developed dysuria at the graft site with concern for possible infection, prompting admission for further management and discussion of treatment options, including self-catheterization versus surgical intervention.During hospitalization, dysuria was confirmed, and she underwent vaginal resection of the aponeurotic sling on (b)(6) 2024.Postoperatively, she continued to experience difficulty with urination, particularly when seated, without significant improvement in symptoms, and declined self-catheterization training.The remainder of her hospital course was uneventful, and she was discharged home on (b)(6) 2024, with plans for follow-up in one month.The total length of stay was eight days, without requirement for intensive or continuous care.In summary, the patient was hospitalized in the urology department from (b)(6) 2024, for dysuria and suspected urinary tract infection following placement of a fascia lata sling.After confirmation of dysuria, she underwent vaginal removal of the aponeurotic sling on (b)(6) 2024.The postoperative course was notable for persistent difficulty with urination, particularly in the seated position, without significant improvement in symptoms, and the patient declined instruction in self-catheterization.She was discharged home with a medication regimen including laroxyl drops with gradual dose escalation, colpotrophin pessaries twice weekly for one month, paracetamol for pain control, orozamudol for breakthrough pain, and spasfon for symptomatic relief.Follow-up was arranged for a postoperative consultation in november.On (b)(6) 2024, the patient was seen in follow-up for persistent neuropathic pelvic pain following placement of a transobturator suburethral sling, wherein it was subsequently removed.She is scheduled for further follow-up in (b)(6) 2025.The patient reports severe neuropathic symptoms, including pelvic cramping and shooting pains, marked hyperesthesia with dysesthesia on contact with the surgical scar on the right thigh, and a reactive depressive state associated with sleep disturbances.Several therapeutic trials have been undertaken; antiepileptic treatment was discontinued due to intolerable nausea.She is currently treated with amitriptyline (laroxyl) 50 mg.Lidocaine infusions administered in october provided a significant clinical benefit, allowing partial resumption of daily activities and improved sleep quality, although nightmares persist.She is also receiving psychological support at the pain clinic.The current management plan includes repeat lidocaine infusions and application of a qutenza patch to the right thigh surgical scar, in addition to continuing laroxyl and initiating duloxetine (doxelene) at 30 mg daily, with escalation to 60 mg in the morning.The patient is scheduled to return to the hospital the following day for qutenza application, with close clinical follow-up planned.On (b)(6) 2025, the patient received outpatient treatment with a qutenza (capsaicin) patch for management of severe neuropathic pain, characterized by pelvic cramping and shooting pains, marked hyperesthesia with dysesthesia over the surgical scar on the right thigh, and an associated reactive depressive state with sleep disturbance.The treatment was associated with local side effects, including cutaneous redness and pruritus, with analgesic benefit expected to develop within approximately one week.On (b)(6) 2025, the patient underwent a course of ketamine infusions for chronic pain management, receiving 25 mg on the first day followed by 50 mg on subsequent days.Pain severity, assessed using the evs scale, remained at 4/4 both at the initiation and completion of treatment.Consideration was given to repeating this therapeutic regimen within three to six months, depending on clinical response.On (b)(6) 2025, the patient received a qutenza patch as an outpatient for neuropathic pain following urinary sling placement.She experienced mild side effects, including localized redness and itching, with analgesic effects expected to appear within one week.On (b)(6) 2025, she presented for consultation due to severe postoperative neuropathic pain affecting the perineal and left thigh regions.The patient has a complex gynecological history, including multiple urethral sling procedures complicated by persistent neuropathic pain requiring removal, some performed via robotic-assisted surgery.The neuropathic pain has had a significant psychological impact; she is being followed by a psychologist, and psychiatric evaluation has been encouraged.Therapeutically, her current regimen includes outpatient ketamine and lidocaine infusions, qutenza patches, and oral medications: laroxyl, duloxetine, pregabalin, and evening lorazepam.Pain management and close psychological support remain ongoing.The patient continues to experience significant neuropathic pain, primarily localized around the scar on her right upper thigh, extending both above and below the pubic region.Additional pain includes clitorodynia, coccygodynia, and bilateral inner thigh involvement, with the most severe symptoms on the anterolateral aspect of the right thigh corresponding to the surgical scar.For management, i recommend initiating a diagnostic and therapeutic test block at the obturator nerve to address her obturator-related pain.Additionally, a botulinum toxin injection will be administered to the patient's allodynic area on (b)(6) 2025.A follow-up consultation will be scheduled thereafter to evaluate the effectiveness of these interventions and determine further management strategies, including the consideration of a botulinum toxin injection at the ganglion impar to target persistent perineal pain.On (b)(6) 2025, the patient was hospitalized in the medical department for management of a chronic pain syndrome.She has a long-standing history of neuropathic perineal pain evolving over several years.The patient lives with her partner and is the mother of three children.She is no longer employed, having previously worked as a childminder, and is currently recognized as having a disability.Physical examination revealed an alert, coherent, and fully oriented, with stable hemodynamic parameters and no fever.Cardiovascular examination revealed regular heart sounds without murmurs or tachycardia, palpable and symmetrical peripheral pulses, no chest pain, and no signs of right or left-sided heart failure.Respiratory assessment showed bilateral, symmetrical vesicular breath sounds without adventitious sounds, and there were no symptoms of cough, dyspnea, sputum production, or respiratory distress.Abdominal examination revealed a soft, non-tender, and compressible abdomen without guarding or rigidity, and the patient reported no gastrointestinal symptoms or bowel habit abnormalities.From a gynecological and urinary standpoint, the patient reported chronic pelvic pain radiating to the lower limbs and sacrum, performs intermittent self-catheterization at home, and experiences occasional stress urinary incontinence.Neurological examination was normal, with a glasgow coma scale score of 15, no focal deficits, intact cranial nerves, and no signs of intracranial hypertension, meningeal irritation, or cerebellar involvement; neuropathic pain affecting the proximal thighs was noted, predominantly on the right side.During hospitalization, pain management was continued, with maintenance of her usual treatment regimen and the addition of oxazepam (seresta) 50 mg in the evening and fentanyl as needed.On (b)(6) 2025, the patient was also evaluated and a perineural toxin injection as soon as possible to address her neuropathic pain was recommended, primarily involving the obturator nerve and potentially the pudendal nerve.She has had multiple pain management consultations.Upon admission, the patient reported left calf pain following a venous pathway; given her personal history of thrombosis, a bilateral lower-limb venous doppler ultrasound was performed, which showed no evidence of thrombosis.From a respiratory standpoint, symptoms suggestive of sleep-disordered breathing were reported, including snoring, nocturnal breathing pauses observed by her partner, non-restorative sleep, and morning headaches, prompting a request for polysomnography.The patient was hospitalized for monitoring and adjustment of treatment for chronic neuropathic pain.At discharge, her treatment regimen included triptorelin (decapeptyl) 11.5 mg every three months, amitriptyline (laroxyl) 50 mg morning and evening, duloxetine 90 mg in the morning, lorazepam 2 mg in the evening, oxazepam (seresta) 10 mg as needed up to three times daily and 50 mg at bedtime, pregabalin (lyrica) 150 mg twice daily, transdermal fentanyl 25 mg every 72 hours, transmucosal fentanyl (abstral) 100 mg every 4-6 hours as needed for severe pain, and lidocaine patches.A polysomnography study is scheduled for (b)(6) 2025.The patient was also evaluated for significant traumatic and post-traumatic psychological distress related to her surgical experience.She reports marked withdrawal, recurrent intrusive recollections and nightmares both before and after the procedures, with associated loss of self-esteem, disruption in her relationship with herself and others, and a pervasive sense of disorientation.She describes psychological dissociation following the second procedure, expressing the feeling of having lost her former identity.It was recommended that treatment with alprazolam (alprax) be initiated at a dose of 2.5 mg in the evening, with a planned increase to 5 mg in the evening once the scheduled ct imaging has been completed.A follow-up consultation is planned upon the patient's return.The patient was placed on continuous medical sick leave beginning on (b)(6) 2024, with an initial certification extending through (b)(6) 2024.This leave was subsequently renewed on a regular basis, without interruption, through multiple extensions issued.Each certification specified that the leave was unrelated to pregnancy, a work-related accident, or an occupational illness, and consistently authorized unrestricted leave.Over time, the patient's employment status transitioned to unemployed as noted in later certificates.The successive extensions ultimately prolonged the sick leave through (b)(6) 2025, resulting in an uninterrupted period of medically prescribed work stoppage lasting more than fourteen months.As of (b)(6) 2025, the patient has been recognized as having a long-term illness with associated disability and has initiated legal action to seek compensation.She reports severe and multifaceted harm, including sexual impairment marked by the complete cessation of sexual relations due to intense pain, bleeding, functional limitation, and significant distress related to bodily changes such as scarring and weight gain.Psychological harm is substantial, with severe emotional distress manifested by suicidal ideation, panic attacks, nightmares, social withdrawal, marked body image insecurity, and multiple hospitalizations for pain management and psychological care, including fear of leaving home and perceived social judgment.She also describes significant financial and professional impact, having been forced to abandon a 15-year career working with children and retrain as a caregiver, while currently experiencing major mobility limitations requiring use of a wheelchair.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's initials will not be documented.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2023, 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 implanting physician is: (b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2401 - unspecified personal injury.E0514 - thrombosis.E2330 - pain.E0717 - dyspnea.E1906 - infection.E0123 - neuralgia.E0505 - hematoma.E050601 - ecchymosis.E233001 - chest pain.E2006 - erosion.The following imdrf impact code capture the reportable event of: f12 - patient had sought for a legal recourse for unknown injuries related to the device.F08 - hospitalization.F1903 - mesh excision.
Event or Problem Description
It was reported to boston scientific that the patient was implanted with a transobturator tape (tot) sling on procedure performed on (b)(6) 2023, for the treatment of stress urinary incontinence.On (b)(6) 2023, the patient presented for evaluation following a recent episode of right lower extremity thrombosis that occurred in the setting of urological surgery.At that time, she developed a right lower limb pain associated with fever, prompting hospitalization, during which a thrombosis of the right lower extremity was diagnosed.She is currently receiving therapeutic-dose anticoagulation.A computed tomography (ct) angiography performed was negative.Subsequently, a doppler ultrasound examination demonstrated normal patency and compressibility of the deep venous system, including the inferior vena cava, which was not dilated, as well as the common iliac, femoral, superficial femoral, and popliteal veins.These vessels showed complete color flow with no evidence of residual thrombosis or post-thrombotic sequelae.There was no evidence of deep venous reflux at the popliteal level, and no signs of recent thrombosis or post-thrombotic changes were observed at the sural level bilaterally.Additionally, no superficial venous thrombosis was identified.There is no evidence of deep, muscular, or superficial venous thrombosis of the lower extremities, nor any post-thrombotic sequelae.Overall, the findings are reassuring and consistent with complete recanalization of the previously documented thrombosis.Given that this represents a recurrent thrombotic event, continuation of therapeutic-dose anticoagulation is recommended for a total duration of three months.The patient will be reassessed at that time for follow-up and further management.On (b)(6) 2023, the patient presented with dyspnea and concern for possible pulmonary embolism in the setting of a suspected infection related to her transobturator (tot) sling, accompanied by cough and ongoing anticoagulation therapy with innohep.A ct angiography was performed to evaluate for pulmonary embolism.Imaging results demonstrated no evidence of pulmonary embolism.There was no axillary, hilar, or mediastinal lymphadenopathy, and no cardiomegaly was observed.Additionally, there was no pleural or pericardial effusion.The lung parenchyma showed no bronchial wall thickening, bronchiectasis, interstitial disease, nodules, masses, or evolving lesions.Bone structures were preserved.Following review and discussion, the findings were considered reassuring, and pulmonary embolism was definitively ruled out.Based on the clinical and imaging assessment, the patient was deemed stable and cleared for discharge, with authorization to proceed with the scheduled surgery the following day.On (b)(6) 2023, the patient presented for surgical revision following treatment of stress urinary incontinence with placement of a suburethral sling via the transobturator (tot) approach, which had been performed approximately one month prior.The initial procedure was completed under appropriate technical conditions, with an initially uncomplicated postoperative course from a voiding standpoint.Approximately one week postoperatively, the patient presented to the emergency department with vaginal discharge and severe pain localized to the right thigh.Clinical evaluation at that time was reassuring, and she was started on antibiotic therapy.Despite treatment, symptoms persisted, and she was reassessed in early september, approximately ten days after the procedure, with ongoing complaints despite unremarkable clinical and imaging findings.Subsequently, following a diagnosis of thrombosis, the patient was hospitalized and underwent doppler ultrasound of the right thigh, which demonstrated superficial thrombosis.Anticoagulation therapy was initiated.A ct angiography was also performed and ruled out pulmonary embolism.She was discharged on both antibiotic therapy for vaginal discharge and anticoagulation.Follow-up demonstrated some clinical improvement; however, the patient continued to experience significant pain along the right thigh and the course of the sling.Given the persistence and severity of symptoms, as well as the patient's request and difficulty tolerating gynecologic examination due to severe pain, the decision was made to proceed with surgical revision.During the procedure, examination revealed no pathological or purulent vaginal discharge; however, a bacteriological swab was obtained.Exploration identified scarring at the level of the prior vaginal incision with mild induration.The vaginal incision was reopened, and careful dissection allowed for removal and excision of the sling, primarily along the right side extending to the level of the obturator foramen on the internal aspect.On the left side, the sling was largely removed.A portion of the excised material was sent for bacteriological analysis.The vaginal incision was then closed.The bladder catheter was removed at the conclusion of the procedure.Overall, the procedure consisted of excision of the right arm of the suburethral sling and partial removal of the left side.Fluoroscopy was utilized during the procedure.On (b)(6) 2023, the patient presented with malodorous vaginal discharge and significant pain along the course of the sling on the right side, involving the inguinal fold and right thigh.She was initiated on antibiotic therapy and analgesics; however, her clinical course was notable for persistent discharge and disabling perineal pain, prompting hospitalization for further evaluation.During hospitalization, doppler ultrasound of the right thigh root identified a superficial thrombosis, and anticoagulant therapy was initiated, with subsequent favorable vascular outcome.A pelvic ct scan performed to evaluate for deep infection or fluid collection was negative, and laboratory studies were within normal limits.Thoracic ct angiography ruled out pulmonary embolism.After several days, she was discharged on antibiotics and analgesics, with follow-up arranged; repeat laboratory and bacteriological evaluations remained unremarkable.Despite these measures, the patient continued to experience severe right-sided perineal pain.Vaginal examination was not feasible due to significant discomfort, and she requested definitive surgical management.Given the persistence and severity of symptoms, a decision was made to proceed with surgical revision, and removal of the right-sided portion of the suburethral sling was performed on (b)(6) 2023, without complication.The immediate postoperative course was uneventful, and the patient was discharged on postoperative day two.On (b)(6) 2023, the patient presented for consultation with complaints of left calf pain in the context of a history of multiple thrombotic events and prior hysterectomy.Clinical evaluation revealed no evidence of a new episode of venous thrombosis, with patent iliac and pelvic veins.She had previously been evaluated in (b)(6) 2021 for chronic pelvic pain, at which time residual endometriosis was suspected and managed with lhrh analogues and add-back therapy, resulting in symptomatic improvement.This treatment was continued until (b)(6) 2023, with plans to transition to dienogest.Due to persistent stress urinary incontinence refractory to physiotherapy, she underwent placement of a suburethral sling via the transobturator approach on (b)(6) 2023.Her postoperative course was complicated by right-sided obturator neuralgia and right lateral pelvic pain radiating to the buttock and thigh, as well as a significant buttock hematoma with subcutaneous ecchymosis exceeding 10 cm.Further workup suggested right lateropelvic thrombosis, for which anticoagulation with eliquis was initiated, along with pain management interventions.Given persistent symptoms and lack of improvement, surgical revision with partial removal of the sling on the right side was performed.At the time of this evaluation, the patient remained in the postoperative recovery phase with ongoing disabling pain, impaired ambulation, and sensory deficits involving the medial and posterior aspects of the right thigh, particularly with lifting and adduction movements.On examination, the suburethral scar appeared to be healing appropriately, though the evaluation was limited by significant pain.The patient reported poorly localized vaginal and right lateral pelvic pain.Abdominal examination was unremarkable, with no evidence of discharge, and continued suture resorption was noted.The clinical picture was most consistent with a postoperative hematoma complicated by obturator neuralgia.At this time, no indication for further surgical intervention was identified.A multidisciplinary approach was recommended, including day hospitalization in a specialized perineology unit for pain management consultation, physiotherapy focused on mobilization and rehabilitation of the right lower limb, and abdominopelvic magnetic resonance imaging (mri) to assess for any residual hematoma.Follow-up was planned for ongoing postoperative evaluation.On (b)(6) 2023, the patient underwent an endovaginal pelvic ultrasound, which demonstrated findings consistent with prior total hysterectomy.No abnormalities were identified, and there were no sonographic signs of endometriosis.Both ovaries were visualized via the vaginal approach and appeared normal, with no notable findings.Additionally, there was no evidence of adnexal masses or fluid collections.Overall, the ultrasound results were normal.On (b)(6) 2023, the patient presented for thrombosis follow-up.Her medical history is notable for thrombosis of the right ovarian vein during pregnancy in 2005, recurrence following hysterectomy in 2011, and a reported but undocumented right perineal thrombosis in 2023.At the time of evaluation, she exhibited no clinical signs suggestive of post-thrombotic syndrome of the right lower extremity.Doppler ultrasound examination demonstrated normal patency and compressibility of the deep venous system, including the inferior vena cava, which was not dilated, as well as the iliac, common femoral, superficial femoral, and popliteal veins.These vessels showed complete color flow without evidence of thrombosis or post-thrombotic sequelae.There was no evidence of deep venous reflux at the popliteal level, and no signs of recent thrombosis or post-thrombotic changes were identified at the sural level bilaterally.Additionally, no superficial venous thrombosis was observed.Overall, there is no evidence of deep, muscular, or superficial venous thrombosis in the lower extremities, and no post-thrombotic sequelae are identified on imaging.This episode is consistent with a thrombotic recurrence in the postoperative setting, without proximal or distal residual findings on ultrasound.Therapeutic anticoagulation at a curative dose is recommended to be continued for a total duration of three months.The patient will be reassessed upon completion of anticoagulant therapy for follow-up evaluation.On (b)(6) 2023, the patient presented with ongoing dyspnea on minimal exertion and persistent chest pain since her procedure on (b)(6) 2023.Her medical history is significant for endometriosis, prior ovarian vein thrombosis in 2011, deep vein thrombosis in 2015 with a negative thrombophilia workup, and a right perineal collateral vein thrombosis identified on (b)(6) 2023.She had previously undergone cardiology evaluation on (b)(6) 2023, including ct angiography, which ruled out pulmonary embolism.Her surgical history includes appendectomy, breast augmentation, tubal sterilization, hysterectomy, placement of a suburethral sling on (b)(6) 2023, and subsequent revision with partial removal of the sling on the right side on (b)(6) 2023.At present, she is maintained on eliquis 5 mg twice daily, with plans for discontinuation in the coming months.Functionally, the patient continues to report fatigue, exertional dyspnea, and persistent right thigh pain despite prior surgical revision.She also describes intermittent swelling of the posterior thigh, with prior concern for compressive hematoma, although pelvic ct imaging was negative.Further evaluation with mri was planned, and referral for pain management consultation has been arranged.Electrocardiogram showed normal sinus rhythm, with normal axis, narrow qrs complexes of normal morphology, no evidence of atrial enlargement, no repolarization abnormalities, and a qtc of 415 ms.No conduction abnormalities were identified.Echocardiographic evaluation demonstrated normal cardiac structure and function, including no left atrial dilation and no left ventricular dilation with preserved systolic function and no segmental wall motion abnormalities or hypertrophy.There was no pericardial or pleural effusion, and right heart chambers were not dilated.Valvular assessment showed no mitral valve disease, a tricuspid aortic valve with normal leaflet morphology, and no regurgitation across the mitral or aortic valves.The ascending thoracic aorta was of normal caliber, and no abnormalities were identified in the aortic arch.Diastolic function was normal and no evidence of elevated filling pressures.There was no significant tricuspid regurgitation to estimate pulmonary artery pressures, and no abnormalities were noted in the abdominopelvic region.Laboratory studies were within normal limits, with no evidence of inflammatory syndrome or hepatic dysfunction.Overall, the cardiovascular assessment was normal from clinical, electrocardiographic, and echocardiographic perspectives.These objective findings appear disproportionate to the severity and variability of the patient's reported symptoms, raising consideration of a potential non-organic or psychogenic component contributing to her presentation.On (b)(6) 2023, the patient presented for evaluation following prior surgical treatment for stress urinary incontinence.During her hospitalization for surgical revision, the patient underwent additional diagnostic evaluations.An abdominopelvic ct scan was performed to assess for hematoma or deep collections and was unremarkable.Laboratory studies were within normal limits, with no evidence of infection or inflammatory response.A doppler ultrasound of the right inguinal region was obtained due to persistent pain and a prior history of ovarian vein thrombosis in 2011; this revealed a minimal thrombus, for which anticoagulation therapy with apixaban (eliquis) was initiated.She was initially discharged with analgesic treatment; however, she soon experienced a recurrence of disabling pain, prompting multiple subsequent emergency department visits.The pain was localized to the right inguinal fold and right thigh and was described as intermittent, non-continuous, and throbbing in nature.Given the persistent nature of her symptoms, a specialist opinion was obtained, with recommendations for a pelvic mri to assess for deep endometriosis and review of the case within a multidisciplinary team (rcp).Despite these measures, the patient has continued to present regularly to the emergency department for the same complaints.From a cardiopulmonary standpoint, she underwent cardiology assessment on (b)(6) which demonstrated a normal cardiovascular evaluation on both clinical examination and echocardiography, despite her significant functional symptoms of dyspnea, fatigue, and chest pain.In light of the ongoing, disabling pain, referral to a pain management clinic was advised, and she was referred for potential management.With regard to her urinary status, further complementary investigations were planned, including an mri in the near future.On (b)(6) 2023, the patient underwent a translabial ultrasound, which demonstrated no abnormalities at the hysterectomy site.Imaging revealed a partially sectioned tot-type sling, with the residual left lateral arm present and a minimal distal portion of the right lateral arm.Significant cervico-urethral hypermobility was noted, though there was no evidence of overt sphincter insufficiency.Subsequent pelvic and perineal mri confirmed these findings, showing no abnormality of the hysterectomy site.The residual left lateral arm of the tot-type sling was clearly visualized at the level of the obturator foramen, while the right lateral arm was not identified.No signs of complications were observed on the mri.On (b)(6) 2024, the patient underwent an mri of the lumbar spine, which revealed no abnormalities in spinal alignment while in the supine position.The conus medullaris terminated normally at the t12-l1 level.Vertebral body heights were preserved, and there were no abnormal findings in the spinal canal diameter or bone signal.Muscle trophicity appeared normal.At the l1-l2 level, the intervertebral disc was intact with normal signal, posterior facet joints showed no arthritic changes, and the neural foramina were clear.On (b)(6) 2024, the patient underwent biopathology testing, including a cytobacteriological examination of urine (ecbu) using a properly collected midstream sample under appropriate storage conditions.The test was performed in preparation for a planned urological or surgical procedure on (b)(6) 2024.Cytological analysis revealed hematuria within the normal reference range, with only rare red blood cells observed.Leukocyturia was elevated with fairly numerous isolated leukocytes and rare clusters of altered leukocytes.No epithelial cells, crystals, casts, or yeast were identified.Overall, findings were notable for elevated leukocyturia without additional abnormalities.On (b)(6) 2024, the patient underwent cystoscopy as planned for evaluation of persistent pelvic pain and irritative voiding symptoms following placement of a transobturator (tot) sling in (b)(6) 2023, with prior partial sling resection.She reported some symptomatic relief on the side where the sling had been removed.Cystoscopic examination revealed a normal-appearing bladder, with no evidence of sling erosion or involvement at the level of the bladder neck or urethra.Given her ongoing and significantly bothersome irritative urinary symptoms, and in the absence of dysuria, symptomatic management with vesicare was recommended while awaiting further evaluation with a specialist scheduled in march.On (b)(6) 2024, the patient presented for an initial pain management consultation.She reported severe neuropathic-type pain originating from the right obturator region following prior surgical intervention.The dn4 (neuropathic pain 4) score was positive, and her pain intensity was rated at 5/10.Clinical examination demonstrated dysesthesia involving the bilateral inner thighs and suprapubic region.She reported intolerance to tight clothing and heightened sensitivity to thermal stimuli, particularly hot water.No hypoesthesia was identified on esthesiometric testing.The pain has significantly impacted her quality of life, including inability to engage in sexual intercourse, disrupted sleep with frequent awakenings, and the development of anxiety with associated mood disturbances.Pelvic mri and ultrasound both confirmed the presence of a partially sectioned transobturator (tot) sling, with a residual left lateral arm clearly visualized at the level of the obturator foramen.In light of persistent symptoms, her case was reviewed for further surgical management, with consideration of removal of the remaining left lateral portion of the sling.She is scheduled for specialist evaluation on (b)(6).In the interim, a neuropathic pain management regimen was initiated.Gabapentin was prescribed starting at 100 mg three times daily, with planned weekly titration in 100 mg increments up to a target dose of 600 mg three times daily (1800 mg/day).Given the severity of her symptoms and their impact on daily functioning, adjunctive therapy with anafranil 25 mg was also initiated.A follow-up consultation was scheduled in one month to assess response and tolerability, with availability for interim support as needed.Additionally, referral for psychological support with a pain clinic psychologist was recommended at the next visit.Please see block h11 for the complete event description.
Event or Problem Description
It was reported to boston scientific that the patient was implanted with a transobturator tape (tot) sling on procedure performed on (b)(6) 2023, for the treatment of stress urinary incontinence.On (b)(6) 2023, the patient presented for evaluation following a recent episode of right lower extremity thrombosis that occurred in the setting of urological surgery.At that time, she developed a right lower limb pain associated with fever, prompting hospitalization, during which a thrombosis of the right lower extremity was diagnosed.She is currently receiving therapeutic-dose anticoagulation.A computed tomography (ct) angiography performed was negative.Subsequently, a doppler ultrasound examination demonstrated normal patency and compressibility of the deep venous system, including the inferior vena cava, which was not dilated, as well as the common iliac, femoral, superficial femoral, and popliteal veins.These vessels showed complete color flow with no evidence of residual thrombosis or post-thrombotic sequelae.There was no evidence of deep venous reflux at the popliteal level, and no signs of recent thrombosis or post-thrombotic changes were observed at the sural level bilaterally.Additionally, no superficial venous thrombosis was identified.There is no evidence of deep, muscular, or superficial venous thrombosis of the lower extremities, nor any post-thrombotic sequelae.Overall, the findings are reassuring and consistent with complete recanalization of the previously documented thrombosis.Given that this represents a recurrent thrombotic event, continuation of therapeutic-dose anticoagulation is recommended for a total duration of three months.The patient will be reassessed at that time for follow-up and further management.On (b)(6) 2023, the patient presented with dyspnea and concern for possible pulmonary embolism in the setting of a suspected infection related to her transobturator (tot) sling, accompanied by cough and ongoing anticoagulation therapy with innohep.A ct angiography was performed to evaluate for pulmonary embolism.Imaging results demonstrated no evidence of pulmonary embolism.There was no axillary, hilar, or mediastinal lymphadenopathy, and no cardiomegaly was observed.Additionally, there was no pleural or pericardial effusion.The lung parenchyma showed no bronchial wall thickening, bronchiectasis, interstitial disease, nodules, masses, or evolving lesions.Bone structures were preserved.Following review and discussion, the findings were considered reassuring, and pulmonary embolism was definitively ruled out.Based on the clinical and imaging assessment, the patient was deemed stable and cleared for discharge, with authorization to proceed with the scheduled surgery the following day.On (b)(6) 2023, the patient presented for surgical revision following treatment of stress urinary incontinence with placement of a suburethral sling via the transobturator (tot) approach, which had been performed approximately one month prior.The initial procedure was completed under appropriate technical conditions, with an initially uncomplicated postoperative course from a voiding standpoint.Approximately one week postoperatively, the patient presented to the emergency department with vaginal discharge and severe pain localized to the right thigh.Clinical evaluation at that time was reassuring, and she was started on antibiotic therapy.Despite treatment, symptoms persisted, and she was reassessed in early september, approximately ten days after the procedure, with ongoing complaints despite unremarkable clinical and imaging findings.Subsequently, following a diagnosis of thrombosis, the patient was hospitalized and underwent doppler ultrasound of the right thigh, which demonstrated superficial thrombosis.Anticoagulation therapy was initiated.A ct angiography was also performed and ruled out pulmonary embolism.She was discharged on both antibiotic therapy for vaginal discharge and anticoagulation.Follow-up demonstrated some clinical improvement; however, the patient continued to experience significant pain along the right thigh and the course of the sling.Given the persistence and severity of symptoms, as well as the patient's request and difficulty tolerating gynecologic examination due to severe pain, the decision was made to proceed with surgical revision.During the procedure, examination revealed no pathological or purulent vaginal discharge; however, a bacteriological swab was obtained.Exploration identified scarring at the level of the prior vaginal incision with mild induration.The vaginal incision was reopened, and careful dissection allowed for removal and excision of the sling, primarily along the right side extending to the level of the obturator foramen on the internal aspect.On the left side, the sling was largely removed.A portion of the excised material was sent for bacteriological analysis.The vaginal incision was then closed.The bladder catheter was removed at the conclusion of the procedure.Overall, the procedure consisted of excision of the right arm of the suburethral sling and partial removal of the left side.Fluoroscopy was utilized during the procedure.On (b)(6) 2023, the patient presented with malodorous vaginal discharge and significant pain along the course of the sling on the right side, involving the inguinal fold and right thigh.She was initiated on antibiotic therapy and analgesics; however, her clinical course was notable for persistent discharge and disabling perineal pain, prompting hospitalization for further evaluation.During hospitalization, doppler ultrasound of the right thigh root identified a superficial thrombosis, and anticoagulant therapy was initiated, with subsequent favorable vascular outcome.A pelvic ct scan performed to evaluate for deep infection or fluid collection was negative, and laboratory studies were within normal limits.Thoracic ct angiography ruled out pulmonary embolism.After several days, she was discharged on antibiotics and analgesics, with follow-up arranged; repeat laboratory and bacteriological evaluations remained unremarkable.Despite these measures, the patient continued to experience severe right-sided perineal pain.Vaginal examination was not feasible due to significant discomfort, and she requested definitive surgical management.Given the persistence and severity of symptoms, a decision was made to proceed with surgical revision, and removal of the right-sided portion of the suburethral sling was performed on (b)(6) 2023, without complication.The immediate postoperative course was uneventful, and the patient was discharged on postoperative day two.On (b)(6) 2023, the patient presented for consultation with complaints of left calf pain in the context of a history of multiple thrombotic events and prior hysterectomy.Clinical evaluation revealed no evidence of a new episode of venous thrombosis, with patent iliac and pelvic veins.She had previously been evaluated in (b)(6) 2021 for chronic pelvic pain, at which time residual endometriosis was suspected and managed with lhrh analogues and add-back therapy, resulting in symptomatic improvement.This treatment was continued until (b)(6) 2023, with plans to transition to dienogest.Due to persistent stress urinary incontinence refractory to physiotherapy, she underwent placement of a suburethral sling via the transobturator approach on (b)(6) 2023.Her postoperative course was complicated by right-sided obturator neuralgia and right lateral pelvic pain radiating to the buttock and thigh, as well as a significant buttock hematoma with subcutaneous ecchymosis exceeding 10 cm.Further workup suggested right lateropelvic thrombosis, for which anticoagulation with eliquis was initiated, along with pain management interventions.Given persistent symptoms and lack of improvement, surgical revision with partial removal of the sling on the right side was performed.At the time of this evaluation, the patient remained in the postoperative recovery phase with ongoing disabling pain, impaired ambulation, and sensory deficits involving the medial and posterior aspects of the right thigh, particularly with lifting and adduction movements.On examination, the suburethral scar appeared to be healing appropriately, though the evaluation was limited by significant pain.The patient reported poorly localized vaginal and right lateral pelvic pain.Abdominal examination was unremarkable, with no evidence of discharge, and continued suture resorption was noted.The clinical picture was most consistent with a postoperative hematoma complicated by obturator neuralgia.At this time, no indication for further surgical intervention was identified.A multidisciplinary approach was recommended, including day hospitalization in a specialized perineology unit for pain management consultation, physiotherapy focused on mobilization and rehabilitation of the right lower limb, and abdominopelvic magnetic resonance imaging (mri) to assess for any residual hematoma.Follow-up was planned for ongoing postoperative evaluation.On (b)(6) 2023, the patient underwent an endovaginal pelvic ultrasound, which demonstrated findings consistent with prior total hysterectomy.No abnormalities were identified, and there were no sonographic signs of endometriosis.Both ovaries were visualized via the vaginal approach and appeared normal, with no notable findings.Additionally, there was no evidence of adnexal masses or fluid collections.Overall, the ultrasound results were normal.On (b)(6) 2023, the patient presented for thrombosis follow-up.Her medical history is notable for thrombosis of the right ovarian vein during pregnancy in 2005, recurrence following hysterectomy in 2011, and a reported but undocumented right perineal thrombosis in 2023.At the time of evaluation, she exhibited no clinical signs suggestive of post-thrombotic syndrome of the right lower extremity.Doppler ultrasound examination demonstrated normal patency and compressibility of the deep venous system, including the inferior vena cava, which was not dilated, as well as the iliac, common femoral, superficial femoral, and popliteal veins.These vessels showed complete color flow without evidence of thrombosis or post-thrombotic sequelae.There was no evidence of deep venous reflux at the popliteal level, and no signs of recent thrombosis or post-thrombotic changes were identified at the sural level bilaterally.Additionally, no superficial venous thrombosis was observed.Overall, there is no evidence of deep, muscular, or superficial venous thrombosis in the lower extremities, and no post-thrombotic sequelae are identified on imaging.This episode is consistent with a thrombotic recurrence in the postoperative setting, without proximal or distal residual findings on ultrasound.Therapeutic anticoagulation at a curative dose is recommended to be continued for a total duration of three months.The patient will be reassessed upon completion of anticoagulant therapy for follow-up evaluation.On (b)(6) 2023, the patient presented with ongoing dyspnea on minimal exertion and persistent chest pain since her procedure on (b)(6) 2023.Her medical history is significant for endometriosis, prior ovarian vein thrombosis in 2011, deep vein thrombosis in 2015 with a negative thrombophilia workup, and a right perineal collateral vein thrombosis identified on (b)(6) 2023.She had previously undergone cardiology evaluation on (b)(6) 2023, including ct angiography, which ruled out pulmonary embolism.Her surgical history includes appendectomy, breast augmentation, tubal sterilization, hysterectomy, placement of a suburethral sling on (b)(6) 2023, and subsequent revision with partial removal of the sling on the right side on (b)(6) 2023.At present, she is maintained on eliquis 5 mg twice daily, with plans for discontinuation in the coming months.Functionally, the patient continues to report fatigue, exertional dyspnea, and persistent right thigh pain despite prior surgical revision.She also describes intermittent swelling of the posterior thigh, with prior concern for compressive hematoma, although pelvic ct imaging was negative.Further evaluation with mri was planned, and referral for pain management consultation has been arranged.Electrocardiogram showed normal sinus rhythm, with normal axis, narrow qrs complexes of normal morphology, no evidence of atrial enlargement, no repolarization abnormalities, and a qtc of 415 ms.No conduction abnormalities were identified.Echocardiographic evaluation demonstrated normal cardiac structure and function, including no left atrial dilation and no left ventricular dilation with preserved systolic function and no segmental wall motion abnormalities or hypertrophy.There was no pericardial or pleural effusion, and right heart chambers were not dilated.Valvular assessment showed no mitral valve disease, a tricuspid aortic valve with normal leaflet morphology, and no regurgitation across the mitral or aortic valves.The ascending thoracic aorta was of normal caliber, and no abnormalities were identified in the aortic arch.Diastolic function was normal and no evidence of elevated filling pressures.There was no significant tricuspid regurgitation to estimate pulmonary artery pressures, and no abnormalities were noted in the abdominopelvic region.Laboratory studies were within normal limits, with no evidence of inflammatory syndrome or hepatic dysfunction.Overall, the cardiovascular assessment was normal from clinical, electrocardiographic, and echocardiographic perspectives.These objective findings appear disproportionate to the severity and variability of the patient's reported symptoms, raising consideration of a potential non-organic or psychogenic component contributing to her presentation.On (b)(6) 2023, the patient presented for evaluation following prior surgical treatment for stress urinary incontinence.During her hospitalization for surgical revision, the patient underwent additional diagnostic evaluations.An abdominopelvic ct scan was performed to assess for hematoma or deep collections and was unremarkable.Laboratory studies were within normal limits, with no evidence of infection or inflammatory response.A doppler ultrasound of the right inguinal region was obtained due to persistent pain and a prior history of ovarian vein thrombosis in 2011; this revealed a minimal thrombus, for which anticoagulation therapy with apixaban (eliquis) was initiated.She was initially discharged with analgesic treatment; however, she soon experienced a recurrence of disabling pain, prompting multiple subsequent emergency department visits.The pain was localized to the right inguinal fold and right thigh and was described as intermittent, non-continuous, and throbbing in nature.Given the persistent nature of her symptoms, a specialist opinion was obtained, with recommendations for a pelvic mri to assess for deep endometriosis and review of the case within a multidisciplinary team (rcp).Despite these measures, the patient has continued to present regularly to the emergency department for the same complaints.From a cardiopulmonary standpoint, she underwent cardiology assessment on november 14, which demonstrated a normal cardiovascular evaluation on both clinical examination and echocardiography, despite her significant functional symptoms of dyspnea, fatigue, and chest pain.In light of the ongoing, disabling pain, referral to a pain management clinic was advised, and she was referred for potential management.With regard to her urinary status, further complementary investigations were planned, including an mri in the near future.On (b)(6) 2023, the patient underwent a translabial ultrasound, which demonstrated no abnormalities at the hysterectomy site.Imaging revealed a partially sectioned tot-type sling, with the residual left lateral arm present and a minimal distal portion of the right lateral arm.Significant cervico-urethral hypermobility was noted, though there was no evidence of overt sphincter insufficiency.Subsequent pelvic and perineal mri confirmed these findings, showing no abnormality of the hysterectomy site.The residual left lateral arm of the tot-type sling was clearly visualized at the level of the obturator foramen, while the right lateral arm was not identified.No signs of complications were observed on the mri.On (b)(6) 2024, the patient underwent an mri of the lumbar spine, which revealed no abnormalities in spinal alignment while in the supine position.The conus medullaris terminated normally at the t12-l1 level.Vertebral body heights were preserved, and there were no abnormal findings in the spinal canal diameter or bone signal.Muscle trophicity appeared normal.At the l1-l2 level, the intervertebral disc was intact with normal signal, posterior facet joints showed no arthritic changes, and the neural foramina were clear.On (b)(6) 2024, the patient underwent biopathology testing, including a cytobacteriological examination of urine (ecbu) using a properly collected midstream sample under appropriate storage conditions.The test was performed in preparation for a planned urological or surgical procedure on (b)(6) 2024.Cytological analysis revealed hematuria within the normal reference range, with only rare red blood cells observed.Leukocyturia was elevated with fairly numerous isolated leukocytes and rare clusters of altered leukocytes.No epithelial cells, crystals, casts, or yeast were identified.Overall, findings were notable for elevated leukocyturia without additional abnormalities.On (b)(6) 2024, the patient underwent cystoscopy as planned for evaluation of persistent pelvic pain and irritative voiding symptoms following placement of a transobturator (tot) sling in (b)(6) 2023, with prior partial sling resection.She reported some symptomatic relief on the side where the sling had been removed.Cystoscopic examination revealed a normal-appearing bladder, with no evidence of sling erosion or involvement at the level of the bladder neck or urethra.Given her ongoing and significantly bothersome irritative urinary symptoms, and in the absence of dysuria, symptomatic management with vesicare was recommended while awaiting further evaluation with a specialist scheduled in (b)(6).On (b)(6) 2024, the patient presented for an initial pain management consultation.She reported severe neuropathic-type pain originating from the right obturator region following prior surgical intervention.The dn4 (neuropathic pain 4) score was positive, and her pain intensity was rated at 5/10.Clinical examination demonstrated dysesthesia involving the bilateral inner thighs and suprapubic region.She reported intolerance to tight clothing and heightened sensitivity to thermal stimuli, particularly hot water.No hypoesthesia was identified on esthesiometric testing.The pain has significantly impacted her quality of life, including inability to engage in sexual intercourse, disrupted sleep with frequent awakenings, and the development of anxiety with associated mood disturbances.Pelvic mri and ultrasound both confirmed the presence of a partially sectioned transobturator (tot) sling, with a residual left lateral arm clearly visualized at the level of the obturator foramen.In light of persistent symptoms, her case was reviewed for further surgical management, with consideration of removal of the remaining left lateral portion of the sling.She is scheduled for specialist evaluation on (b)(6).In the interim, a neuropathic pain management regimen was initiated.Gabapentin was prescribed starting at 100 mg three times daily, with planned weekly titration in 100 mg increments up to a target dose of 600 mg three times daily (1800 mg/day).Given the severity of her symptoms and their impact on daily functioning, adjunctive therapy with anafranil 25 mg was also initiated.A follow-up consultation was scheduled in one month to assess response and tolerability, with availability for interim support as needed.Additionally, referral for psychological support with a pain clinic psychologist was recommended at the next visit.
Event or Problem Description
It was reported to boston scientific that the patient was implanted with a transobturator tape (tot) sling on procedure performed on (b)(6) 2023, for the treatment of stress urinary incontinence.On (b)(6) 2023, the patient presented for evaluation following a recent episode of right lower extremity thrombosis that occurred in the setting of urological surgery.At that time, she developed a right lower limb pain associated with fever, prompting hospitalization, during which a thrombosis of the right lower extremity was diagnosed.She is currently receiving therapeutic-dose anticoagulation.A computed tomography (ct) angiography performed was negative.Subsequently, a doppler ultrasound examination demonstrated normal patency and compressibility of the deep venous system, including the inferior vena cava, which was not dilated, as well as the common iliac, femoral, superficial femoral, and popliteal veins.These vessels showed complete color flow with no evidence of residual thrombosis or post-thrombotic sequelae.There was no evidence of deep venous reflux at the popliteal level, and no signs of recent thrombosis or post-thrombotic changes were observed at the sural level bilaterally.Additionally, no superficial venous thrombosis was identified.There is no evidence of deep, muscular, or superficial venous thrombosis of the lower extremities, nor any post-thrombotic sequelae.Overall, the findings are reassuring and consistent with complete recanalization of the previously documented thrombosis.Given that this represents a recurrent thrombotic event, continuation of therapeutic-dose anticoagulation is recommended for a total duration of three months.The patient will be reassessed at that time for follow-up and further management.On (b)(6) 2023, the patient presented with dyspnea and concern for possible pulmonary embolism in the setting of a suspected infection related to her transobturator (tot) sling, accompanied by cough and ongoing anticoagulation therapy with innohep.A ct angiography was performed to evaluate for pulmonary embolism.Imaging results demonstrated no evidence of pulmonary embolism.There was no axillary, hilar, or mediastinal lymphadenopathy, and no cardiomegaly was observed.Additionally, there was no pleural or pericardial effusion.The lung parenchyma showed no bronchial wall thickening, bronchiectasis, interstitial disease, nodules, masses, or evolving lesions.Bone structures were preserved.Following review and discussion, the findings were considered reassuring, and pulmonary embolism was definitively ruled out.Based on the clinical and imaging assessment, the patient was deemed stable and cleared for discharge, with authorization to proceed with the scheduled surgery the following day.On (b)(6) 2023, the patient presented for surgical revision following treatment of stress urinary incontinence with placement of a suburethral sling via the transobturator (tot) approach, which had been performed approximately one month prior.The initial procedure was completed under appropriate technical conditions, with an initially uncomplicated postoperative course from a voiding standpoint.Approximately one week postoperatively, the patient presented to the emergency department with vaginal discharge and severe pain localized to the right thigh.Clinical evaluation at that time was reassuring, and she was started on antibiotic therapy.Despite treatment, symptoms persisted, and she was reassessed in early september, approximately ten days after the procedure, with ongoing complaints despite unremarkable clinical and imaging findings.Subsequently, following a diagnosis of thrombosis, the patient was hospitalized and underwent doppler ultrasound of the right thigh, which demonstrated superficial thrombosis.Anticoagulation therapy was initiated.A ct angiography was also performed and ruled out pulmonary embolism.She was discharged on both antibiotic therapy for vaginal discharge and anticoagulation.Follow-up demonstrated some clinical improvement; however, the patient continued to experience significant pain along the right thigh and the course of the sling.Given the persistence and severity of symptoms, as well as the patient's request and difficulty tolerating gynecologic examination due to severe pain, the decision was made to proceed with surgical revision.During the procedure, examination revealed no pathological or purulent vaginal discharge; however, a bacteriological swab was obtained.Exploration identified scarring at the level of the prior vaginal incision with mild induration.The vaginal incision was reopened, and careful dissection allowed for removal and excision of the sling, primarily along the right side extending to the level of the obturator foramen on the internal aspect.On the left side, the sling was largely removed.A portion of the excised material was sent for bacteriological analysis.The vaginal incision was then closed.The bladder catheter was removed at the conclusion of the procedure.Overall, the procedure consisted of excision of the right arm of the suburethral sling and partial removal of the left side.Fluoroscopy was utilized during the procedure.On (b)(6) 2023, the patient presented with malodorous vaginal discharge and significant pain along the course of the sling on the right side, involving the inguinal fold and right thigh.She was initiated on antibiotic therapy and analgesics; however, her clinical course was notable for persistent discharge and disabling perineal pain, prompting hospitalization for further evaluation.During hospitalization, doppler ultrasound of the right thigh root identified a superficial thrombosis, and anticoagulant therapy was initiated, with subsequent favorable vascular outcome.A pelvic ct scan performed to evaluate for deep infection or fluid collection was negative, and laboratory studies were within normal limits.Thoracic ct angiography ruled out pulmonary embolism.After several days, she was discharged on antibiotics and analgesics, with follow-up arranged; repeat laboratory and bacteriological evaluations remained unremarkable.Despite these measures, the patient continued to experience severe right-sided perineal pain.Vaginal examination was not feasible due to significant discomfort, and she requested definitive surgical management.Given the persistence and severity of symptoms, a decision was made to proceed with surgical revision, and removal of the right-sided portion of the suburethral sling was performed on (b)(6) 2023, without complication.The immediate postoperative course was uneventful, and the patient was discharged on postoperative day two.On (b)(6) 2023, the patient presented for consultation with complaints of left calf pain in the context of a history of multiple thrombotic events and prior hysterectomy.Clinical evaluation revealed no evidence of a new episode of venous thrombosis, with patent iliac and pelvic veins.She had previously been evaluated in (b)(6) 2021 for chronic pelvic pain, at which time residual endometriosis was suspected and managed with lhrh analogues and add-back therapy, resulting in symptomatic improvement.This treatment was continued until (b)(6) 2023, with plans to transition to dienogest.Due to persistent stress urinary incontinence refractory to physiotherapy, she underwent placement of a suburethral sling via the transobturator approach on (b)(6) 2023.Her postoperative course was complicated by right-sided obturator neuralgia and right lateral pelvic pain radiating to the buttock and thigh, as well as a significant buttock hematoma with subcutaneous ecchymosis exceeding 10 cm.Further workup suggested right lateropelvic thrombosis, for which anticoagulation with eliquis was initiated, along with pain management interventions.Given persistent symptoms and lack of improvement, surgical revision with partial removal of the sling on the right side was performed.At the time of this evaluation, the patient remained in the postoperative recovery phase with ongoing disabling pain, impaired ambulation, and sensory deficits involving the medial and posterior aspects of the right thigh, particularly with lifting and adduction movements.On examination, the suburethral scar appeared to be healing appropriately, though the evaluation was limited by significant pain.The patient reported poorly localized vaginal and right lateral pelvic pain.Abdominal examination was unremarkable, with no evidence of discharge, and continued suture resorption was noted.The clinical picture was most consistent with a postoperative hematoma complicated by obturator neuralgia.At this time, no indication for further surgical intervention was identified.A multidisciplinary approach was recommended, including day hospitalization in a specialized perineology unit for pain management consultation, physiotherapy focused on mobilization and rehabilitation of the right lower limb, and abdominopelvic magnetic resonance imaging (mri) to assess for any residual hematoma.Follow-up was planned for ongoing postoperative evaluation.On (b)(6) 2023, the patient underwent an endovaginal pelvic ultrasound, which demonstrated findings consistent with prior total hysterectomy.No abnormalities were identified, and there were no sonographic signs of endometriosis.Both ovaries were visualized via the vaginal approach and appeared normal, with no notable findings.Additionally, there was no evidence of adnexal masses or fluid collections.Overall, the ultrasound results were normal.On (b)(6) 2023, the patient presented for thrombosis follow-up.Her medical history is notable for thrombosis of the right ovarian vein during pregnancy in 2005, recurrence following hysterectomy in 2011, and a reported but undocumented right perineal thrombosis in 2023.At the time of evaluation, she exhibited no clinical signs suggestive of post-thrombotic syndrome of the right lower extremity.Doppler ultrasound examination demonstrated normal patency and compressibility of the deep venous system, including the inferior vena cava, which was not dilated, as well as the iliac, common femoral, superficial femoral, and popliteal veins.These vessels showed complete color flow without evidence of thrombosis or post-thrombotic sequelae.There was no evidence of deep venous reflux at the popliteal level, and no signs of recent thrombosis or post-thrombotic changes were identified at the sural level bilaterally.Additionally, no superficial venous thrombosis was observed.Overall, there is no evidence of deep, muscular, or superficial venous thrombosis in the lower extremities, and no post-thrombotic sequelae are identified on imaging.This episode is consistent with a thrombotic recurrence in the postoperative setting, without proximal or distal residual findings on ultrasound.Therapeutic anticoagulation at a curative dose is recommended to be continued for a total duration of three months.The patient will be reassessed upon completion of anticoagulant therapy for follow-up evaluation.On (b)(6) 2023, the patient presented with ongoing dyspnea on minimal exertion and persistent chest pain since her procedure on (b)(6) 2023.Her medical history is significant for endometriosis, prior ovarian vein thrombosis in 2011, deep vein thrombosis in 2015 with a negative thrombophilia workup, and a right perineal collateral vein thrombosis identified on (b)(6) 2023.She had previously undergone cardiology evaluation on (b)(6) 2023, including ct angiography, which ruled out pulmonary embolism.Her surgical history includes appendectomy, breast augmentation, tubal sterilization, hysterectomy, placement of a suburethral sling on (b)(6) 2023, and subsequent revision with partial removal of the sling on the right side on (b)(6) 2023.At present, she is maintained on eliquis 5 mg twice daily, with plans for discontinuation in the coming months.Functionally, the patient continues to report fatigue, exertional dyspnea, and persistent right thigh pain despite prior surgical revision.She also describes intermittent swelling of the posterior thigh, with prior concern for compressive hematoma, although pelvic ct imaging was negative.Further evaluation with mri was planned, and referral for pain management consultation has been arranged.Electrocardiogram showed normal sinus rhythm, with normal axis, narrow qrs complexes of normal morphology, no evidence of atrial enlargement, no repolarization abnormalities, and a qtc of 415 ms.No conduction abnormalities were identified.Echocardiographic evaluation demonstrated normal cardiac structure and function, including no left atrial dilation and no left ventricular dilation with preserved systolic function and no segmental wall motion abnormalities or hypertrophy.There was no pericardial or pleural effusion, and right heart chambers were not dilated.Valvular assessment showed no mitral valve disease, a tricuspid aortic valve with normal leaflet morphology, and no regurgitation across the mitral or aortic valves.The ascending thoracic aorta was of normal caliber, and no abnormalities were identified in the aortic arch.Diastolic function was normal and no evidence of elevated filling pressures.There was no significant tricuspid regurgitation to estimate pulmonary artery pressures, and no abnormalities were noted in the abdominopelvic region.Laboratory studies were within normal limits, with no evidence of inflammatory syndrome or hepatic dysfunction.Overall, the cardiovascular assessment was normal from clinical, electrocardiographic, and echocardiographic perspectives.These objective findings appear disproportionate to the severity and variability of the patient's reported symptoms, raising consideration of a potential non-organic or psychogenic component contributing to her presentation.On (b)(6) 2023, the patient presented for evaluation following prior surgical treatment for stress urinary incontinence.During her hospitalization for surgical revision, the patient underwent additional diagnostic evaluations.An abdominopelvic ct scan was performed to assess for hematoma or deep collections and was unremarkable.Laboratory studies were within normal limits, with no evidence of infection or inflammatory response.A doppler ultrasound of the right inguinal region was obtained due to persistent pain and a prior history of ovarian vein thrombosis in 2011; this revealed a minimal thrombus, for which anticoagulation therapy with apixaban (eliquis) was initiated.She was initially discharged with analgesic treatment; however, she soon experienced a recurrence of disabling pain, prompting multiple subsequent emergency department visits.The pain was localized to the right inguinal fold and right thigh and was described as intermittent, non-continuous, and throbbing in nature.Given the persistent nature of her symptoms, a specialist opinion was obtained, with recommendations for a pelvic mri to assess for deep endometriosis and review of the case within a multidisciplinary team (rcp).Despite these measures, the patient has continued to present regularly to the emergency department for the same complaints.From a cardiopulmonary standpoint, she underwent cardiology assessment on (b)(6), which demonstrated a normal cardiovascular evaluation on both clinical examination and echocardiography, despite her significant functional symptoms of dyspnea, fatigue, and chest pain.In light of the ongoing, disabling pain, referral to a pain management clinic was advised, and she was referred for potential management.With regard to her urinary status, further complementary investigations were planned, including an mri in the near future.On (b)(6) 2023, the patient underwent a translabial ultrasound, which demonstrated no abnormalities at the hysterectomy site.Imaging revealed a partially sectioned tot-type sling, with the residual left lateral arm present and a minimal distal portion of the right lateral arm.Significant cervico-urethral hypermobility was noted, though there was no evidence of overt sphincter insufficiency.Subsequent pelvic and perineal mri confirmed these findings, showing no abnormality of the hysterectomy site.The residual left lateral arm of the tot-type sling was clearly visualized at the level of the obturator foramen, while the right lateral arm was not identified.No signs of complications were observed on the mri.On (b)(6) 2024, the patient underwent an mri of the lumbar spine, which revealed no abnormalities in spinal alignment while in the supine position.The conus medullaris terminated normally at the t12-l1 level.Vertebral body heights were preserved, and there were no abnormal findings in the spinal canal diameter or bone signal.Muscle trophicity appeared normal.At the l1-l2 level, the intervertebral disc was intact with normal signal, posterior facet joints showed no arthritic changes, and the neural foramina were clear.On (b)(6) 2024, the patient underwent biopathology testing, including a cytobacteriological examination of urine (ecbu) using a properly collected midstream sample under appropriate storage conditions.The test was performed in preparation for a planned urological or surgical procedure on (b)(6) 2024.Cytological analysis revealed hematuria within the normal reference range, with only rare red blood cells observed.Leukocyturia was elevated with fairly numerous isolated leukocytes and rare clusters of altered leukocytes.No epithelial cells, crystals, casts, or yeast were identified.Overall, findings were notable for elevated leukocyturia without additional abnormalities.On (b)(6) 2024, the patient underwent cystoscopy as planned for evaluation of persistent pelvic pain and irritative voiding symptoms following placement of a transobturator (tot) sling in (b)(6) 2023, with prior partial sling resection.She reported some symptomatic relief on the side where the sling had been removed.Cystoscopic examination revealed a normal-appearing bladder, with no evidence of sling erosion or involvement at the level of the bladder neck or urethra.Given her ongoing and significantly bothersome irritative urinary symptoms, and in the absence of dysuria, symptomatic management with vesicare was recommended while awaiting further evaluation with a specialist scheduled in (b)(6).On (b)(6) 2024, the patient presented for an initial pain management consultation.She reported severe neuropathic-type pain originating from the right obturator region following prior surgical intervention.The dn4 (neuropathic pain 4) score was positive, and her pain intensity was rated at 5/10.Clinical examination demonstrated dysesthesia involving the bilateral inner thighs and suprapubic region.She reported intolerance to tight clothing and heightened sensitivity to thermal stimuli, particularly hot water.No hypoesthesia was identified on esthesiometric testing.The pain has significantly impacted her quality of life, including inability to engage in sexual intercourse, disrupted sleep with frequent awakenings, and the development of anxiety with associated mood disturbances.Pelvic mri and ultrasound both confirmed the presence of a partially sectioned transobturator (tot) sling, with a residual left lateral arm clearly visualized at the level of the obturator foramen.In light of persistent symptoms, her case was reviewed for further surgical management, with consideration of removal of the remaining left lateral portion of the sling.She is scheduled for specialist evaluation on (b)(6).In the interim, a neuropathic pain management regimen was initiated.Gabapentin was prescribed starting at 100 mg three times daily, with planned weekly titration in 100 mg increments up to a target dose of 600 mg three times daily (1800 mg/day).Given the severity of her symptoms and their impact on daily functioning, adjunctive therapy with anafranil 25 mg was also initiated.A follow-up consultation was scheduled in one month to assess response and tolerability, with availability for interim support as needed.Additionally, referral for psychological support with a pain clinic psychologist was recommended at the next visit.Please see block h11 for the complete event description.
Additional Manufacturer Narrative
Block h11: with all the available information, boston scientific concludes that the reported adverse events of injury, nos (not otherwise specified), thrombosis, pain, fever, dyspnea, infection, urinary incontinence, vaginal discharge, scarring, discomfort, nerve damage, ecchymosis, chest pain, swelling, fatigue, unspecified mental, emotional or behavioral problem, sleep disorders, erosion, and palpitations are known risks of the surgical procedure.The device was not returned for evaluation; therefore, a technical analysis could not be performed, and the reported incident could not be confirmed.The device was not returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.The investigation concluded that the most probable cause for this event is known inherent risk of device, which indicates that the reported adverse event is known and documented in the labeling (including both short or long term known complications or adverse reactions).Continuation of block b5: on (b)(6) 2024, the patient presented for evaluation following prior surgical management of stress urinary incontinence.She had undergone placement of a suburethral transobturator tape on (b)(6) 2023, which was performed without intraoperative complications and followed by an initially uncomplicated postoperative course with discharge within the expected timeframe.Approximately one week later, she presented to the emergency department with pain localized along the right-sided sling pathway, involving the inguinal fold and right thigh, as well as malodorous vaginal discharge.Gynecologic examination was largely unremarkable aside from tenderness on palpation in the affected areas.She was treated with antibiotics and analgesics; however, her course was notable for persistent and debilitating perineal pain, prompting hospitalization and further evaluation.Doppler ultrasound of the right lower extremity identified a superficial thrombosis, for which anticoagulation therapy was initiated, resulting in subsequent vascular improvement.Additional investigations, including a pelvic ct scan, showed no evidence of deep fluid collection or infection, and laboratory studies were within normal limits without evidence of an inflammatory process.A thoracic ct angiogram was performed to evaluate complaints of dyspnea and rule out pulmonary embolism; results were normal.After several days of hospitalization, the patient was discharged with analgesics and appropriate follow-up.However, she returned shortly thereafter due to persistent, disabling pain involving the perineal region, right inguinal fold, and right thigh.Repeat clinical and gynecological examinations remained unremarkable.Given the severity and daily impact of her symptoms, multiple emergency visits, and the patient's request, a surgical revision was performed on (b)(6) 2023, consisting of complete removal of the right arm of the sling.Although there was initial improvement, the pain recurred and was described as stabbing and throbbing in nature, consistent with neuropathic pain affecting the right inguinal fold and thigh.Further evaluation of pelvic mri was recommended to assess for possible endometriosis or deep collections, along with physical therapy and multidisciplinary pain management consultation.Despite these interventions, her symptoms persisted.By (b)(6)2024, she reported significant improvement on the right side but noted the onset of similar disabling pain on the left side, involving the left inguinal fold and thigh.After discussion, she expressed a desire for removal of the remaining left arm of the sling and is now seeking further evaluation and opinion regarding this management option.On (b)(6) 2024, the patient presented for follow-up evaluation of persistent and disabling neuropathic pain following prior placement of a transobturator (tot) sling for urinary incontinence.She has demonstrated intolerance to several treatments, including gabapentin, which was discontinued.She is currently managed on laroxyl 20 drops in the evening and lorazepam 2 mg.While laroxyl has provided partial pain relief and is well tolerated, she continues to experience sleep disturbances and notable psychological impact, including declining mood.She has recently been evaluated by a pain clinic psychologist.The patient is awaiting a scheduled consultation on (b)(6) 2024, for consideration of sling removal.In the interim, it was recommended to increase laroxyl up to 50 mg in the evening in tablet form, and zopiclone was introduced on an as-needed basis for insomnia.The option of lidocaine infusions in a day hospital setting was also discussed in the event of inadequate response or intolerance to current therapy; however, the patient prefers to defer this intervention at this time.On (b)(6) 2024, the patient presented for pain consultation in the context of stress urinary incontinence (sui) refractory to perineal rehabilitation.In (b)(6)2023, a vaginal section of the tot was performed without improvement in symptoms.Follow-up resulted in trials of gabapentin, amitriptyline (laroxyl), solifenacin (vesicare), and bromazepam; only pregabalin (lyrica) provided partial pain relief.The pain remains localized primarily to the right thigh root and significantly limits ambulation.Moderate sui persists, requiring one to two pads per day, and the patient reports cessation of sexual activity.Symptom assessment demonstrated significant severity, with usp scores of 9/9 for stress urinary incontinence, 15/21 for overactive bladder symptoms, and 2/9 for dysuria, along with an iciq score of 10/21 and a maximal quality-of-life impact score of 10/10.Translabial ultrasound showed minimal urethral mobility with an angle of 1 degree.Cystoscopic evaluation revealed a patent urethra without evidence of urethral or bladder erosion, normal ureteral orifices, and intact bladder mucosa, while vaginoscopy demonstrated no evidence of prosthetic exposure.Gynecologic examination was limited due to severe pain, preventing speculum insertion.Uroflowmetry demonstrated a small bell-shaped curve with a voided volume of 300 ml, a maximum flow rate (qmax) of 18 ml/s, and no post-void residual.Overall, these findings are consistent with a pelvic pain syndrome, most likely secondary to the transobturator sling.Complete sling removal via laparoscopy and bilateral inguinal approach is recommended and scheduled for (b)(6) 2024.The potential for concurrent or subsequent placement of an autologous pubovaginal sling or bulkamid was discussed, along with associated risks.The patient demonstrated clear understanding of the proposed procedure and associated risks.On (b)(6) 2024, the patient presented for thrombosis monitoring in the context of a history significant for multiple thrombotic events.Anticoagulant therapy had been discontinued, and there was no evidence of pelvic compression syndrome.She is planned to undergo a pubovaginal aponeurotic sling procedure.Doppler ultrasound evaluation of the venous system demonstrated normal findings, with complete patency and compressibility of the inferior vena cava, as well as the common iliac, femoral, popliteal, and lower leg veins.There was no evidence of deep, superficial, or muscular venous thrombosis, nor any post-thrombotic sequelae.Venous flow was normal, with no reflux observed, and the primitive iliac veins were well visualized without abnormalities.Overall, the examination was entirely reassuring, showing no current thrombosis or residual thrombotic changes.Given the patient's history of recurrent thrombosis in association with pelvic surgical procedures, prophylactic measures to prevent thromboembolic events in the upcoming postoperative period are strongly recommended.On (b)(6) 2024, the patient underwent a cardiological evaluation as part of her preoperative assessment for planned urological surgery.Her current medications included lormetazepam 2 mg nightly and decapeptyl 11.5 mg injections administered every three months, with the most recent dose given in early (b)(6)2024.Clinically, she described intermittent left-sided chest pain occurring mostly at rest in the evening, characterized as stabbing in nature, lasting approximately one hour, and resolving spontaneously without treatment.She also reported persistent dyspnea since (b)(6)2023 following a prior urologic procedure, along with occasional palpitations.Electrocardiogram demonstrated a regular sinus rhythm with a normal pr interval and narrow qrs complex with normal axis.There was an incomplete right bundle branch block with t-wave inversions in leads v1 and v2, and a corrected qt interval (qtc).Overall, no acute cardiac abnormalities were identified.Echocardiography also demonstrated a normal-sized left ventricle with preserved systolic function and normal wall motion.Ventricular relaxation was good, with low left filling pressures.The left atrium was normal in size.The aortic valve was tricuspid with no stenosis or significant regurgitation.Mild mitral regurgitation was noted without stenosis.Right heart cavities were normal, with preserved right ventricular function and no indirect signs of pulmonary hypertension.The pericardium appeared normal.Laboratory results from (b)(6) 2024, were within normal limits.In summary, there are no cardiac contraindications for surgery.The ecg showed sinus rhythm with an incomplete right bundle branch block.A holter ecg was proposed to further evaluate palpitations.The patient will continue her current medications, and the referring physician may consider iron supplementation given the ferritin level.On (b)(6) 2024, the patient was admitted for evaluation of chest pain and dyspnea, describing left-sided chest discomfort radiating to the left lateral neck, characterized as a "stretching" sensation in the context of stress and concern about her health.Clinical examination was overall normal.Cardiovascular assessment revealed atypical, non-anginal chest pain with no signs of heart failure or phlebitis; heart sounds were regular, and ecg obtained during symptoms showed sinus rhythm at 101 bpm with an incomplete right bundle branch block.Pulmonary examination was unremarkable, with no cough or dyspnea and normal, symmetrical breath sounds.Abdominal examination showed a soft, non-tender but mildly bloated abdomen without signs of peritoneal irritation.Neurological evaluation was normal, with a glasgow coma scale score of 15 and no focal deficits.Laboratory evaluation, including cardiac enzymes (cpk, troponin) and d-dimer, was within normal limits.Repeat ecg prior to discharge demonstrated sinus rhythm at 58 bpm with no dynamic changes.The patient's symptoms resolved spontaneously following reassurance after the initial normal ecg.Overall, the presentation was consistent with atypical chest pain, with normal electrocardiographic and laboratory findings.Cardiac monitoring and blood gas analysis were performed, and no acute pathology was identified.On (b)(6) 2024, the patient underwent mesh revision with removal of the remaining transobturator tape and creation of an autologous fascial sling.During the procedure, a strip of fascia lata measuring approximately 10x1.5 cm was harvested from the right lateral thigh through a 6 cm incision, with careful hemostasis and layered closure of the aponeurosis, subcutaneous tissue, and skin.The left arm of the transobturator tape was identified at the level of the obturator foramen, transected at the endopelvic fascia, and meticulously dissected free along its transobturator course.A separate approximately 5 cm incision at the root of the left thigh allowed access through the fascia and aponeurosis, with dissection between the gracilis and adductor brevis muscles to reach the obturator membrane.The left arm of the sling was then fully identified and removed in continuity under direct visualization, with both dissection planes connected, yielding a specimen measuring approximately 7 cm.Attention was then directed to the right side through a similar incision at the root of the thigh; however, the right arm of the transobturator tape could not be identified and was not palpable on vaginal examination.A robotic approach was utilized to carefully retract the endopelvic fascia and separate the fibers of the obturator musculature while preserving the branches of the obturator nerve and vessels.Dissection revealed a fibrotic sheath consistent with the prior course of the tape, from which three small polypropylene fiber fragments were identified and removed.No intact right obturator arm was found, a finding later confirmed with laparoscopic ultrasound, which demonstrated no residual mesh within the obturator foramen.A suburethral tunnel was then created at the level of the mid-urethra, followed by a small vaginal incision that was subsequently closed with a running v-loc suture.A suprapubic incision of approximately 3 cm was made to access the rectus abdominis fascia, and the previously harvested fascia lata graft was introduced.The autologous sling was secured bilaterally at the bladder neck using four vicryl 4-0 sutures to ensure appropriate positioning and distribution.Suspension was achieved by placing pds 2-0 sutures through the suprapubic incision using a reverdun needle, anchoring the four corners of the sling and tying them in pairs with minimal tension approximately 4 cm above the rectus fascia.The retropubic space was then closed with a running v-loc suture, and pneumoperitoneum was released.All trocars were removed under direct visualization.Closure was performed in layers, including reapproximation of the gracilis aponeuroses at the thigh incisions, closure of the suprapubic subcutaneous tissue with polysorb sutures, and skin closure with running monocryl sutures.The trocar sites were similarly closed, with fascial closure at the 12 mm ports and skin closure using monocryl.On (b)(6) 2024, the patient presented for evaluation following recent surgical intervention and was noted to have significantly limited mobility.Given her condition, she requires special assistance to facilitate safe return transport to lille.It was certified that she is only able to move minimally and requires accompaniment as well as the use of a wheelchair for transport.On (b)(6) 2024, the patient underwent vaginal sectioning of the aponeurotic sling.During the procedure, a 4 cm inverted u-shaped vaginal incision with the apex positioned at the mid-urethra was created.Careful dissection of the ventral and lateral aspects of the urethra was performed, allowing access to the retropubic aponeurotic sling.The left lateral aspect of the urethra was approached, and a dissector was successfully passed around the sling, which was then transected.Methylene blue was injected via the urethra to confirm the integrity of the urethral wall, with no evidence of injury.The incision was subsequently closed in standard fashion.On (b)(6) 2024, the patient was evaluated for pain management due to persistent neuropathic pelvic pain following prior placement of transobturator suburethral slings in (b)(6)2023 and subsequent surgical interventions, including robotic-assisted removal and replacement with a fascial sling, as well as a recent vaginal procedure for sling removal due to severe dysuria.She reports intense neuropathic pain characterized by burning sensations and constant shooting pain, contributing to reactive depression and sleep disturbances.Physical examination revealed dysesthesia along the surgical sites, particularly in the right thigh and suprapubic region.Her current medications include laroxyl and acupan; she had previously trialed gabapentin but was unable to tolerate it.Laroxyl was resumed and increased to 50 mg for improved symptom control.Plans were made for hospital admission for lidocaine infusions to address refractory neuropathic pain, with close follow-up scheduled during the week.Additionally, referral to a psychologist was arranged to support the psychological impact of her chronic pain.On (b)(6) 2024, it was documented that the patient had been hospitalized from (b)(6) 2024, for scheduled evaluation and management of dysuria related to a previously placed aponeurotic fascia lata sling.Her history included prior removal of residual transobturator tape on (b)(6) 2024, during which the right arm was not identified, having reportedly been removed previously, and a fascia lata graft was placed.She subsequently developed dysuria at the graft site with concern for possible infection, prompting admission for further management and discussion of treatment options, including self-catheterization versus surgical intervention.During hospitalization, dysuria was confirmed, and she underwent vaginal resection of the aponeurotic sling on (b)(6) 2024.Postoperatively, she continued to experience difficulty with urination, particularly when seated, without significant improvement in symptoms, and declined self-catheterization training.The remainder of her hospital course was uneventful, and she was discharged home on (b)(6) 2024, with plans for follow-up in one month.The total length of stay was eight days, without requirement for intensive or continuous care.In summary, the patient was hospitalized in the urology department from (b)(6) 2024, for dysuria and suspected urinary tract infection following placement of a fascia lata sling.After confirmation of dysuria, she underwent vaginal removal of the aponeurotic sling on (b)(6) 2024.The postoperative course was notable for persistent difficulty with urination, particularly in the seated position, without significant improvement in symptoms, and the patient declined instruction in self-catheterization.She was discharged home with a medication regimen including laroxyl drops with gradual dose escalation, colpotrophin pessaries twice weekly for one month, paracetamol for pain control, orozamudol for breakthrough pain, and spasfon for symptomatic relief.Follow-up was arranged for a postoperative consultation in (b)(6).On (b)(6) 2024, the patient was seen in follow-up for persistent neuropathic pelvic pain following placement of a transobturator suburethral sling, wherein it was subsequently removed.She is scheduled for further follow-up in (b)(6)2025.The patient reports severe neuropathic symptoms, including pelvic cramping and shooting pains, marked hyperesthesia with dysesthesia on contact with the surgical scar on the right thigh, and a reactive depressive state associated with sleep disturbances.Several therapeutic trials have been undertaken; antiepileptic treatment was discontinued due to intolerable nausea.She is currently treated with amitriptyline (laroxyl) 50 mg.Lidocaine infusions administered in october provided a significant clinical benefit, allowing partial resumption of daily activities and improved sleep quality, although nightmares persist.She is also receiving psychological support at the pain clinic.The current management plan includes repeat lidocaine infusions and application of a qutenza patch to the right thigh surgical scar, in addition to continuing laroxyl and initiating duloxetine (doxelene) at 30 mg daily, with escalation to 60 mg in the morning.The patient is scheduled to return to the hospital the following day for qutenza application, with close clinical follow-up planned.On (b)(6) 2025, the patient received outpatient treatment with a qutenza (capsaicin) patch for management of severe neuropathic pain, characterized by pelvic cramping and shooting pains, marked hyperesthesia with dysesthesia over the surgical scar on the right thigh, and an associated reactive depressive state with sleep disturbance.The treatment was associated with local side effects, including cutaneous redness and pruritus, with analgesic benefit expected to develop within approximately one week.On (b)(6) 2025, the patient underwent a course of ketamine infusions for chronic pain management, receiving 25 mg on the first day followed by 50 mg on subsequent days.Pain severity, assessed using the evs scale, remained at 4/4 both at the initiation and completion of treatment.Consideration was given to repeating this therapeutic regimen within three to six months, depending on clinical response.On (b)(6) 2025, the patient received a qutenza patch as an outpatient for neuropathic pain following urinary sling placement.She experienced mild side effects, including localized redness and itching, with analgesic effects expected to appear within one week.On (b)(6) 2025, she presented for consultation due to severe postoperative neuropathic pain affecting the perineal and left thigh regions.The patient has a complex gynecological history, including multiple urethral sling procedures complicated by persistent neuropathic pain requiring removal, some performed via robotic-assisted surgery.The neuropathic pain has had a significant psychological impact; she is being followed by a psychologist, and psychiatric evaluation has been encouraged.Therapeutically, her current regimen includes outpatient ketamine and lidocaine infusions, qutenza patches, and oral medications: laroxyl, duloxetine, pregabalin, and evening lorazepam.Pain management and close psychological support remain ongoing.The patient continues to experience significant neuropathic pain, primarily localized around the scar on her right upper thigh, extending both above and below the pubic region.Additional pain includes clitorodynia, coccygodynia, and bilateral inner thigh involvement, with the most severe symptoms on the anterolateral aspect of the right thigh corresponding to the surgical scar.For management, i recommend initiating a diagnostic and therapeutic test block at the obturator nerve to address her obturator-related pain.Additionally, a botulinum toxin injection will be administered to the patient's allodynic area on (b)(6) 2025.A follow-up consultation will be scheduled thereafter to evaluate the effectiveness of these interventions and determine further management strategies, including the consideration of a botulinum toxin injection at the ganglion impar to target persistent perineal pain.On (b)(6) 2025, the patient was hospitalized in the medical department for management of a chronic pain syndrome.She has a long-standing history of neuropathic perineal pain evolving over several years.The patient lives with her partner and is the mother of three children.She is no longer employed, having previously worked as a childminder, and is currently recognized as having a disability.Physical examination revealed an alert, coherent, and fully oriented, with stable hemodynamic parameters and no fever.Cardiovascular examination revealed regular heart sounds without murmurs or tachycardia, palpable and symmetrical peripheral pulses, no chest pain, and no signs of right or left-sided heart failure.Respiratory assessment showed bilateral, symmetrical vesicular breath sounds without adventitious sounds, and there were no symptoms of cough, dyspnea, sputum production, or respiratory distress.Abdominal examination revealed a soft, non-tender, and compressible abdomen without guarding or rigidity, and the patient reported no gastrointestinal symptoms or bowel habit abnormalities.From a gynecological and urinary standpoint, the patient reported chronic pelvic pain radiating to the lower limbs and sacrum, performs intermittent self-catheterization at home, and experiences occasional stress urinary incontinence.Neurological examination was normal, with a glasgow coma scale score of 15, no focal deficits, intact cranial nerves, and no signs of intracranial hypertension, meningeal irritation, or cerebellar involvement; neuropathic pain affecting the proximal thighs was noted, predominantly on the right side.During hospitalization, pain management was continued, with maintenance of her usual treatment regimen and the addition of oxazepam (seresta) 50 mg in the evening and fentanyl as needed.On (b)(6) 2025, the patient was also evaluated and a perineural toxin injection as soon as possible to address her neuropathic pain was recommended, primarily involving the obturator nerve and potentially the pudendal nerve.She has had multiple pain management consultations.Upon admission, the patient reported left calf pain following a venous pathway; given her personal history of thrombosis, a bilateral lower-limb venous doppler ultrasound was performed, which showed no evidence of thrombosis.From a respiratory standpoint, symptoms suggestive of sleep-disordered breathing were reported, including snoring, nocturnal breathing pauses observed by her partner, non-restorative sleep, and morning headaches, prompting a request for polysomnography.The patient was hospitalized for monitoring and adjustment of treatment for chronic neuropathic pain.At discharge, her treatment regimen included triptorelin (decapeptyl) 11.5 mg every three months, amitriptyline (laroxyl) 50 mg morning and evening, duloxetine 90 mg in the morning, lorazepam 2 mg in the evening, oxazepam (seresta) 10 mg as needed up to three times daily and 50 mg at bedtime, pregabalin (lyrica) 150 mg twice daily, transdermal fentanyl 25 mg every 72 hours, transmucosal fentanyl (abstral) 100 mg every 4-6 hours as needed for severe pain, and lidocaine patches.A polysomnography study is scheduled for (b)(6) 2025.The patient was also evaluated for significant traumatic and post-traumatic psychological distress related to her surgical experience.She reports marked withdrawal, recurrent intrusive recollections and nightmares both before and after the procedures, with associated loss of self-esteem, disruption in her relationship with herself and others, and a pervasive sense of disorientation.She describes psychological dissociation following the second procedure, expressing the feeling of having lost her former identity.It was recommended that treatment with alprazolam (alprax) be initiated at a dose of 2.5 mg in the evening, with a planned increase to 5 mg in the evening once the scheduled ct imaging has been completed.A follow-up consultation is planned upon the patient's return.The patient was placed on continuous medical sick leave beginning on (b)(6) 2024, with an initial certification extending through (b)(6) 2024.This leave was subsequently renewed on a regular basis, without interruption, through multiple extensions issued.Each certification specified that the leave was unrelated to pregnancy, a work-related accident, or an occupational illness, and consistently authorized unrestricted leave.Over time, the patient's employment status transitioned to unemployed as noted in later certificates.The successive extensions ultimately prolonged the sick leave through (b)(6) 2025, resulting in an uninterrupted period of medically prescribed work stoppage lasting more than fourteen months.As of (b)(6) 2025, the patient has been recognized as having a long-term illness with associated disability and has initiated legal action to seek compensation.She reports severe and multifaceted harm, including sexual impairment marked by the complete cessation of sexual relations due to intense pain, bleeding, functional limitation, and significant distress related to bodily changes such as scarring and weight gain.Psychological harm is substantial, with severe emotional distress manifested by suicidal ideation, panic attacks, nightmares, social withdrawal, marked body image insecurity, and multiple hospitalizations for pain management and psychological care, including fear of leaving home and perceived social judgment.She also describes significant financial and professional impact, having been forced to abandon a 15-year career working with children and retrain as a caregiver, while currently experiencing major mobility limitations requiring use of a wheelchair.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's initials will not be documented.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6)2023, 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 implanting physician is: (b)(6) block h6: the following imdrf patient code capture the reportable event of: e2401 - unspecified personal injury e0514 - thrombosis e2330 - pain e0717 - dyspnea e1906 - infection e0123 - neuralgia e0505 - hematoma e050601 - ecchymosis e233001 - chest pain e2006 - erosion the following imdrf impact code capture the reportable event of: f12 - patient had sought for a legal recourse for unknown injuries related to the device.F08 - hospitalization f1903 - mesh excision.
Additional Manufacturer Narrative
Block h11: correction to block h6 (patient code).Continuation of block b5: on (b)(6), 2024, the patient presented for evaluation following prior surgical management of stress urinary incontinence.She had undergone placement of a suburethral transobturator tape on (b)(6), 2023, which was performed without intraoperative complications and followed by an initially uncomplicated postoperative course with discharge within the expected timeframe.Approximately one week later, she presented to the emergency department with pain localized along the right-sided sling pathway, involving the inguinal fold and right thigh, as well as malodorous vaginal discharge.Gynecologic examination was largely unremarkable aside from tenderness on palpation in the affected areas.She was treated with antibiotics and analgesics; however, her course was notable for persistent and debilitating perineal pain, prompting hospitalization and further evaluation.Doppler ultrasound of the right lower extremity identified a superficial thrombosis, for which anticoagulation therapy was initiated, resulting in subsequent vascular improvement.Additional investigations, including a pelvic ct scan, showed no evidence of deep fluid collection or infection, and laboratory studies were within normal limits without evidence of an inflammatory process.A thoracic ct angiogram was performed to evaluate complaints of dyspnea and rule out pulmonary embolism; results were normal.After several days of hospitalization, the patient was discharged with analgesics and appropriate follow-up.However, she returned shortly thereafter due to persistent, disabling pain involving the perineal region, right inguinal fold, and right thigh.Repeat clinical and gynecological examinations remained unremarkable.Given the severity and daily impact of her symptoms, multiple emergency visits, and the patient's request, a surgical revision was performed on (b)(6), 2023, consisting of complete removal of the right arm of the sling.Although there was initial improvement, the pain recurred and was described as stabbing and throbbing in nature, consistent with neuropathic pain affecting the right inguinal fold and thigh.Further evaluation of pelvic mri was recommended to assess for possible endometriosis or deep collections, along with physical therapy and multidisciplinary pain management consultation.Despite these interventions, her symptoms persisted.By january 2024, she reported significant improvement on the right side but noted the onset of similar disabling pain on the left side, involving the left inguinal fold and thigh.After discussion, she expressed a desire for removal of the remaining left arm of the sling and is now seeking further evaluation and opinion regarding this management option.On (b)(6), 2024, the patient presented for follow-up evaluation of persistent and disabling neuropathic pain following prior placement of a transobturator (tot) sling for urinary incontinence.She has demonstrated intolerance to several treatments, including gabapentin, which was discontinued.She is currently managed on laroxyl 20 drops in the evening and lorazepam 2 mg.While laroxyl has provided partial pain relief and is well tolerated, she continues to experience sleep disturbances and notable psychological impact, including declining mood.She has recently been evaluated by a pain clinic psychologist.The patient is awaiting a scheduled consultation on(b)(6) 2024, for consideration of sling removal.In the interim, it was recommended to increase laroxyl up to 50 mg in the evening in tablet form, and zopiclone was introduced on an as-needed basis for insomnia.The option of lidocaine infusions in a day hospital setting was also discussed in the event of inadequate response or intolerance to current therapy; however, the patient prefers to defer this intervention at this time.On (b)(6) 2024, the patient presented for pain consultation in the context of stress urinary incontinence (sui) refractory to perineal rehabilitation.In september 2023, a vaginal section of the tot was performed without improvement in symptoms.Follow-up resulted in trials of gabapentin, amitriptyline (laroxyl), solifenacin (vesicare), and bromazepam; only pregabalin (lyrica) provided partial pain relief.The pain remains localized primarily to the right thigh root and significantly limits ambulation.Moderate sui persists, requiring one to two pads per day, and the patient reports cessation of sexual activity.Symptom assessment demonstrated significant severity, with usp scores of 9/9 for stress urinary incontinence, 15/21 for overactive bladder symptoms, and 2/9 for dysuria, along with an iciq score of 10/21 and a maximal quality-of-life impact score of 10/10.Translabial ultrasound showed minimal urethral mobility with an angle of 1 degree.Cystoscopic evaluation revealed a patent urethra without evidence of urethral or bladder erosion, normal ureteral orifices, and intact bladder mucosa, while vaginoscopy demonstrated no evidence of prosthetic exposure.Gynecologic examination was limited due to severe pain, preventing speculum insertion.Uroflowmetry demonstrated a small bell-shaped curve with a voided volume of 300 ml, a maximum flow rate (qmax) of 18 ml/s, and no post-void residual.Overall, these findings are consistent with a pelvic pain syndrome, most likely secondary to the transobturator sling.Complete sling removal via laparoscopy and bilateral inguinal approach is recommended and scheduled for(b)(6), 2024.The potential for concurrent or subsequent placement of an autologous pubovaginal sling or bulkamid was discussed, along with associated risks.The patient demonstrated clear understanding of the proposed procedure and associated risks.On july 3, 2024, the patient presented for thrombosis monitoring in the context of a history significant for multiple thrombotic events.Anticoagulant therapy had been discontinued, and there was no evidence of pelvic compression syndrome.She is planned to undergo a pubovaginal aponeurotic sling procedure.Doppler ultrasound evaluation of the venous system demonstrated normal findings, with complete patency and compressibility of the inferior vena cava, as well as the common iliac, femoral, popliteal, and lower leg veins.There was no evidence of deep, superficial, or muscular venous thrombosis, nor any post-thrombotic sequelae.Venous flow was normal, with no reflux observed, and the primitive iliac veins were well visualized without abnormalities.Overall, the examination was entirely reassuring, showing no current thrombosis or residual thrombotic changes.Given the patient's history of recurrent thrombosis in association with pelvic surgical procedures, prophylactic measures to prevent thromboembolic events in the upcoming postoperative period are strongly recommended.On july 8, 2024, the patient underwent a cardiological evaluation as part of her preoperative assessment for planned urological surgery.Her current medications included lormetazepam 2 mg nightly and decapeptyl 11.5 mg injections administered every three months, with the most recent dose given in early july 2024.Clinically, she described intermittent left-sided chest pain occurring mostly at rest in the evening, characterized as stabbing in nature, lasting approximately one hour, and resolving spontaneously without treatment.She also reported persistent dyspnea since september 2023 following a prior urologic procedure, along with occasional palpitations.Electrocardiogram demonstrated a regular sinus rhythm with a normal pr interval and narrow qrs complex with normal axis.There was an incomplete right bundle branch block with t-wave inversions in leads v1 and v2, and a corrected qt interval (qtc).Overall, no acute cardiac abnormalities were identified.Echocardiography also demonstrated a normal-sized left ventricle with preserved systolic function and normal wall motion.Ventricular relaxation was good, with low left filling pressures.The left atrium was normal in size.The aortic valve was tricuspid with no stenosis or significant regurgitation.Mild mitral regurgitation was noted without stenosis.Right heart cavities were normal, with preserved right ventricular function and no indirect signs of pulmonary hypertension.The pericardium appeared normal.Laboratory results from may 23, 2024, were within normal limits.In summary, there are no cardiac contraindications for surgery.The ecg showed sinus rhythm with an incomplete right bundle branch block.A holter ecg was proposed to further evaluate palpitations.The patient will continue her current medications, and the referring physician may consider iron supplementation given the ferritin level.On august 2, 2024, the patient was admitted for evaluation of chest pain and dyspnea, describing left-sided chest discomfort radiating to the left lateral neck, characterized as a "stretching" sensation in the context of stress and concern about her health.Clinical examination was overall normal.Cardiovascular assessment revealed atypical, non-anginal chest pain with no signs of heart failure or phlebitis; heart sounds were regular, and ecg obtained during symptoms showed sinus rhythm at 101 bpm with an incomplete right bundle branch block.Pulmonary examination was unremarkable, with no cough or dyspnea and normal, symmetrical breath sounds.Abdominal examination showed a soft, non-tender but mildly bloated abdomen without signs of peritoneal irritation.Neurological evaluation was normal, with a glasgow coma scale score of 15 and no focal deficits.Laboratory evaluation, including cardiac enzymes (cpk, troponin) and d-dimer, was within normal limits.Repeat ecg prior to discharge demonstrated sinus rhythm at 58 bpm with no dynamic changes.The patient's symptoms resolved spontaneously following reassurance after the initial normal ecg.Overall, the presentation was consistent with atypical chest pain, with normal electrocardiographic and laboratory findings.Cardiac monitoring and blood gas analysis were performed, and no acute pathology was identified.On august 27, 2024, the patient underwent mesh revision with removal of the remaining transobturator tape and creation of an autologous fascial sling.During the procedure, a strip of fascia lata measuring approximately 10x1.5 cm was harvested from the right lateral thigh through a 6 cm incision, with careful hemostasis and layered closure of the aponeurosis, subcutaneous tissue, and skin.The left arm of the transobturator tape was identified at the level of the obturator foramen, transected at the endopelvic fascia, and meticulously dissected free along its transobturator course.A separate approximately 5 cm incision at the root of the left thigh allowed access through the fascia and aponeurosis, with dissection between the gracilis and adductor brevis muscles to reach the obturator membrane.The left arm of the sling was then fully identified and removed in continuity under direct visualization, with both dissection planes connected, yielding a specimen measuring approximately 7 cm.Attention was then directed to the right side through a similar incision at the root of the thigh; however, the right arm of the transobturator tape could not be identified and was not palpable on vaginal examination.A robotic approach was utilized to carefully retract the endopelvic fascia and separate the fibers of the obturator musculature while preserving the branches of the obturator nerve and vessels.Dissection revealed a fibrotic sheath consistent with the prior course of the tape, from which three small polypropylene fiber fragments were identified and removed.No intact right obturator arm was found, a finding later confirmed with laparoscopic ultrasound, which demonstrated no residual mesh within the obturator foramen.A suburethral tunnel was then created at the level of the mid-urethra, followed by a small vaginal incision that was subsequently closed with a running v-loc suture.A suprapubic incision of approximately 3 cm was made to access the rectus abdominis fascia, and the previously harvested fascia lata graft was introduced.The autologous sling was secured bilaterally at the bladder neck using four vicryl 4-0 sutures to ensure appropriate positioning and distribution.Suspension was achieved by placing pds 2-0 sutures through the suprapubic incision using a reverdun needle, anchoring the four corners of the sling and tying them in pairs with minimal tension approximately 4 cm above the rectus fascia.The retropubic space was then closed with a running v-loc suture, and pneumoperitoneum was released.All trocars were removed under direct visualization.Closure was performed in layers, including reapproximation of the gracilis aponeuroses at the thigh incisions, closure of the suprapubic subcutaneous tissue with polysorb sutures, and skin closure with running monocryl sutures.The trocar sites were similarly closed, with fascial closure at the 12 mm ports and skin closure using monocryl.On september 7, 2024, the patient presented for evaluation following recent surgical intervention and was noted to have significantly limited mobility.Given her condition, she requires special assistance to facilitate safe return transport to lille.It was certified that she is only able to move minimally and requires accompaniment as well as the use of a wheelchair for transport.On october 8, 2024, the patient underwent vaginal sectioning of the aponeurotic sling.During the procedure, a 4 cm inverted u-shaped vaginal incision with the apex positioned at the mid-urethra was created.Careful dissection of the ventral and lateral aspects of the urethra was performed, allowing access to the retropubic aponeurotic sling.The left lateral aspect of the urethra was approached, and a dissector was successfully passed around the sling, which was then transected.Methylene blue was injected via the urethra to confirm the integrity of the urethral wall, with no evidence of injury.The incision was subsequently closed in standard fashion.On october 17, 2024, the patient was evaluated for pain management due to persistent neuropathic pelvic pain following prior placement of transobturator suburethral slings in august 2023 and subsequent surgical interventions, including robotic-assisted removal and replacement with a fascial sling, as well as a recent vaginal procedure for sling removal due to severe dysuria.She reports intense neuropathic pain characterized by burning sensations and constant shooting pain, contributing to reactive depression and sleep disturbances.Physical examination revealed dysesthesia along the surgical sites, particularly in the right thigh and suprapubic region.Her current medications include laroxyl and acupan; she had previously trialed gabapentin but was unable to tolerate it.Laroxyl was resumed and increased to 50 mg for improved symptom control.Plans were made for hospital admission for lidocaine infusions to address refractory neuropathic pain, with close follow-up scheduled during the week.Additionally, referral to a psychologist was arranged to support the psychological impact of her chronic pain.On november 7, 2024, it was documented that the patient had been hospitalized from october 4 to october 12, 2024, for scheduled evaluation and management of dysuria related to a previously placed aponeurotic fascia lata sling.Her history included prior removal of residual transobturator tape on august 27, 2024, during which the right arm was not identified, having reportedly been removed previously, and a fascia lata graft was placed.She subsequently developed dysuria at the graft site with concern for possible infection, prompting admission for further management and discussion of treatment options, including self-catheterization versus surgical intervention.During hospitalization, dysuria was confirmed, and she underwent vaginal resection of the aponeurotic sling on october 8, 2024.Postoperatively, she continued to experience difficulty with urination, particularly when seated, without significant improvement in symptoms, and declined self-catheterization training.The remainder of her hospital course was uneventful, and she was discharged home on october 12, 2024, with plans for follow-up in one month.The total length of stay was eight days, without requirement for intensive or continuous care.In summary, the patient was hospitalized in the urology department from october 4 to october 12, 2024, for dysuria and suspected urinary tract infection following placement of a fascia lata sling.After confirmation of dysuria, she underwent vaginal removal of the aponeurotic sling on october 8, 2024.The postoperative course was notable for persistent difficulty with urination, particularly in the seated position, without significant improvement in symptoms, and the patient declined instruction in self-catheterization.She was discharged home with a medication regimen including laroxyl drops with gradual dose escalation, colpotrophin pessaries twice weekly for one month, paracetamol for pain control, orozamudol for breakthrough pain, and spasfon for symptomatic relief.Follow-up was arranged for a postoperative consultation in november.On december 2, 2024, the patient was seen in follow-up for persistent neuropathic pelvic pain following placement of a transobturator suburethral sling, wherein it was subsequently removed.She is scheduled for further follow-up in march 2025.The patient reports severe neuropathic symptoms, including pelvic cramping and shooting pains, marked hyperesthesia with dysesthesia on contact with the surgical scar on the right thigh, and a reactive depressive state associated with sleep disturbances.Several therapeutic trials have been undertaken; antiepileptic treatment was discontinued due to intolerable nausea.She is currently treated with amitriptyline (laroxyl) 50 mg.Lidocaine infusions administered in october provided a significant clinical benefit, allowing partial resumption of daily activities and improved sleep quality, although nightmares persist.She is also receiving psychological support at the pain clinic.The current management plan includes repeat lidocaine infusions and application of a qutenza patch to the right thigh surgical scar, in addition to continuing laroxyl and initiating duloxetine (doxelene) at 30 mg daily, with escalation to 60 mg in the morning.The patient is scheduled to return to the hospital the following day for qutenza application, with close clinical follow-up planned.On january 7, 2025, the patient received outpatient treatment with a qutenza (capsaicin) patch for management of severe neuropathic pain, characterized by pelvic cramping and shooting pains, marked hyperesthesia with dysesthesia over the surgical scar on the right thigh, and an associated reactive depressive state with sleep disturbance.The treatment was associated with local side effects, including cutaneous redness and pruritus, with analgesic benefit expected to develop within approximately one week.On january 17, 2025, the patient underwent a course of ketamine infusions for chronic pain management, receiving 25 mg on the first day followed by 50 mg on subsequent days.Pain severity, assessed using the evs scale, remained at 4/4 both at the initiation and completion of treatment.Consideration was given to repeating this therapeutic regimen within three to six months, depending on clinical response.On february 4, 2025, the patient received a qutenza patch as an outpatient for neuropathic pain following urinary sling placement.She experienced mild side effects, including localized redness and itching, with analgesic effects expected to appear within one week.On april 8, 2025, she presented for consultation due to severe postoperative neuropathic pain affecting the perineal and left thigh regions.The patient has a complex gynecological history, including multiple urethral sling procedures complicated by persistent neuropathic pain requiring removal, some performed via robotic-assisted surgery.The neuropathic pain has had a significant psychological impact; she is being followed by a psychologist, and psychiatric evaluation has been encouraged.Therapeutically, her current regimen includes outpatient ketamine and lidocaine infusions, qutenza patches, and oral medications: laroxyl, duloxetine, pregabalin, and evening lorazepam.Pain management and close psychological support remain ongoing.The patient continues to experience significant neuropathic pain, primarily localized around the scar on her right upper thigh, extending both above and below the pubic region.Additional pain includes clitorodynia, coccygodynia, and bilateral inner thigh involvement, with the most severe symptoms on the anterolateral aspect of the right thigh corresponding to the surgical scar.For management, i recommend initiating a diagnostic and therapeutic test block at the obturator nerve to address her obturator-related pain.Additionally, a botulinum toxin injection will be administered to the patient's allodynic area on may 19, 2025.A follow-up consultation will be scheduled thereafter to evaluate the effectiveness of these interventions and determine further management strategies, including the consideration of a botulinum toxin injection at the ganglion impar to target persistent perineal pain.On august 7, 2025, the patient was hospitalized in the medical department for management of a chronic pain syndrome.She has a long-standing history of neuropathic perineal pain evolving over several years.The patient lives with her partner and is the mother of three children.She is no longer employed, having previously worked as a childminder, and is currently recognized as having a disability.Physical examination revealed an alert, coherent, and fully oriented, with stable hemodynamic parameters and no fever.Cardiovascular examination revealed regular heart sounds without murmurs or tachycardia, palpable and symmetrical peripheral pulses, no chest pain, and no signs of right or left-sided heart failure.Respiratory assessment showed bilateral, symmetrical vesicular breath sounds without adventitious sounds, and there were no symptoms of cough, dyspnea, sputum production, or respiratory distress.Abdominal examination revealed a soft, non-tender, and compressible abdomen without guarding or rigidity, and the patient reported no gastrointestinal symptoms or bowel habit abnormalities.From a gynecological and urinary standpoint, the patient reported chronic pelvic pain radiating to the lower limbs and sacrum, performs intermittent self-catheterization at home, and experiences occasional stress urinary incontinence.Neurological examination was normal, with a glasgow coma scale score of 15, no focal deficits, intact cranial nerves, and no signs of intracranial hypertension, meningeal irritation, or cerebellar involvement; neuropathic pain affecting the proximal thighs was noted, predominantly on the right side.During hospitalization, pain management was continued, with maintenance of her usual treatment regimen and the addition of oxazepam (seresta) 50 mg in the evening and fentanyl as needed.On august 5, 2025, the patient was also evaluated and a perineural toxin injection as soon as possible to address her neuropathic pain was recommended, primarily involving the obturator nerve and potentially the pudendal nerve.She has had multiple pain management consultations.Upon admission, the patient reported left calf pain following a venous pathway; given her personal history of thrombosis, a bilateral lower-limb venous doppler ultrasound was performed, which showed no evidence of thrombosis.From a respiratory standpoint, symptoms suggestive of sleep-disordered breathing were reported, including snoring, nocturnal breathing pauses observed by her partner, non-restorative sleep, and morning headaches, prompting a request for polysomnography.The patient was hospitalized for monitoring and adjustment of treatment for chronic neuropathic pain.At discharge, her treatment regimen included triptorelin (decapeptyl) 11.5 mg every three months, amitriptyline (laroxyl) 50 mg morning and evening, duloxetine 90 mg in the morning, lorazepam 2 mg in the evening, oxazepam (seresta) 10 mg as needed up to three times daily and 50 mg at bedtime, pregabalin (lyrica) 150 mg twice daily, transdermal fentanyl 25 mg every 72 hours, transmucosal fentanyl (abstral) 100 mg every 4-6 hours as needed for severe pain, and lidocaine patches.A polysomnography study is scheduled for october 14, 2025.The patient was also evaluated for significant traumatic and post-traumatic psychological distress related to her surgical experience.She reports marked withdrawal, recurrent intrusive recollections and nightmares both before and after the procedures, with associated loss of self-esteem, disruption in her relationship with herself and others, and a pervasive sense of disorientation.She describes psychological dissociation following the second procedure, expressing the feeling of having lost her former identity.It was recommended that treatment with alprazolam (alprax) be initiated at a dose of 2.5 mg in the evening, with a planned increase to 5 mg in the evening once the scheduled ct imaging has been completed.A follow-up consultation is planned upon the patient's return.The patient was placed on continuous medical sick leave beginning on january 31, 2024, with an initial certification extending through march 1, 2024.This leave was subsequently renewed on a regular basis, without interruption, through multiple extensions issued.Each certification specified that the leave was unrelated to pregnancy, a work-related accident, or an occupational illness, and consistently authorized unrestricted leave.Over time, the patient's employment status transitioned to unemployed as noted in later certificates.The successive extensions ultimately prolonged the sick leave through april 10, 2025, resulting in an uninterrupted period of medically prescribed work stoppage lasting more than fourteen months.As of march 5, 2025, the patient has been recognized as having a long-term illness with associated disability and has initiated legal action to seek compensation.She reports severe and multifaceted harm, including sexual impairment marked by the complete cessation of sexual relations due to intense pain, bleeding, functional limitation, and significant distress related to bodily changes such as scarring and weight gain.Psychological harm is substantial, with severe emotional distress manifested by suicidal ideation, panic attacks, nightmares, social withdrawal, marked body image insecurity, and multiple hospitalizations for pain management and psychological care, including fear of leaving home and perceived social judgment.She also describes significant financial and professional impact, having been forced to abandon a 15-year career working with children and retrain as a caregiver, while currently experiencing major mobility limitations requiring use of a wheelchair.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's initials will not be documented.Block b3 date of event: the exact event onset date is unknown.The provided event date of august 24, 2023, 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 implanting physician is: dr.Majid mbarek 16 rue du saint-sepulcre saint-omer, pas-de-calais france, 62500 block h6: the following imdrf patient code capture the reportable event of: e2401 - unspecified personal injury e0514 - thrombosis e2330 - pain e0717 - dyspnea e1906 - infection e0123 - neuralgia e0505 - hematoma e050601 - ecchymosis e233001 - chest pain e2006 - erosion the following imdrf impact code capture the reportable event of: f12 - patient had sought for a legal recourse for unknown injuries related to the device.F08 - hospitalization f1903 - mesh excision.

• Brand Name: OBTRYX SYSTEM - HALO
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23996634
• Report Number: 2124215-2026-01105
• Device Sequence Number: 10523803
• Product Code: OTN
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2026
• Device Model Number: M0068505000
• Device Catalogue Number: M0068505000
• Device Lot Number: 0031357272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 03/12/2026; 04/20/2026; 05/22/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 04/10/2026; 05/20/2026; 06/18/2026
• Date Device Manufactured: 04/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability; Other
• Patient Sex: Unknown