|
BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
|
Back to Search Results |
|
| Model Number M0068502110 |
| Device Problem
Material Integrity Problem (2978)
|
| Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Fatigue (1849); Fistula (1862); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Depression (2361); Obstruction/Occlusion (2422); Prolapse (2475); Dysuria (2684); Fibrosis (3167); Dyspareunia (4505); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
| Event Date 04/03/2017 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Date of event: the exact event onset date is unknown.The provided event date of april 3, 2017 was chosen as a best estimate based on the date of first revision surgery.The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Initial reporter name: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(4).
|
| |
|
Event Description
|
|
Note: this manufacturer report pertains to the first of two devices used during different procedures.It was reported to boston scientific corporation that an advantage fit sling device and non-bsc device (coloplast restorelle xl 30x30cm) were implanted into the patient during a procedure performed on (b)(6) 2016, for the treatment of stress urinary incontinence and pelvic organ prolapse.As reported by the patient's attorney, the patient returned to the operating room for a revision surgery on (b)(6) 2017.During the procedure, salpingo-oopherectomy was performed and then addressed the advantage fit sling.According to the operative note, the prior advantage fit sling implanted was identified and "freed and mobilized away from the vagina and also away from the overlying urethra." thereafter, a second advantage fit sling was implanted.The second advantage fit sling was placed with increased tension and was lying slightly proximal to the previously placed sling.The subsequent erosion, pain, mesh removal procedures and surgeries were caused by the products implanted.Patient continues to suffer from mesh related complications and pain to the present day.On (b)(6) 2018, the patient returned to the operation room for a second revision.During this procedure, a non-bsc device (coloplast direct fix mesh) was implanted transvaginally to correct anterior prolapse.The patient returned to the operation room for a third revision on (b)(6) 2018.Prior to procedure, she was experiencing incomplete bladder emptying.During this procedure, one of the prior boston scientific advantage fit slings was removed from sulci to sulci.According to the operative note, "the sling was fully mobilized laterally and then transected and then freed from the overlying urethra and then excised lateral to the sulci bilaterally." this does not mean that the entire sling was removed, but only a small portion that existed under the urethra.On (b)(6) 2019, the patient returned to the operating room for a fourth revision.Preoperative diagnosis for this surgery was "dyspareunia and nonspecific lower pelvic pain following prior vaginal mesh repair." this diagnosis was confirmed during the procedure.A revision of the anterior vaginal mesh and subsequent anterior repair with cervicopexy were performed for the removal of coloplast direct fix mesh device using a dissection that extended laterally to expose the path of the mesh towards the sacrospinous ligaments.On (b)(6) 2020, the patient returned to the operating room for a fifth revision to remove additional portions of the coloplast mesh.Preoperatively, patient was diagnosed with dyspareunia, sexual pain, and vaginal scarification.As a result of being implanted with the products, patient has experienced degradation of the polypropylene mesh and the pelvic tissue, chronic inflammation of the pelvic tissue, mesh shrinkage or mesh contraction of the mesh causing chronic pain, mesh deformation causing chronic pain, nerve entrapment, chronic inflammation, chronic infectious response, chronic pain, pain while sitting, painful sexual relations, significant urinary dysfunction, vaginal shortening, vaginal and rectal anatomic deformation, and a severe adverse reactions to the mesh.The products implanted have caused life-altering and permanent injuries, severe emotional pain and injury.Patient has suffered and will suffer apprehension of increased risk for injuries, infections, pain, mental anguish, infection, bodily disfigurement, and multiple corrective procedures/surgeries as a result of implantation of mesh.She continues to suffer from mesh related complications and pain to this day that and, in a reasonable degree of medical probability, will continue for the remainder of her life.She will need additional corrective procedures and surgeries due to injuries associated to the vaginal mesh products implanted.Patient has suffered serious and permanent bodily injuries including: pain and suffering.Loss of capacity of the enjoyment of life.Pelvic and vaginal pain.Complex extrusion and erosion of the mesh.Chronic inflammation.Swollen inflamed tissue in vagina.Mesh adhesion in vagina and surrounding tissue.Tissue damage.Death of her vaginal wall tissue and nerves.Failure of the mesh to treat her underlying conditions.New onset urinary and pelvic complications.Mesh deformation including coiling, contracting, pore collapse, and curling of the mesh inside the vagina, mesh hardening and stiffening, vaginal deformation.Surgical intervention for her pain.Future medical care and treatment.The injuries, conditions, and complications suffered by the patient, as a result of being implanted with the products include, but are not limited to, erosion, mesh contraction, mesh deformation infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia (pain during sexual intercourse), blood loss, neuropathic and other acute and chronic nerve damage and pain, pelvic floor damage, chronic pelvic pain, multiple mesh revision surgeries, emotional distress and mental anguish, and other debilitating complications, including those listed above.
|
| |
|
Manufacturer Narrative
|
|
Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2017 was chosen as a best estimate based on the date of first revision surgery.Block e1: this event was reported by the patient's legal representation.Implant surgeon (for both devices) is dr.(b)(6).Facility: (b)(6).(b)(6).Phone: (b)(6).Block h6: patient codes e2006, e2330, e1309, e2101, e211401, e1715, e2015, e1405, e2314, e2401, e1906, e2326, e0126, e0123, e1310, e1002 capture the reportable events of erosion and extrusion, lower pelvic pain and other pain sufferings, incomplete bladder emptying, mesh adhesion in vagina and surrounding tissue, organ perforation, scar tissue, tissue damage, dyspareunia, fistula, death of her vaginal wall tissue and nerves, mesh deformation infection, chronic inflammation, neuropathic and other acute and chronic nerve damage, uti and abdominal pain.Impact codes f1905 and f2301 capture the following reportable events of multiple mesh revision surgeries and placement of second advantage fit and another non-bsc device.
|
| |
|
Event Description
|
|
Note: this manufacturer report pertains to the first of two devices used during different procedures.--- (b)(6) 2016--- the first advantage fit sling was implanted into the patient.Preoperative/postoperative diagnoses: 1.Peritoneal endometriosis with incomplete uterovaginal prolapse 2.Lateral cystocele 3.Stress incontinence 4.Rectocele.Procedures performed: 1.Da vinci excision of retroperitoneal endometriosis with subsequent da vinci sacral colpopexy 2.Da vinci paravaginal repair 3.Transvaginal tvt using the advantage fit technique 4.Rectocele repair with insertion of mesh in the posterior compartment (using coloplast restorelle xl 30x30cm).The patient tolerated the procedure well.---(b)(6) 2017--- the patient returned to the operating room for a revision surgery, during which a second advantage fit sling was implanted.Preoperative/postoperative diagnoses: 1.Hemorrhagic right ovarian benign neoplasm 2.Intrinsic sphincteric deficiency with persistent stress incontinence following mid-urethral sling done at the time of sacrocolpopexy and hysterectomy.Procedures performed: 1.Da vinci bilateral salpingo-oophorectomy, 2.Transvaginal tvt sling using the advantage fit technique with urethrolysis.During this procedure, the prior advantage fit sling implanted was identified and "freed and mobilized away from the vagina and also away from the overlying urethra." all fibrosis towards the retropubic space was lysed in order to allow for second sling passage.The second advantage fit sling was placed with increased tension and was lying slightly proximal to the previously placed sling.The subsequent erosion, pain, mesh removal procedures and surgeries were caused by the products implanted.The patient continued to suffer from mesh related complications and pain to the present day.---(b)(6) 2017--- the patient reported during a follow-up that she felt her urinary stream was slower.---(b)(6) 2018--- the patient reported urinary tract infection and persistent bladder pain despite multiple interventions including multiple antibiotic and estrogen.In addition, she started to develop dyspareunia and lower abdominal pain.Incidentally, she also had cholecystectomy in (b)(6) 2018.Given the patient's persistently elevated pvr's and poor stream, sling excision was planned, however, at the time of surgery it was noted that patient had recurrent anterior defect, and this was repaired rather than the sling removal.---(b)(6) 2018--- she went to the er for the treatment of uti with rocefin and foley catheterization.---(b)(6) 2018--- the patient underwent paravaginal repair with mesh.She initially had difficulty emptying post procedure with resolution of symptoms by around 1-week post-op.During the first week post-op, she was treated with gent injections.Two weeks post procedure, she started to develop abdominal bloating symptoms and had elevated pvrs.She was instructed to self-catheterize and start flomax.---(b)(6) 2018--- the patient underwent a second revision surgery.Preoperative/postoperative diagnoses: 1.Incomplete bladder emptying with urge incontinence following mid-urethral sling.2.Status post sacral colpoperineopexy with supracervical hysterectomy.Procedures performed: 1.Vaginal paravaginal repair with insertion of mesh in the anterior compartment using the direct fix technique 2.Bilateral sacrospinous ligament colpopexy using the directfix technique.---(b)(6) 2018--- the patient returned to the operation room a third revision surgery.Preoperative/postoperative diagnoses: incomplete bladder emptying following mid urethral sling.Procedure performed: sling excision.During this procedure, one of the prior boston scientific advantage fit slings was removed from sulci to sulci.According to the operative note, "the sling was fully mobilized laterally and then transected and then freed from the overlying urethra and then excised lateral to the sulci bilaterally." this does not mean that the entire sling was removed, but only a small portion that existed under the urethra.Reportedly, the patient developed e.Coli uti.She was started on weekly monurol treatment and gentamicin irrigations were started.Bladder pain persisted despite multiple interventions including multiple antibiotic use and estrogen.---(b)(6) 2019--- the patient was hospitalized for uti.Incidentally, she underwent cervical spine surgery in (b)(6) 2019.Urinary tract infections resolved for a short period of time but still with complaints of vaginal pain and discomfort.---(b)(6) 2019--- the patient presented for follow-up of recurrent urinary tract infections (utis).She had been treated with suprax and cipro for persistent symptoms but with no improvement.Her current symptoms at that time were: right flank pain and new onset of left flank pain, dysuria and frequency.She was also complaining of discomfort, fatigue, dull vaginal discomfort.On physical exam, the only remarkable finding was tenderness at the vaginal apex, but it did not explain flank pain and/or dysuria.---(b)(6) 2019--- the patient presented for cystoscopy and to follow up on recurrent utis.---(b)(6) 2019--- the patient underwent a fourth revision surgery.Preoperative/postoperative diagnosis: dyspareunia and nonspecific lower pelvic pain following prior vaginal mesh repair.Procedures performed: 1.Revision of anterior vaginal mesh 2.Subsequent anterior repair with cervicopexy by way of vaginal mesh revision.This diagnosis was confirmed during the procedure.A revision of the anterior vaginal mesh and subsequent anterior repair with cervicopexy were performed for the removal of coloplast direct fix mesh device using a dissection that extended laterally to expose the path of the mesh towards the sacrospinous ligaments.Dermapure graft used to augment repair.Cystourethroscopy was performed and noted mild trabeculations.The patient tolerated the procedure well.---(b)(6) 2019--- the patient presented for follow-up at 7 weeks post-op, reporting occasional spotting.Physical exam noted a well elevated vagina with some discharge from the cervix.There was mesh exposure at distal anterior vagina (not sling) which was trimmed in its entirety.She tolerated the procedure well.---(b)(6) 2019--- the patient reported she had been sexually active, with some discomfort present.She stated that her partner felt something poking in the vagina.Additionally, she noted lower abdominal pain radiating laterally.On physical exam, no mesh exposure was noted.---(b)(6) 2020--- the patient presented for follow-up with the following chief complaints: 1.Pelvic prolapse symptoms have gotten worse over the last year.2.Having recurrent infections over the last 16 months.Symptoms include dysuria, urgency and frequency.3.Experiencing painful sex and worries that the sing was somehow "dislodged".4.Pelvic pain and painful sex, feeling like something "poking" during sex.Pain described as dull and sharp.---(b)(6) 2020--- pathology report: vaginal graft, excision: connective tissue with prosthetic material consistent with mesh, dense surrounding fibrosis, and attendant lymphohistiocytic inflammation; negative for atypia or malignancy.Clinical history: excision of anterior vaginal graft, cystoscopy.Diagnoses: pain, mesh extrusion, rectocele, prolapse.---(b)(6) 2020--- the patient underwent another revision surgery.Preoperative/postoperative diagnoses: 1.Dyspareunia 2.Sexual pain and vaginal wound 3.Status post anterior repair vaginal mesh/biologic graft composite for prolapse.Procedures performed: 1.Removal of composite anterior vaginal wall graft 2.Suture of vaginal wound (colporrhaphy) 3.Enterocele repair 4.Cystourethroscopy.There were no complications as a result of this procedure.The patient was awakened and transported to the recovery room in stable condition.---(b)(6) 2021--- the patient presented for a follow-up with the following chief complaints: 1.Recent dysuria, flank pain, lower abdominal pain with a long history of recurrent utis.Symptoms also included urgency and frequency.2.Pelvic prolapse symptoms have gotten worse over the last year 3.Pelvic pain and painful sex, feeling like something was "poking" during sex.Noted during physical exam was what looked to be scarring at vaginal fornix.Her pain was described as dull and sharp.Summary: as a result of being implanted with the products, patient has experienced degradation of the polypropylene mesh and the pelvic tissue, chronic inflammation of the pelvic tissue, mesh shrinkage or mesh contraction of the mesh causing chronic pain, mesh deformation causing chronic pain, nerve entrapment, chronic inflammation, chronic infectious response, chronic pain, pain while sitting, painful sexual relations, significant urinary dysfunction, vaginal shortening, vaginal and rectal anatomic deformation, and a severe adverse reactions to the mesh.The products implanted have caused life-altering and permanent injuries, severe emotional pain and injury.Patient has suffered and will suffer apprehension of increased risk for injuries, infections, pain, mental anguish, infection, bodily disfigurement, and multiple corrective procedures/surgeries as a result of implantation of mesh.She continues to suffer from mesh related complications and pain to this day that and, in a reasonable degree of medical probability, will continue for the remainder of her life.She will need additional corrective procedures and surgeries due to injuries associated to the vaginal mesh products implanted.Patient has suffered serious and permanent bodily injuries including: - pain and suffering - loss of capacity of the enjoyment of life - pelvic and vaginal pain - complex extrusion and erosion of the mesh - chronic inflammation - swollen inflamed tissue in vagina - mesh adhesion in vagina and surrounding tissue - tissue damage - death of her vaginal wall tissue and nerves - failure of the mesh to treat her underlying conditions - new onset urinary and pelvic complications - mesh deformation including coiling, contracting, pore collapse, and curling of the mesh inside the vagina, mesh hardening and stiffening, vaginal deformation - surgical intervention for her pain - future medical care and treatment.The injuries, conditions, and complications suffered by the patient, as a result of being implanted with the products include, but are not limited to, erosion, mesh contraction, mesh deformation infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia (pain during sexual intercourse), blood loss, neuropathic and other acute and chronic nerve damage and pain, pelvic floor damage, chronic pelvic pain, multiple mesh revision surgeries, emotional distress and mental anguish, and other debilitating complications, including those listed above.
|
| |
|
Event Description
|
|
Note: this manufacturer report pertains to the first of two devices used during different procedures.(b)(6) 2016: the first advantage fit sling was implanted into the patient.Preoperative/postoperative diagnoses: 1.Peritoneal endometriosis with incomplete uterovaginal prolapse.2.Lateral cystocele.3.Stress incontinence.4.Rectocele.Procedures performed: 1.Da vinci excision of retroperitoneal endometriosis with subsequent da vinci sacral colpopexy.2.Da vinci paravaginal repair.3.Transvaginal tvt using the advantage fit technique.4.Rectocele repair with insertion of mesh in the posterior compartment (using coloplast restorelle xl 30x30cm).The patient tolerated the procedure well.These procedures were done in conjunction with a hysterectomy.(b)(6) 2017.The patient returned to the operating room for a revision surgery, during which a second advantage fit sling was implanted.Preoperative/postoperative diagnoses: 1.Hemorrhagic right ovarian benign neoplasm.2.Intrinsic sphincteric deficiency with persistent stress incontinence following mid-urethral sling done at the time of sacrocolpopexy and hysterectomy.Procedures performed: 1.Da vinci bilateral salpingo-oophorectomy.2.Transvaginal tvt sling using the advantage fit technique with urethrolysis.During this procedure, the prior advantage fit sling implanted was identified and "freed and mobilized away from the vagina and also away from the overlying urethra." all fibrosis towards the retropubic space was lysed in order to allow for second sling passage.The second advantage fit sling was placed with increased tension and was lying slightly proximal to the previously placed sling.The subsequent erosion, pain, mesh removal procedures and surgeries were caused by the products implanted.The patient continued to suffer from mesh related complications and pain to the present day.(b)(6) 2017.The patient reported during a follow-up that she felt her urinary stream was slower.The patient was prescribed flomax use but pvr's were normal and obstructive voiding resolved as of a visit in (b)(6) 2017.(b)(6) 2018.The patient reported urinary tract infection and persistent bladder pain despite multiple interventions including multiple antibiotic and estrogen.In addition, she started to develop dyspareunia and lower abdominal pain.Incidentally, she also had cholecystectomy in (b)(6) 2018.Given the patient's persistently elevated pvr's and poor stream, sling excision was planned, however, at the time of surgery it was noted that patient had recurrent anterior defect, and this was repaired rather than the sling removal.(b)(6) 2018.She went to the er for the treatment of uti with rocefin and foley catheterization.(b)(6) 2018.The patient underwent paravaginal repair with mesh.She initially had difficulty emptying post procedure with resolution of symptoms by around 1-week post-op.During the first week post-op, she was treated with gent injections.Two weeks post procedure, she started to develop abdominal bloating symptoms and had elevated pvrs.She was instructed to self-catheterize and start flomax.(b)(6) 2018.The patient underwent a second revision surgery.Preoperative/postoperative diagnoses: 1.Incomplete bladder emptying with urge incontinence following mid-urethral sling.2.Status post sacral colpoperineopexy with supracervical hysterectomy.Procedures performed: 1.Vaginal paravaginal repair with insertion of mesh in the anterior compartment using the direct fix technique.2.Bilateral sacrospinous ligament colpopexy using the directfix technique.(b)(6) 2018.The patient returned to the operation room a third revision surgery.Preoperative/postoperative diagnoses: incomplete bladder emptying following mid urethral sling.Procedure performed: sling excision.During this procedure, one of the prior boston scientific advantage fit slings was removed from sulci to sulci.According to the operative note, "the sling was fully mobilized laterally and then transected and then freed from the overlying urethra and then excised lateral to the sulci bilaterally." this does not mean that the entire sling was removed, but only a small portion that existed under the urethra.Reportedly, the patient developed e.Coli uti.She was started on weekly monurol treatment and gentamicin irrigations were started.Bladder pain persisted despite multiple interventions including multiple antibiotic use and estrogen.(b)(6) 2019.The patient was hospitalized for uti.Incidentally, she underwent cervical spine surgery in (b)(6) 2019.Urinary tract infections resolved for a short period of time but still with complaints of vaginal pain and discomfort.(b)(6) 2019.The patient presented for follow-up of recurrent urinary tract infections (utis).She had been treated with suprax and cipro for persistent symptoms but with no improvement.Her current symptoms at that time were: right flank pain and new onset of left flank pain, dysuria and frequency.She was also complaining of discomfort, fatigue, dull vaginal discomfort.On physical exam, the only remarkable finding was tenderness at the vaginal apex, but it did not explain flank pain and/or dysuria.(b)(6) 2019.The patient presented for cystoscopy and to follow up on recurrent utis.Patient recently completed a course of cipro as well as gentamicin injection after recent positive e.Coli culture on (b)(6) 2019.Patient states that symptoms have remained the same despite completion of antibiotics.Patient did not start methenamine after last visit as prescribed.Cystoscopy showed no evidence of foreign body.Diffuse erythema and debris were present.Recent ct scan on (b)(6) 2019 was negative for stones.Urine was sent for culture.Given patient's history of recurrent uti and in the past some difficulty treating and requiring hospitalization for inpatient antibiotic therapy, will plan to treat from a prevention standpoint at this time.Reviewed the below plan: start methenamine; hold off on treating uti's unless culture proven.Discussed possibility of starting on demand antibiotics for treatment in the future vs suppression therapy for 90 days.Discussed s/s of uti's including dysuria/bladder pain/fever/chills/back and flank pain.Start probiotic supplement.Start cranberry supplement.Continue hygiene measures.Start timed voids.Increase hydration.Restart estradiol.Follow up in one month.Reassess symptoms and decide on suppression therapy at that time if indicated.(b)(6) 2019.The patient underwent a fourth revision surgery.Preoperative/postoperative diagnosis: dyspareunia and nonspecific lower pelvic pain following prior vaginal mesh repair.Procedures performed: 1.Revision of anterior vaginal mesh.2.Subsequent anterior repair with cervicopexy by way of vaginal mesh revision.This diagnosis was confirmed during the procedure.A revision of the anterior vaginal mesh and subsequent anterior repair with cervicopexy were performed for the removal of coloplast direct fix mesh device using a dissection that extended laterally to expose the path of the mesh towards the sacrospinous ligaments.Dermapure graft used to augment repair.Cystourethroscopy was performed and noted mild trabeculations.The patient tolerated the procedure well.(b)(6) 2019.The patient presented for follow-up at 7 weeks post-op, reporting occasional spotting.Physical exam noted a well elevated vagina with some discharge from the cervix.There was mesh exposure at distal anterior vagina (not sling) which was trimmed in its entirety.She tolerated the procedure well.(b)(6) 2019.The patient reported she had been sexually active, with some discomfort present.She stated that her partner felt something poking in the vagina.Additionally, she noted lower abdominal pain radiating laterally.On physical exam, no mesh exposure was noted.(b)(6) 2020.The patient presented for follow-up with the following chief complaints: 1.Pelvic prolapse symptoms have gotten worse over the last year.2.Having recurrent infections over the last 16 months.Symptoms include dysuria, urgency and frequency.3.Experiencing painful sex and worries that the sing was somehow "dislodged".4.Pelvic pain and painful sex, feeling like something "poking" during sex.Pain described as dull and sharp.Vaginal exam revealed the transverse mesh was palpable but the posterior fourchette looked better.The plan was to leave the posterior fourchette alone but proceed with avw meshectomy and revision anterior repair.(b)(6) 2020.Pathology report: vaginal graft, excision: connective tissue with prosthetic material consistent with mesh, dense surrounding fibrosis, and attendant lymphohistiocytic inflammation; negative for atypia or malignancy.Clinical history: excision of anterior vaginal graft, cystoscopy.Diagnoses: pain, mesh extrusion, rectocele, prolapse.(b)(6) , 2020.The patient underwent another revision surgery.Preoperative/postoperative diagnoses: 1.Dyspareunia.2.Sexual pain and vaginal wound.3.Status post anterior repair vaginal mesh/biologic graft composite for prolapse.Procedures performed: 1.Removal of composite anterior vaginal wall graft.2.Suture of vaginal wound (colporrhaphy).3.Enterocele repair.4.Cystourethroscopy.There were no complications as a result of this procedure.The patient was awakened and transported to the recovery room in stable condition.(b)(6) 2021.The patient presented for a follow-up with the following chief complaints: 1.Recent dysuria, flank pain, lower abdominal pain with a long history of recurrent utis.Symptoms also included urgency and frequency.2.Pelvic prolapse symptoms have gotten worse over the last year 3.Pelvic pain and painful sex, feeling like something was "poking" during sex.Noted during physical exam was what looked to be scarring at vaginal fornix.Her pain was described as dull and sharp.Summary: as a result of being implanted with the products, patient has experienced degradation of the polypropylene mesh and the pelvic tissue, chronic inflammation of the pelvic tissue, mesh shrinkage or mesh contraction of the mesh causing chronic pain, mesh deformation causing chronic pain, nerve entrapment, chronic inflammation, chronic infectious response, chronic pain, pain while sitting, painful sexual relations, significant urinary dysfunction, vaginal shortening, vaginal and rectal anatomic deformation, and a severe adverse reactions to the mesh.The products implanted have caused life-altering and permanent injuries, severe emotional pain and injury.Patient has suffered and will suffer apprehension of increased risk for injuries, infections, pain, mental anguish, infection, bodily disfigurement, and multiple corrective procedures/surgeries as a result of implantation of mesh.She continues to suffer from mesh related complications and pain to this day that and, in a reasonable degree of medical probability, will continue for the remainder of her life.She will need additional corrective procedures and surgeries due to injuries associated to the vaginal mesh products implanted.Patient has suffered serious and permanent bodily injuries including: - pain and suffering.- loss of capacity of the enjoyment of life.- pelvic and vaginal pain.- complex extrusion and erosion of the mesh.- chronic inflammation.- swollen inflamed tissue in vagina.- mesh adhesion in vagina and surrounding tissue.- tissue damage.- death of her vaginal wall tissue and nerves.- failure of the mesh to treat her underlying conditions.- new onset urinary and pelvic complications.- mesh deformation including coiling, contracting, pore collapse, and curling of the mesh inside the vagina, mesh hardening and stiffening, vaginal deformation.- surgical intervention for her pain.- future medical care and treatment.The injuries, conditions, and complications suffered by the patient, as a result of being implanted with the products include, but are not limited to, erosion, mesh contraction, mesh deformation infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia (pain during sexual intercourse), blood loss, neuropathic and other acute and chronic nerve damage and pain, pelvic floor damage, chronic pelvic pain, multiple mesh revision surgeries, emotional distress and mental anguish, and other debilitating complications, including those listed above.
|
| |
|
Manufacturer Narrative
|
|
Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2017 was chosen as a best estimate based on the date of first revision surgery.Block e1: this event was reported by the patient's legal representation.Implant surgeon (for both devices) is: dr.(b)(6).(b)(6).Phone: (b)(6) fax: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2006 - erosion and extrusion.E2330 - lower pelvic pain and other pain sufferings.E1309 - incomplete bladder emptying.E2101 - mesh adhesion in vagina and surrounding tissue.E211401 - organ perforation.E1715 - scar tissue.E2015 - tissue damage.E1405 - dyspareunia.E2314 - fistula.E2401 - death of her vaginal wall tissue and nerves.E1906 - mesh deformation infection.E2326 - chronic inflammation.E0126 - neuropathy.E0123 - chronic nerve damage.E1310 - urinary tract infection.E1002 - abdominal pain.The following imdrf impact codes capture the reportable events of: f1905 - multiple events of mesh revision surgeries.F2301 - placement of second advantage fit and another non-bsc device.F2303 - medication required.F0101 - therapeutic response decreased.
|
| |
|
Search Alerts/Recalls
|
|
|
