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BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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| Model Number M0068502110 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Micturition Urgency (1871); Hair Loss (1877); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Rash (2033); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Numbness (2415); Dysuria (2684); Fibrosis (3167); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572)
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| Event Date 05/31/2012 |
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Event Type
Injury
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Event Description
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It was reported to boston scientific corporation (bsc) that an advantage fit system was implanted into the patient during a robotically assisted laparoscopic supracervical hysterectomy with sacrocolpopexy (non-bsc y-mesh) and right ovarian cystectomy, retropubic midurethral sling using boston scientific advantage fit and limited cystoscopy procedure performed on (b)(6) 2011.Associated pre and post-operative diagnoses are: menometrorrhagia, fibroid, and stress urinary incontinence.Findings: a 12- to 14-week, globular uterus was appreciated with a very wide fundus.A small right ovarian cyst was identified and drained.The cul-de-sacs were clear.There were no complications during the procedure.On (b)(6) 2012, the patient was seen for an office visit with a chief complaint of pelvic pain.The pelvic pain began gradually one year ago and has been progressively worsening.She states the pain is located in the lower back and rectal pressure and does not radiate.The patient describes the pain as being moderate in severity and having a dull and a pressure-like quality.The patient also complains of dyspareunia and headaches.The patient denies constipation and diarrhea.The pain is aggravated by bowel movements, sexual intercourse, and exercise and is alleviated by warm baths and rest.The patient was evaluated by a healthcare provider in new hampshire a year prior for pelvic pain and the impression at that time was endometriosis for which she was treated with hysterectomy in (b)(6) 2011.The pain started as dysmenorrhea and then became more constant.She also had vaginal pressure pain which has not come back since her surgery.She had no pain for 3 months after the surgery.The pain started coming back in december.The pain really started coming back after she resumed having intercourse.The pain is constant but periodically gets worse.She had a colonoscopy showing precancerous polyps, but nothing else to explain her pain.She is taking oral progesterone as well as a progesterone cream - has been on them for a few months without any change in her symptoms.She really wants to know if she does have endometriosis.Genitourinary exam found normal external female genitalia, normal vagina, physiologic vaginal discharge noted, no lesions, tender to palpation of the posterior fornix, normal bladder, normal cervix without lesion or polyps, no cmt, no adnexal mass or tenderness.The patient and her healthcare provider discussed possible causes of her pain as well as diagnostic and treatment options.The patient elected to pursue laparoscopic evaluation (laparoscopy with possible lysis of adhesions, ablation of endometriosis or other treatment).The patient had a preop appointment on (b)(6) 2012.On (b)(6) 2012, the patient underwent a robotically assisted diagnostic laparoscopy with lysis of adhesions, and peritoneal biopsy procedure.Findings: the patient had one string-like adhesion from the omentum to just under the umbilicus.The mesh bridge from the sacral colpopexy to the right side of the top of the cervix was visualized and there was a window created by that mesh bridge between the mesh and the sidewall.The right adnexa was adherent to the sigmoid.There were 2 small bluish lesions on the sigmoid colon.During the procedure, an incision superior to the umbilicus was made (using her old incision) and a v cross needle inserted.Pneumoperitoneum was achieved with caron dioxide gas under low flow and low pressure.Two robotic ports were then placed lateral to the umbilical port and an 8 mm assistant port was placed in the left lower quadrant, all under video visualization.The robot was then docked without difficulty.The robotic scope was placed as where the instruments under visualization.The pelvis was inspected with the above findings noted.The fenestrated bipolar was initially used in the left hand and the harmonic scalpel in the right.The ovary was grasped and the fallopian tube appeared quite friable and bled easily and therefore a portion of the fallopian tube was excised.The fallopian tube was transected off of the colon using the harmonic scalpel.Bleeding from the ovary was cauterized using a combination of bipolar and harmonic energy sources.The remainder of the pelvis was then inspected.The band-like adhesion to the umbilicus was excised using the harmonic scalpel.The 2 small bluish peritoneal lesions overlying the sigmoid were grasped.The fenestrated bipolars was replaced with the maryland.They were grasped and the hot shears were used to replace the harmonic scalpel.Careful blunt dissection was used to remove the bluish lesion of the sigmoid.The pelvis was copiously irrigated, and no bleeding was seen.The procedure was then completed.The robot was undocked and instruments were removed.The skin incisions were closed with interrupted subcutaneous sutures of 4-0 monocryl.After the ports and gas were allowed to escape, dressings were applied.The patient was then reversed from aesthesia and taken to the recovery room in satisfactory condition.The right fallopian tube and peritoneal biopsy was sent to pathology.Estimated blood loss for the procedure was 10 ml.All counts were reported as correct.On (b)(6) 2013, the patient had a consult for mesh complications.At that consult, it was reported that immediately after the (b)(6) 2011 surgery, the patient began to have difficulties with chronic yeast infections, vaginal bleeding, increasing amounts of rashes and hair loss as well as severe dyspareunia and hispareunia, where her husband's penis had been caught up on engaging in intercourse.She also describes a significant pain in her back, pressure in her rectum, difficulties with bowel movements, and bilateral hip pain and increased left leg pain and left foot and leg numbness.She was taken back for a laparoscopic exploration in 2012, which just showed some adhesions of the fallopian tubes.This was done again for endometriosis.In addition, she also was examined by her gynecologist, who told her that she had possible mesh exposure and the mesh needed to be removed.She needs to splint now for her bowel movements, and still has occasional vaginal spotting.No urinary tract infections or gross hematuria.She voids every 2 to 3 hours, has nocturia times 1 to 3, does have urgency as well as some urge incontinence about once per week.Her force of stream is slower.She has some difficulties with emptying, occasional dysuria.She denies any stress incontinence, does not wear any protection.Does, again, have constipation.Genitourinary exam was performed and the patient was examined by both palpation and speculum.She had normal external genitalia.The introitus was normal.No evidence of vaginal atrophy.No urethral hypermobility.The area of the sling did not have any evidence of mesh exposure.She was nontender in the area of the sling.The vaginal examination itself was very difficult secondary to the vagina being so highly supported.The cervix could be palpated and visualized; however, we could not actually visualize the area of mesh exposure or palpate this area as well.The patient was tender to examination of the cervix itself.On the posterior vaginal wall, more distally, there appeared to be what was close to intraepithelial invasion of the mesh; however, no frank exposure was noted.There was no significant prolapse present.Laboratory studies: postvoid residual was 3 cc.Urinalysis showed small leukocyte esterase.Assessment/plan: chronic pelvic pain, back pain, leg pain, and dyspareunia secondary to abdominal sacrocolpopexy mesh.Vaginal bleeding.Plan: discussed with the patient we will need further diagnostic studies including an mri of the pelvis, a cystoscopy, translabial ultrasound for mesh, as well as urodynamic studies.We will plan for exploratory laparotomy, mesh excision, and autologous rectus fascia abdominal sacrocolpopexy in the same setting.We will likely not need to address the patient's retropubic sling, that does not appear to be causing any significant problems at this time.On (b)(6) 2013, the patient had an office visit for possible infection with the mesh.The patient complained of vaginal discharge which she was told to be due to mesh erosion and also complained of pelvic pain.She had been getting steroids injections to her back to relieve pain.Exam found the abdomen soft, nontender/nondistended, with bowel sounds present.External genitalia were normal with no lesions.Vaginal exam found a moderate amount of thick, yellow discharge.Cervical exam: parous os, normal appearance, cervical motion tenderness.There were no adnexal masses or tenderness bilaterally.Wet prep for vaginal discharge was positive for clue cells and wbc's.The patient was prescribed metrogel-vaginal gel, 0.75 %, 1 application vaginally at bedtime, once a day for 5 days and tindamax tablet, 500 mg, 4 tablets to be taken orally with food (stat).On (b)(6) 2013, the patient had an office visit complaining of pelvic pain, dyspareunia.She reported history of mesh erosion post sacro-colpopexy (non-bsc sacrocolpopexy mesh used).She denies sui (stress urinary incontinence).She plans to have mesh removed in (b)(6) (b)(6) 2013.Exam found normal external genitalia with no lesions.Her vagina was sore to touch around cervix, irregular, but no definite erosion was felt.The cervix had normal appearance, parous os, with cervical motion tenderness.Assessment: erosion of vaginal mesh - 996.39 (primary).Vaginitis - 616.10.Ovarian cyst - 620.2.Pelvic pain in female - 625.9.Plan: erosion of vaginal mesh.Labs ordered: cbc, comprehensive metabolic panel, prothrombin w/inr + partial thromboplastin times.Pelvic pain in female.Diagnostic imaging: transvaginal us, non-obstetric.Others.Wet prep done due to vaginal discharge.Findings: positive clue cells, positive wbc's, negative trichomonads.Refill metrogel-vaginal gel, 0.75 %, 1 application at bedtime, vaginal, once a day, 5 day(s), 5, refills 0.On (b)(6) 2013 the patient underwent videourodynamic study due to complications of abdominal sacrocolpopexy and retropubic mesh, urge urinary incontinence, dyspareunia, hispareunia, leg pain, and back pain.Description of procedure: a multichannel videourodynamic study was performed in the upright position.The patient was initially catheterized for 5 cc of residual urine.A rectal catheter was placed for intra-abdominal pressure measurements.A separate 7-french dual-lumen catheter was placed within the bladder.Filling phase of the study revealed a compliant bladder.First sensation was noted at 40 cc, first urge at 59 cc, and strong urge at 61 cc.Detrusor overactivity occurred multiple times during the procedure.Detrusor leak point pressure occurred at 8 cm of water.The patient tolerated filling to a capacity of 293 cc.Videofluoroscopic views were obtained during the filling phase.At rest, the bladder neck was closed.With valsalva, there was funneling of the bladder neck and the patient did not leak with valsalva.Emg showed normal activity.There was ramping of the emg activity during filling.During voiding, there was electrical silence.The emg study was technically successful.At a capacity of 293 ml, the patient was allowed to void.The patient was able to void in the standing position with the catheter in place.Maximum detrusor pressure was measured at 25 cm of water.This correlated with a peak flow of 22 cc/second.Abdominal straining was not necessary for emptying.Fluoroscopic postvoid residual was 0 cc.There was no reflux to the kidneys seen.Assessment and plan: the patient is a (b)(6) female with a history of abdominal sacrocolpopexy with mesh, supracervical hysterectomy, and retropubic vaginal sling in 2011 with numerous complications including vaginal pain, dyspareunia, hispareunia, multiple urinary tract infections, urge urinary incontinence, leg pain, and abdominal pain.The patient was scheduled for (b)(6) 2013, for removal of her retropubic and abdominal sacrocolpopexy mesh.She was to undergo an autologous fascial abdominal sacrocolpopexy procedure and removal of her cervix.On (b)(6) 2013, the patient underwent a mesh removal procedure.The operation involved: transvaginal urethrolysis, abdominal vaginal exploration of the retropubic space for mesh removal (complex), abdominal exploration, lysis of adhesion, excision of sacrocolpopexy mesh, cervical hysterectomy, closure of vaginal cuff, sacrocolpopexy using autologous fascia with the donor site from the left abdominal wall and anterior vaginal wall reconstruction for complications of mesh.The patient was transferred to recovery room in good condition.Estimated blood loss: 1000 cc.Specimens: retropubic mesh and culture of mesh.Cervical hysterectomy and sacrocolpopexy mesh.Degree of complexity: this was a very difficult and complex exploration.The retropubic mesh was on the bladder wall and urethra, fixed to the pubic bone and obturator fascia.Severe bleeding encountered in the area.The removal of the sacrocolpopexy mesh and cervical hysterectomy in the presence of eroded mesh made the dissection difficult and extensive.Pathology of the retropubic mesh (3 pieces of removed mesh material) found fragments of benign fibroadipose tissue with focal mild chronic inflammation and foreign material.On (b)(6) 2013, the patient was seen for a well-woman exam (wwe).The patient still complains of pelvic pain after the surgery where the mesh was removed.On (b)(6) 2014 the patient was seen for a follow-up on the (b)(6) 2013 surgery for trachelectomy, mesh removal, and urethral suspension.The patient had developed difficulty urinating and had granulation tissue at the level of the cuff which was treated with silver nitrate.The patient was referred to a continence clinic.This report was originally submitted via asr.Report identification number: (b)(4).Submission period: may 2, 2014 to july 1, 2014.Asr exemption number: e2013036.Pro code: otn.
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.Law firm: (b)(6).Implant surgeon: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Manufacturer Narrative
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Correction to blocks b5, h6: patient codes, and h6: impact codes.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.Law firm: (b)(6).Implant surgeon: (b)(6).Block h6: patient codes e1405, e1906, e2101, e2330, e1310, e2313, e2313, e1715, e1301, e1309, e2326, e0506, and e1002 capture the reportable events of dyspareunia, infections, adhesion, pain, urinary tract infections, fibrosis, granulation tissue, dysuria, urinary retention, inflammation, blood loss of 1000cc during a mesh removal procedure, and abdominal pain.Impact codes f1903, f2303 and f19 capture the reportable events of mesh removal, medications and lysis of adhesion.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation (bsc) that an advantage fit system was implanted into the patient during a robotically assisted laparoscopic supracervical hysterectomy with sacrocolpopexy (non-bsc y-mesh) and right ovarian cystectomy, retropubic midurethral sling using boston scientific advantage fit and limited cystoscopy procedure performed on (b)(6), 2011.Associated pre and post-operative diagnoses are: menometrorrhagia, fibroid, and stress urinary incontinence.Findings: a 12- to 14-week, globular uterus was appreciated with a very wide fundus.A small right ovarian cyst was identified and drained.The cul-de-sacs were clear.There were no complications during the procedure.On (b)(6) 2012, the patient was seen for an office visit with a chief complaint of pelvic pain.The pelvic pain began gradually one year ago and has been progressively worsening.She states the pain is located in the lower back and rectal pressure and does not radiate.The patient describes the pain as being moderate in severity and having a dull and a pressure-like quality.The patient also complains of dyspareunia and headaches.The patient denies constipation and diarrhea.The pain is aggravated by bowel movements, sexual intercourse, and exercise and is alleviated by warm baths and rest.The patient was evaluated by a healthcare provider in new hampshire a year prior for pelvic pain and the impression at that time was endometriosis for which she was treated with hysterectomy in (b)(6) 2011.The pain started as dysmenorrhea and then became more constant.She also had vaginal pressure pain which has not come back since her surgery.She had no pain for 3 months after the surgery.The pain started coming back in december.The pain really started coming back after she resumed having intercourse.The pain is constant but periodically gets worse.She had a colonoscopy showing precancerous polyps, but nothing else to explain her pain.She is taking oral progesterone as well as a progesterone cream - has been on them for a few months without any change in her symptoms.She really wants to know if she does have endometriosis.Genitourinary exam found normal external female genitalia, normal vagina, physiologic vaginal discharge noted, no lesions, tender to palpation of the posterior fornix, normal bladder, normal cervix without lesion or polyps, no cmt, no adnexal mass or tenderness.The patient and her healthcare provider discussed possible causes of her pain as well as diagnostic and treatment options.The patient elected to pursue laparoscopic evaluation (laparoscopy with possible lysis of adhesions, ablation of endometriosis or other treatment).The patient had a preop appointment on (b)(6), 2012.On (b)(6), 2012, the patient underwent a robotically assisted diagnostic laparoscopy with lysis of adhesions , and peritoneal biopsy procedure.Findings: the patient had one string-like adhesion from the omentum to just under the umbilicus.The mesh bridge from the sacral colpopexy to the right side of the top of the cervix was visualized and there was a window created by that mesh bridge between the mesh and the sidewall.The right adnexa was adherent to the sigmoid.There were 2 small bluish lesions on the sigmoid colon.During the procedure, an incision superior to the umbilicus was made (using her old incision) and a v cross needle inserted.Pneumoperitoneum was achieved with caron dioxide gas under low flow and low pressure.Two robotic ports were then placed lateral to the umbilical port and an 8 mm assistant port was placed in the left lower quadrant, all under video visualization.The robot was then docked without difficulty.The robotic scope was placed as where the instruments under visualization.The pelvis was inspected with the above findings noted.The fenestrated bipolar was initially used in the left hand and the harmonic scalpel in the right.The ovary was grasped and the fallopian tube appeared quite friable and bled easily and therefore a portion of the fallopian tube was excised.The fallopian tube was transected off of the colon using the harmonic scalpel.Bleeding from the ovary was cauterized using a combination of bipolar and harmonic energy sources.The remainder of the pelvis was then inspected.The band-like adhesion to the umbilicus was excised using the harmonic scalpel.The 2 small bluish peritoneal lesions overlying the sigmoid were grasped.The fenestrated bipolars was replaced with the maryland.They were grasped and the hot shears were used to replace the harmonic scalpel.Careful blunt dissection was used to remove the bluish lesion of the sigmoid.The pelvis was copiously irrigated, and no bleeding was seen.The procedure was then completed.The robot was undocked and instruments were removed.The skin incisions were closed with interrupted subcutaneous sutures of 4-0 monocryl.After the ports and gas were allowed to escape, dressings were applied.The patient was then reversed from aesthesia and taken to the recovery room in satisfactory condition.The right fallopian tube and peritoneal biopsy was sent to pathology.Estimated blood loss for the procedure was 10 ml.All counts were reported as correct.On (b)(6), 2013, the patient had a consult for mesh complications.At that consult, it was reported that immediately after the (b)(6), 2011 surgery, the patient began to have difficulties with chronic yeast infections, vaginal bleeding, increasing amounts of rashes and hair loss as well as severe dyspareunia and hispareunia, where her husband's penis had been caught up on engaging in intercourse.She also describes a significant pain in her back, pressure in her rectum, difficulties with bowel movements, and bilateral hip pain and increased left leg pain and left foot and leg numbness.She was taken back for a laparoscopic exploration in 2012, which just showed some adhesions of the fallopian tubes.This was done again for endometriosis.In addition, she also was examined by her gynecologist, who told her that she had possible mesh exposure and the mesh needed to be removed.She needs to splint now for her bowel movements, and still has occasional vaginal spotting.No urinary tract infections or gross hematuria.She voids every 2 to 3 hours, has nocturia times 1 to 3, does have urgency as well as some urge incontinence about once per week.Her force of stream is slower.She has some difficulties with emptying, occasional dysuria.She denies any stress incontinence, does not wear any protection.Does, again, have constipation.Genitourinary exam was performed and the patient was examined by both palpation and speculum.She had normal external genitalia.The introitus was normal.No evidence of vaginal atrophy.No urethral hypermobility.The area of the sling did not have any evidence of mesh exposure.She was nontender in the area of the sling.The vaginal examination itself was very difficult secondary to the vagina being so highly supported.The cervix could be palpated and visualized; however, we could not actually visualize the area of mesh exposure or palpate this area as well.The patient was tender to examination of the cervix itself.On the posterior vaginal wall, more distally, there appeared to be what was close to intraepithelial invasion of the mesh; however, no frank exposure was noted.There was no significant prolapse present.Laboratory studies: postvoid residual was 3 cc.Urinalysis showed small leukocyte esterase.Assessment/plan: 1.Chronic pelvic pain, back pain, leg pain, and dyspareunia secondary to abdominal sacrocolpopexy mesh.2.Vaginal bleeding.Plan: 1.Discussed with the patient we will need further diagnostic studies including an mri of the pelvis, a cystoscopy, translabial ultrasound for mesh, as well as urodynamic studies.2.We will plan for exploratory laparotomy, mesh excision, and autologous rectus fascia abdominal sacrocolpopexy in the same setting.We will likely not need to address the patient's retropubic sling, that does not appear to be causing any significant problems at this time.On (b)(6), 2013, the patient had an office visit for possible infection with the mesh.The patient complained of vaginal discharge which she was told to be due to mesh erosion and also complained of pelvic pain.She had been getting steroids injections to her back to relieve pain.Exam found the abdomen soft, nontender/nondistended, with bowel sounds present.External genitalia were normal with no lesions.Vaginal exam found a moderate amount of thick, yellow discharge.Cervical exam: parous os, normal appearance, cervical motion tenderness.There were no adnexal masses or tenderness bilaterally.Wet prep for vaginal discharge was positive for clue cells and wbc's.The assessment included urinary tract infection and vaginitis.The patient was prescribed metrogel-vaginal gel, 0.75 %, 1 application vaginally at bedtime, once a day for 5 days and tindamax tablet, 500 mg, 4 tablets to be taken orally with food (stat).On (b)(6) 2013, the patient had an office visit complaining of pelvic pain, dyspareunia.She reported history of mesh erosion post sacro-colpopexy (non-bsc sacrocolpopexy mesh used).She denies sui (stress urinary incontinence).She plans to have mesh removed in california (b)(6), 2013.Exam found normal external genitalia with no lesions.Her vagina was sore to touch around cervix, irregular, but no definite erosion was felt.The cervix had normal appearance, parous os, with cervical motion tenderness.Assessment: 1.Erosion of vaginal mesh - 996.39 (primary).2.Vaginitis - 616.10.3.Ovarian cyst - 620.2.4.Pelvic pain in female - 625.9.Plan: 1.Erosion of vaginal mesh.- labs ordered: cbc, comprehensive metabolic panel, prothrombin w/inr + partial thromboplastin times.2.Pelvic pain in female.- diagnostic imaging: transvaginal us, non-obstetric.3.Others - wet prep done due to vaginal discharge.Findings: positive clue cells, positive wbc's, negative trichomonads.- refill metrogel-vaginal gel, 0.75 %, 1 application at bedtime, vaginal, once a day, 5 day(s), 5, refills 0.On (b)(6), 2013 the patient underwent videourodynamic study due to complications of abdominal sacrocolpopexy and retropubic mesh, urge urinary incontinence, dyspareunia, hispareunia, leg pain, and back pain.Description of procedure: a multichannel videourodynamic study was performed in the upright position.The patient was initially catheterized for 5 cc of residual urine.A rectal catheter was placed for intra-abdominal pressure measurements.A separate 7-french dual-lumen catheter was placed within the bladder.Filling phase of the study revealed a compliant bladder.First sensation was noted at 40 cc, first urge at 59 cc, and strong urge at 61 cc.Detrusor overactivity occurred multiple times during the procedure.Detrusor leak point pressure occurred at 8 cm of water.The patient tolerated filling to a capacity of 293 cc.Videofluoroscopic views were obtained during the filling phase.At rest, the bladder neck was closed.With valsalva, there was funneling of the bladder neck and the patient did not leak with valsalva.Emg showed normal activity.There was ramping of the emg activity during filling.During voiding, there was electrical silence.The emg study was technically successful.At a capacity of 293 ml, the patient was allowed to void.The patient was able to void in the standing position with the catheter in place.Maximum detrusor pressure was measured at 25 cm of water.This correlated with a peak flow of 22 cc/second.Abdominal straining was not necessary for emptying.Fluoroscopic postvoid residual was 0 cc.There was no reflux to the kidneys seen.Assessment and plan: the patient is a 40-year-old female with a history of abdominal sacrocolpopexy with mesh, supracervical hysterectomy, and retropubic vaginal sling in 2011 with numerous complications including vaginal pain, dyspareunia, hispareunia, multiple urinary tract infections, urge urinary incontinence, leg pain, and abdominal pain.The patient was scheduled for (b)(6), 2013, for removal of her retropubic and abdominal sacrocolpopexy mesh.She was to undergo an autologous fascial abdominal sacrocolpopexy procedure and removal of her cervix.On (b)(6), 2013, the patient underwent a mesh removal procedure.The operation involved: transvaginal urethrolysis, abdominal vaginal exploration of the retropubic space for mesh removal (complex), abdominal exploration, lysis of adhesion, excision of sacrocolpopexy mesh, cervical hysterectomy, closure of vaginal cuff, sacrocolpopexy using autologous fascia with the donor site from the left abdominal wall and anterior vaginal wall reconstruction for complications of mesh.The patient was transferred to recovery room in good condition.Estimated blood loss: 1000 cc.Specimens: 1.Retropubic mesh and culture of mesh.2.Cervical hysterectomy and sacrocolpopexy mesh.Degree of complexity: this was a very difficult and complex exploration of the retropubic space.The mesh was attached to the obturator fossa and the bladder wall and extensive retropubic dissection in the right side required freeing all the adhesions, and the mesh was dissected from the superior and the inferior rami of the pubic bone, and a laparotomy pad was inserted in the right retropubic space.The left side showed more complication.The mesh of the periurethral fascia was dissected, entered the retropubic space, and the mesh was found deeply attached to the urethral wall, attached to the bladder wall and encased in a significant fibrosis with inflammatory changes.Every dissection that we did in the retropubic space led to venous bleeding that was significant.We were able to free up the mesh from the attachment to the obturator fossa and the pubic bone requiring a very extensive and difficult dissection.A laparotomy pad again was inserted into the retropubic space in the left side.The removal of the sacrocolpopexy mesh and cervical hysterectomy in the presence of eroded mesh made the dissection difficult and extensive.Exploration of the suprapubic area, where the retropubic mesh was present, was performed.Under finger control in the vagina, the mesh was followed toward the retropubic space.The mesh was transferred from the vaginal area to the suprapubic area and followed to the fascia and subcutaneous tissue, where it was found encased in fibrosis and inflammatory changes, particularly in the left side.A similar maneuver in the right side was performed to dissect the mesh from the retropubic space, that had been freed up completely in the vagina and then advanced the mesh to expose the retropubic space and detached it from the periosteum of the pubic bone and the subcutaneous tissues.Almost 1 inch of mesh in each side was found in the subcutaneous tissue.Laparotomy pads were inserted in each side in the retropubic space.As the insignificant bleeding continued in spite of the packing into the retropubic space, therefore gelfoam was inserted in the left retropubic space and further packing and retraction allowed us the control of the bleeding.Pathology of the retropubic mesh (3 pieces of removed mesh material) found fragments of benign fibroadipose tissue with focal mild chronic inflammation and foreign material.On (b)(6), 2013, the patient was seen for a well-woman exam (wwe).The patient still complains of pelvic pain after the surgery where the mesh was removed.On (b)(6), 2014 the patient was seen for a follow-up on the (b)(6), 2013 surgery for trachelectomy, mesh removal, and urethral suspension.The patient had developed difficulty urinating and had granulation tissue at the level of the cuff which was treated with silver nitrate.She also reported urinary urgency.The patient was referred to a continence clinic.This report was originally submitted via asr.- report identification number: (b)(4) - submission period: may 2, 2014 to july 1, 2014 - asr exemption number: (b)(4) - pro code: otn.
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