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BOSTON SCIENTIFIC CORPORATION UPHOLD VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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| Model Number M0068317080 |
| Device Problem
Material Integrity Problem (2978)
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| Patient Problems
Erosion (1750); Bruise/Contusion (1754); Fatigue (1849); Fever (1858); Flatus (1865); Micturition Urgency (1871); Headache (1880); Pyrosis/Heartburn (1883); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Inflammation (1932); Itching Sensation (1943); Muscle Weakness (1967); Pain (1994); Rash (2033); Scar Tissue (2060); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Stenosis (2263); Urinary Frequency (2275); Anxiety (2328); Depression (2361); Numbness (2415); Obstruction/Occlusion (2422); Diaphoresis (2452); Sleep Dysfunction (2517); Weight Changes (2607); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)
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| Event Date 01/08/2013 |
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Event Type
Injury
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Manufacturer Narrative
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Date of event: date of event was approximated to (b)(6) 2019, explant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(6) medical center.(b)(6).The explant surgeon is: (b)(6).Patient codes (b)(4).Impact codes (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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Event Description
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It was reported to boston scientific corporation that an uphold vaginal support system was used during an anterior and posterior vaginal repair with uphold graft placement and cystoscopy procedure performed on (b)(6) 2013 to treat a second to third degree high central cystocele, second degree rectocele and perineal deficiency.On (b)(6) 2019, the patient underwent a bilateral paravaginal dissection, bilateral pararectal dissection removal of mesh, removal of mesh from the levator muscles, and anterior and posterior colporrhaphy procedures for the preoperative diagnoses of vaginal pain, dyspareunia, and vaginal scarring.It was noted that there was severe scarring in every space and segment of the pelvic floor which resulted in a very complicated and difficult surgery.Two kocher clamps were used and the skin was dissected off the perineum and rectum until the rectovaginal space was reached for the full extent of the posterior vaginal wall to the uphold mesh.A foley catheter was then inserted draining clear yellow urine.Two allis clamps were placed on the anterior of the vagina and an incision was made in the anterior vaginal wall for the full extent of the anterior vaginal wall past the upper placement of the uphold mesh.This extended past the apex into the posterior vaginal wall.The uphold mesh was then cut in the midline and was dissected cephaled, caudad and laterally.Initially done on the vaginal side and then on the bladder side taking the mesh off the bladder.The right paravaginal space was entered and the mesh was dissected laterally as far as possible.On the left, the uphold mesh was bunched up and corded.The arm was dissected as far lateral as possible into the left vaginal and paravaginal space.It was then dissected and removed from levator muscles.The uphold mesh was also dissected initially on the right and then the left pararectal space until further laterally as far as possible deep into the levator muscles.The mesh and arms were removed from the pelvic floor muscles initially on the right and then on the left.The anterior vaginal wall was then closed using a running suture of #2-0 dexon.The posterior vaginal wall was closed with a running suture of #2-0 dexon.The vagina was then lightly packed with iodoform gauze packing.The foley was connected to gravity drainage.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to july 15, 2019, explant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(6) medical center.(b)(6).The explant surgeon is: (b)(6).Block h6: patient code e1405 captures the reportable event of dyspareunia.Patient code e1715 captures the reportable event of vaginal scarring.Patient code e2330 captures the reportable event of pain.Impact code f1903 captures the reportable event of device explantation.Impact code f19 captures the reportable event of surgical intervention.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.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.Block h11: block g2 has been corrected.Blocks a6, b5, b7, e1 (initial reporter address 1, initial reporter city, initial reporter state and initial reporter phone number), h6 and h10 have been updated based on the additional information received on november 3, 2022 and november 16, 2022.Block h6: patient code e020201 captures the reportable event of anxiety.Patient code e020202 captures the reportable event of depression.Patient code e0130 captures the reportable event of sleep disorder (insomnia).Patient code e2006 captures the reportable event of extrusion.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.
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Event Description
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It was reported to boston scientific corporation that an uphold vaginal support system was used during an anterior and posterior vaginal repair with uphold graft placement and cystoscopy procedure performed on (b)(6) 2013 to treat a second to third degree high central cystocele, second degree rectocele and perineal deficiency.On (b)(6) 2019, the patient underwent a bilateral paravaginal dissection, bilateral pararectal dissection removal of mesh, removal of mesh from the levator muscles, and anterior and posterior colporrhaphy procedures for the preoperative diagnoses of vaginal pain, dyspareunia, and vaginal scarring.It was noted that there was severe scarring in every space and segment of the pelvic floor which resulted in a very complicated and difficult surgery.Two kocher clamps were used and the skin was dissected off the perineum and rectum until the rectovaginal space was reached for the full extent of the posterior vaginal wall to the uphold mesh.A foley catheter was then inserted draining clear yellow urine.Two allis clamps were placed on the anterior of the vagina and an incision was made in the anterior vaginal wall for the full extent of the anterior vaginal wall past the upper placement of the uphold mesh.This extended past the apex into the posterior vaginal wall.The uphold mesh was then cut in the midline and was dissected cephaled, caudad and laterally.Initially done on the vaginal side and then on the bladder side taking the mesh off the bladder.The right paravaginal space was entered and the mesh was dissected laterally as far as possible.On the left, the uphold mesh was bunched up and corded.The arm was dissected as far lateral as possible into the left vaginal and paravaginal space.It was then dissected and removed from levator muscles.The uphold mesh was also dissected initially on the right and then the left pararectal space until further laterally as far as possible deep into the levator muscles.The mesh and arms were removed from the pelvic floor muscles initially on the right and then on the left.The anterior vaginal wall was then closed using a running suture of #2-0 dexon.The posterior vaginal wall was closed with a running suture of #2-0 dexon.The vagina was then lightly packed with iodoform gauze packing.The foley was connected to gravity drainage.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.Additional information received on november 3, 2022 and november 16, 2022: on (b)(6) 2019, the patient was seen and examined.The patient's symptoms began six years ago generally lasts six years.The symptoms were reported as being severe.The symptoms occurred daily and the location was the vagina.Aggravating factors include intercourse.Relieving factors include not sure.The patient stated the symptoms were chronic and were uncontrolled.The patient reported inability to have intercourse because of pain that she felt she has had since the surgery in 2013.She also reported that the mesh was exposed vaginally.Surgery has been offered for removal of the previous uphold mesh, paravaginal dissection, anterior colporrhaphy, pararectal dissection, posterior colporrhaphy and colpoperineorrhaphy.The patient was extensively counselled that even with the removal of her mesh, she may continue to have pain and there was no guarantee that she will be pain-free or even improved from the pain.She was also counselled that she would not undergo reconstruction with the surgery as this would be only to remove the mesh.The patient has been counselled on the risks and benefits of the surgery, alternate approaches and procedures as well as complications which included but are not limited to bleeding, infection, as well as failure to achieve the desired psychologic result.The patient stated that she understood, had no questions, was given an opportunity to ask questions and wished to proceed with surgery.The review of systems was positive for the following: fatigue, night sweats and weight gain;sinus pressure;constipation, flatulence and heartburn; nocturia, urge incontinence, urgency, and urinary frequency; headache, numbness in extremity,; anxiety, depression, insomnia; pruritis, rash; back pain, joint pain, muscle weakness; easy bruising; dyspareunia.On (b)(6) 2019, the patient underwent a bilateral paravaginal dissection, bilateral pararectal dissection removal of mesh, removal of mesh from the levator muscles, anterior and posterior colporrhaphy to treat vaginal pain, dyspareunia, vaginal scarring due to uphold mesh.During the procedure, the patient was taken to the operating room and placed on the operating room table in a comfortable supine position.Following an adequate level of general endotracheal anesthesia, the patient was repositioned in the modified dorsal lithotomy position and prepped and draped in the usual manner for combined abdomino-vaginal surgery.There was severe scarring noted in every space and segment of the pelvic floor.Two kocher clamps were then placed at the 5 o'clock and 7 o'clock position at the level of the hymeneal ring.A midline incision was made between these two kochers and the skin was dissected off the perineum and rectum until the rectovaginal space was reached for the full extent of the posterior vaginal wall to the uphold mesh.The foley catheter was then inserted and noted to be draining clear yellow urine.Two allis clamps were placed on the anterior vaginal and an incision was made in the anterior vaginal wall for the full extent of the anterior vaginal wall past the upper placement of the uphold mesh.This extended past into the posterior vaginal wall.The uphold mesh was cut in the midline and was dissected cephalad, caudad and laterally initially on the vaginal side and then on the bladder side taking the mesh off the bladder.The right paravaginal space was entered and the mesh was dissected laterally as far as possible.On the left, the uphold mesh was bunched up and corded and entering the paravaginal space was difficult due to the scarring from the mesh.The arm was dissected as far lateral as possible into the left vaginal paravaginal space and the dissection and removed from the levator muscles.The right pararectal space was entered, initially on the right and the left and the uphold mesh were dissected further laterally as far as possible deep into the levator muscles and the mesh arms were removed from the pelvic floor muscles initially on the right and hen the left.The anterior vaginal wall was closed with a running suture of #2-0 dexon.The posterior vaginal wall was closed with a running suture of #2-0 dexon.The vagina was lightly packed with iodoform gauze packing.The foley was connected to gravity drainage.Needle, sponge and instrument count was correct times two.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.The specimen was received for gross examination in a single container labeled with the patient's name and uphold vaginal mesh and consists of two irregularly shaped pieces of fabric mesh that were 8.5 x 0.4 to 1.5 x 0.3 cm and 8.8 x 0.4 to 3.2 x 0.4 cm.The mesh has a small amount of pink, fibrous tissue attached to the surface.Also in the container was a single blue, plastic suture that was 11.3 cm in length x less than 0.1 cm in diameter.Photographs were taken prior to sectioning.Representative sections were submitted in cassette a1.The remaining unsubmitted tissue was saved indefinitely.
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Event Description
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It was reported to boston scientific corporation that an uphold vaginal support system was used during an anterior and posterior vaginal repair with uphold graft placement and cystoscopy procedure performed on (b)(6) 2013 to treat a second to third degree high central cystocele, second degree rectocele and perineal deficiency.On (b)(6) 2019, the patient underwent a bilateral paravaginal dissection, bilateral pararectal dissection removal of mesh, removal of mesh from the levator muscles, and anterior and posterior colporrhaphy procedures for the preoperative diagnoses of vaginal pain, dyspareunia, and vaginal scarring.It was noted that there was severe scarring in every space and segment of the pelvic floor which resulted in a very complicated and difficult surgery.Two kocher clamps were used and the skin was dissected off the perineum and rectum until the rectovaginal space was reached for the full extent of the posterior vaginal wall to the uphold mesh.A foley catheter was then inserted draining clear yellow urine.Two allis clamps were placed on the anterior of the vagina and an incision was made in the anterior vaginal wall for the full extent of the anterior vaginal wall past the upper placement of the uphold mesh.This extended past the apex into the posterior vaginal wall.The uphold mesh was then cut in the midline and was dissected cephaled, caudad and laterally.Initially done on the vaginal side and then on the bladder side taking the mesh off the bladder.The right paravaginal space was entered and the mesh was dissected laterally as far as possible.On the left, the uphold mesh was bunched up and corded.The arm was dissected as far lateral as possible into the left vaginal and paravaginal space.It was then dissected and removed from levator muscles.The uphold mesh was also dissected initially on the right and then the left pararectal space until further laterally as far as possible deep into the levator muscles.The mesh and arms were removed from the pelvic floor muscles initially on the right and then on the left.The anterior vaginal wall was then closed using a running suture of #2-0 dexon.The posterior vaginal wall was closed with a running suture of #2-0 dexon.The vagina was then lightly packed with iodoform gauze packing.The foley was connected to gravity drainage.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.Additional information received on november 3, 2022 and november 16, 2022: on (b)(6) 2019, the patient was seen and examined.The patient's symptoms began six years ago generally lasts six years.The symptoms were reported as being severe.The symptoms occurred daily and the location was the vagina.Aggravating factors include intercourse.Relieving factors include not sure.The patient stated the symptoms were chronic and were uncontrolled.The patient reported inability to have intercourse because of pain that she felt she has had since the surgery in 2013.She also reported that the mesh was exposed vaginally.Surgery has been offered for removal of the previous uphold mesh, paravaginal dissection, anterior colporrhaphy, pararectal dissection, posterior colporrhaphy and colpoperineorrhaphy.The patient was extensively counselled that even with the removal of her mesh, she may continue to have pain and there was no guarantee that she will be pain-free or even improved from the pain.She was also counselled that she would not undergo reconstruction with the surgery as this would be only to remove the mesh.The patient has been counselled on the risks and benefits of the surgery, alternate approaches and procedures as well as complications which included but are not limited to bleeding, infection, as well as failure to achieve the desired psychologic result.The patient stated that she understood, had no questions, was given an opportunity to ask questions and wished to proceed with surgery.The review of systems was positive for the following: fatigue, night sweats and weight gain;sinus pressure;constipation, flatulence and heartburn; nocturia, urge incontinence, urgency, and urinary frequency; headache, numbness in extremity,; anxiety, depression, insomnia; pruritis, rash; back pain, joint pain, muscle weakness; easy bruising; dyspareunia.On (b)(6) 2019, the patient underwent a bilateral paravaginal dissection, bilateral pararectal dissection removal of mesh, removal of mesh from the levator muscles, anterior and posterior colporrhaphy to treat vaginal pain, dyspareunia, vaginal scarring due to uphold mesh.During the procedure, the patient was taken to the operating room and placed on the operating room table in a comfortable supine position.Following an adequate level of general endotracheal anesthesia, the patient was repositioned in the modified dorsal lithotomy position and prepped and draped in the usual manner for combined abdomino-vaginal surgery.There was severe scarring noted in every space and segment of the pelvic floor.Two kocher clamps were then placed at the 5 o'clock and 7 o'clock position at the level of the hymeneal ring.A midline incision was made between these two kochers and the skin was dissected off the perineum and rectum until the rectovaginal space was reached for the full extent of the posterior vaginal wall to the uphold mesh.The foley catheter was then inserted and noted to be draining clear yellow urine.Two allis clamps were placed on the anterior vaginal and an incision was made in the anterior vaginal wall for the full extent of the anterior vaginal wall past the upper placement of the uphold mesh.This extended past into the posterior vaginal wall.The uphold mesh was cut in the midline and was dissected cephalad, caudad and laterally initially on the vaginal side and then on the bladder side taking the mesh off the bladder.The right paravaginal space was entered and the mesh was dissected laterally as far as possible.On the left, the uphold mesh was bunched up and corded and entering the paravaginal space was difficult due to the scarring from the mesh.The arm was dissected as far lateral as possible into the left vaginal paravaginal space and the dissection and removed from the levator muscles.The right pararectal space was entered, initially on the right and the left and the uphold mesh were dissected further laterally as far as possible deep into the levator muscles and the mesh arms were removed from the pelvic floor muscles initially on the right and hen the left.The anterior vaginal wall was closed with a running suture of #2-0 dexon.The posterior vaginal wall was closed with a running suture of #2-0 dexon.The vagina was lightly packed with iodoform gauze packing.The foley was connected to gravity drainage.Needle, sponge and instrument count was correct times two.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.The specimen was received for gross examination in a single container labeled with the patient's name and uphold vaginal mesh and consists of two irregularly shaped pieces of fabric mesh that were 8.5 x 0.4 to 1.5 x 0.3 cm and 8.8 x 0.4 to 3.2 x 0.4 cm.The mesh has a small amount of pink, fibrous tissue attached to the surface.Also in the container was a single blue, plastic suture that was 11.3 cm in length x less than 0.1 cm in diameter.Photographs were taken prior to sectioning.Representative sections were submitted in cassette a1.The remaining unsubmitted tissue was saved indefinitely.Additional information received on july 12, 2023: on (b)(6) 2017, the patient presented with pelvic pain.The pain began just after her bladder repair in 2013 and has progressively worsened.She reported that her pain is in the vaginal region and does not radiate.She described her pain as being 5/10 in severity.She had not been evaluated for pelvic pain prior to this visit.Additionally, she complained of a vaginal discharge described as brown and blood-tinged after intercourse.She claimed that she has not had "pleasurable intercourse since 2013." physical examination performed during the visit revealed some vaginal stenosis noted posteriorly with some possible mild mesh extrusion noted at cuff that was very tender to touch.Assessment: acute pain in pelvis ; dyspareunia.Plan: image-guided thinprep papanicolaou smear with reflex to high-risk human papillomavirus detection for any pathology; patient was instructed to call if pain or fever increases.To schedule a follow-up visit as needed, give lubricants and provided options for dilators, or referral to urogynaecology or monitoring.On (b)(6) 2019, the patient presented to discuss the following: her bladder sling that came through vaginally; right groin pain; change of her medication from citalopram to fluoxetine; and chronic skin rash for which she just finished prednisone.Her physical exam on genitourinary showed vaginal cuff with possible mesh extrusion on the right corner noted visually and on palpation.Assessment: assessed dyspareunia as deteriorated - recommended evaluation by urogynecology.Assessed tachycardia as improved; assessed essential hypertension as unchanged - continue medicines (nifedipine er); anxiety - updated meds (citalopram has been changed to fluoxetine); assessed urinary incontinence as deteriorated - concern for mesh erosion.On (b)(6) 2019, the patient presented for a postoperative visit after bilateral paravaginal dissection, bilateral pararectal dissection removal of mesh, removal of mesh from the levator muscles, anterior and posterior colporrhaphy.She reported some right hip/buttock numbness, and some pre and post void dribbling.Assessment and plan: exposure of implant vaginal prosthetic material into vagina.Plan: the patient was well after surgery.She was advised to continue regular care with ob/gyn (obstetrician gynecologist) and follow-up as needed.During the annual exam on (b)(6) 2020, the patient raised concerns about a few problems, including bladder problems, depression, and new medications.She also mentioned that her ears were itching (for which she used hydroxyzine as needed) and suspected it was due to her hormone blocker, which she had stopped taking for a year because of abnormal liver function test results.Additionally, she reported having difficulty with weight loss despite going for walks, some mucus discharge in (b)(6) 2019, urinary discomfort, burning sensation and foul smell.She reported that she was on bactrim medication for one week.Furthermore, she reported still having depression and anxiety, but better than it was six months prior.She lost her father last year and her mother was hospitalized.Problem assessment: assessed urinary tract infection (uti) as new and refractory - counseled stop bactrim, will start a new antibiotic.Counseled on diet, exercise.Discussed age appropriate, cancer screenings, utd on colonoscopy, will give pneumovax.Breast cancer - updated meds.Depression - updated meds.Appears stable.Assessed essential hypertension as unchanged.Fatty liver disease - laboratories were performed during the visit.Impressions: counseled continue working on exercise, weight loss, focus on how clothes fit better more than the number on the scale.Counseled recent mucus loss could be sloughing off.She likely needs cystoscopy.The patient was advised to try to get an appointment sooner than her scheduled appointment in september.On (b)(6) 2020, the patient presented for a follow-up visit due to the following: 1.Recurrent utis.Initially presenting with chronic cystitis symptoms.Her last visit was in (b)(6) 2018 in follow-up of chronic cystitis but with resolution on prolonged antibiotic courses.Converted to self-treated for periodic acute cystitis.After her mesh removal surgery, she started developing recurrent uti symptoms again more consistent with chronic cystitis.She reported getting better on bactrim but her uti would promptly recur.She was then put on a more extended course of ciprofloxacin with resolution of her symptoms.Culture in early february showed no clear bacteria.Her symptoms did not recur since quitting the ciprofloxacin.It was recommended to continue self-treatment program with ciprofloxacin given her response described above.Recheck in 6 months.2.Pelvic floor prolapse.3.Nocturia.Diagnoses at the time of visit: 1.History of recurrent uti; 2.Renal calculus, left.
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Manufacturer Narrative
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Blocks b3, b5, b7, h6: patient codes and h6: impact codes have been updated based on the additional information received on july 12, 2023.Block b3 date of event: date of event was approximated to (b)(6) 2013, implant date, based on the report that the patient experienced pain just after her mesh implantation procedure.Block e1: this event was reported by the patient's legal representation located at: (b)(6).The implant surgeon is: (b)(6).The explant surgeon is: (b)(6).Block h6: imdrf patient code e1405 captures the reportable event of dyspareunia.Imdrf patient code e1715 captures the reportable event of vaginal scarring.Imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e020201 captures the reportable event of anxiety.Imdrf patient code e020202 captures the reportable event of depression.Imdrf patient code e0130 captures the reportable event of sleep disorder (insomnia).Imdrf patient code e2006 captures the reportable event of extrusion.Imdrf patient code e1401 captures the reportable event of vaginal discharge.Imdrf patient code e2337 captures the reportable event of vaginal stenosis noted posteriorly.Imdrf patient code e2328 captures the reportable event of renal calculus.Imdrf patient code e1310 captures the reportable event of urinary tract infection.Imdrf patient code e2326 captures the reportable event of chronic cystitis.Imdrf patient code e2320 captures the reportable event of hypertension treated with medications.Imdrf impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Imdrf impact code f1903 captures the reportable event of device explantation.Imdrf impact code f19 captures the reportable event of surgical intervention.Imdrf impact code f2303 captures the reportable event of antibiotics and other medications.
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Search Alerts/Recalls
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