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Transvaginal Mesh Case Report
Date of Implant
Reason for mesh
implantation
Type of
procedure
Surgical
Approach
Implant Details
11/23/2009
Stress Urinary Incontinence (SUI), cystocele, rectocele
Anterior posterior enterocele repair, elevate anterior elevate posterior enterocele mesh, sacrospinous ligament fixation, cystourethroscopy, bilateral ureteroscopy
Dilation of mild left ureteral narrowing with placement of SPARC sling
Vaginal and abdominal
Implant #1:
Product name (brand name): Elevate® Apical and Posterior System with IntePro®Lite™
Manufacturer’s name: XXXX
Catalog number: XXXX
Lot number: XXXX
Size: Unavailable
Product label:
Implant #2:
Product name (brand name): Elevate® Anterior and Apical System with IntePro®Lite™
Manufacturer’s name: XXXX
Catalog number: XXXX
Lot number: XXXX
Size: Unavailable.
Product label:
1 of 6
Implant #3:
Product name (brand name): SPARC™ Sling System
Manufacturer’s name: XXXX
Catalog number: XXXX
Lot number: XXXX
Size: Unavailable.
Product Labels:
Complications
post mesh implant
& Interventions
for the same
Date of Explant
Operative
Findings
Condition of mesh
on removal
Details of the
adverse event and
medical and/or
surgical
interventions
Condition of the
patient post meshexplant



12/07/2009: Fecal incontinence – Sitz bath and topical anesthetic.
12/18/2009: Spotting – Estrogen cream.
01/06/2010: Abdominal pain, one sore area of posterior mucosa on the left side, urinary
retention – Uroxatral, self catheterization.
 02/10/2010: Scarring, urinary retention – Release of sling and partial excision of the mesh
02/10/2010 (partial removal)
Tightened suprapubic mid urethral sling. Good anterior posterior support with no exposed mesh.
Good bit of scarring noted.
Not available
Urinary retention requiring cystourethroscopy with ureteroscopy, dilation of distal ureteral
narrowing, urethral dilation with lysis of urethral septum, anterior colporrhaphy with excision of
suprapubic mid-urethral sling.
02/24/2010: No leakage, voiding well; voids to completion and totally continent.
2 of 6
Patient History
Past Medical History: Frequent urinary tract infections.
Surgical History: Partial cystectomy, cystoplasty, hysterectomy, cesarean section thrice.
Family History: Positive for history of hypertension and Coronary Artery Disease.
Social History: Smoked half pack a day for 10 years, drinks beer occasionally.
Allergy: Levaquin (rash), Hydrocodone (irritation).
Detailed Chronology
DATE
06/29/2009
PROVIDER
Saylor All
Saints
Medical
Center
OCCURRENCE/TREATMENT
PDF REF
Follow-Up: [David L. Mould, M.D.]
259
Patient presents to the office on 06/26/09 for follow-up. She had a laparoscopic 179
procedure done to her ovary and ended up with a bladder injury. This was 191-192
repaired. She had significant discomfort with hematuria and underwent a
cystoscopy by an outside urologist which demonstrated some foreign body at
the site of the injury. I scoped her and she does in fact have a fluffy appearing
lesion at the site of her injury. She additionally complains of urge and stress
incontinence. I have discussed this with her and she is interested in
cystoscopic removal, and if this is not possible, open removal. She is also
interested, in repair of her cystocele and incontinence. We will schedule this.
Operative Report:
Pre-Operative Diagnosis:
Possible foreign body in bladder, prior bladder injury.
Post-Operative Diagnosis:
Breakdown of prior bladder repair with early fistulization.
11/09/2009
11/23/2009
Saylor All
Procedure Performed:
Cystourethroscopy with biopsy of small whitish material followed by
laparotomy with cystotomy with partial cystectomy with cystoplasty.
Progress Notes:
Patient comes in. I did an operative consultation on June 29th for Dr. Mould
repairing bladder injury and having recurrent UTI. She has a large cystocele
that was diagnosed at that time. She also loses urine with coughing and
sneezing. She had a previous hysterectomy for large ovarian cyst and then
removing the other ovary back in April, had the injury when she: went
undiagnosed. Exam Bartholin, urethra Skene’s glands are normal. She has a
third degree cystocele, positive Q-tip test and second degree rectocele.
times a week. She would like to try to wait after Christmas. She understands
the risks, benefits and alternatives including rejection of mesh, injury to
the bowel, bladder and urethra requiring further surgery as a result of
the mesh requiring further surgeries. She verbalized understanding.
Operative Report: [John E. Syers, D.O.]
3 of 6
284
114-120
DATE
PROVIDER
Saints
Medical
Center
OCCURRENCE/TREATMENT
PDF REF
Pre & Post-Operative Diagnosis:
Stress urinary incontinence status post partial cystectomy for bladder, fistula,
post hysterectomy in June of this year.
Procedure: Anterior posterior enterocele repair, elevate anterior elevate
posterior enterocele mesh, sacrospinous ligament fixation.
Operative Findings: Third degree cystocele, second degree rectocele, second
degree cuff prolapse with enterocele.
Operative Procedure:
After adequate general anesthesia, the patient was prepped and draped in the
dorsal lithotomy position. The apex of the enterocele was identified and a
suture ligature of 0 Vicryl was placed through the posterior vaginal mucosa
and tagged. Posterior vaginal mucosa was infiltrated with 10 milliliters of
vasopressin solution. The introitus was incised. The vaginal mucosa was
opened in the midline to the tagged suture. Utilizing retraction hooks from the
Lone Star retractor, the endopelvic fascia was rolled off laterally to the
inguinal ligaments, down to the ischial spines and sacrospinous ligaments with
open Ray-Tee sponges. The enterocele and bowel were similarly mobilized.
The uterosacral ligaments were palpated from the hollow of the sacrum up to
their insertion site. They were plicated in the midline with simple stitches of 0
Vieryl. These sutures were tagged. Again, the ischial spines were palpated and
approximately a centimeter proximally was penetrated with an elevated
posterior trocar, leaving the probe in place. These were fitted through the
eyelets of the mesh. The previously tagged uterosacral ligament sutures were
placed at each corner and on either side of the midline of the superior portion
of the mesh and fled. With a gloved hand in the rectum, the eyelets were
pushed down against the sacrospinous ligaments, followed by placement of
locking rings. The mesh was then attached to the lateral endopelvic fascia
and proximal to the introitus through the endopelvic fascia with simple
stitches of 0 Vicryl. Excess mesh was excised the vaginal mucosa was then
closed with running interlocking 2-0 chromic. There was excellent
posterior and apical support. Foley catheter was placed. The base of the
cystocele identified, Anterior vaginal mucosa was infiltrated with 10 milliliters
of vasopressin solution in the midline and the vaginal mucosa was incised with
a sharp knife, at the base of the cystocele. The vaginal mucosa was opened in
the midline up to the UV angle, Again the retraction hooks were used to retract
the vaginal mucosa and endopelvic fascia was rolled off laterally to the
obturator foramen, down to the ischial spines and the sacrospinous ligaments.
The bladder was also mobilized with open Ray-Tee sponges. A stitch was
placed in the sub-periurethral tissue and attached on either side of the
midline to the superior portion of the elevated anterior mesh. Upper arms
were then passed through the obturator foramen into their respective
obturator internus muscles bilaterally. The ischial spines were palpated
approximately 1 centimeter proximal to the previously placed posterior
trocars. The anterior trocars were then placed leaving the probes which
were placed through the eyelets. The eyelets were pushed down against
the sacrospinous ligaments. The endopelvic fascia was attached to the
4 of 6
110-113
DATE
PROVIDER
OCCURRENCE/TREATMENT
PDF REF
lateral endopelvic fascia with simple stitch of 0 Vicryl and underneath the
bladder with simple stitches of 0 Vicryl. Dr. Mould then did a SPARC
procedure and cystoscopy and ureteroscopy. The vaginal mucosa was closed
with running interlocking 2-0 chromic. Vaginal depth was 10 centimeters. A
vaginal pack soaked in gentamicin and Premarin cream was placed, The
patient was placed in supine position, awakened, extubated and returned to the
recovery room in satisfactory condition, having tolerated the procedure well.
Operative Report: [David L. Mould, M.D.]
Procedure:
 Cystourethroscopy.
 Bilateral ureteroscopy.
 Dilation of mild left ureteral narrowing with placement of SPARC
sling.
12/07/2009
12/18/2009
Procedure Details:
When I arrived, the patient was already in the lithotomy position. She was
prepped and draped in the usual sterile fashion. The scope was advanced into
the bladder using camera guided vision. Cystoscopy was negative. It was
advanced into the right ureter, which was clear. It was advanced into the
left. There was mild narrowing. This was dilated. There was no evidence
of proximal pathology. The scope was removed and the catheter
reinserted. Two small stab wounds were made in the anterior abdominal
wall, and a periurethral dissection was carried out. SPARC needles were
advanced through these stab wounds onto the operative field. Once again, 108-109
a formal cystoscopy was performed, and it was negative. The scope was
removed, the catheter reinserted, sling placed and properly tensioned. The
residual portion of the sling was removed, the anterior vaginal wall was
closed in the usual fashion. A sterile dressing was applied. A pack was
placed. She was taken out of the lithotomy position. Anesthesia was
reversed. She was brought to the recovery room in good condition.
283
Progress Notes:
Patient comes in two weeks status post vaginal reconstruction and sling with
Dr. Mould. Complains of rectal itching, loose bowels and self cathing. She’s
not having any leakage of urine. She’s discussed but is unclear. She’s had
some fecal incontinence; small pellet type that’s occurred three times. She has
good sphincter tone. Sitting clown in the tub a week or so ago she tore her
perineum and this is somewhat tender. She does have to do some self cathing
however, residual today in the office was less than 100 cc. She has excellent
anterior-posterior apical supporters. There’s a small separation of the
perineum. Have her do the Sitz baths four times a day, use a topical
anesthetic gel as needed for pain. She started telling me about milk of
magnesia; I told her I didn’t want her taking any laxatives. I think she
understood this but she has excellent vaginal and rectal sphincter tone.
Urinalysis is negative. I’m going to place her on Uroxatral 10 mg a day for
two weeks and I want to see her back in two weeks and have her see Dr.
Mould next week as well continue on this plan.
283
Telephone Encounter:
Patient called. Complains of going to restroom, having spotting with change
5 of 6
DATE
12/21/2009
01/26/2010
02/24/2010
PROVIDER
OCCURRENCE/TREATMENT
of activity. Had kind of heavy spotting and has had to slow down since and
states she has appointment on Monday. Patient states she does not feel dizzy,
short of breath, denies fever and denies redness; she feels fine, just had heavy
spotting.
Progress Notes:
Patient comes in still having difficulty emptying her bladder; complains her
bladder stays full. Still taking Uroxatral for few days; was actually starting to
void but she’s still having residuals of 300 cc. I don’t want her to have
intercourse. She had some spotting; there is no evidence of any area that’s not
feeling well. She has excellent anterior-posterior apical support, good UV
angle, doesn’t palpate being high. We went over the importance of using her
Uroxatral. She is going to see Dr. Mould and me back on January 6th and
Estrogen cream three times a week quarter of an applicator. No
intercourse otherwise full activities and we’ll follow-up with her at that time.
Urinalysis was negative today. If her retention continues, we might have to
release the sling but we’ll both evaluate her.
Follow-Up Visit: [David L. Mould, M.D.]
Patient presents once again with difficulty in urinating. She had a post-void
residual which was 127 cc. We have placed her back on a trial of
Uroxatral. I have recommended that she continue intermittent
catheterization. If she is unable to void in the next couple of weeks, she
does want her sling removed.
Progress Notes:
Patient comes in two weeks from incision of mid urethral sling. She’s voiding
well having no leakage sleeping through the night. Has been in self cathing
primarily; it sounds like habits more than anything else. She is feeling well.
Her Colporrhaphy is well-healed. She’s using the Estrogen cream three times a
week quarter of an applicator. We’re going to have her continue that. No limits
on her activity except still no intercourse. I want to see her back in two weeks.
She’s going to return to work on Monday.
_______________________________________________________________
Follow-Up Visit: [David L. Mould, M.D.]
Patient presents to the office for follow-up. She is very happy and is doing
very, very well. She is voiding well, feels like she voids to completion, and
is totally continent. She had presented me with papers from her lawyer to fill
out regarding Dr. Miller and Dr. Diamond; I will review these. In the
meantime, she is to return to me on an as-needed basis.
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