Complications of transvaginal silicone-coated polyester synthetic mesh sling.
OBJECTIVE
To report a premarket multicenter trial to test the feasibility of a transvaginal silicone-coated polyester synthetic mesh sling in women with anatomic incontinence.


METHODS
Fifty-one patients in four centers underwent transvaginal placement of a silicone-coated polyester synthetic mesh sling (American Medical Systems) during an 8-month period. Of the 51 patients, 31 were part of a prospective institutional review board-approved feasibility trial in three centers funded by American Medical Systems (group 1) and 20 underwent implantation by a single surgeon and their data were retrospectively reviewed (group 2). The studies were done concomitantly, and all slings were fixed transvaginally with bone anchors. All patients in group 1 were followed up at 4 weeks, 6 months, and 1 year (as applicable) with repeat questionnaires, physical examinations, and pad tests.


RESULTS
In group 1, 20 patients completed 6 months of follow-up. Ten patients (32%) required a second surgical procedure at an average of 183 days (range 68 to 343) postoperatively. Eight patients (26%) had vaginal extrusion of the mesh, one (3%) required sling lysis, and one (3%) required sling removal because of infection. In group 2, 8 patients (40%) underwent sling removal for vaginal extrusion at a mean of 160 days (range 83 to 214).


CONCLUSIONS
Transvaginally placed silicone-coated mesh slings used for the treatment of urinary incontinence demonstrated an unacceptably high vaginal extrusion rate in this study. Once identified, this study was immediately terminated, and this product was not marketed for this application in the United States.
Govier
F E
FE
Virginia Mason Medical Center, Seattle, Washington 98111, USA. urofeg@vmmc.org
Kobashi
K C
KC
Kuznetsov
D D
DD
Comiter
C
C
Jones
P
P
Dakil
S E
SE
James
R
R
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D011091:Polyesters; D011446:Prospective Studies; D019736:Prostheses and Implants / Q000009:adverse effects*; D012189:Retrospective Studies; D013526:Surgical Mesh / Q000009:adverse effects*; D014549:Urinary Incontinence / Q000601:surgery*; D013520:Urologic Surgical Procedures / Q000379:methods
D011091:Polyesters