MAUDE Adverse Event Report: ETHICON INC. GYNECARE UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Citation: int urogynecol j.2008; 19: 827¿831.Doi: 10.1007/s00192-007-0537-z.(b)(4).

Event Description

It was reported via journal article: "title: bacteriological analysis of meshes removed for complications after surgical management of urinary incontinence or pelvic organ prolapse" authors: loïc boulanger, malik boukerrou, chrystèle rubod, pierre collinet, a.Fruchard, rené j.Courcol, michel cosson citation: int urogynecol j.2008; 19: 827¿831.Doi: 10.1007/s00192-007-0537-z.The aim of this study was to examine the role of bacterial infection in complications following surgical management of urinary incontinence and genital prolapse using meshes.A total of 16 prostheses (age range: 30 to 72 years old) were removed between november 2005 and july 2006 after treatment if either urinary incontinence or genital prolapse.Of which, 6 women with genital prolapse were treated by vaginal mesh procedure with anterior and posterior prosthesis: 4 patients by total vaginal mesh (tvm) using gynecare gynemesh soft mesh (ethicon), 1 patient by polypropylene mesh collagen coated ugytex and 1 patient by polyester mesh collagen coated cousin.One patient had only an anterior tvm and 1 patient had only 1 posterior tvm using gynecare gynemesh soft mesh.Two (2) patients had laparoscopic sacrocolpopexy with mersuture polyester prostheses (ethicon).Four (4) patients had suburethral slings; 3 patients with silicone-coated polyester and 1 patient with thermoformed polypropylene and central silicone core.The last 2 patients had transobturator mid-urethral slings with knitted prolene soft mesh (ethicon).Reported complications included patient 1 (gynecare gynemesh soft mesh) with anterior vaginal retraction and bacterial colonization of coagulase-negative staphylococcus, patient 2 (gynecare gynemesh soft mesh) with vaginal erosion and bacterial colonization of streptococcus salivarius, patient 3 (gynecare gynemesh soft mesh) with vaginal erosion and bacterial colonization of strepto agalactiae and propionibacterium acnes, patient 4 (gynecare gynemesh soft mesh) with perirectal infected hematoma and bacterial colonization of proteus mirabilis and coagulase-negative staphylococcus, patient 5 (gynecare gynemesh soft mesh) with fornix erosion and perirectal retraction and bacterial colonization of staphylococcus warneri, patient 6 (gynecare gynemesh soft mesh) with vaginal erosion and bacterial colonization of enterococcus faecalis, patient 7 (prolene soft mesh) with uretrovaginal fistula and bacterial colonization of streptococcus gordonii, patient 8 (prolene soft mesh) with bacterial colonization of strepto agalactiae, patient 15 (mersuture polyester prostheses) with vaginal erosion and bacterial colonization of strepto anginosus and prevotella corporis, and patient 16 (mersuture polyester prostheses) with vaginal erosion and bacterial colonization of strepto constellatus.It was reported that the isolated bacteria responsible for prosthetic infections in the excised mesh segment in this study were mainly resident and transient skin germs or bacteria of the vaginal flora.It may happen post-operatively as the vaginal flora comes in contact with the mesh prior to complete re-approximation of the vaginal mucosal closure.Bacterial colonization is an important consideration after mesh-augmented surgical repair of vaginal prolapse, and its exact role must be explored by other experimental studies.

• Brand Name: GYNECARE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7757284
• MDR Text Key: 116256481
• Report Number: 2210968-2018-74974
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention