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

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Peritonitis (2252); Post Operative Wound Infection (2446); Hematuria (2558); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: int urogynecol j.2008; 19: 1415-1422.Doi: 10.1007/s00192-008-0657-0.(b)(4).

Event Description

It was reported via journal article title: "laparoscopic sacrocolpopexy for uterine and post-hysterectomy prolapse: anatomical results, quality of life and perioperative outcome¿a prospective study with 101 cases." authors: dimitri sarlos, sonja brandner, lavonne kots, nicolle gygax, gabriel schaer.Citation: int urogynecol j.2008; 19: 1415-1422.Doi: 10.1007/s00192-008-0657-0.The authors prospective study evaluates laparoscopic sacrocolpopexy for vaginal vault prolapse focusing on perioperative data, objective anatomical results using the pelvic organ prolapse quantification (pop-q) system and postoperative quality of life using the kings health questionnaire.A total of 101 patients (age: 36 to 81 years old; bmi: 19 to 38) completed the study.Fifty five patients had laparoscopic supracervical hysterectomy and sacrocolpopexy for uterine prolapse, 46 patients had laparoscopic sacrocolpopexy for post-hysterectomy prolapse, it was also reported that 30 patients in the study groups had concurrent suburethral sling (tvt-o [ethicon]) procedure because of urinary stress incontinence.During the procedure, anteriorly, the vesico-vaginal fascia was dissected up to the lower third of the vagina just below the trigonum of the bladder.Two separate gynemesh mesh (ethicon) a macro porous multifilament polypropylene mesh, were used for the anterior and posterior compartment.All fixations were performed by laparoscopic suturing using ethibond 2-0 sutures (ethicon) with extra corporal knotting technique.At the end of the procedure, a tvt-o suburethral sling (ethicon), was placed under the mid-urethra when urodynamically proven concomitant stress urinary incontinence was present.Reported complications included severe adhesions (n-1) which required conversion to laparotomy, septical peritonitis (n-1) which required laparotomy with flushing and drainage and a sigmoidostomy.The mesh was excised during the revision laparotomy.Post-operatively, the patient did well, bladder lesion (n-4) which required laparoscopic repair and foley catheter insertion for 7 days after surgery, dysuria and hematuria due to mesh erosion (n-1) which required laparoscopic cystotomy with partial resection of the anterior mesh and bladder repair, post-operative voiding dysfunction (n-8) which required suprapubic drainage and 2 patients needed transection of the suburethral slings, mechanical ileus (n-1) which required laparotomy, adhesiolysis, and bowel segment resection , urinary tract infection (n-17), wound infection at trocar site insertion (n-1), de novo stress incontinence (n-24) which required a secondary tvt or tvt-o procedure in 15 patients and managed conservatively with physiotherapy, de novo urge incontinence (n-2) which were treated medically and disappeared at 6 months follow-up visit, de novo dyspareunia (n-1), recurrence in the posterior compartment (n-2), and recurrence in the anterior vaginal wall (n-6) which required vaginal prolapse surgery with an isolated prolift vaginal mesh augmentation of the anterior wall.It was concluded that the laparoscopic sacrocolpopexy with or without supracervical hysterectomy is a feasible and reproducible procedure with high subjective and objective cure rates, with very low rates of vaginal mesh erosions and de-novo dyspareunia in the short time follow-up.

• 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.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7969700
• MDR Text Key: 123864521
• Report Number: 2210968-2018-76560
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• 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: 09/24/2018
• 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
• Treatment: ETHIBOND SUTURE
• Patient Outcome(s): Required Intervention