MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Hematoma (1884); Pain (1994); Urinary Tract Infection (2120); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/09/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device not returned.(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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Events related to vicryl single-buttress suture captured via 2210968-2021-04514 events related to tvt-o mesh captured via 2210968-2021-04516.Events related to tvt-secur captured via 2210968-2021-04517.Citations:int urogynecol j (2013) 24:645¿653 doi 10.1007/s00192-012-1895-8.

Event Description

Title: midurethral sling incision: indications and outcomes.The aim of this study was to identify indications for this type of surgical intervention and the impact of the surgery on resolving complications and the sui recurrence rate.A review was conducted of the medical records of women who underwent sling incision between 2003 and 2010.Data such as surgical indications, ultrasound findings and medical outcomes were extracted from 198 records, and descriptive and inferential statistical methods of analysis were used.The mean age of the women was 64 years (±12; range 36¿89 years) and a median weight of 72.8 kg (range, 52¿ 103) with a median body mass index (bmi) of 26.4 kg/m2 (range, 21¿38).The sling incision procedure was performed with the patient in the lithotomy position.In patients with sling exposure, the sling was localized visually and by palpation.Using information about sling position obtained from pelvic floor ultrasound, slings close to the urethra were then identified by intraurethrally palpating the sling edge with a charrière 21 to 24 bougie à boule.A tight sling with a stop cock mechanism was identified by withdrawing and rotating a no.5 to 7 hegar dilator through the urethra.After complete midline transection of the sling, the vaginal skin was closed with 3-0 vicryl single-buttress sutures (ethicon).Postoperative follow-up visits scheduled at 2-, 6- and 12- week intervals were done to assess the patient¿s condition regarding complications and sui.A total of 198 women were included in this retrospective review.The majority of the women had the sling insertion procedure at another institution.However, 95 women underwent tvt or tvt-o (ethicon, somerville, ma, usa) insertion at our center, which accounts for approximately 5.6 % (1,696) of the total number of tvt insertion procedures performed during this time period.The types of slings most frequently used in all patients were tvt and tvt-o.The remaining 7 % of the slings were distributed among monarc¿ (ams, minnetonka, mn, usa), serasis® (serag-wiessner kg, naila, germany),safyre (promedon, córdoba, argentina), sparc¿ (ams), tvt-secur¿, (ethicon), and miniarc (ams).Reported complications included small hematoma developed at the operative site in (n=13) and resolved spontaneously in all cases.The median length of hospitalization was 1.4 days.Voiding dysfunction, overactive bladder,recurrent urinary tract infections, dyspareunia was due to sling exposure into the vagina, chronic pelvic pain.In conclusion these findings indicate that sling incision can be highly successful in improving voiding dysfunction and dyspareunia, and moderately successful in curing overactive bladder and chronic pain.However, sui may recur in more than 60 % of the patients undergoing sling incision.Consequently, patients being considered for a sling incision procedure should be informed about this possible complication.

• Brand Name: TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11815860
• MDR Text Key: 264758444
• Report Number: 2210968-2021-04515
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/12/2021
• 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