TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

Report

Report Number: 2210968-2018-76156
Event Type: Injury
Date Received: September 28, 2018
Report Date: September 5, 2018
Manufacturer: ETHICON INC.
Product Code: OTN
PMA / PMN Number: K033568
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (TENSION FREE VAGINAL TAPE - ABBREVO AND TENSION FREE VAGINAL TAPE - OBTURATOR) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? CITATION: INT UROGYNECOL J (2015) 26:1509¿1516; DOI 10.1007/S00192-015-2723-8. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: POSTOPERATIVE GROIN PAIN AND SUCCESS RATES FOLLOWING TRANSOBTURATOR MIDURETHRAL SLING PLACEMENT: TVT ABBREVO® SYSTEM VERSUS TVT¿ OBTURATOR SYSTEM". AUTHOR(S): VIRGINIE CANEL & THIBAULT THUBERT & INGRID WIGNIOLLE & HERVÉ FERNANDEZ & XAVIER DEFFIEUX. CITATION: INT UROGYNECOL J (2015) 26:1509¿1516; DOI 10.1007/S00192-015-2723-8. THIS RETROSPECTIVE COMPARATIVE STUDY AIMED TO COMPARE THE RESULTS USING A ¿NEW¿ DEVICE EXPECTED TO REDUCE POSTOPERATIVE PAIN, THE TVT ABBREVO® SYSTEM (TVT-ABB), WITH THOSE USING THE TVT¿ OBTURATOR SYSTEM (TVT-O). FROM 2009 TO 2013, 100 FEMALE PATIENTS UNDERWENT TRANS-OBTURATOR MID-URETHRAL SLING PROCEDURE USING TVT-ABB (N=50; MEAN AGE SD OF 53.6 [9.6] YEARS) AND TVT-O (N=50; MEAN AGE SD OF 52.2 [9.9] YEARS). OPERATIVE COMPLICATIONS INCLUDED BLADDER INJURY (N=1 TVT-ABB GROUP) AND VAGINAL FORNIX INJURY (N=1 TVT-ABB GROUP, N=2 TVT-O GROUP). AT 6 WEEKS, COMPLICATIONS INCLUDED DE NOVO BLADDER OUTLET OBSTRUCTION (N=4 TVT-ABB GROUP, N=6 TVT-O GROUP), PERSISTENT URINARY STRESS INCONTINENCE N (N=4 TVT-ABB GROUP, N=6 TVT-O GROUP), URINARY URGENCY INCONTINENCE N (N=4 TVT-ABB GROUP, N=5 TVT-O GROUP), BLADDER OUTLET OBSTRUCTION N (N=15 TVT-ABB GROUP, N=15 TVT-O GROUP), PAIN VAS SCORE =20/100 N (N=3 TVT-ABB GROUP, N=7 TVT-O GROUP), VAGINAL PROSTHESIS EXPOSURE N (N=1 TVT-ABB GROUP, N=1 TVT-O GROUP) WHICH REQUIRED RE-INTERVENTION. AT 12 MONTHS, COMPLICATIONS INCLUDED PERSISTENT URINARY INCONTINENCE (N=4 TVT-ABB GROUP, N=5 TVT-O GROUP) TREATED WITH REOPERATION (N=3 TVT-ABB GROUP, N=5 TVT-O GROUP), URINARY URGENCY INCONTINENCE (N=3 TVT-ABB GROUP, N=7 TVT-O GROUP), OVERACTIVE BLADDER (N=9 TVT-ABB GROUP, N=14 TVT-O GROUP), DE NOVO DYSPAREUNIA (N=1 TVT-O GROUP), PAIN VAS SCORE =20/100 (N=1 TVT-ABB GROUP, N=4 TVT-O GROUP). PAIN INTENSITY WAS SIGNIFICANTLY LOWER WITH THE ¿¿DERIVED¿/¿MODIFIED¿ TVT-O THAN WITH THE ¿CLASSIC¿ TVT-O IMMEDIATELY AFTER SURGERY. A POSSIBLE REASON WHY TVT-ABB WAS ASSOCIATED WITH LESS PAIN IS THAT THE SHORTER INSIDE-OUT TO TAPE OF THE TVT-ABB TRAVERSES FEWER MUSCLE STRUCTURES THAN THE ORIGINAL TVT-O. THE DECREASE IN POSTOPERATIVE GROIN PAIN IN TVT-ABB PROCEDURE WAS ASSOCIATED WITH THE DEVICE, LENGTH OF THE SLING AND SURGICAL PLACEMENT TECHNIQUE. IN THIS STUDY, THE IMMEDIATE POSTOPERATIVE PAIN WAS SIGNIFICANTLY LESS WITH TVT-ABB THAN WITH TVT-O, BUT THERE WAS NO LONGER ANY DIFFERENCE AT 6 WEEKS AFTER SURGERY. THE PREVALENCE OF COMPLICATIONS AND THE SUCCESS RATES WERE SIMILAR AT 12 MONTHS AFTER SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
758450	TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD	MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL	OTN	ETHICON INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention