MAUDE Adverse Event Report: ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problems Material Erosion (1214); Protective Measures Problem (3015)

Patient Problems Erosion (1750); Hematoma (1884); Incontinence (1928); Unspecified Infection (1930); Urinary Retention (2119); Not Applicable (3189)

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.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 products 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 products used in this procedure? citation: int urol nephrol (2015) 47:609¿615; doi 10.1007/s11255-015-0930-3.(b)(4).

Event Description

It was reported via journal article: title: "secondary surgery after vaginal prolapse repair with mesh is more common for stress incontinence and voiding dysfunction than for mesh problems or prolapse recurrence." author(s): jamie m.Bartley, larry t.Sirls, kim a.Killinger, judith a.Boura.Citation: int urol nephrol (2015) 47:609¿615; doi 10.1007/s11255-015-0930-3.The study aimed to report reoperation rates using the iuga/ics definitions and secondarily, to explore whether clinical or demographic risk factors were associated with the need for secondary surgery in women that had transvaginal prolapse repair with mesh.Between 2005 and 2011, 335 female patients (mean age was 67 ± 10 years [range 35¿89 years]) underwent vaginal prolapse repair with mesh using prolift (n=265) and elevate (n=70) of which 194 had an anterior repair, 48 had a posterior repair and 93 had anterior and posterior repair (total repair).There were two bladder injuries with the prolift trocar, both repaired and mesh was placed.Complications included recurrent prolapse at different site which required primary prolapse surgery (n=4), recurrent prolapse at same site which required repeat surgery (n=3), mesh exposure which required surgery (n=17), urethral prolapse which required surgery (n=1), groin sinus tract which required excision (n=1), granulation tissue which required cautery (n=2), urinary retention which required cutting of distal anterior compartment mesh (n=1), infected pelvic hematoma which required drainage (n=1), persistent stress urinary incontinence (n=20) treated with repeat sling (n=9) and urethra bulking agent (n=11), and urinary retention or obstructive voiding symptoms which required loosening of the string (n =21).Additional treatment of sling procedure and injection were administered on patients who did not have sui procedure at the time of prolapse.All of our patients that had recurrence were in the prolift group.Increased rates of sui retreatment, whether de novo or persistent, may be due to placement of the distal mesh anchors that limit bladder neck and urethral mobility.This may further alter the normal urethrovesical angle that contributes to the continence mechanism and may limit the dynamic kinking mechanism of action of the mid-urethral sling.Most reoperations were for sling management and sui; few were for mesh complications or prolapse recurrence.

• Brand Name: PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7903932
• MDR Text Key: 121566534
• Report Number: 2210968-2018-75966
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• 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: 08/30/2018
• 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