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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Hematoma (1884); Incontinence (1928)

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.To date no response has been provided.If further details are received at a 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 (prolene mesh, ethibond suture, prolene suture) 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 (prolene mesh, ethibond suture, prolene suture) used in this procedure? citation: int urogynecol j.2004; 15: 399¿406.Doi: 10.1007/s00192-004-1185-1.(b)(4).

Event Description

It was reported via journal article: title: "factors that affect recurrence after anterior colporrhaphy procedure reinforced with four-corner anchored polypropylene mesh," authors: m.J.Hung, z.S.Liu, p.S.Shen, g.D.Chen, l.Y.Lin, e.S.C.Ho, citation: int urogynecol j.2004; 15: 399¿406.Doi: 10.1007/s00192-004-1185-1.The purpose of this study was to evaluate the effectiveness of the anterior colporrhaphy procedure reinforced with four-corner anchored polypropylene mesh in patients with severe (stage iii or iv) anterior vaginal prolapse.A total of 38 consecutive women (age range: 33 to 80 years old; bmi: 19.4 to 35.0) were enlisted for this prospective study.The anterior colporrhaphy procedure reinforced with four-corner anchored polypropylene mesh was modified from the methods described by nicita.In brief, a self-fashioned prolene 10 × 10 cm mesh patch (ethicon) was prepared before the operation.The obturator internus fascia and the arcus tendinous fasciae pelvis were identified by palpation and then visually.Two ethibond 2-0 sutures (ethicon) were placed in the arcus tendinous fasciae pelvis in a helical fashion at the level of the bladder neck and just anterior to the ischial spine, respectively.The stability of the four sutures, which were anchored at the four corners of the bilateral arcus tendinous fasciae pelvis, was tested before they were left untied and held with kelly clamps.It was also reported that the strategy for management of concomitant stress incontinence in this study was that, for patients who were diagnosed preoperatively as having urodynamic stress incontinence, either overt or occult type, a prolene tvt (ethicon) procedure was performed.Reported complications included unsatisfactory result (n-5), de novo urodynamic stress incontinence (n-5), vaginal erosions of mesh (n-4), retropubic hematoma (n-1) which was closely monitored and complete resolution was noted at post-operative 3 months, and patient 5, a (b)(6) female patient with recurrence at 13 months post-operatively.It was reported that the identified risk factor for patient 5 was vaginal erosions of mesh (2 episodes at 4 months and 13 months post-operatively).In conclusion, the anterior colporrhaphy procedure reinforced with four-corner anchored polypropylene mesh was effective for most, but failed in some patients who had specific risk factors within short convalescence periods.Since there is a trend of increasing usage of artificial mesh in pelvic reconstructive surgeries, the mechanism of how patient characteristics (co-morbidities) affect the result of such a procedure should be further investigated in order to improve patient care.

• Brand Name: PROLENE POLYPROPYLENE MESH 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 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8345223
• MDR Text Key: 136342948
• Report Number: 2210968-2019-78920
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• 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: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• 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: 01/23/2019
• 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