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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Injury (2348); Blood Loss (2597); 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.Adverse events regarding prolift mesh submitted via (b)(4).Adverse events regarding pds suture submitted via 2210968-2020-04062.Citation: pelviperineology 2009; 28: 82-88.(b)(4).

Event Description

Title: pelvic organ prolapse repair with prolift® mesh: a prospective study this paper describes a prospective cohort study using monofilament polypropylene mesh kits (gynecare prolift®, ethicon, somerville, nj, usa) for the management of vaginal prolapse over the first year of implantation including complications, anatomical success rates and functional outcomes using longitudinal quality of life (qol) data.Between jul2005 and jun2007, 64 women underwent transvaginal pelvic floor repair using anterior mesh (n=14; mean ± sd age of 62.4±9.1 years; mean ± sd bmi of 25.5±4.0), posterior mesh (n=27; mean ± sd age of 62.4±9.0 years; mean ± sd bmi of 26.4±43.1) and total mesh (n=23; mean ± sd age of 56.2±7.0 years; mean ± sd bmi of 26.2±3.3).In the procedure, tension free vaginal mesh kits for anterior, posterior or total repair were utilized according to the general manufacturer guidelines for gynecare prolift.There was minimal fixation of mesh at the bladder neck and the vaginal vault only with 2-0 polydioxone sutures (pds - ethicon).Low rectovaginal fascia defects were repaired with two layers of 2-0 pds.Intra-operatively, complications included bladder puncture with a transobturator trocar managed by trocar withdrawal and replacement, and significant haemorrhage of >500 ml from the obturator area requiring blood transfusion.Postoperative complications included short term urinary retention (n=1) of which patient was taught intermittent self-catheterization; mesh erosion (n=1 anterior mesh; n=1 posterior mesh; and n=1 total mesh) which were surgically excised in a day case setting; dyspareunia (n=2 anterior mesh and n=2 total mesh) of which 3 cases settled within the first six months of follow up and one patient required division of an arm anchored through the sacrospinous ligament of a total prolift ® mesh for relief; de novo stress urinary incontinence (n=2 total mesh) who underwent a subsequent successful suburethral tape surgery; de novo urgency (n=1 anterior mesh and n=3 posterior mesh) which were treated conservatively with exercises and anticholinergic therapy; and recurrent urinary tract infection (n=1 posterior mesh).For the anterior mesh at 6 months follow-up, 2 patients developed pop-q stage 2 cystocele of which one of these patients diagnosed with stage 2 rectocele.At 12 months, one patient developed stage 2 rectocele.For the posterior mesh at 6 months follow-up, 7 patients developed recurrent prolapse of the anterior compartment of whom 2 underwent successful anterior mesh repair.At 12 months, one patient developed de novo stage 2 rectocele and one patient developed de novo stage 2 cystocele.For total mesh at 6 months, 2 patients were diagnosed with recurrent cystocele.At 12 months, one patient had recurrent cystocele.The appearance of a new prolapse in a previously well supported compartment is an issue which occurs after all prolapse surgery whether conventional or using mesh.This finding seems to be comparable to what has been reported after sacrospinous colpopexy and, given that the mesh is fixed through the sacrospinous ligament bilaterally, may well be for the same reason.In the series, surgical complication rate directly related to the use of mesh placed with trocars was 3.1% (2/64) including one bladder piercing and one haemorrhage from the obturator area.This study confirms the intra-operative safety of the prolift® mesh kits for prolapse correction.Follow up at one year shows minimal serious morbidity, continued anatomical support and significant improvement in qol measures.

• 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
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10078969
• MDR Text Key: 191701459
• Report Number: 2210968-2020-04061
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• 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: 05/06/2020

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
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/21/2020
• 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