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

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Erosion (1750); Hematoma (1884); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Therapeutic Response, Decreased (2271); Discomfort (2330); 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.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 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 involved? citation: scientific reports.2018; 8: 2829.Doi: 10.1038/s41598-018-21090-w.[(b)(4)].

Event Description

It was reported via journal article: "title: long term follow-up of transvaginal anatomical implant of mesh in pelvic organ prolapse".Authors: de-yi luo1,2, tong-xin yang1,2,3 & hong shen1,2.Citation: scientific reports.2018; 8: 2829.Doi: 10.1038/s41598-018-21090-w.Transvaginal mesh (tvm) is a minimally invasive but effective treatment for pelvic organ prolapse (pop).However, mesh exposure is a common and problematic complication after tvm.This study assessed the safety and long-term outcomes of tvm.A retrospective review was performed on the medical records of 175 consecutive patients (age: 64.5 ± 11.4; bmi: 23.1 ± 2.5) who underwent tvm with the anatomical implant technique for pelvic organ prolapse at our center from april 2007 to december 2012.The available tvm surgical kits were gynecare prolift a (ethicon; n-36), gynecare prolift t (ethicon; n-114), gynecare prolift p (ethicon; n-4), gynecare prosima a (ethicon; n-3), and gynecare prosima c (ethicon; n-18).The mesh was monofilament, type i and macroporous.All operations were performed by the experienced surgeon using the anatomical implant technique and the standard method of mesh insertion was based on the product¿s design.The mesh was positioned tension-free under the bladder and was fixed to the bladder neck and uterine isthmus with a prolene suture (ethicon) to support the uterus.Posterior implant placement was performed similarly to the anterior implant per the manufacturer¿s instructions.In all groups, reported complications included pelvic hematoma (n-1) which required conservative treatment and was cured, transvaginal incision delayed healing (n-2) which required conservative treatment (n-1) and re-suturing (n-1) and the transvaginal incision healed well, vaginal wall mesh exposure (n-2), bladder wall mesh exposure (n-1) which required holmium laser cystoscopy lithotripsy and removal of the foreign body, unusual vaginal discharge (n-4), urinary tract infection (n-3) which required oral antibiotics, chronic pain and discomfort (n-17) which required conservative treatment, and dyspareunia (n-2).In the gynecare prosima c group, reported complication included pop recurrence (n-1) which required asc 9 months after the initial surgery.The anatomical implant technique for correcting pop is feasible in tvm procedures, which lead to favorable subjective and objective outcomes with the lowest rates of mesh exposure in published data.Therefore, performing tvm operations with the appropriate technique could consider to be permitted.

• Brand Name: PROSIMA 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; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7870551
• MDR Text Key: 120098690
• Report Number: 2210968-2018-75804
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063562
• 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: 08/22/2018

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: 08/22/2018
• Initial Date FDA Received: 09/12/2018
• 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