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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Urinary Retention (2119); Unspecified Tissue Injury (4559)

Event Date 12/08/2018

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.  the single complaint was reported with multiple events.There are no additional details regarding the additional events.  citation of article: j.Obstet.Gynaecol.Res.Vol.45, no.4: 915¿922, april 2019.Doi:10.1111/jog.13908.Event related to tension free vaginal tape - obturator reported via mw # 2210968-2021-05011.

Event Description

It was reported in a journal article with title: comparison between laparoscopic uterus/sacrocolpopexy and total pelvic floor reconstruction with vaginal mesh for the treatment of pelvic organ prolapse.The aim of this study was to compare total pelvic floor reconstruction with vaginal mesh (tvm) and laparoscopic uterus/sacrocolpopexy (lsc) for the treatment of pelvic organ prolapse (pop).Six hundred and seventy patients with pop stage 3 and 4 underwent lsc (n = 350) or tvm (n = 320) at the west china second hospital, sichuan university between january 2011 and december 2016.Retrospective analysis was done to compare the pop-q value before operation and 6 months, 5 years after operation, also compare the, patient global impression of change (pgi-c), pelvic floor distress inventory (pfdi-20) and pelvic floor impact questionnaire (pfiq-7).Patients were followed for a median 36 months.Thirty-five patients in the lsc and 37 in the tvm groups were lost to follow-up.For the lsc procedure, the polypropylene mesh was cut into a y shape (the anterior and posterior ends were fixed onto the anterior wall and posterior wall of the vaginal stump, respectively) or into a t shape (the mesh was wrapped around the uterine isthmus and sutured with cervical fascia, the long arm was fixed to anterior longitudinal ligament of sacrum with nonabsorbable suture without tension).For the tvm procedure, the operation followed the description by the tvm collaboration group published in 2004, and the prolift mesh (johnson & johnson) was used.Cervical resection was conducted simultaneously for patients concurrent with elongation of cervix, or tension-free trans-obturator vaginal tape surgery tvt-o (ethicon) was managed for the patients with stress urinary incontinence.The other corresponding operations were conducted for patients with concurrent other gynecological diseases.Reported complications included bladder injury (n=9), postoperative urinary retention(n=32), perineal pain (n=62), new onset urinary incontinence (n=45), new stress urinary incontinence (n=73), mesh exposure and erosion (n=16), postoperative recurrence(n=41) and reoperation (n=19).There were 27 patients in the tvm group with postoperative recurrence that was considered to be moderate to severe for 6 cases of prolapse in the anterior and posterior walls of vagina; 15 of them received secondary operation to remove the partial mesh and repair the anterior/posterior vaginal wall.Five of them underwent hysterectomy.Among 15 patients who received secondary repair operation, 10 underwent sacral colpopexy via the vagina and recovered well after operation.The patients with mesh exposure were treated with local trimming of mesh and estrogen ointment.In conclusion lsc showed no serious adverse events and led to higher postoperative satisfaction than tvm in selected patients.Nevertheless, treatment should be selected in accordance with the willingness and condition of each patient.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 06/27/2021.The following information was requested, but unavailable: were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that the ethicon products (tension free vaginal tape - obturator and prolift pelvic floor repair) 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? patient demographics? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11888591
• MDR Text Key: 266438782
• Report Number: 2210968-2021-05010
• 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
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 05/31/2021
• Supplement Dates FDA Received: 06/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention