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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

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 used in this procedure? citation: taiwanese journal of obstetrics & gynecology.2017; 56: 346 352.Doi: http://dx.Doi.Org/10.1016/j.Tjog.2017.04.015.[(b)(4)].

Event Description

It was reported via journal article: "title: a 52-month follow-up on the transvaginal mesh surgery in vaginal cuff eversion" authors: tsia-shu lo a, b, c, *, faridah mohd yusoff d, e, chuan-chi kao a, sukanda jaili d, e, ma.Clarissa uy patrimonio.Citation: taiwanese journal of obstetrics & gynecology.2017; 56: 346 352.Doi: http://dx.Doi.Org/10.1016/j.Tjog.2017.04.015.Transvaginal mesh anterior-posterior (tvm-ap) provides better cure rates in the surgical treatment of vaginal cuff eversion than anterior transvaginal mesh combined with sacrospinous ligament fixation (tvm-a).The authors determine the outcomes after tvm-a and tvm-ap surgeries in advanced vaginal cuff prolapse.The charts of 97 women (mean age: 65.2 ± 9.5; bmi: 25.2 ± 3.4) who underwent pelvic organ prolapse (pop) surgery from july 2006 to january 2012 in chang gung memorial hospitals were reviewed.The authors included women who presented with advanced cuff eversion and treated with tvm surgery.Of which, 61 patients underwent tvm-a and 36 patients underwent tvm-ap insertion.In the tvm-ap procedure, prolift mesh (ethicon) was used.In the tvm-ap group, reported complications included pain (n-1) and recurrent pulsion enterocele (n-1).It was concluded that the tvm-ap surgery in cuff eversion is more beneficial objectively in the long-term.Tvm-ap showed better improvement in the posterior compartment with only 3 cases of recurrent cuff eversion which were successfully treated conservatively.The cure rate of tvm-a was still acceptably good with the benefits of reduced risks and morbidities.

• 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; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7848209
• MDR Text Key: 119326575
• Report Number: 2210968-2018-75643
• 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,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2018

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: 08/20/2018
• Initial Date FDA Received: 09/05/2018
• 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