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 Problem 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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.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: int j clin exp med 2018;11(5):4771-4778.[(b)(4)].

Event Description

It was reported in a journal article title : efficacy of pelvic floor reconstruction combined with pelvic floor rehabilitation instrument on mmp-7, timp-1 and pelvic floor dysfunction in women.The study aimed to investigate the efficacy of pelvic floor reconstruction combined with pelvic floor rehabilitation instrument on pelvic floor dysfunction (pfd) in women and on the expression of matrix metalloproteinase-7 (mmp-7), tissue inhibitor of metalloproteinase-1 (timp-1) in ligaments.From sep 2016 to oct 2017, 97 female patients with pfd were divided into two groups for treatment methods.In control group (n=48; average age of 59.78±13.45 years), the patients were treated by laparoscopic high uterosacral ligament suspension combined with pelvic floor rehabilitation instrument.In the study group (n=49; average age of 60.12±14.01 years), gynecare prolift pelvic floor repair system combined with pelvic floor rehabilitation instrument were used for the treatment of pfd.In the study group, 1 patient had relapse three months after the treatment and 2 patients had relapse six months after the treatment.The use of prolift system for pelvic floor reconstruction of pfd patients with postoperative follow-up more than 12 months could reach a high cure rate of 90-95%.The results indicated that pelvic floor reconstruction combined with pelvic floor rehabilitation instrument for the treatment of pfd could promote postoperative recovery and significantly improve pelvic floor muscle strength of patients.

• 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-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7836073
• MDR Text Key: 118870714
• Report Number: 2210968-2018-75558
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/15/2018

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: 08/15/2018
• Initial Date FDA Received: 08/30/2018
• 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