GYNEMSH PS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for GYNEMSH PS manufactured by Ethicon, Inc..

Event Text Entries

[180775664] Mesh erosion; i had a partial hysterectomy due to a uterine prolapse in 2009. I had a laparoscopic sacrocolpopexy and a vaginal mid-ureteral sling with miniarc. The mesh used in my laparoscopic sacrocolpopexy was the gynemesh ps (ethicon of johnson and johnson). I have suffered complications for years: bladder issues (i am now on a daily medication for bladder control as well as painful sex, pain after sex, and a modified sex life). I was officially diagnosed with a mesh erosion in (b)(6) of 2019. Apparently, according to my medical records, i had mesh erosion in 2013. However, i was not counseled on this. I was told it was a normal part of the healing process. Last year my husband felt the mesh cut him during intercourse. This as well as the constant pain after intercourse led me back to the dr. I have seen 5 specialists since the surgery. It has been recommended that i have a surgery to attempt to repair the damaged area where the mesh erosion is located. But i have also been warned of the risks, the fact that it may be unsuccessful. Both devices are now off of the market. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093259
• MDR Report Key: 9751249
• Date Received: 2020-02-25
• Date of Report: 2020-02-23
• Date Added to Maude: 2020-02-25
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GYNEMSH PS
• Generic Name: MESH, SURGICAL, SYNTHETIC UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAPS
• Product Code: OTO
• Date Received: 2020-02-25
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ETHICON, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-02-25