MAUDE Adverse Event Report: ETHICON INC. GYNECARE UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problems Malposition of Device (2616); Material Protrusion/Extrusion (2979); Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Urinary Tract Infection (2120); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Doi: 10.1097/spv.0b013e3182175da6.(b)(4).

Event Description

It was reported via journal article: "title: prospective clinical assessment of the transvaginal mesh technique for treatment of pelvic organ prolapse v5-year results" author: dennis miller, md,* vincent lucente, md,þ elizabeth babin, md, patricia beach, mba, ma, peter jones, msc, bsc, and david robinson, md.Doi: 10.1097/spv.0b013e3182175da6.The objective of the study was to assess the effectiveness and complication rates for the transvaginal (tvm) technique in the treatment of pelvic organ prolapse (pop).A total of 85 women (age: 61.6 years; bmi: 28.45) with symptomatic pop (pop-q stage iiyiv) were invited to participate in this institutional review board approved 5-year study at 3 us centers.The tvm technique comprised placement of gynecare gynemesh ps mesh (ethicon), cut using a template to replicate the correct size and shape.The anterior component was inserted between the bladder and the vagina and secured bilaterally by 2 arms through each obturator foramen, using an emmet-like needle.The posterior component was placed between the rectum and the vagina and secured by 1 arm passing through each ischiorectal fossa and sacrospinous ligament.The intermediate section corresponding to the vaginal apex separated the anterior and posterior parts.At 1 year post-operative, reported complications included stage 1 pop recurrence (n-30), stage 2 pop recurrence (n-8), and stage 4 pop recurrence (n-1).At 3 years post-operative, reported complications included stage 1 pop recurrence (n-22), stage 2 pop recurrence (n-14), and stage 3 pop recurrence (n-1).At 5 years post-operative, reported complications included stage 1 pop recurrence (n-20) and stage 2 pop recurrence (n-10).It was reported that by 5 years, a total of 5 patients had required intervention for recurrent prolapse.Two patients underwent re-operation in a treated compartment.One who had an anterior tvm had a sacral colpopexy, whereas the other who had a total tvm repair underwent a traditional anterior and posterior vaginal wall repair by a different surgeon.The other 3 reinterventions were anterior tvms failing in the untreated compartment and leading to posterior vaginal wall repairs.Other complications included mesh exposure (n-16) which required partial excision of the exposed mesh (n-8) and urinary tract infection (n-11) in which all were resolved.This is the first long-term study on the tvm technique, indicating that the technique offers durable anatomic support, although no unexpected late complications were observed.These long-term anatomic, functional, and safety data will be helpful when counseling patients regarding the outcomes of similar mesh procedures to treat pop.

• Brand Name: GYNECARE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7746309
• MDR Text Key: 115900204
• Report Number: 2210968-2018-74871
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2018
• 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