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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Therapeutic Response, Decreased (2271); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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 involved? please confirm if the ¿failed cases¿ reported were due to the ethicon products mentioned.If yes, please specify what are those ¿failed cases¿ mentioned.Please specify what mesh(es) were used in prolift-a tvt mesh group? citation: arch gynecol obstet.2012; 285: 1593 1597.Doi: 10.1007/s00404-011-2200-7.(b)(4).

Event Description

It was reported via journal article: "title : a modified anterior compartment reconstruction and prolift-a for the treatment of anterior pelvic organ prolapse: a non-inferiority study." author: xiang yang ¿ huaifang li.Citation: arch gynecol obstet.2012; 285: 1593 1597.Doi: 10.1007/s00404-011-2200-7.The objectives of the study was to evaluate in terms of efficacy and safety a modified anterior compartment reconstruction procedure for anterior pelvic organ prolapse (pop).The patients were assigned to 2 groups according to their individual willingness and economical condition.Of which, 68 patients (age range: 63 to 76 years old; bmi: 23.52 ± 2.72) were treated with the modified procedure and 37 patients (age range: 66 to 74 years old; bmi: 24.29 ± 2.33) were treated with the ¿prolift-a¿ procedure.In the modified procedure, a single piece of monofilament macroporous gynemesh-soft ps mesh (ethicon) was tailed for anterior vaginal repair, which consisted of four arms and a joint portion.A prolift-a tvt mesh (ethicon) were used in the prolift-a group.In the modified procedure group, reported complications included failed cases (n-4) which required colpocleisis (n-1) and 3 patients altered to prolift-a procedure and mesh erosion (n-3) in which their mesh were removed.In the prolift-a group, reported complications included failed case (n-1) in which the patient refused reoperation and was conversed to the biofeedback therapy.It was concluded that both the modified total pelvic reconstruction and prolift-a procedures are safe, efficacious, and minimally invasive surgical treatments, while the modified procedure is relatively inexpensive, which has great perspective of clinical application in developing countries.

• 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: 7747152
• MDR Text Key: 115935340
• Report Number: 2210968-2018-74880
• Device Sequence Number: 1
• Product Code: OTO
• 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,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