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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Not Applicable (3189)

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.No specific patient information regarding events has been provided.If further details are received at the later date a supplemental medwatch will be sent.(b)(4).

Event Description

Title: a study on the effect of tension-free vaginal mesh surgery on urinary function and quality of life for female patients suffering from pelvic organ prolapse.The aim of this report was to evaluate the effects of the perioperative results, the lower urinary tract symptoms before and after the surgery, and the urination function and quality of life (qol) for the patients whom the authors' have been able to observe for over half a year.From october 2007 to september 2009, anatomical evaluation in 51 patients (average age 65.3 years [range 52-78]; average bmi 25.7 kg/m2 [range 21.8-31.1 kg/m2]) by pelvic organ prolapse-quantification (pop-q) degree of sexual depression ("piercing of 1 cm of mouth") or more, were performed at the hospital with the same surgeon doing tension-free vaginal mesh (tvm) surgery.During the procedure, a 25 x 25 cm proline soft mesh gynemesh ps (johnson and johnson co., (b)(4)) was cut using a prolift type paper pattern.For bladder cancer, a mesh was inserted between the cavity wall bladders, and the four mesh legs adhering to the main body were fixed through the pelvic fascia vein and closing hole tvm-anterior (tvm-a ) was enforced.For rectal cancer, a mesh was similarly inserted between the cavity wall and rectum, and two mesh legs were fixed to the sacral ligament.The post-operative mesh exposure was experienced in 2 cases (3.9%).In one case, the mesh which was exposed under local anesthesia was excised and the cavity wall was re-stitched, and the other example was "nimble only by the tri methylamine oral".There were 2 cases (3.9%) of post-operative pop recurrence which were admitted.These were determined to be difficult to heal and were cured by adding tvm-p surgery after the cavity-type simple hysterectomy.In conclusion, the short median recovery rate of tvm surgery for pelvic organ prolapse was good and improvement effect on lower urinary tract symptoms, micturition function and quality of life was good.It seems necessary to evaluate a wide range of therapeutic effects including not only anatomical treatment effect but also urination and sexual function over the long term in the future.

• 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.-SAN LORENZO PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7500366
• MDR Text Key: 107785435
• Report Number: 2210968-2018-72693
• Device Sequence Number: 1
• Product Code: OTO
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• 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: 04/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention