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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Micturition Urgency (1871); Hematoma (1884); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); 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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: none provided in the article (b)(4).

Event Description

Journal article title : prolift like (pl) surgery: a management option for severe pelvic organ prolapse (pop) in a public hospital in a developing country.The aim of this abstract was to present the authors¿ experience with this anchored arms-mesh surgery in a public hospital in a developing country and to report epidemiological features, type of surgery, surgical results, intraoperative - perioperative complications, postoperative recurrence, mesh erosion, subjective surgery satisfaction and quality of life (qol).The authors developed a prolift like technique with the prolift device parts but the mesh is made with gynemesh ps following the figure of the original prolift (anterior, posterior or total).Between the periods of january 2008 to december 2009, prolift like (pl) surgeries were performed in 88 female patients ages 42 to 79 years with mean body mass index (bmi) of 28.5 +/- 4.2.There were 13 recurrences reported under apl: 4 asymptomatic anterior pop, 1 asymptomatic hypertrophic cervix elongation not diagnosed in preoperative, 8 posterior (unaffected compartment) pop 2 of them symptomatic one undergo to ppl, 4 under tpl: 3 asymptomatic hypertrophic cervix elongation not diagnosed in preoperative and 1 uterine pop undergo to vaginal hysterectomy.Post -operative events were reported: 18 under apl; 1 pielonefritis, 6 de novo sui, 6 persistent sui or miccional urgency, 4 urinary infection, 1 perineal persistent pain; 1 under ppl: 1 vaginal hematoma drained spontaneously, 4 under tpl: 3 de novo sui, 1 painful retraction of posterior mesh.Mesh erosion was reported in 3 patients under apl and 3 patients under tpl.In conclusion, the ¿hand-made¿ pl allows the management of pop in public hospitals in developing countries, being important to maintain the standard of the original surgery.For this aim seems relevant to use gynemesh ps mesh, which determine low complication rates.It is plantable to apply this model in other developing countries as advanced techniques of managing 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.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7745823
• MDR Text Key: 115887927
• Report Number: 2210968-2018-74866
• 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,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• 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: 07/19/2018
• 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