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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Hematoma (1884); Hemorrhage/Bleeding (1888); Inflammation (1932); Necrosis (1971); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Respiratory Failure (2484)
Event Date 10/10/2017
Event Type  Injury  
Manufacturer Narrative

Product complaint # (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: world j surg (2018) 42:974¿980 https://doi. Org/10. 1007/s00268-017-4268-0 please see article attached. 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 product (prolene mesh) 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 product (prolene mesh) used in this procedure? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Patient demographics: please provide the reason/cause of death in the 6 patients prior to examination? were these death events attributed to the ethicon product (prolene mesh) used in the procedures?.

 
Event Description

It was reported in a journal article with title: long-term follow-up of retromuscular incisional hernia repairs: recurrence and quality of life. This study aims to investigate the long-term qol as measured by the sf-36, recurrence rate and remaining complaints after midline incisional hernia repair (ihr) using a standardized rs procedure with a polypropylene mesh. Between 1998 and 2006 , a total of 301 patients with midline incisional repairs were identified, and 217 accepted participation. Of these, 103 attended a clinical examination. During the procedures, the retro-rectus space was covered with a heavyweight monofilament polypropylene mesh the dominant meshes used were surgiprotm (covidien), atrium mesh, and prolenetm (ethicon). Follow-up was 7 years until examination and 11 years to reassessment of medical records. Reported complications included : 6 patients died prior to examination (n=6), 26%, a recurrent incisional hernia was repaired (n=?). Re-operation within 30 days: for arterial bleeding from the rectus muscles (n=1), hematoma (n=1),umbilical skin necrosis (n=1). Reoperation within 90 days: for deep wound (mesh) infections (n=3) were treated with antibiotics dressing changes, and negative pressure wound therapy, small bowel obstruction in a parastomal hernia (n=1), migrant thrombophlebitis (n=1), and severe neuropathic pain (exploratory) (n=1). Abdominal wall complaints: monthly by 9. 4% (n=?), weekly by 4. 3% (n=?), and daily by 14. 5% (n=?) of the patients, a total of 9. 8% continued to use analgesics on a daily basis because of abdominal wall symptoms. Half of those who were definitely not satisfied suffered a recurrence, and all had chronic or intermittent pain in the operated area (n=?). Overall recurrence rate was 8. 1% (n = 17); 3. 3% (n = 6) were diagnosed via medical records; and 4. 8% (n = 11) were found at the clinical examination. One patient had a recurrent hernia and a second repair. Recurrences were identified in 7. 1% (n=?) after primary ihr and in 10. 9% (n=?) after recurrent ihr (p\0. 366). 12% were clavien¿dindo grade i postoperative complications (n=?) , 14% were clavien¿dindo grade ii postoperative complications, and 1% clavien¿dindo grade iiib postoperative complications. One patient suffered severe postoperative respiratory insufficiency and received a tracheostomy, spending 29 days in the intensive care unit. This was a clavien¿dindo grade iv complication. Mean (sd) vas pain score was 13 (22) mm around md (iqr) of 3 mm (0¿15 mm), and 87% 9 (n=?) scored 30 or less. Mean (sd) perceived fatigue and movement limitation vas scores were 10 (2) and 11 (2) mm, respectively, and 89 (n=?) and 86% (n=?), respectively, scored less than 30. It was concluded, that the retromuscular rs repair of midline incisional hernias has a low and acceptable recurrence rate in the long-term perspective and is equally efficient when treating recurrent incisional hernias. About one-third of diagnosed. Recurrences were reoperated, all without mesh removal. Patient satisfaction is high, provided chronic conditions, such as recurrence or pain, do not occur. Quality of life is reduced to a level similar to that experienced by patients with two chronic conditions.

 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11739573
MDR Text Key250954204
Report Number2210968-2021-03931
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeSW
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 03/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 04/28/2021 Patient Sequence Number: 1
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