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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Hernia (2240); Impaired Healing (2378); Post Operative Wound Infection (2446); Swelling/ Edema (4577)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 any of the 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 any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-00828, 2210968-2022-00829, and 2210968-2022-00830.Citation: ann plast surg 2021;87: 542¿546.

Event Description

It was reported in a journal article with title: the plane of mesh placement does not impact abdominal donor site complications in microsurgical breast reconstruction.The purpose of this retrospective study was to analyze donor site complications related to the position of mesh placement in patients undergoing breast reconstruction with muscle-sparing transverse rectus abdominis myocutaneous (ms-tram) flaps or deep inferior epigastric perforator (diep) flaps.Between 2014 and 2018, a total of 312 female patients underwent the procedure.They had different flap types and different mesh positions including overlay (n = 90), inlay and overlay (i-o; n = 134), and sublay (n = 88) with a mean age of 52.9 years, 49.9 years and 51.3 years respectively.In patients who received mesh in an inlay and overlay (i-o) position, the first piece of mesh was anchored to the abdominal wall bilaterally with interrupted 0-ethibond (ethicon, sommerville, nj) sutures.The entire abdomen was then reinforced with a second piece of polypropylene mesh in an overlay position, which was secured with interrupted and running polydioxanone (pds) (ethicon) sutures.When mesh was placed in an underlay position, the anterior rectus sheath was closed over the mesh with 1-0 pds (ethicon) interrupted sutures.In patients who received overlay mesh only, the anterior rectus sheath was closed with 0-vicryl (ethicon), followed by 1-0 prolene (ethicon), and the mesh was secured with 2-0 pds sutures.Patients used the polypropylene mesh (prolene; johnson & johnson, new brunswick, nj).Overlay: (n=13) abdominal complications, (n=4) hernia, (n=2) bulge, (n=1) wound dehiscence, (n=3) wound infection, (n=1) delayed wound healing, i-o: (n=18) abdominal complications, (n=3) hernia, (n=4) bulge, (n=4) wound dehiscence, (n=3) wound infection, (n=1) skin necrosis, (n=2) hematoma.Sublay: (n=9) abdominal complications, (n=2) hernia, (n=2) wound infection, (n=3) skin necrosis.Our data indicate that the plane of synthetic mesh placement in relation to the rectus abdominis muscle does not impact the rate of postoperative donor site complications in patients undergoing breast reconstruction with ms-tram or diep flaps.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, 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 Key: 13559839
• MDR Text Key: 290452182
• Report Number: 2210968-2022-01176
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• 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: 01/20/2022
• 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