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

Catalog Number VYPROUNK

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

Patient Problems Wound Dehiscence (1154); Granuloma (1876); Hematoma (1884); Pain (1994); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)

Event Date 09/06/2020

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; doi: https://doi.Org/10.1007/s00268-020-05788-5.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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products (vypro mesh and vicryl 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 products involved? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Event related to vypro mesh reported via mw # 2210968-2021-02576.Event related to vicryl mesh reported via mw # 2210968-2021-02577.

Event Description

It was reported in a journal article with title: donor site morbidity of patients receiving vertical rectus abdominis myocutaneous flap for perineal, vaginal or inguinal reconstruction.The aim of this retrospective observational cohort study was to evaluate postoperative donor site morbidity and the incidence of incisional as well as parastomal hernia after vertical rectus abdominis musculotaneous (vram) flap reconstruction for inguinal, vaginal or perineal defects.Between january 2003 and september 2015, 192 patients were enrolled in the study.The patients were divided into four groups: closure of the donor-site with vypro meshes (male=76, female=41; median age=63.5 years, age range=29 ¿ 89 years; mean bmi=25.9 kg/m^2, bmi range=16 ¿ 42 kg/m^2), vicryl meshes (male=30, female=16; median age=63 years, age range=37 ¿ 84 years; mean bmi=24.4 kg/m^2, bmi range=17 ¿ 35.5 kg/m^2), primary closure (male=11, female=12; median age=64 years, age range=36 ¿ 79 years; mean bmi=23.6 kg/m^2, bmi range=16.0 ¿ 44.5 kg/m^2), and a different techniques/combination of meshes (male=4, female=2; median age=61 years, age range=36 ¿ 67 years; mean bmi=26.8 kg/m^2, bmi range=18 ¿ 32.7 kg/m^2).During the procedure, at the level of the resulting muscular defect above the arcuate line, the defect of the anterior rectus sheath is reconstructed by the following four techniques: primary closure of the abdominal wall, enforcement of abdominal fascia by vypro mesh (ethicon), vicryl mesh (ethicon) or different techniques.Primary closure means the conventional abdominal wound closure without any mesh implantation.Different techniques include the combination of a vypro and a vicryl mesh implantation in two patients and the use of polypropylene ¿ meshes in four patients.After subcutaneous closure, two suction drains were inserted and the skin is closed with a skin stapler.Reported complications needing conservative treatment for vypro mesh group included wound infection (n=3); seroma (n=4); hematoma (n=2); granuloma (n=1); chronical pain syndrome (n=1).Complications needing surgical treatment for vypro mesh group included wound infection (n=1); seroma (n=3); fascial dehiscence (n=1).Late complications included incisional hernia (n=7) which includes incisional hernia alone (n=5) and incisional hernia in combination with one parastomal hernia (n=2); parastomal hernia (n=16).Reported complications needing conservative treatment for vicryl mesh group included wound infection (n=5); seroma (n=4); hematoma (n=2).Complications needing surgical treatment for vicryl mesh group included wound infection (n=1); hematoma (n=1); fascial dehiscence (n=2).Late complications included incisional hernia (n=8) which includes incisional hernia alone (n=6) and incisional hernia in combination with one parastomal hernia (n=2); parastomal hernia (n=8).Reported complication needing conservative treatment for different techniques/combinations group included seroma (n=?).Complication needing surgical treatment for different techniques/combinations group included hematoma (n=?).In conclusion, the use of vypro mesh for donor site closure appears to be associated with a low postoperative incidence of complications and can therefore be recommended as a preferred technique.

• Brand Name: VYPRO MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11532071
• MDR Text Key: 241436413
• Report Number: 2210968-2021-02576
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K002672
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VYPROUNK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/19/2021
• 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