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

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

Patient Problems Fistula (1862); Hematoma (1884); Unspecified Infection (1930); Nausea (1970); Pain (1994); Seroma (2069); Urinary Retention (2119); Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/04/2019

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: irish journal of medical science (1971 -) (2019) 188:13571362 https://doi.Org/10.1007/s11845-019-02012-9 ¿ 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 the ethicon product (physiomesh) 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 involved? patient demographics? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported in a journal article with title: laparoscopic ventral hernia repair with intraperitoneal onlay meshresults from a general surgical unit.This study aimed to review our experience with ipom in the repair of ventral hernia by a single surgical team.A total of 108 patients undergoing laparoscopic ipom for ventral hernia in a single surgical service from 01/01/2010 to 01/12/2016 were included.Following confirmation of peritoneal access, adhesiolysis was performed when required utilising a combination of sharp and blunt dissection.The necessity for adhesiolysis was variable as several procedures were performed for recurrent incisional hernias or for herniation following major abdominal surgery.Use of diathermy and ultrasonic scalpel was limited to minimise risk of iatrogenic intestinal injury.If required, the falciform ligament was taken down to facilitate adequate space for mesh placement in abdominal wall defect.The herniation was reduced in its entirety.Primary closure of the fascial defect was then performed with intra-abdominal suturing using nonabsorbable monofilament suture.The predominant suture material was endoknot¿ suture (ethicon), although nonabsorbable locking suture (v-lock by medtronic) was utilised in later cases.Adjuvant component separation was not performed.The mesh was placed intraperitoneally via the 10-mm camera port.Meshes included composite physiomesh" (ethicon, subsequently withdrawn) or parietex" (medtronic).A minimum overlap of 5 cm outside the sutured fascial defect was utilised to allow for mesh shrinkage.The mesh was secured with absorbable tacks in a double crown pattern (absorbatack" medtronic).Patients were discharged on the day of surgery.Eightyseven patients (80.5%) had repair using parietex"composite, a hydrocolloid-treated lightweight polyester mesh (medtronic.) the remainder were repaired with physiomesh", a composite polypropylene (ethicon).The mean operating time was 82.98 ¿ 33.5 min.Seventy-four (68.5%) of the patients were admitted on the day of surgery and stayed an average of 2.9 days (median 1 day with a range from 1 to 55 days).Patients were initially reviewed in the surgical outpatients department post-operatively with long-term follow-up achieved utilising a postal questionnaire.Nonresponders were surveyed by telephone.Any patient reporting difficulty was again recalled to the surgical outpatient department for re-examination.Reported complications included n=7 mild desaturation, n=8 acute post-operaitve pain, n=1 wound hematoma, n=3 nausea, n=2 ileus, n=3 urinary retention, n=1 post-operative infection, n=1 undetected enterotomy, n=1 seroma, n=1 enterocutaneous fistula and n=2 hernia recurrence.In conclusion, our experience in lvhr with ipom has shown that it can be safely and effectively used in a variety of hernia morphology and is suitable for large and recurrent hernias.Complication and recurrence rate was lower than open repair and comparable to other laparoscopic techniques for mesh repair.There is a need for longterm observational studies to assess for mesh complications well beyond a typical 5-year follow-up as mesh implantation is a life-long prosthetic device.

• Brand Name: PHYSIOMESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12148165
• MDR Text Key: 267746981
• Report Number: 2210968-2021-06205
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K093932
• 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: 06/11/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/10/2021
• 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