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

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

Patient Problems Unspecified Infection (1930); Seroma (2069); Obstruction/Occlusion (2422)

Event Date 03/04/2021

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: surgical endoscopy https://doi.Org/10.1007/s00464-021-08402-4.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 products (physiomesh, proceed 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? patient demographics? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Adverse events associated with the proceed mesh device reported via mw # 2210968-2021-06202.

Event Description

It was reported in a journal article with title: long-term outcomes and quality of life assessment after posterior component separation with transversus abdominis muscle release (tar).This prospective study aims to evaluate postoperative outcomes and long-term follow-up after transversus abdominis muscle release (tar) for incisional hernia repair.Between 2014 and 2019, 50 patients (30 males, 20 females) mean age was 65 (3583) years, underwent posterior component separation technique with transversus abdominis muscle release (pcs-tar).During surgery ,after transversus abdominis muscle release was completely performed, the posterior rectus sheath was closed with an absorbable running suture.If that was not possible, a synthetic absorbable mesh (polyglactin) was used to bridge the gap.Next, a flat piece of mesh was placed in a sublay fashion in the retromuscular space, achieving a complete reinforcement including a lateral overlap beyond tar.When mesh fixation was decided, transfascial stitches with buried knots and suturing to cooper ligaments were performed.Sublay mesh reinforcement was used in 46 patients, and a heavy-weight polypropylene mesh was the most common prosthesis utilized.In 4 patients, a synthetic absorbable mesh (polyglactin) was used to bridge the posterior sheath gap.Mid-weight macroporous polypropylene prosthesis were used in patients with bmi < 30 and contaminated procedures.A bio-synthetic mesh was used in dirty procedures or patients colonized with multiple-resistant bacteria (one case).Prosthesis used included physiomesh (ethicon) , proceed (ethicon) and other competitor's device.Follow-up was planned at day postoperative day 10, 30, 6 months, and 1 year and then annually.Reported complication included: thirty-day morbidity (n=12).Surgical site infections ,2 deep, 6 superficial, (n=8), that were successfully treated with wound opening and antibiotic therapy.Surgical site occurrences (sso), all of them seromas (n=3).One patient underwent an enterectomy and mesh removal due to small bowel obstruction with gangrene on postoperative day 5 (n=1).Clinical and imaging recurrence, after 28.2 ¿ 20.1 months of follow-up (n=2),one patient developed a midline hernia and the second patient developed a parastomal recurrence.It was concluded, that component separation technique with tar represents an effective treatment modality for complex incisional hernias.This procedure showed low morbidity, a significant improvement in qol, and low recurrence rates at long-term follow-up.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 08/05/2021.Additional information was requested and the following was obtained: 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 products (physiomesh, proceed 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? patient demographics? first, the cases were not previously reported to ethicon.Second, we do not believe that the products used in our work were related or contributed to any post-operative complication.Finally, we do not believe that there were any deficiency in the products used.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PHYSIOMESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12147990
• MDR Text Key: 267746059
• Report Number: 2210968-2021-06201
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• 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: 07/09/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 08/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention