MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

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

Patient Problems Wound Dehiscence (1154); Calcium Deposits/Calcification (1758); Hematoma (1884); Inflammation (1932); Pain (1994); Seroma (2069); Not Applicable (3189); No Code Available (3191)

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: yonsei med j 52(5):803-808, 2011; http://dx.Doi.Org/10.3349/ymj.2011.52.5.803 (b)(4).

Event Description

Title : results from over one year of follow-up for absorbable mesh insertion in partial mastectomy this retrospective study aimed to review the immediate and the long-term post-operative outcomes over a year after mesh insertion.From february 2008 to march 2009, a total of 34 breast cancer patients (mean age: 50.1 years, age range: 31-82 years, mean bmi: 23.8 kg/m2, bmi range: 20-28.8) were included in the study.The patients received partial mastectomy with axillary procedure, such as sentinel lymph node biopsy or axillary lymph node dissection, followed by insertion of absorbable mesh (polylactic 910, vicryl) (ethicon).To prevent adhesion between mesh and the tissue, the mesh is sealed up with oxidized regenerated cellulose (interceed) (ethicon).Complaints included persistent pain (n=2), skin contraction (n=2), repeated seroma formation (n=1).Three cases of serious complications occurred: because of recurrent mastitis (n=1) and because of wound dehiscence (n=2).In patients with serious complications, mesh removal was inevitable.During mammography, microcalcifications at the operation site suggesting fat necrosis were noted (n=3), increase in the number of microcalcifications (n=2).The other two patients presented with mass-like densities (fluid collection), and reticular density (foreign body shadow).In ultrasound examination, the most common findings were persistent fluid collection (n=6), including one case with organizing hematoma, fat necrosis (n=4), and a benign-looking mass at the operation site (n=1).In conclusion, absorbable mesh insertion has been established as a technically feasible, time-saving procedure after breast excision.

• Brand Name: VICRYL POLYGLACTIN 910 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.
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9549404
• MDR Text Key: 178625111
• Report Number: 2210968-2020-00096
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K810428
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• 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: 12/11/2019
• 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