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U.S. Department of Health and Human Services

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

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ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Seroma (2069); Insufficient Information (4580)
Event Date 02/01/2021
Event Type  Injury  
Event Description
Title: the 10-year experience with volume distribution mastopexy: a novel, safe, and efficient method for breast rejuvenation. This study presents a clinical experience with the volume distribution mastopexy technique over the past 10 years. Between 2010 and 2020, 50 patients (mean age of 41 years) operated on for mastopexy or contralateral symmetrization following breast reconstruction were included in the study. A vicryl mesh (ethicon) was used in the first 23 patients, and a mixed competitor¿s mesh was used in the following 27 patients. During the procedure, a 2-0 vicryl suture (ethicon) was used to anchor the central flap to the pectoralis fascia cephalad. If more projection is desired, the flap can be folded onto itself with plicating sutures using 2-0 vicryl suture (ethicon). Ultimately, the flap is wrapped and secured in place using a mesh that is fixed onto the fascia using 2-0 vicryl suture (ethicon). The areola is sutured using the interlocking purse-string technique. The vertical scar may then be closed using inverted figure-of-eight deep dermal boxing sutures using 3-0 vicryl suture (ethicon) to shorten it to 6 to 8 cm. Final closure is done using 3-0 and 4-0 monocryl (ethicon) for the vertical incision and the areola, leaving also a drain in the site. A surgical bra is recommended for the first 4 weeks. Sports and strenuous activities are avoided for 6 weeks. At an average of 18-month follow-up (range, 3 to 36 months), the sternal notch¿to-nipple distance and the lower pole distance were measured. The clinical follow-up was 3 years on average (range, 3 to 108 months). Complications include wound dehiscence (n
=
1) and persistent breast asymmetry with lateral fullness which required repeated mastopexy (n
=
1). In conclusion, the volume distribution mastopexy technique repositions the ptotic gland with a mesh to suspend the breast gland and to maintain the lifting effect. However, the synthetic mixed mesh proved to be significantly more effective in achieving this goal.
 
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. Does the surgeon believe that any of the ethicon products (vicryl mesh, vicryl suture, monocryl suture) 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 / events were submitted via 2210968-2022-02755 and 2210968-2022-02756. Citation: plast. Reconstr. Surg. , volume 148, pages 55-64, july 2021; doi: 10. 1097/prs. 0000000000008112.
 
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Brand NameVICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-GMBH
robert- koch strass1
norderstedt
GM
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key14140390
MDR Text Key289488784
Report Number2210968-2022-02754
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K810428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/19/2022 Patient Sequence Number: 1
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