PMID- 20031943
OWN - NLM
STAT- MEDLINE
DCOM- 20100401
LR  - 20221207
IS  - 1553-3514 (Electronic)
IS  - 1553-3506 (Linking)
VI  - 16
IP  - 4
DP  - 2009 Dec
TI  - Major complications associated with xenograft biologic mesh implantation in 
      abdominal wall reconstruction.
PG  - 324-9
LID - 10.1177/1553350609353609 [doi]
AB  - BACKGROUND: There is limited research for xenograft biologic mesh performance in 
      the setting of infection despite widespread use and significant associated costs. 
      DESIGN: The authors retrospectively reviewed an FDA database for reported 
      xenograft adverse events (AEs). All meshes were used in the setting of abdominal 
      wall reconstruction from 1997 to 2008. RESULTS: The authors identified 150 AEs. 
      Permacol and Collamend comprised 75% (n = 112) of reported cases. Main AEs 
      included acute mechanical failure (42%; n = 63), mesh disintegration (32%; n = 
      48), and poor mesh integration (13%; n = 20); 80% of cases were described as 
      infected, and nearly 90% of AEs required reoperation. CONCLUSIONS: Major 
      complications are reported to the FDA for xenograft biologic meshes. Cross-linked 
      meshes had the most AE reports to the FDA. The intrinsic properties of meshes and 
      how they relate to infection-related outcomes are poorly understood. The findings 
      from this FDA database review point toward a need to carefully evaluate these 
      products.
FAU - Harth, Karem C
AU  - Harth KC
AD  - University Hospitals Case Medical Center, Case Western Reserve School of 
      Medicine, Cleveland, OH, USA.
FAU - Rosen, Michael J
AU  - Rosen MJ
LA  - eng
PT  - Journal Article
DEP - 20091222
PL  - United States
TA  - Surg Innov
JT  - Surgical innovation
JID - 101233809
SB  - IM
CIN - Surg Innov. 2010 Jun;17(2):170; author reply 171. PMID: 20504796
CIN - Surg Innov. 2010 Sep;17(3):273-5; author reply 276. PMID: 20513724
MH  - Abdominal Wall/*surgery
MH  - Humans
MH  - *Plastic Surgery Procedures
MH  - Retrospective Studies
MH  - Surgical Mesh/*adverse effects
MH  - Transplantation, Heterologous/*adverse effects
EDAT- 2009/12/25 06:00
MHDA- 2010/04/02 06:00
CRDT- 2009/12/25 06:00
PHST- 2009/12/25 06:00 [entrez]
PHST- 2009/12/25 06:00 [pubmed]
PHST- 2010/04/02 06:00 [medline]
AID - 1553350609353609 [pii]
AID - 10.1177/1553350609353609 [doi]
PST - ppublish
SO  - Surg Innov. 2009 Dec;16(4):324-9. doi: 10.1177/1553350609353609. Epub 2009 Dec 
      22.