Complications due to gastric band surgery

Complications due to gastric band surgery
- BIORING and Literature rates Issue 1
TYPOLOGY
RATE (%)
BIORING AND ADHESIX
BIORING*
DEFINITION
RATE (%)
LITERATURE
REFERENCES
0.027%
0.7 % to 6.4 %
[2] ; [9] ; [15]
0.005%
1 % to 33 %
[1] ; [3] ; [7] ;
[8] ; [12] ; [13] ;
[14] ; [15]
0.029%
2.5 % to 7.1 %
[15] ; [16]
0.013%
0.4 % to 9.5 %
[4] ; [6] ; [8] ;
[10] ; [11] ;
[12] ; [13] ; [14]
BAND COMPLICATIONS
Band leakage
Band slippage
Band intolerance
Band erosion
Result from balloon or catheter puncture
or failure. Suspected when unexplained
loss of eating restriction occurs and when
there was insufficient filling volume with
consequent deflating of the band.
Confirmed by contrast radiography, with
contrast agent introduced through the
injection port.
Abnormal increase in stomach pouch
size that results in excessive volume
capacity that results in retain/regain
weight.
Diagnosed by contrast radiography.
Some patients’ bodies just can’t handle the band. After all, the band is a foreign
object in the human body. Band
intolerance includes vomiting excessively
or feeling uncomfortable all of the time.
Permanent removal of the band is
required in these cases.
Erosion
occurs
when
the
band
penetrates the stomach wall and enters
the stomach.
PORT COMPLICATIONS
Port
disconnection
Separation of the catheter from the
injection port resulting in band leakage.
0.011%
1.1 % to 6.9 %
Port (or catheter)
leakage
Leakage from the injection port of the
fluid used to inflate the gastric band
0.040 %
0.6 % to 10.4 %
Port site infection
Infection of the implanted subcutaneous
access port.
0.027%
0.39 % to 9 %
[1] ; [5] ; [8] ;
[12] ; [16]
[1] ; [5] ; [6] ;
[11] ; [12] ; [14]
; [16]
[1] ; [5] ; [10] ;
[11] ; [12] ;
[13] ; [16]
* Complication rate of BIORING and ADHESIX BIORING gastric band compared to the amount of
product sold.
-
Literature References :
[1] Obes Surg. 2004 Mar;14(3):407-14. « Complications after laparoscopic adjustable gastric banding for
morbid obesity: experience with 1,000 patients over 7 years. »
Chevallier JM, Zinzindohoué F, Douard R, Blanche JP, Berta JL, Altman JJ, Cugnenc PH.
Departments of Digestive Surgery and Nutrition, Hopital Européen Georges Pompidou, 20-40 rue Leblanc,
75908 Paris cedex 15, France.
[2] Obes Surg. 2009 Dec;19(12):1636-41. « Results and complications after Swedish adjustable gastric
banding-10 years experience. »
Mittermair RP, Obermüller S, Perathoner A, Sieb M, Aigner F, Margreiter R.
Department of Surgery, Medical University Innsbruck, Anichstrasse 35, A-6020 Innsbruck, Austria.
Ref.: Literature rates, gastric bands
Date: August 2013
Page: 1 / 3
Headquarters: 8, rue de l’Abbé Bonpain - 59117 Wervicq-Sud – France Tel +33 (0) 3 20 14 41 19 - Fax +33 (0) 3 20 14 40 13
Factory: Allée des roses - 59117 Wervicq-Sud – France Tel +33 (0) 3 20 14 41 20 - Fax +33 (0) 3 20 14 40 45
www.cousin-biotech.com - e-mail [email protected]
Cousin Biotech SAS au capital de 320 000 € - NAF 1396Z- N° TVA FR 34 398 460 261 - Siren 398 460 261 RCS Lille
Complications due to gastric band surgery
- BIORING and Literature rates Issue 1
[3] Journal de Radiologie ; Vol 86, N° 12-C1 - décembre 2005 pp. 1763-1772. « Traitement de l’obésité morbide par anneau gastrique ajustable : un suivi clinique et radiologique ».
M-A Pierredon-Foulongne (1), D Nocca (2), J-M Fabre (2), J-M Bruel (1), BP Gallix (1)
(1) Service d’Imagerie Médical,
(2) Service de Chirurgie Digestive, Hôpital Saint-Eloi, CHU Montpellier, 80 avenue Augustin.
[4] HAS / Service des bonnes pratiques professionnelles ; « Obésité : prise en charge chirurgicale chez
l’adulte. »
Le TEC a réalisé en 2007 une revue systématique des études contrôlées randomisées ou non ayant comparé
la morbidité précoce et tardive après AGAL et après BPGL
BlueCross BlueShield Association.- Laparoscopic adjustable gastric banding for morbid obesity. Tec Assess
Progr 2007;21(13).
[5] Obesity Surgery ; Volume 20, Number 4, 410-414, DOI: 10.1007/s11695-008-9561-4 Research Article. «
Injection Port and Connecting Tube Complications after Laparoscopic Adjustable Gastric Banding»
Ezio Lattuada, Marco Antonio Zappa, Enrico Mozzi, Ilaria Antonini, Paolo Boati and Gian Carlo Roviaro.
[6] The American Journal of Surgery. 2002 Dec;184(6B):46S-50S. «US experience with the LAP-BAND
system».
Ren CJ, Horgan S, Ponce J.
New York University School of Medicine, 530 First Avenue, Suite 105, New York 10016, USA.
[email protected]
[7] The Lap-Band® adjustable gastric banding system. Summary of safety and effectiveness data FDA, PMA
P000008.
[8] Summary of safety and effectiveness data FDA, PMA P070009.
[9] Obesity Surgery, Volume 13, Number 6, 913-917, DOI: 10.1381/096089203322618768 «Band Leakage
after Laparoscopic Adjustable Gastric Banding».
Reinhard P Mittermair, Helmut G Weiss, Hermann Nehoda, Regina Peer, Eveline Donnemiller, Roy Moncayo
and Franz Aigner.
[10] Obes Surg. 2003 Oct;13(5):776-9. « Outcome after laparoscopic adjustable gastric banding, using the
Lap-Band and the Héliogast band: a prospective randomized study ».
Blanco-Engert R, Weiner S, Pomhoff I, Matkowitz R, Weiner RA.
Division of Surgery, Rotes Kreuz Krankenhaus, Frankfurt am Main, Germany.
[11] Can J Surg, Vol 54, No. 1, February 2011. « Complications associated with adjustable gastric banding for
morbid obesity: a surgeon’s guide ».
I. Eid, MD, MRCS ; D. W. Birch, MSc, MD ; A. M. Sharma, MD ; V. Sherman, MD ; S. Karmali, MD.
[12] www.bariatric-surgery-source.com
« Lap Band Problems & Lap Band Complications ». Reviewed by: Nick Nicholson, MD. 02/22/2011.
[13] Post’U (2010) 55-70. « Les complications de la chirurgie bariatrique ».
Dr O. Emungania, Service de chirurgie générale, digestive et endocrinienne.
®
®
[14] LAP-BAND Adjustable Gastric Banding System with OMNIFORM Design. Directions for use (DFU).
[15] Obesity Surgery DOI 10.1007/s11695-008-9675-8, 28 August 2008. «Successful Multi-Intervention
Treatment of Severe Obesity: A 7-year Prospective Study with 96 % Follow-up».
R. Steffen , N. Potoczna, N. Bieri, F. Horber.
Ref.: Literature rates, gastric bands
Date: August 2013
Page: 2 / 3
Headquarters: 8, rue de l’Abbé Bonpain - 59117 Wervicq-Sud – France Tel +33 (0) 3 20 14 41 19 - Fax +33 (0) 3 20 14 40 13
Factory: Allée des roses - 59117 Wervicq-Sud – France Tel +33 (0) 3 20 14 41 20 - Fax +33 (0) 3 20 14 40 45
www.cousin-biotech.com - e-mail [email protected]
Cousin Biotech SAS au capital de 320 000 € - NAF 1396Z- N° TVA FR 34 398 460 261 - Siren 398 460 261 RCS Lille
Complications due to gastric band surgery
- BIORING and Literature rates Issue 1
[16] Obesity Surgery, 13, 404-411, 2003. « Laparoscopic Swedish Adjustable Gastric Banding: A Five-Year
Prospective Study ».
R. Steffen, MD ; L. Biertho, MD ; T. Ricklin, MD ; G. Piec, PhD ; F. Horber, MD.
OBEX – Institute, Hirslanden Clinic, Department of Surgery, Zurich and Berne, Swizerland.
Ref.: Literature rates, gastric bands
Date: August 2013
Page: 3 / 3
Headquarters: 8, rue de l’Abbé Bonpain - 59117 Wervicq-Sud – France Tel +33 (0) 3 20 14 41 19 - Fax +33 (0) 3 20 14 40 13
Factory: Allée des roses - 59117 Wervicq-Sud – France Tel +33 (0) 3 20 14 41 20 - Fax +33 (0) 3 20 14 40 45
www.cousin-biotech.com - e-mail [email protected]
Cousin Biotech SAS au capital de 320 000 € - NAF 1396Z- N° TVA FR 34 398 460 261 - Siren 398 460 261 RCS Lille