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. 2017 Dec 6;7(12):e017125. doi: 10.1136/bmjopen-2017-017125

Table 1.

Comparison of randomised controlled trial publication date of transvaginal mesh and date of US FDA approval

Author and year Mesh intervention Publication Approval date and 510(k) Time difference
(years)
1. Al-Nazer 2007 GYNEMESH*PS, Gynecare, Ethicon, France). International Urogynecology Journal and Pelvic Floor Dysfunction 2007;18(Suppl 1):49–50 2002:
K013718		 5 
2. Ali 2006 B GYNEMESH*PS International Urogynecology Journal and Pelvic Floor Dysfunction 2006;17(Suppl 2):221 2002:
K013718		 4 
3. Allahdin 2008 Polyglactin (Vicryl) mesh Journal of Obstetrics and Gynaecology 2008;28(4):427–31 2005:
K051701		 3 
4. Altman 2011 Gynecare Prolift Anterior Pelvic Floor Repair System kit Neurourology and Urodynamics 2010;29:527–31 2008:
K071512		 2 
5. Carey 2009 Gynemesh PS; Ethicon BJOG 2009;116(10):1380–6 2002:
K013718		 7 
6. da Silveira 2014 Mesh repair (Prolift) International Urogynecology Journal 2015;3:335–42 2008:
K071512		 7 
7. Delroy 2013 Nazca TC International Urogynecology Journal 2013;24(11):1899–907 Not approved
8. De Tayrac 2008 The IVS Tunneller International Journal of Gynaecology and Obstetrics 2008;100(2):154–9 2001:
K010035		 7 
9. De Tayrac 2013 Ugytex, Sofradim International Urogynecology Journal 2013;24:1651–61 2004:
K033376		 9 
10. Gupta 2014 Low-weight, monofilament, macroporous, vicryl-polypropylene (VYPRO mesh) South African Journal of Obstetrics and Gynaecology 2014;20(3):47–50 2000:
K002672		 14 
11. Halaska 2012 Prolift; Gynecare/Ethicon Journal of Obstetrics and Gynecology 2012;207(301):e1-7 2008:
K071512		 4 
12. Hviid 2010 Pelvicol International Urogynecology Journal 2010;21(5):529–34 [39449] 2003:
K081272		 7 
13. Iglesia 2010 Anterior prolift, modified anterior prolift with apical arms, or total prolift Obstetrics and Gynecology2010;116 (2 Pt 1):293–303 2008:
K071512		 2 
14. Lamblin 2014 The Perigee International Urogynecology Journal 2014;25:961–70 2004:
K040623		 10 
15. Maher 2011 Gynecare Prolift Ethicon International Urogynecology Journal 2009;20 Suppl 2:S151-2 2008: K071512 1 
16. Menefee 2011 Polyform Neurourology and Urodynamics 2009;28(7):894–5 2005:
K051245		 4 
17. Meschia 2004a IVS Tunneler* International Urogynecological Association, 2004 Aug 23–27, Paris. 2004. 2001
K010035
18. Meschia 2007 Pelvicol Neurourology and Urodynamics 2005;24 (5/6):587–8 2003:
K081272		 2 
19. Natale 2010 GYNECARE GYNEMESH Neurourology and Urodynamics 2005;24 (5/6):585–6 2002:
K013718		 3 
20. Nguyen 2008 Perigee Transobturator Prolapse Repair System Obstetrics and Gynecology 2008;111(4):891–8 2004:
K040623		 4 
21. Nieminen 2008 Parietene light, Sofradim Co. Obstetrics and Gynecology 2007;110 (2 pt 2):455–62 1999
K991400		 9 
22. Paraiso 2006 Unclear American Journal of Obstetrics and Gynecology 2006;195:1762–71
23. Qatawneh 2013 Gynemesh, PS Gynecological Surgery 2013;10:79–85 2002:
K013718		 11 
24. Rudnicki 2014 Avaulta Plus—anterior biosynthetic mesh procedure BJOG 2014;121:102–11 2007:
K063712		 7 
25. Sand 2001 Polyglactin 910 mesh American Journal of Obstetrics and Gynecology 2001;184(7):1357–64 1996:
K955646		 5 
26. Sivaslioglu 2008 Sofradim Parietene International Urogynecology Journal 2008;19(4):467–71 1999:
K991400		 9 
27. Svabik 2014 Prolift Total Ultrasound in Obstetrics and Gynecology 2014;43(4):365–71 2008: K071512 6 
28. Tamanini 2014 Nazca TC device The Journal of Urology 2015;193(4):1298–304 Not approved
29. Thijs 2010 Perigee Urogynecology Journal and Pelvic Floor Dysfunction 2010;21 Suppl 1:S142-3 2004
K040623		 6 
30. Turgal 2013 Sofradim, Parieten European Journal of Obstetrics and Gynecology and Reproductive Biology 2013;170(2):555–8. 1999:
K991400		 14 
31. Vollebregt 2011 Avaulta anterior system British Journal of Obstetrics and Gynaecology 2011;118(12):1518–27 2007:
K063712		 4 
32. Weber 2001 Polyglactin 910 mesh American Journal of Obstetrics and Gynecology 2001;185 (6 Pt 1):1299–306 1996: K955646 5 
33. Withagen 2011 Prolift The Journal of Sexual Medicine 2011;8 (10):2944–53 2008:
K071512		 3 

*Described as posterior IVS in abstract http://www.ics.org/Abstracts/Publish/41/000277.pdf.