Table 1

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

Author and yearMesh interventionPublicationApproval date and 510(k)Time difference
(years)
1. Al-Nazer 2007GYNEMESH*PS, Gynecare, Ethicon, France). International Urogynecology Journal and Pelvic Floor Dysfunction 2007;18(Suppl 1):49–502002:
K013718
5 
2. Ali 2006 BGYNEMESH*PS International Urogynecology Journal and Pelvic Floor Dysfunction 2006;17(Suppl 2):2212002:
K013718
4 
3. Allahdin 2008Polyglactin (Vicryl) mesh Journal of Obstetrics and Gynaecology 2008;28(4):427–312005:
K051701
3 
4. Altman 2011Gynecare Prolift Anterior Pelvic Floor Repair System kit Neurourology and Urodynamics 2010;29:527–312008:
K071512
2 
5. Carey 2009Gynemesh PS; Ethicon BJOG 2009;116(10):1380–62002:
K013718
7 
6. da Silveira 2014Mesh repair (Prolift) International Urogynecology Journal 2015;3:335–422008:
K071512
7 
7. Delroy 2013Nazca TC International Urogynecology Journal 2013;24(11):1899–907Not approved
8. De Tayrac 2008The IVS Tunneller International Journal of Gynaecology and Obstetrics 2008;100(2):154–92001:
K010035
7 
9. De Tayrac 2013Ugytex, Sofradim International Urogynecology Journal 2013;24:1651–612004:
K033376
9 
10. Gupta 2014Low-weight, monofilament, macroporous, vicryl-polypropylene (VYPRO mesh) South African Journal of Obstetrics and Gynaecology 2014;20(3):47–502000:
K002672
14 
11. Halaska 2012Prolift; Gynecare/Ethicon Journal of Obstetrics and Gynecology 2012;207(301):e1-72008:
K071512
4 
12. Hviid 2010Pelvicol International Urogynecology Journal 2010;21(5):529–34 [39449]2003:
K081272
7 
13. Iglesia 2010Anterior prolift, modified anterior prolift with apical arms, or total prolift Obstetrics and Gynecology2010;116 (2 Pt 1):293–3032008:
K071512
2 
14. Lamblin 2014The Perigee International Urogynecology Journal 2014;25:961–702004:
K040623
10 
15. Maher 2011Gynecare Prolift Ethicon International Urogynecology Journal 2009;20 Suppl 2:S151-22008: K0715121 
16. Menefee 2011Polyform Neurourology and Urodynamics 2009;28(7):894–52005:
K051245
4 
17. Meschia 2004aIVS Tunneler* International Urogynecological Association, 2004 Aug 23–27, Paris. 2004.2001
K010035
18. Meschia 2007Pelvicol Neurourology and Urodynamics 2005;24 (5/6):587–82003:
K081272
2 
19. Natale 2010GYNECARE GYNEMESH Neurourology and Urodynamics 2005;24 (5/6):585–62002:
K013718
3 
20. Nguyen 2008Perigee Transobturator Prolapse Repair System Obstetrics and Gynecology 2008;111(4):891–82004:
K040623
4 
21. Nieminen 2008Parietene light, Sofradim Co. Obstetrics and Gynecology 2007;110 (2 pt 2):455–621999
K991400
9 
22. Paraiso 2006Unclear American Journal of Obstetrics and Gynecology 2006;195:1762–71
23. Qatawneh 2013Gynemesh, PS Gynecological Surgery 2013;10:79–852002:
K013718
11 
24. Rudnicki 2014Avaulta Plus—anterior biosynthetic mesh procedure BJOG 2014;121:102–112007:
K063712
7 
25. Sand 2001Polyglactin 910 mesh American Journal of Obstetrics and Gynecology 2001;184(7):1357–641996:
K955646
5 
26. Sivaslioglu 2008Sofradim Parietene International Urogynecology Journal 2008;19(4):467–711999:
K991400
9 
27. Svabik 2014Prolift Total Ultrasound in Obstetrics and Gynecology 2014;43(4):365–712008: K0715126 
28. Tamanini 2014Nazca TC device The Journal of Urology 2015;193(4):1298–304Not approved
29. Thijs 2010Perigee Urogynecology Journal and Pelvic Floor Dysfunction 2010;21 Suppl 1:S142-32004
K040623
6 
30. Turgal 2013Sofradim, Parieten European Journal of Obstetrics and Gynecology and Reproductive Biology 2013;170(2):555–8.1999:
K991400
14 
31. Vollebregt 2011Avaulta anterior system British Journal of Obstetrics and Gynaecology 2011;118(12):1518–272007:
K063712
4 
32. Weber 2001Polyglactin 910 mesh American Journal of Obstetrics and Gynecology 2001;185 (6 Pt 1):1299–3061996: K9556465 
33. Withagen 2011Prolift The Journal of Sexual Medicine 2011;8 (10):2944–532008:
K071512
3