Table 2.
Mesh Characteristics That May Influence Number of Reports Per Mesh Product and Adverse Events
| Approved or Introduced | Withdrawn | Reports (n) | Time on Market (days)a | Weight (g/m2)17–20 | Stiffness (N/mm)b | Porosity (%) or pore size (μm) | Cut/Sealedc | |
|---|---|---|---|---|---|---|---|---|
|
| ||||||||
| Transvaginal Prolapse Mesh Products | ||||||||
|
| ||||||||
| Prolift Family | 6334 | 4277d | ||||||
| Prolift | 03/01/2005 | 08/15/2012 | 2724 | 42 | 0.29–1.37 | 62% | ||
| Prolift+M | 05/15/2008 | 08/15/2012 | 1328 | 28 | 0.01–0.24 | 67% | ||
|
| ||||||||
| Uphold | 12/13/2012 | 04/16/2019 | 2027 | 2315 | 25 | 0.2 | 72% | |
|
| ||||||||
| Avaulta Family | 1115 | 3878 | ||||||
| Avaulta Solo | 03/12/2007 | 07/02/2012 | 1939 | 18 | 0.16 | 75% | ||
| Avaulta Plus/Biosynthetic | 03/12/2007 | 07/02/2012 | 1939 | 100 | ||||
|
| ||||||||
| Perigeee | 05/17/2004 | 01/03/2012 | 723 | 2787 | ||||
|
| ||||||||
| Exair | 05/08/2009 | 01/07/2014 | 26 | 1705 | 19 | 0.072 | 67% | |
|
| ||||||||
| Ascend | 03/31/2009 | 10/15/2012 | 5 | 1294 | 33 | 0.72–1.66 | 51% | |
|
| ||||||||
| Sacrocolpopexy Mesh Products | ||||||||
|
| ||||||||
| Gynecare Gynemesh | 01/08/2002 | 2056 | 6291 | 42 | 0.3–0.45 | 62% | ||
|
| ||||||||
| Restorelle | 08/04/2009 | 1168 | 3526 | 19 | 0.16–0.41 | 78% | ||
|
| ||||||||
| Upsylon | 12/18/2012 | 64 | 2294 | 25 | 0.2 | 72% | ||
|
| ||||||||
| Artisyn | 06/11/2012 | 31 | 2484 | 28 | 0.08–0.49 | 68% | ||
|
| ||||||||
| Midurethral Sling Mesh Products | ||||||||
|
| ||||||||
| Gynecare Obturator | 12/08/2013 | 11604 | 1939 | 100 | 0.09–2.0 | 54% | Laser or Mechanical | |
|
| ||||||||
| Gynecare TVT Combined | 10/26/2001 | 5444 | 6365 | 100 | 0.09–2.0 | 54% | Laser or Mechanical | |
|
| ||||||||
| Advantage Fit Blue | 12/20/2017 | 1063 | 466 | 100 | 0.05–1.9 | 58% | Mechanical; Heat Sealed | |
|
| ||||||||
| Desara Blueg | 09/23/2013 | 673 | 2015 | 103 | 0.23–2.23 | 33% | Heat Sealed | |
|
| ||||||||
| Gynecare TVT Exact | 03/16/2010 | 667 | 3302 | 100 | 0.09 | 1379 μm | Laser cut | |
|
| ||||||||
| Solyx | 12/20/2017 | 552 | 466 | 100 | 0.05–1.9 | 58% | Heat sealed | |
|
| ||||||||
| Gynecare TVT Abbrevo | 07/01/2010 | 437 | 3195 | 100 | 0.09 | 1379 μm | Laser cut | |
|
| ||||||||
| Altis | 11/05/2012 | 362 | 2337 | 70 | 1.5 | 375 μm | Heat sealed | |
|
| ||||||||
| Supris | 06/04/2011 | 86 | 2857 | 70 | 1.5 | 375 μm | Heat sealed | |
|
| ||||||||
| Aris | 03/09/2005 | 48 | 5135 | 70 | 1.5 | 375 μm | Heat sealed | |
Time on market was calculated through 3/31/2019, which was when this analysis was performed. Withdraw dates are from the manufacturer or FDA.
Stiffness is given as a range from low stiffness to high stiffness when mechanical testing throughout the stiffness curve is available. Lowest reported stiffness was used for linear regression in order to ensure comparable comparisons across meshes.
Cut technique and heat sealing has been shown to significantly influence stiffness for midurethral slings.
Cumulative days on the market were used for mesh families.
Information on Perigee was not available, despite contacting Boston Scientific, as it was manufactured by AMS but was not included in the company purchase.