ObTape causes erosion problems at a much higher rate than competing products because the mesh weave is very tight, restricting tissue ingrowth. Click here to read about why ObTape has high levels of erosion. The FDA maintains the MAUDE voluntary database to keep track of related incidents. Click here to see more than 200 reported incidents to the FDA. It is estimated that only 1-10% of actual incidents are reported. Mentor ObTape did not undergo clinical trials prior to receiving approval from the FDA in 2003. Check here to see where Mentor incorrectly claimed that its product is “substantially equivalent in material, function, performance and design to the urethral support tape products manufactured and marketed by Johnson & Johnson.” The Johnson & Johnson product had a much wider mesh weave, and problems with it were relatively rare. http://www.fda.gov/cdrh/pdf3/k031767.pdf Please review the following links for more information on ObTape. - Complications Associated with TransObdurator Sling Procedures
- Mentor’s 2003 FDA Approval
- Johnson & Johnson announced on December 1, 2008 that it would acquire Mentor Corporation for $1.07 billion. Click here to view article from MarketWatch.
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