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FDA & drug industry studies

Timely Insights on Laws, Issues and New Developements

Though the FDA  indicated in June 2011 that it sees no benefit for pelvic (transvaginal) mesh vs. traditional methods used in Pelvic Organ Prolapse (POP) repair, the agency has conversely announced that it does see advantages in using synthetic sling material for Stress Urinary Incontinence (SUI). The agency’s current position, however, is based on limited and perhaps even tainted data. It will take an enormous amount of research to sort through it all to get a true risk-benefit analysis and a clear safety profile of slings used for SUI.

In the FDA’s Executive Summary of Sept. 2011, the agency largely seems to agree with mesh makers’ data that show the sling effective for SUI compared with traditional repair.  However,  FDA looked mostly at industry backed studies which were designed by sling manufacturers and administered by sling maker employees or by doctors hired as consultants by sling manufacturers.

More than 6,000 cases – a combination of pelvic mesh material used to treat POP and synthetic slings used to treat SUI – have been filed in multi-district litigation court (MDL) since those studies which the FDA evaluated were done. It seems certain that the FDA had not yet considered all the thousands of those adverse events (presuming cases that were filed represent real mesh injuries), many of which were being filed as lawsuits just as the agency was reviewing the data.

The key point here is that the data is not static. The FDA may need to reevaluate its position entirely as new cases continue to pile up in big numbers since the FDA’s last review of drug-industry-sponsored research.


by Matthews & Associates

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