The NWHN Testifies for the Use of Better Evidence at the FDA

By Tessa Ruff

In 2016, the FDA reclassified transvaginal mesh used to repair pelvic organ prolapse (POP) as a Class III device—the highest risk category—in response to over 20,000 adverse event reports during a three-year period alone. The NWHN actively fought for the change, which also should have required manufacturers to submit thorough, randomized safety and effectiveness studies before new mesh products could go on the market.

On February 12, 2019 the FDA met again regarding the safety and effectiveness of transvaginal surgical mesh. But this unusual recovening of the advisory committee was not to review the data submitted. Rather, it was to discuss the priorities of the FDA in its own review. The FDA appears to be considering weakening its already weak standards vaginal mesh approval: the studies submitted were not rigorous premarket approval studies but rather postmarket surveillance. Testifying on behalf of the NWHN, Executive Director Cindy Pearson noted, “The FDA decision to allow manufacturers to use post-market surveillance studies for pre-market approval may seem fair to companies that began clinical studies sometime between 2011 and 2016, but it is not fair to women who deserve the information from high-quality, controlled PMA studies.

In our testimony, the NWHN took the lead in getting to the heart of the questions the FDA poised to the advisory committee. The FDA explicitly asked the committee to discuss whether both subjective and objective outcomes are important for consideration. In other words, should women’s quality of life be considered? And how seriously should we be taking the reports of thousands of women?

These should never be questions that have to be asked. Women’s voices should be lifted up, and their experiences taken seriously. Women from all over the country came to make sure theirs were heard by the committee on Tuesday: stories of continuous complications, crippling pain, and countless surgeries.

In other words, should women’s quality of life be considered? And how seriously should we be taking the reports of thousands of women? These should never be questions that have to be asked.

Doctors don’t warn women about the risks, and they might not even know that they should be. The risks are hard to quantify, often occur years later, and are not taken seriously enough. Nevertheless, the committee continues to recommend the use of transvaginal surgical mesh for pelvic organ prolapse repair.

“We still don’t know how to tell women how likely a devastating outcome will be. Nothing that happened today gets us closer to that,” said Pearson.

 

Read the NWHN’s full testimony here.

 

Tessa Ruff is the NWHN Policy Fellow.