The Food and Drug Administration "fast-tracked" the approval process for vaginal mesh products through its 510(k) system. Because the products were similar to existing products, manufacturers were not required to conduct clinical trials. After hundreds of complaints from injured consumers, the agency has directed the manufacturers to study the devices' safety and effectiveness for the next three years.

The failure rate of the devices has added to mounting criticism of the 510(k) system as well as the products. Injured women have filed more than 650 lawsuits against manufacturers. The FDA itself issued a report last summer about the adverse effects of vaginal mesh. The data showed that the devices were linked to greatly increased health risks, including death, injuries and malfunctions.

Without human trials, the manufacturers have put the products into the marketplace without any data to back up their claims of safety and effectiveness. As one patient advocate and mesh recipient said, "It's all been marketing."

In September 2011, an advisory panel urged the FDA to reclassify mesh used to treat some conditions as "high-risk" devices that require human testing. The agency has neither agreed nor disagreed. Nor has agency leadership responded to the growing cries to recall the devices.

The agency sticks to its argument that more data is needed before they take any further steps. According to one agency official, some researchers believe that the devices may be appropriate in some circumstances but not in others. That's why more research is needed -- the agency wants "to make sure the right women use it at the right time," he explained.

Continued in our next post.

Source: BusinessWeek.com, "J&J, C.R. Bard Must Study Safety of Vaginal Mesh, FDA Says," Alex Nussbaum and David Voreacos, Jan. 10, 2012