In 2010 alone, manufacturers sold more than 300,000 vaginal mesh devices in this country. Physicians implanted the devices in women to treat incontinence or pelvic organ prolapse. The devices were approved by the Food and Drug Administration, but more than 600 women learned that FDA approval does not guarantee that a product is safe. Manufacturers did not test the devices on women before they sent them to market.

As we said in our last post, the FDA has asked vaginal mesh manufacturers to backtrack a bit and conduct clinical trials on the devices for three years. The FDA's own research has raised questions about the devices' effectiveness compared to other products. Consumer advocates and injured women have been raising questions about safety for some time.

Testing wasn't necessary because the products were closely related to an existing, FDA-approved product already on the market. According to Bloomberg News, though, some fast-track approvals were based on a mesh product that had been recalled in 1999.

The new study mandate falls short of a recall, much to the disappointment of a growing number of critics. In fact, critics accuse the FDA of dragging its feet to protect women but rushing products to market to placate the medical device industry.

Patient advocates hope that the mere fact of the clinical studies will warn women off the devices. One speculated that companies are going to find it difficult to recruit women for the studies -- they are already aware of the potential complications, so why would they sign up?

Few manufacturers have responded to the FDA's notice, much less to the press. A J&J representative said that its Ethicon devices are "already among the most studied devices on the market." He added that the company supports clinical trials.

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