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FDA calling for new safety studies of vaginal mesh

A surge in the number of reports of complications in women due to surgical mesh implants is prompting a call for new safety studies. The U.S. Food and Drug Administration in Washington says it wants to make sure that the mesh is safe after seeing a rise in the number of complaints about fabric erosion and infection.

Vaginal mesh is either synthetic or biological mesh commonly implanted in women to shore up weakened internal tissue. It's often used to remedy pelvic organ prolapse in which organs begin to squeeze into the vagina. It is also used to help ease incontinence from overactive bladders. In recent years there has been an uptick in reported personal injury from mesh deteriorating into the vagina or causing bleeding and infection.

In July, the FDA issued a warning about the mesh saying that it may be more dangerous to patients than other traditionally used remedies. More recently, the agency said that it's received more than 1,500 reports of mesh problems between 2008 and 2010. That's more than five times the rate of troubles reported from 2005 to 2007.

This week, regulators informed 35 manufacturers of mesh, including Boston Scientific and Johnson & Johnson, that it wants a formal three-year study done on thousands of women to find out how severe the side effects are and to assess whether mesh is really better than some other treatments at improving women's quality of life.

The FDA has also received recommendations that clinical trials be made mandatory before giving mesh products for sale, something that isn't required now.

Surgical mesh has been around for decades. It started being used in the 1950s to repair abdominal hernias. In the 1990s, use of the mesh expanded to treat POP and incontinence and the surgical implants have continued on the rise since.

As reported problems have begun to mount, so have the number of lawsuits over transvaginal mesh. One attorney representing a number of women plaintiffs says mesh devices have been allowed on the market without serious testing and he hopes the suits will change that.

Source: Reuters, "FDA wants new studies on surgical mesh implants," Anna Yukhananov, Jan. 5, 2012

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