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Mesh Manufacturers Must Test Safety
Serving Alabama, Mississippi & Florida including Mobile, Pascagoula, Gulfport, Biloxi & Pensacola
Thu, 01/05/2012
We learned yesterday that the Food and Drug Administration has written letters to 31 manufacturers of vaginal mesh implants, including Johnson & Johnson and C.R. Bard, telling them that they must conduct three years of trials on the safety and effectiveness of their products. Considering that these synthetic meshes have been on the market for years, most people would assume such testing had been done long ago. It wasn't. In fact, these products came on the market without ever having been tested in humans. Under the FDA's system, if a product is similar to one already on the market, it can be approved without thorough testing.
And it's because of the present FDA approval system and manufacturer neglect that we got to this point: An FDA report in July found a fivefold jump in deaths, injuries or malfunctions related to vaginal meshes and more than 650 lawsuits have now been filed against their manufacturers.
The letters sent to manufacturers asks for collected data on the results and potential complications of transvaginal procedures. Studies have found that the edges of the mesh fibers can constrict or cut into internal organs after they have been implanted. The FDA still hasn't made a decision whether to reclassify mesh used for pelvic procedures to a higher level of risk.
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