The U.S. Food and Drug Administration (FDA) is looking at claims that Boston Scientific’s urogynecologic surgical mesh could contain counterfeit materials. The device maker has launched an investigation which is said likely to take months. In an announcement on its website, the FDA said there are allegations the mesh “may contain counterfeit raw material, and that health care professionals and their patients should be aware of this investigation.”
The company will begin conducting tests that will probably take months to complete. “The additional testing should be sufficient for the FDA to determine whether or not the urogynecologic surgical mesh manufactured from the alleged counterfeit raw material are equivalent to the urogynecologic surgical mesh manufactured from the original raw material supplier,” the FDA said. Surgical mesh is used to provide additional support when weakened or damaged tissue is being repaired. There have been tremendous problems caused to women by the mesh. As we have stated, there is a great deal of litigation.
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