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FDA Issues New Warnings for Surgical Mesh Grafts

Posted on August 4th, 2011 No Comments

The United States Food and Drug Administration has issued new warnings for surgical mesh patches.

According to officials with the FDA, the risks of using mesh patches such as AlloDerm in pelvic organ prolapsed surgeries may outweigh the benefits. Risks include mesh erosion, pain, infection, bleeding, organ perforation from tools used in the placement of the mesh patch, and urinary problems. Additional surgeries and/or hospitalization may be needed to treat the complications or remove the mesh.

In 2010, there were at least 100,000 pelvic organ prolapsed repairs that used surgical mesh. About 75,000 of these were transvaginal. These are the only procedures that the new FDA warning applies to.

The agency first issued a safety communication in 2008 after they received reports of adverse events associated with mesh patches. Since that time, the number of adverse events has increased. The FDA will convene an outside panel of experts to meet in September and discuss the safety and effectiveness of surgical mesh patches.

Mesh patches are used in a variety of procedures, including hernia repair. If you have suffered a painful side effect after receiving a mesh graft such as AlloDerm, please contact the AlloDerm Attorneys of Williams Kherkher by calling 800-761-3187.

Tagged AlloDerm Defective Mesh Lawsuit, alloderm erosion attorneys, Alloderm erosion lawyers, hernia-patch lawsuit | Leave a comment

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